Lormetazepam 0.5 Mg Tablets
ARTWORK INFORMATION:
PRODUCT: Lormetazepam 0.5 mg & 1 mg Tablets LICENCE: PL 17507/0131-132
ITEM / SIZE: Generic package leaflet / 148 mm (w) x 250 mm (h) [flat] ID CODE: A1000223/3 ITERATION: Version 1; 18/02/2016 INK: Black
PATIENT INFORMATION LEAFLET
LORMETAZEPAM 0.5 MG & 1 MG TABLETS
Read all of this leaflet carefully before you start taking this medicine.
• 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is LORMETAZEPAM and what is it used for?
2. Before you take LORMETAZEPAM 0.5 mg or 1 mg Tablets
3. How to take LORMETAZEPAM 0.5 mg or 1 mg Tablets
4. Possible side effects
5. Storing LORMETAZEPAM 0.5 mg or 1 mg Tablets
6. Further information
The name of this medicine is Lormetazepam 0.5 mg or 1 mg Tablets. Lormetazepam is one of a group of medicines called benzodiazepines.
Lormetazepam is prescribed as a short-term therapy to help with sleeping difficulties which are significantly affecting normal daily life.
Do not take LORMETAZEPAM if you:
• have severe breathing or chest problems
• have an allergic reaction to benzodiazepines or any of the ingredients in Lormetazepam Tablets (see list under Section 6). An allergic reaction can be a rash, itchiness or shortness of breath
• have myasthenia gravis (very weak or tired muscles)
• have serious liver problems
• have sleep apnoea (breathing problems when you are asleep)
• are breastfeeding.
Special Precautions
Check with your doctor or pharmacist before taking your medicine if any of the following applies to you:
• You are pregnant, or trying to become pregnant (see below).
• You abuse or have in the past abused drugs or alcohol.
• You have a personality disorder. If so, you have a greater chance of becoming dependent on lormetazepam.
• You have any kidney or liver problems.
• You have suffered from depression before, since it could re-occur during treatment with lormetazepam.
• You are suffering from depression, since lormetazepam may increase any suicidal feelings which you may have.
• You are suffering from an eye problem called glaucoma.
• You suffer from breathing problems.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
The beneficial effect of Lormetazepam Tablets may be less apparent after several weeks of use.
If you are given lormetazepam for more than 4 weeks, your doctor might want to take blood samples occasionally to check your blood and liver, since drugs like lormetazepam have occasionally affected liver function.
Lormetazepam Tablets are usually prescribed for short courses of treatment, lasting from a few days to 2 weeks.
You should not usually take Lormetazepam Tablets for longer than 4 weeks including a dose reduction at the end. This reduces the risk of becoming dependent on Lormetazepam Tablets, or suffering unpleasant effects when you stop taking it. (See “Stopping your medicine”, at the end of section 3).
LORMETAZEPAM and other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines as the dose of these drugs may need to be reduced before you take lormetazepam:
• Sedatives •Anti-anxiety drugs
• Antidepressants
• Strong pain-killers (e.g. methadone)
• Drugs for epilepsy
• Anaesthetics
• Antihistamines
• Drugs for mood or mental disorders (e.g. chlorpromazine)
• Medicines that help with breathing e.g. theophylline and aminophylline
• Drugs that inhibit certain liver enzymes e.g ketoconazole or ritonavir
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Taking LORMETAZEPAM with food and drink
You should avoid alcohol while you are taking Lormetazepam Tablets, since this may make you very drowsy and seriously affect your ability to drive or use machines.
Pregnancy and breast feeding
Lormetazepam may cause damage to the foetus if taken during early pregnancy. Therefore, do not take this medicine if you are pregnant or might become pregnant without consulting your doctor. If you take this medicine during late pregnancy or during labour, your baby, when born, may be less active than other babies, have a low body temperature, be floppy, or have breathing or feeding difficulties for a while.Your baby’s response to the cold might be temporarily impaired also. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms after birth.
Lormetazepam should not be used during breast feeding.
Driving and using machines
Lormetazepam may make you feel dizzy or sleepy during the day, or may affect your concentration. This may affect your performance at skilled tasks such as driving and operating machinery.
• 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
o 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.
Lormetazepam Tablets contain lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you.You should check with them if you are not sure. Lormetazepam Tablets should be taken orally. Adults:
The recommended adult dose of Lormetazepam Tablets is 0.5 mg to 1.5 mg.You should swallow your tablets with water just before you go to bed at night.
Make sure you can have 7 or 8 hours of uninterrupted sleep before taking Lormetazepam Tablets. Treatment usually lasts from a few days to 2 weeks. It should not usually last longer than 4 weeks including a dose reduction at the end.
For patients with mild to moderate difficulties in breathing or patients with liver impairment a dose reduction should be considered.
Elderly:
The dose for elderly patients will be reduced to either half the adult dose or less.
Children:
This product should not be taken by children.
If you take more LORMETAZEPAM than you
should:
Taking too much lormetazepam can result in symptoms including drowsiness, confusion, problems with co-ordination, balance and speech, decreased muscle tone, shallow or slow breathing or even coma.
Do not take more tablets than stated on the label of your medicine. If you take too many tablets you should seek medical attention immediately, either by calling your doctor, or going to the nearest casualty department. Always take the labelled medicine container with you, even if there are no tablets left.
If you forget to take LORMETAZEPAM:
If you forget to take a dose, don’t worry, just take your next tablet when it is due. Never take a double dose of tablets to make up for a forgotten dose.
Stopping your medicine:
• After you have finished your prescribed treatment with Lormetazepam Tablets, your doctor will decide whether or not you need further treatment.
• The number of Lormetazepam Tablets and how often you take them should always be reduced slowly before you stop taking them altogether. This allows your body to get used to being without your tablets, and reduces the risk of unpleasant effects when you stop taking them. Your doctor will tell you how to do this.
• On stopping lormetazepam, you may experience symptoms such as headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Your original sleeplessness may also return. If you suffer from any of these symptoms. Ask your doctor for advice.
Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as a loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some have experienced numbness or tingling of the arms or legs, seeing and hearing things that are not real (hallucinations), spinning feeling (vertigo), loss of appetite, agitation, poor short term memory, severe confusion (delirium), vomiting, tinnitus (ringing sounds in your ears), abnormal twitching and convulsions (hyper-relexia), abnormal movement and behaviour (catatonia), and hypersensitivity to light, sound and touch. If you suffer from any of these symptoms, ask your doctor for advice immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, lormetazepam can have side effects, although not everybody gets them.
Occasionally you may have unwanted effects while taking Lormetazepam Tablets. These are usually not serious and do not last long.
If you experience any of the following more rare unwanted effects, you should tell your doctor immediately.
(These effects are more likely to occur in children and elderly
Patients): AI000223/3
• Restlessness, agitation, irritability, aggressiveness, violent anger, nightmares, hallucinations, personality changes, abnormal behaviour or false beliefs.
• Signs and symptoms of blood count changes e.g. any unexplained bruising or bleeding, sudden fever, sore throat, tiredness, mouth sores.
• Abnormal liver function and the signs and symptoms associated with jaundice e.g. yellowing of the whites of the eyes and skin, abdominal pain, vomiting.
• Tremor, slurred speech, poor muscle control, slowing of movement or thought processes.
• Collapse, difficulty breathing or any kind of skin rash or itching of the skin. These may be signs of an allergic reaction.
You should tell your doctor if any of the following symptoms are severe, last more than a few days or become troublesome:
Very common (may affect more than 1 in 10 people)
Daytime drowsiness, dizziness.
Common (may affect up to 1 in 10 people)
Fatigue, muscle weakness, abnormal physical weakness or lack of energy.
Rare (may affect up to 1 in 1000 people)
Sleep problems, confusion, depression, numbed emotions, changes in appetite, changes in sex drive, sexual problems, difficulty controlling urges and impulses to speak, act or show emotions, an intense feeling of excitement and happiness, problems with vision, stomach upsets, nausea, headaches, reduced alertness, memory loss or forgetfulness, difficulty in passing stools, salivation changes, a drop in blood pressure, feeling cold.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.
Keep all medicines out of the sight and reach of children.
Do not use Lormetazepam Tablets after the expiry date on the carton and blister. The expiry date refers to the last day of that month.
Keep the tablets in the carton, in their blister pack, in order to 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.
What LORMETAZEPAM contains:
Each tablet contains either 0.5 mg or 1 mg of lormetazepam as the active ingredient.
The tablets also contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, talc and magnesium stearate.
What LORMETAZEPAM looks like and contents of the pack:
Lormetazepam 0.5 mg tablets are round white tablets with the marking 'LMT 0.5’ on one side and plain on the other. Lormetazepam 1 mg tablets are round white tablets with the marking 'LMT I’ on one side and plain on the other. Lormetazepam tablets are available in boxes of 30 tablets.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL, UK
Manufacturer:
Tiofarma, Benjamin Franklinstraat 9,
3261 LW Oud-Beijereland, Netherlands
This leaflet was last revised in February 2016.