_NRIM Clonazepam nrim 0.5mg & 2MG tablets

PATIENT INFORMATION LEAFLET

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THE LEAFLET CONTAINS INFORMATION ON:

1.    What Clonazepam Tablets are and what they are used for

2.    Before you take Clonazepam Tablets

3.    How to take Clonazepam Tablets

4.    Possible side effects

5.    How to store Clonazepam Tablets

6.    Further Information

1.    WHAT CLONAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR?

The name of your medicine is Clonazepam NRIM 0.5mg or 2mg Tablets (called Clonazepam tablets throughout this leaflet). Clonazepam tablets belongs to a group of medicines called 'benzodiazepines'. They are used to treat an illness called epilepsy. Clonazepam works by preventing seizures or fits.

2.    BEFORE YOU TAKE CLONAZEPAM TABLETS

You should not take Clonazepam tablets until you are sure it is safe for you to do so.

Do not take this medicine and tell your doctor:

•    If you are allergic (hypersensitive) to clonazepam or any of the other ingredients of Clonazepam tablets (listed in Section 6 below) or to other benzodiazepines (such as diazepam, chlordiazepoxide, bromazepam, or flurazepam).

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

•    If you suffer from lung disease.

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

•    If you suffer from sleeping disorders, such as difficulty breathing while asleep.

•    If you have a severe liver condition.

Take special care with Clonazepam Tablets and check with your doctor or pharmacist before taking your medicine if you:

•    have a lung, liver or kidney condition.

•    regularly drink alcohol or use recreational drugs.

•    suffer from a form of inco-ordination of the muscles called cerebellar ataxia.

•    have a history of depression and/or suicide attempts.

•    suffer from the disease which affects the skin and/or nervous system called porphyria.

•    have recently suffered a death of a near friend or relative.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Clonazepam tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Clonazepam tablets affect the way some other medicines work. Also some medicines can affect the way Clonazepam tablets work.

Tell your doctor if you are taking any of the following medicines;

•    hydantoins, phenobarbital, sodium valproate or carbamazepine (medicines used to treat epilepsy). The effect of Clonazepam tablets may be increased by these drugs.

•    cimetidine (medicine used to treat stomach problems).

•    rifampicin (an antibiotic).

•    anaesthetics.

•    hypnotics (sleep inducing drugs).

•    tranquillisers.

•    analgesics (drugs that relieve pain).

•    baclofen, tizanidine (muscle relaxants).

Taking phenytoin or primidone with Clonazepam tablets may affect the amount of drug in your blood.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Clonazepam tablets.

Taking Clonazepam tablets with food or drink

Clonazepam tablets should be taken with a drink that does not contain alcohol. Do not drink alcohol while you are taking clonazepam tablets as it may cause fits (epileptic seizures) and increase the risk of having side effects.

Pregnancy or breast-feeding

Do not take this medicine if you are pregnant, might become pregnant unless your doctor tells you to. Contact your doctor if you think you may be pregnant, or are intending to become pregnant. If advised to take this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, breathing and feeding difficulties, an irregular heart beat. The baby may have become dependent on clonazepam and could suffer withdrawal symptoms.

Do not take this medicine if you are breast-feeding or planning to breast-feed as clonazepam passes into breast milk.

Driving and using machines:

Clonazepam may affect your ability to drive, operate machinery and carry out other hazardous activities and should therefore be avoided altogether or at least during the first few days of treatment. This may be made worse if you take alcoholic drinks. If you increase your dose or change the timings of when you take your medication this may also modify your reactions.

You must not drink alcohol whilst taking Clonazepam tablets as this may provoke epileptic seizures.

Important information about some of the ingredients of Clonazepam tablets

Clonazepam Tablets contains lactose. 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 CLONAZEPAM TABLETS

Always take Clonazepam tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.

How much to take

The dose your doctor prescribes will depend on your illness. Follow your doctor's instructions carefully.

Clonazepam tablets are taken 3 - 4 times a day They are started at a low dose and increased over 2-4 weeks until the right dose for you is reached (the maintenance dose). The maximum dose is 20mg in a 24 hour period. The

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tablets should be swallowed with water and can be broken in half to give a smaller dose.

Adults

•    The starting dose should be no more than 1.0mg in a 24 hour period.

•    The maintenance dose is usually a total of 4 to 8mg in a 24 hour period however your doctor may tell you to take more.

Elderly

•    The starting dose should be no more than 0.5mg in a 24 hour period, as elderly people are particularly sensitive to the effects of clonazepam and may become confused to begin with.

•    The maintenance dose is usually a total of 4 to 8mg in a 24 hour period however your doctor may tell you to take more.

Children and Infants

Infants: The starting dose should be no more than 0.25mg in a 24 hour period (half a 0.5mg Tablet) and the maintenance dose is usually a total of 0.5 - img in a 24 hour period.

Children 1 - 5 years: The starting dose should be no more than 0.25mg in a 24 hour period (half a 0.5mg Tablet) and the maintenance dose is usually a total of 1 - 3mg in a 24 hour period.

Children 5 -12 years: The starting dose should be no more than 0.5mg in a 24 hour period and the maintenance dose is usually a total of 3 - 6mg in a 24 hour period.

If you take more Clonazepam tablets than you should

It is important to stick to the dose on the label of the medicine. If you or someone else takes too much medicine, contact your doctor or nearest hospital emergency department immediately. Always take any medicine left over with you and also the box, as this will allow easier identification of the medicine.

If you forget to take Clonazepam tablets

If you forget to take a dose, simply take the next dose when it is due. Never take an extra dose to make up for a forgotten dose.

If you stop taking Clonazepam tablets

Keep taking Clonazepam tablets until your doctor tells you to stop. Treatment with clonazepam may last all your life, therefore you must always tell your doctor if you want to stop taking clonazepam, as sudden discontinuation of treatment can cause the reappearance of seizures as well as withdrawal symptoms.

After a period of usage it is advisable to reduce dosage gradually.

Sometimes withdrawal effects occur if the medicine is stopped suddenly and these may include sleep disturbances, muscle pain, extreme anxiety tension, restlessness, confusion, mood changes, irritability, sweating, tremor, headaches and agitation. In serious cases, withdrawal effects can also include being oversensitive to light, noise and physical contact, hallucinations, tingling and numbness and a feeling of being unreal.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Clonazepam Tablets can cause side effects although not everybody gets them.

Tell your doctor immediately if you experience any of the following as he/she may want you to stop taking this medicine:

•    Rarely changes in behaviour may occur including aggression, excitement, irritability, nervousness, hostility, agitation, anxiety, sleep disturbances, nightmares, vivid dreams, psychotic disorders, severe behavioural disturbances, and new types of seizure may arise.

The following side effects have been reported:

•    feeling drowsy or tired, especially at the start of treatment, muscle weakness, dizziness, light-headedness, floppiness of the muscles or bad co-ordination and unsteadiness when walking. In rare cases breathing difficulties may occur. Your doctor can help to avoid most of these effects by adjusting the dose. The effects are temporary and disappear over the course of treatment.

•    poor concentration, restlessness, confusion, disorientation and memory loss.

•    increased salivation and secretion from the lungs in infants and small children. Children should therefore be watched carefully as this might cause difficulties in breathing and/or severe choking and coughing.

•    hives or itching, swelling of the soft tissue, especially around the eyes, lips and hands, hairloss, changes in your colouring (i.e. skin), nausea, headache, loss of sexual desire, impotence, urinary incontinence, early sexual development in children (this is reversible), abdominal problems or allergic reactions including severe hypersensitivity and shock.

•    seizures as a result of long-term treatment (only with certain forms of epilepsy), slowing or slurring of speech, reduced co-ordination of movements or changes in vision (e.g. double vision, involuntary jerky movements of the eye).

•    Depression, but it may also be associated with the underlying disease.

•    Rarely changes in your blood and liver may occur and your doctor will monitor for these.

•    convulsions in patients with a metabolic disorder called porphyria.

•    development of physical and psychological dependence may make it difficult to come off or stop treatment if taken for too long.

•    increased risk of falls and consequent injury especially if you are elderly as benzodiazepines have a muscle relaxing effect.

If any of the side effects get serious or lasts longer than a few days, or if you notice other unwanted effects, tell your doctor or pharmacist.

5.    HOW TO STORE CLONAZEPAM TABLETS

•    Keep out of the reach and sight of children.

•    Do not use Clonazepam tablets after the expiry date, which is stated on the end of the carton. The expiry date refers to the last day of the month.

•    Do not store above 25°C. Store in the original packaging.

•    Medicines should 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 Clonazepam Tablets contains?

The name of this medicine is Clonazepam NRIM 0.5mg or 2mg Tablets. The active substance in your tablet is clonazepam. Each Tablet contains 0.5mg or 2mg of clonazepam respectively Other ingredients include anhydrous lactose, pregelatinized starch, microcrystalline cellulose, magnesium stearate. Clonazepam NRIM 0.5mg Tablets also contain ferric oxide yellow (E172) and ferric oxide red (E172).

What Clonazepam looks like and contents of the pack

Clonazepam NRIM 0.5mg Tablets are peach coloured flat circular bevelled tablets with cross scoring on one side and plain on the other side. The tablets can be divided in to equal quarters.

Clonazepam NRIM 2mg Tablets are white to off white flat circular bevelled tablets with cross scoring on one side and plain on the other side. The tablets can be divided in to equal quarters.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and manufacturer of this medicine is NRIM Limited, Unit 15 Moorcroft, Harlington Road, Hillingdon, UB8 3HD, United Kingdom.

This leaflet was prepared in 11/2013

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