STESOLID RECTAL TUBE 10MG

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 breastfeeding).

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.

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AAAF0330

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

colours/plates:
1. Black

item no: AAAF0330

dimensions: 200 x 210

print proof no: 2

pharmacode:

origination date: 27.02.13

min pt size: 8pt

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6.

originated by: DR
approved for print/date

2.

revision date: 06.03.13

Technical Approval

revised by: DR

date sent: 27.02.13

supplier: Actavis Jakarta

technically app. date: 01.03.13

Non Printing Colours
1.
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• 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.

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.

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

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.

If you forget to use Stesolid rectal tubes

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.

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
Manufacturers
Actavis B.V., Baarnsche Dijk 1, 3741 LN Baarn, The Netherlands
Actavis Group PTC ehf, Reykjavikurvegur 76-78, IS-220 Hafnarfjörður, Iceland
Distributor
Actavis, Barnstaple, EX32 8NS, UK
Date of Revision: February 2013

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAF0330

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

colours/plates:
1. Black

item no: AAAF0330

dimensions: 200 x 210

print proof no: 2

pharmacode:

origination date: 27.02.13

min pt size: 8pt

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 06.03.13

Technical Approval

revised by: DR

date sent: 27.02.13

supplier: Actavis Jakarta

technically app. date: 01.03.13

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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