Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Promazine hydrochloride
DE Pharmaceuticals
N05AA03
Promazine hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
PAGE 1: FRONT FACE (INSIDE OF REEL) Pharma code 83 HOW TO TAKE PROMAZINE Always take Promazine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a drink of water. The usual dose is: ADULTS: • FOR PSYCHOMOTOR AGITATION 100-200 mg four times daily. THE ELDERLY: • FOR AGITATION AND RESTLESSNESS 25-50 mg four times daily. CHILDREN: Promazine is not recommended for use in children. IF YOU TAKE MORE PROMAZINE THAN YOU SHOULD If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, confusion, low blood pressure, low body temperature, fits and coma are possible. Rarely breathing difficulties may occur. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed. IF YOU FORGET TO TAKE PROMAZINE If you forget to take a tablet, take one as soon as you remember unless it is more than 2 hours after the missed dose; if so, ignore the missed dose and wait until the time of the next dose. DO NOT take a double dose to make up for a forgotten dose. STOPPING TREATMENT WITH PROMAZINE DO NOT stop taking your medicine without talking to your doctor first even if you feel better. Your medicine should only be withdrawn gradually under close supervision by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. POSSIBLE SIDE EFFECTS Like all medicines, Promazine can cause side effects, although not everybody gets them. STOP TAKING THE TABLETS AND TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital if the following happens: • an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing or severe skin rash or hives. This is a very Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Promazine 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of promazine hydrochloride. Excipient(s) with known effect Each tablet contains 120 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Orange, round, biconvex film-coated tablets, embossed with 7Z2 on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Agitation and restlessness in the elderly Short-term adjunctive management of psychomotor agitation 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. _ADULTS_:_ _For psychomotor agitation, 100-200mg four times daily _ELDERLY_: For agitation and restlessness, 25-50mg four times daily. These tablets are not recommended for use in children. 4.3 CONTRAINDICATIONS • Known sensitivity to phenothiazines or to any of the excipients • Comatose states • CNS depression • Phaeochromocytoma 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Promazine should be used only with great caution in the following conditions; history of jaundice, blood dyscrasias (perform blood counts if unexplained infection or fever develops), renal and hepatic impairment, respiratory disease, Parkinsonism, epilepsy, hypothyroidism, depression, myasthenia gravis, prostatic hypertrophy, personal or a family history of angle-closure glaucoma. As with other neuroleptics, caution is advised in patients with cardiovascular diseases and patients with a family history of QT prolongation. Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Promazine and preventive measures undertaken As photosensitisation may occur with higher dosages, patients should avoid direct sunlight. In patients with Parkinson’s disease the a Lue koko asiakirja