DOLIPRANE 300MG SACHETS 12 for sale in your approved pharmacy ars
For warnings, precautions for use and contraindications, please consult the instructions for use.
DOLIPRANE 300MG SACHETS 12 is indicated in case of pain and / or fever such as headache, flu-like conditions, dental pain, body aches.
Here is a table showing you the normal temperature values according to the method chosen to take it:
Body parts Normal temperature range
Rectum 36.6˚C to 38.4˚C (97.9˚F to 101.1˚F)
Mouth 35.5˚C to 37.9˚C (95.9˚F to 100.2˚F)
Ear 35.8˚C to 38.0˚C (96.4˚F to 100.4˚F)
Armpit 34.7˚C to 37.4˚C (94.5˚F to 99.3˚F)
If your child's temperature is higher than the values described in this table, it means that he has a fever.
Dosage:
Pour the contents of the sachet into a glass then add a small amount of drink (eg water, milk, fruit juice), stir and drink immediately after.
Contraindications:
Oral use
Read the instructions carefully.
Box of 12 sachets
Attention, the drug is not a product like the others. Read the package leaflet 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 - Last updated: 26/07/2017
DOLIPRANE 300 mg powder for oral solution in sachet-dose
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 300 mg powder for oral solution in sachet-dose and in which cases it is used?
2. What should I know before taking DOLIPRANE 300 mg powder for oral solution in a sachet-dose?
3. How to take DOLIPRANE 300 mg powder for oral solution in a sachet-dose?
4. What are the possible side effects?
5. How to store DOLIPRANE 300 mg powder for oral solution in a sachet-dose?
6. Package contents and other information.
1. WHAT IS DOLIPRANE 300 mg powder for oral solution in a sachet-dose AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER ANALGESICS and ANTIPYRETICS - 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, muscle aches.
This presentation is reserved for the child from 16 to 48 kg (about 4 to 15 years). Read the "Dosage" section carefully.
For children of different weights, there are other presentations of paracetamol with a more appropriate dosage. Do not hesitate to ask your doctor or pharmacist for advice.
2. BEFORE YOU TAKE DOLIPRANE 300 mg powder for oral solution in a sachet-dose?
Do not give DOLIPRANE 300 mg powder for oral solution in sachet-dose:
· If your child is allergic (hypersensitive) to the active substance (paracetamol) or to any of the other ingredients of DOLIPRANE. You will find the list of components in section 6,
· if your child has a serious liver disease.
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 this medicine.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
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 giving this medicine to your child:
o if he has a liver disease or a serious kidney disease,
o if he suffers from dehydration,
o suffering from chronic malnutrition, fasting, weight loss recently, AIDS or chronic viral hepatitis, suffering from chronic malnutrition, (genetic and hereditary disease, characterized in particular by serious respiratory infections), or if he is suffering from Gilbert's disease (a hereditary disease associated with an increase in the level of bilirubin in the blood),
o if your child is allergic to aspirin and / or nonsteroidal anti-inflammatory drugs.
· For information: the consumption of alcoholic beverages during the treatment is not recommended. 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 300 mg, powder for oral solution in a sachet-dose?").
· In case of acute viral hepatitis, stop treatment and see your doctor.
Blood tests
Tell your doctor if you are giving DOLIPRANE to your child and should have a blood test because this medicine can affect the results of 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 300 mg powder for oral solution in sachet-dose
Inform your doctor or pharmacist if your child is taking or has recently taken or could take any other medicines, including non-prescription medicines.
Do not take other medicines containing paracetamol. You may be overdosed.
If your child is on an oral anticoagulant therapy (warfarin or AVK), taking DOLIPRANE at maximum doses for more than 4 days requires enhanced monitoring of biological tests including INR. In this case, consult your doctor.
The effectiveness of paracetamol may be decreased if your child is taking chelating resins - a drug that lowers blood cholesterol levels (observe an interval of more than 2 hours between the 2 doses).
If your child is receiving paracetamol treatment with flucloxacillin (an antibiotic), your child may develop metabolic acidosis (too acidic blood to cause an increase in respiratory rate).
The toxicity of paracetamol can be increased, if your child takes:
· Potentially toxic drugs for 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 300 mg powder for oral solution in sachet-dose with 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.
Driving and using machines
Not applicable.
DOLIPRANE 300 mg, powder for oral solution in sachet-dose contains a sugar (sucrose) and sodium.
· This medicine contains a sugar (sucrose) which breaks down into fructose and glucose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases). If your doctor has already told you that your child has an intolerance to certain sugars, contact him before giving him this medicine.
· This medicine contains sodium. The sodium content is less than 1 mmol per sachet-dose, ie without sodium.
3. HOW TO TAKE DOLIPRANE 300 mg powder for oral solution in a sachet-dose?
This presentation is reserved for the child from 16 to 48 kg (about 4 to 15 years).
For children of different weights, there are other presentations of paracetamol with a more appropriate dosage. Do not hesitate to ask your doctor or pharmacist for advice.
Dosage
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, starting at 4 or 6 times, ie approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours .
Examples:
· For a child aged 16 to 24 kg (approximately 4 to 9 years): the usual dosage is 1 sachet per dose, to be renewed if necessary after 6 hours, without exceeding 4 sachets per day.
· For a child of 25 to 30 kg (approximately 8 to 11 years): the usual dosage is 1 sachet per dose, to be renewed if necessary after 4 hours, not to exceed 6 sachets per day.
· For a child aged 31 to 48 kg (approximately 10 to 15 years): the usual dosage is 2 sachets per dose, to be renewed if necessary after 6 hours, without exceeding 8 sachets per day.
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
If you feel that the effect of DOLIPRANE is too strong or too weak, talk to your doctor or pharmacist.
Method and route of administration
This medication is used orally.
Shake the sachet before use. You should pour the contents of the sachet into a glass and then add a small amount of drink (eg water, milk, fruit juice). Stir and have your child drink immediately afterwards.
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.
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
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 your child has a serious kidney disease (severe kidney failure), you should wait at least 8 hours between each bag.
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 or have given your child more than DOLIPRANE 300 mg powder for oral solution in a sachet-dose you should not have:
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 or give your child DOLIPRANE 300 mg powder for oral solution in sachet-dose:
Do not give a double dose to compensate for the dose you have forgotten to give.
If you stop taking or giving your child DOLIPRANE 300 mg powder for oral solution in sachet-dose:
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 Buttons 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 giving your child this medication and consult your doctor promptly. In the future, you will never have to give your child any medicine containing paracetamol.
o Very rare cases of serious adverse reactions have been reported,
o exceptionally, this drug may decrease the number of certain blood cells: white blood cells (leucopenia, neutropenia), platelets (thrombocytopenia) that can manifest themselves by bleeding from the nose or gums. In this case, consult a doctor,
o other possible adverse reactions (the frequency of which can not be estimated from the available data): liver function disorders, severe reduction in certain white blood cells that can cause serious infections (agranulocytosis), destruction of red blood cells in the blood 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, 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 300 mg powder for oral solution in sachet-dose?
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 300 mg contains, powder for oral solution in sachet-dose
· The active substance is:
Paracetamol................................................. .................................................. 300 mg
For a sachet-dose.
· The other ingredients are: sodium benzoate, povidone K30, acetylated monoglycerides, titanium dioxide, orange flavor *, sucrose.
* Composition of the orange flavor: water, maltodextrin, gum arabic, orange essential oil.
What is DOLIPRANE 300 mg powder for oral solution in sachet-dose and contents of the pack
This medication is in the form of a powder for oral solution in a sachet-dose.
Box of 10, 12, 24 or 100 sachets.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
82 AVENUE RASPAIL
94250 GENTILLY
SANOFI WINTHROP INDUSTRIE
ZI NORTH EAST
RUE EDOUARD BRANLY
14104 LISIEUX CEDEX
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}.
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 children from 16 to 48 kg (about 4 to 15 years).
If the disorders that fever causes are too troublesome, you can give your child this medication that contains paracetamol in accordance with the indicated dosages.
To avoid the risk of dehydration, consider frequent drinking.
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 she wakes up your child 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:
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