NOTICE
ANSM - Updated on: 26/07/2017
Description of the Medicine
DOLIPRANE ADULTS 1000 mg, suppository
© PARACA Tamol
© framed
Please read this leaflet carefully before you start using this medication as it contains important information for you.
You should always use this medication carefully following the information provided in this leaflet or by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· 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.
AT· Do not allow this medication to reach children.
What is in this leaflet?
1. What is DOLIPRANE ADULTS 1000 mg, suppository and in which cases is it used?
2. What should be known before using DOLIPRANE ADULTS 1000 mg suppository?
3. How to use DOLIPRANE ADULTS 1000 mg suppository?
4. What are the possible undesirable effects?
5. How to store DOLIPRANE ADULTS 1000 mg suppository?
6. Contents of the package and other information.
1. WHAT DOLIPRANE ADULTS 1000 mg, suppository AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: OTHER ANALGESIC ANALGES AND ANTI-PYRETICS ANCIDALS ATC code: N02BE01
DOLIPRANE is an analgesic (calms the pain) and an antipyretic (lowers the fever).
The active substance of this medication 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, painful rulers.
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 paracetamol specimens with a more suitable dosage. Do not hesitate to ask your doctor or pharmacist for advice.
2. WHAT TO DO ABOUT BEFORE USING DOLIPRANE ADULTS 1000 mg, suppository?
Do not use DOLIPRANE ADULTS 1000 mg, suppository:
AT· If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medication, listed in section 6.
AT· If you have a severe liver disease.
AT· If you have recently had anal or rectal inflammation or bleeding from the rectum.
This medicine contains paracetamol. Other medicines contain it. Check that you are not taking any other medicines containing paracetamol, including if they are medicines obtained without a prescription. Do not combine them , so as not to exceed the recommended daily dose. (see "Dosage" and "Symptoms and Instructions for Overdose") |
Warnings and Precautions
Talk to your doctor or pharmacist before using DOLIPRANE ADULS 1000 mg suppository .
Take special care with DOLIPRANE
AT· If the pain persists more than 5 days , or the fever is longer than 3 days , or if there is insufficient efficacy or any other signs, do not continue treatment without your doctor's advice.
AT· Taking paracetamol may cause liver function problems.
AT· You should seek the advice of your doctor before taking this medication:
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 the middle of the day, if you have lost a lot of weight recently, if you are over 75 or if you are over 65 and you if you have AIDS or a chronic viral hepatitis, if you suffer from cystic fibrosis (genetic and hereditary disease characterized by long-term illness) (Eg, severe respiratory infections), or if you have Gilbert's disease (a hereditary condition associated with increased bilirubin levels in the blood).
o if you are allergic to aspirin and / or non-Steroidal anti-inflammatory drugs
AT· The consumption of alcoholic beverages during treatment is discouraged.
AT· In cases of recent withdrawal from chronic alcoholism, the risk of hepatic disease is increased.
AT· In case of administration in a child, the dose depends on its weight (see section "How to use DOLIPRANE ADULAS 1000 mg, suppository?").
AT· In case of acute viral hepatitis, stop your treatment and consult your doctor.
Blood tests
Tell your doctor if you are taking DOLIPRANE and you need to take a blood test because this medication can affect the results of your uric acid and sugar levels, in the blood.
IN CASE OF DOUBT DO NOT HESITATE TO ASK THE NOTICE OF YOUR DOCTOR OR YOUR PHARMACIST.
children
Not applicable.
Other medicines and DOLIPRANE ADULTS 1000 mg suppository
Inform your doctor or pharmacist if you are taking, have recently taken or could take any other medicines.
Do not take any other medicines containing paracetamol. You may be overdosed.
If you are taking an oral anticoagulant therapy (warfarin or AVK), the use of DOLIPRANE ADULAS 1000 mg, suppository at maximum doses (4 g / day) for more than 4 days requires enhanced monitoring biological examinations including the INR. In this case, consult your doctor.
If you are receiving paracetamol, a treatment with flucloxacillin (an antibiotic), you may be at risk of metabolic acidosis (too acidic blood, causing an acute respiratory frequency).
The toxicity of paracetamol can be increased if you take:
AT· medicines that are potentially toxic to the liver,
AT· medicines that promote the production of paracetamol toxic metabolite such as anti-epileptic medicines (phenobarbital, phenytoin, carbamazepine, topiramate),
AT· rifampicin (an antibiotic),
AT· at the same time alcohol.
DOLIPRANE ADULTS 1000 mg, suppository with food, drink and alcohol
The consumption of alcoholic beverages during treatment is discouraged.
Pregnancy, breastfeeding and fertility
If you are pregnant or nursing, planning to become pregnant or planning a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Pregnancy and breast feeding
This medication can be used during pregnancy and breast-feeding. Use the minimum 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.
© FertilitÃ
It is possible that paracetamol may alter women's fertility, in a manner that is reversible at the end of treatment.
Sport
Not applicable.
Driving and using machines
Not applicable.
3. HOW TO USE DOLIPRANE ADULTS 1000 mg, suppository?
Dosage
Always follow the dosage prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Due to the risk of rectal irritation, suppository administration should be as short as possible, should not exceed 4 suppositories per day and will be replaced as soon as possible by oral therapy.
In case of diarrhea, the suppository form is not adapted.
This presentation is reserved for the adult and the child weighing more than 50 kg (that is to say from about 15 years).
For children weighing less than 50 kg, there are other paracetamol dosages that are more suitable for dosing. 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 suppository per dose, to be renewed after 6 to 8 hours. If necessary, the plug can be reapplied after a minimum of 4 hours.
Caution: this presentation contains 1000 mg paracetamol per suppository: Never use 2 suppositories at a time. |
Dose of paracetamol never to exceed
AT· In an adult or a child weighing more than 50 kg:
It is generally not necessary to exceed 3 grams of paracetamol per day (ie 3 suppositories per day).
However, if you have more severe pain, and only on the advice of your doctor , the total dose can be increased to 4 grams of paracetamol per day (ie 4 suppositories per day).
NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking all medicines containing paracetamol into their formula).
AT· Special situations:
The maximum daily dose should not exceed 60 mg / kg / day (without exceeding 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 lately,
o if you suffer from dehydration,
o if you are suffering from chronic malnutrition, if you are in the summer, if you have lost a lot of weight recently, if you are over 75 or if you are over 65 and you have long-term illnesses, if you have AIDS or a chronic viral hepatitis, if you suffer from cystic fibrosis (genetic disease and characteristic hereditary disease) including severe respiratory infections), or if you have Gilbert's disease (a hereditary condition associated with an increase in blood bilirubin levels).
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST .
Method and route of administration
This medication is used rectally.
Detach a suppository according to the dotted lines | Remove the 2 edges to open | Meaning of suppository introduction (flat tip first to avoid rejection) |
Frequency of administration
Regular intakes prevent pain or fever from returning: see section "Dosage".
In children, the catch should be kept at regular intervals, including at night, preferably 6 hours , and at least 4 hours.
In adults , catches should 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, consult your doctor or pharmacist.
Duration of treatment
Unless medical notice is given, the duration of the treatment is limited:
AT· At 5 days in case of pain,
AT· 3 days in case of fever
If the pain persists more than 5 days or the fever more than 3 days, if they worsen, do not continue treatment without the advice of your doctor.
If you have used more than DOLIPRANE ADULTS 1000 mg, suppository you should not have:
Immediately consult your doctor or pharmacist or medical emergencies.
Overdose can lead to liver disease (hepatic insufficiency), gastrointestinal bleeding, brain disease (encephalopathy), coma, or even especially in populations at higher risk, such as young children, the elderly and in certain situations (liver disease, alcoholism, chronic malnutrition). In the first 24 hours, the main symptoms of poisoning are: nausea, vomiting, loss of appetite, abdominal pain, fetus.
Overdosage may also result in: pancreas (pancreatitis), hyperamylaseemia (increased amylase in the blood), 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 results in:
AT· fatigue, shortness of breath, and a finger;
AT· frequent infections accompanied by severe fever and chills, sore throat or ulcers of the mouth;
AT· a tendency to bleed or present spontaneous bruising, nosebleeds.
If you forget to use DOLIPRANE ADULTS 1000 mg suppository:
Do not take a double dose to make up for a forgotten dose.
If you stop using DOLIPRANE ADULTS 1000 mg, suppository:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
AT· 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 can cause difficulty breathing (Quedocotic edema),
o abnormal discomfort with significant drop in arterial pressure (anaphylactic shock).
If an allergy occurs, you should immediately stop using this medication and consult your doctor promptly. In the future, you will never have to take medicines containing paracetamol.
AT· Very rare adverse effects of severe skin have been reported.
AT· Exceptionally, this drug may decrease the number of certain blood cells: white blood cells (leukopenia, neutropenia), platelets (thrombocytopenia), which may manifest as nosebleeds or gums. In this case, consult a physician.
AT· Other possible undesirable effects (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 (hemolytic anemia in patients with glucose deficiency 6 'phosphate dehydrogenase), cutaneous eruption in rounded red patches with d Eating and burning sensation, leaving colored tasks that can appear at the same locations in the event of a medication recurrence (fixed pigmented rhythm), localized pain 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 physician.
AT· With the suppository form, there is a risk of rectal or anal irritation (see "Take special care with Doliprane").
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Centers of Pharmacovigilance â € 'Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE DOLIPRANE ADULTS 1000 mg suppository?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the carton.
Keep away from heat.
Do not throw any medicines into the whole sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DOLIPRANE ADULTS 1000 mg contains, suppository
AT· The active substance is:
© PARACA Tamol ............................................... .................................................. ................ 1000 mg
For a suppository.
AT· The other components are: solid synthetic hemi-glycerides.
What is DOLIPRANE ADULT 1000 mg, suppository and contents of the outer packaging
This medication is presented as a suppository. Each box contains 8 suppositories.
Holder of the marketing authorization
SANOFIâ € 'AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Operator of the marketing authorization
SANOFIâ € 'AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
SANOFI WINTHROP INDUSTRIE
ZI NORDâ € ™ EAST
RUE EDOUARD BRANLY
14104 LISIEUX CEDEX
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last day on which this notice was revised is as follows:
{month YYYY}.
Other
Detailed information on this medicinal product can be found on the website of the ANSM (France).
Health Education Council:
WHAT TO DO IN THE EVENT OF FEVER?
Normal body temperature varies from person to person and is between 36.5Â ° C and 37.5Â ° C. A rise above 38 ° C is considered a fever, but it is advised to treat the fever with a medication below 38.5Â ° C ° C.
This medication is for the adult and the child from 50 kg (ie from about 15 years).
If the disorders that the fever causes are too troublesome, you can take this medication that contains paracetamol in the doses indicated.
To avoid any risk of dehydration, consider frequent drinking.
With this medication, the fever must fall rapidly, nevertheless:
AT· if other signs appear,
AT· if the fever persists for more than 3 days or if it worsens,
AT· if the headache becomes violent, or in case of vomiting,
CONSULT YOUR DOCTOR IMMEDIATELY
WHAT TO DO IN CASE OF PAIN?
The intensity of the perception of pain and the ability to resist it vary from person to person.
AT· If there is no improvement after 5 days of treatment,
AT· if the pain is violent, unexpected and occurs abruptly (including severe pain in the chest) and / or reverses regularly,
AT· if it is accompanied by other signs such as general discomfort, fever, unusual swelling of the painful area, decreased strength in a limb,
AT· if it wakes you up at night,
CONSULT YOUR DOCTOR IMMEDIATELY