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DIAZEPAM GSP 2MG TABLETS

Active substance(s): DIAZEPAM / DIAZEPAM / DIAZEPAM

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Package leaflet: Information for the user
Diazepam GSP 2 mg tablets
Diazepam GSP 5 mg tablets
Diazepam GSP 10 mg tablets
Diazepam
Read all of this leaflet carefully before you start taking 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 only. 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 this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Diazepam GSP is and what it is used for
What you need to know before you take Diazepam GSP
How to take Diazepam GSP
Possible side effects
How to store Diazepam GSP
Contents of the pack and further information

1.

What Diazepam GSP is and what it is used for

Diazepam GSP contains the active substance diazepam which belongs to a group of medicines called
benzodiazepines.
Diazepam GSP is indicated in the treatment of the following conditions:
In Adults:
symptoms of anxiety.
symptoms that occur during alcohol withdrawal.
In Adults and Children over 6 years old:
muscle spasms or pain caused by inflammation of muscles and joints, trauma, including
spasms caused by diseases such as cerebral palsy (group of disorders that affect the ability to
move, maintain balance and posture) and paraplesia (paralysis of the lower half of the body,
affecting both legs) as well as athetosis (continuous, involuntary, slow movements and
unusual fingers and hands) and stiff-person syndrome.

2.

What you need to know before you take Diazepam GSP

Do not take Diazepam GSP:
if you are allergic to diazepam or any of the other ingredients of this medicine (listed in
section 6).
if you have a condition called myasthenia gravis which causes muscles to weaken and tire
easily.
if you have acute respiratory problems (slow and/or shallow breathing).
if you suffer from sleep apnoea (a sleep disorder where you have abnormal pauses in
breathing during sleep).

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if you have severe liver disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam GSP
if you have liver, heart or kidney problems;
if you have a history of alcoholism or drug abuse;
if you have muscle weakness;
if you have breathing problems;
if you have mental problems. Benzodiazepines are not recommended as first-line treatment for
psychosis (mental diseases). These medicines should not be used to treat depression or anxiety
associated with depression as the symptoms may get worse;
if you have epilepsy or a history of seizures.
Talk to your doctor:
if after a few weeks you notice that the tablets are not working as well as they did when first
starting treatment. Tolerance to benzodiazepines may occur.
if you experience side effects or behavioural changes (see section 4).
There is a risk of dependence when taking this medicine.
Children and adolescents
Do not give this medicine to children under the age of 6 years unless it is done after decision and
under strict medical supervision of a specialist (paediatrician, neurologist, psychiatric,
anaesthesiologist and intensivist) that will determine the dose
Children have an increased sensitivity to the effects of benzodiazepines on the central nervous system.
In this patient group, a non-complete development of the transformation mechanism in the body could
cancel or reduce the production of degradation products, leading to more activity.
Other medicines and Diazepam GSP
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Some other medicines may also change the way Diazepam GSP works. Especially:
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antidepressants (e.g. fluvoxamine, fluoxetine);
antipsychotics such as clozapine (to treat mental problems);
muscle relaxants (e.g. suxamethonium, tubocurarin);
barbiturates such as phenobarbital (to treat epilepsy and mental disorders);
other central nervous system depressants (buprenorphine, narcotic analgesics, opioids and
derivatives used to treat cough, baclofen, thalidomide, pizotifen, centrally acting
antihypertensives).
Taking these medicines with diazepam could affect your mental status, make you very sleepy and
suppress your breathing and blood pressure.
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 e.g. phenytoin and carbamazepine, as these can reduce the effect of
diazepam. Diazepam can furthermore affect how phenytoin works;
theophylline (to treat asthma and other breathing disorders), as it can weaken the effect of
diazepam;
cimetidine, omeprazole or esomeprazole (stomach acid reducing medicines), as these can
cause diazepam to be removed from the body more slowly than usual;
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;
atazanavir, ritonavir, delavirdine , efavirenz, indinavir, nelfinavir or saquinavir
(antivirals), fluconazole, itraconazole, ketoconazole or voriconazole (anti-fungal medicines)

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as these can cause diazepam to be removed from the body more slowly than usual and therefore
increase the risk of side effects;
isoniazid (used to treat tuberculosis), as it can cause diazepam to be removed from the body
more slowly than usual;
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;
cisapride (used to treat stomach problems), as it can cause diazepam to be removed from the
body more slowly than usual;
corticosteroids (medicines used to treat inflammation in the body) as they can weaken the
effect of diazepam;
levodopa (used to treat Parkinson’s disease). Diazepam can reduce the effect of levodopa;
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. Valproic acid taken with diazepam increases
the risk of psychoses (mental diseases);
ketamine (an anaesthetic) as diazepam increases the effect of ketamine.

Diazepam GSP with food, drink and alcohol
Do not drink alcohol while you are taking diazepam. Alcohol may increase the sedative effects of
Diazepam GSP.
Grapefruit juice might increase the effect of diazepam.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
You should not take Diazepam GSP if you are pregnant, planning to become pregnant or are breast
feeding. This medicine might affect your baby.
Driving and using machines
Ask your doctor before driving or using machines as Diazepam GSP may slow your reactions. These
effects are increased by the use of alcohol and lack of sleep.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
a.
b.
c.

Do not drive while taking this medicine until you know how it affects you.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
i. The medicine has been prescribed to treat a medical or dental problem and
ii. You have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
iii. 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.
Diazepam GSP contain lactose monohydrate
If you have been told that you have intolerance to some sugars contact your doctor before taking this
medicine.

3.

How to take Diazepam GSP

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.

4

Do not give this medicine to children under the age of 6 years unless it is done after decision and
under strict medical supervision of a specialist (paediatrician, neurologist, psychiatrist,
anaesthesiologist and intensivist) that will determine the dose.
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Your doctor will prescribe a low dose and then gradually increase it until the appropriate dose
is reached.
The dose will depend on your condition and on your response to the treatment.
The duration of treatment should be as short as possible. In general, the treatment should not
exceed 8 to 12 weeks.

Use in adults
The recommended dose is 2 to 20 mg per day. Never take more than 10 mg at once.
Recommended dose for:
- Anxiety symptoms: 10 mg per day (2.5 mg in the morning and 2.5 mg at noon and 5 mg in the
evening).
- Alcohol withdrawal syndrome: 10 mg, 3 to 4 times during the first 24 hours, and reducing to 5 mg 3
to 4 times a day, as needed.
- Treatment of muscle spasms: 2 mg to 10 mg, 3 to 4 times per day.
Use in children and adolescents
- Treatment of muscle spasms in children over 6 years old and adolescents
Recommended dose for:
Children aged 6-12 years old: 5 mg, 2 times a day.
Children aged 12-18 years old: 10 mg, 2 times a day.
Long-term chronic (prolonged) use is not recommended.
Diazepam GSP is not recommended for children below 6 years of age due to possible swallowing
difficulties. More suitable pharmaceutical forms may be available for younger children.
Use in elderly
Your doctor will decide how much Diazepam GSP you should be given and how often. The dose will
be lower than the usual dose prescribed for other adults. Treatment should be initiated with the lowest
possible dose (2 to 2.5 mg, once or twice a day) and increased gradually as necessary and tolerated.
Use in patients with renal failure
Dose adjustment is usually not necessary. However, patients with renal failure should be careful when
taking diazepam.
Benzodiazepines with active metabolites such as diazepam should be avoided in patients with endstage renal disease.
Use in patients with liver failure
Your doctor will decide how much Diazepam GSP you should be given and how often. The dose will
be lower than the usual dose prescribed for other adults.
Use in overweight patients
If you are overweight, it may take longer time for the medicine to work. Furthermore, the effects of
Diazepam GSP may take longer time to wear off including possible side effects.

You should take this medicine preferably in the afternoon or evening.
The tablet can be divided into equal doses.

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If you take more Diazepam GSP than you should
If you have taken too many tablets (more than prescribed), or you think a child may have
swallowed any, contact your nearest hospital casualty department or tell your doctor or
pharmacist immediately.
Signs of an overdose include loss of coordination of muscle movements, apnoea (severe
breathing difficulties), low blood pressure (hypotension), heart and lung problems
(cardiorespiratory depression) and coma (unarousable unconsciousness).
If you forget to take Diazepam GSP
Do not take a double dose to make up for a forgotten dose. 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.
If you stop taking Diazepam GSP
Do not stop taking your medicine without talking to your doctor. If you stop taking Diazepam
GSP suddenly you may experience withdrawal symptoms, including: sleep disorders, headache,
muscle pain, tension, confusion, irritability or aggression, mood changes and hypersensitivity to
light, noise and physical contact. Less common withdrawal symptoms are: seeing or hearing
things which are not there (hallucinations) and loss of perception of reality (derealisation).
You should gradually reduce the number or strength of tablets you take before stopping them
completely. Your doctor will tell you how.
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.
Some side effects can be serious and may require immediate medical attention:
Allergic reactions
If you develop an allergic reaction you should seek medical attention immediately. The side effects
are as follows:
Sudden swelling of your throat, face and lips which can lead to difficulties to breathe and to
swallow
Sudden swelling of the hand, feet and ankles, rash or itching.
Behavioural effects
Talk to your doctor if you notice any of the following side effects. The doctor may ask you to stop
the treatment:
Aggression, irritability, nervousness, agitation, anxiety, delusions, anger.
Sleep problems, nightmares and vivid dreams.
For possible withdrawal symptoms please see “If you stop taking Diazepam GSP” in Section 3.
They are more likely to occur in children and the elderly.
Elderly patients
There is an increased risk of falls and associated fractures in elderly patients using benzodiazepines.
Other side effects:
At the beginning of the treatment with Diazepam GSP, you may experience the following side
effects:
Drowsiness, fatigue, dizziness and light-headedness.
Muscle weakness, loss of coordination of muscle movements (ataxia) and other movement
disorders.
The doctor may propose a lower dose of Diazepam GSP and then slowly increase it.

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The following side effects might occur during the treatment:
Psychiatric disorders and nervous system
Difficulty in concentrating, decreased alertness, confusion and disorientation, agitation.
Memory loss, headache, depression.
Slurred speech, loss of coordination, including instability when walking.
Changes in sexual drive (libido).
Liver and blood (very rare)
Changes in certain liver enzymes as seen in blood tests.
Yellowing of the skin or eyes (jaundice).
Blood problems. The signs may include fatigue, easy bruising, shortness of breath and
nosebleeds. Your doctor may ask you to take blood tests from time to time.
Heart, circulation and blood vessels
Heart problems such as slow heartbeat (bradycardia), heart failure and cessation of heartbeat
(cardiac arrest).
Low blood pressure (hypotension). You might experience dizziness or light-headedness while
standing.
Circulation problems (circulatory depression).
Stomach and intestine (occasionally)
Nausea, constipation, stomach pain.
Dry mouth and increased salivation.
Lungs and kidneys
Respiratory depression.
Lack of ability to urinate (urinary retention), loss of bladder control (leakage of urine).
Eyes, skin and hair
Double vision, blurred vision, vertigo whose signs can be dizziness or spinning sensation.
The most common reactions are skin rash, hives, itching and rash erythematous.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard).By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to store Diazepam GSP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

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What Diazepam GSP contains
The active substance is diazepam. Each tablet contains 2 mg/5 mg/10 mg of diazepam.
The other ingredients are lactose monohydrate, pregelatinised maize starch and magnesium
stearate.
What Diazepam GSP looks like and contents of the pack
Diazepam GSP 2 mg tablets: Tablet is white to almost white round, flat, 8.0 mm in diameter, with “2”
on one side and break line on the other side.
Diazepam GSP 5 mg tablets: Tablet is white to almost white round, flat, 8.0 mm in diameter, with
“5” on one side and break line on the other side.
Diazepam GSP 10 mg tablets: Tablet is white to almost white round, flat, 8.0 mm in diameter, with
“10” on one side and break line on the other side.
Diazepam GSP are packed in Al/PVC blisters. Blisters together with patient information leaflet are
placed in a carton with imprinted label text.
10, 20, 25, 28, 30, 40, 50, 56, 60 and 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Generics Specialty Pharma (GSP) Ltd
Stephenstown Industrial Park,
Balbriggan
Co. Dublin,
Ireland
Manufacturer
S.C. SANTA S.A.
Str. Carpatilor nr. 60, Obiectiv nr. 47, 48, 58, 133, 156
Brasov
jud. Brasov, cod 500269
Romania

This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium - Diazetop
Luxembourg - Diazetop
Spain – Diazepam Apotex
United Kingdom – Diazepam GSP
Poland – Diazepam GSP
This leaflet was last revised in September 2016.

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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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