patient information leaflet dalmane

Patient Information Leaflet

Dalmane® 15 mg and 30 mg Capsules

Flurazepam (as monohydrochloride)

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

WHAT ARE DALMANE CAPSULES?

Dalmane capsules contain the active ingredient flurazepam, which belongs to a group of medicines known as benzodiazepines. Flurazepam shortens the time taken to fall asleep and lengthens the duration of sleep.

Two strengths of capsules are available:

The grey/yellow capsules marked “ICN 15” contain the equivalent of 15 mg flurazepam in each capsule.
The black/grey capsules marked “ICN 30” contain the equivalent of 30 mg flurazepam in each capsule.

Both capsules also contain the inactive ingredients lactose, talc, magnesium stearate, gelatin and the colourants iron oxide black (E 172) and titanium dioxide (E 171).

In addition, the 15 mg capsules contain the colourant iron oxide yellow (E 172).

Both capsule strengths come in packs of 30 capsules.

WHAT ARE DALMANE CAPSULES USED FOR?

Dalmane capsules are used for the short term treatment of severe sleeplessness (or insomnia). It can help overcome any difficulties in getting to sleep and may help if you wake up frequently in the middle of the night.

Your doctor will assess the cause of your insomnia. Please note that Dalmane capsules help you sleep but do not cure the underlying cause of your insomnia.

WHEN MUST DALMANE CAPSULES NOT BE USED?

If you are allergic to the group of medicines known as benzodiazepines.
If you are allergic to any of the ingredients in Dalmane capsules. Allergic reactions can include the following symptoms: rash, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, low blood pressure.
If you suffer from severe lung or severe liver disease.
If you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily).
If you are suffering from a psychiatric illness or personality disorder (severe mental problems).
If you suffer from breathing difficulties when sleeping (sleep apnoea syndrome).

Dalmane should not be given to children.

WHEN SHOULD YOU BE EXTRA CAREFUL WHILE TAKING DALMANE CAPSULES?

Make sure your doctor knows if:

You have a lung, liver or kidney condition.
You suffer from depression or have recently suffered the death of a close friend or relative.
You regularly drink alcohol or abuse drugs. You should not drink alcohol or use drugs with Dalmane.
You are taking any other medicines, including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.

The following medicines can increase the effect of Dalmane:

Tranquillisers, sleep-inducing drugs and other such medications which act on the brain and nerves
Antidepressants
Medicines used to relieve pain (analgesics)
Anaesthetics
Medicines to treat epilepsy (anti-epileptics) (e.g. phenytoin and phenobarbital)

In addition, cimetidine (a medicine used to treat acid indigestion or stomach ulcers) and the antibiotic rifampicin may affect the action of Dalmane.

These 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.

IMPORTANT

Dalmane capsules may make you sleepy or affect your concentration. This may affect your performance at skilled tasks, e.g. driving and operating machinery.

Alcohol will increase the sedative effects of Dalmane capsules and should therefore be avoided for as long as you are using this medicine.

MAY DALMANE CAPSULES BE TAKEN DURING PREGNANCY OR WHILE BREAST-FEEDING?

Do not take this medicine if you are pregnant, or might become pregnant. 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. Additionally, if you take this medicine during the latter part of your pregnancy your unborn baby may be at risk of developing dependency to the drug and after birth may be at some risk of developing withdrawal symptoms. These symptoms are explained in the section “When and how does treatment with Dalmane capsules end?”.

Dalmane passes into breast-milk, therefore, if you are breast-feeding this medicine should be avoided. Your doctor will be able to discuss this with you.

HOW SHOULD DALMANE CAPSULES BE TAKEN?

Always take the capsules as your doctor tells you to. He/she will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight. The normal starting dose is 15 mg which if necessary may be increased to a maximum of 30 mg. If you are elderly or suffer from a lung, liver or kidney condition or are generally unwell, your starting dose should not exceed 15 mg.
Your doctor will find the lowest dose to control your symptoms. You may not need to take this medicine every night. Treatment will not normally be continued for more than four weeks.
Take the medicine just before going to bed and swallow the capsule whole, together with a drink of water or another non-alcoholic drink.
If you forget to take one dose, you should never make up for the missing dose by doubling the dose next time. Instead you should simply continue with the next dose when it is due.
Remember that after taking this medicine you will feel sleepy. Therefore make sure that you can sleep without interruptions for 7 to 8 hours after taking Dalmane capsules.
Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.
If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

WHEN AND HOW DOES TREATMENT WITH DALMANE CAPSULES END?

Your doctor will advise you when to stop taking the medicine.

Please remember that it is not suitable for long-term use and that, after a few weeks, it is worth trying to get by without it. This will help to prevent you becoming used to it and reduce the risk of dependence.

After a period of usage it is advisable to reduce the dosage gradually. Sometimes withdrawal effects occur if the medicine is stopped suddenly and these may be: depression, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia (a recurrence of sleep problems), irritability, sweating, diarrhoea, headaches and muscle pain. In severe cases the following symptoms may occur: changes in behaviour, numbness and tingling of the extremities, over-sensitivity to light, noise and touch, hallucinations or fits.

If you have taken benzodiazepines for a long time, the reduction in your dosage will be over a longer period than it would normally take to stop taking this medicine. Special help may be needed. Your doctor will be able to discuss this with you.

WHAT ARE THE POSSIBLE UNWANTED EFFECTS OF DALMANE CAPSULES?

Side effects include drowsiness during the day, a feeling of emptiness, confusion, tiredness, headache, dizziness, muscle weakness, poor muscle co-ordination and double vision. These effects are likely to occur at the start of treatment and usually disappear after a while.

In rare cases, changes in behaviour, including aggression, excitement, confusion, restlessness, agitation, delusions, irritability, rage, hallucinations and nightmares may occur. If these symptoms occur, you must inform your doctor. He/she may want you to stop taking this medicine.

Other unwanted effects which can also occur rarely include:

Giddiness
Reduced blood pressure
Stomach upsets
Skin rashes
Other problems with your vision
Changes in the level of sexual desire
Inability to pass urine/holding of urine in the bladder
Jaundice (yellowing of the skin and/or eyes)
Blood dyscrasias (an abnormality in the blood)
Unexplained changes in behaviour
Memory loss if you are woken up too early

Occasionally some patients have noticed a bitter taste in their mouth after swallowing the capsules.

If you are concerned about these or any other unwanted effects, talk to your doctor or pharmacist.

HOW SHOULD DALMANE CAPSULES BE STORED?

The capsules should be stored in a dry place below 25ºC (at room temperature and away from heat).
Keep this medicine out of the reach and sight of children.
This medicine must not be used after the date (EXP) printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.
REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

HOW CAN YOU HELP YOURSELF TO SLEEP BETTER?

Changes in your daily habits can often lead to improved natural sleep.

Try the following suggestions:

Do not drink any caffeine-containing drinks in the evening, such as cola, coffee or tea.
Do not have a heavy evening meal.
Pursue relaxing activities before going to sleep.
Try to ensure the bedroom is quiet, well aired and only dimly lit.
If the above suggestions do not work, medication may help. However, you must avoid taking sleep-inducing medicines for long periods and always discuss it with your doctor.

Medicine: dalmane