DIVIDOL Coated tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Dividol 10 mg coated tablets.

2. Qualitative and quantitative composition

Each coated tablet contains 10 mg hyoscine butylbromide. Excipient(s) with known effect: This product contains 32.5 mg lactose and 47.718 mg sucrose. For the full list of excipients, see section ...

3. Pharmaceutical form

Coated tablet. White, round, sugar-coated tablets.

4.1. Therapeutic indications

Dividol 10 mg coated tablets are indicated for the relief of spasm of the gastro-intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome (IBS).

4.2. Posology and method of administration

Posology Relief of spasm of gastrointestinal tract Adults and children over 12 years: Two tablets (20 mg) four times daily. For the symptomatic relief of Irritable Bowel Syndrome Adults and ...

4.3. Contraindications

Dividol 10 mg coated tablets are contraindicated in patients with: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 myasthenia gravis mechanical stenosis in the ...

4.4. Special warnings and precautions for use

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, ...

4.5. Interaction with other medicinal products and other forms of interaction

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics ...

4.6. Fertility, pregnancy and lactation

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 ...

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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. ...

4.9. Overdose

Symptoms Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic effects such as urinary retention, dry mouth, reddening of the skin, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for Functional Gastrointestinal Disorders; Belladonna and Derivatives, Plain ATC code: A03BB01 Hyoscine butylbromide exerts a spasmolytic action on the smooth ...

5.2. Pharmacokinetic properties

Absorption As a quaternary ammonium compound, hyoscine butylbromide is highly polar and hence only partially absorbed following oral (8%) or rectal (3%) administration. After oral administration of single ...

5.3. Preclinical safety data

Hyoscine butylbromide was neither embryotoxic nor teratogenic at oral doses of up to 200 mg/kg in the diet (rat) or 200 mg/kg by gavage or 50 mg/kg s.c. (rabbit). Fertility was not impaired at doses of ...

6.1. List of excipients

Core: Cellulose, microcrystalline Lactose monohydrate Maize starch Povidone Starch, pregelatinised Magnesium stearate Talc Coating: Gelatin Macrogol 6000 Povidone Sucrose Talc Calcium carbonate ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protected from light and moisture.

6.5. Nature and contents of container

PVC/Aluminium blisters. Pack sizes of 20 and 100 coated tablets. PP containers with PE closure. Pack size of 1000 coated tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

19675

9. Date of first authorization / renewal of the authorization

Date of first authorization: 07 June 2005 Date of latest renewal: 11 April 2011

10. Date of revision of the text

07/2020

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