DIAZEPAM RECTUBES 2.5MG RECTAL SOLUTION

PACKAGE LEAFLET: INFORMATION FOR THE USER Diazepam RecTubes 2.5mg Rectal Solution Diazepam RecTubes 5mg Rectal Solution Diazepam RecTubes 10mg Rectal Solution (referred to as Diazepam RecTubes in this leaflet) Read all of this leaflet carefully before you start to take this medicine. - eep this leaflet. You may need to read it again K while administering the treatment. - f you have any further questions, please ask your I doctor or pharmacist. - his medicine has been prescribed for you. Do not T pass it on to others. It may harm them, even if their symptoms are the same as yours. - f any of the side effects get serious, or if you I notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. hat Diazepam RecTubes are and what they are W used for 2. Before using Diazepam RecTubes 3. How to use Diazepam RecTubes 4. Possible side effects 5. How to store Diazepam RecTubes 6. Further information 1. hat Diazepam RecTubes are and what they are W used for The name of your medicine is Diazepam RecTubes. The active ingredient is diazepam. Diazepam belongs to a group of medicines known as benzodiazepines, which are used as sedatives and anticonvulsants (to control fits) or to relax tense muscles. Diazepam RecTubes are used in adults and children above one year: o treat severe anxiety or agitation t o treat epileptic and feverish convulsions (fits) t o relieve muscle spasm t efore minor surgical or dental procedures b n circumstances where a rapid effect is required i and where injection may be impracticable or undesirable. 2. Before using Diazepam RecTubes You should not be given Diazepam RecTubes if you: re allergic (hypersensitive) to diazepam or any of a the other ingredients in Diazepam RecTubes (see section 6, Further information) uffer from sleep apnoea (stopping breathing during s sleep) uffer from severe breathing difficulties s ave severe liver problems h uffer from any fears (phobias) or obsessions s uffer from depression, with or without anxiety s re suffering and being treated for any long a standing mental illness h ave experienced recent loss or bereavement. Diazepam RecTubes should not be given to patients who are in a coma, or used to treat anxiety in children without careful prior assessment. If you are elderly or severely unwell speak to your doctor first before using Diazepam RecTubes. Talk to your doctor or pharmacist before using Diazepam RecTubes if you: uffer from any kidney or liver disease s uffer from severe muscle weakness (myasthenia s gravis) uffer from a rare blood disorder (porphyria) s ave difficulty with breathing h uffer from poor blood supply to the brain or any s brain damage uffer from any kind of personality disorder s ave suicidal tendencies h re prone to aggressive outbursts harming either a yourself or others ave had problems with addiction to drugs or h alcohol urrently smoke or drink alcohol. c Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or can be affected by Diazepam RecTubes: edicines used to reduce pain (e.g. codeine) m edicines used before surgery (anaesthetics) m edicines used to treat depression (e.g. m fluvoxamine) edicines used to treat mental illness (e.g. m clozapine, zotepine) edicines used to treat bacterial infection (e.g. m erythromycin, isoniazid, rifampicin) edicines used to treat hayfever or other allergic m conditions edicines used to treat high blood pressure (e.g. m moxonidine) edicines used to treat viral infections (e.g. m amprenavir and ritonavir) edicines used to treat anxiety (e.g. other drugs of m benzodiazepine group) edicines used for asthma and bronchitis (e.g. m theophylline) ral contraceptives o edicines used to treat heart failure (e.g. digoxin) m edicines used to treat alcohol dependence (e.g. m disufiram) edicines used to treat heroin withdrawal (e.g. m lofexidine) edicines used to treat vomiting due to cancer m therapy (e.g. nabilone) edicines used to treat parkinsons disease (e.g. m levodopa) edicines used to relax the muscles (e.g. baclofen, m tinidazine) edicines used to treat stomach ulcers (e.g. m cimetidine, omeprazole) edicines used to treat epilepsy (e.g. phenytoin, m carbamazepine). Pregnancy and breast-feeding You should not take this medicine if you are pregnant or breast-feeding unless your doctor specifically recommends you to. If you are using this medicine and planning to get pregnant or think you are pregnant speak to your doctor immediately. Driving and using machinery Diazepam RecTubes may affect your muscles or make you feel sleepy or forgetful (especially if you dont have enough sleep). If you are affected in this way, do not drive or use any tools or machinery. Important information regarding some of the ingredients in Diazepam RecTubes Diazepam RecTubes contains Benzoic acid and sodium benzoate which may cause mild irritation to the skin, eyes and mucous membrane. The propylene glycol may cause skin irritation. Diazepam RecTubes contains alcohol and diazepam, so you should not drink alcohol as sedation may be enhanced. 3. How to use Diazepam RecTubes This medicine is for rectal use only. The tubes are for single use only. Always use Diazepam RecTubes as your doctor has told you. Your doctor will decide the right dose for you according to your weight, age and state of health. The dose will be on the pharmacists label. This medicine is not to be used in children under one year old. Children above 1 year old: the usual dose is 0.5mg/kg. Adults: he usual dose is 0.5mg/kg body weight t f Diazepam RecTubes are being prescribed for i anxiety, your doctor will normally recommend that you do not use them for more than 8-12 weeks, including a period during which the dose will be reduced gradually. Step by step instruction on how to administer the Diazepam RecTubes: 1. f possible, turn adults to lie on their side, or front I for a child. 2. Tear open the foil pack 3. Remove the tube cap

4. nsert the nozzle completely into the rectum, I pointing it downwards NOTE: In children under 15kgs (33 lbs) insert the nozzle only half way

5. mpty the tube by pressing firmly between the E thumb and index finger

6. eep the tube completely pressed together until K you have withdrawn it out of the rectum. Note: A small amount of the solution is intended to be left in the tube after the dose is given. 7. aintain the patients position and hold the M buttocks together for a few minutes to prevent seepage

If you accidentally insert too much of the medicine If you (or anybody else, including a child) has accidentally had an overdose of this medicine, then you should contact your nearest hospital casualty department or your doctor immediately. Always take the container and this leaflet with you. The symptoms of mild overdose may include confusion, loss of consciousness with a sleep-like state, abnormally slow breathing, slurred speech, difficulty in controlling movements, loss of muscle co-ordination, difficulty in breathing, low blood pressure and muscular weakness. The symptoms of severe overdose include deep coma and severe depression of breathing. Stopping Diazepam Treatment If Diazepam RecTubes are given continuously for too long, there is a risk of becoming dependent on diazepam or developing withdrawal symptoms when stopped or rebound phenomenon whereby the problem for which you were being treated recurs. You should not stop the treatment suddenly and it is recommended that the dose is decreased gradually. 4. Possible side effects Like all medicines, Diazepam RecTubes can cause side effects in some patients, especially the elderly, although not everybody gets them. As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, tell your doctor immediately: ash, itching, swelling of the face and eyes, R difficulty breathing. f you feel restless, have nightmares or notice I behavioural changes after applying Diazepam. lood disorders (you may develop a sore throat, B nose bleeds or infections). hest pain, slow pulse, slow heart rate, stopping C breathing during sleeping, yellow skin (jaundice). Rarely instead of feeling sleepy, opposing effects may be seen in some patients especially in children or elderly which include aggressive behaviour, irritability, over excitement, increased anxiety, feeling high and difficulty sleeping. Tell your doctor or pharmacist if you notice any of the following side effects or notice any other effects not listed: forgetfulness drowsiness (feeling sleepy) difficulty in controlling dizziness movements muscle weakness loss of coordination or slurred speech reduced alertness low blood pressure confusion trembling hands increased liver enzymes problems with vision loss of memory with dry mouth inappropriate behaviour changes in sexual stomach or bowel upset desire problems in passing urine fatigue or tiredness inability to control flow of enlargement of urine (incontinence) breasts in males difficulty in breathing headache with kin rash or other s hangover effect allergic symptoms. Withdrawal symptoms often include anxiety, depression, loss of concentration, sleeplessness, headache, dizziness, ringing noise in the ears, loss of appetite, trembling hands, perspiration, irritability, nausea, vomiting, abdominal cramps, abnormal heart rate. As can happen with any medicine, a few people may develop an allergic reaction. A severe form of allergic reaction (anaphylactic shock) is extremely rare but should be treated immediately. If you experience any side effects not mentioned here or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately. 5. How to store Diazepam RecTubes Keep out of the reach and sight of children. Diazepam RecTubes should be stored at room temperature (below 25C). Store in the original container to protect from light; do not transfer to another container. Once foil is opened use immediately. Do not use Diazepam RecTubes after the expiry date which is stated on the tube and the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. 6. Further information What Diazepam RecTubes contains: The active ingredient is: diazepam The other ingredients are: benzoic acid (E210), benzyl alcohol, sodium benzoate (E211), ethanol, propylene glycol and purified water. What Diazepam RecTubes look like and the contents of the pack The pack consists of 2 or 5 white polythene rectal tubes wrapped individually in alufoil packs and placed in an outer carton. The tubes have a nozzle attached for application. The rectal solution is a clear, colourless or almost yellow solution. Diazepam RecTubes are available in the following strengths: Diazepam RecTubes 2.5mg in 1.25ml (2mg/ml) Diazepam RecTubes 5mg in 2.5ml (2mg/ml) Diazepam RecTubes 10mg in 2.5ml (4mg/ml)

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham LL13 9UF, UK. Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only). Please be ready to give the following information: Product name Diazepam RecTubes 2.5mg in 1.25ml Rectal Solution Diazepam RecTubes 5mg in 2.5ml Rectal Solution Diazepam RecTubes 10mg in 2.5ml Rectal Solution Reference number 29831/0067

29831/0068

29831/0066

This is a service provided by the Royal National Institute of Blind People. Leaflet Prepared: October 2011 Common questions and answers 1. How long does it take to work? Usually it works within 10 minutes. 2. What if I give it and theres no change? Your doctor would have told you what to do in these circumstances. If you are in doubt talk to your doctor. 3. What if I cant turn the patient on his/her side? Under these circumstances it may be more difficult to administer Diazepam RecTubes. If you think this may be a problem we recommend that you consult the doctor. 4. Do I need to lubricate the tube? No, the plastic is very smooth and designed to be used without lubrication. 5. Can I give less than the whole tube to see what happens? The whole dose should be given as prescribed. 6. Why do I have to maintain pressure on the tube? avoid the solution being sucked back into the To tube as it is being withdrawn. 7. What if the solution leaks out of the patients bottom? you hold the patients buttocks together for a few If minutes keeping the patient in the same position, this should not happen. 8. What if I find there is some solution left in the tube afterwards? Perhaps you forgot to keep the tube compressed as you withdrew it. A small amount of solution is intended to be left in the tube after the dose has been given. If you are worried about how much you have been given, we recommend that you consult the doctor. 9. Will I hurt the patient? No, using Diazepam RecTubes should not hurt the patient. 10.How important is it to point the tube downwards? Emptying the tube is easiest when pointing downwards. It is possible to empty it at other angles but this is usually more difficult. 11.Why do I have to keep the tube in the foil? Diazepam RecTubes have a shelf life of 36 months in the foil bag. 12.Do I need to keep Diazepam RecTubes in the fridge? No, they can be stored at room temperature (but not above 25C).