Diazepam

RecTubes®

Rectal Tubes INFORMATION FOR PATIENTS

5mg and 10mg

If you are the patient, parent or carer, please read this leaflet carefully before you have to use this medicine. It gives a brief outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist

THE NAME OF YOUR MEDICINE IS DIAZEPAM RECTUBES®

The active ingredient in Diazepam RecTubes® is diazepam. The tubes are available In two strengths: 5mg and 10mg. Other ingredients include: benzoic acid, benzyl alcohol, sodium benzoate, ethanol, propylene glycol and purified water.

The presentation consists of a white polythene rectal tube in alufoil wrap in a printed outer carton of 2 or 5 tubes.

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.

The product is manufactured by Desitin Arzneimittel, Hamburg, Germany for the product licence holder, CP Pharmaceuticals Ltd, Ash Road North, Wrexham, Clwyd LL13 9UF

WHAT IS DIAZEPAM FOR?

Diazepam can be used for severe anxiety or agitation, for the control of epileptic or feverish convulsions (fits), for sedation before minor surgical or dental procedures and for muscle spasm. Diazepam is for use in adults, children and infants (weighing more than 10kg).

BEFORE ADMINISTERING THE MEDICINE

Diazepam should not be given to you if

Special care will be necessary if you have kidney or liver problems, difficulty with breathing, glaucoma (high pressure in the eyeball or poor blood supply to the brain or any brain damage.

There may be some problems when diazepam is taken with other medicines such as drugs which have sedative properties Including some drugs used In the treatment of epilepsy, schizophrenia, anxiety, depression, pain killers, sleeping tablets or anaesthetics. Some drugs can interfere with the metabolic breakdown in the liver. These include disulfiram, rifampicin, some oral contraceptives, some drugs for stomach ulcers (cimetidine and omeprazole), some drugs for Parkinson痴 disease, some cough medicines, and some medicines you can buy without a prescription. Smoking can also interfere with the metabolic breakdown in the liver, so make sure your doctor knows about all your medicines and if you smoke.

This product contains more than 10% alcohol as well as diazepam so sedation may be enhanced and you should not drive or operate machinery while you are being treated with Diazepam RecTubes®

If you have any doubts about whether you should use these rectal tubes then discuss things more fully with your doctor BEFORE using them.

TAKING THIS MEDICINE

These tubes are for rectal use only. The usual dose is 0.5mg/kg body weight but the dose will vary according to the patient痴 weight, age and state of health. This would normally be one 5mg tube for children (10-15kg), one 10mg tube for children (more than 15kg) and two 10mg tubes for adults.

Your doctor will decide the dose which is best for you. Your doctor痴 instructions must be followed completely, and any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

If used continuously for too long, there is a risk of becoming dependent on diazepam or of having problems when stopping it, as there is a risk of withdrawal symptoms.

When the medicine is withdrawn the following symptoms may occur:- headache, muscle pain, extreme anxiety, tension, restlessness, depression, confusion and irritability.

If too much diazepam is accidentally inserted you should contact your doctor or nearest Casualty Department immediately.

AFTER TAKING THIS MEDICINE

Like many medicines diazepam may cause side effects but these are usually mild except in overdose situations. The most common side effects are sedation, drowsiness, headaches, muscle weakness, dizziness (with risk of falls In the elderly), unsteadiness, convulsion, slurred speech, trembling hands, numbing of the emotions, reduced alertness, tiredness, seeing double, forgetfulness and a hangover effect. Elderly or run down patients are more likely to have side effects and may need lower doses. Other effects which may occur rarely are dry mouth, increased appetite, stomach or bowel upsets, eye changes, jaundice (yellow skin), problems passing water, low blood pressure, slow pulse, changes in sexual desire, problems with periods, skin rashes, blood cell changes, spasm of the airway, chest pain and difficulty with breathing. Diazepam may uncover depression In susceptible individuals. Rarely instead of feeling sleepy, some patients, particularly if they are children or elderly, may feel agitated with a change in their personality.

If any of these side effects are troublesome or if you experience any side effects other than the ones mentioned here, tell your doctor or pharmacist.

SAFE KEEPING FOR YOUR MEDICINE

Do not use the tubes if the expiry date on the tube has passed or if they show signs of deterioration. These tubes should be kept at room temperature (below 25ーC) in the package or container in which they were given to you. Do not transfer them to another container.

KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT THEM

REMEMBER this medicine is for YOU only NEVER give it to anyone else It may harm them, even I their symptoms are the same as yours Unless your doctor tells you to do not keep the tubes that you no longer need Give them back to the pharmacist

DATE OF REVIEW

August 1995

© Registered Trademark

INFORMATION FOR YOUR CARER

HOW TO ADMINISTER THE MEDICINE

  1. If possible, turn patient on side, or front for a child.
  2. Tear open the foil pack.
  3. Remove the tube cap.
  1. Insert the nozzle completely Into the anus, pointing it downwards.

NOTE: In children under 15kg (33lbs) insert the nozzle only half way.

  1. Empty the tube by pressing firmly between the thumb and index finger.
  1. Keep the tube COMPLETELY PRESSED TOGETHER until you have drawn it out of the rectum.
  2. NOTE: A small amount of the solution IS intended to be left in the tube after the dose has been given.

  3. Maintain the patient痴 position and hold the buttocks together for a few minutes to prevent seepage.

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COMMON QUESTIONS AND ANSWERS

  1. How long does it take to work?
  2. Usually it works within 10 minutes

  3. What if I give it and there痴 no change?
  4. It is usually possible to repeat the dose but you should only do so according to advice from the doctor

  5. What it I can稚 turn the patient on his/her side?
  6. Under these circumstances it may be more difficult to administer Diazepam RecTubes®. If you think this may be a problem we recommend you consult the doctor

  7. Do I need to lubricate the tube?
  8. No, the plastic is very smooth and designed to be used without lubrication

  9. Can I give less than the whole tube to see what happens?
  10. We strongly advise that you administer the whole dose as prescribed.

  11. Why do I have to maintain pressure on the tube?
  12. To avoid the solution being sucked back into the tube as it is being withdrawn

  13. What if the solution leaks out of the patient痴 bottom?

If you hold the patient痴 buttocks together for a few minutes keeping the patient in the same position, this should not happen

  1. What if I find there is some solution left in the tube afterwards?
  2. 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 given, we recommend you consult the doctor

  3. Will I hurt the patient?
  4. No, using Diazepam RecTubes® should not hurt the patient.

  5. 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.
  6. Why do I have to keep the tube in the foil?
  7. Diazepam RecTubes® have a shelf life of 36 months in the foil bag. Once the foil is opened, the shelf life is reduced to 6 months.

  8. Do I need to keep Diazepam RecTubes® in the fridge?

No - they can be stored at room temperature (below 25コC).