Lormetazepam Normon 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lormetazepam Normon 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lormetazepam Normon is and what it is used for
2. What you need to know before taking Lormetazepam Normon
3. How to take Lormetazepam Normon
4. Possible side effects
5. How to store Lormetazepam Normon
6. Contents of the pack and other information

1. What Lormetazepam Normon is and what it is used for

Lormetazepam Normon is a hypnotic medicine that promotes sleep:

it normalizes the time required to fall asleep and the total duration of sleep, while reducing the number of sleep interruptions.

It is indicated for:

• Short-term treatment of insomnia.
• Sleep induction in pre- and post-operative periods.

Lormetazepam Normon belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's daily activities or cause considerable stress.

2. What you need to know before starting to take Lormetazepam Normon

Do not take Lormetazepam Normon

• if you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6),
• if you have myasthenia gravis (a disease characterized by the appearance of abnormal muscle weakness),
• if you have severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease),
• if you have sleep apnea syndrome (a condition characterized by brief episodes of breathing cessation occurring during sleep),
• in case of acute intoxication with alcohol, hypnotics, analgesics, or medicines acting on the central nervous system (neuroleptics, antidepressants, lithium),
• if you have severe hepatic insufficiency,
• if you are pregnant or breastfeeding (see also “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Consult your doctor or pharmacist before taking Lormetazepam Normon:

• if you have chronic respiratory insufficiency, as you should receive a lower than usual dose,
• if you have severe renal insufficiency,
• if you have hepatic insufficiency,
• Lormetazepam Normon should not be used as first-line treatment for psychotic illness nor as sole treatment for anxiety or sleep disorders associated with depression.
• Lormetazepam Normon should be administered with caution in patients with medullary or cerebellar ataxia.

Tolerance

• After continuous use for several weeks, a certain degree of reduced efficacy regarding hypnotic effects may be observed.
• In the presence of lormetazepam, tolerance to other CNS depressants may decrease; these substances should be avoided or taken at reduced doses.

Dependence

• Lormetazepam Normon may lead to physical and psychological dependence. The risk of dependence increases with dose and duration of treatment, and is also higher in patients with a history of drug or alcohol abuse. Abrupt discontinuation of treatment may be accompanied by withdrawal symptoms such as headache, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and rebound phenomena (temporary re-emergence of symptoms that led to initiating treatment). It may be difficult to distinguish between these symptoms and the original symptoms for which the medicine was prescribed. Follow exactly the administration instructions for Lormetazepam Normon given by your doctor to minimize the risk of these symptoms occurring.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient re-emergence of symptoms that led to starting treatment). This episode may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. The likelihood of developing a withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until complete withdrawal. Follow exactly the usage recommendations and administration instructions for Lormetazepam Normon given by your doctor to minimize the risk of these symptoms occurring.

Amnesia

• Lormetazepam Normon may induce anterograde amnesia, i.e., difficulty in remembering recent events; this occurs more frequently within the first few hours after taking the medicine. To reduce this risk, you should ensure that you will be able to sleep uninterrupted for 7–8 hours (see section 4).

Psychiatric and paradoxical reactions

• Lormetazepam Normon may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders causing reduced mental function). Your doctor will discontinue treatment with Lormetazepam Normon if such reactions occur.
• Inform your doctor if you suffer from depression. Lormetazepam Normon should not be used as the sole treatment for sleep disturbances associated with depression.
• Lormetazepam Normon should not be used as first-line treatment for psychotic illness (see section 4).

Other warnings

• Some patients have developed blood dyscrasias and some have experienced increased liver enzymes while taking benzodiazepines. Hematological and liver function monitoring is recommended periodically when repeated treatments are considered clinically necessary.

• Although hypotension occurs only rarely, benzodiazepines should be administered with caution in patients for whom a drop in blood pressure could lead to cardiovascular or cerebrovascular complications. This is especially important in elderly patients.

• Cases of benzodiazepine abuse have been reported.

• Use with caution in patients with narrow-angle glaucoma.

Children and adolescents

Lormetazepam Normon should not be administered to patients under 18 years of age for the treatment of insomnia without careful medical evaluation of the necessity. In addition, the duration of treatment should be as short as possible (see section 3).

Use in elderly patients

Elderly patients should receive a lower than usual dose, as they are more susceptible to the effects of the medicine. Your doctor will recommend the most appropriate dosage (see section 3).

Other medicines and Lormetazepam Normon

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

The effect of Lormetazepam Normon may be enhanced when taken 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, which could increase psychological dependence.
• Medicines used to treat epilepsy (antiepileptics).
• Anesthetics.
• Medicines used to treat allergic symptoms (sedating 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 may increase sedative effects, increase salivation, and cause ataxia.

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

If you are taking other medicines, consult your doctor.

Use of Lormetazepam Normon with food, drinks and alcohol

During treatment with Lormetazepam Normon, avoid alcoholic beverages.

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be enhanced when the product is taken together with alcohol; therefore, the use of alcoholic beverages is not recommended. This should be especially noted as it affects the ability to drive or operate machinery (see section “Driving and use of machines”).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

As a general precaution, you should not use lormetazepam during pregnancy, childbirth, or breastfeeding.

If, due to strict medical necessity, the medicine is administered during the third trimester of pregnancy or at high doses during delivery, effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression may be expected.

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

Breastfeeding

Due to the fact that benzodiazepines pass into breast milk, their use is contraindicated in nursing mothers.

Driving and use of machinery

Lormetazepam Normon is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or if you notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

Lormetazepam Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially “sodium-free”.

3. How to take Lormetazepam Normon

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Short-term treatment of insomnia

Your doctor will indicate the duration of your treatment with lormetazepam. Do not stop the treatment prematurely, as it may not produce the desired effect.

The treatment duration should be as short as possible. In general, it ranges from a few days to two weeks, with a maximum period, including gradual dose reduction, of four weeks.

The tablets should be taken with some liquid shortly before going to bed.

Use in adults

The recommended dose is 1 mg of lormetazepam (1 tablet of Lormetazepam Normon 1 mg), taken as a single dose.

In cases of severe or persistent insomnia, and always according to medical judgment, the dose may be increased to 2 mg.

Use in children and adolescents

Lormetazepam must not be used in children and adolescents under 18 years of age without careful assessment of the need for treatment. Other lormetazepam formulations are available if necessary for this patient group.

Use in elderly patients

The recommended dose is 0.5 mg of lormetazepam per day (½ tablet of lormetazepam 1 mg), as a single dose.

In elderly patients, benzodiazepines may be associated with an increased risk of falls due to possible side effects such as muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will determine the dose best suited to your condition.

Use in patients with respiratory problems

A dose reduction should be considered in patients with mild or moderate breathing difficulties.

Use in patients with liver problems

A dose reduction should be considered in patients with hepatic insufficiency.

If you think that the effect of lormetazepam is too strong or too weak, consult your doctor or pharmacist.

• Sleep induction in pre- and post-operative periods

Doses will depend on the patient's age, weight, and general condition.

Use in adults:

A recommended daily dose of 2 mg of lormetazepam (ranging from 0.5 to 3 mg) is advised.

Use in children and adolescents:

Lormetazepam must not be used in children and adolescents under 18 years of age without careful assessment of the need for treatment.

A dose of 0.5 to 1 mg of lormetazepam/day (½ to 1 tablet of Lormetazepam 1 mg) is recommended.

Use in elderly patients

A daily dose of 1 mg is generally recommended.

Use in patients with respiratory problems

A dose reduction should be considered in patients with mild or moderate breathing difficulties.

Use in patients with liver problems

A dose reduction should be considered in patients with hepatic insufficiency.

One hour before surgery, half of these doses is recommended.

Other lormetazepam formulations are available if Lormetazepam 1 mg does not allow the prescribed dose to be achieved.

If you take more Lormetazepam Normon than you should

Overdose is not life-threatening unless lormetazepam is taken together with other central nervous system depressants (including alcohol). In cases of overdose, consider the possibility that the patient may have ingested multiple substances.

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

In case of accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.

If you go to a medical facility, do not forget to bring this leaflet with you.

If you forget to take Lormetazepam Normon

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

If you stop taking Lormetazepam Normon

Your doctor will indicate the duration of treatment with lormetazepam. Do not stop treatment prematurely, as it may not have the desired effect.

When stopping treatment, the symptoms that led to taking the medicine may reappear, possibly including restlessness, anxiety, insomnia, headache, and sweating. Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lormetazepam Normon may cause adverse effects, although not everyone experiences them.

If the dosage is not adjusted to the individual condition of each patient, adverse effects due to excessive sedation and muscle relaxation may occur.

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

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

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

Very common adverse effects

(may affect more than 1 in 10 patients)

• Headache

Common adverse effects

(may affect up to 1 in 10 patients)

• Angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing).
• Anxiety, decreased libido (sexual desire).
• Dizziness, sedation, somnolence (drowsiness), attention disturbance, amnesia, visual disturbance, speech disorder, dysgeusia, mental slowing.
• Tachycardia (increased heart rate).
• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
• Pruritus (itching).
• Urinary disturbance.
• Asthenia (lack of energy), excessive sweating.

Adverse effects of unknown frequency

(cannot be estimated from available data)

• Suicide attempt or completed suicide (due to masking of a pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, depression (due to masking of a pre-existing depression), delirium (false beliefs held as true and impossible to disprove), withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage attacks, nightmares, inappropriate behavior, emotional disturbances.
• Confusion, decreased level of consciousness, ataxia (impaired coordination of movements), muscle weakness.
• Urticaria, exanthema (rash).
• Fatigue.
• Falls.

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

Dependence:

Administration of Lormetazepam Normon and other benzodiazepines may lead to the development of physical and psychological dependence (see section “Warnings and precautions”).

Psychiatric disorders:

Rebound insomnia may occur upon discontinuation of the medicine (see section “Warnings and precautions”).

• Psychiatric and paradoxical reactions: When using Lormetazepam Normon, reactions such as restlessness, agitation, irritability, aggressiveness, delirium (false beliefs held as true and impossible to disprove), rage attacks, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate abnormal behavior, and other behavioral disturbances may occur.

• Depression: The use of benzodiazepines may mask pre-existing depression. In such patients, suicide may be triggered. Lormetazepam Normon should be used with caution in patients with depression.

Nervous system disorders

• Amnesia: Lormetazepam Normon may cause anterograde amnesia (difficulty in remembering recent events). (See section “Warnings and precautions”).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lormetazepam NORMON

Keep out of the reach and sight of children.

Store below 30°C.

Do not use Lormetazepam Normon after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lormetazepam Normon

• The active substance is lormetazepam. Each tablet contains 1 mg of lormetazepam.
• The other components are: monohydrate lactose, microcrystalline cellulose, magnesium stearate and sodium carboxymethylstarch type A (derived from potato).

Nature of the product and pack contents

Lormetazepam Normon 1 mg tablets are supplied in a pack containing 30 tablets, each tablet containing 1 mg of lormetazepam. The tablets are white or slightly cream-coloured, round and scored.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: June 2018

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63611/P_63611.html