Summary of Product Characteristics (SmPC) - Simalvia 60 mg/300 mg, soft capsules
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 CLINICAL PARTICULARS
4.1 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.
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. These elevations may be associated with a concomitant elevation in total serum bilirubin (see section 4.8). In case of an elevation in hepatic aminotransferases > 3 times the ULN and/or in the case of jaundice, treatment with alverine/simeticone should be discontinued.
Patients should be warned to report immediately any signs and symptoms of unexplained persistent nausea, decreased appetite, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale faeces. Patients with these symptoms should discontinue taking SimAlvia and the patient's hepatic function should be immediately evaluated.
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
Alverine/simeticone 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 affect 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) and not known frequency (cannot be estimated on the basis of the available data).
Due to the presence of alverine:
Hepatobiliary disorders
Very rare
Cytolytic hepatitis (see section 4.4).
Investigation
Not known
Elevated transaminases, alkaline phosphatase, and bilirubin.
Skin and subcutaneous tissue disorders:
Not known
Angioedema, skin rash, urticaria, and pruritus.
Immune system disorders
Very rare
Anaphylactic type reactions, and anaphylactic shock.
Ear and labyrinth disorders
Not known
Vertigo.
Nervous system disorders
Not known
Headache.
Gastrointestinal disorders
Not known
Nausea.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Cases of vertigo have been reported when a higher-than-recommended dosage is taken.
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
31/08/2022
10 DATE OF REVISION OF THE TEXT
31/08/2022