Sparex, 200 mg capsules 60 pcs

How to take, the dosage

Tablets should be swallowed without chewing, with plenty of water (at least 100 ml).
One tablet 3 times a day, about 20 minutes before meals.

The duration of preparation intake is not limited.

If the patient forgot to take one or more doses the preparation should be continued from the next dose. One or more missed doses should not be taken in addition to the usual dose.

Dosing studies in elderly patients, patients with renal and/or hepatic impairment have not been conducted. Available data on post-marketing use of the drug did not identify specific risk factors for its use in elderly patients and patients with renal and/or hepatic impairment. There is no need to change the dosing regimen in elderly patients and patients with renal and/or hepatic impairment.

Interaction

Only studies on the interaction of this drug with alcohol have been conducted. Animal studies have shown no interaction between mebeverine and ethanol.

Special Instructions

Consult your doctor before taking Sparex® if:

• if symptoms occur for the first time;
• unintentional and unexplained weight loss;
• anemia;
• reproctal bleeding or blood in the stool;
• fever;
colorectal cancer, celiac disease, or inflammatory bowel disease in your family;
• over 50 years of age and if symptoms occur for the first time;
• previous use of antibiotics.

Check with your doctor if the condition worsens or symptoms do not improve after 2 weeks of treatment.

Influence of the drug on the ability to drive vehicles, mechanisms

There have been no studies of the drug effect on the ability to drive vehicles and other mechanisms. Pharmacological properties of the drug as well as experience of its use do not indicate any adverse effect of mebeverine on the ability to drive vehicles and other mechanisms.

Contraindications

• Hypersensitivity;
• porphyria;
• pregnancy;
• children under 12 years of age (due to insufficient data on efficacy and safety).

With caution: use during lactation.

Side effects

Reports on the listed side effects were spontaneous, and for an accurate assessment of the frequency of cases the available data is insufficient.

Allergic reactions were observed mainly on the skin, but other manifestations of allergies were also noted.

Skin and subcutaneous tissue disorders

Urticaria (allergic rash), angioedema (serious allergic reaction that may include: difficulty breathing, swelling of the face, neck, lips, tongue, throat), facial edema, exanthema (skin rash).
Immune system disorders

Hypersensitivity reactions (anaphylactic reactions – serious allergic reactions which may include: difficulty breathing, rapid pulse, a sharp decrease in blood pressure (weakness and dizziness), sweating).

If you experience any of the side effects, including those not specified in these instructions, stop taking Sparex® and immediately see a physician!

Overdose

Symptoms: CNS agitation.

Pregnancy use

Pregnancy

There are only very limited data on the use of mebeverine in pregnant women. Data from animal studies are insufficient to assess reproductive toxicity. It is not recommended that mebeverine be used during pregnancy.

Breastfeeding

Information on the excretion of mebeverine or its metabolites into breast milk is insufficient. Studies of the excretion of mebeverine into milk in animals have not been conducted. Mebeverine should not be taken while breastfeeding.

Fertility

There are no clinical data on the effect of the drug on fertility in men or women, but known animal studies have shown no adverse effects of mebeverine.

Similarities

Duspatalin, Niaspam, Sparex, Mebeverine, Irritable bowel