PATIENT INFORMATION LEAFLET

Lormetazepam Normon 2 mg Tablets EFG

Read this 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Lormetazepam Normon is a medication from the group of hypnotics that promotes sleep: normalizes the time needed to fall asleep and its total duration, while reducing the number of interruptions of the same.

It is indicated for:

• Treatment of short-term insomnia.
• Induction of sleep in pre and post-operative periods.

Lormetazepam Normon belongs to a group of hypnotic medications called benzodiazepines. Benzodiazepines are only indicated for the treatment of an intense disorder, which limits the patient's activity or subjects them to an important stress situation.

Do not take Lormetazepam Normon

• if you are allergic (hypersensitive) to the active ingredient or any of the other components of this medicine (listed in section 6),
• if you have myasthenia gravis (a disease characterized by the appearance of an abnormal degree of muscle weakness),
• if you have severe respiratory failure (for example, severe chronic obstructive pulmonary disease),
• if you have sleep apnea syndrome (a condition characterized by episodes of brief respiratory arrest that occur during sleep),
• in case of acute intoxication with alcohol, hypnotics, analgesics, or medications that act on the central nervous system (neuroleptics, antidepressants, lithium),
• if you have severe liver failure,
• if you are pregnant or breastfeeding (also see “Pregnancy, lactation, and fertility”).

Warnings and precautions

Consult your doctor or pharmacist before taking Lormetazepam Normon:

• if you have chronic respiratory failure, as you should receive a lower dose than usual,
• if you have severe renal failure,
• if you have liver failure
• Lormetazepam Normon should not be used as first-line treatment for psychiatric disease or as a single treatment for anxiety or sleep disorders associated with depression.
• Lormetazepam Normon should be administered with caution to patients with medullary or cerebellar ataxia.

Tolerance

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

Dependence

• Lormetazepam Normon may induce the appearance of 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 abuse or alcohol consumption. Abrupt termination 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 reappearance of the symptoms that led to initiation of treatment). It may be difficult to distinguish these symptoms from the original symptoms for which the medication was prescribed. Follow exactly the administration instructions for Lormetazepam Normon indicated by your doctor, in order to avoid, as much as possible, the appearance of these symptoms.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of the symptoms that led to initiation of treatment). This episode may be accompanied by other reactions such as mood changes, anxiety, or sleep and restlessness disorders. The probability of appearance of a withdrawal/rebound syndrome is higher after abrupt termination of treatment, so it is recommended to gradually reduce the dose until its definitive suppression. Follow exactly the use recommendations and administration instructions for Lormetazepam Normon indicated by your doctor, in order to avoid, as much as possible, the appearance of these symptoms.

Amnesia

• Lormetazepam Normon may induce anterograde amnesia, that is, difficulty remembering recent events; this occurs more frequently in the first hours after taking the medication, so to reduce this risk, you should ensure that you can sleep uninterrupted for 7-8 hours (see section 4).

Psychiatric and paradoxical reactions

• Lormetazepam Normon may produce restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. These reactions occur more frequently in children, the elderly, and patients with organic brain syndrome (physical disorders that produce a decrease in mental functions). Your doctor will suspend treatment with Lormetazepam Normon if these reactions appear.
• Inform your doctor if you have depression. Lormetazepam Normon should not be used as a single treatment for sleep disorders associated with depression.
• Lormetazepam Normon should not be used as first-line treatment for psychiatric disease (see section 4).

Other warnings

• Some patients have developed blood disorders and some have experienced an increase in liver enzymes while taking benzodiazepines. It is recommended to perform hematological and liver function tests periodically when repeated treatments are considered clinically necessary.

• Although hypotension occurs only in rare cases, benzodiazepines should be administered with caution in patients who may experience cardiovascular or cerebrovascular complications due to a decrease in blood pressure. This is especially important in older people.

• Cases of benzodiazepine abuse have been reported.

• It should be used 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 a careful evaluation of the need for it by the doctor. In addition, the duration of treatment should be the minimum possible (see section 3).

Use in older people

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

Other medications and Lormetazepam Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any medication.

A potentiation of the effect of Lormetazepam Normon may occur when administered with the following medications:

• Medications used to treat psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medications used to relieve strong pain (narcotic analgesics). With these medications, an increase in the sensation of euphoria may also occur, which may increase psychological dependence.
• Medications used to treat epilepsy (antiepileptics).
• Anesthetics.
• Medications used to treat allergic symptoms (sedating antihistamines).
• Medications used to treat cardiovascular diseases (calcium antagonists, cardiac glycosides).
• Medications 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 produce ataxia.

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

Inform your doctor if you are taking other medications.

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 consumption. The sedative effect may be potentiated when the product is administered in combination with alcohol, so it is recommended to avoid the use of alcoholic beverages. This should be taken into account especially since it affects the ability to drive or operate machinery (see section “Driving and operating machinery”).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

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

If, for strict medical reasons, the medication is administered during the third trimester of pregnancy, or at high doses during childbirth, it is predictable that there may be effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression.

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

Lactation

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

Driving and operating machinery

Lormetazepam is a medication that produces sleep. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Lormetazepam Normon contains lactose and sodium.

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

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

Follow exactly the administration instructions indicated by your doctor. In case of doubt, consult your doctor or.

• Treatment of short duration insomnia

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

The duration of treatment should be as short as possible. Generally, it varies between a few days and two weeks, with a maximum period, including a gradual dose reduction, of four weeks.

The tablets should be taken with a little liquid a short time before going to bed.

Use in adults

It is recommended to administer 1 mg of lormetazepam (½ tablet of Lormetazepam 2 mg), in a single dose.

In cases of severe or persistent insomnia, and always according to medical criteria, the dose can be increased to 2 mg (1 tablet of Lormetazepam 2 mg).

Use in children and adolescents

Lormetazepam should not be used in children and adolescents under 18 years of age without a careful evaluation of the need for treatment. There are other presentations of lormetazepam in case it is necessary for this group of patients.

Use in elderly patients

It is recommended to administer 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 a higher risk of falls due to muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will indicate the dose that best suits 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 liver insufficiency.

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

Induction of sleep in pre- and post-operative periods

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

Use in adults

It is recommended to administer a medium/daily dose of 2 mg of lormetazepam (from 0.5 to 3 mg).

Use in children and adolescents

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

It is recommended to administer a dose of 0.5 to 1 mg of lormetazepam per day (from ½ to 1 tablet of Lormetazepam 1 mg).

Use in elderly patients

It is generally recommended to administer a dose of 1 mg per day.

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 liver insufficiency.

An hour before the operation, it is recommended to administer half of these doses.

There are other presentations of lormetazepam in case Lormetazepam 2mg does not allow compliance with the prescribed dose.

If you take more Lormetazepam Normon than you should

Overdose does not represent a vital threat unless its administration is combined with other central nervous system depressants (including alcohol). In case of overdose, it should be taken into account that the patient may have ingested multiple products.

Overdosing with benzodiazepines generally manifests itself by different degrees of depression of the central nervous system, which can range from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, ataxia (alteration of movement coordination), hypotonia (muscle tone decrease), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death.

In case of accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

In case of assistance at a care center, do not forget to bring this prospectus.

If you forgot to take Lormetazepam Normon

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lormetazepam Normon

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

When stopping administration, the symptoms that led to the use of the medication may reappear, including restlessness, anxiety, insomnia, headaches, and sweating, so your doctor will indicate precisely how to gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist

Like all medicines, Lormetazepam Normon can cause side effects, although not everyone will experience them.

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

At the beginning of treatment, daytime somnolence, emotional alteration, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (alteration of movement coordination) or double vision may appear. All these side effects predominantly appear 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 or attempted suicide, usually 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 side effects

(can affect more than 1 in 10 patients)

• Headache

Common side effects

(can affect up to 1 in 10 patients)

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

Side effects of unknown frequency

(cannot be estimated from available data)

• Completed or attempted 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 cannot be proven), withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, anger attacks, nightmares, inappropriate behavior, emotional alterations.
• Confusion, decreased level of consciousness, ataxia (alteration of movement coordination), muscle weakness.
• Urticaria, exanthema (rash).
• Fatigue.
• Falls.

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

Dependence:

The administration of Lormetazepam Normon and other benzodiazepines may induce the development of physical and psychological dependence (see "Warnings and precautions" section).

Mental disorders:

Rebound insomnia may appear when the medication is withdrawn (see "Warnings and precautions" section).

• Psychiatric and paradoxical reactions: When using Lormetazepam Normon, reactions such as restlessness, agitation, irritability, aggression, delirium (false ideas that are believed to be true and cannot be proven), anger attacks, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), abnormal and inadequate behavior, and other conduct alterations may appear.

• Depression: The use of benzodiazepines may mask a pre-existing depression. In these patients, suicides 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 remembering recent events). (See "Warnings and precautions" section).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Store below 30°C.

Do not use Lormetazepam Normon after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lormetazepam Normon

• The active ingredient is lormetazepam. Each tablet contains 2 mg of lormetazepam.
• The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium carboxymethylcellulose type A (from potato).

Appearance of the product and contents of the packaging

Lormetazepam Normon 2 mg tablets are presented in a pack of 20 tablets, each containing 2 mg of lormetazepam. The tablets are white or slightly cream-colored, round, and scored.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: June 2018

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63612/P_63612.html