DIVIDOL Coated tablet Ref.[28246] Active ingredients: Butylscopolamine

In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool, medical advice should be sought immediately.

Dividol 10 mg coated tablets should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Due to the risk of anticholinergic complications, caution should be used in patients susceptible to intestinal or urinary outlet obstruction.

Because of the possibility that anticholinergics may reduce sweating, Dividol 10 mg coated tablets should be administered with caution to patients with pyrexia.

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Dividol 10 mg coated tablets in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision whilst or after taking Dividol 10 mg coated tablets.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Before taking Dividol 10 mg coated tablets a doctor should be consulted if any of the following apply:

• if this is the first time the patient has symptoms of Irritable Bowel Syndrome.
• the patient is 40 years or over and it is some time since the last episode of IBS/abdominal cramps or the symptoms are different this time.
• the patient has recently passed blood from the bowel.
• the patient is feeling sick or vomiting.
• the patient has lost his/her appetite or lost weight.
• the patient looks pale and is feeling tired.
• the patient is suffering from severe constipation.
• the patient has a fever.
• the patient has recently travelled abroad.
• the patient has abnormal vaginal bleeding or discharge.
• the patient has difficulty or pain passing urine.

If symptoms do not improve or if they worsen after 2 weeks of treatment, a doctor should be consulted.

Paediatric population

Dividol 10 mg coated tablets are not recommended for use in children under 12 years of age.

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by Dividol 10 mg coated tablets.

Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

The tachycardic effects of beta-adrenergic agents may be enhanced by Dividol 10 mg coated tablets.

Pregnancy

There is limited data from the use of hyoscine butylbromide in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Breast-feeding

There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk.

As a precautionary measure, it is preferable to avoid the use of Dividol 10 mg coated tablets during pregnancy and lactation.

Fertility

No studies on the effects on human fertility have been conducted.

No studies on the effects on the ability to drive and use machines have been performed. Because of visual accommodation disturbances patients should not drive or operate machinery if affected.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of hyoscine butylbromide. Anticholinergic side effects of Dividol 10 mg coated tablets are generally mild and self-limited.

Adverse events have been ranked under headings of frequency using the following convention: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from the available data).

Immune system disorders

Not known*: anaphylactic shock, anaphylactic reactions, dyspnoea and hypersensitivity.

Cardiac disorders

Uncommon: tachycardia.

Gastrointestinal disorders

Uncommon: dry mouth, constipation.

Eye disorders

Not known: visual accommodation disturbances.

Skin and subcutaneous tissue disorders

Uncommon: skin reactions (e.g. urticaria, pruritus), abnormal sweating.

Not known*: rash, erythema.

Renal and urinary disorders

Rare: urinary retention.

^* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon (3/1,368), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 1,368 patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 national reporting system.

Cyprus: Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs

Not applicable.