Indications
Treatment of pain related to smooth muscle spasm of gastrointestinal tract such as irritable bowel syndrome, painful diverticular disease of the colon, pain caused by biliary-tract spasm, renal colic pain, primary dysmenorrhoea.
Administration, dosage:
Administration
SPAS-AGI 60 tablets should be swallowed whole with a glass of water, preferably with meal or after meal.
Dosage:
Adults (including the elderly): 1 – 2 tablets, 1-3 times daily.
Children under 12 years old: Not recommended.
Some attention on handling of the medicine before and after use
There are no special requirements for handling this medicine after use.
Contraindications:
Hypersensitivity to any of the composition of this medicine.
Intestinal obstruction or paralytic ileus.
Warnings and precautions for use:
Conditions where caution should be taken
Patients from 40 years of age.
Rectal bleeding or abnormal vaginal bleeding.
Feeling sick or vomiting, loss of appetite or weight loss, pallor, fatigue, fever.
Severe constipation, dysuria, painful urination; recent return from abroad travel.
Pregnant or of childbearing potential.
This medicine contains lactose, aspartame:
Lactose: Patients with rare genetic problems with galactose intolerance, Lapp lactase enzyme deficiency or glucose-galactose malabsorption should not take this medicine.
Aspartame: It is a source of phenylalanine, this substance can be dangerous for patients with phenylketonuria.
Pregnancy and lactation:
Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies is limited.
Women of childbearing potential or those currently using contraceptive methods should consult doctor carefully before being treated with this medication.
There is no information on the toxicity of alverine to the fetus.
Effects on ability to drive and use machines:
The influence of SPAS-AGI 60 on the ability to drive and use machines has not been studies. However, alverine citrate should be used with caution because it may cause headache, dizziness.
Interactions, incompatibilities of medicine:
Interaction with other medicinal products and other forms of interaction
Interactions between alverine and other drugs have not been reported.
Incompatibilities
Because there are no studies about the incompatibility of the medicine, it should not be mixed with other medicines.
Undesirable effects
Undesirable effects are classified according to frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR < 1/10), uncommon (1/1,000 ≤ ADR < 1/100), rare (1/10,000 ≤ ADR < 1/1,000), very rare (ADR < 1/10,000); cannot be estimated from the available data “Not known”.
Not known:
Immune system disorders: Allergic reaction, anaphylaxis, dyspnoea and/or wheezing.
Nervous system disorders: Headache, dizziness.
Gastrointestinal disorders: Nausea.
Hepato-biliary disorders: Jaundice due to hepatitis.
Skin and subcutaneous tissue disorders: Itching, rash.
Overdose and management
Overdose: Alverine overdose can produce hypotension and atropine-like toxic effects.
Management: Gastric lavage is recommended. Activated charcoal should be given before gastric lavage and supportive measure to treat hypotension is required.
Pharmacodynamic properties
Pharmacological group: Other drugs for functional bowel disorders
ATC code: A03AX08
Alverine citrate is a spasmolytic, which has a specific action on the smooth muscle of the alimentary tract and uterus, without affecting the heart, blood vessels and tracheal muscle at therapeutic doses.
Pharmacokinetic properties
After absorption from the gastrointestinal tract, alverine citrate is rapidly metabolized into an active metabolite, with peak plasma concentration reached 1 to 1.5 hours post ingestion. Subsequently, the drug is further converted into inactive metabolites and actively excreted in the urine via renal secretion.
The plasma half-life averages 0.8 hours for alverine and 5.7 hours for the active primary metabolite.
Storage conditions, shelf life, quality specification of the medicine:
Storage conditions: Protect from humidity and light, below 300C.
Shelf life: 36 months from the manufacturing date.
Quality specification: In house
A1202043701
