Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Temazepam
McDermott Laboratories Ltd., T/A Gerard Laboratories
N05CD; N05CD07
Temazepam
10 milligram(s)
Tablet
Benzodiazepine derivatives; temazepam
Not marketed
1997-07-25
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT INSOMNIGER 10 MG AND 20 MG TABLETS temazepam 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 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 Insomniger is and what it is used for 2. What you need to know before you take Insomniger 3. How to take Insomniger 4. Possible side effects 5. How to store Insomniger 6. Contents of the pack and other information. 1. WHAT INSOMNIGER IS AND WHAT IT IS USED FOR Insomniger belongs to a group of medicines called benzodiazepines or hypnotics. Benzodiazepines are used to make you feel less anxious, they can also be used to make you feel sleepy, relax your muscles and stop or prevent fits. Insomniger can be used for the following: difficulty sleeping (insomnia), when your lack of sleep is causing you a lot of distress to be given before minor surgery and other similar procedures (pre-medication) to make you feel more relaxed (or less anxious). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INSOMNIGER DO NOT TAKE INSOMNIGER: if you are allergic to temazepam, or any other benzodiazepine medicine (such as diazepam or nitrazepam), or any of the other ingredients in this medicine (listed in section 6) if you suffer from long term fatigue and muscle weakness (myasthenia gravis) if you suffer from irregular breathing whilst asleep (sleep apnoea syndrome) if you have severe lung or liver problems if you have a genetic disease called spinocerebellar ataxia (SCA) if you have a dependence on alcohol or drugs (including sedatives and Read the complete document
Health Products Regulatory Authority 25 February 2022 CRN00CKW4 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Insomniger 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of temazepam. Excipients with known effect: Each tablet contains 68.69 mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to pale yellow, round, flat bevelled-edged scored tablets with 7 mm diameter, marked ‘T/10’ on the scored side, and ‘G’ on the other. 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 Short-term management of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. For premedication prior to minor surgery or other related procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults including the elderly_ Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. _Insomnia _ Dosage should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation. Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including tapering-off, of four weeks. The tapering-off process should be tailored to the individual. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status. The product should be taken on retiring or up to 30 minutes before going to bed. Adults: 10-20 mg. In exceptional circumstances the dose may be increased to 30-40 mg. Elderly: 10 mg. In exceptional circumstances the dose may be increased to 20 mg. _Premedication_ Adults: The usual dose is 20-40 mg, 30 to 60 minutes before procedure. Elderly: El Read the complete document