Nitrazepam Generic (Mogadon) US$ 2.00 ea

What is Nitrazepam?

Nitrazepam contains the active ingredient nitrazepam, which belongs to a group of medicines known as benzodiazepines. Nitrazepam shortens the time taken to fall asleep and lengthens the duration of sleep.

The white tablets are round with ROCHE and two semi-circles marked on one side and a line across the other so that they can be broken in half easily. They contain 5mg nitrazepam and the inactive ingredients lactose, maize starch and magnesium stearate.

The tablets come in packs of 30.

The product Licence/Authorisation holder and manufacturer is Roche Products Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, UK.

What is Nitrazepam used for?

Nitrazepam is used for the short term treatment of severe sleeplessness (also known as insomnia) which is disabling, or subjecting you to unacceptable distress. It can help overcome any difficulties in getting to sleep, but does not cure the underlying cause of your insomnia.

When must Nitrazepam not be used?

• If you are allergic to the group of medicines known as benzodiazepines, eg. Diazepam, Chlordiazepoxide, Nitrazepam, Temazepam.

• If you are allergic to Nitrazepam or any of the ingredients it contains.

• If you suffer from lung disease.

• If you suffer from myasthenia gravis (severe muscle tiredness).

• If you are suffering from a psychiatric illness or a personality disorder.

• If you suffer from sleep apnoea (difficulty breathing while asleep).

Nitrazepam must not be given to children.

When should you be extra careful while taking Nitrazepam?

Make sure your doctor knows if you:

• have a lung, liver or kidney condition.

• 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 effects of the medicines involved. The effects of Nitrazepam may be increased by tranquillisers, antidepressants, hypnotics (sleep-inducing drugs), analgesics (drugs that relieve pain), anaesthetics, and drugs used in the treatment of allergies (antihistamines) and epilepsy (anti- epileptics). When Nitrazepam is used in combination with anti-epileptic drugs, side-effects may occur more frequently and your doctor may decide to adjust your dose. In addition, cimetidine (a medicine used to treat stomach problems) and rifampicin (an antibiotic) are also known to affect Nitrazepam.

• if you suffer from depression or have recently suffered a death of a near friend or relative.

• regularly drink alcohol or use recreational drugs.

• prolonged use of Nitrazepam may lead to tolerance. If you think that your medicine is no longer working, you should consult your doctor.

IMPORTANT

Nitrazepam may affect your ability to drive or operate machinery. If affected you should not drive or operate machinery. This may be made worse if you take alcoholic drinks. Because of this it is best that you do not drink alcohol for as long as you are using this medicine.

May Nitrazepam be taken during pregnancy or while breast feeding?

You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should take this medicine. If you 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 your 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 Nitrazepam end?"

Nitrazepam 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 Nitrazepam be taken?

• Always take the tablets 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 5mg. However, if you are elderly, or suffer from a lung, liver or kidney condition your starting dose will not be more than 2.5mg (half a tablet).

• If you are suffering from a psychotic disorder your dose should not exceed 5mg.

• 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 tablet whole with water or another non-alchoholic drink.

• After taking Nitrazepam, you should ensure that you have 7 to 8 hours uninterrupted sleep.

• 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.

• 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 tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

When and how does treatment with Nitrazepam 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 dosage gradually. Sometimes withdrawal effects occur if the medicine is stopped abruptly and these may include depression, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia (a recurrence of sleep problems), irritability, sweating, diarrhoea.

In severe cases the following symptoms may occur: depersonalisation (a sense of floating outside the body), derealisation (loss of sense of reality), hyperacusis (increased sensitivity to sounds), pins and needles in the extremities, hypersensitivity to light and physical contact and hallucinations or epileptic seizures.

In the unusual case where patients have taken benzodiazepines for a long time, a longer period will be needed over which their dosage will be reduced. Special help may be needed. Your doctor will be able to discuss this with you.

What are the possible unwanted effects of Nitrazepam?

If you are woken up soon after taking the medicine your memory may be temporarily affected.

Side effects include drowsiness during the day, a feeling of emptiness, reduced alertness, confusion, tiredness, dizziness, muscle weakness, and poor muscle co-ordination. 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, irritability, rages, 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:

- headache
- giddiness
- reduced blood pressure
- stomach upsets
- skin rashes
- changes in vision
- changes in the level of sexual desire
- inability to pass urine/holding of urine in the bladder
- jaundice - yellowing of the eyes and skin
- blood disorders - resulting in severe tiredness and possible infections
- depression

If you experience these or any other unwanted effects talk to your doctor.

How should Nitrazepam be stored?

• The tablets should be stored below 25°C and protected from light. The blister packs should be protected from moisture.

• Keep this medicine out of the reach and sight of children.