What it is and what it is used for

FOR The name of your medicine is Loprazolam 1mg Tablets (called loprazolam throughout this leaflet). Loprazolam contains a medicine called loprazolam mesylate. This medicine has been prescribed for you to treat short term sleep problems. Loprazolam belongs to a class of medicines called benzodiazepines. It works by acting on your brain to help you sleep. This medicine has been prescribed to you and should not be given to anyone else. Loprazolam is used to treat sleep problems such as:

• Difficulty falling asleep
• Waking often during the night Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. 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. Do not use long term. Treatment should be as short as possible because the risk of dependence increases with the duration of treatment. Ask your doctor for advice if you are unsure.

What you need to know before you take it

E LOPRAZOLAM Do not take this medicine and tell your doctor if:

• 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.

Warnings and precautions 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. 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 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. 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 have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take it

LOPRAZOLAM Always take loprazolam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your prescriber should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. 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. 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 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). 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

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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. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

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.

How to store it

LOPRAZOLAM

• Keep out of the reach and sight of children
• Do not store above 25°C
• Do not use loprazolam after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Store in the original package and protect from light.
• 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 1mg Tablets contain

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. What loprazolam looks like and contents of the pack 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 and Manufacturer Marketing Authorisation Holder Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom Manufacturer Opella Healthcare Poland Sp. z.o.o. Oddział w Rzeszowie ul. Lubelska 52 35-233 Rzeszów Poland This leaflet was last revised in: November 2025