NOTICE
ANSM - Updated on: 30/07/2015
Name of the medicinal product
RHINADVIL RHEUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet
Ibuprofen / pseudoephedrine hydrochloride
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment and illness.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU TAKE RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet?
3. HOW TO TAKE RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
This medicine contains a non-steroidal anti-inflammatory drug, with analgesic and antipyretic properties, ibuprofen and a vasoconstrictor, pseudoephedrine hydrochloride.
Therapeutic indications
Adolescent (15-17 years) and adult colds are indicated for symptomatic treatment of stuffy nose sensations accompanied by headache and / or fever.
2. BEFORE YOU TAKE RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet:
Child and adolescent less than 15 years old.
· From 6 th month of pregnancy.
· Patients with a history of allergy or asthma triggered by the use of this drug or a related drug, including other non-steroidal anti-inflammatory drugs, aspirin or a history of allergy to others components of the tablet.
· Patients with a history of gastrointestinal bleeding or perforation associated with prior NSAID therapy or a history of recurrent peptic ulcer or hemorrhage.
· Severe liver disease.
· Serious kidney disease.
· Severe heart failure.
· severe or poorly balanced arterial hypertension.
· Gastrointestinal bleeding or other abnormal red blood cells.
· If you have had a stroke.
· Severe heart disease (coronary insufficiency).
· certain forms of glaucoma (increased pressure in the eye).
· difficulty urinating from prostatic or other causes.
· convulsions.
· history of myocardial infarction.
· systemic lupus erythematosus.
· If you are treated by:
o other vasoconstrictive medicinal products intended for decongesting the nose whether they are administered orally or nasally (phenylpropanolamine, phenylephrine, ephedrine, etc.) or methylphenidate,
o non-selective MAOI drugs (iproniazide), medicines prescribed in some depressive states.
· If you are breastfeeding.
You should not use this medication unless your doctor has advised otherwise:
· until the 5th month of pregnancy
· in association with:
o oral anticoagulants,
o antiplatelet agents,
o other non-steroidal anti-inflammatory drugs (including aspirin and other high-dose salicylates),
o corticosteroids,
o heparin injectable at curative doses or in the elderly,
o lithium,
o selective serotonin reuptake inhibitors,
o methotrexate (used at doses greater than 20 * mg per week).
Precautions for use; special warnings
Take special care with RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet:
At 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 serious discomforts, which are observed with anti-inflammatory drugs - inflammatory.
DO NOT LEAVE THIS MEDICINE OR SCOPE OR CHILDHOOD.
In case of overdosage or mistakenly taking too high a dose, immediately notify a doctor.
It is imperative to strictly observe the dosage, the duration of treatment of 5 days, and the contraindications.
Drugs such as RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE 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, have had a stroke, or if you think you may have a risk (eg, high blood pressure, diabetes, high cholesterol, or to take this treatment you should talk to your doctor or pharmacist.
BEFORE YOU USE THIS MEDICINE, CONSULT YOUR DOCTOR IN CASE:
· A history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose; the administration of this specialty may lead to an asthma attack, especially in some people who are allergic to aspirin or to a non-steroidal anti-inflammatory drug ( see section 2, Information required before taking RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE ... );
· Taking anticoagulant therapy. This medication may cause severe gastrointestinal symptoms;
· A history of gastrointestinal problems (hiatus hernia, digestive hemorrhage, old stomach or duodenal ulcer);
· Diseases of the heart, liver, kidney;
· Hypertension;
· Cardiac disorders, hyperthyroidism (hyperfunction of the thyroid gland);
· Personality or diabetes disorders;
· When taking medicines to treat migraine (especially alkaloid drugs derived from rye ergot);
· When taking the following medicines: ciclosporin, tacrolimus, trimethoprim.
DURING TREATMENT, IN CASE OF:
· Eye disorders, PREVENT YOUR DOCTOR;
· Feeling of acceleration of heartbeat, palpitations, onset or increase of headache, nausea, behavioral disturbances;
· Gastrointestinal haemorrhage (discharge from the mouth or stool, stool coloration in black);
· Possible side effects with RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet? ). Allergic reactions such as asthma or angioedema ( see section 4 "Possible side effects with RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet" ).
STOP TREATMENT AND CONTACT IMMEDIATELY MEDICAL OR EMERGENCY MEDICAL SERVICE
Because of the presence of sucrose, this medication should not be used in cases of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases.
Due to the presence of methyl and propyl parahydroxybenzoates (preservatives), possible allergic reactions or even 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 and notify the anesthesiologist.
This drug contains a non-steroidal anti-inflammatory drug, ibuprofen and a vasoconstrictor, pseudoephedrine hydrochloride.
You should not take other medicines containing non-steroidal anti-inflammatory drugs and / or aspirin and / or pseudoephedrine together with this medication.
Read carefully the leaflets for other medicines you are taking to ensure that there are no non-steroidal anti-inflammatory drugs and / or aspirin and / or pseudoephedrine.
Interaction with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including:
· antiplatelet agents and oral anticoagulants,
· other non-steroidal anti-inflammatory drugs including aspirin and its derivatives at high doses,
· corticosteroids,
· of the injectable heparin,
· lithium,
· selective serotonin reuptake inhibitors,
· of high-dose methotrexate (greater than 20 * mg per week),
· ticlopidine,
· ciclosporin, tacrolimus, trimethoprim,
· medicines for the treatment of high blood pressure,
Even if it is a non-prescription drug.
In addition, this medicinal product contains a vasoconstrictor, pseudoephedrine hydrochloride, which should NOT be mixed:
· to other vasoconstrictive drugs intended for decongesting the nose whether they are administered orally or nasally (phenylpropanolamine, phenylephrine, ephedrine, etc.) and to methylphenidate,
· medications prescribed in certain depressive states: non-selective MAOIs (iproniazide).
It is also not recommended to combine this medication:
· to selective MAO-A,
· to linezolid,
· dopaminergic or vasoconstrictive ergot alkaloids such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine.
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
If you are pregnant or breastfeeding: Do not take this medicine without consulting your doctor or pharmacist. |
Use of this medicine is not recommended until the 5th month of pregnancy and included is against-indicated from the 6th month of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Due to possible adverse effects in infants, taking this medication is contraindicated if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Sport
Pseudoephedrine hydrochloride may induce a positive reaction from tests performed during doping controls.
Effects on ability to drive or use machines
Driving and using machines
In rare cases, taking this medicine may cause dizziness and blurred vision.
List of excipients with known effect
List of excipients with a known effect: sucrose, methyl parahydroxybenzoates and propyl.
3. HOW TO TAKE RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED TO ADOLESCENT (15-17 years) AND THE ADULT
1 tablet (200 mg ibuprofen / 30 mg pseudoephedrine hydrochloride) per dose, to be renewed if necessary after 6 hours.
In case of more severe symptoms, 2 tablets (400 mg ibuprofen / 60 mg pseudoephedrine hydrochloride) per dose, to be renewed if necessary after 6 hours, without exceeding 6 tablets (1200 mg ibuprofen / 180 mg pseudoephedrine hydrochloride) per day.
In all cases, never exceed the maximum dose of 6 tablets per day (1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride per day).
Administration mode
Oral use.
The tablets should be swallowed as they are with a large glass of water, preferably during meals.
Frequency of Administration
Catches must be spaced at least 6 hours apart.
If you feel that the effect of RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet, does not work as you expected: consult your doctor or pharmacist.
Duration of treatment
The maximum duration of treatment is 5 days.
Symptoms and Instructions for Overdose
If you take more RHINADVIL RHEUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet than you should:
Take the advice of your doctor.
Instructions for omission of one or more doses
If you forget to take RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
If you stop taking RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet:
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet is likely to have side effects, although not everyone is subject to it.
Some drugs, such as RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE may be associated with a slight increase in the risk of myocardial infarction or stroke.
Tell your doctor or pharmacist if you experience any gastrointestinal disturbances (such as pain or heartburn) at the start of treatment, or if you have experienced problems with previous anti-inflammatory treatments, especially if you are an elderly person.
Stop your treatment immediately if you notice any skin, mucous membrane (eg inside the mouth) or signs of allergy.
RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet may cause the following side effects:
· Sensation of acceleration of heartbeat, palpitations, onset or increase of headache, nausea, behavioral disorders (linked to the presence of pseudoephedrine hydrochloride).
· Gastrointestinal haemorrhage (discharge from the mouth or in the stool, stool coloration in black) in rare cases; this is all the more frequent because the dosage used is high (linked to the presence of ibuprofen).
· Signs suggestive of allergy to this medication include asthma attack, angioedema (abrupt swelling of the face and neck with respiratory discomfort) or skin allergies (rash on the skin, itching, swelling, aggravation of urticaria chronic, erythema).
· Bullous manifestations of the skin or mucous membranes, (burning sensations accompanied by redness with bubbles, blisters, ulcerations).
IN THESE CASES, STOP THE TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR AN EMERGENCY MEDICAL SERVICE.
In addition, during treatment, the following effects may occur:
· Digestive disorders: stomach upset, vomiting, nausea, diarrhea, constipation;
· The possibility of triggering an acute glaucoma crisis in predisposed subjects;
· Urinary disorders (significant decrease urine difficulty urinating) especially in cases of abnormal urethra, prostate, renal failure;
· Dryness of the mouth, palpitations;
· Convulsions, hallucinations, agitation, anxiety, insomnia, especially in children.
You should tell your doctor.
Exceptionally, may occur:
· Headache accompanied by nausea, vomiting and stiff neck;
· Changes in liver function or blood count (reduction in white blood cells or red blood cells) may be severe;
· Difficulty in sight;
· Hemorrhagic strokes have been reported in patients treated with medicinal products containing pseudoephedrine, in particular in the case of non-compliance with contraindications or warnings ( see section 2 "INFORMATION REQUIRED BEFORE TAKING RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE , coated tablet " ).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding + 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE contain in a coated tablet?
The active substances are :
Ibuprofen ................................................. .................................................. ................................ 200.00 mg
Pseudoephedrine hydrochloride ............................................... .................................................. .. 30.00 mg
For a coated tablet.
The other components are :
Corn starch, pregelatinized potato starch, croscarmellose sodium, anhydrous colloidal silica, sodium laurilsulfate, stearic acid.
Coating: sucrose, microcrystalline cellulose, OPAGLOS GS-2-0310 (shellac, povidone K30) Opalux AS-3739 (titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), sucrose , povidone K30, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)), black ink (OPACODE S-1-17823), carnauba wax.
Pharmaceutical form and content
What is RHINADVIL RHUME IBUPROFENE / PSEUDOEPHEDRINE, coated tablet and contents of the pack?
This medication is in the form of a coated tablet, oval, brown-pink, printed RHINADVIL on one side. Box of 20.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
PFIZER FAMILY HEALTH
23-25, AVENUE OF DOCTOR LANNELONGUE
75014 PARIS
exploiting
PFIZER FAMILY HEALTH
23-25 rue du Docteur Lannelongue
75014 PARIS
Maker
WYETH SpA
VIA NETTUNENSE, 90
04011 APRILIA
ITALY
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.