NOTICE
ANSM - Updated on: 08/01/2016
Name of the medicinal product
ATEPADENE 30 mg capsule
Adenosine triphosphate trihydrate trihydrate
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for your treatment.
You should always take this medication exactly as prescribed by your doctor, pharmacist or nurse.
· Keep this leaflet, you may need to read it again.
· Ask your pharmacist for advice or information.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist. See section 4.
Review summary
What this leaflet contains:
1. What is ATEPADENE 30 mg capsule and in which cases is it used?
2. What information should I take before taking ATEPADENE 30 mg capsule?
3. How to take ATEPADENE 30 mg capsule?
4. What are the possible side effects?
5. How to store ATEPADENE 30 mg capsule?
6. Additional information.
1. WHAT ATEPADENE 30 MG, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic group
muscle relaxant
(M: Muscle and Skeleton)
Therapeutic indications
This medication is used in the treatment of back pain.
2. BEFORE YOU TAKE ATEPADENE 30 Mg, capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take ATEPADENE 30 mg capsule:
· If you are allergic (hypersensitive) to adenosine triphosphate disodium trihydrate or any of the other ingredients of this medication mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with ATEPADENE 30 mg capsule:
Precautions for use
If pain persists or worsens, DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DOCTOR OR PHARMACIST.
This medication contains an azo dye (E122) and may cause allergic reactions.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
Generally, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before using any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
ATEPADENE 30 mg, capsule contains zorubine (E122).
3. HOW TO TAKE ATEPADENE 30 mg capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
2 to 3 capsules per day distributed throughout the day.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Method and route of administration
Oral use.
In all cases comply with medical prescription.
Symptoms and Instructions for Overdose
If you take more ATEPADENE 30 mg capsule than you should:
No case of overdose has been reported. However, a case of overdose may lead to an increase in adverse effects.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Very rare cases: Nausea, and skin manifestations such as erythematous eruptions, urticaria.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ATEPADENE 30 mg capsule?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use ATEPADENE 30 mg capsule after the expiry date which is stated on the outer packaging.
Storage conditions
Keep away from moisture.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment .
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What ATEPADENE contains: 30 mg capsule
The active substance is:
Adenosine triphosphate trihydrate trihydrate
Amount corresponding to Disodium Adenosine Triphosphate ............................................ .................. 30.00 mg
For a capsule.
The other components are:
Microcrystalline cellulose (Avicel PH 101), magnesium stearate, anhydrous colloidal silica (Aerosil 200).
Composition of the capsule shell : gelatin, azorubine (E122), titanium dioxide.
Pharmaceutical form and content
Aspect of ATEPADENE 30 mg capsule and contents of the pack
This medication is in the form of a capsule. Box of 20 or 30 capsules or aluminum tube of 30 capsules.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
XO LABORATORY
170, OFFICES OF THE HILL
92213 SAINT-CLOUD CEDEX
exploiting
EURODEP PHARMA
10 RUE ANTOINE DE SAINT EXUPERY
COMPAN PARK ZAC
77290 MITRY MORY
Maker
Laboratories MAYOLY SPINDLER
6, avenue de l'Europe
BP 51
78401 Chatou Cedex
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.