To avoid these things happening, treatment quickly than usual.

The effect of diazepam can

should be stopped gradually, under the advice be weakened.
of a doctor. • a tazanavir, ritonavir, delavirdine, efavirenz,
Package leaflet: Information for the patient indinavir, nelfinavir or saquinavir (antivirals),
Other medicines and Stesolid rectal fluconazole, itraconazole, ketoconazole or
Stesolid® Rectal Tubes tubes
Tell your doctor or pharmacist if you are taking
voriconazole (anti-fungal medicines) as these
can cause diazepam to be removed from the
5 mg and 10 mg or have recently taken or might take any other
medicines, including medicines obtained without
body more slowly than usual and therefore
increase the risk of side effects.
diazepam a prescription. Especially: • isoniazid (used to treat tuberculosis), as it can
• a ntidepressants (e.g. fluvoxamine, fluoxetine) cause diazepam to be removed from the body
Read all of this leaflet carefully before you start • have a condition called myasthenia gravis
• a ntipsychotics such as clozapine (to treat more slowly than usual.
using this medicine because it contains important which causes muscles to weaken and tire easily
mental problems) •o  ral contraceptives, as they can slow down the
information for you. • suffer from sleep apnoea (a sleep disorder
• a ntihistamines (to treat allergies) removal of diazepam from the body and increase
•  Keep this leaflet. You may need to read it again. where you have abnormal pauses in breathing
• lofexidine (to help relieve symptoms when you its effect. Breakthrough bleeding can occur when
•   If you have any further questions, ask your doctor during sleep)
stop using opioids) using diazepam and oral contraceptives together,
or pharmacist. • have severe liver disorders
•g  eneral anaesthetics but the contraceptive protection is not reduced.
•   This medicine has been prescribed for you only. Do • have porphyria (an inherited condition causing
• s edatives (used to give calming effects) • c orticosteroids (medicines used to treat
not pass it on to others. It may harm them, even if skin blisters, abdominal pain and brain or
•h  ypnotics (to help you sleep) inflammation in the body) as they can weaken
their signs of illness are the same as yours. nervous system disorders)
• s odium oxybate (to treat narcolepsy) the effect of diazepam.
•  If you get any side effects, talk to your doctor or • planning a pregnancy or are pregnant (see
•m  uscle relaxants (e.g. suxamethonium, •m  edicines to lower high blood pressure,
pharmacist. This includes any possible side effects Pregnancy and breast-feeding)
tubocurarin, baclofen, tizanidine) diuretics (water tablets), nitrates (for heart
not listed in the leaflet. See section 4.
Warnings and precautions • some strong pain killers such as morphine conditions), hydralazine, minoxidil, sodium
What is in this leaflet: Talk to your doctor or pharmacist before using (opioids) nitroprusside as these could lower your blood
Stesolid rectal tubes if you •b  arbiturates such as phenobarbital (to treat pressure too much.
1 What Stesolid rectal tubes are and • have a history of alcoholism or drug abuse epilepsy and mental disorders) • levodopa (used to treat Parkinson’s disease).
what they are used for • have someone close to you who has recently • St John’s wort (h.p) (used to treat depression) Diazepam can reduct the effect of levodopa.
2 What you need to know before you died Concomitant use of Stesolid rectal tubes and
• v alproic acid (used to treat epilepsy and mental
• are elderly. Stesolid rectal tubes can cause disorders) as it can slow down the removal of
use Stesolid rectal tubes opioids (strong pain killers, medicines for
diazepam from the body and increase its effect.
confusion and have effects on muscles causing substitution therapy and some cough medicines)
3 How to use Stesolid rectal tubes falls and injuries • k etamine (an anaesthetic) as diazepam
increases the risk of drowsiness, difficulties in
4 Possible side effects • have a personality disorder breathing (respiratory depression), coma and may
increases the effect of ketamine.
• have liver disease
5 How to store Stesolid rectal tubes • suffer from depression
be life-threatening. Because of this, concomitant Stesolid rectal tubes with food and drink
use should only be considered when other Do not drink alcohol while you are using
6 Contents of the pack and other • have suicidal thoughts treatment options are not possible. diazepam. Alcohol may increase the sedative
information Warnings about stopping treatment effects of Stesolid rectal tubes and make you
However if your doctor does prescribe Stesolid
•P  sychiatric side effects – contact your doctor very sleepy.
1 What Stesolid rectal tubes are and if you experience side effects such as agitation,
rectal tubes together with opioids the dose and
duration of concomitant treatment should be You should not drink grapefruit juice while using
what they are used for irritability, delusions, rage, inappropriate limited by your doctor. diazepam as it causes diazepam to be removed
Stesolid rectal tubes contain diazepam which behaviour, restlessness, aggressiveness, from the body more slowly and increases the risk
belongs to a group of medicines called nightmares or hallucinations. These side effects Please tell your doctor about all opioid medicines of side effects.
benzodiazepines. Diazepam is used to treat: are more likely to occur in children or the elderly. you are taking, and follow your doctor’s dose
• severe anxiety and agitation •D  ependence – when using this medicine there recommendation closely. It could be helpful to Drinks containing caffeine may reduce the effects
• muscle spasms is a risk of dependence, which increases with inform friends or relatives to be aware of the signs of diazepam.
• epilepsy or febrile convulsions the dose and duration of treatment and also in and symptoms stated above. Contact your doctor
• symptoms of alcohol withdrawal Pregnancy and breast-feeding
patients with a history of alcoholism and drug when experiencing such symptoms.
You should not use Stesolid rectal tubes if you are
abuse or personality disorder. Therefore, you pregnant, planning to become pregnant or are
Stesolid rectal tubes can also be used to provide Taking these medicines with diazepam could
should use Stesolid rectal tubes for as short a breast-feeding. If you use Stesolid rectal tubes late
sedation before operations (premedication). affect your mental status, make you very sleepy
period of time as possible. in pregnancy or during labour your baby might
and suppress your breathing and blood pressure.
Your doctor may prescribe Stesolid rectal tubes • T olerance – if after a few weeks you notice that have a low body temperature, floppiness and
•d  isulfiram (to treat alcohol addiction). Using this
for other uses. Please follow your doctor’s this medicine is not working as well as it did breathing difficulties. If used regularly during late
medicine with diazepam could make you very
instructions. when first starting treatment, you should speak pregnancy, your baby may develop withdrawal
sleepy and can cause diazepam to be removed
to your doctor. symptoms.
from the body more slowly than usual.
2 What you need to know before you •W  ithdrawal – treatment should be gradually
•m  edicines for epilepsy e.g. phenytoin and
use Stesolid rectal tubes withdrawn. Withdrawal symptoms occur with Driving and using machines
carbamazepine, as these can reduce the effect of
Do not use Stesolid rectal tubes if you Stesolid rectal tubes even when normal doses Stesolid rectal tubes may make you feel sleepy,
diazepam. Diazepam can furthermore affect how
• are allergic to diazepam or to other are given for short periods of time. See Section 3, forgetful, have poor co-ordination and affect
phenytoin works.
benzodiazepine medicines or to any of the other ‘If you stop using Stesolid rectal tubes’. your concentration along with other side effects
• t heophylline (to treat asthma and other
ingredients of this medicine (listed in section 6) •R  ebound sleeplessness and anxiety that can affect everyday activities (see Section 4,
breathing disorders), as it can weaken the effect
• have acute respiratory depression (slow and/ When you stop using this type of medicine, ‘Possible side effects’). It may also affect how
of diazepam.
or shallow breathing) some of the symptoms that led to treatment your muscles work. These effects may continue
• c imetidine, omeprazole or esomeprazole
• s uffer from depression (with or without can return more intensely than before, such for several days after discontinuation of treatment
(stomach acid reducing medicines), as these can
anxiety) or hyperactivity as sleep disturbances, anxiety, restlessness or with diazepam. Do not drive, use any tools or
cause diazepam to be removed from the body
• have a phobia (a fear of a particular object or mood changes. The risk of this is greater if you machines, or take part in such activities where, if
more slowly than usual.
situation) or other mental illness stop suddenly. affected, you could put yourself or others at risk.
• r ifampicin (an antibiotic) as this can cause
BBBA8234 diazepam to be removed from the body more Continued over page

Diazepam (Stesolid) All Strengths Rectal Tubes PIL - UK

approved for print/date
Item number: BBBA8234 Colours Non Printing Colours
1. Black 1.
Originator: T. Hull Dimensions: 200x210
Origination Date: 27.05.2020 Min Body Text Size: 7pt 2. 2.
Revision Date: Supplier: Teva Jakarta 3. 3.
Revised By: 4.
5.
Proof Round
2 Technical
Approval
Date sent: 27.05.2020
Date received: 28.05.2020
6.

EU-Artwork-Support@accord-healthcare.com
Cartons and label leaflets only
(labels only when specified) German GTIN 14 (incorporating PZN):
* Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7
12.02.2020
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.
 The medicine can affect your ability to drive as it heartbeat, uncontrolled eye movement and Tell your doctor if you notice any of the following Reporting of side effects
may make you sleepy or dizzy. muscle weakness. An extreme overdose may lead side effects or notice any other effects not listed: If you get any side effects, talk to your doctor,
•D  o not drive while using this medicine until you to coma (unrousable unconsciousness), low body pharmacist or nurse. This includes any possible
Very common: affects more than 1 user in 10
know how it affects you. temperature (hypothermia), low blood pressure, side effects not listed in this leaflet. You can also
• Drowsiness
• It is an offence to drive if this medicine affects slow pulse and severe breathing difficulties. report side effects directly via the Yellow Card
your ability to drive. Common: affects 1 to 10 users in 100 Scheme at: www.mhra.gov.uk/yellowcard or
•H  owever, you would not be committing an If you forget to use Stesolid rectal tubes • F atigue, sedation search for MHRA Yellow Card in the Google Play or
offence if: If you forget a dose, use Stesolid as soon as you • Withdrawal symptoms (for possible symptoms Apple App Store.
- The medicine has been prescribed to treat a remember it. If you are about to use the next dose, please see Section 3, ‘If you stop using Stesolid
medical or dental problem and skip the missed dose. Do not use a double dose to rectal tubes’) By reporting side effects you can help provide
- You have used it according to the instructions make up for a forgotten dose. • Confusion more information on the safety of this medicine.
given by the prescriber or in the information • L oss of coordination of muscle movements
If you stop using Stesolid rectal tubes 5 How to store Stesolid rectal tubes
provided with the medicine and (ataxia) and other movement disorders, tremor
Do not stop using your medicine without talking Keep out of the sight and reach of children.
- It was not affecting your ability to drive safely
to your doctor. You should gradually reduce Uncommon: affects 1 to 10 users in 1,000 Do not store above 25°C.
Talk to your doctor or pharmacist if you are not the number or strength of rectal tubes you use •M  uscle weakness Do not use Stesolid rectal tubes after the expiry
sure whether it is safe for you to drive while using before stopping them completely. If you stop •M  emory loss (which may be experienced several date stated on the label/carton/bottle. The expiry
this medicine. using Stesolid rectal tubes suddenly, you may hours after using diazepam. If possible, to reduce date refers to the last day of that month.
experience withdrawal symptoms including: the risk allow 7 to 8 hours of uninterrupted sleep Medicines should not be disposed of via
Stesolid rectal tubes contains benzoic acid, anxiety, panic attack, palpitations (strong and after using) wastewater or household waste. Ask your
sodium benzoate and propylene glycol pounding heartbeat), sweating, tremor, stomach •D  ifficulty in concentrating pharmacist how to dispose of medicines no
These may cause mild irritation to the skin and/or problems, irritability, aggression, sensory disorder, • Balance disorders, dizziness, headache longer required. These measures will help protect
mucous membranes. muscle spasms, generally feeling unwell, loss of • S lurred speech the environment.
appetite, insomnia, mental side effects such as • S tomach and intestinal problems such as feeling
3 How to use Stesolid rectal tubes severe confusion and seizures. The likelihood and or being sick, constipation, diarrhoea 6 C
 ontents of the pack and other
Always use this medicine exactly as your severity of withdrawal symptoms depends on the • Increased salivation
doctor has told you. Check with your doctor or duration of treatment, dose strength and degree
Information
pharmacist if you are not sure. Rare: affects 1 to 10 users in 10,000 What Stesolid rectal tubes contain:
of dependency.
The tubes are inserted into the anus using the • P sychiatric side effects such as excitation, • The active substance (the ingredient that makes
nozzle provided. Instructions for inserting the If you have epilepsy or history of seizures and agitation, restlessness, irritability, inappropriate the medicine work) is diazepam. Each rectal tube
tubes are on the folded label on each bag. Please suddenly stop using Stesolid rectal tubes, there behaviour, aggressiveness, memory loss, contains either 5mg or 10mg of diazepam.
read the instructions very carefully before using is a risk of convulsions or long-lasting epileptic delusion, rages, psychoses, nightmares or • The other ingredients are benzoic acid, ethanol,
your medicine. seizure. There is also risk of seizures if you have an hallucinations. May be or become serious. These propylene glycol, sodium benzoate, benzyl
alcohol or drug abuse problem and suddenly stop side effects are more likely to occur in children alcohol, water.
The recommended dose is using Stesolid rectal tubes. or the elderly.
Adults: 0.5mg per kg of body weight. •D  ecreased alertness What Stesolid rectal tubes look like and
Elderly: 0.25mg per kg of body weight. If you have any further questions on the use of this • Depression contents of the pack
medicine, ask your doctor or pharmacist. • E motional withdrawal Stesolid rectal tubes contains a clear, colourless to
Children and adolescents above 1 year of age:
0.5mg per kg of body weight. • Insomnia (problems sleeping) yellowish liquid in a yellow polyethylene tube.
4 Possible side effects •H  eart problems such as slow heartbeat
If you have breathing problems, you may also be Like all medicines, this medicine can cause side (bradycardia), heart failure and cessation of Pack size of 5 x 2.5ml, singly packed in aluminium
given a lower dose. effects, although not everybody gets them. heartbeat (cardiac arrest). foil.
After inserting into the anus, the medicine is • L ow blood pressure, fainting (syncope)
Stop treatment and contact a doctor at once Marketing Authorisation Holder:
quickly absorbed and will start to take effect • Increased mucus in the lungs
if you have the following symptoms of an Accord Healthcare Limited
within 5 minutes. •D  ry mouth
allergic reaction e.g. itchy skin, rash, swelling Sage House, 319 Pinner Road
Your doctor will decide the appropriate dose and of the face, lips, tongue or throat, or difficulty • Increased appetite North Harrow, Middlesex
for how long you need to use this medicine. The breathing or swallowing. •C  hanges in certain liver enzymes as seen in HA1 4HF, United Kingdom
usual duration of treatment is not longer than 4 blood tests
weeks. If needed, your doctor might increase the Contact your doctor immediately, if you notice • L ack of ability to urinate, loss of bladder control Manufacturers
duration of treatment. any of the following side effects or notice any (leakage of urine) Balkanpharma - Dupnitsa AD
other effects not listed: • B reast enlargement in men 3 Samokovsko Shosse Str.
If you don’t feel better • Impotence, changes in sexual drive (libido) Dupnitsa 2600, Bulgaria
If your symptoms or the fits are not brought Uncommon: affects 1 to 10 users in 1,000 • B lood disorders (you may develop sore throat,
under control with Stesolid rectal tubes, contact • Respiratory depression (very slow and/or shallow Merckle GmbH
nose bleeds or infections)
a doctor for advice. Further doses should only be breathing) Graf-Arco-Str. 3, 89079 Ulm, Germany
given after consulting a doctor. The maximum Very rare: affects less than 1 user in 10,000
Rare: affects 1 to 10 users in 10,000 • L ow levels of white blood cells (leukopenia) This leaflet was last revised in June 2020.
dose is 30mg. • Respiratory arrest (cessation of breathing) •H  igher level of a certain enzyme in the blood
If you use more Stesolid than you should • Unconsciousness (transaminase)
If you have used too many rectal tubes (more • Jaundice (yellowing of your skin or the white of
your eyes) Not known: frequency cannot be estimated from
than prescribed), or you think a child may
the available data
have swallowed any, contact your nearest Very rare: affects less than 1 user in 10,000 • B lurred vision, double vision and involuntary eye
hospital casualty department or tell your doctor • Anaphylaxis (severe allergic reaction) with movements (these side effects dissappear after
immediately. symptoms such as sudden wheezing, swelling you have stopped using diazepam)
Signs of an overdose include loss of coordination of your lips, tongue and throat or body, rash, •U  ncovering of depression with suicidal thoughts
of muscle movements, sleep-like drowsy state, fainting or difficulties to swallow and dependence or abuse of this medicine or
confusion, slurred speech, irregular or slow similar medicines.
•A  bnormal pauses in breathing
BBBA8234 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

Diazepam (Stesolid) All Strengths Rectal Tubes PIL - UK

approved for print/date
Item number: BBBA8234 Colours Non Printing Colours
1. Black 1.
Originator: T. Hull Dimensions: 200x210
Origination Date: 27.05.2020 Min Body Text Size: 7pt 2. 2.
Revision Date: Supplier: Teva Jakarta 3. 3.
Revised By: 4.
5.
Proof Round
2 Technical
Approval
Date sent: 27.05.2020
Date received: 28.05.2020
6.

EU-Artwork-Support@accord-healthcare.com
Cartons and label leaflets only
(labels only when specified) German GTIN 14 (incorporating PZN):
* Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7
12.02.2020
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.