NOTICE
ANSM - Last updated: 26/07/2017
Name of the medicinal product
DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR,
drinkable suspension in sachet sweetened with liquid maltitol and sorbitol
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 DOLIPRANELIQUIZ 200 mg SUGAR-FREE, oral suspension in sachets sweetened with liquid maltitol and sorbitol and in which cases it is used?
2. What should I know before taking DOLIPRANELIQUIZ 200 mg SUGAR-FREE, drinkable suspension in a sweetened sachet with liquid maltitol and sorbitol?
3. How to take DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?
4. What are the possible side effects?
5. How to store DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?
6. Package contents and other information.
1. WHAT IS DOLIPRANELIQUIZ 200 mg SUGAR-FREE, oral suspension in sachet sweetened with liquid maltitol and sorbitol AND WHAT IT IS USED FOR?
DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR is an analgesic (calms the pain) and an antipyretic (lowers the fever): code ATC N02BE01.
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 the child from 11 to 25 kg (about 18 months to 10 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 DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?
Never give DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR:
· If your child is allergic (hypersensitive) to the active substance (paracetamol) or to any of the other ingredients of DOLIPRANELIQUIZ 200 mg SUGAR-FREE. 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 using DOLIPRANELIQUIZ 200 mg SUGAR-FREE.
Take special care with DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR:
· 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 by severe respiratory infections), or with 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 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 DOLIPRANELIQUIZ 200 mg?").
· In case of acute viral hepatitis, stop treatment and see your doctor.
Blood tests
Tell your doctor if you are giving DOLIPRANELIQUIZ 200 mg SUGAR-FREE to your child and should have a blood test because this medicine can disturb the results of 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 DOLIPRANELIQUIZ 200 mg SUGAR-FREE, oral suspension in sachet sweetened with liquid maltitol and sorbitol
Tell 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.
Do not combine this drug with sulfosodium catioresin (an active substance used in case of hyperkalaemia, an excess of potassium in the blood): the combination may cause a risk of colic necrosis which can be fatal.
If your child is taking oral anticoagulant therapy (warfarin or AVK), taking DOLIPRANELIQUIZ 200 mg SUGAR-FREE at maximum doses 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 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 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
DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol with food, drinks 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 cessation of treatment.
Sport
Not applicable.
Driving and using machines
Not applicable.
Important information about some of the ingredients of DOLIPRANELIQUIZ 200 mg SANS SUGAR, oral suspension in liquid-maltitol and sorbitol sweetened sachet
· This medicine contains sugars (sorbitol and liquid maltitol). Its use is discouraged in patients with fructose intolerance (rare hereditary disease).
· If your doctor has told you that your child has an intolerance to certain sugars, contact your doctor before giving this medicine.
· This medicinal product contains an azo dyestuff (E122 azorubine), ethyl, methyl and propyl hydroxybenzoate (NIPASEPT) and may cause allergic reactions
3. HOW TO TAKE DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
This presentation is reserved for the child from 11 to 25 kg (about 18 months to 10 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 of 11 to 16 kg (approximately 18 months to 5 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 between 17 and 20 kg (approximately 4 to 7 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 of 21 to 25 kg (approximately 6 to 10 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 DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR is too strong or too weak, talk to your doctor or pharmacist.
Method and route of administration
This medication is used orally.
The suspension can be pure or diluted in a small amount of beverage (eg water, milk, fruit juice).
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.
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
Frequency of Administration
Regular intakes prevent oscillations of pain or fever:
· Catches should be evenly spaced, including at night , preferably 6 hours and a minimum of 4 hours (refer to the "Dosage" section).
· If your child has a severe kidney disease (severe kidney failure), you should wait at least 8 hours between each sachet (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 have given your child more DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR 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 or give your child DOLIPRANELIQUIZ 200 mg SUGAR-FREE:
Do not give a double dose to make up for the missed dose.
If you stop taking DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol:
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 Sudden malaise with a significant 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.
· 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 in certain white blood cells that can cause serious infections (agranulocytosis), destruction of red blood cells in the blood (anemia hemolytic deficiency in patients with glucose-6-phosphate dehydrogenase deficiency, rounded red skin rash 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 which 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.
Like all medicines, this medicine may cause side effects, although not everybody gets them.
5. HOW TO STORE DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, drinkable suspension in sachet sweetened with liquid maltitol and sorbitol?
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 at a temperature not exceeding 30 ° C.
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 DOLIPRANELIQUIZ contains 200 mg SANS SUGAR, oral suspension in sachet sweetened with liquid maltitol and sorbitol
· The active substance is:
Paracetamol................................................. .................................................. 200 mg
For a bag of 8.3 ml
· The other components are:
Malic acid, xanthan gum, liquid maltitol (LYCASIN), 70% non-crystallizable sorbitol, sorbitol, anhydrous citric acid, ethyl methyl and propyl hydroxybenzoate (NIPASEPT), azorubine (E122) purified.
* Strawberry aroma composition: flavoring substances identical to natural, natural flavoring substances, propylene glycol, benzyl alcohol, ethyl maltol, maltol
What is DOLIPRANELIQUIZ 200 mg SANS SUGAR, oral suspension in a sweetened sachet with liquid maltitol and sorbitol and contents of the pack
Aspect of DOLIPRANELIQUIZ 200 mg WITHOUT SUGAR, oral suspension in sachet sweetened with liquid maltitol and sorbitol and contents of the pack
This medication is in the form of a drinkable suspension in 8.3 ml sachets.
Box of 12 or 100 sachets.
Marketing Authorization Holder
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
A. NATTERMANN & CIE GMBH
NATERMANNALLEE 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 notice has been 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 children from 11 to 25 kg (about 18 months to 10 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 hot place.
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 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 abruptly (including severe pain in the chest) and / or reverses regularly,
· If it is accompanied by other signs such as a state of 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.