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SIMALVIA 60 MG/300 MG SOFT CAPSULES

Active substance(s): ALVERINE CITRATE / SIMETICONE / ALVERINE CITRATE / ALVERINE CITRATE / SIMETICONE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
SimAlvia 60 mg/300 mg, soft capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 60 mg alverine citrate and 300 mg simeticone.
Excipient with known effect: soya lecithin (traces).
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Capsule, soft.
Soft oblong capsule, size 6, shiny opaque white, containing a thick whitish
suspension.

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
Relief of abdominal pain in irritable bowel syndrome.
SimAlvia, soft capsule is indicated in adults only.

4.2

Posology and method of administration
Posology
Paediatric population
The safety and efficacy of SimAlvia, soft capsules in children under 18 years of age
have not been established.
Method of administration
For oral administration
Adults (including the elderly
1 soft capsule two to three times daily at the beginning of meals.

4.3

Contraindications
Paralytic ileus
Intestinal obstruction
Use in pregnancy and lactation

History of allergic reaction or intolerance to alverine or to any of the excipients
Hypersensitivity to peanut or soya.

4.4

Special warnings and precautions for use
Other causes of gastro intestinal pathology should be outruled, and patients not
improving after 2 weeks of treatment should be reviewed by physician.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Fertility, pregnancy and lactation
Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to
reproductive toxicity (see section 5.3).
A moderate amount of data on pregnant women indicate no malformative or feto/
neonatal toxicity of alverine citrate. There are no data from the use of simeticone or
the combination in pregnant women.
As a precautionary measure, it is preferable to avoid the use of SimAlvia, soft
capsules during pregnancy.
Breastfeeding
It is unknown whether alverine citrate or simeticone and their metabolites are
excreted in human milk. This medicinal product should be avoided during
breastfeeding.
Fertility
There are no data on the effects of alverine citrate or simeticone on human fertility.

4.7

Effects on ability to drive and use machines
SimAlvia, soft capsules have no influence on the ability to drive and use machines.

4.8

Undesirable effects
The side effects 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 (<1/10,000). Within each frequency grouping,
undesirable effects are presented in order of decreasing seriousness.
Due to the presence of alverine:
Hepatobiliary disorders
Very rare
Liver disorders which resolve after treatment discontinuation.

Respiratory, thoracic and mediastinal disorders
Very rare
Laryngeal oedema
Skin and subcutaneous tissue disorders:
Very rare
Urticaria

Vascular disorders
Very rare
Shock
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the MHRA Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

4.9

Overdose
No case of overdose has been reported.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Musculotropic antispasmodic / Anti-flatulent, ATC code:
A03AX58
Alverine citrate is a non-atropinic, papaverine-like musculotropic antispasmodic.
Simeticone is an inert substance which has a physical action by altering the surface
tension of gas bubbles, leading to their coalescence.

5.2

Pharmacokinetic properties
Simeticone is not absorbed from the gastrointestinal tract. Following oral
administration, it is eliminated in unchanged form in the faeces.
A clinical study confirmed that alverine crosses the gastro-intestinal barrier with
inter-individual variability. However in most patients, plasma concentrations were
lower than 1ng/ml.
Steady-state for plasma concentrations of alverine were reached within 5 days,
therefore no more increase in plasma levels is expected in case of repeated
administration for a period of time longer than 7 days.

5.3

Preclinical safety data
Non clinical studies of single and repeated dose toxicity, genotoxicity, toxicity to
reproduction and development provide evidence that alverine citrate has no
significant systemic toxicity potential.
Simeticone is not absorbed from the intestinal lumen. Systemic effects are therefore
not expected.
No long term studies to evaluate carcinogenicity have been performed in animals with
alverine citrate or with the combination of alverine citrate and simeticone.
Simeticone was shown to have no carcinogenicity potential.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Soft capsule shell:
Gelatin
Glycerol
Titanium dioxide (E171).
External lubricant composition:
Soya lecithin
Fractionated coconut oil.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
30 months

6.4

Special precautions for storage
Store below 25°C.
Keep in outer carton in order to protect from light.

6.5

Nature and contents of container
PVC/Aluminium thermoformed blister of 10 soft capsules.
Pack sizes of 10, 20, 30, 40, 60 or 90 capsules.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Laboratoires GALENIQUES VERNIN
20, rue Louis-Charles Vernin
77190 Dammarie-les-Lys
FRANCE

8

MARKETING AUTHORISATION NUMBER(S)
PL 15490/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/12/2014

10

DATE OF REVISION OF THE TEXT
27/07/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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