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PHARMACODE

Package leaflet: Information for the user Loprazolam 1mg Tablets

loprazolam

Read all of this leaflet carefully before you start

using this medicine because it contains

important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Loprazolam is and what it is used for

2.    What you need to know before you take Loprazolam

3.    How to take Loprazolam

4.    Possible side effects

5.    How to store Loprazolam

6.    Contents of the pack and other information

1. What Loprazolam is and what it is used for

The name of this medicine is Loprazolam 1 mg Tablets (called Loprazolam throughout this leaflet). The active substance is loprazolam mesilate. Loprazolam belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep. Loprazolam is used to treat sleep problems in adults such as:

-    difficulty falling asleep

-    waking frequently during the night Loprazolam is used for short term sleep problems. Loprazolam is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.

2. What you need to know before you take loprazolam

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Do not loprazolam, and tell your doctor if you:

-    are allergic (hypersensitive) to loprazolam mesilate, other benzodiazepines or any of the other ingredients of this medicine (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

-    have severe muscle weakness (myasthenia gravis)

-    have lung problems

-    have heart problems

-    suffer from depression, anxiety or mental problems including phobias and obsessive disorders

-    have ever been addicted to alcohol

-    have a problem where you stop breathing for short periods at night (sleep apnoea)

-    are pregnant or breastfeeding (see “Pregnancy and breast-feeding”)

-    have severe liver problems.

Do NOT take this medicine if any of the above applies to you, and tell your doctor. If you are not sure, talk to your doctor or pharmacist before taking Loprazolam.

Warnings and Precautions

Talk to your doctor or pharmacist before taking

Loprazolam if you:

-    have any liver problems

-    have any kidney problems

-    have a history of drug abuse

-    have been told by your doctor that you have had or are likely to have a stroke

-    have been told by a doctor that you have a personality disorder

-    have recently taken Loprazolam or other similar medicines for more than four weeks

-    feel you will never be able to stop taking Loprazolam or other medicines used to treat sleep problems.

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

Caution should be used in the treatment of patients with narrow-angle glaucoma.

When you stop taking Loprazolam, you may experience withdrawal symptoms (see “If you stop taking Loprazolam').

Children and adolescents

Do NOT give this medicine to children.

Other medicines and Loprazolam

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines you buy without a prescription, and herbal medicines. This is because Loprazolam can affect the way in which some other medicines work, and some medicines can affect the way Loprazolam works.

Tell your doctor if you are taking any of the

following:

-    medicines to treat stomach problems, such as cisapride

-    medicines which relax muscles (neuromuscular depressants). These are often used during operations or in intensive care units (ICUs).

-    medicines for mental problems (antipsychotics)

-    medicines for depression

-    medicines for epilepsy (anticonvulsants)

-    medicines used in surgery (anaesthetics)

-    other medicines to calm or reduce anxiety, or for sleep problems (hypnotics)

-    medicines for hay fever, rashes or other allergies, that can make you sleepy (sedative antihistamines), such as chlorphenamine or promethazine

-    medicines for moderate to severe pain (narcotic analgesics), such as codeine, methadone, morphine, oxycodone, pethidine or tramadol.

Tolerance

-    Some loss of efficacy with regard to the hypnotic effects may develop after repeated use for a few weeks

-    Tolerance for other Central Nervous System (CNS) depressants will be diminished in the presence of loprazolam, these substances should either be avoided or taken in reduced dosage.

Dependence

-    Loprazolam may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. Abrupt termination of treatment may be accompanied by withdrawal symptoms such as headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating and the occurrence of "rebound" phenomena (temporary reappearance of symptoms which led to starting treatment). These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. Always take loprazolam exactly as your doctor has told you, in order to avoid the onset of these symptoms as far as possible.

Rebound insomnia and anxiety

-    You may have a rebound episode (temporary reappearance of symptoms which led to starting treatment). This episode may be accompanied by other reactions such as mood changes, anxiety or sleep disorders and restlessness. The likelihood of a withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore it is recommended that the dose is decreased bit by bit until it is finally withdrawn. Follow the recommendations for use and instructions for administration of loprazolam exactly as your doctor has told you, in order to avoid the appearance of these symptoms as far as possible.

Amnesia

-    Benzodiazepines may induce anterograde amnesia, that is, difficulty in remembering recent events. To reduce this risk, you should ensure that you will be able to have uninterrupted sleep for 7-8 hours (see section “4. Possible side effects”).

Psychiatric and paradoxical reactions

-    Benzodiazepines may cause restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects. These reactions are more common in children and the elderly, as well as in patients with organic brain syndrome (physical disorders which cause decreased mental function). Your doctor will discontinue treatment should these reactions appear

-    Depression prior to treatment with loprazolam may be unmasked during loprazolam treatment. There is a risk of suicide in these patients (see section “4. Possible side effects”).

Other warnings

-    Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematologic and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary

-    Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients

-    Abuse of benzodiazepines has been reported.

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Loprazolam with alcohol

Do NOT drink alcohol while you are taking Loprazolam. Alcohol can increase the effects of Loprazolam and make you sleep very deeply so that you do not breathe properly, or have difficulty waking.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do NOT take Loprazolam if you are in the last 3 months of pregnancy or during labour because it may be harmful to your baby. However, in some cases your doctor may feel it is absolutely necessary for you to take this medicine during this time. Taking it during this time means your baby may be born with breathing difficulties, limp or weak muscles, a low body temperature (hypothermia), and may have withdrawal symptoms.

Loprazolam passes into the breast milk, therefore you should not take Loprazolam while breast-feeding.

Driving and using machines

This medicine may cause drowsiness, lack of concentration, muscle weakness and memory loss. If this happens, do not drive or use any tools or machines.

Loprazolam contains lactose

This medicine contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Loprazolam

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

-    Swallow the tablets) whole with a drink of water

-    Take your dose just before bedtime

-    You should not normally take Loprazolam for more than 4 weeks

-    The tablet can be divided into equal doses. Adults

The recommended dose is one tablet (1 mg) just before bedtime. This dose may be increased by your doctor to one and a half tablets (1.5mg) or 2 tablets (2mg).

Elderly or frail patients

The starting dose is half a tablet (0.5mg) just before bedtime. This dose may be increased by your doctor to one whole tablet.

Use In children

Do NOT give this medicine to children.

If you take more Loprazolam than you should

If you think that you, or any other person, may have taken too many tablets, contact your doctor or hospital casualty department immediately. Take any remaining tablets and this leaflet with you so the medical staff knows exactly what you have taken.

If you forget to take Loprazolam

Loprazolam must only be taken at bedtime. If you forget to take your tablet at bedtime, you should NOT take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day.

Do not take a double dose to make up for a forgotten tablet. Simply skip the missed dose and take the next dose as usual.

If you stop taking Loprazolam

Keep taking Loprazolam until your doctor tells you to stop. Do not stop taking Loprazolam suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose gradually over a period of time before you stop.

If you stop taking Loprazolam suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below:

•    feeling anxious, irritable, confused or restless

•    changes in your behaviour

•    depression (low mood)

•    sleep problems

•    headaches.

See a doctor straight away if you get any of these effects.

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

Tell your doctor straight away if you have any of the following side effects:

Common side effects: may affect up to 1 in 10 people

•    limp or weak muscles.

Rare: may affect up to 1 in 1,000 people

•    thoughts of harming or killing yourself, depression (low mood)

•    behavioural changes. This might include angry outbursts or feeling very excited.

Very rare: may affect up to 1 in 10,000 people

•    liver problems that may cause the eyes or skin to go yellow (jaundice).

Not known: frequency cannot be estimated from available data

•    poor memory (amnesia).

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Common side effects: may affect up to 1 in 10 people

•    headache

•    feeling dizzy, sleepy

•    feeling unsteady or clumsy

•    blurred vision

•    feeling sick (nausea).

Rare: may affect up to 11n 1,000 people

•    confused.

Very rare: may affect up to 1 in 10,000 people

•    getting infections or bruises more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)

•    changes in your sex drive

•    problems with your eyesight

•    feeling dizzy, light headed or faint. These effects are due to low blood pressure

•    stomach problems

•    skin rash

•    difficulty passing water (urine).

Not known: frequency cannot be estimated from available data

•    difficulty coping with emotional situations including bereavement.

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 Loprazolam

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

•    Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Store in the original package in order to protect from light and moisture.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc.) and that Amdipharm have license approval to distribute this component for sale in the relevant market.

Accept Artwork / Reject Artwork

(Please strike off whichever NOT applicable)

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Loprazolam and see a doctor or go to hospital straight away if you get:

•    swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty in swallowing or breathing

or

•    an itchy, lumpy rash (hives) or nettle rash (urticaria).

These may mean you are having an allergic reaction to Loprazolam tablets.

What Loprazolam contains

The active substance is loprazolam. Each tablet contains loprazolam mesilate equivalent to 1mg loprazolam.

The other ingredients are lactose anhydrous, microcrystalline cellulose and magnesium stearate. What Loprazolam 1 mg Tablets look like and contents of the pack

Loprazolam 1 mg tablets are light yellow, biconvex, round, uncoated tablets with ‘L1 ’ debossed on one side and a deep break-line on the other side. They are supplied in cartons of 7,10,14,15,20,28 and 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited,

Capital House, 85 King William Street London, EC4N 7BL, UK

Manufacturer

Primegen Limited,

Unit 15 Moorcroft Harlington Road,

Uxbridge, UB8 3HD UK

This leaflet was last revised In December 2015

103559/LF/249/02