NOTICE
ANSM - Updated on: 18/12/2019
Name of the drug
PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet
Paracetamol / Caffeine
Box
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
· G rdez this manual. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel any improvement or if you feel worse after 3 days in case of fever and beyond 5 days in case of pain.
What does this booklet contain ?
1. What is PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet and in which cases is it used?
2. What you need to know before you take PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet?
3. How to take PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet?
4. What are the possible side effects?
5. How to store PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet?
6. Contents of the pack and other information.
1. WHAT PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code:
ANTALGIC peripheral / ANTIPYRETIC, (N. Central nervous system), ATC code: N02BE51
Therapeutic indications :
This medication contains paracetamol and caffeine.
It is indicated in adults and children over 50 kg (from 15 years) in case of fever and / or pain such as headache, flu-like conditions, dental pain, body aches, painful periods.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet?
Do not take PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet in the following cases:
· known allergies to paracetamol, caffeine or to one of the constituents of the product,
· severe liver disease,
· child under 15 (linked to the presence of caffeine).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Take special care with PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet:
Special warnings
In case of overdose or mistakenly taking too high a dose, notify a doctor immediately.
This medication contains paracetamol and caffeine.
Other drugs contain it. Do not combine them, so as not to exceed the recommended daily dose ( see section “3. HOW TO TAKE PRONTADOL ADULTS 500 mg / 50 mg, film-coated tablet breakable?” Paragraph “Dosage ”).
Precautions for use
This medicine contains potassium. The potassium level is less than 1 mmol per tablet, ie "potassium-free".
If the pain persists for more than 5 days or the fever for more than 3 days , or in the event of insufficient efficacy or the occurrence of any other sign, do not continue treatment without the advice of your doctor.
In case of severe liver or kidney disease, it is necessary to consult your doctor before taking paracetamol.
Due to the presence of caffeine, this medication can cause insomnia; it should not be taken at the end of the day.
IF IN DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Children and adolescents
This medication should not be used in children and adolescents under 15 years of age.
Other medicines and PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
· Report this medication if you are prescribed uric acid or blood sugar levels.
· This medication should be avoided in combination with enoxacin (antibiotic).
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medication will only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue it.
Feeding with milk
Large doses of caffeine may affect your child (restlessness, sleep disturbances). You should not exceed 100 to 200 mg of caffeine per day (either 2 to 4 tablets per day or 1 to 2 cups of coffee).
Therefore, if taking this medication is essential, it is important:
· avoid other intakes in the form of coffee, tea;
· take the medicine right after breastfeeding;
· to space out the catches as much as possible.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Please note : this specialty contains an active ingredient (caffeine) which can induce a positive reaction from tests carried out during doping controls.
Driving and using machines
Not applicable.
PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet contains
Not applicable.
3. HOW TO TAKE PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet?
Always take this medication exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.>
Reserved for adults and children over 50 kg (from 15 years old).
The recommended dose is 1 to 2 500 mg tablets per dose, depending on the intensity of the pain, to be renewed if necessary after at least 4 hours.
It is generally not necessary to exceed 3 grams of paracetamol per day, or 6 tablets per day.
However, in case of more severe pain, and on the advice of your doctor, the total dose may be increased up to 4 grams per day, or 8 tablets per day.
However:
· doses above 3 grams of paracetamol per day require medical advice.
· NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking into account all drugs containing paracetamol in their formula).
Always respect an interval of at least 4 hours between doses.
In case of severe kidney disease (severe renal failure), the doses should be spaced 8 hours apart, and the total dose should not exceed 6 tablets per day (3 grams).
If you have the impression that the effect of PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet is too strong or too weak, talk to your doctor or pharmacist.
If in doubt, ask your doctor or pharmacist for advice.
Method and route of administration
Oral use.
Swallow the tablet without chewing it with a large glass of water.
Frequency of administration
Systematic taking helps to avoid peaks of pain or fever.
In adults and children over 50 kg (from 15 years), they must be spaced at least 4 hours apart.
In case of severe kidney disease (severe renal failure), the catches will be spaced at least 8 hours apart.
Due to the presence of caffeine, avoid taking at the end of the day.
Duration of the treatment
The duration of treatment is limited:
· 5 days in case of pain
· 3 days in case of fever
If the pain persists for more than 5 days or the fever for more than 3 days or if it worsens, do not continue treatment without the advice of your doctor (see section “Take special care with PRONTADOL ADULTS 500 mg / 50 mg, tablet scored film ”paragraph“ Precautions for use ”).
If you take more PRONTADOL ADULTS 500 mg / 50 mg scored film-coated tablet than you should
In case of overdose or accidental poisoning, notify a doctor immediately.
If you forget to take PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
RELATED TO PARACETAMOL:
· In some rare cases, it is possible that a rash or redness or an allergic reaction may occur, which may be sudden swelling of the face and neck or sudden discomfort with a drop in blood pressure.
· Very rare cases of serious skin reactions have been reported. Symptoms may include redness, blisters, or rashes.
· If any of these effects occur, stop treatment immediately, tell your doctor and never take medicines containing paracetamol again.
· Exceptionally, biological changes requiring control of the blood balance have been observed: liver functioning disorders, abnormally low levels of certain white blood cells or certain blood cells such as platelets which can result in nosebleeds or gum bleeding. In this case, consult a doctor.
CAFEINE RELATED:
Possibility of excitement, insomnia, palpitations .
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or the blister. The expiration date refers to the last day of this month.
This medication does not require any special storage precautions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What PRONTADOL ADULTS 500 mg / 50 mg contains, scored film-coated tablet
· The active substances are:
Paracetamol................................................. .................................................. ................... 500.0 mg
Caffeine................................................. .................................................. ............................ 50.0 mg
For a film-coated tablet.
· The other components are:
Corn starch, pre-gelatinized corn starch, polyvidone, potassium sorbate, talc, stearic acid, croscarmellose sodium, hypromellose, triacetin.
What PRONTADOL ADULTS 500 mg / 50 mg, scored film-coated tablet looks like and contents of the pack
This medication is in the form of a scored film-coated tablet. Box of 10, 12, 16 tablets.
Not all presentations may be marketed.
Marketing authorization holder
ipsen consumer healthcare
65 quai georges gorse
92100 boulogne billancourt
Marketing authorization operator
ipsen consumer healthcare
65 quai georges gorse
92100 boulogne billancourt
Maker
DELPHARM EVREUX
5 rue du Guesclin
27000 EVREUX
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).