DIAZEPAM RECTAL TUBES 10MG

Active substance: DIAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Diazepam Rectal Tubes 5 mg and 10 mg
Read all of this leaflet carefully before you start taking your medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Diazepam Rectal Tubes are and what they are used for
2. Before you take Diazepam Rectal Tubes
3. How to take Diazepam Rectal Tubes
4. Possible side effects
5. How to store Diazepam Rectal Tubes
6. Further Information

1

What Diazepam Rectal Tubes are and what they are used for

The name of your medicine is Diazepam Rectal Tubes 5 mg or 10 mg.
The active ingredient, diazepam, belongs to a group of therapeutic medicines known
as benzodiazepines, which have sedative, anti-convulsant and muscle relaxant
properties.
Diazepam Rectal Tubes are commonly prescribed for the following uses:
• For the short term relief (2 to 4 weeks only) of extreme anxiety, which may occur
alone, or be associated with sleep problems or psychiatric problems
• As a sedative and pre-medication before investigative or surgical procedures, such
as prior to dental surgery
• As an anti-convulsant in the management of some types of epilepsy, convulsions
associated with fever and in poisoning
• For the control of muscle spasms, as in tetanus
• For the management of alcohol withdrawal symptoms
• For difficulties with sleeping, but only when this is severe, disabling or extremely
distressing for the patient.

2

Before you take Diazepam Rectal Tubes

Do not take Diazepam Rectal Tubes if you:
• are allergic or sensitive to benzodiazepines, diazepam or any of the other
ingredients in this medicine.
• have breathing difficulties.
• are or might be pregnant, planning to become pregnant or are breast-feeding,
(see Pregnancy and breast-feeding information).
• have any mental illnesses including depression, phobia, obsession or anxiety.
• have suffered with a recent bereavement.
• have porphyria (an inherited condition causing skin blisters, abdominal pain and
brain or nervous system disorders).
• have myasthenia gravis (a condition which causes muscles to weaken and tire
easily).
Take special care with Diazepam Rectal Tubes
Tell your doctor if any of the following applies to you:
• you have liver disease.
• you have kidney problems.
• you are elderly.
• you have any disorder of the brain (hardening of the arteries in the brain).
• you are or have been a user/abuser of alcohol and/or drugs or have a personality
disorder (In these circumstances your doctor should monitor you regularly whilst
you are taking diazepam and not prescribe further tablets unless there are very
particular reasons to do so).
You should take the lowest dose possible and you should not continue the treatment
beyond 4 weeks.
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.
Please tell your doctor if you are taking any of the following drugs as you may notice
an increase sedative effect with some of these drugs:
• Antidepressants, sedatives (to calm you down), hypnotics (for mental conditions),
neuroleptics (for mental illness) and other medicines for mental illness such as
zotepine or fluvoxamine, tranquilisers (sleeping tablets) or analgesics (strong pain
killers). These medicines act in the same way as diazepam and could make you
very sleepy.
• Antivirals such as ritonavir (anti-infection medicines).
• Medicines for alcohol dependence such as disulfiram.
• Medicines for epilepsy e.g. phenobarbitone, sodium valporate.
These can make the side effects of diazepam worse.

• Cimetidine (for ulcers) as these can cause diazepam to be removed from the body
more slowly than usual.
• ACE inhibitors (for high blood pressure e.g. Captopril, Enalapril or Lisinopril).
• Medicines for hypertension e.g.hydralazine, methyldopa, minoxidil or clonidine.
• Medicines to treat tuberculosis (e.g. rifampicin, isoniazid)
• Beta-blockers (e.g. propanolol or atenolol for heart problems).
• Baclofen (for cerebral palsy).
• Levodopa (for Parkinson’s disease).
• Antihistamines (for allergies).
• Anaesthetics (surgery or dental treatment).
If you are going to have an operation involving an anaesthetic, the hospital will need
to know in advance that you are using Diazepam Rectal Tubes.
Using with food and drink
Do not drink alcohol while you are taking diazepam. Alcohol may increase the
sedative effects of Diazepam and make you very sleepy. If you regularly drink alcohol
please tell your doctor before using this medicine.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant or planning to be pregnant, might
become pregnant, or are breast-feeding. If your doctor has decided that you should
receive this medicine during late pregnancy or during labour, your baby might have a
low body temperature, floppiness, and breathing and feeding difficulties. If this
medicine is taken regularly in late pregnancy, your baby may develop withdrawal
symptoms.
Driving and using machines
Diazepam may make you feel sleepy, affect your concentration or you may have
problems with the way your muscles work.
Do not:
• drive or use any tools or machines if you are affected in this way
• take part in other activities where this would put you or others at risk
• drink alcohol, as this will make these effects worse.
You should make sure that you get enough sleep, otherwise you may experience
difficulty staying alert. If this happens do not drive, use tools or operate machines.
Important information about some of the ingredients of Diazepam Rectal Tubes
This product contains benzoic acid. Benzoic acid and benzoates may cause mild
irritation to the skin, eyes and mucous membrane (for example the nasal cavity), and
may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in
newborn babies.

3

How to take Diazepam Rectal Tubes

Always use Diazepam Rectal Tubes exactly as your doctor has told you. You should
check with your pharmacist if you are not sure. When you must use a rectal tube will
be written on the label. Please read it carefully.
Your doctor will have prescribed the lowest dose which can control your symptoms.
Doses should only be repeated on medical advice.
Treatment should not be continued beyond 4 weeks. Long term use is not
recommended.
Recommended doses follow. Doctors sometimes prescribe different doses to these: if
this applies to you, discuss it with the doctor, if you have not already done so.
Diazepam Rectal Tubes are for single use only. Remove the cap and insert the rectal
tube into the anus/rectum. For small children and those less than three years old, the
nozzle should only be inserted for about half its length, about 2.5cm Squeeze the
rectal tube to dispense the product.

Continued on the next page >>

Usual dosages
Adults and children (over 3 years): 1 x 10 mg rectal tube. For small children, this
dose may be reduced to 1 x 5 mg rectal tube.
Children (aged 1 to 3 years): 1 x 5 mg rectal tube.
Children (under 1 year): Diazepam Rectal Tubes are not recommended for children
less than 1 year old.
Elderly or debilitated patients: Dosage should be half that recommended for other
adults.
For acute muscle spasm, acute anxiety or agitation
You will be prescribed 1 x 10mg rectal tube with a repeat dose after 4 hours, if
necessary.
For sedative cover during dental or other surgical or medical procedures
You will be prescribed a dose depending on your response using the guide 0.2 mg of
diazepam per kilogram of your body weight.
If you are using diazepam for sleep problems, your treatment should be
intermittent, if possible i.e. not regularly.
If you use more Diazepam Rectal Tube than you should
If you use an unintentional extra dose, you may feel drowsy, experience shaky
movements and slurred speech. In very severe cases you may lose consciousness.
It is important to seek medical help from your doctor or local casualty department.














Vertigo, fainting or giddiness
Confusion
Visual problems (including seeing things which are not there)
Changes in sex drive
Stomach upsets
Headaches
Slurred speech
Tremor
Skin rashes
Loss of co-ordination
Incontinence
Urinary retention (inability to pass urine).

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5

How to store Diazepam Rectal Tubes

Keep out of the reach and sight of children.
Do not use Diazepam Rectal Tubes after the expiry date shown on the tube/carton.
Any out of date medicines should be returned to your pharmacist for disposal. The
expiry date refers to the last day of that month.
Diazepam Rectal Tubes should be stored in a cool, dry place below 22°C.

If you forget to use Diazepam Rectal Tube
Do not double the dose in order to make up for a forgotten dose. If you are at all
concerned, you should consult your doctor or pharmacist, for advice.
• If you remember within one hour of the missed dose take your medicine now and
continue with your next dose at the usual time.
• If your next dose is less than 2 hours away, skip the missed dose and take the
next dose now.
If you stop using Diazepam Rectal Tube
Do not stop taking your medicine without telling your doctor as he may wish to
gradually reduce the amount you take before stopping it completely. If you stop taking
Diazepam suddenly you may experience unpleasant side effects including confusion,
serious mood or behavioural changes, tremors or convulsions. Nervousness,
insomnia, irritability, sweating, diarrhoea and depression may also occasionally if
your treatment has only been for a short period of time.
As with other benzodiazepine drugs, there is the possibility of dependence on
treatment occurring, but this normally does not happen with low doses and short
courses of treatment.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4

Possible side effects

Like all medicines, Diazepam can cause side effects, although not everybody gets
them.
If you experience the following, stop taking Diazepam Rectal Tubes and tell your
doctor immediately or go to the casualty department of your nearest hospital.
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that
may cause difficulty in swallowing or breathing).
The following rare side effects have been reported. If you experience any of
these see your doctor at once:
• Depression with suicidal tendencies.
• Jaundice (yellowing of skin and whites of the eyes).
• Breathing problems such as breathlessness.
• Abnormal behaviour changes such as aggression, excitement and confusion.
• Low blood pressure (symptoms such as dizziness, fainting, blurred vision, or
irregular heart beat).
• Blood disorders (increased risk of infections particularly frequent throat infections,
mouth ulcers, pale skin, bruising, prolonged bleeding from gums or elsewhere).
• Muscle weakness
• Amnesia (forgetfulness)

Do not use Diazepam Rectal Tubes if you notice any defects in the rectal tubes. Take
them to your pharmacist for advice before using them.
Medicines should not be disposed of via household waste or wastewater. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6

Further information

What Diazepam Rectal Tubes contains
Each rectal tube contains 5 mg or 10 mg of the active ingredient diazepam BP in an
expressed volume of 2.5 ml.
The other ingredients are: benzoic acid, absolute alcohol, propylene glycol, sodium
benzoate, benzyl alcohol and water.
Contents of the pack
Diazepam Rectal Tubes are supplied in packs of 2, 5, 10, 15 and 20.
However, the quantity dispensed by the pharmacist will be tailored according to your
prescription.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Sandoz Ltd,
Woolmer Way, Bordon,
Hampshire, GU35 9QE.
The manufacturer is:
Pharmasol Ltd,
North Way, Walworth Industrial Estate,
Andover, Hampshire, SP10 5AZ
This leaflet was last approved in 07/2010 (to be amended on approval).

Other side effects include:
• Drowsiness
• Sedation (feeling sleepy)
• Unsteadiness when walking
• Blurring of vision
• Difficulties performing skilled tasks and reduced alertness.
Drinking alcohol may exaggerate these effects.
You could notice the above side effects even after a single dose and they may
continue for more than 24 hours. If you are elderly you are more likely to suffer from
side effects, especially confusion
Less common effects include:
If you experience any of these side-effects you should reduce your dose and
seek advice from your doctor.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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