LOPRAZOLAM 1 MG TABLETS - patient leaflet, side effects, dosage

Loprazolam 1mg Tablets

(loprazolam mesilate)

Read all of this leaflet carefully before you start taking 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. 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.
• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

The name of your medicine is Loprazolam 1mg Tablets, but will be referred as Loprazolam throughout this leaflet.

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

Loprazolam contains a medicine called loprazolam mesilate. This 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 such as:

• Difficulty falling asleep
• Waking often 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

Do not take this medicine and tell your doctor if:

• You are allergic (hypersensitive) to Loprazolam mesilate 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
• You are allergic (hypersensitive) to other benzodiazepines such as nitrazepam or temazepam
• You have a problem that causes severe muscle weakness (myasthenia gravis)
• Your lungs do not work properly
• You have heart problems
• You suffer from depression, anxiety or mental problems including phobias and obsessive disorders
• You have ever been addicted to alcohol
• You have a problem where you stop breathing for short

periods at night (sleep apnoea)

Do not take this medicine if any of the above applies to you. 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
• You have any kidney problems
• You have a history of drug abuse
• You have been told by your doctor that you have had or are likely to have a stroke
• You have been told by a doctor that you have a personality disorder
• You have recently taken Loprazolam or other similar medicines for more than four weeks
• You do not feel you will ever be able to stop taking Loprazolam or other medicines used to treat sleep problems
• You are taking medicines to relieve pain (opioids such as codeine, methadone, morphine, oxycodone, pethidine or tramadol). Your doctor will decide if you should receive Loprazolam (see also ‘Other medicines’ section below).
• You are elderly, as Loprazolam can cause drowsiness and decreased consciousness which can lead to falls and severe injuries.

Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.

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

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, including herbal medicines. This is because Loprazolam can affect the way some other medicines work. Also 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.
• Medicines for mental problems (antipsychotics)
• Medicines for depression
• Medicines for epilepsy (anticonvulsants)
• Medicines used in surgery (anaesthetics)
• 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
• Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol

Taking Loprazolam with food and drink

• 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, breast-feeding and fertility

• Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
• 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.
• Do not take Loprazolam if you are breast-feeding or planning to breast-feed. This is because small amounts may pass into mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or 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.

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

Loprazolam

Lactose : This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.

3. how to take loprazolam

Always take Loprazolam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Swallow the tablet whole with a drink of water
• Take just before bedtime
• You should not normally take Loprazolam for more than 4 weeks.

Adults

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

Elderly or frail people

The starting dose is half a 1mg tablet just before bedtime. This dose may be increased by your doctor to one whole tablet.

Children

Do not give this medicine to children.

If you take more Loprazolam than you should

If you take more Loprazolam than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows 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, then 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.

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 and stop your tablets over a period of time.

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.

See a doctor straight away if you get any of the following effects:

• Feeling anxious, irritable, confused or restless
• Changes in your behaviour
• Depression (low mood)
• Sleep problems
• Headaches

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

4. POSSIBLE SIDE EFFECTS

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

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

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Loprazolam tablets.

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

• Poor memory since taking Loprazolam (amnesia)
• Thoughts of harming or killing yourself, depression (low mood)
• Limp or weak muscles
• Behavioural changes. This might include angry outbursts or feeling very excited
• Liver problems that may cause the eyes or skin to go yellow (jaundice)
• Drowsiness and decreased level of consciousness leading to falls and severe injuries in elderly patients.

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

• Skin rash
• Difficulty passing water (urine)
• Feeling unsteady or clumsy
• Feeling sick (nausea), stomach problems
• If you have recently suffered a bereavement you may find it more difficult to cope
• Feeling dizzy, sleepy or confused
• Headache
• Problems with your eyesight such as blurred vision
• Changes in your sex drive
• Feeling dizzy, light headed or faint. These effects are due to

low blood pressure

• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia)
• Speech problems.

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:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LOPRAZOLAM

• Keep out of the sight and reach of children
• Do not store above 25°C. Store in a dry place. Protect from

light.

• Do not take your tablets after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.
• If the tablets becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
• Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
• 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. contents of the pack and other information

What Loprazolam contains

The active ingredient in the Loprazolam is loprazolam (as the mesilate).

Each tablet contains 1mg loprazolam (as the mesilate).

The other ingredients are colloidal silicon dioxide, lactose, povidone, microcrystalline cellulose, maize starch, and magnesium stearate.

What Loprazolam looks like and contents of the pack

Loprazolam is pale yellow, biconvex tablet, with a score line on one side and plain on the other.

Loprazolam are supplied in blister packs of 30 tablets.

Manufactured by: Teofarma S.r.L. Via F.lli Cervi 8, 27010 Valle Salimbene (PV), Italy.

Procured from within the EU and repackaged by the

Product Licence holder: B&S Healthcare, Unit 4,

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. ______

Loprazolam 1mg Tablets; PL 18799/1973 | POM | \CD/

Leaflet date: 16.04.2021

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