STESOLID RECTAL TUBE 5MG

Active substance: DIAZEPAM

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Stesolid® Rectal Tubes 5mg and 10mg
(diazepam)
Read all of this leaflet carefully before you start using this 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 Stesolid rectal tubes are and what they are used for
2 Before you use
3 How to use
4 Possible side effects
5 How to store
6 Further information
1 What Stesolid rectal tubes are and what they are used for

Stesolid rectal tubes 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
Stesolid rectal tubes can also be used to cause relaxation and sleepiness before an operation or
dental procedure.

2 Before you use
Do not use Stesolid rectal tubes and tell your doctor if you

• are allergic (hypersensitive) to diazepam, other benzodiazepine medicines or to any of the
other ingredients (see section 6)
• have severe breathing problems or have difficulty 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 myasthenia gravis (a condition which causes muscle weakness)
• suffer from sleep apnoea (a condition where you stop breathing whilst asleep)
• have severe liver disorders
• have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or
nervous system disorders)
• planning a pregnancy or are pregnant (see below Pregnancy and breast-feeding).

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AAAG5592

Check with your doctor or pharmacist before using Stesolid rectal tubes if you






have a history of alcoholism or drug abuse
have someone close to you who has recently died
are elderly (as there is an increased risk of side effects).
have a personality disorder

smoke
Warnings about stopping treatment

• Withdrawal symptoms
There is a risk of becoming dependent on this medicine, particularly with high doses,
continued use or if you have a history of alcoholism or drug abuse.
If dependence has developed, withdrawal symptoms will occur if you suddenly stop
treatment. Withdrawal symptoms include: headaches, muscle pain, anxiety, tension,
restlessness confusion and irritability and in severe cases: feelings of things being unreal or
strange or that your mind is separated from your body, numbness and tingling in the hands
and feet, hallucinations, fits or sensitivity to light, noise or touch.
• Rebound sleeplessness and anxiety
When you stop taking 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.

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. Especially:
• antidepressants, antipsychotics (to treat mental problems), antihistamines (to treat
allergies), general anaesthetics, lofexidine (to help relieve symptoms when you stop taking
opioids), nabilone (to treat nausea and vomiting), hypnotics (to help you sleep), alpha
blockers or moxonidine (to lower high blood pressure), muscle relaxants (eg baclofen,
tizanidine). Taking these medicines with diazepam could make you very sleepy.
• some strong pain killers may give you a heightened sense of well being when taken with
diazepam, which can increase your desire to continue taking these medicines (dependency) or
can make you very sleepy.
• disulfiram (to treat alcohol addiction). Taking 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 eg phenobarbital, phenytoin, carbamazepine, or sodium valproate,
(diazepam can affect the blood levels of these medicines).
• cimetidine or omeprazole (for ulcers), oestrogen-containing contraceptives, erythromycin
(an antibiotic), antifungals (fluconazole, voriconazole) or isoniazid (to treat tuberculosis) as
these can cause diazepam to be removed from the body more slowly than usual.
• rifampicin (to treat infections) or theophylline (to treat asthma) as this can cause diazepam
to be removed from the body more quickly than usual.
• amrenavir or ritonavir (antivirals) as these can make you feel sleepy for longer or cause
difficulty breathing.
• medicines to lower high blood pressure, diuretics (water tablets), nitrates (for heart
conditions) as these could lower your blood pressure too much.
• levodopa (to treat Parkinson’s Disease) as diazepam may cause levodopa to not work so well.

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Diazepam (Stesolid) 5mg & 10mg Rectal Tubes PIL - UK

colours/plates:
1. Black

item no: AAAG5592

dimensions: 200 x 210

print proof no: 2

pharmacode:

origination date: 13.02.14

min pt size: 8pt

3.
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6.

originated by: S.Anson
approved for print/date

2.

revision date: 01.04.14

Technical Approval

revised by: S.Anson

date sent: 13.02.14

supplier: Actavis Jakarta

technically app. date: 01.04.14

Non Printing Colours
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Using Stesolid and food and drink

Grapefruit juice may increase the amount of diazepam in your blood. If you are elderly, suffer
from cirrhosis or any of the conditions listed in section 2, this could possibly increase the
sedative effects of Stesolid and you should speak to your doctor or pharmacist.
Drinks containing caffeine may reduce the effects of diazepam.

Alcohol

Do not drink alcohol while you are using Stesolid rectal tubes. Alcohol may increase the sedative
effects of diazepam and make you very sleepy.

Pregnancy and breast-feeding

You should not use Stesolid rectal tubes if you are pregnant, planning to become pregnant or
are breast feeding. If you use Stesolid rectal tubes late in your pregnancy or during labour, your
baby might have a low body temperature, floppiness, and breathing difficulties. Your baby may
also develop withdrawal symptoms.

Driving and using machines

Stesolid rectal tubes can make you sleepy, forgetful, have poor co-ordination along with other
side effects that can affect everyday activities (see Possible side effects). You should not drive,
operate machinery or take part in such activities where, if affected, you could put yourself or
others at risk.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking 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.

3 How to use

Always use Stesolid rectal tubes exactly as your doctor has told you.
The tubes are inserted into the anus using the nozzle provided. Instructions for inserting the
tubes are on the folded label on each bag. Please read the instructions very carefully before
using your medicine.
Doses
• Adults and children above 1 year of age: 0.5mg per kg of body weight
• Elderly: 0.25mg per kg of body weight
If you have breathing problems you may be given a lower dose.
After giving into the anus, the medicine is quickly absorbed and will start to take effect within
5 minutes.

If you don’t feel better

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

If you use more Stesolid rectal tubes than you should

4 Possible side effects

Like all medicines, Stesolid rectal tubes 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.
Tell your doctor if you notice any of the following side effects or notice any other effects not
listed:
• drowsiness, sedation, tiredness, slurred speech, light-headedness, unsteadiness or clumsiness
and loss of co-ordination (you may notice these even after a single dose and this may continue
into the following day)
• confusion, memory loss (which may be experienced several hours after taking diazepam. If
possible, to reduce the risk allow 7 to 8 hours of uninterrupted sleep after taking), seeing or
sensing things that are not there, inappropriate behaviour, difficulty concentrating, agitation/
irritability, restlessness, experiencing rage, excitement, numbed emotions, depression with
suicidal tendencies, headache, ‘spinning’ sensation
• blood disorders (you may develop sore throats, nose bleeds or infections) changes in sex drive,
visual disturbances, low blood pressure, stomach upsets, yellowing of the skin or whites of the
eyes (jaundice)
• muscle spasms/shaking or weakness, breathing difficulties
• difficulty passing urine, increase in amount of saliva
• you feel you are abusing or becoming dependant on this product
• Stesolid rectal tubes contain sodium benzoate and benzoic acid which may cause irritation to
the anus (you may feel a stinging sensation).
If you notice any side effects, they get worse, or if you notice any not listed, please tell your
doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Stesolid rectal tubes after the expiry date stated on the label/carton/bottle. 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 to protect the
environment.

6 Further Information
What Stesolid rectal tubes contain:

• The active substance (the ingredient that makes the medicine work) is diazepam. Each rectal
tube contains either 5mg or 10mg of diazepam.
• The other ingredients are benzoic acid, ethanol, propylene glycol, sodium benzoate, benzyl
alcohol, water.

What Stesolid rectal tubes look like and contents of the pack

Stesolid rectal tubes contains a clear, colourless to yellowish liquid in a yellow polyethylene tube.
Pack size of 5 x 2.5ml, singly packed in aluminium foil.
Marketing Authorisation Holder:
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

If you (or someone else) use a lot of medicine at the same time, 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 clumsiness and loss of coordination, feeling sleepy or
deep sleep, speech problems, irregular or slow heartbeat, uncontrolled eye movement, muscle
weakness or excitement. An extreme overdose may lead to coma (unrousable unconsciousness),
reflex problems and breathing difficulties.

Manufacturers
Actavis B.V., Baarnsche Dijk 1, 3741 LN Baarn, The Netherlands
Actavis Group PTC ehf, Reykjavikurvegur 76-78, IS-220 Hafnarfjörður, Iceland

If you forget to use Stesolid rectal tubes

Date of Revision: February 2014

If you forget to use a dose, use it as soon as you remember it and then use the next dose at the
right time. Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Distributor
Actavis, Barnstaple, EX32 8NS, UK

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAG5592

Diazepam (Stesolid) 5mg & 10mg Rectal Tubes PIL - UK

colours/plates:
1. Black

item no: AAAG5592

dimensions: 200 x 210

print proof no: 2

pharmacode:

origination date: 13.02.14

min pt size: 8pt

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 01.04.14

Technical Approval

revised by: S.Anson

date sent: 13.02.14

supplier: Actavis Jakarta

technically app. date: 01.04.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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