Skip to Content

UK Edition. Click here for US version.

STESOLID RECTAL TUBE 10MG

Active substance(s): DIAZEPAM

PDF options:  View Fullscreen   Download PDF

PDF Transcript

mood changes. The risk of this is greater if you
stop suddenly.
Package leaflet: Information for the patient

Stesolid® Rectal Tubes
5 mg and 10 mg
diazepam
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
•  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 signs of illness are the same as yours.
•  If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in the leaflet. See section 4.

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)
• planning a pregnancy or are pregnant (see
Pregnancy and breast-feeding)

What is in this leaflet:
1 What Stesolid rectal tubes are and
what they are used for
2 What you need to know before you
use Stesolid rectal tubes
3 How to use Stesolid rectal tubes
4 Possible side effects
5 How to store Stesolid rectal tubes
6 Contents of the pack and other
information

Warnings and precautions

1 What Stesolid rectal tubes are and
what they are used for

Warnings about stopping treatment

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 provide
sedation before operations (premedication).
Your doctor may prescribe Stesolid rectal tubes
for other uses. Please follow your
doctor’s instructions.

2 What you need to know before you
use Stesolid rectal tubes

Do not use Stesolid rectal tubes if you
• 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)
• s uffer from depression (with or without
anxiety) or hyperactivity
• have a phobia (a fear of a particular object or

Talk to 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. Stesolid rectal tubes 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
•P
 sychiatric side effects – contact your doctor
if you experience side effects such as agitation,
irritability, delusions, rage, inappropraite
behaviour, restlessness, aggressiveness,
nightmares or hallucinations. These side
effects are more likely to occur in children or
the elderly.
•D
 ependence – 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 Stesolid rectal
tubes for as short period of time as possible.
• T olerance – 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.
•W
 ithdrawal – treatment should be gradually
withdrawn. Withdrawal symptoms occur with
Stesolid rectal tubes even when normal doses
are given for short periods of time. See Section
3, ‘If you stop using Stesolid rectal tubes’.
•R
 ebound 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

BBBA0863

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

Other medicines and Stesolid rectal
tubes

Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, including medicines obtained
without a prescription. Especially:
• a ntidepressants (e.g. fluvoxamine, fluoxetine)
• a ntipsychotics such as clozapine (to treat
mental problems)
• a ntihistamines (to treat allergies)
• l ofexidine (to help relieve symptoms when
you stop using opioids)
•g
 eneral anaesthetics
• s edatives (used to give calming effects)
•h
 ypnotics (to help you sleep)
• s odium oxybate (to treat narcolepsy)
•m
 uscle 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)
Taking these medicines with diazepam could
affect your mental status, make you very
sleepy and suppress your breathing and blood
pressure.
•d
 isulfiram (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.
•m
 edicines for epilepsy e.g. phenytoin and
carbamazepine, as these can reduce the effect
of diazepam. Diazepam can furthermore affect
how phenytoin works.
• t heophylline (to treat asthma and other
breathing disorders), as it can weaken the
effect of diazepam.
• c imetidine, omeprazole or esomeprazole
(stomach acid reducing medicines), as these
can cause diazepam to be removed from the
body more slowly than usual.
• r ifampicin (an antibiotic) as this can cause
diazepam to be removed from the body more
quickly than usual. The effect of diazepam can
be weakened.
• a tazanavir, 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.
• i soniazid (used to treat tuberculosis), as it can
cause diazepam to be removed from the body
more slowly than usual.
•o
 ral contraceptives, as they can slow down
the removal of diazepam from the body and
increase its effect. Breakthrough bleeding

can occur when using diazepam and oral
contraceptives together, but the contraceptive
protection is not reduced.
• c orticosteroids (medicines used to treat
inflammation in the body) as they can weaken
the effect of diazepam.
•m
 edicines 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.
• l evodopa (used to treat Parkinson’s disease).
Diazepam can reduct the effect of levodopa.
• v alproic acid (used to treat epilepsy and
mental disorders) as it can slow down the
removal of diazepam from the body and
increase its effect.
• k etamine (an anaesthetic) as diazepam
increases the effect of ketamine.

Stesolid rectal tubes with food and
drink

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

You should not take Stesolid rectal tubes if you
are pregnant, planning to become pregnant
or are breast-feeding. If you take Stesolid rectal
tubes 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 machines

Stesolid rectal tubes 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 put yourself or others at risk.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
•D
 o 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.
•H
 owever, you would not be committing an
offence if:
- The medicine has been prescribed to treat a
medical or dental problem and
Continued over page

Diazepam (Stesolid) 5mg and 10mg Rectal Tubes PIL - UK
approved for print/date

Proof Round

4a

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0863

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
31.05.17
05.10.17
S.Anson

Date sent:
31.05.17
Date received: 02.06.17

Dimensions:
200 x 210
Min Body Text Size: 7pts
Supplier:
Actavis Jakarta

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

- 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
using this medicine.
Stesolid rectal tubes contains benzoic acid,
sodium benzoate and propylene glycol
These may cause mild irritation to the skin and/
or mucous membranes.

3 How to use Stesolid rectal tubes

Always use this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
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.
The recommended dose is
Adults: 0.5mg per kg of body weight.
Elderly: 0.25mg per kg of body weight.
Children and adolescents above 1 year of
age: 0.5mg per kg of body weight.
If you 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.

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 only after consulting a
doctor. The maximum dose is of 30mg.

If you use more Stesolid 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, sleeplike 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 Stesolid rectal
tubes

Very common: affects more than 1 user in 10
• Drowsiness

If you stop using Stesolid rectal tubes

Common: affects 1 to 10 users in 100
• Fatigue, sedation
• Withdrawal symptoms (for possible
symptoms please see ‘If you stop using Stesolid
rectal tubes’ in Section 3)
• Confusion
• Loss of coordination of muscle movements
(ataxia) and other movement disorders,
tremor

If you forget to take a dose take it as soon as
you remember it. If you are about to take the
next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten dose.
Do not stop using your medicine without
talking to your doctor. You should gradually
reduce the number or strength of rectal tubes
you use before stopping them completely. If
you stop using Stesolid rectal tubes 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 Stesolid rectal tubes, 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, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine 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 in 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:

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)
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 dissappear
after you have stopped using 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 Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side affects you can help provide
more information on the safety of this
medicine.

5 How to store Stesolid rectal tubes

Keep out of the sight and reach 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
protect the environment.

6 C
 ontents of the pack and other
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:
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF, United Kingdom
Manufacturers
Actavis Group PTC ehf,
Reykjavikurvegur 76-78, IS-220
Hafnarfjörður, Iceland
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600, Bulgaria
Distributor
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in September 2017.

Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

BBBA0863

Diazepam (Stesolid) 5mg and 10mg Rectal Tubes PIL - UK
approved for print/date

Proof Round

4a

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0863

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
31.05.17
05.10.17
S.Anson

Date sent:
31.05.17
Date received: 02.06.17

Dimensions:
200 x 210
Min Body Text Size: 7pts
Supplier:
Actavis Jakarta

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

+ Expand Transcript

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.

Hide