Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Lofepramine hydrochloride
Creo Pharma Limited
N06AA; N06AA07
Lofepramine hydrochloride
70 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Non-selective monoamine reuptake inhibitors; lofepramine
Marketed
1984-05-14
1 Package leaflet: Information for the user GAMANIL 70MG FILM-COATED TABLETS lofepramine (as hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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. WHAT IS IN THIS LEAFLET 1. What Gamanil is and what it is used for 2. What you need to know before you take Gamanil 3. How to take Gamanil 4. Possible side effects 5. How to store Gamanil 6. Contents of the pack and other information 1. WHAT GAMANIL IS AND WHAT IT IS USED FOR Gamanil belongs to a group of medicines called tricyclic antidepressants. Gamanil is used to treat symptoms of depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAMANIL DO NOT TAKE GAMANIL IF YOU: are allergic to lofepramine or any of the other ingredients of this medicine (listed in section 6) are allergic to other tricyclic antidepressants such as clomipramine and imipramine suffer from any mental illness other than depression (known as mania) have serious liver or kidney problems suffer from any serious heart problems, including irregular heart rhythms or have recently had a heart attack have untreated glaucoma (raised pressure of the fluid inside the eye) suffer from prostate problems with urinary retention suffer from chronic constipation are currently suffering from alcohol or drug poisoning or deliria are taking medicines to treat depression known as MONOAMINE OXIDASE INHIBITORS (MAOIS) such as phenelzine and iproniazid or you have taken MAOIs within the last 14 days WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Gamani সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 29 July 2019 CRN0090YL Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gamanil 70mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains lofepramine hydrochloride 76.10mg equivalent to 70.0mg lofepramine. Excipient(s) with known effect Each tablet contains 126.05mg lactose (as lactose monohydrate) and 1.15mg Ponceau 4R Red Aluminium Lake (E124). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, lacquered, brown-violet tablet, with occasional white dots, with a spindle shaped score line on one side, approximately 10 mm in diameter. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gamanil 70mg film-coated tablets are indicated for the treatment of symptoms of depressive illness. This includes depression/anxiety states associated with panic disorder features. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ The usual dose is 70mg twice daily (140mg) or three times daily (210mg) depending on the patient’s response. The daily dose should always be given in divided doses not exceeding 70mg per dose. In the treatment of depression/anxiety states associated with panic disorder features, the initial dosage should be 70mg daily for the first week. _Elderly patients: _Elderly patients may respond to lower doses in some cases. _Paediatric population: _The safety and efficacy of Gamanil in children under 18 years of age have not been established. No data are available. The use of Gamanil is not recommended in children and adolescents under the age of 18. Method of administration Gamanil 70mg film-coated tablets are for oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Gamanil must not be used in patients hypersensitive to dibenzazepines. Gamanil must not be used in patients: He সম্পূর্ণ নথি পড়ুন