Dalmane 30mg Capsules
Dalmane® 30mg Capsules
(flurazepam hydrochloride)
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.
■ 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Dalmane 30mg Capsules but will be referred to as Dalmane Capsules throughout this leaflet.
In this leaflet:
1. What Dalmane Capsules are and what they are 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 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:
■ 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.
■ 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:
■ have a long-term lung, liver or kidney condition.
■ suffer from depression or have recently suffered the death of
a close friend or relative.
■ regularly drink alcohol or abuse drugs. You must not drink alcohol or use drugs while taking Dalmane Capsules.
■ 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:
■ antidepressants, other tranquillisers or sleeping pills, or other such medicines that act on the brain and nerves.
■ medicines used to relieve pain or anaesthetics.
■ medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
■ medicines that affect the liver (e.g. the antibiotic rifampicin and cimetidine, a medicine used to treat stomach problems).
■ 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.
Tell your doctor before taking Dalmane Capsules if you are breast-feeding. Avoid taking Dalmane Capsules if you are breast-feeding as Dalmane 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.
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.
■ 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:
■ The medicine has been prescribed to treat a medical or dental problem and
■ You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
■ 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.
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.
■ depression
■ nervousness
■ extreme anxiety
■ tension
■ restlessness
■ confusion
■ mood changes
dizziness
muscle weakness
poor muscle co-ordination double vision dependence
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:
■ a recurrence of sleep problems
■ irritability
■ sweating
■ diarrhoea
■ headaches
■ muscle pain
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 Capsules 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
■ reduced alertness
■ confusion
■ tiredness
■ headache
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
■ 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.
5. How to store Dalmane Capsules
■ 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.
6. Further information
What Dalmane Capsules contain
Each capsule contains 30mg flurazepam (as hydrochloride).
Other ingredients are: lactose monohydrate, talc, magnesium stearate, gelatin, titanium dioxide (E 171) and the colourant black iron oxide (E 172).
The printing ink contains red iron oxide (E 172), shellac glaze, soya lecithin and dimeticone.
What Dalmane Capsules look like and contents of the pack
Dalmane are hard capsules with a black cap and a grey body, with "ICN 30" 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: 21828/0457 I POM
Leaflet issue and revision date (Ref): 21.05.14
Dalmane® is a registered trademark of Valeant Pharmaceuticals International.
Flurazepam 30mg Capsules
(flurazepam hydrochloride)
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.
■ 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
In this leaflet:
1. What Flurazepam 30mg Capsules are and what they are used for
2. Before you take Flurazepam 30mg Capsules
3. How to take Flurazepam 30mg Capsules
4. Possible side effects
5. How to store Flurazepam 30mg Capsules
6. Further information
1. What Flurazepam 30mg 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 30mg 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 30mg 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 30mg Capsules
Do not take Flurazepam 30mg Capsules if you:
■ are allergic (hypersensitive) to flurazepam or any of the other ingredients of Flurazepam 30mg 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.
■ 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.
Flurazepam 30mg Capsules are not for use in anyone under 18 years of age.
Take special care with Flurazepam 30mg Capsules
Tell your doctor before you take these capsules if you:
■ have a long-term lung, liver or kidney condition.
■ suffer from depression or have recently suffered the death of
a close friend or relative.
■ regularly drink alcohol or abuse drugs. You must not drink alcohol or use drugs while taking Flurazepam 30mg Capsules.
■ are pregnant or breast-feeding. Refer to section Pregnancy and breast-feeding below.
Taking Flurazepam 30mg 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:
■ antidepressants, other tranquillisers or sleeping pills, or other such medicines that act on the brain and nerves.
■ medicines used to relieve pain or anaesthetics.
■ medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
■ medicines that affect the liver (e.g. the antibiotic rifampicin and cimetidine, a medicine used to treat stomach problems).
■ anti-viral medicines (e. g. ritonavir)
Taking Flurazepam 30mg Capsules with food and drink
Do not drink alcohol for as long as you are taking Flurazepam 30mg Capsules as this will increase the effects of the medicine, and this can be dangerous.
Pregnancy and breast-feeding
Tell your doctor before taking Flurazepam 30mg 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 30mg Capsules if you are breast-feeding. Avoid taking Flurazepam 30mg Capsules if you are breast-feeding as Flurazepam 30mg 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.
Driving and using machines
Flurazepam 30mg 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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
■ 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:
■ The medicine has been prescribed to treat a medical or dental problem and
■ You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
■ 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 Flurazepam 30mg Capsules
Flurazepam 30mg 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 30mg 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 Flurazepam 30mg 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.
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 30mg 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.
■ depression
■ nervousness
■ extreme anxiety
■ tension
■ restlessness
■ confusion
■ mood changes
dizziness
muscle weakness
poor muscle coordination double vision dependence
Also, you may become dependent on the capsules if you use them at high doses and for long periods. Therefore, Flurazepam 30mg 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 30mg Capsules and reduce the risk of dependence. Discuss with your doctor prior to stopping taking Flurazepam 30mg Capsules. See section "When you stop taking Flurazepam 30mg Capsules" below.
If you take more Flurazepam 30mg 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 30mg 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 30mg Capsules
Your doctor will advise you when to stop taking the capsules. Do not stop taking Flurazepam 30mg 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
■ irritability
■ sweating
■ diarrhoea
■ headaches
■ muscle pain
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, Flurazepam 30mg Capsules 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
■ reduced alertness
■ confusion
■ tiredness
■ headache
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
■ 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.
5. How to store Flurazepam 30mg Capsules
■ 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 30mg 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.
6. Further information
What Flurazepam 30mg Capsules contain
Each capsule contains 30mg flurazepam (as hydrochloride).
Other ingredients are: lactose monohydrate, talc, magnesium stearate, gelatin, titanium dioxide (E 171) and the colourant black iron oxide (E 172).
The printing ink contains red iron oxide (E 172), shellac glaze, soya lecithin and dimeticone.
What Flurazepam 30mg Capsules look like and contents of the pack
Flurazepam 30mg are hard capsules with a black cap and a grey body, with "ICN 30" printed in red on both cap and body.
Flurazepam 30mg 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: 21828/0457 I POM
Leaflet issue and revision date (Ref): 21.05.14
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