DIAZEPAM RECTUBES 5 MG RECTAL SOLUTION - patient leaflet, side effects, dosage

1. What Diazepam RecTubes

Diazepam RecTubes® contain diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat:

• severe anxiety and agitation
• muscle spasms
• epilepsy or febrile convulsions
• symptoms of alcohol withdrawal

Diazepam RecTubes® can also be used to provide sedation before operations (premedication).

Your doctor may prescribe Diazepam RecTubes® for other uses. Please follow your doctor’s instruc­tions.

2. what you need to know before you take diazepam rectubes

Do not use Diazepam RecTubes ® ifyou:

• are allergic to diazepam or to other benzodiazepine medicines or to any of the other ingredients of this medicine (listed in section 6).
• have acute respiratory depression (slow and/or shallow breathing)
• suffer from depression (with or without anxiety) or hyperactivity
• have a phobia (a fear of a particular object or situation) or other mental illness
• have a condition called myasthenia gravis which causes muscles to weaken and tire easily
• suffer from sleep apnoea (a sleep disorder where you have abnormal pauses in breathing during sleep)
• have severe liver disorders
• have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders)
• are planning a pregnancy or are pregnant

(see Pregnancy and breast-feeding)

Warnings and precautions

Talk to your doctor or pharmacist before using Diazepam Rectubes® ifyou

• have a history of alcoholism or drug abuse
• have someone close to you who has recently died
• are elderly. Diazepam Rectubes® can cause confusion and have effects on muscles causing falls and injuries
• have a personality disorder
• have liver disease
• suffer from depression
• have suicidal thoughts

Warnings about stopping treatment

• Psychiatric side effects – contact your doctor ifyou experience side effects such as agitation, irritability, delusions, rage, inappropriate behaviour, restlessness, aggressiveness, nightmares or hallucinations. These side effects are more likely to occur in children or the elderly.
• Dependence – when using this medicine there is a risk of dependence, which increases with the dose and duration of treatment and also in patients with a history of alcoholism and drug abuse or personality disorder. Therefore, you should take Diazepam Rectubes® for as short period of time as possible.
• Tolerance -if after a few weeks you notice that this medicine is not working as well as they did when first starting treatment, you should speak to your doctor.
• Withdrawal – treatment should be gradually withdrawn. Withdrawal symptoms occur with Diazepam Rectubes® even when normal doses are given for short periods of time. See Section 3, ‘If you stop taking Diazepam Rectubes®’.
• Rebound sleeplessness and anxiety

When you stop using this type of medicine, some of the symptoms that led to treatment can return more intensely than before, such as sleep disturbances, anxiety, restlessness or mood changes. The risk of this is greater if you stop suddenly.

To avoid these things happening, treatment should be stopped gradually , under the advice of a doctor.

Other medicines and Diazepam Rectubes ®

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription. Especially:

• antidepressants (e.g. fluvoxamine, fluoxetine)
• antipsychotics such as clozapine (to treat mental problems)
• antihistamines (to treat allergies)
• lofexidine (to help relieve symptoms when you stop taking opioids)
• general anaesthetics
• sedatives (used to give calming effects)
• hypnotics (to help you sleep)
• sodium oxybate (to treat narcolepsy)
• muscle relaxants (e.g. suxamethonium, tubocurarin, baclofen, tizanidine)
• some strong pain killers such as morphine (opioids)
• barbiturates such as phenobarbital (to treat epilepsy and mental disorders)
• St John’s wort (h.p) (used to treat depression) Concomitant use of Diazepam RecTubes® and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Diazepam RecTubes® together with opioids the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Taking these medicines with diazepam could affect your mental status, make you very sleepy and suppress your breathing and blood pressure.

• disulfiram (to treat alcohol addiction). Using this medicine with diazepam could make you very sleepy and can cause diazepam to be removed from the body more slowly than usual.
• medicines for epilepsy e.g. phenytoin and carbamazepine, as these can reduce the effect of diazepam. Diazepam can furthermore affect how phenytoin works.
• theophylline (to treat asthma and other breathing disorders), as it can weaken theeffect of diazepam.
• cimetidine, omeprazole or esomeprazole (stomach acid reducing medicines), as these can cause diazepam to be removed from the body more slowly than usual.
• rifampicin (an antibiotic) as this can cause diazepam to be removed from the body more quickly than usual. The effect of diazepam can be weakened.
• atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir (antivirals), fluconazole, itraconazole, ketoconazole or voriconazole (anti-fungal medicines) as these can cause diazepam to be removed from the body more slowly than usual and therefore increase the risk of side effects.
• isoniazid (used to treat tuberculosis), as it can cause diazepam to be removed from the body more slowly than usual.
• oral contraceptives, as they can slow down the removal of diazepam from the body and increase its effect. Breakthrough bleeding can occur when taking diazepam and oral contraceptives together, but the contraceptive protection is not reduced.
• corticosteroids (medicines used to treat inflammation in the body) as they can weaken the effect of diazepam.
• medicines to lower high blood pressure, diuretics (water tablets), nitrates (for heart conditions), hydralazine, minoxidil, sodium nitroprusside as these could lower your blood pressure too much.
• levodopa (used to treat Parkinson’s di­sease). Diazepam can reduce the effect of levodopa.
• valproic acid (used to treat epilepsy and mental disorders) as it can slow down the removal of diazepam from the body and increase its effect.
• ketamine (an anaesthetic) as diazepam increases the effect of ketamine.

Diazepam Rectubes ® with food, drink and alcohol

Do not drinkalcohol while you are using diazepam. Alcohol may increase the sedative effects of Diazepam Rectubes® and make you very sleepy.

You should not drink grapefruit juice while taking diazepam as it causes diazepam to be removed from the body more slowly and increases the risk of side effects. Drinks containing caffeine may reduce the effects of diazepam.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Diazepam Rectubes® ifyou are pregnant, planning to become pregnant or are breast feeding. Ifyou take Diazepam Rectubes® late in pregnancy or during labour your baby might have a low body temperature, floppiness and breathing difficulties. If taken regularly during late pregnancy, your baby may develop withdrawal symptoms.

Driving and using machinery

Diazepam Rectubes® may make you feel sleepy, forgetful, have poor co-ordination and affect your concentration along with other side effects that can affect everyday activities (see Possible side effects). It may also affect how your muscles work. These effects may continue for several days after discontinuation of treatment with diazepam. Do not drive, use any tools or machines, or take part in such activities where, if affected, you could putyourself or others at risk.

This medicine can affect your ability to drive as it may make you feel sleepy or dizzy.

• Do not drive while using this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

• – The medicine has been prescribed to treat a medical or dental problem and

• – You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

• – It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Diazepam RecTubes ® contains Benzoic acid, sodium benzoate, propylene glycol and alcohol

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.

Diazepam RecTubes® contains 15 mg/ml benzyl alcohol. May cause toxic reactions and allergic reactions in infants and children up to 3 years old.

3. how to use diazepam rectubes

Always use Diazepam RecTubes® exactly as your doctor has told you. Check with your doctor ifyou are not sure.

This medicine is for rectal use only.

The tubes are for single use only.

The recommended dose is:

Adults: 0.5mg per kg of bodyweight

Elderly: 0.25mg per kg of body weight

Children and adolescents above 1 year of age:

0.5 mg per kg of body weight.

Ifyou have breathing problems you may also be given a lower dose.

After giving into the anus, the medicine is quickly absorbed and will start to take effect within 5 minutes.

Your doctor will decide the appropriate dose and for how long you need to take this medicine. The usual duration of treatment is not longer than 4 weeks. If needed, your doctor might increase the duration of treatment.

Step by Step instruction on how to administer the Diazepam RecTubes

• 1. If possible turn adults to lie on their side, or front for a child.

• 2. Tear open the foil pack

• 3. Remove the tube cap

• 4. Insert the nozzle completely into the rectum, pointing it downwards

NOTE: In children under 15kgs (33 lbs) insert the nozzle only halfway

5. Empty the tube by pressing firmly between the thumb and indexfinger

• 6. Keep the tube completely pressed together until 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. Maintain the patient's position and hold the buttocks together for a few minutes

If you don’t feel better

If your symptoms or the fit are not brought under control with Diazepam RecTubes®, contact a doctor for advice. Further doses should only be given only after consulting a doctor. The maximum dose is of 30mg.

If you use more Diazepam RecTubes ® than you should

If you have used too many rectal tubes (more than prescribed), or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

Signs of an overdose include loss of coordination of muscle movements, sleep-like drowsy state, confusion, slurred speech, irregular or slow heartbeat, uncontrolled eye movement and muscle weakness. An extreme overdose may lead to coma (unrousable unconsciousness), low body temperature (hypothermia), low blood pressure, slow pulse and severe breathing difficulties.

If you forget to use Diazepam RecTubes ®

If you forget to take a dose take it as soon as you remember it. If you areabout to take the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Diazepam Rectubes ®

Do not stop using your medicine without talking to your doctor. You should gradually reduce the number of strength of rectal tubes you use before you stopping them completely. If you stop using Diazepam RecTubes® suddenly, you may experience withdrawal symptoms including: anxiety, panic attack, palpitations (strong and pounding heartbeat), sweating, tremor, stomach problems, irritability, aggression, sensory disorder, muscle spasms, generally feeling unwell, loss of appetite, insomnia, mental side effects such as severe confusion and seizures. The likelihood and severity of withdrawal symptoms depends on the duration of treatment, dose strength and degree of dependency.

If you have epilepsy or history of seizures and suddenly stop using Diazepam RecTubes®, there is a risk of convulsions or long-lasting epileptic seizure. There is also risk of seizures if you have an alcohol or drug abuse problem and suddenly stop using Stesolid rectal tubes.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. possible side effects

Like all medicines, Diazepam RecTubes® can cause side effects, although not everybody gets them.

Stop treatment and contact a doctor at once if you have the following symptoms of an allergic reaction e.g. itchy skin, rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Contact your doctor immediately, if you notice any of the following side effects or notice any other effects not listed: Uncommon: affects 1 to 10 users on 1,000

• Respiratory depression (very slow and/or shallow breathing)

Rare: affects 1 to 10 users in 10,000

• Respiratory arrest (cessation of breathing )
• Unconsciousness
• Jaundice (yellowing of your skin or the white of your eyes)

Very rare: affects less than 1 user in 10,000

• Anaphylaxis (severe allergic reaction) with symptoms such as sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties to swallow

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common: affects more than 1 user in 10

• Drowsiness

Common: affects 1 to 10 users in 100

• Fatigue, sedation
• Withdrawal symptoms (for possible symptoms please see ‘If you stop using Diazepam RecTubes®’ in Section 3)
• Confusion
• Loss of coordination of muscle movements (ataxia) and other movement disorders, tremor

Uncommon: affects 1 to 10 users in 1,000

• Muscle weakness
• Memory loss (which may be experienced several hours after using diazepam. If possible, to reduce the risk allow 7 to 8 hours of uninterrupted sleep after using)
• Difficulty in concentrating
• Balance disorders, dizziness, headache
• Slurred speech
• Stomach and intestinal problems such as feeling or being sick, constipation, diarrhoea
• Increased salivation

Rare: affects 1 to 10 users in 10,000

• Psychiatric side effects such as excitation, agitation, restlessness, irritability, inappropriate behaviour, aggressiveness, memory loss, delusion, rages, psychoses, nightmares or hallucinations. May be or become serious. These side effects are more likely to occur in children or the elderly.
• Decreased alertness
• Depression
• Emotional withdrawal
• Insomnia (problems sleeping)
• Heart problems such as slow heartbeat (bradycardia), heart failure and cessation of heartbeat (cardiac arrest).
• Low blood pressure, fainting (syncope)
• Increased mucus in the lungs
• Dry mouth
• Increased appetite
• Changes in certain liver enzymes as seen in blood tests
• Lack of ability to urinate, loss of bladder control (leakage of urine)
• Breast enlargement in men
• Impotence, changes in sexual drive (libido)
• Blood disorders (you may develop sore throat, nose bleeds or infections)
• Feeling of faintness and/or dizziness
• Difficulty speaking
• Intermittent spasmodic or sustained involuntary contractions of muscles in the face, neck, trunk, pelvis, extremities, and even the larynx

Very rare: affects less than 1 user in 10,000

• Low levels of white blood cells (leukopenia)
• Higher level of a certain enzyme in the blood (transaminase)

Not known: frequency cannot be estimated from the available data

• Blurred vision, double vision and involuntary eye movements (these side effects disappear after you have stopped taking diazepam)
• Uncovering of depression with suicidal thoughts and dependence or abuse of this medicine or similar medicines.
• Abnormal pauses in breathing

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below

UNITED KINGDOM:

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

MALTA:

ADR Reporting:

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. Howto store Diazepam RecTubes

Keep this medicine out of the sight and reach of children. Diazepam RecTubes® should be stored at room temperature (below 25°C). 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.

Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other 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 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 in UK: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Marketing Authorisation Holder in Malta: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland

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:

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 01/2020.

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Twockhardt