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RHINADVILCAPS cold 16 capsules fast action
Over-the-counter medication

RHINADVILCAPS cold 16 capsules fast action

Brand : GlaxoSmithKline GlaxoSmithKline
€5.41 EXCL. VAT €5.95 INCL. VAT
Out of stock
Reference : 3400930122914
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RHINADVILCAPS cold 16 capsules fast action in our pharmacy bio, Comment on the advice of use and dosage with our partner Avis checked after your purchase.

RHINADVILCAPS cold 16 capsules fast action

RhinAdvil Caps Cold is a medicine that contains a nonsteroidal anti-inflammatory drug, which has analgesic properties, ibuprofen and a vasoconstrictor, pseudoephedrine hydrochloride.

Indications of RHINADVILCAPS cold 16 capsules fast action

RhinAdvil Caps Cold is used to treat the symptoms of colds and flu, including headache, fever, sore throat, pain, stuffy nose in adults and adolescents over the age of 15 years.

Advice for use and dosage

Adults and children over 15

The recommended dose is one capsule every 4 to 6 hours
For more intense symptoms, you can take 2 capsules at the same time
Do not exceed 6 capsules in 24 hours

Comment on the advice of use and dosage of RHINADVILCAPS cold 16 capsules fast action with our partner Avis checked after your purchase.

Composition

The active substances are:

Ibuprofen 200.00 mg
Pseudoephedrine Hydrochloride 30.00 mg

The other components are:

Liquid filling: potassium hydroxide, macrogol 600, purified water
Gelatin capsule: sorbitol E420, gelatin, black printing ink (Macrogol 400, polyvinyl phthalate acetate, propylene glycol, black iron oxide E172
Auxiliary manufacturing: soy lecithin in triglycerides

Precaution of use

Please consult the instructions

Do not take RHINADVIL:

Child and teenager under 15 years old.

Take care with RHINADVIL:

In high doses, greater than 6 tablets per day (1200 mg / day of ibuprofen and 180 mg / day of pseudoephedrine), this drug has anti-inflammatory properties and can cause sometimes serious disadvantages which are those observed with anti-inflammatory drugs. - inflammatory.
DO NOT LEAVE THIS MEDICINE NOR WITHIN THE SCOPE OR SIGHT OF CHILDREN.
In case of overdose or mistakenly taking a high dose, notify a doctor immediately.
It is imperative to strictly adhere to the dosage, the duration of treatment of 5 days, and contraindications.
Medications, such as RHINADVIL, may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke; the risk is more likely with high doses and long-term treatment; do not exceed the dose or duration of treatment (5 days).
If you have heart problems, if you have had a stroke, or if you think you may be at risk (eg, high blood pressure, diabetes, or high cholesterol, or if you smoke), before take this treatment you should talk to your doctor or pharmacist.

Due to the presence of sucrose, this drug should not be used in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucraseisomaltase deficiency (rare metabolic diseases.

Due to the presence of methyl and propyl parahydroxybenzoates (preservatives), possible allergic reactions or delayed allergy reaction may occur.

In case:
Purulent nasal discharge
Persistence of fever
Lack of improvement after 5 days of treatment,
CONSULT YOUR DOCTOR.

If you have to undergo anesthesia, stop the treatment beforehand and tell the anesthetist.
This medication contains a nonsteroidal anti-inflammatory drug, ibuprofen, and a vasoconstrictor, pseudoephedrine hydrochloride.
You should not take this medicine at the same time as other medicines containing nonsteroidal anti-inflammatory drugs and / or aspirin and / or pseudoephedrine.
Read the leaflets for other medicines you are taking carefully to make sure you are not taking nonsteroidal anti-inflammatory drugs and / or aspirin and / or pseudoephedrine.

Pregnancy and breast feeding :

Do not take RHINADVIL if you are pregnant or breastfeeding
If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine

Sportsmen:

Pseudoephedrine hydrochloride can induce a positive reaction of the tests performed during
doping controls.

Driving and using machines

In rare cases, taking this medicine may cause dizziness and visual disturbances.

Presentation of RHINADVILCAPS cold

1 box of 16 soft capsules

Our advice and expert advice in pharmacy

For warnings, precautions for use, composition, dosage, contraindications, please consult the instructions for use.

If your symptoms persist, consult your doctor.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Updated: 10/07/2018

Name of the drug

RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule

Ibuprofen / pseudoephedrine

framed

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Talk to your pharmacist for any advice or information.

· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or if you feel worse after 5 days

What does this booklet contain ?

1. What is RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule and in what cases is it used?

2. What you need to know before taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE 200 mg / 30 mg soft capsule?

3. How to take RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule?

4. What are the possible side effects?

5. How to store RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule?

6. Contents of the package and other information.

1. WHAT IS RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule AND WHAT IT IS USED FOR?

RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE contains 2 active ingredients: ibuprofen and pseudoephedrine.

· Ibuprofen belongs to a group of medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs). It helps to reduce the pain and lower a fever (high temperature).

· Pseudoephedrine belongs to a group of drugs called "vasoconstrictors". It helps clear the nasal passages and facilitates nasal decongestion.

RHINADVILCAPS COLUMN ibuprofen / pseudoephedrine is used to treat the symptoms of colds and flu, including headache, fever (high temperature), sore throat, pain, stuffy nose in adults and adolescents. over 15 years old.

Use this medication only if you have a stuffy nose, headache and fever. Do not use if you only have one of the symptoms listed above.

2. BEFORE YOU TAKE RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule?

Do not take RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule if:

· You are allergic to ibuprofen or pseudoephedrine or any of the components listed in section 6, or if you have ever had an allergic reaction to a similar drug in the past, such as aspirin / acetylsalicylic acid or other NSAIDs. Signs of an allergic reaction include rash, hives, itching, difficulty breathing, tightness of the chest, swelling of the mouth, face, lips, or tongue.

· you have had gastrointestinal problems after taking RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE, ibuprofen, aspirin / acetylsalicylic acid or other NSAIDs in the past, such as stomach ulcers, bleeding stomach or perforation

· you currently have a stomach ulcer or stomach bleeding

· you have severe liver or kidney problems

· you are pregnant or breastfeeding

· you are under 15 years old

· you have had an asthma attack after taking RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE, ibuprofen, aspirin / acetylsalicylic acid or other NSAIDs in the past

· you currently have a cerebral hemorrhage (bleeding in your brain), or any other sign of bleeding or a problem with your blood count,

· you have serious problems with your heart, including;

o severe heart failure

o severe or poorly balanced high blood pressure

o severe heart disease

o you have ever had a heart attack

· you have ever had a stroke

· you already had seizures

· you have systemic lupus erythematosus (SLE) - a condition that affects the immune system, causing joint pain, skin changes and other problems

· if you take:

o other medicines containing NSAIDs for pain relief such as ibuprofen

o or aspirin / acetylsalicylic acid.

o other medications to clean nasal passages by mouth (through the mouth) or nasally (through the nose), such as pseudoephedrine, phenylpropanolamine, phenylephrine or ephedrine

o a drug used to treat attention deficit hyperactivity disorder (ADHD) called methylphenidate

o medicines to treat depression called non-selective monoamine oxidase inhibitors (MAOIs) such as iproniazid, or if you took them in the last 14 days

· you have diabetes, thyroid problems or a tumor of the adrenal gland (called pheochromocytoma)

· you have glaucoma (high pressure in the eye)

· you have problems urinating, due to prostate problems or other causes.

Do not take RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE, if any of the above apply to you. If in doubt, talk to your doctor or pharmacist before taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE.

Warnings and precautions

Talk to your doctor or pharmacist before taking RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule if:

· you have heart problems including heart failure, angina pectoris (chest pain) or if you have had a heart attack, surgical bypass, peripheral arterial disease (poor circulation in the legs or feet due to narrowed arteries) or blocked) or any kind of stroke (including "mini-stroke" or transient ischemic attacks (TIA)).

· You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke, you have asthma - because of the risk of a seizure. asthma

· you have liver problems, kidney problems

· you have prostate problems

· you have problems with bleeding

· you have had gastrointestinal problems in the past, such as stomach ulcers, stomach bleeding, ulcerative colitis, Crohn's disease or hiatal hernia

· you have an overactive thyroid gland (hyperthyroidism)

· you have a personality disorder.

Pseudoephedrine can provoke a positive reaction during anti-doping tests. Do not take RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE if this may affect you

If any of the above applies to you or if you are not sure, talk to your doctor or pharmacist before taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE.

You should talk to your doctor if you do not feel better or if you feel worse after 5 days. In particular if:

· you have a runny nose of green or yellow color

· you have a high fever that persists.

Talk to a doctor if any of the above applies to you.

Cardiac Attack and Stroke

Anti-inflammatory / analgesic medications such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

The elderly

If you are a senior taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE, you are more likely to have side effects such as stomach bleeding or perforation (signs may include stomach pain and heartburn). ). It can put your life in danger. See "Undesirable effects to be monitored at the start of treatment" in section 4 for more information.

Children and adolescents

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE should not be used in children under 15 years of age.

Talk to your doctor or pharmacist before taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE if you are 15 to 18 years old and you are not drinking fluids or are dehydrated because of diarrhea or if you have an illness. The risk of kidney problems with RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE is higher in case of dehydration.

Other medicines and RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes nonprescription drugs and herbal medicines.

Do not take RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule if you are taking any of the following medicines:

· other medicines containing NSAIDs to relieve pain such as ibuprofen or aspirin / acetylsalicylic acid

· other medications to clear the nasal passages orally or nasally, such as pseudoephedrine, phenylpropanolamine, phenylephrine or ephedrine

· a drug used to treat attention deficit hyperactivity disorder (ADHD) called methylphenidate

· medicines to treat depression called non-selective monoamine oxidase inhibitors (MAOIs) such as iproniazid, or if you have taken them within the last 14 days.

Do not take RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE if any of the above apply to you. If in doubt, talk to your doctor or pharmacist before taking this medicine.

Tell your doctor or pharmacist before taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE 200 mg / 30 mg soft capsule if you are taking any of the following medicines:

RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE is not recommended for the following medications:

· medicines to treat depression called reversible inhibitors of monoamine oxidase A (RIMA) and selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine

· linezolid

· methylene blue

· bromocriptine, pergolide, lisuride, cabergoline, ergotamine or dihydroergotamine

· Anticoagulant medications (ie, which fluidify the blood / prevent the appearance of clots such as aspirin / acetylsalicylic acid, warfarin, ticlopidine)

· heparin when used to treat a blood clot

· lithium, when used to treat severe mood problems

· methotrexate at doses greater than 20 mg per week

· pemetrexed if you have kidney problems

· corticosteroids

Taking RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE with the following medications requires a warning. . Taking RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE may affect or may be affected by taking other medications. For example :

· drugs that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol), angiotensin II receptor antagonists (such as losartan), or diuretics

· methotrexate at doses less than 20 mg per week

· pemetrexed if you have normal kidney function

· medicines to treat depression called tricyclic antidepressants such as amitriptyline

· digoxin or quinidine used to treat heart problems

· ciclosporin or tacrolimus used after transplantation.

· Tell your doctor that you are taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE if you need anesthesia before an operation or procedure. Your doctor will ask you to stop taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE a few days before your anesthesia.

· You should also tell your anesthetist that you have taken RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE

The use of RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE with the following drugs should be taken into account:

· blood coagulation medications used to thin the blood, such as low-dose aspirin (75 mg / day or less), clopidogrel or ticlopidine

· potassium-sparing diuretics such as amiloride or spironolactone

· trimethoprim (antibiotic)

· iron-chelating substances such as deferasirox

· corticosteroids like prednisolone

· phenytoin used to treat epilepsy

· probenecid and sulfinpyrazone used to treat gout

· zidovudine used to treat HIV

· sulfonylureas such as gliclazide or glimepiride used to treat diabetes

· quinolone antibiotics such as ciprofloxacin

· ginkgo biloba

· heparin when used to prevent blood clots.

Some other drugs may also affect or be affected by RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE treatment. Therefore, you should always seek the advice of your doctor or pharmacist before using RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE together with other medicines.

RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule with food, drink and alcohol

Not applicable.

Pregnancy, lactation and fertility

Do not take RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE if you are pregnant or breastfeeding.

If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ibuprofen can affect the woman's ability to get pregnant. This effect is reversible when the treatment is stopped.

It is unlikely that ibuprofen, if used from time to time, will affect your chances of becoming pregnant. Talk to your doctor before taking this medicine if you have had problems getting pregnant in the past.

Driving and using machines

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE may cause dizziness, unusual headache, or vision or hearing problems, including audible or visual hallucinations. If this happens, do not drive, ride a bicycle, or use any tools or machines .

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule, contains sorbitol (E 420) of soy lecithin and potassium.

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE contains sorbitol (E 420), a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE contains soy lecithin. If you are allergic to peanut or soy, do not use this medicine.

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE contains 0.41 mmol of potassium per capsule. Take into account in patients with reduced renal function or patients on a low potassium diet.

3. HOW TO TAKE RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule?

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Adults and children over 15:

Dosage

· The recommended dose is one capsule every 4 to 6 hours.

· For more intense symptoms, you can take 2 capsules at the same time.

· Do not exceed 6 capsules in 24 hours.

Administration mode

Take the whole capsule (as is) with a large glass of water.

Duration of treatment

Do not take this medicine for more than 5 days.

· This medication should be used in the short term only, take the lowest dose for the shortest time needed to treat your symptoms.

· You must talk to a doctor if you do not feel better or if your symptoms worsen after 5 days. He will advise you on what to do.

If you take more RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE

200 mg / 30 mg, soft capsule that you should have or if children have accidentally taken the medicine, always contact a doctor or the nearest hospital for advice on the risk and advice on the measures to take.

Take the medicine with you.

Symptoms may include nausea, abdominal pain, vomiting (may contain traces of blood), headache, ringing in the ears, confusion and unsteady eye movements. In high doses, the following symptoms have been reported: drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems.

If you forget to take RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE:

Do not take a double dose to make up for the dose you have forgotten to take.

If you stop taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE

Not applicable.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest duration necessary to relieve symptoms.

The following side effects may occur with this medicine.

Stop taking RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule immediately and tell your doctor or pharmacist if you notice any of the following side effects:

Frequent: may affect up to 1 in 10 people:

· nausea

· bleeding from the stomach or intestine, signs include vomiting blood, blood in the stools, or black stools.

Uncommon: May affect up to 1 in 100 people:

· Severe headaches or headaches more painful than usual.

Very rare: Can affect up to 1 in 10,000 people:

· heart attack

· fast heartbeat or palpitations

· allergic reaction to RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE , signs include: rash, hives, itching, difficulty breathing, tightness of the chest, swelling of the mouth, face, lips or tongue

· bullous lesions on the skin or mucous membranes such as the inside of the mouth. The signs include a burning sensation, with redness, blisters and ulcers.

Frequency unknown:

· stroke

· behavioral problems such as: excitement, agitation, anxiety or nervousness.

Stop taking RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE immediately and tell your doctor or pharmacist if you notice any of the side effects listed above.

Adverse effects to monitor at the beginning of treatment

Tell your doctor or pharmacist if you have stomach problems such as stomach bleeding or perforation (signs may include stomach upset and heartburn) at the beginning of treatment with RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE . Older people may be more likely to have these adverse effects that may be life-threatening.

Other side effects

Tell your doctor or pharmacist if you experience any of the following side effects:

Frequent: may affect up to 1 in 10 people:

· indigestion, upset stomach, vomiting, diarrhea, constipation, flatulence.

Uncommon: May affect up to 1 in 100 people:

· stomach ulcer

· insomnia

· feeling drowsy or tired

· feeling dizzy or irritable

· sight problems

· persistent headaches

· hypersensitivity such as wheezing and difficulty breathing in patients who have ever had bronchial asthma or allergic disease.

Rare: Can affect up to 1 in 1,000 people:

· kidney problems

· ear buzz (tinnitus).

Very rare: Can affect up to 1 in 10,000 people:

· depression

· cardiac arrest

· renal failure

· high blood pressure

· painful or inflamed mouth

· pancreatitis

· intestinal stenosis (narrowing)

· aseptic meningitis, aggravation of infectious inflammations

· blood disorders that may result in bruising or susceptibility to infection

· liver problems including abnormal liver function, hepatitis or jaundice (yellowing of the skin or eyes).

Frequency unknown

· sweat

· chest pain

· swelling of the stomach

· dry mouth, feeling thirsty

· abnormal spasm, seizures

· dizziness (vertigo)

· increased transaminases (revealed in tests (blood)

· visual or auditory hallucinations

· skin rash, red or purple discoloration of the skin, fluid retention (edema)

· decrease in the frequency of urine, presence of blood or protein in the urine (revealed in urine tests)

· glaucoma in patients at risk.

· A severe skin reaction called hypersensitivity syndrome (DRESS syndrome) can occur. The symptoms of hypersensitivity are: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).

Tell your doctor or pharmacist if you experience any of the side effects listed above .

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information about the safety of the medicine.

5. HOW TO STORE RHINADVILCAPS COLD IBUPROFEN / PSEUDOEPHEDRINE 200 mg / 30 mg, soft capsule?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.

Store at a temperature not exceeding 25 ° C

Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.

6. CONTENTS OF PACKAGING AND OTHER INFORMATION

What RHINADVILCAPS RHUME contains ibuprofen / pseudoephedrine 200 mg / 30 mg, soft capsule

· The active substances are:

Ibuprofen................................................. .................................................. ................. 200 mg

Pseudoephedrine hydrochloride ............................................... .................................... 30 mg

· The other components are:

Filling liquid : Potassium hydroxide, Macrogol 600, purified water

Gelatin capsule : sorbitol (E 420), gelatin, black printing ink [(Macrogol 400, polyvinyl phthalate acetate, propylene glycol, black iron oxide (E 172)], processing aid : soy lecithin in triglycerides.

What RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE 200 mg / 30 mg soft capsule looks like and contents of the pack

RHINADVILCAPS RHUME IBUPROFENE / PSEUDOEPHEDRINE comes in the form of a light-colored, oval soft capsule printed with "200/30" in black ink.

RHINADVILCAPS RHUME IBUPROFEN / PSEUDOEPHEDRINE is available from your pharmacist in white, opaque, aluminum blisters of 2, 4, 8, 10, 12, 16, 20 or 24 capsules. Not all presentations may be marketed.

Marketing Authorization Holder

PFIZER FAMILY HEALTH

23-25 ​​Avenue of Dr. Lannelongue

75014

PARIS

LA FRANCE

Operator of the marketing authorization

PFIZER FAMILY HEALTH

23-25 ​​Avenue of Dr. Lannelongue

75014

PARIS

LA FRANCE

Maker

PFIZER CONSUMER MANUFACTURING ITALY Srl

Via Nettunense 90

04011

Aprilia

Italy

Names of the drug in the member states of the European Economic Area

This medicine is authorized in the member states of the European Economic Area under the following names:

[to be completed later by the holder]

The last date this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).



[1] To be specified for amendment requests and to indicate the code according to the guidelines https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-2/c_2013_2008/c_2013_2008_pdf /c_2013_2804_fr.pdf

VIDAL OF THE FAMILY

RHINADVILCAPS

Antirhume medication

ibuprofen, pseudoephedrine

. Presentations . Composition . Indications . Contraindications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS (summary)

RHINADVILCAPS: soft capsule; box of 16.
Not refunded - Free price -

Pfizer Family Health Laboratory

COMPOSITION (summary)
p caps
Ibuprofen 200mg
Pseudoephedrine hydrochloride 30 mg
Soy lecithin +

INDICATIONS (summary)
This medication contains ibuprofen, a nonsteroidal anti-inflammatory drug ( NSAID ) that has analgesic and antipyretic action, and pseudoephedrine, a decongestant vasoconstrictor that reduces the feeling of stuffy nose.
It is used to relieve cold symptoms: stuffy nose, runny nose, headache and / or fever.
CONTRAINDICATIONS (summary)
This medicine should not be used in the following cases:
ATTENTION (summary)
Any prolonged treatment or overdose of NSAIDs can lead to serious side effects.
Although sold over the counter, this medicine contains a vasoconstrictor that can cause potentially serious cardiac or neurological adverse reactions. Its use requires certain precautions, especially the respect of doses and contraindications. Make sure you do not combine it with any other drug containing a decongestant vasoconstrictor , especially nasal.
Decongestant vasoconstrictors can increase heart rate ( tachycardia ) and cause palpitations and nausea. If these side effects are too severe, treatment should be discontinued.
They can also be responsible for rare neurological complications ( convulsions , hallucinations, abnormal agitation), especially in case of excessive dosage . Respect the recommended dose.
It is recommended to take medical advice in case of arterial hypertension , heart disease, nervous disorders, history of stomach ulcer or duodenum or risk of haemorrhage, especially digestive ( Crohn 's disease , ulcerative colitis ).
Certain situations must lead to continue treatment only after medical advice:
  • severe heartburn or black, foul-smelling stools that may indicate irritation or bleeding from the digestive tract;
  • rash without obvious cause;
  • asthma attack ;
  • Unusual and intense fatigue, or abrupt and significant decrease in the volume of urine in a person suffering from heart failure , dehydration or diuretic therapy .
Taking this medicine can cause acute glaucoma in susceptible individuals: red, hard and sore eyes with blurred vision. An emergency consultation with an ophthalmologist is necessary.
NSAIDs have an inhibitory effect on ovulation and are likely to decrease fertility in women. This effect is reversible when the treatment is stopped.
Some doctors consider that anti-inflammatory drugs can decrease the effectiveness of intrauterine devices (IUDs) and expose them to a risk of unwanted pregnancy. This risk is very controversial.
Driver: This medication may be responsible in rare cases for vertigo or visual disturbances.
Sports: This medicine contains a substance considered stimulant (phenylephrine, pseudoephedrine or synephrine) which is included in the 2004 surveillance program of the Ministry of Youth and Sports. It can be sought in the urine of athletes to detect a possible misuse.
DRUG INTERACTIONS (summary)
This drug should not be associated with:
  • a nonselective MAOI antidepressant ( MARSILID ): a delay of at least 15 days must be respected between taking these 2 drugs;
  • another oral vasoconstrictor (phenylephrine, pseudoephedrine, methylphenidate) or a nasal vasoconstrictor (naphazoline, oxymetazoline, ephedrine or tuaminoheptane sulfate): risk of hypertensive crisis.
It may interact with vasoconstrictors used in Parkinson's disease (bromocriptine, pergolide, lisuride, cabergoline) or in migraine (ergotamine, dihydroergotamine, methysergide) or with MAOI selective A (moclobemide).
It may also interact with other drugs, including aspirin, other nonsteroidal anti-inflammatory drugs, anticoagulants , platelet aggregation inhibitors, and drugs containing lithium or methotrexate.
Also, tell your doctor or pharmacist if you are taking an antihypertensive drug, a diuretic, or a medicine containing guanethidine.
PREGNANCY and BREASTFEEDING (summary)
Pregnancy :
Adverse effects for the unborn child have been demonstrated when NSAIDs are used during the last 4 months of pregnancy; the risk exists even with a single dose and even if the pregnancy is complete. Use of this medication is contraindicated during this time.
During the first 5 months, the effect of this medicine is poorly known: only your doctor can evaluate the possible risk of its use in your case.

Breastfeeding:
This medicine passes into breast milk. It is contraindicated during breastfeeding.
DIRECTIONS AND DOSAGE (summary)
The capsules are swallowed with a glass of water, preferably during meals.

Usual dosage:

  • Adult and child over 15 years: 1 or 2 capsules, to renew if necessary every 6 hours, without exceeding 6 capsules per day.
The duration of treatment should not exceed 5 days.
TIPS (summary)
This medicine has no anti-infective effect. If the symptoms persist for more than a few days, consult your doctor.
ADVERSE POSSIBLE EFFECTS (summary)
Related to ibuprofen:
Nausea, vomiting, gastritis .
Rarely: Linked to pseudoephedrine:
Dry mouth, urinary retention.
Nausea, vomiting.
Palpitations , heart acceleration, insomnia, anxiety, headache, sweating.
More rarely: hallucinations, agitation.


LEXICON (summary)


prostate adenoma
Increase in the volume of the prostate gland located under the bladder of the man. This increase in volume is benign, has nothing to do with cancer, but may hinder the passage of urine in the canal (urethra) that passes through the gland.
The symptoms that suggest the presence of a prostate adenoma are:
  • Difficulty urinating (slow, weak jet)
  • the need to get up several times a night to urinate;
  • urges to urinate imperious and difficult to control.
Some drugs, especially atropine, may have the undesirable effect of aggravating the discomfort and may lead to a complete blockage of the evacuation of the bladder. They are therefore contraindicated or should be used with caution in men with the symptoms described above.


NSAIDs
Abbreviation for nonsteroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known is aspirin.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication or ingestion of a food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


anemia
Decreased hemoglobin level in the blood, which most often results in a decrease in the number of red blood cells. Iron is essential for the synthesis of hemoglobin. Iron deficiency during pregnancy, vegetarian diet, heavy or repeated bleeding (menstruation) is a common cause of anemia. Other, rarer causes are related to vitamin B deficiencies.


analgesic
Drug that acts against pain. Analgesics act either directly on the centers of pain located in the brain, or by blocking the transmission of pain to the brain.
Synonym: analgesic.


antecedent
Affection healed or still evolving. The antecedent can be personal or family. The antecedents are the story of a person's health.


antiplatelet agents
Drug that prevents platelets from clumping together and clots from forming. The oldest platelet antiaggregant is aspirin taken in small doses.
Antiaggregants should not be confused with anticoagulants with different mechanisms of action.


anti coagulants
A drug that prevents blood from clotting and prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also help prevent clots in the heart during rhythm disorders such as atrial fibrillation or in the case of artificial heart valves.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: the INR (formerly TP);
  • injectable anticoagulants, derived from heparin, the effectiveness of which can be controlled by the blood determination of the anti-Xa activity, the Howell's Time (TH) or the Kaolin Cephalin Time (TCK) according to the products used. Regular dosing of blood platelets is necessary throughout the duration of use of a heparin derivative.


antidepressant
Drug that acts against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, some rebel pain, enuresis, etc.
Depending on their mode of action and their adverse effects, antidepressants are divided into different families: imipramine antidepressants, serotonin reuptake inhibitors, MAOIs (selective or non-selective). Finally, other antidepressants do not belong to any of these families because they possess original properties.
The mode of action of antidepressants has two main aspects: the relief of the moral suffering and the fight against the inhibition which removes any will of action to the depressed. Sometimes there is a discrepancy between these two effects: the moral suffering can persist, while the capacity for action reappears. During this short period, the suicidal risk present in some depressed may be increased. The doctor takes this into account when prescribing (possible association with a tranquilizer) and this must be strictly observed.


antihypertensive
Drug that fights against excess blood pressure. The main ones are beta-blockers, diuretics, calcium channel blockers, ACE inhibitors, angiotensin II inhibitors and vasodilators.


anti-inflammatory
Drug that fights inflammation. It can be either derived from cortisone (steroidal anti-inflammatory drug), or not derived from cortisone (nonsteroidal anti-inflammatory drug or NSAID).


antipyretic
Medication used to lower body temperature during fever attacks.


asthma
Disease characterized by difficulty breathing, often resulting in whistling. Asthma, permanent or occurring by crisis, is due to narrowing and bronchial inflammation.


convulsions
Involuntary contractions limited to a few muscles or generalized to the whole body. They are due to suffering or excessive stimulation of the brain: fever, intoxication, lack of oxygen, brain damage. Seizures may be due to an epileptic seizure or high fever in young children.


Crohn
Inflammation disease of the intestine, which can cause ulcers and narrowing. It often becomes chronic and can be accompanied by persistent diarrhea and malnutrition.


diabetes
General term for diseases resulting in the emission of abundant urine and intense thirst. Employed alone, the word diabetes generally concerns diabetes mellitus, which corresponds to a disruption of the body's sugar regulation by insulin. It results in the increase of sugar (glucose) in the blood and by its possible presence in the urine. There are two types of diabetes mellitus: type 1 diabetes, or insulin-dependent diabetes, which requires treatment with insulin injection, and type 2 diabetes, or non-insulin-dependent diabetes mellitus, which may initially be treated with oral antidiabetic drugs.


diuretic
Drug allowing an increased elimination of water by the kidneys. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other more rare conditions.
These drugs cause a loss of sodium and potassium (except for some of them called "potassium sparing"). Their prolonged intake therefore requires regular control of blood potassium, to avoid the cardiac disorders that could result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible consequence, but rarer at usual dosages, from prolonged use of diuretics; it is also detected by a blood test.


duodenum
Part of the intestine into which food from the stomach enters.


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, to a drug, and to translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatories.


glaucoma
Disease characterized by the increase of the pressure of the liquids contained in the eye (intraocular hypertension).
This general term covers two completely different affections:
  • Open-angle glaucoma or chronic glaucoma is the most common; it is usually symptom free, detected by measurement of intraocular pressure in the ophthalmologist. It does not cause an acute attack, and the treatment is essentially based on beta-blocker eye drops. People with open-angle glaucoma should not use cortisone derivatives without prior ophthalmic advice.
  • Angle-closure glaucoma or acute glaucoma is more rare. Between seizures, intraocular tension is normal. But the inadvertent use of atropine drugs (especially eye drops) causes an acute attack of intraocular hypertension that can permanently damage the retina in a few hours. It is an ophthalmological emergency that can be recognized by a brutally red eye, horribly painful, hard as a glass ball, and whose vision becomes blurred.
The angle referred to in these two affections is the iridocorneal angle. It is indeed between the iris and the cornea that the liquid evacuation system of the eye is located. A slightly open angle (closed) exposes to a total obstruction of the evacuation system. This obstruction can occur when the iris is open to the maximum (mydriasis) under the effect of an atropine drug: the iris then sticks to the cornea.
The contraindications for atropine medications only apply to people who have had an angle-closure glaucoma attack, or for whom an ophthalmologist has detected this risk. Those with chronic open angle glaucoma are not affected by these contraindications.


haemorrhage
Loss of blood from an artery or vein. Hemorrhage can be external, but also internal and go unnoticed.


high blood pressure
Excess pressure (tension) of the blood in the arteries. This pressure is provided by the heart and is expressed by two numbers. It is maximal during the contraction of the heart, or systole (first digit), and minimum during the cardiac rest, or diastole (second digit). Hypertension is characterized by a maximal (systolic) pressure greater than or equal to 16, or a minimum (diastolic) pressure greater than or equal to 9.5. Treatment is initiated when these numbers are exceeded or for lower voltages in some people with cardiovascular risk factors: heredity, smoking, diabetes, excess cholesterol. Permanent antihypertensive therapy can reduce the damage to the heart and blood vessels caused by high blood pressure.


hyperthyroidism
Excess thyroid hormones including heart acceleration, poor heat tolerance, weight loss and chronic fatigue.


MAOIs
Abbreviation of monoamine oxidase inhibitor. Family of drugs used in psychiatry and neurology (depression, Parkinson's disease). These drugs are divided into two types: non-selective MAOIs, which are incompatible with many drugs and even certain foods, and selective MAOIs (A or B), for which these drawbacks are absent or limited.


heart failure
Inability of the heart to fulfill its pump function. The main symptoms of heart failure are fatigue and shortness of breath during exercise.


coronary insufficiency
Partial inability of the arteries of the heart (coronary arteries) to irrigate the heart muscle. Angina attacks can occur, most often during an effort.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of certain wastes, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to dispose of waste or drugs. Advanced renal failure does not necessarily result in a decrease in the amount of urine eliminated. Only a blood test and the determination of creatinine can reveal this disease.


lupus erythematosus
Skin disease causing redness of the central part of the face. There are two main forms: discoid lupus (cutaneous only) and disseminated lupus (associated with deep organ lesions).


blood count
The count measures the number of red blood cells (red blood cells), white blood cells (leucocytes) and platelets in the blood. The blood formula specifies the percentage of different white blood cells: neutrophils, eosinophils, basophils, lymphocytes, monocytes.
Abbreviation: NFS.


edema
Accumulation of water or lymph causing localized swelling.


palpitations
Abnormal perception of irregular heartbeat.


Parkinson
Chronic disorder of the nervous system related to the alteration of certain brain cells and resulting in mobility disorders and sometimes tremors.


pheochromocytoma
Very rare tumor of the adrenal glands, manifested mainly by attacks of arterial hypertension.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
Reaction due to the hypersensitivity of the body to a drug. Allergic reactions can be very varied: urticaria, angioedema, eczema, rash of measles-like pimples, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort by sudden drop in blood pressure.


ulcerative colitis
Inflammatory disease of the rectum and colon, which evolves by outbreaks. Each thrust is accompanied by fever, glairy and bloody stools.


overdose
Excessive intake of a drug may lead to an increase in the intensity of the adverse effects, or even to the occurrence of particular adverse effects.
This overdose can result from an accidental intoxication, or voluntary for the purpose of suicide: it is then advisable to consult the poison control center of your region (list in appendix of the work). But most often, the overdose is the consequence of an error in the understanding of the prescription, or the search for an increase of the effectiveness by a surpassing the recommended dosage. Finally, untimely self-medication can lead to the excessive absorption of the same substance contained in different drugs. Some drugs are particularly exposed to this risk, because they are considered (wrongly) as harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake can eliminate the problems associated with overdose.


tachycardia
Acceleration of the rhythm of the heartbeat. It may be due to fever, hyperthyroidism, heart disease, the action of certain drugs, etc.


transaminases
Enzymes dosed in the blood, the rate of which rises during certain hepatitis. They appear in blood tests under the name of SGOT and SGPT or ASAT and ALAT.


ulcer
Intense lesion of the skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Peptic ulcer: localized wound of the mucosa of the stomach or duodenum, due to an excess of acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


vasoconstrictor
Drug that causes a contraction of the blood vessels, as opposed to vasodilator.


dizziness
Symptom that may indicate a sense of loss of balance (common sense) or, more strictly, a feeling of rotation on oneself or the environment (medical sense).

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