PRO-BANTHINE Tablet (2018)

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Περιεχόμενα

1. Name of the medicinal product

Pro-Banthine tablets 15 mg.

2. Qualitative and quantitative composition

Propantheline Bromide 15 mg. Excipients with known effect: This medicinal product contains lactose (31 mg) and sucrose (26.74 mg), see section 4.4 for further details. For the full list of excipients, ...

3. Pharmaceutical form

Tablets.

4.1. Therapeutic indications

Pro-Banthine is indicated in adults for the following conditions: Adjunctive in GI disorders characterised by smooth muscle spasm Hyperhidrosis Adult enuresis

4.2. Posology and method of administration

Posology Adults The recommended initial starting dose is one tablet before each meal and two tablets at bedtime. Subsequently, dosage should be adjusted according to the patients individual response and ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pro-Banthine is contraindicated in patients with obstructive diseases of the gastrointestinal or urinary tract, ...

4.4. Special warnings and precautions for use

In some patients, especially those with ileostomy or colostomy, diarrhoea may be a symptom of incomplete intestinal obstruction. Pro-Banthine therapy should be avoided in such patients. Patients with severe ...

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

Since antimuscarinics tend to delay gastric emptying they may alter the absorption of other medication given concomitantly. Analgesics: increased risk of antimuscarinic side effects when antimuscarinics ...

4.6. Pregnancy and lactation

Animal reproduction and teratology studies have not been performed. Cohort data on parasympatholytics indicate a possible association with minor malformations. In view of this, Pro-Banthine should not ...

4.7. Effects on ability to drive and use machines

Pro-Banthine may produce drowsiness or blurred vision. Patients should not drive or operate machinery if affected in this way.

4.8. Undesirable effects

Side effects of antimuscarinics include dryness of the mouth with difficulty in swallowing and thirst, dilatation of the pupils with loss of accommodation and sensitivity to light, increased intra-ocular ...

4.9. Overdose

Intensification of the usual side effects may occur. In severe intoxication disturbances of the central nervous system may occur resulting in convulsion, coma, circulatory failure, respiratory depression, ...

5.1. Pharmacodynamic properties

Pharmacotherapuetic group: Synthetic anticholinergics, quaternary ammonium compounds ATC Code: A03AB05 Pro-Banthine inhibits parasympathetic activity by blocking the action of the neurohormone, ...

5.2. Pharmacokinetic properties

Propantheline bromide is extensively metabolised in man. Some enzymatic hydrolysis of the drug may occur in the gastrointestinal tract prior to its absorption. Studies in healthy men demonstrated that ...

5.3. Preclinical safety data

Not applicable.

6.1. List of excipients

In the tablet core: lactose monohydrate, talc, maize starch, magnesium stearate and light liquid paraffin. In the coating: sucrose, calcium carbonate, saccharin sodium, titanium dioxide (E171), ...

6.2. Incompatibilities

None reported.

6.3. Shelf life

18 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Foil/PVC-PVdC strips of 100 or 112 tablets. HDPE bottles of the appropriate size to accommodate 1000 or 5000 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

8. Marketing authorization number(s)

PL 16508/0050

9. Date of first authorization / renewal of the authorization

28 February 1998

10. Date of revision of the text

October 2018

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