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STESOLID RECTAL TUBE 10MG

Active substance(s): DIAZEPAM / DIAZEPAM / DIAZEPAM

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Stesolid® Rectal Tubes
5 mg and 10 mg
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:
• 6 severe anxiety and agitation
• 6 muscle spasms
• 6 epilepsy or febrile convulsions
• 6 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 Before you use

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

• 6 are allergic (hypersensitive) to diazepam
or to other benzodiazepine medicines
or to any of the other ingredients (see
section 6)
• 6 have acute respiratory depression
(slow and/or shallow breathing)
• 6 suffer from depression (with or
without anxiety) or hyperactivity
BBBA0682

• 6 have a phobia (a fear of a particular
object or situation) or other mental
illness
• 6 have a condition called myasthenia
gravis which causes muscles to weaken
and tire easily
• 6 suffer from sleep apnoea (a sleep
disorder where you have abnormal
pauses in breathing during sleep)
• 6 have severe liver disorders
• 6 have porphyria (an inherited condition
causing skin blisters, abdominal pain
and brain or nervous system disorders)
• 6 planning a pregnancy or are pregnant
(see Pregnancy and breast-feeding)

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

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

Warnings about stopping
treatment

• 6 Psychiatric 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.
• 6 Dependence – when taking 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.
• 6 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.
• 6 Withdrawal – 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 taking Stesolid
rectal tubes’.

• 6 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:
• 6 antidepressants (e.g. fluvoxamine,
fluoxetine)
• 6 antipsychotics such as clozapine (to
treat mental problems)
• 6 antihistamines (to treat allergies)
• 6 lofexidine (to help relieve symptoms
when you stop taking opioids)
• 6 general anaesthetics
• 6 sedatives (used to give calming effects)
• 6 hypnotics (to help you sleep)
• 6 sodium oxybate (to treat narcolepsy)
• 6 muscle relaxants (e.g. suxamethonium,
tubocurarin, baclofen, tizanidine)
• 6 some strong pain killers such as
morphine (opioids)
• 6 barbiturates such as phenobarbital (to
treat epilepsy and mental disorders)
• 6 st John’s wart (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.
• 6 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.
• 6 medicines for epilepsy e.g. phenytoin
and carbamazepine, as these can reduce
the effect of diazepam. Diazepam can
furthermore affect how phenytoin
works.
• 6 theophylline (to treat asthma and other
breathing disorders), as it can weaken
the effect of diazepam.
• 6 cimetidine, omeprazole or
esomeprazole (stomach acid reducing
medicines), as these can cause diazepam
to be removed from the body more
slowly than usual.
• 6 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.
• 6 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.

• 6 isoniazid (used to treat tuberculosis), as
it can cause diazepam to be removed
from the body more slowly than usual.
• 6 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.
• 6 corticosteroids (medicines used to treat
inflammation in the body) as they can
weaken the effect of diazepam.
• 6 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.
• 6 levodopa (used to treat Parkinson’s
disease). Diazepam can reduct the effect
of levodopa.
• 6 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.
• 6 ketamine (an anaesthetic) as diazepam
increases the effect of ketamine.

Taking Stesolid with food and
drink

Do not drink alcohol while you are taking
diazepam. Alcohol may increase the
sedative effects of Stesolid rectal tubes 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.

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

Ask your doctor or pharmacist for advice
before taking any medicine.
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.

Diazepam (Stesolid) 5mg and 10mg Rectal Tubes PIL - UK
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S.Anson
20.04.17
25.04.17
S.Anson

Date sent:
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Date received: 20.04.17

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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.
• 6 Do not drive while taking this medicine
until you know how it affects you.
• 6 It is an offence to drive if this medicine
affects your ability to drive.
• 6 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
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 take 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,
sleep-like drowsy state, confusion, slurred
speech, irregular or slow heartbeat,
uncontrolled eye movement and muscle
weakness.
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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

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.
If you stop taking 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 taking 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
taking 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, 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.
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
• 6 Respiratory depression (very slow and/or
shallow breathing)
Rare: affects 1 to 10 users in 10,000
• 6 Respiratory arrest (cessation of breathing)
• 6 Unconsciousness
• 6 Jaundice (yellowing of your skin or the
white of your eyes)
Very rare: affects less than 1 user in 10,000
• 6 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
• 6 Drowsiness

If you notice any side effects, they get
worse, or if you notice any not listed,
please tell your doctor or pharmacist.

Common: affects 1 to 10 users in 100
• 6 Fatigue
• 6 Withdrawal symptoms (for possible
symptoms please see ‘If you stop taking
Stesolid rectal tubes’ in Section 3)
• 6 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)
• 6 Loss of coordination of muscle
movements (ataxia) and other
movement disorders, tremor

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

Uncommon: affects 1 to 10 users in 1,000
• 6 Muscle weakness
• 6 Memory loss
• 6 Difficulty in concentrating
• 6 Balance disorders
• 6 Dizziness
• 6 Headache
• 6 Slurred speech
• 6 Stomach and intestinal problems such
as feeling or being sick, constipation,
diarrhoea
• 6 Increased salivation

Stesolid rectal tubes contains Benzoic acid
which can mildly irritate the skin, eyes and
mucous membranes.

Rare: affects 1 to 10 users in 10,000
• 6 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.
• 6 Decreased alertness
• 6 Depression
• 6 Emotional withdrawal
• 6 Insomnia (problems sleeping)
• 6 Heart problems such as slow heartbeat
(bradycardia), heart failure and
cessation of heartbeat (cardiac arrest).
• 6 Low blood pressure, fainting (syncope)
• 6 Increased mucus in the lungs
• 6 Dry mouth
• 6 Increased appetite
• 6 Changes in certain liver enzymes as
seen in blood tests
• 6 Lack of ability to urinate, loss of bladder
control (leakage of urine)
• 6 Breast enlargement in men
• 6 Impotence, changes in sexual drive
(libido)
• 6 Blood disorders (you may develop sore
throat, nose bleeds or infections)
Very rare: affects less than 1 user in 10,000
• 6 Low levels of white blood cells
(leukopenia)
• 6 Higher level of a certain enzyme in the
blood (transaminase)

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

Important information about
some of the ingredients or
Stesolid rectal tubes

5 How to store

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 to protect the environment.

6 Further Information

What Stesolid rectal tubes
contain:

• 6 The active substance (the ingredient
that makes the medicine work) is
diazepam. Each rectal tube contains
either 5mg or 10mg of diazepam.
• 6 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.
Not known: frequency cannot be
Dupnitsa 2600, Bulgaria
estimated from the available data
• 6 Blurred vision, double vision and
Distributor
involuntary eye movements (these
Actavis, Barnstaple, EX32 8NS, UK
side effects dissappear after you have
Date of Revision: May 2017
stopped taking diazepam)
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

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

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0682

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
20.04.17
25.04.17
S.Anson

Date sent:
20.04.17
Date received: 20.04.17

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.

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