NOTICE
ANSM - Last updated: 26/07/2017
Name of the medicinal product
DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet
Paracetamol / Vitamin C
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 3 days in case of fever, or 5 days in case of pain.
Do not use this medication for children.
What is in this leaflet?
1. What is DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet and in which cases it is used?
2. What should I know before taking DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet?
3. How to take DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet?
4. What are the possible side effects?
5. How to store DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet?
6. Package contents and other information.
1. WHAT IS DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER ANALGESICS and ANTIPYRETICS-ANILIDES
ATC code: N02BE01.
DOLIPRANEVITAMINEC is an analgesic (calms the pain) and an antipyretic (lowers the fever). The active ingredients of this medication are paracetamol and vitamin C.
It is used to treat pain and / or fever, for example in the case of headaches, flu-like symptoms, dental pain, body aches and painful periods.
This presentation is reserved for adults and children from 27 kg (about 8 years old). Please read the package insert carefully.
For children weighing less than 27 kg, there are other presentations of paracetamol with a more appropriate dosage. Do not hesitate to ask your doctor or pharmacist for advice.
You should contact your doctor if you experience no improvement or feel worse after 3 days in case of fever, or after 5 days in case of pain.
2. BEFORE YOU TAKE DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet?
Do not take DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet:
· If you are allergic (hypersensitive) to any of the active ingredients (paracetamol or vitamin C) or to any of the other ingredients of this medication mentioned in section 6.
· If you have severe liver disease.
· If you suffer from kidney stones.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
This medicine contains paracetamol and vitamin C. Other medicines contain this medication. Make sure you do not take any other medicines containing paracetamol, including medicines obtained without a prescription. Do not combine them , so as not to exceed the recommended daily dose. ( see "Posology " and "Symptoms and Instructions for Overdose") |
Warnings and Precautions
Talk to your doctor or pharmacist before taking DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet .
Take special care with DOLIPRANEVITAMINEC
· If the pain persists more than 5 days , or fever more than 3 days , or if there is insufficient efficacy or any other signs, do not continue treatment without your doctor's advice.
· Due to a slightly stimulating effect due to the presence of vitamin C, it is advisable not to take this medication at the end of the day.
· Taking paracetamol may cause liver function problems.
· You should seek the advice of your doctor before taking this medicine:
o If you are an adult weighing less than 50 kg
o If you have a liver disease or a serious kidney disease,
o if you frequently drink alcohol or have stopped drinking alcohol recently,
o If you suffer from dehydration,
o If you suffer from chronic malnutrition, if you are in a fasting period, if you have lost a lot of weight recently, if you are over 75, or if you are over 65 and have long-term illnesses , if you are infected with the AIDS virus or chronic viral hepatitis, if you suffer from cystic fibrosis (genetic and hereditary diseases characterized in particular by serious respiratory infections), or if you have Gilbert disease (hereditary disease associated with increased bilirubin levels in the blood).
o if you are allergic to aspirin and / or nonsteroidal anti-inflammatory drugs,
· The consumption of alcoholic beverages during treatment is discouraged.
· In the event of recent withdrawal from chronic alcoholism, the risk of hepatic impairment is increased.
· In case of administration in a child, the dose depends on its weight (see section "How to take DOLIPRANEVITAMINEC?")
· In case of acute viral hepatitis, stop your treatment and see your doctor.
Blood tests
Tell your doctor if you are taking DOLIPRANEVITAMINEC and you need to take a blood test as this medicine can affect your uric acid (blood uric acid) and sugar (blood sugar) levels.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other medicines and DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including non-prescription medicines
Do not take other medicines containing paracetamol. You may be overdosed.
· If you are taking an oral anticoagulant therapy (warfarin or AVK), taking DOLIPRANEVITAMINEC at maximum doses (4 g / day) for more than 4 days requires enhanced monitoring of the biological examinations including INR. In this case, consult your doctor.
· The effectiveness of paracetamol may be reduced if you take chelating resins - a drug that lowers blood cholesterol levels (observe an interval of more than 2 hours between the two).
· If you are receiving paracetamol, a treatment with flucloxacillin (an antibiotic), you are at risk of metabolic acidosis (blood too acid causing an acceleration of the respiratory rate).
· The toxicity of paracetamol can be increased if you take:
o drugs potentially toxic to the liver
o drugs that promote the production of the toxic metabolite of paracetamol such as anti-epileptic drugs (phenobarbital, phenytoin, carbamazepine, topiramate),
o rifampicin (an antibiotic),
o at the same time alcohol.
DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet with food, beverages and alcohol
The consumption of alcoholic beverages during treatment is discouraged.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Pregnancy and breast feeding
This medicine may be used during pregnancy and lactation. Use the lowest dose to reduce your pain and / or fever for as short a time as possible and as often as possible. Contact your doctor or midwife if pain and / or fever does not decrease or if you need to take this medication more frequently during your pregnancy.
Fertility
It is possible that paracetamol may alter the fertility of women, reversibly upon cessation of treatment.
Sport
Not applicable.
Driving and using machines
Not applicable.
DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet contains 390 mg of sodium per tablet. You should consider this if you control your sodium dietary intake.
3. HOW TO TAKE DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
This presentation is reserved for the adult and the child from 27 kg (from about 8 years).
The dosage of paracetamol depends on the weight of the child. The ages are mentioned for information purposes.
If you do not know the weight of the child, weigh it to give it the best dose.
Paracetamol exists in many dosages, allowing the treatment to be adapted to the weight of each child.
The recommended daily dose of paracetamol is approximately 60 mg / kg / day, divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours (see also below depending on your weight).
· Children from 27 to 40 kg (approximately 8 to 13 years)
The usual dosage is 1 effervescent tablet per dose, to be renewed if necessary after 6 hours , without exceeding 4 effervescent tablets per day .
· Children from 41 to 50 kg (approximately 12 to 15 years)
The usual dosage is 1 effervescent tablet per dose, to be renewed if necessary after 4 hours, without exceeding 6 effervescent tablets per day.
· Adult and children from 50 kg (ie from about 15 years)
The usual dosage is 1 to 2 effervescent tablets per dose depending on the intensity of the pain, to be renewed if necessary after 4 hours minimum.
Dose of paracetamol never to be exceeded
· In adults or children weighing more than 50 kg:
· It is generally not necessary to exceed 3 grams of paracetamol per day (6 effervescent tablets per day).
· However, if you have more severe pain, and only on the advice of your doctor or pharmacist , the total dose can be increased to 4 grams of paracetamol per day (8 effervescent tablets per day). If you feel that the effect of DOLIPRANEVITAMINEC is too strong or too weak, talk to your doctor or pharmacist.
NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking all medicines containing paracetamol into their formula).
Special situations:
The maximum daily dose should not exceed 60 mg / kg / day (not to exceed 3 g / day) in the following situations:
· If you are an adult weighing less than 50 kg
· If you have a liver disease or a serious kidney disease,
· If you frequently drink alcohol or have stopped drinking alcohol recently,
· If you suffer from dehydration,
· If you suffer from chronic malnutrition, if you are in fasting periods, have lost a lot of weight recently, if you are over 75, or if you are over 65 and have long-term illnesses , if you have AIDS or chronic viral hepatitis, if you suffer from cystic fibrosis (genetic and hereditary disease characterized by severe respiratory infections), or if you have Gilbert's disease (hereditary disease associated with an increase in the level of bilirubin in the blood.
Method and route of administration
This medication is used orally. You should dissolve the tablets in a glass of water. Wait for complete dissolution before drinking the contents of the glass.
In addition, if your child has a fever greater than 38.5 ° C, you can improve the effectiveness of the drug treatment by:
· Discover your child,
· Make the drink,
· Do not leave your child in a hot place.
Frequency of Administration
Regular intakes prevent oscillations of pain or fever:
· The catch should be evenly spaced, including at night, preferably 6 hours and at least 4 hours (refer to the section "Dosage").
· If you have severe kidney disease (severe kidney failure), you should wait at least 8 hours between taking each effervescent tablet (s).
Duration of treatment
Except for medical advice, the duration of treatment is limited:
· at 5 days in case of pain,
· at 3 days in case of fever.
Stop treatment and see your doctor immediately:
· if the pain persists more than 5 days or the fever lasts more than 3 days,
· if the pain or fever worsens,
· or if new symptoms appear.
If you take more DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet than you should:
Consult your doctor or pharmacist or medical emergencies immediately.
Overdosage may lead to liver disease (hepatic impairment), gastrointestinal bleeding, brain disease (encephalopathy), coma, or even death, including in populations at higher risk, such as young children, the elderly and in certain situations (liver disease, alcoholism, chronic malnutrition). Within the first 24 hours, the main symptoms of poisoning are: nausea, vomiting, loss of appetite, abdominal pain, pallor.
Overdosage may also result in: pancreatic disease (pancreatitis), hyperamylaseemia (increased blood amylase), kidney disease (acute renal failure), and a blood problem in which red blood cells, white blood cells and platelets are all reduced in number which entails:
· fatigue, shortness of breath, and pallor;
· frequent infections with severe fever and chills, sore throat or mouth ulcers;
· a tendency to bleed or present spontaneous bruising, nosebleeds.
Overdose of vitamin C:
· At doses above 1 g / day in vitamin C, possibility of:
o digestive disorders (heartburn, diarrhea),
o urinary disorders (formation of kidney stones).
· Vitamin C may interfere with the following biological tests in doses above 2 g / day in vitamin C: blood and urine creatinine and glucose (glucose oxidase).
· In doses greater than 3 g / day in vitamin C, risk of haemolysis (destruction of red blood cells) in people suffering from a lack of glucose 6 phosphate dehydrogenase (specific enzyme of red blood cells).
Immediately consult your doctor or pharmacist.
If you forget to take to use DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet:
Do not take a double dose to make up for the missed dose.
If you stop taking DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Rarely, an allergic reaction may occur:
o pimples and / or redness on the skin,
o urticaria,
o sudden swelling of the face and neck may cause difficulty breathing (Quincke edema),
o malaise with severe drop in blood pressure (anaphylactic shock).
If an allergy occurs, you should immediately stop taking this medication and consult your doctor promptly. In the future, you should never take medicines containing paracetamol.
o Very rare cases of serious adverse reactions have been reported.
o Exceptionally, this drug may decrease the number of certain cells in the blood: white blood cells (leucopenia, neutropenia), platelets (thrombocytopenia) that can manifest themselves by bleeding from the nose or gums. In this case, consult a doctor.
· Other possible adverse reactions (the frequency of which can not be estimated from the available data): liver function disorders, severe reduction of certain white blood cells that can cause serious infections (agranulocytosis), destruction of red blood cells in the blood (anemia hemolytic in patients with glucose-6-phosphate dehydrogenase deficiency), rash in rounded red patches with itching and burning sensation, leaving colored spots and appearing in the same places when the drug is resumed (fixed pigmented erythema ), localized pain in the chest that can radiate to the left shoulder and jaw of allergic origin (Kounis syndrome), difficulty breathing (bronchospasm).
In this case, consult a doctor.
· Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton.
Store in the original package in order to protect from moisture.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DOLIPRANEVITAMINEC 500 mg / 150 mg contains, effervescent tablet
· The active substances are:
Paracetamol................................................. .................................................. 500 mg
Vitamin C................................................ .................................................. 150 mg
For an effervescent tablet
· The other ingredients are anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, sodium saccharin, povidone K90, leucine, mannitol, orange coloring PB-23074 (red iron oxide (E172), quinoline yellow alumina ), mannitol (E421), orange flavoring (orange essential oil, concentrated orange juice, maltodextrin, gum arabic).
What is DOLIPRANEVITAMINEC 500 mg / 150 mg, effervescent tablet and contents of the pack
This medication is in the form of an effervescent tablet. Each box contains 8/16 effervescent tablets.
Marketing Authorization Holder
sanofi-aventis France
82 avenue Raspail
94250 Gentilly
Marketing Authorization Operator
sanofi-aventis France
82 avenue Raspail
94250 Gentilly
Maker
CREAPHARM GANNAT SA
03800 GANNAT
LA FRANCE
or
NATTERMANN & Cie GmbH
COLOGNE
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Advice
WHAT TO DO IN CASE OF FEVER:
The normal temperature of the body varies from person to person and is between 36.5 ° C and 37.5 ° C. A rise in temperature above 38 ° C may be considered a fever, but it is not advisable to treat fever with a drug below 38.5 ° C.
This medication is intended for adults and children from 27 kg (ie from about 8 years).
If the disorders that the fever causes are too troublesome, you can take this drug that contains paracetamol in accordance with the indicated dosages.
To avoid any risk of dehydration, consider drinking frequently.
If your child has a fever greater than 38.5 ° C, you can improve the effectiveness of drug therapy by:
· discover your child,
· make the drink,
· do not leave your child in a place too hot.
With this medication, the fever should drop rapidly, nevertheless:
· if other unusual signs appear,
· if the fever persists for more than 3 days or if it worsens,
· if the headache becomes violent, or in case of vomiting,
CONSULT YOUR DOCTOR IMMEDIATELY
WHAT TO DO IF PAIN:
The intensity of the perception of pain and the ability to resist it vary from person to person.
· If there is no improvement after 5 days of treatment,
· if the pain is violent, unexpected and occurs suddenly (including severe pain in the chest) and / or reverses regularly,
· if accompanied by other signs such as general malaise, fever, unusual swelling of the painful area, decreased strength in a limb,
· if it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY
Detailed information on this medicine is available on the ANSM website (France).