NOTICE
ANSM - Last updated: 26/07/2017
Name of the medicinal product
DOLIPRANE 500 mg, effervescent tablet
Paracetamol
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 DOLIPRANE 500 mg, effervescent tablet and in which cases is it used?
2. What should I know before taking DOLIPRANE 500 mg, effervescent tablet?
3. How to take DOLIPRANE 500 mg, effervescent tablet?
4. What are the possible side effects?
5. How to store DOLIPRANE 500 mg, effervescent tablet?
6. Package contents and other information.
Do not use this medication for children.
1. WHAT IS DOLIPRANE 500 mg, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Other analgesics and antipyretics-anilides - ATC code: N02BE01.
DOLIPRANE is an analgesic (calms the pain) and an antipyretic (lowers the fever).
The active substance of this drug is paracetamol.
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). Read the Posology section carefully .
For children weighing less than 27 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.
2. BEFORE YOU TAKE DOLIPRANE 500 mg, effervescent tablet?
Do not take DOLIPRANE 500 mg, effervescent tablet:
· if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medication mentioned in section 6.
· If you have severe liver disease
· To treat a child under 6 years old, as it can swallow and choke. Use another form.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
This medicinal product contains paracetamol. Other medicines contain it. 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 DOLIPRANE 500 mg, effervescent tablet .
Take special care with DOLIPRANE
· 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 the advice of your doctor.
· Taking paracetamol may cause liver function problems.
· You should seek the advice of your doctor before taking this medicine:
· If you weigh less than 50 kg,
· If you have liver disease or 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 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 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 increased bilirubin levels in the blood).
· 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.
· When administered to a child, the dose depends on its weight (see section "How to take DOLIPRANE 500 mg, effervescent tablet").
· In case of acute viral hepatitis, stop your treatment and see your doctor.
Blood tests
Tell your doctor if you are taking DOLIPRANE 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 ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Other medicines and DOLIPRANE 500 mg, effervescent tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Do not take other medicines containing paracetamol. You may be overdosed.
If you are taking an oral anticoagulant therapy (warfarin or AVK), taking DOLIPRANE at maximum doses (4 g / day) for more than 4 days requires stronger 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:
· Potentially toxic drugs for the liver,
· Drugs that promote the production of the toxic metabolite of paracetamol such as antiepileptic drugs (phenobarbital phenytoin, carbamazepine, topiramate),
· Rifampicin (an antibiotic),
· At the same time alcohol.
DOLIPRANE 500 mg, effervescent tablet with food, drink and alcohol
The consumption of alcoholic beverages during treatment is discouraged.
Pregnancy, breast-feeding and fertility
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 discontinuation of therapy.
Sport
Not applicable.
Driving and using machines
Not applicable.
DOLIPRANE 500 mg, effervescent tablet contains sodium, sodium metabisulphite (E223), potassium metabisulphite (E224).
This medicine contains 204 mg sodium per effervescent tablet. You should consider this if you control your sodium dietary intake.
This medicine contains "sulfite" and can cause severe allergic reactions and respiratory discomfort.
3. HOW TO TAKE DOLIPRANE 500 mg, effervescent tablet?
Dosage
This presentation is reserved for the adult and the child from 27 kg (from about 8 years).
In the child
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 dependent on the weight of the infant: it is approximately 60 mg / kg per day , divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours or 10 mg / kg all the 4 hours.
The usual dosage is:
For children weighing 27 to 40 kg (approximately 8 to 13 years), the dosage is 1 tablet at 500 mg per dose, to be renewed if necessary after 6 hours, without exceeding 4 tablets per day.
For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 tablet at 500 mg per dose, to be renewed if necessary after 4 hours, without exceeding 6 tablets per day.
For adults and children weighing more than 50 kg (from about 15 years old):
The usual dosage is 1 or 2 tablets at 500 mg per dose (according to the intensity of the pain), to be renewed if necessary after 4 hours minimum.
It is generally not necessary to exceed 3 g of paracetamol per day, ie 6 tablets per day.
However, in case of more severe pain, and on the advice of your doctor or pharmacist , the total dose can be increased up to 4 g per day, ie 8 tablets per day. If you feel that the effect of DOLIPRANE is too strong or too weak, talk to your doctor or pharmacist.
Warning :
· Dosages above 3 g of paracetamol per day require medical advice ,
· NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking all medicines containing paracetamol into their formula).
· Always respect an interval of at least 4 hours between the catches.
In severe kidney disease (severe kidney failure), catches should be spaced 8 hours apart and the total daily dose should not exceed 6 tablets (3 g).
Special situations
The maximum daily dose shall not exceed 60 mg / kg (not to exceed 3 g) per day in the following situations:
· adults 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 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 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 increased bilirubin levels in the blood).
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
Method and route of administration
Oral use.
Drink after complete dissolution in a glass of water.
Taking a tablet or capsule is contraindicated in children before 6 years because it can swallow and choke. Use another form.
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 place too hot.
Frequency of Administration
Regular intakes prevent pain or fever from returning: see section "Posology".
In children, catches should be regularly spaced, including at night, preferably 6 hours , and at least 4 hours.
In adults , catches must be spaced at least 4 hours apart.
In case of severe kidney disease (severe kidney failure), you should wait at least 8 hours between each dose.
If you feel that the effect of DOLIPRANE is too strong or too weak, talk to your doctor or pharmacist.
Duration of treatment
Except for medical advice, the duration of treatment is limited:
· at 5 days in case of pain,
· to 3 days in case of fever
If the pain persists more than 5 days or fever more than 3 days, if they worsen, do not continue treatment without the advice of your doctor.
If you take more DOLIPRANE 500 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 some 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.
If you forget to take DOLIPRANE 500 mg, effervescent tablet:
Do not take a double dose to make up for a missed dose.
If you stop taking DOLIPRANE 500 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 abrupt swelling of the face and neck, which may cause difficulty breathing (angioedema)
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.
· Very rare cases of serious adverse reactions have been reported.
· 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 disorder in patients with glucose-6-phosphate dehydrogenase deficiency, 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), pain localized in the chest that can radiate to the left shoulder and the 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 DOLIPRANE 500 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.
Keep away from moisture and heat.
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 DOLIPRANE 500 mg contains, effervescent tablet
· The active substance is:
Paracetamol................................................. .................................................. ........... 500.00 mg
· The other components are:
Sodium bicarbonate, anhydrous citric acid, mannitol, leucine, anhydrous sodium carbonate, sodium saccharin, orange flavoring (containing sodium metabisulphite (E223) and potassium metabisulfite (E224)), povidone and sodium laurilsulfate. See section 2 "DOLIPRANE 500 mg, effervescent tablet contains".
What is DOLIPRANE 500 mg, effervescent tablet and contents of the pack
This medication is in the form of an effervescent tablet.
Each box contains 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
SANOFI WINTHROP INDUSTRIE
NORTH-EAST AREA
RUE EDOUARD BRANLY
14104 LISIEUX CEDEX
or
A NATTERMANN & CIE GMBH
NATTERMANNALLEE 1
50829 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 Council:
WHAT TO DO IN THE EVENT 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 medicine is reserved for adults and children from 27 kg (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.
With this medication, the fever should drop rapidly. However :
· 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.