Spark

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SPARK® (SPARK)

Composition:

Active ingredient: mebeverine hydrochloride;

One film-coated tablet contains mebeverine hydrochloride – 135.0 mg;

Excipients: lactose monohydrate; microcrystalline cellulose; potato starch; sodium starch glycolate (type A); povidone; talc; magnesium stearate;

Film coating Opadry II White 85F18422: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol (macrogol), talc.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: white or almost white, round, biconvex tablets with a film coating.

Pharmacotherapeutic group.

Agents used in functional gastrointestinal disorders. Synthetic anticholinergic agents, esterified tertiary amines. ATC code A03A A04.

Pharmacological properties.

Pharmacodynamics.

Mebverine is a myotropic spasmolytic with direct action on the smooth musculature of the gastrointestinal tract. It relieves spasms without suppressing normal intestinal motility.

Pharmacokinetics.

Absorption

Mebverine is rapidly and completely absorbed following oral administration in tablet form.

Distribution

No significant accumulation is observed after repeated administration.

Biological transformation

Mebverine hydrochloride is mainly metabolized by esterases, which in the first stage of metabolism cleave the ester bonds, forming veratric acid and mebeverine alcohol.

In plasma, demethylcarboxylic acid (DMCA) is the main metabolite. The elimination half-life of DMCA at steady state is 2.45 hours. With repeated administration, Cmax and tmax of DMCA are 1670 ng/mL and 1 hour, respectively.

Elimination

Mebverine is completely metabolized and is not excreted unchanged; its metabolites are almost entirely eliminated. Veratric acid is excreted in urine. Mebeverine alcohol is also excreted by the kidneys, partially as the corresponding carboxylic acid and partially as DMCA.

Clinical characteristics.

Indications.

Symptomatic relief of irritable bowel syndrome.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients listed in the section "Composition".

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted, except for interaction with alcohol. In vitro and in vivo studies in animals have demonstrated absence of any interaction between mebeverine hydrochloride and ethanol.

Special precautions for use.

Since the coated tablets contain lactose, if you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicinal product.

Do not use the medicinal product without consulting a doctor and seek medical advice as soon as possible in the following cases:

• age over 40 years,
• gastrointestinal bleeding,
• malaise or vomiting,
• pallor and fatigue,
• severe constipation,
• fever,
• recent travel abroad,
• pregnancy or suspicion of pregnancy,
• abnormal vaginal bleeding or discharge,
• difficult urination or pain during urination.

Consult your doctor if new symptoms occur, if existing symptoms worsen, or if there is no improvement after 2 weeks of treatment.

Use during pregnancy or breastfeeding.

Pregnancy

There are only very limited data on the use of mebeverine in pregnant women. Reproductive toxicity studies in animals are insufficient. Mebeverine is not recommended during pregnancy.

Breastfeeding

It is unknown whether mebeverine or its metabolites are excreted in human breast milk. Excretion of mebeverine into animal breast milk has not been studied. Mebeverine should not be used during breastfeeding.

Fertility

There are no clinical data on the effect on male or female fertility; however, animal studies do not indicate any harmful effect of mebeverine on fertility.

Ability to influence reaction speed when driving or operating machinery.

Studies on the influence of mebeverine on the ability to drive vehicles or operate machinery have not been conducted. However, the pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effect of mebeverine on the ability to drive or operate machinery.

Dosage and Administration

For oral use.

Tablets should be taken with sufficient amount of water (not less than 100 mL). Chewing the tablet is not recommended due to its unpleasant taste.

Duration of use is not limited.

If one or several doses are missed, the patient should take the next dose as scheduled. Missed dose(s) should not be compensated by taking additional doses on top of the regular dose.

Adults (including elderly patients)

Take 1 tablet three times daily, preferably 20 minutes before meals.

If symptoms persist for more than 2 weeks, a doctor should be consulted.

Warning

Do not exceed the recommended dose.

Special populations

Dosage studies in elderly patients and in patients with impaired renal and/or hepatic function have not been conducted. However, based on available post-marketing data, no specific risk has been identified in elderly patients or in patients with impaired renal and/or hepatic function. Dose adjustment in elderly patients and in patients with impaired renal and/or hepatic function is not considered necessary.

Children

Due to insufficient data on safety and efficacy, the drug is not recommended for use in children and adolescents (under 18 years of age).

Overdose

Symptoms: In case of overdose, theoretically, central nervous system stimulation may occur. With mebeverine overdose, no symptoms have been observed or were of moderate severity and resolved rapidly. Observed overdose symptoms were of neurological and cardiovascular origin.

Treatment: No specific antidote is known. Symptomatic treatment is recommended in case of overdose. Gastric lavage is recommended only in cases of intoxication with multiple drugs or when overdose symptoms are diagnosed within 1 hour after drug intake. Measures to reduce absorption are not necessary.

Side effects

The adverse reactions listed below have been reported spontaneously during post-marketing use. The exact frequency cannot be determined from the available data.

Allergic reactions, primarily affecting the skin, as well as systemic reactions not limited to skin manifestations, have been observed.

Immune system disorders:

Hypersensitivity (anaphylactic reactions).

Skin and subcutaneous tissue disorders:

Urticaria, angioneurotic edema, facial swelling, rash.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 30 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister pack. 2, 3 or 5 blisters per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.