Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clomipramine hydrochloride
Actavis UK Ltd
N06AA04
Clomipramine hydrochloride
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5012617010377
Pharma code 546 BLACK PANTONE® GREEN C ZINC Ref: EAS4843A LEA CLOMIPRAMINE 10MG 25MG 50MG CAP TUK 27 APRIL 2020 Version: 1 Colours Used: Length: Width: Depth: 323 MM 210 MM - TEMPLATE UK & Ireland Artwork Department CLOMIPRAMINE 10 MG, 25 MG AND 50 MG CAPSULES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT CLOMIPRAMINE IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE CLOMIPRAMINE 3. HOW TO TAKE CLOMIPRAMINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLOMIPRAMINE 6. FURTHER INFORMATION WHAT CLOMIPRAMINE IS AND WHAT IT IS USED FOR Clomipramine belongs to a group of drugs called tricyclic antidepressants. Clomipramine is used: • to treat depression • to treat phobias and obsessive states • to treat cataplexy (collapse) associated with narcolepsy (a sleep disorder). BEFORE YOU TAKE CLOMIPRAMINE DO NOT TAKE CLOMIPRAMINE IF YOU: • are allergic (hypersensitive) to clomipramine hydrochloride, tricyclic antidepressants or any of the other ingredients of this medicine • have severe liver problems • have recently had a heart attack or you suffer from any other heart problems • have difficulty in passing urine • have narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye) • suffer from mania (a mood disorder characterised by high levels of excitement and activity) • are taking, or have taken within the last three weeks a medicine for depression called a monoamine oxidase inhibitor (MAOI) • you are aged under 18. TAKE SPECIAL CARE WITH CLOMIPRAMINE Tell your doctor before you start to take this medicine if you: • suffer from epileptic fits Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clomipramine 25 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25 mg clomipramine hydrochloride. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Size 4 gelatin capsule, brown cap and orange body. Printed '1807'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clomipramine capsules are indicated for the symptoms of depressive illness, especially where sedation is required, and obsessive and phobic states. Clomipramine capsules are also indicated for cataplexy associated with narcolepsy. CHILDREN AND ADOLESCENTS In children and adolescents, there is not sufficient evidence of safety and efficacy of clomipramine in the treatment of depressive states, phobias and cataplexy associated with narcolepsy. The use of clomipramine in children and adolescents (0-17 years of age) in these indications is therefore not recommended (see section 4.4 Special Warnings and Precautions for use). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Before initiating treatment with clomipramine, hypokalemia should be treated (see 4.4. Special Warnings and Precautions for use). As a precaution against possible QTc prolongation and serotonergic toxicity, adherence to the recommended doses of clomipramine is advised and any increase in dose should be made with caution if other serotonergic agents are co-administered (see sections 4.4 Special Warnings and Precautions for use and 4.5 Interaction with other Medicinal Products and other forms of Interaction). DEPRESSION _Adults_ Initially 10 mg daily, increasing gradually to 30 - 150 mg daily if required, in divided doses throughout the day, or as a single dose at bedtime. In most patients the adequate maintenance dose is 30 - 50 mg daily, although some patients may require higher doses, particularly those suffering from obsessional or phobic disorders. In severe cases the dosage may be increased up to 250 mg per day. Once a distinct improvement has set in, the daily dosage may be adjusted Read the complete document