Composition
Chlordiazepoxide 5 mg
Clidinium bromide 2.5 mg

Properties, effects
Chlordiazepoxide and clidinium bromide complement each other in their effect on disordered gastrointestinal and genitourinary functions.
Chlordiazepoxide is a well tolerated benzodiazepine which relieves anxiety and tension and has a muscle-relaxant action. It is indicated when anxiety or tension has a causative or secondary effect on the clinical picture.
Clidinium bromide is a synthetic anticholinergic, which has a spasmolytic effect on smooth muscle and inhibits secretion.
The combination of the two active components exerts simultaneous peripheral and central effects on symptoms observed in functional disorders of the gastrointestinal and genitourinary tracts. It rapidly stabilizes disturbed autonomic functions in appropriate indications.

Indications
Digestive tract: irritable or spastic colon, functional manifestations of hypersecretion and hypermotility, diarrhea, colitis, gastritis, duodenitis, gastric ulcer, duodenal ulcer, biliary dyskinesia.
Genitourinary tract: spasm and dyskinesia, nocturnal enuresis, irritable bladder, dysmenorrhea.

Standard dosage
3-4 dragées daily, preferably taken with fluid half an hour before meals.

Special dosage instructions
Elderly and debilitated patients: initially 1-2 tablets daily, to be increased to the most effective dose that is well tolerated.
Children: 1-2 tablets daily according to age and condition.
The tablets are taken with fluid and can either be swallowed whole or crushed.

Restrictions on use
Librax is contraindicated for patients with known hypersensitivity to chlordiazepoxide or clidinium bromide, and also in the presence of glaucoma. Particular caution is advised in patients with prostatic hypertrophy or myasthenia gravis. Depending on dosage, administration and individual susceptibility,
Librax may modify the patient’s reactions (e.g. driving ability, behavior in traffic). Blood, renal and hepatic function tests are recommended if treatment is given for prolonged periods.

Dependence
The use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychic dependence. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

Pregnancy, nursing mothers
For fundamental medical reasons,
Librax should not be administered in early pregnancy unless it is considered imperative to do so.Chlordiazepoxide and clidinium bromide pass into the milk of nursing mothers. For the treatment of gastrointestinal and genitourinary tract symptoms caused by anxiety and tension.

Undesirable effects
Librax is well tolerated in therapeutic doses. Side effects such as dryness of the mouth, constipation and disorders of micturition may occasionally occur. In elderly patients slight drowsiness may sometimes be observed, especially at the beginning of treatment. This usually disappears spontaneously or in response to a dosage reduction.

Interactions
If Librax is taken concurrently with preparations containing anticholinergic ingredients, e.g. amantadine, various antihistamines, butyrophenones, phenothiazines, tricyclic and tetracyclic antidepressants, the anticholinergic action of clidinium is potentiated.
During treatment with Librax, patients should avoid alcohol since the individual response cannot be foreseen.

Overdosage
Measures recommended for accidental or deliberate overdosage are gastric lavage, maintenance of airway patency and surveillance of the patient. If symptoms attributable to chlordiazepoxide predominate flumazenil is indicated.

Stability
This medicine should not be used after the expiry date (EXP) shown on the pack.

Packing
Pack of 30 Coated tablets