METEOSPASMYL Soft capsule (2017)
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Περιεχόμενα
1. Name of the medicinal product
METEOSPASMYL, soft capsule.
2. Qualitative and quantitative composition
<u>Alverine citrate:</u> 60.00 mg <u>Simeticone:</u> 300.00 mg For 1 soft capsule. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Soft capsule. Soft oblong capsule, size 6, shiny opaque white, containing a thick whitish suspension.
4.1. Therapeutic indications
Symptomatic treatment of functional bowel disorders, especially those with bloating.
4.2. Posology and method of administration
For oral administration. FOR ADULTS ONLY. 1 soft capsule 2 to 3 times daily at the beginning of meals or when in pain.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Liver function Elevations in ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) > twice the upper limit of normal (ULN) have been reported in patients receiving treatment with alverine/simeticone. ...
4.5. Interaction with other medicinal products and other forms of interaction
The available to date data do not suggest the existence of clinically significant interactions.
4.6. Fertility, pregnancy and lactation
Pregnancy <u>Simeticone:</u> No effect is expected during pregnancy with the intake of simeticone due to negligible systemic exposure. <u>Alverine:</u> There are no exhaustive data of teratogenicity in ...
4.7. Effects on ability to drive and use machines
METEOSPASMYL has a minor influence on the ability to drive and use machines. Adverse effects such as vertigo have been reported in some patients (see sections 4.8 and 4.9). These types of disorders may ...
4.8. Undesirable effects
The adverse reactions listed below have been reported at frequencies corresponding to: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare ...
4.9. Overdose
Cases of vertigo have been reported when a higher-than-recommended dosage is taken.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> MUSCULOTROPIC ANTISPASMODIC/ANTIFLATULENT <b>ATC code:</b> A03AX08 – Other drugs for functional gastrointestinal disorders. Alverine citrate is a musculotropic antispasmodic. ...
5.2. Pharmacokinetic properties
After oral administration, simeticone is not absorbed and passes through the gastrointestinal tract before being excreted unchanged. Alverine is absorbed from the gastrointestinal tract and rapidly converted ...
5.3. Preclinical safety data
Simeticone is chemically inert and is not absorbed systemically. Systemic toxic effects are therefore not expected. Conventional non-clinical studies of repeated dose toxicity and genotoxicity, provide ...
6.1. List of excipients
Soft capsule shell: Gelatin, glycerol, titanium dioxide (E171).
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
PVC/Aluminium blister packs: Store below 30°C. PVC/PE/PVDC-Aluminium blister packs: This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
20, 30 or 40 soft capsules in blister packs (PVC/PE/PVDC-Aluminium). 20, 30 or 40 soft capsules in blister packs (PVC/Aluminium). Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Laboratoires MAYOLY SPINDLER, 6 Avenue de lEurope – B.P. 51, 78401 CHATOU CEDEX France, Standard: Tel.: +33(0) 134805555, Medical information: Tel.: +33(0) 134807260
8. Marketing authorization number(s)
34009 278 526 4 0: 20 soft capsules in blister packs (PVC/PE/PVDC-Aluminium) 34009 278 527 0 1: 30 soft capsules in blister packs (PVC/PE/PVDC-Aluminium) 34009 278 528 7 9: 40 soft capsules in blister ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 05 June 1990 Date of latest renewal: 05 June 2010
10. Date of revision of the text
10 March 2017
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