Doliprane 1000 mg tablets scored , is indicated in case of pain and / or fever such as headache, flu, dental pain, body aches and painful periods. It can also be prescribed in the pain of osteoarthritis . The active substance in doliprane is paracetamol .
For warnings, precautions for use and contraindications, please consult the instructions for use of DOLIPRANE 1000 mg 8 tablets.
Doliprane paracetamol 1000 mg tablets to swallow, is recommended in cases of pain and / or fever such as headache, flu-like conditions, dental pain, muscle aches and painful periods. It can also be prescribed in case of osteoarthritis pain.
Reserved for adults and children over 50 kg.
Paracetamol (the active ingredient in doliprane) is often a good choice. Paracetamol is one of the most common pain relievers and antipyretics.
Paracetamol is indicated for mild to moderate pain and fever (joint pain such as osteoarthritis, back pain, fever control, relief of fever and pain associated with the flu). On the other hand, paracetamol is not suitable for the treatment of inflammatory pain since it has no anti-inflammatory effect.
Contraindications:
Oral use
Read the package leaflet for DOLIPRANE 1000 mg in scored tablets carefully.
Box of 8 scored tablets
Attention, the drug DOLIPRANE 1000 mg 8 tablets is not a product like the others. Read the package leaflet for DOLIPRANE 1000 mg 8 tablets carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 27/07/2017
Paracetamol
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.
1. What is DOLIPRANE 1000 mg, tablet and in which cases it is used?
2. What should I know before taking DOLIPRANE 1000 mg tablet?
3. How to take DOLIPRANE 1000 mg tablet?
4. What are the possible side effects?
5. How to store DOLIPRANE 1000 mg tablets?
6. Package contents and other information.
1. WHAT DOES DOLIPRANE 1000 mg, tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER ANALGESICS AND ANTI-PYRETICS-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.
It may also be prescribed by your doctor in the pains of osteoarthritis.
This presentation is reserved for the adult and the child from 50 kg (that is to say from about 15 years). Read the Posology section carefully.
For children weighing less than 50 kg, there are other presentations of paracetamol whose dosage is more suitable. Do not hesitate to ask your doctor or pharmacist for advice.
2. BEFORE YOU TAKE DOLIPRANE 1000 mg tablets?
Do not take DOLIPRANE 1000 mg, 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.
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 1000 mg 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 your doctor's advice.
· Taking paracetamol may cause liver function problems.
· You should seek the advice of your doctor before taking this medicine:
o If you weigh 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 have an AIDS virus 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),
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.
· When administered to a child, the dose depends on its weight (see section "How to take DOLIPRANE 1000 mg 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 REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other medicines and DOLIPRANE 1000 mg 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 taking oral anticoagulant therapy (warfarin or AVK), taking DOLIPRANE 1000 mg tablet at maximum doses (4 g / day) for more than 4 days requires enhanced monitoring of 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 2 doses).
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:
· drugs potentially toxic to the liver,
· drugs that promote the production of the toxic metabolite of paracetamol such as anti-epileptic drugs (phenobarbital, phenytoin, carbamazepine, topiramate),
· rifampicin (an antibiotic),
· at the same time alcohol.
DOLIPRANE 1000 mg, tablet with food, beverages 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.
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.
Not applicable.
3. HOW TO TAKE DOLIPRANE 1000 mg tablet?
Always take the dose as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
This presentation is reserved for adults and children weighing more than 50 kg (ie from about 15 years).
For children weighing less than 50 kg, there are other presentations of paracetamol with a more appropriate dosage. Do not hesitate to ask your doctor or pharmacist for advice .
Dosage in adults and children from 50 kg (ie from about 15 years)
The usual dose is 1 tablet per dose, to be renewed after 6 to 8 hours. If necessary, the receptacle can be repeated after a minimum of 4 hours.
Caution: this presentation contains 1000 mg of paracetamol per tablet: never take 2 tablets at a time. |
Dose of paracetamol never to be exceeded
· In adults or children weighing more than 50 kg:
It is usually not necessary to exceed 3 grams of paracetamol per day (3 tablets per day).
However, if you have more intense pain, and only on the advice of your doctor , the total dose can be increased up to 4 grams of paracetamol per day (ie 4 tablets per day).
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:
o if you weigh 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 are suffering 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 disease characterized by severe respiratory infections), or if you have Gilbert disease (hereditary disease associated with increased bilirubin levels in the blood).
Method and route of administration
This medication is used orally.
You should swallow the tablets as is with a drink (eg water, milk, fruit juice).
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), catches will be spaced at least 8 hours apart. Do not exceed 3 tablets per day.
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 1000 mg 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.
If you forget to take DOLIPRANE 1000 mg, tablet:
Do not take a double dose to make up for the missed dose.
If you stop taking DOLIPRANE 1000 mg, 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 (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 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 DOLIPRANE 1000 mg 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.
No special storage conditions.
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 1000 mg contains: tablet
· The active substance is:
Paracetamol................................................. .................................................. .............. 1000 mg
For a tablet.
· The other components are: povidone, pregelatinized starch, sodium carboxymethyl starch (type A), talc, magnesium stearate.
What is DOLIPRANE 1000 mg tablets and contents of the pack
This medicine comes in tablet form. Each box contains 8 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
SANOFI WINTHROP INDUSTRIE
1360 RUE EDOUARD BRANLY
14100 LISIEUX
Or
SANOFI WINTHROP INDUSTRIE
56 CHOISY-AU-BAC ROUTE
60205 COMPIEGNE
Or
CHINOIN PRIVATE CO. LTD
LEVAI U 5
2112 VERESEGYHAZ
HUNGARY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this notice has been revised is
{month YYYY}.
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 above 38 ° C is 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 50 kg (ie from about 15 years).
If the disorders that the fever causes are too troublesome, you can take this medicine which contains paracetamol in the doses indicated.
To avoid any risk of dehydration, consider drinking frequently.
With this medication, the fever should drop rapidly, nevertheless:
· if other 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
Analgesic and antipyretic
paracetamol
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
DOLIPRANE 2.4% WITHOUT SUGAR: oral suspension (strawberry flavor); bottle of 100 ml with syringe graduated by half-kilo of body weight.
Refunded at 65%. - price: 1,29 euro (s).
DOLIPRANE 100 mg: powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,33 euro (s).
DOLIPRANE 100 mg: suppository scored; box of 10.
Refunded at 65%. - price: 1,24 euro (s).
DOLIPRANE 150 mg: powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,33 euro (s).
DOLIPRANE 150 mg: suppository; box of 10.
Refunded at 65%. - price: 1,24 euro (s).
DOLIPRANE 200 mg: powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,33 euro (s).
DOLIPRANE 200 mg: suppository; box of 10.
Refunded at 65%. - price: 1,24 euro (s).
DOLIPRANE 300 mg: powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,33 euro (s).
DOLIPRANE 300 mg: suppository; box of 10.
Refunded at 65%. - price: 1,24 euro (s).
DOLIPRANE 500 mg: scored tablet (white); box of 16.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 500 mg: effervescent tablet (white); box of 16.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 500 mg: capsule (yellow and blue); box of 16.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 500 mg: powder for oral solution (orange flavoring); box of 12 bags.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 1000 mg adult: tablet; box of 8.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 1000 mg adult: split effervescent tablet (orange flavoring); box of 8.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 1000 mg adult: capsule; box of 8.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 1000 mg adult: powder for oral solution (orange flavoring); box of 8 sachets.
Refunded at 65%. - price: 1,08 euro (s).
DOLIPRANE 1000 mg adult: suppository; box of 8.
Refunded at 65%. - price: 1,36 euro (s).
Laboratory Sanofi-Aventis France
| p grad 1 kg | p sachet | p assumed | |
| Paracetamol | 15 mg | 100 mg | 100 mg |
| sorbitol | 71.25 mg | ||
| maltitol | + | ||
| sugars | 270 mg | ||
| Sodium | 0.19 mg |
| p sachet | p assumed | p sachet | |
| Paracetamol | 150 mg | 150 mg | 200 mg |
| sugars | 40054 mg | 540 mg | |
| Sodium | 0.29 mg | 0.38 mg |
| p assumed | p sachet | p assumed | |
| Paracetamol | 200 mg | 300 mg | 300 mg |
| sugars | 800 mg | ||
| Sodium | 0.57 mg |
| p cp | pcp efferv | p gel | |
| Paracetamol | 500 mg | 500 mg | 500 mg |
| Sodium | 0.56 mg | 408 mg | |
| Gluten (wheat starch) | + |
| p sachet | p cp | pcp efferv | |
| Paracetamol | 500 mg | 1000 mg | 1000 mg |
| Sucrose | 1.34 g | 408 mg | |
| Sodium | 1.28 mg |
| p gel | p sachet | p assumed | |
| Paracetamol | 1000 mg | 1000 mg | 1000 mg |
| Sucrose | 2.68 g | ||
| Sodium | 1.88 mg |
Usual dosage:
