Patient Leaflet Updated 07-Apr-2022 | Zentiva
Loprazolam 1mg Tablets
Package leaflet: Information for the patient
LOPRAZOLAM 1MG TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 your medicine is Loprazolam 1mg Tablets (called loprazolam throughout this leaflet). Loprazolam contains a medicine called loprazolam mesylate. 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:
Loprazolam is used for short term sleep problems.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPRAZOLAM
Do not take this medicine and tell your doctor if:
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:
The risk of dependence is greater in patients with a history of mental disorders and/or alcohol or drug abuse. Tell your doctor or pharmacist if you have ever had a mental disorder, or have abused or have been dependent on alcohol or drugs.
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:
Taking loprazolam with food and drink
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.
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.
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
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.
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:
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:
Tell your doctor straightaway if you have any of the following side effects:
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Reporting of side effects
If you get any side effects, talk to your doctor or 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.
5. HOW TO STORE LOPRAZOLAM
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
This leaflet was last revised in: March 2022
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