Loprazolam 1mg Tablets

• 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.

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

• You are allergic (hypersensitive) to loprazolam mesylate 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.

Talk to your prescriber before taking loprazolam if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of loprazolam to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
• do not feel you will ever be able to stop taking loprazolam or other medicines used to treat sleep problems
• have any liver problems
• have any kidney problems
• 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
• are taking medicines to relieve from 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).
• 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.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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

• 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.

Use of this medicine is not recommended during pregnancy.

If you discover that you are pregnant or are planning to have a baby, consult your doctor right away to re-assess the need for treatment.

A large amount of data has not shown evidence of malformations associated with the use of benzodiazepines. However, some studies have shown a potentially increased risk of cleft lip and palate in newborn babies compared to that in the general population. Use of this medicine is not recommended during pregnancy.

Cleft lip and palate (sometimes called “harelip”) is a deformation at birth caused by incomplete fusion of the palate and upper lip.

Reduced fetal movement and fetal heart rate variability may occur after taking loprazolam during the second and/or third trimester of pregnancy.

If loprazolam is taken at the end of pregnancy, your baby may show muscle weakness (hypotonia or floppy infant syndrome), a drop in body temperature (hypothermia), difficulty feeding (problems suckling causing poor weight gain) and breathing problems (respiratory distress).

If taken regularly in late pregnancy, your baby may get withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.

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.

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.

Lactose: This is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• 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, 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.

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.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms may include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

• 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
• Dependence and addiction (frequency unknown) – see section “How do I know if I am tolerant or addicted?)

Drug Withdrawal

When you stop taking loprazolam, you may experience drug withdrawal symptoms, which include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking loprazolam, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

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 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.

Each tablet contains 1mg of loprazolam mesylate as the active substance. The other ingredients are lactose, povidone, colloidal silicon dioxide, maize starch, microcrystalline cellulose and magnesium stearate.

Loprazolam tablets are light yellow, biconvex, marked with an ‘A’ and ‘026’, separated by a score line, on one side. The other side is blank. They are supplied in cartons of 28 tablets.

Marketing Authorisation Holder

Manufacturer