DALMANE 15MG CAPSULES

Active substance: FLURAZEPAM MONOHYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Dalmane 15 mg and 30 mg Capsules
Flurazepam (as monohydrochloride)

Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

•  his medicine has been prescribed for you. Do not pass it on to
T
others. It may harm them, even if their symptoms are the same
as yours.
• f you experience any side effect and this becomes serious, tell
I
your doctor or pharmacist.
In this leaflet:
1. What Dalmane is and what it is used for
2. Before you take Dalmane Capsules
3. How to take Dalmane Capsules
4. Possible side effects
5. How to store Dalmane Capsules
6. Further information

1. WHAT DALMANE IS AND WHAT IT IS 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 if you:
•  re allergic (hypersensitive) to flurazepam or any of the other
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ingredients of Dalmane Capsules (these are listed in section 6,
“Further Information”).
•  re allergic (hypersensitive) to any medicine known as a
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benzodiazepine (e.g. nitrazepam, diazepam, chlordiazepoxide, or
temazepam).
• suffer from lung disease.
• suffer from difficulty breathing while awake or asleep.
• suffer from myasthenia gravis (a condition in which the muscles
become weak and tire easily).
•  re suffering from a psychiatric illness or a personality disorder
a
(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
Tell your doctor before you take these capsules if you:
• have a long-term lung, liver or kidney condition.
•  uffer from depression or have recently suffered the death of a
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close friend or relative.
•  egularly drink alcohol or abuse drugs. You must not drink
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alcohol or use drugs while taking Dalmane.
•  re pregnant or breast-feeding. Refer to section Pregnancy and
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breast-feeding below.

Taking Dalmane 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:
•  ntidepressants, other tranquillisers or sleeping pills, or other such
a
medicines that act on the brain and nerves.
• medicines used to relieve pain or anaesthetics.
• medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
•  edicines that affect the liver (e.g. the antibiotic rifampicin and
m
cimetidine, a medicine used to treat stomach problems).
• anti-viral medicines (e. g. ritonavir)
Taking Dalmane 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.
Tell your doctor before taking Dalmane Capsules if you are breastfeeding. Avoid taking Dalmane if you are breast-feeding as Dalmane
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.
Driving and using machines
Dalmane 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.
Important information about some of the ingredients of Dalmane
Dalmane Capsules contain lactose. 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 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 15 mg which may be increased to a maximum
of 30 mg.
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 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.
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 capules. This will help to prevent you becoming used to
Dalmane and reduce the risk of dependence. Discuss with your doctor
prior to stopping taking Dalmane. See section “When you stop taking
Dalmane” below.
If you take more Dalmane 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
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
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:
• depression

• a recurrence of sleep problems
• nervousness

• irritability
• extreme anxiety

• sweating
• tension

• diarrhoea
• restlessness

• headaches
• confusion

• muscle pain
• mood changes
In severe cases the following symptoms may occur:
• changes in behaviour
• hallucinations
• numbness and tingling • fits
of the extremities
• over-sensitivity to light,
noise and touch
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
Like all medicines, Dalmane can cause side effects, although not
everybody gets them.
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
• a feeling of emptiness

• dizziness

• reduced alertness

• muscle weakness

• confusion

• poor muscle co-ordination

• tiredness

• double vision

• headache

• dependence

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

Rare side effects:










• giddiness
• reduced blood pressure
• stomach upsets
• skin rashes
•  roblems with your vision (other than double
p
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.
If you are concerned about any of these side effects, or if you
notice any side effects not listed in this leaflet, tell your doctor or
pharmacist.

5. HOW TO STORE DALMANE CAPSULES
• Store Dalmane Capsules out of the reach and sight of children.
• Store Dalmane Capsules in a dry place below 25°C.
• 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.
•  edicines must not be disposed of via wastewater or household
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waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Dalmane contains
Active substance: Flurazepam (as monohydrochloride). Each capsule
contains the equivalent of 15 mg or 30 mg of
flurazepam.
Other ingredients: Lactose, talc, magnesium stearate, gelatin and
colouring agents iron oxide black (E 172) and
titanium dioxide (E 171). In addition, the 15 mg
capsules contain the colouring agent iron oxide
yellow (E 172).
What Dalmane looks like and contents of the pack
•  almane 15 mg capsules are grey and yellow and are marked with
D
“ICN 15”.
• almane 30 mg capsules are black and grey and are marked with
D

“ICN 30”.
• Both capsule strengths come in packs of 30 capsules.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK
Manufacturer
Labiana Pharmaceuticals S.L.U., Casanova 27-31
08757-Corbera de Llobregat (Barcelona), Spain
For any information about this medicine, please contact the Marketing
Authorisation Holder.
This leaflet was last revised in March 2010.

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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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