Lormetazepam 0.5mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lormetazepam 0.5 mg and 1mg tablets

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 further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What lormetazepam is and what it is used for

2. What you need to know before you take lormetazepam

3. How to take lormetazepam

4. Possible side effects

5. How to store lormetazepam

6. Contents of the pack and other information

1. What lormetazepam is and what it is used for

Lormetazepam is a medicine in the hypnotic group which promotes sleep: it normalises the time necessary to fall asleep and its total duration, while reducing sleep disruption.

It is indicated for:

- Short-term treatment of insomnia.

Lormetazepam belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

2. What you need to know before you take lormetazepam Do not take lormetazepam

- if you are allergic (hypersensitive) to the active substance or any of the other ingredients of lormetazepam (listed in section 6).

- if you suffer from myasthenia gravis (a disease characterised by the appearance of an abnormal degree of muscle weakness),

- if you have severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease),

- if you suffer from sleep apnoea syndrome (a condition characterised by short episodes of stopping breathing which appear during sleep),

- in the case of acute intoxication with alcohol, hypnotics, analgesics or drugs which act on the central nervous system (neuroleptics, antidepressants, lithium).

- if you suffer from severe hepatic insufficiency.

- If you are pregnant or breast-feeding (see also “Pregnancy, breast-feeding and fertility)

Warnings and precautions

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Talk to your doctor or pharmacist before taking lormetazepam:

- if you have chronic respiratory insufficiency, as you must take a lower dose than usual,

- if you have severe renal insufficiency,

- if you have hepatic insufficiency,

- lormetazepam should not be used as first line treatment of psychotic disease or as sole treatment for anxiety or sleep disorders associated with depression.

- lormetazepam must be administered with caution in patinets with spinal ataxia or cerebellar ataxia.

Tolerance

- Some loss of efficacy with regard to the hypnotic effects may develop after repeated use for a few weeks.

- Tolerance for other Central Nervous System (CNS) depressants will be diminished in the presence of lormetazepam, these substances should either be avoided or taken in reduced dosage.

Dependence

- Lormetazepam may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. Abrupt termination of treatment may be accompanied by withdrawal symptoms such as headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating and the occurrence of "rebound" phenomena (temporary reappearance of symptoms which led to starting treatment). These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. Always take lormetazepam exactly as your doctor has told you, in order to avoid the onset of these symptoms as far as possible.

Rebound insomnia and anxiety

- You may have a rebound episode (temporary reappearance of symptoms which led to starting treatment). This episode may be accompanied by other reactions such as mood changes, anxiety or sleep disorders and restlessness. The likelihood of a withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore it is recommended that the dose is decreased bit by bit until it is finally withdrawn. Follow the recommendations for use and instructions for administration of lormetazepam exactly as your doctor has told you, in order to avoid the appearance of these symptoms as far as possible.

Amnesia

Lormetazepam may induce anterograde amnesia, that is, difficulty in remembering recent facts. This occurs most commonly in the first few hours after taking the medicine. Therefore, to reduce this risk, you should ensure that you will be able to get 7-8 hours of uninterrupted sleep (see section 4).

- Psychiatric and paradoxical reactions

- Lormetazepam may cause restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects. These reactions are more common in children and the elderly, as well as in patients with organic brain syndrome (physical disorders which cause decreased mental function). Your doctor will discontinue treatment with lormetazepam should these reactions appear.

- Tell your doctor if you suffer from depression. Lormetazepam must not be used as a single-dose treatment for sleep abnormalities associated with depression.

- Lormetazepam must not be used as a first treatment for psychotic disease (see section 4).

Other warnings

- Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematologic and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary

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- Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.

- Abuse of benzodiazepines has been reported.

- Caution should be used in the treatment of patients with narrow-angle glaucoma

Children and adolescents

Lormetazepam must not be administered to patients under 18 years of age to treat insomnia without a careful assessment by the doctor of the need for the treatment. In addition, treatment duration must be as short as possible (see section 3).

Use in elderly people

Elderly patients should receive a lower dose than the usual dose since they are more susceptible to the effects of the medicine. Your doctor will recommend the most appropriate dose for you (see section

3).

Using lormetazepam with other medicines

Please tell your doctor or pharmacist about any other medicines you are taking, have recently taken or may need to take.

Enhancement of the effect of lormetazepam may occur when administered concomitantly with the following medicines:

- Medicines used to treat psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).

- Medicines used to relieve severe pain (narcotic analgesics). With these medicines, an increased feeling of euphoria may also occur. This may increase psychic dependence.

- Medicines used to treat epilepsy (antiepileptics).

- Anaesthetics.

- Medicines used to treat allergy symptoms (sedative antihistamines).

- Medicines used to treat cardiovascular diseases (calcium antagonists, cardiac glycosides).

- Medicines used to treat hypertension (beta blockers).

- Oral contraceptives.

- Certain antibiotics (such as rifampicin).

- Theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lormetazepam

- Clozapine should cause enhanced sedative effects, increased salivation and ataxia

Interactions with some medicines used to treat hypertension (beta blockers) and with central nervous system stimulants (methylxanthines) have also been reported.

Tell your doctor if you are taking other medicines.

Using lormetazepam with food, drink and alcohol

During treatment with lormetazepam, avoid alcoholic beverages.

Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. The sedative effect may be enhanced when the product is used in combination with alcohol, so the use of alcoholic beverages should be avoided. This should be particularly considered as it affects the ability to drive and use machinery (see section “Driving and using machines").

Pregnancy, breast-feeding and fertility

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Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As a general precaution, you should not use lormetazepam during pregnancy, labour or breast-feeding.

If, for strict medical reasons, the medicine is administered during the third trimester of pregnancy, or at high doses during labour, effects on the newborn, such as hypothermia, hypotonia and moderate respiratory depression may appear.

Infants born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence and develop a withdrawal syndrome in the postnatal period.

Breast-feeding

Since benzodiazepines pass into breast milk, their use is contraindicated in breast-feeding mothers. Driving and using machines

Lormetazepam is a medicine that causes sleep. Do not drive or use machinery if you feel drowsy and if you notice that your attention and ability to react are reduced. Pay special attention at the start of treatment or if the dose is increased.

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:

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 contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Lormetazepam

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

Your doctor will tell you the duration of your treatment with lormetazepam. Do not stop treatment earlier as it may not have the desired effect.

Treatment should be as short as possible. Generally, it varies from a few days to two weeks with a maximum period of four weeks, including the gradual dose reduction period.

The tablets should be taken with a small amount of liquid before going to bed.

Ver5 draft PSUSA update and response to comments for Renewal and renewal changes reinstated Ver 6 draft Renewal without PSUSA

Adults

The recommended dose is 1 mg of lormetazepam as a single dose.

In cases of severe or persistent insomnia, and always according to the doctor’s opinion, the dose can be increased to 2 mg.

Elderly patients

The recommended dose is 0.5 mg of lormetazepam per day as a single dose.

In the elderly, benzodiazepines may be associated with an increased risk of falling as they can cause muscle weakness, dizziness, drowsiness and fatigue. Therefore, your doctor will tell you the dose that best suits your condition.

Talk to your doctor or pharmacist if you think that the effect of lormetazepam is too strong or too weak.

There are other forms of lormetazepam in case lormetazepam tablets do not comply with the prescribed dose.

If you take more lormetazepam than you should

Overdose is not life-threatening unless combined with other centrally-acting depressants (including alcohol). In the case of overdose, it should be taken into account that the patient may have taken multiple agents.

Overdose of benzodiazepines generally appears as varying degrees of central nervous system depression ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion and lethargy; in more serious cases, ataxia (impaired coordination of movements), hypotonia (decrease in muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma and very rarely death may occur.

In the event of overdose or accidental intake, please consult your doctor or pharmacist immediately, indicating the medicine and the amount taken.

If you go to a health care centre, remember to take this package leaflet with you.

If you forget to take lormetazepam

Do not take a double dose to make up for a forgotten dose.

If you stop taking lormetazepam

Your doctor will tell you the duration of treatment with lormetazepam. Do not stop treatment early; otherwise it may not have the desired effect.

When stopping treatment, the symptoms that led you to take the medicine may recur; restlessness, anxiety, insomnia, headache and sweating may occur, so your doctor will explain clearly how to decrease the dose gradually.

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

4. Possible side effects

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

If the dose is not adapted to the individual conditions of each patient, side effects may appear due to excessive sedation and muscle relaxation.

At the start of treatment, the following may occur: daytime somnolence, emotional disturbance, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (abnormal coordination of movements) and double vision. All these effects occur predominantly at the start of treatment and usually disappear with repeated administration.

The most serious adverse reactions observed in patients treated with Lormetazepam are angioedema (swelling) completed suicide and attempted suicide, generally associated with masking of pre-existing depression.

The most commonly observed adverse reactions in patients treated with Lormetazepam are headache, sedation and anxiety.

Very common side effects

(can affect more than 1 out of every 10 people)

• Headache

Common side effects

(can affect up to 1 out of every 10 people)

• Angioedema (swelling of the face, lips, mouth, tongue and throat which may cause difficulty swallowing and breathing).

• Anxiety, decreased libido (sexual desire).

• Dizziness, sedation, somnolence (drowsiness), attention disorder, amnesia, vision disorder, speech disorder, dysgeusia, mental slowness.

• Tachycardia (fast heart rate).

• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.

• Pruritus (itching).

• Micturition disorder.

• Asthenia (lack of energy), excessive sweating.

Side effects with unknown frequency (cannot be estimated from the available data)

• Attempted suicide or completed suicide (masking of pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false perceptions of the senses), dependence, depression (masking of pre-existing depression), delirium (false ideas that are believed to be true and that are impossible to prove), withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, jumpiness, fits of rage, nightmares, inappropriate behaviour, emotional disturbances.

• Confusion, decreased level of consciousness, ataxia (abnormal coordination of movements), muscle weakness.

• Urticaria, exanthem (rash).

• Fatigue.

• Falls.

For more information on the following points, see section “Warnings and precautions”.

Dependence:

Administration of Lormetazepam and other benzodiazepines may induce the development of physical and psychic dependence (see section “Warnings and precautions”).

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Psychiatric disorders:

Rebound insomnia may occur when the medicine is stopped (see section “Warnings and precautions”).

- Psychiatric and paradoxical reactions: When Lormetazepam is used, reactions such as jumpiness, agitation, irritability, aggressiveness, delirium (false ideas that are believed to be true and that are impossible to prove), fits of rage, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), inappropriate abnormal behaviour or other behavioural abnormalities may occur.

- Depression: The use of benzodiazepines may mask pre-existing depression. Suicides may be triggered in these patients. Lormetazepam must be used with caution in patients with depression.

Nervous system disorders

- Amnesia: Lormetazepam may cause anterograde amnesia (difficulty remembering recent facts). (See section “Warnings and precautions”).

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 at: www.mhra.gov .uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store lormetazepam

Keep this medicine out of the sight and reach of children.

Lormetazepam does not require any special storage conditions.

Do not use lormetazepam after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment.

6. Contents of the pack and other information What lormetazepam contains

- The active substance is lormetazepam. Each tablet contains either 0.5 mg or 1 mg of lormetazepam.

- The other ingredients are: lactose monohydrate, croscarmellose sodium, magnesium stearate, maize starch and povidone K-25.

What the product looks like and contents of the pack

Lormetazepam 0.5 mg tablets come in boxes containing blister strips with 30 tablets. The tablets are round and white.

Lormetazepam 1 mg tablets come in boxes containing blister strips with 14, 30 or 500 tablets. The tablets are round, white and scored on one side. The score is used to divide the tablet into equal halves.

Ver5 draft PSUSA update and response to comments for Renewal and renewal changes reinstated Ver 6 draft Renewal without PSUSA Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS

Manufacturer:

Kern Pharma, S.L.

Venus 72

Poligono Ind. Colon II

08228 Terrassa (Barcelona) - Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

SPAIN

Lormetazepam Kern Pharma 0.5 mg and 1mg comprimidos

UNITED KINGDOM Lormetazepam 0.5 mg and 1mg tablets

FRANCE

Lormetazepam Actavis 1 mg comprimes

BELGIUM

Lormetazepam Sandoz 1 mg tabletten LUXEMBURG

Lormetazepam Sandoz 1 mg comprimes ITALY

Lormetazepam Sandoz GmbH