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FLURAZEPAM 15MG CAPSULES

Active substance(s): FLURAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ƒ
ƒ

Dalmane® 15mg Capsules
(flurazepam hydrochloride)
Your medicine is available using the name Dalmane 15mg
Capsules but will be referred to as Dalmane Capsules throughout
this leaflet.

Read all of this leaflet carefully before you
start taking this medicine.
ƒ
ƒ
ƒ

ƒ

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 you experience any side effect and this becomes serious,
tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Dalmane Capsules are and what they are used for
Before you take Dalmane Capsules
How to take Dalmane Capsules
Possible side effects
How to store Dalmane Capsules
Further information

1. What Dalmane Capsules are and what they
are used for
Dalmane belongs to a group of medicines known as
benzodiazepines, which are tranquillisers (medicines that have a
calming effect). Dalmane shortens the time taken to fall asleep
and lengthens the duration of sleep.
Dalmane Capsules are used for the short term treatment of
sleeplessness (also known as insomnia) when it is severe. It can
help overcome difficulties in getting to sleep and may help if you
wake up frequently in the middle of the night.
Dalmane Capsules help you to sleep but do not cure the
underlying cause of your insomnia, which you should discuss with
your doctor.

2. Before you take Dalmane Capsules
Do not take Dalmane Capsules if you:
ƒ

ƒ

ƒ
ƒ

are allergic (hypersensitive) to flurazepam or any of the
other ingredients of Dalmane Capsules (these are listed in
section 6, “Further Information”).
are allergic (hypersensitive) to any medicine known as a
benzodiazepine (e.g. nitrazepam, diazepam,
chlordiazepoxide, or temazepam).
suffer from lung disease.
suffer from difficulty breathing while awake or asleep.

ƒ
ƒ

suffer from myasthenia gravis (a condition in which the
muscles become weak and tire easily).
are suffering from a psychiatric illness or a personality
disorder (severe mental problems).
have a liver condition.
suffer from porphyria.

Dalmane Capsules are not for use in anyone under 18 years
of age.

Take special care with Dalmane Capsules

Tell your doctor before you take these capsules if you:
ƒ
have a long-term lung, liver or kidney condition.
ƒ
suffer from depression or have recently suffered the death of
a close friend or relative.
ƒ
regularly drink alcohol or abuse drugs. You must not drink
alcohol or use drugs while taking Dalmane Capsules.
ƒ
are pregnant or breast-feeding. Refer to section Pregnancy
and breast-feeding below.

Taking Dalmane Capsules with other medicines

Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. This is extremely important, as using more than
one medicine at the same time can strengthen or weaken the
effect of the medicines involved. In particular, tell your doctor if
you are taking any of the following medicines:
ƒ
antidepressants, other tranquillisers or sleeping pills, or
other such medicines that act on the brain and nerves.
ƒ
medicines used to relieve pain or anaesthetics.
ƒ
medicines for treating epilepsy (e.g. phenytoin and
phenobarbital).
ƒ
medicines that affect the liver (e.g. the antibiotic rifampicin
and cimetidine, a medicine used to treat stomach problems).
ƒ
anti-viral medicines (e. g. ritonavir)

Taking Dalmane Capsules with food and drink

Do not drink alcohol for as long as you are taking Dalmane
Capsules as this will increase the effects of the medicine, and this
can be dangerous.

Pregnancy and breast-feeding

Tell your doctor before taking Dalmane Capsules if you are
pregnant, think that you are pregnant or intend to become
pregnant during treatment. Your doctor will then decide whether
you should take this medicine.

Driving and using machines

Dalmane Capsules may cause side effects such as reduced
alertness, confusion, tiredness, dizziness, poor muscle coordination and double vision. This may affect your ability to drive
and operate machinery. Do not drive or operate machinery if you
experience any of these side effects.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
ƒ
Do not drive while taking this medicine until you know how it
affects you.
ƒ
It is an offence to drive if this medicine affects your ability to
drive.
ƒ
However, you would not be committing an offence if:
ƒ
The medicine has been prescribed to treat a medical or
dental problem and
ƒ
You have taken it according to the instructions given
by the prescriber or in the information provided with
the medicine and
ƒ
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.

Important information about some of the
ingredients of Dalmane Capsules

Dalmane Capsules contain lactose monohydrate. Therefore, if you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

3. How to take Dalmane Capsules
Your doctor will find the lowest dose to control your symptoms.
The dose that your doctor prescribes will depend on the nature of
your illness, your reaction to the medicine, your age and
bodyweight.
Always take Dalmane Capsules exactly as your doctor has told
you. Do not change the prescribed dose yourself. You should
check with your doctor or pharmacist if you are not sure how to
take this medicine. If you think that the effect of your medicine is
too weak or too strong, talk to your doctor.
The usual starting dose is 15mg which may be increased to a
maximum of 30mg.

Tell your doctor before taking Dalmane Capsules if you are breastfeeding. Avoid taking Dalmane Capsules if you are breast-feeding
as Dalmane Capsules passes into breast-milk.

Take the medicine just before going to bed. Make sure that you
can sleep without interruptions for 7 to 8 hours after taking the
capsules.

If your doctor has decided that you should receive this medicine
during late pregnancy or during labour, your baby might have a
low body temperature, floppiness and breathing and feeding
difficulties. Also, your unborn baby may be at risk of developing
dependency to this medicine and after birth may be at some risk
of developing withdrawal symptoms.

Swallow the capsule(s) whole with water or another non-alcoholic
drink.
Treatment will not normally be continued for more than four
weeks.
This is because Dalmane Capsules may become less effective if
you take them for more than four weeks. If you think that your
medicine is no longer working, you must consult your doctor.

Page 1 of 2

Also, you may become dependent on the capsules if you use them
at high doses and for long periods. Therefore, Dalmane Capsules
are not suitable for long-term use and after a few weeks it is
worth trying to get by without these capsules. This will help to
prevent you becoming used to Dalmane Capsules and reduce the
risk of dependence. Discuss with your doctor prior to stopping
taking Dalmane Capsules. See section “When you stop taking
Dalmane Capsules” below.

If you take more Dalmane Capsules than you should

If you take too many capsules or someone else accidentally takes
your medicine, contact your doctor, pharmacist or nearest hospital
straight away.

If you forget to take Dalmane Capsules

Do not take a double dose to make up for a forgotten dose.
Instead you should simply continue with the next dose when it is
due.

When you stop taking Dalmane Capsules

Your doctor will advise you when to stop taking the capsules. Do
not stop taking Dalmane Capsules abruptly. You may experience
withdrawal effects if your treatment is stopped suddenly. This is
less likely if your dose is gradually reduced towards the end of
your treatment.

Withdrawal symptoms may include:

4. Possible side effects

5. How to store Dalmane Capsules

Like all medicines, Dalmane Capsules can cause side effects,
although not everybody gets them.

ƒ
ƒ
ƒ
ƒ

Changes in behaviour can also occur rarely. These changes may
include aggression, excitement, confusion, restlessness, agitation,
irritability, rage, hallucinations, nightmares and depression. If
these behavioural symptoms occur, you must inform your
doctor. He/she may want you to stop taking this medicine.
Other side effects that have been reported are listed below in
order of the frequency they occur.

Common side effects:
drowsiness during the
day

ƒ

dizziness

6. Further information

ƒ

a feeling of emptiness

ƒ

muscle weakness

What Dalmane Capsules contain

ƒ

reduced alertness

ƒ

poor muscle
co-ordination

ƒ

confusion

ƒ

double vision

ƒ

tiredness

ƒ

dependence

ƒ

headache

ƒ

a recurrence of sleep
problems

ƒ

nervousness

ƒ

irritability

Rare side effects:

ƒ

extreme anxiety

ƒ

sweating

ƒ

tension

ƒ

diarrhoea

ƒ

restlessness

ƒ

headaches

ƒ

confusion

ƒ

muscle pain

ƒ

mood changes

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

changes in behaviour

ƒ

hallucinations

ƒ

numbness and tingling
of the extremities
over-sensitivity to light,
noise and touch

ƒ

fits

ƒ

If you have taken benzodiazepines for a long time, the reduction
in your dosage will be over a longer period of time than would
normally be required when you stop taking this medicine. You
may need additional help. Your doctor will be able to discuss this
with you.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Each capsule contains 15mg flurazepam (as hydrochloride).
Other ingredients are: lactose monohydrate, talc, magnesium
stearate, gelatin, titanium dioxide (E 171) and the colourants
black iron oxide (E 172) and yellow iron oxide (E 172).
The printing ink contains red iron oxide (E 172), shellac glaze,
soya lecithin and dimeticone.

These effects are likely to occur at the start of treatment and
usually disappear after a while.

depression

ƒ

ƒ

ƒ

ƒ

In severe cases the following symptoms may occur:

ƒ

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in a dry place in the original package.
Do not use Dalmane Capsules after the expiry date which is
stated on the blister and the outer carton after “EXP”. The
expiry date refers to the last day of that month.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return it to your
pharmacist who will advise you further.
Medicines must 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.

giddiness
reduced blood pressure
stomach upsets
skin rashes
problems with your vision (other than double vision)
changes in the level of sexual desire
inability to pass urine
yellowing of the skin and/or eyes (jaundice)
abnormality in the blood (blood dyscrasias)

Occasionally some patients have noticed a bitter taste in their
mouth after swallowing the capsules.
If you are woken up soon after taking the medicine your memory
may be temporarily affected.
If you are an elderly patient, you may be more susceptible to side
effects. If this happens, tell your doctor and he/she may decide to
change your dose.

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 effects, you can help provide more information
on the safety of this medicine.

Page 2 of 2

What Dalmane Capsules look like and contents of
the pack
Dalmane are hard capsules with a grey cap and a yellow body,
with “ICN 15” printed in red on both cap and body.
Dalmane Capsules come in packs of 30 capsules.

Manufacturer

Manufactured by: Labiana Pharmaceuticals S.L., Casanova 27-31,
08757-Corbera de Llobregat, Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0456

POM

Leaflet issue and revision date (Ref): 21.05.14
Dalmane® is a registered trademark of Valeant Pharmaceuticals
International.

PACKAGE LEAFLET: INFORMATION FOR THE USER

ƒ
ƒ

Flurazepam 15mg Capsules
(flurazepam hydrochloride)

ƒ
ƒ

suffer from myasthenia gravis (a condition in which the
muscles become weak and tire easily).
are suffering from a psychiatric illness or a personality
disorder (severe mental problems).
have a liver condition.
suffer from porphyria.

Read all of this leaflet carefully before you
start taking this medicine.

Flurazepam 15mg Capsules are not for use in anyone under
18 years of age.

ƒ
ƒ

Take special care with Flurazepam 15mg Capsules

ƒ

ƒ

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 you experience any side effect and this becomes serious,
tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Flurazepam 15mg Capsules are and what they are used
for
Before you take Flurazepam 15mg Capsules
How to take Flurazepam 15mg Capsules
Possible side effects
How to store Flurazepam 15mg Capsules
Further information

1. What Flurazepam 15mg Capsules are and
what they are used for
Flurazepam belongs to a group of medicines known as
benzodiazepines, which are tranquillisers (medicines that have a
calming effect). Flurazepam shortens the time taken to fall asleep
and lengthens the duration of sleep.
Flurazepam 15mg Capsules are used for the short term treatment
of sleeplessness (also known as insomnia) when it is severe. It
can help overcome difficulties in getting to sleep and may help if
you wake up frequently in the middle of the night.
Flurazepam 15mg Capsules help you to sleep but do not cure the
underlying cause of your insomnia, which you should discuss with
your doctor.

2. Before you take Flurazepam 15mg
Capsules
Do not take Flurazepam 15mg Capsules if you:
ƒ

ƒ

ƒ
ƒ

are allergic (hypersensitive) to flurazepam or any of the
other ingredients of Flurazepam 15mg Capsules (these are
listed in section 6, “Further Information”).
are allergic (hypersensitive) to any medicine known as a
benzodiazepine (e.g. nitrazepam, diazepam,
chlordiazepoxide, or temazepam).
suffer from lung disease.
suffer from difficulty breathing while awake or asleep.

Driving and using machines

Flurazepam 15mg Capsules may cause side effects such as
reduced alertness, confusion, tiredness, dizziness, poor muscle
co-ordination and double vision. This may affect your ability to
drive and operate machinery. Do not drive or operate machinery if
you experience any of these side effects.

Tell your doctor before you take these capsules if you:
ƒ
have a long-term lung, liver or kidney condition.
ƒ
suffer from depression or have recently suffered the death of
a close friend or relative.
ƒ
regularly drink alcohol or abuse drugs. You must not drink
alcohol or use drugs while taking Flurazepam 15mg
Capsules.
ƒ
are pregnant or breast-feeding. Refer to section Pregnancy
and breast-feeding below.

The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
ƒ
Do not drive while taking this medicine until you know how it
affects you.
ƒ
It is an offence to drive if this medicine affects your ability to
drive.
ƒ
However, you would not be committing an offence if:
ƒ
The medicine has been prescribed to treat a medical or
dental problem and
ƒ
You have taken it according to the instructions given
by the prescriber or in the information provided with
the medicine and
ƒ
It was not affecting your ability to drive safely

Taking Flurazepam 15mg Capsules with other
medicines

Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.

Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. This is extremely important, as using more than
one medicine at the same time can strengthen or weaken the
effect of the medicines involved. In particular, tell your doctor if
you are taking any of the following medicines:
ƒ
antidepressants, other tranquillisers or sleeping pills, or
other such medicines that act on the brain and nerves.
ƒ
medicines used to relieve pain or anaesthetics.
ƒ
medicines for treating epilepsy (e.g. phenytoin and
phenobarbital).
ƒ
medicines that affect the liver (e.g. the antibiotic rifampicin
and cimetidine, a medicine used to treat stomach problems).
ƒ
anti-viral medicines (e. g. ritonavir)

Important information about some of the
ingredients of Flurazepam 15mg Capsules

Flurazepam 15mg Capsules contain lactose monohydrate.
Therefore, if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.

3. How to take Flurazepam 15mg Capsules
Your doctor will find the lowest dose to control your symptoms.
The dose that your doctor prescribes will depend on the nature of
your illness, your reaction to the medicine, your age and
bodyweight.

Taking Flurazepam 15mg Capsules with food and
drink

Always take Flurazepam 15mg Capsules exactly as your doctor
has told you. Do not change the prescribed dose yourself. You
should check with your doctor or pharmacist if you are not sure
how to take this medicine. If you think that the effect of your
medicine is too weak or too strong, talk to your doctor.

Pregnancy and breast-feeding

The usual starting dose is 15mg which may be increased to a
maximum of 30mg.

Do not drink alcohol for as long as you are taking Flurazepam
15mg Capsules as this will increase the effects of the medicine,
and this can be dangerous.

Tell your doctor before taking Flurazepam 15mg Capsules if you
are pregnant, think that you are pregnant or intend to become
pregnant during treatment. Your doctor will then decide whether
you should take this medicine.
Tell your doctor before taking Flurazepam 15mg Capsules if you
are breast-feeding. Avoid taking Flurazepam 15mg Capsules if you
are breast-feeding as Flurazepam 15mg Capsules passes into
breast-milk.
If your doctor has decided that you should receive this medicine
during late pregnancy or during labour, your baby might have a
low body temperature, floppiness and breathing and feeding
difficulties. Also, your unborn baby may be at risk of developing
dependency to this medicine and after birth may be at some risk
of developing withdrawal symptoms.
Page 1 of 2

Take the medicine just before going to bed. Make sure that you
can sleep without interruptions for 7 to 8 hours after taking the
capsules.
Swallow the capsule(s) whole with water or another non-alcoholic
drink.
Treatment will not normally be continued for more than four
weeks.
This is because Flurazepam 15mg Capsules may become less
effective if you take them for more than four weeks. If you think
that your medicine is no longer working, you must consult your
doctor.

Also, you may become dependent on the capsules if you use them
at high doses and for long periods. Therefore, Flurazepam 15mg
Capsules are not suitable for long-term use and after a few weeks
it is worth trying to get by without these capsules. This will help to
prevent you becoming used to Flurazepam 15mg Capsules and
reduce the risk of dependence. Discuss with your doctor prior to
stopping taking Flurazepam 15mg Capsules. See section “When
you stop taking Flurazepam 15mg Capsules” below.

If you take more Flurazepam 15mg Capsules than
you should

If you take too many capsules or someone else accidentally takes
your medicine, contact your doctor, pharmacist or nearest hospital
straight away.

If you forget to take Flurazepam 15mg Capsules

Do not take a double dose to make up for a forgotten dose.
Instead you should simply continue with the next dose when it is
due.

When you stop taking Flurazepam 15mg Capsules

Your doctor will advise you when to stop taking the capsules. Do
not stop taking Flurazepam 15mg Capsules abruptly. You may
experience withdrawal effects if your treatment is stopped
suddenly. This is less likely if your dose is gradually reduced
towards the end of your treatment.

Withdrawal symptoms may include:
a recurrence of sleep
problems

ƒ

depression

ƒ

ƒ

nervousness

ƒ

irritability

ƒ

extreme anxiety

ƒ

sweating

ƒ

tension

ƒ

diarrhoea

ƒ

restlessness

ƒ

headaches

ƒ

confusion

ƒ

muscle pain

ƒ

mood changes

In severe cases the following symptoms may occur:
ƒ

changes in behaviour

ƒ

hallucinations

ƒ

numbness and tingling
of the extremities
over-sensitivity to light,
noise and touch

ƒ

fits

ƒ

If you have taken benzodiazepines for a long time, the reduction
in your dosage will be over a longer period of time than would
normally be required when you stop taking this medicine. You
may need additional help. Your doctor will be able to discuss this
with you.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects

5. How to store Flurazepam 15mg Capsules

Like all medicines, Flurazepam 15mg Capsules can cause side
effects, although not everybody gets them.

ƒ
ƒ
ƒ
ƒ

Changes in behaviour can also occur rarely. These changes may
include aggression, excitement, confusion, restlessness, agitation,
irritability, rage, hallucinations, nightmares and depression. If
these behavioural symptoms occur, you must inform your
doctor. He/she may want you to stop taking this medicine.
Other side effects that have been reported are listed below in
order of the frequency they occur.

Common side effects:

ƒ

ƒ

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in a dry place in the original package.
Do not use Flurazepam 15mg Capsules after the expiry date
which is stated on the blister and the outer carton after
“EXP”. The expiry date refers to the last day of that month.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return it to your
pharmacist who will advise you further.
Medicines must 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.

ƒ

drowsiness during the
day

ƒ

dizziness

6. Further information

ƒ

a feeling of emptiness

ƒ

muscle weakness

What Flurazepam 15mg Capsules contain

ƒ

reduced alertness

ƒ

poor muscle coordination

ƒ

confusion

ƒ

double vision

ƒ

tiredness

ƒ

dependence

ƒ

headache

Other ingredients are: lactose monohydrate, talc, magnesium
stearate, gelatin, titanium dioxide (E 171) and the colourants
black iron oxide (E 172) and yellow iron oxide (E 172).
The printing ink contains red iron oxide (E 172), shellac glaze,
soya lecithin and dimeticone.

These effects are likely to occur at the start of treatment and
usually disappear after a while.

Rare side effects:
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Each capsule contains 15mg flurazepam (as hydrochloride).

giddiness
reduced blood pressure
stomach upsets
skin rashes
problems with your vision (other than double vision)
changes in the level of sexual desire
inability to pass urine
yellowing of the skin and/or eyes (jaundice)
abnormality in the blood (blood dyscrasias)

Occasionally some patients have noticed a bitter taste in their
mouth after swallowing the capsules.
If you are woken up soon after taking the medicine your memory
may be temporarily affected.
If you are an elderly patient, you may be more susceptible to side
effects. If this happens, tell your doctor and he/she may decide to
change your dose.

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 effects, you can help provide more information
on the safety of this medicine.

Page 2 of 2

What Flurazepam 15mg Capsules look like and
contents of the pack

Flurazepam 15mg are hard capsules with a grey cap and a yellow
body, with “ICN 15” printed in red on both cap and body.
Flurazepam 15mg Capsules come in packs of 30 capsules.

Manufacturer

Manufactured by: Labiana Pharmaceuticals S.L., Casanova 27-31,
08757-Corbera de Llobregat, Barcelona, Spain
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0456

POM

Leaflet issue and revision date (Ref): 21.05.14

Expand view ⇕

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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