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STESOLID RECTAL TUBE 10MG

Active substance(s): DIAZEPAM

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Stesolid® Rectal Solution
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 a re 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

AAAG8390

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

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

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

Warnings about stopping
treatment

•6 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.
•6 D
 ependence – 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 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.
•6 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 taking Stesolid
rectal tubes’.

•6 R
 ebound sleeplessness and anxiety
6 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)
T aking 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.

 tazanavir, ritonavir, delavirdine,
•6 a
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 i soniazid (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 coordination 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.
•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:
6 - The medicine has been prescribed
to treat a medical or dental problem
and
6 - You have taken it according to the
instructions given by the prescriber
or in the information provided with
the medicine and
6 - 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.
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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. 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 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

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

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

Important information about
some of the ingredients or
Stesolid rectal tubes

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)
Not known: frequency cannot be
estimated from the available data
•6 Blurred vision, double vision and
involuntary eye movements (these
side effects dissappear after you have
stopped taking diazepam)

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.

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

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 T he active substance (the ingredient
that makes the medicine work) is
diazepam. Each rectal tube contains
either 5mg or 10mg of diazepam.
•6 T he 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: June 2014

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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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