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SPC, UK: CLOMIPRAMINE Capsules (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clomipramine 10 mg Capsules, Hard.

Qualitative and quantitative composition

Clomipramine capsules contains 10 mg of clomipramine hydrochloride. Excipient with known effect: Each capsule contains 100 mg lactose monohydrate. Each capsule contains 0.0009 mg Sunset yellow (E110). ...

Pharmaceutical form

Capsule, hard. Clomipramine 10 mg capsules are red and yellow capsules, marked G CI10 and contain a white powder.

Therapeutic indications

Adults Clomipramine capsules are indicated for the treatment of: the symptoms of depressive illness especially where sedation is required. obsessional and phobic states. adjunctive treatment of cataplexy ...

Posology and method of administration

Posology Before initiating treatment with clomipramine, hypokalaemia should be treated (see section 4.4). After a response has been obtained, maintenance therapy should be continued at the optimum dose ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or cross-sensitivity to tricyclic antidepressants of the dibenzazepine group. Recent myocardial infarction, any ...

Special warnings and precautions for use

Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant ...

Interaction with other medicinal products and other forms of interaction

Interactions resulting in a contraindication MAO inhibitors Do not give clomipramine for at least 3 weeks after discontinuation of treatment with MAO inhibitors (there is a risk of severe symptoms consistent ...

Fertility, pregnancy and lactation

Women of child-bearing potential There are no data supporting any special recommendations in women of child-bearing potential. Pregnancy There is limited amount of data from the use of clomipramine in ...

Effects on ability to drive and use machines

Patients receiving clomipramine should be warned that blurred vision, drowsiness and other nervous system and psychiatric related disorders such as somnolence, disturbance in attention, confusion, disorientation, ...

Undesirable effects

Unwanted effects are usually mild and transient, disappearing under continued treatment or with a reduction in the dosage. They do not always correlate with plasma drug levels or dose. It is often difficult ...

Overdose

The signs and symptoms of overdose with clomipramine are similar to those reported with other tricyclic antidepressants. Cardiac abnormalities and neurological disturbances are the main complications. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antidepressants, Non-selective monoamine reuptake inhibitors ATC code: N06AA04 Mechanism of action The therapeutic activity of clomipramine is believed to be based on its ability ...

Pharmacokinetic properties

Absorption The active substance is completely absorbed following oral administration and intramuscular injection. The systemic bioavailability of unchanged clomipramine is reduced by 50% by first-pass ...

Preclinical safety data

Repeat-dose toxicity Phospholipidosis and testicular changes considered to be secondary to the phospholipidosis, commonly associated with tricyclic compounds, have been observed with clomipramine hydrochloride ...

List of excipients

Lactose monohydrate Maize starch Talc Silica, colloidal anhydrous Magnesium stearate Capsule Body: Sunset yellow (E110) Quinoline yellow (E104) Titanium dioxide (E171) Gelatin Capsule Cap: Iron oxide red ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in a dry place below 25°C.

Nature and contents of container

Packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 180 capsules in either: Polypropylene containers with tamper evident polythylene caps and optional use of polyethylene ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Potters Bar, Herts, EN6 1TL

Marketing authorization number(s)

PL 04569/0229

Date of first authorization / renewal of the authorization

Date of first authorisation: 13 November 1990 Date of latest renewal: 7 February 1996

Date of revision of the text

April 2016

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