NOTICE
ANSM - Last updated: 04/05/2017
Name of the medicinal product
SPASFON, coated tablet
phloroglucinol / Trimethylphloroglucinol
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 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 talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is SPASFON, coated tablet and in which cases it is used?
2. What should be known before taking SPASFON, coated tablet?
3. How to take SPASFON, coated tablet?
4. What are the possible side effects?
5. How to store SPASFON, coated tablet?
6. Package contents and other information.
1. WHAT IS SPASFON, coated tablet AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: ANTISPASMODIQUE MUSCULOTROPE, ATC code: A03AX12 (A .: digestive system and metabolism) (G: genitourinary system)
SPASFON belongs to a class of medications called antispasmodics. It acts against spasms (contractions).
This medication is indicated for the treatment of spasmodic pain in the intestine, bile ducts, bladder and uterus.
2. BEFORE YOU TAKE SPASFON, coated tablet?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take SPASFON, coated tablet:
· if you are allergic to phloroglucinol, trimethylphloroglucinol or any of the other ingredients of this medication mentioned in section 6.
· if you are allergic to wheat, because of the presence of wheat starch.
Warnings and Precautions
Talk to your doctor or pharmacist before using SPASFON, a coated tablet .
Children and Youth
Not applicable.
Other drugs and SPASFON, coated tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
SPASFON, tablet coated with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of this medication should only be considered during pregnancy if necessary.
feeding
Administration of this medication is not recommended for nursing mothers.
Driving and using machines
SPASFON has no or negligible effect on the ability to drive and use machines.
SPASFON, coated tablet contains:
· Lactose and sucrose. Its use is not recommended in patients with galactose or fructose intolerance, Lapp lactase deficiency, sucrase / isomaltase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
· Wheat starch. Wheat starch can contain gluten, but only trace, and is therefore considered safe for people with celiac disease. It can therefore be used if you have celiac disease.
3. HOW TO TAKE SPASFON, coated tablet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Spasfon is a symptomatic treatment. The duration of treatment varies according to the indication. If the symptoms persist, consult your doctor.
Dosage
In adults :
Take 2 tablets per dose, three times a day, with a minimum interval of 2 hours between each dose without exceeding 6 tablets per 24 hours.
The tablets can take over from an attack treatment in injectable form, at the maximum dosage of 6 tablets per 24 hours.
Use in children
This presentation is not suitable for children under 6 years of age.
For children over 6 years of age: 1 tablet per dose, twice daily, with a minimum interval of 2 hours between each dose without exceeding 2 tablets per 24 hours.
In children over 6 years old, it should be ensured that the tablets can be swallowed, otherwise another form will be preferred.
Method and route of administration
Oral use.
The tablets should be swallowed with a glass of water.
If you take more SPASFON, coated tablet than you should:
Immediately consult your doctor or pharmacist.
If you forget to take SPASFON, coated tablet:
Do not take a double dose to make up for the missed dose.
If you stop taking SPASFON, coated tablet:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
In some cases an allergy may occur.
You will recognize the signs of an allergy:
· by pimples and / or redness on the skin, itching,
· by a sudden swelling of the face and neck (Quincke's edema),
· or a sudden discomfort due to a fall in blood pressure (anaphylactic shock).
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 SPASFON, coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medication after the expiry date indicated on the box. The expiry date refers to the last day of that month.
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 SPASFON contains, coated tablet
· The active substances are:
Phloroglucinol hydrate ................................................ .................................................. 80,000 mg
Corresponding amount of anhydrous phloroglucinol ............................................. 62.233 mg
Trimethylphloroglucinol ................................................. .................................................. 80,000 mg
For a coated tablet.
· The other components are:
Lactose monohydrate, sucrose, polyvinyl acetate, wheat starch, stearic acid, magnesium stearate.
Coating : polyvinyl acetate, talc, sucrose, gum arabic, gelatin, titanium dioxide (E171), erythrosine (E127), carnauba wax.
What is SPASFON, coated tablet and contents of the pack
This medication is in the form of a coated tablet. Box of 20, 30 or 500.
Marketing Authorization Holder
TEVA HEALTH
100-110 ESPLANADE OF GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Marketing Authorization Operator
TEVA HEALTH
100-110 ESPLANADE OF GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Maker
MACORS LABORATORIES
RUE DES CAILLOTTES
ZI PLAINE DES ISLES
89000 AUXERRE
Or
Sophartex
21 RUE DU PRESSOIR
28500 VERNOUILLET
Or
Galien LPS
98 rue bellocier
89100 SENS
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:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).