Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indoramin hydrochloride
Lexon (UK) Ltd
C02CA02
Indoramin hydrochloride
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100
3. HOW TO TAKE DORALESE Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. HOW MUCH TO TAKE The usual dose is one tablet (20 mg) twice a day. The tablet should be swallowed with water. Some elderly patients may need just one tablet at night. Your doctor may increase your dose to a maximum total daily dose of 100 mg. Do not take more than your doctor has recommended. IF YOU TAKE MORE DORALESE THAN YOU SHOULD If you take more Doralese than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose have included deep sedation leading to coma, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), abnormally low blood pressure and fits. IF YOU FORGET TO TAKE DORALESE If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. IF YOU STOP TAKING DORALESE Do not stop taking Doralese without talking to your doctor. If you stop taking your tablets, your symptoms may come back. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: when you start taking Doralese you may feel sleepy. This will usually go after a few days other less common side effects include dry mouth, stuffy nose, weight gain, dizziness, failure to ejaculate, depression, headache and dizziness caused by low blood pressure, which can occur on standing. The dizziness may or may not be accompanied by fainting. RARE (affects less than 1 in 1,000 people) allergic (hypersensitivity) reactions, such as a rash and itching Parkinson's diseas Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doralese Tiltab Tablets 20 mg Indoramin 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains indoramin hydrochloride equivalent to 20 mg of indoramin base. Excipient with known effect Each film-coated tablet contains 152 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets (tablets) Pale yellow, triangular film-coated tablet, bearing a raised kite shape on each face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Conditions for which alpha blockade is indicated. Management of urinary outflow obstruction due to benign prostatic hyperplasia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hyperplasia _ _ _Adults_: 20 mg twice daily. Dosage may be increased in 20 mg increments at two-weekly intervals up to max. 100 mg per day if required. _ _ _Elderly_: 20 mg at night may be adequate. _ _ _Paediatric population: _ Not recommended. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Patients with established heart failure. Patients already under treatment with a monoamine oxidase inhibitor. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Incipient cardiac failure should be controlled before treatment with indoramin. Caution should be observed in prescribing indoramin for patients with hepatic or renal insufficiency. A few cases of extrapyramidal disorders have been reported in patients treated with indoramin. Caution should be observed in prescribing indoramin in patients with Parkinson's disease. In animals and in the one reported case of overdose in humans, convulsions have occurred. Due consideration should be given, and great caution exercised in the use of indoramin in patients with epilepsy. The 'Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on Прочитајте комплетан документ