LORMETAZEPAM NORMON 1 mg TABLETS

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

Do not take Lormetazepam Normon

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have myasthenia gravis (a disease characterized by an abnormal degree of muscle weakness),
• if you have severe respiratory failure (e.g., 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 medicines that act on the central nervous system (neuroleptics, antidepressants, lithium),
• if you have severe liver failure,
• 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 failure, as you should receive a lower dose than usual,
• if you have severe kidney failure,
• if you have liver failure
• Lormetazepam Normon should not be used as a first-line treatment for psychotic illness or as the sole 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 the 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 physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also greater in patients with a history of drug or alcohol abuse. Abrupt cessation 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 symptoms that led to the initiation of treatment). It may be difficult to distinguish between these symptoms and the original symptoms for which the medicine was prescribed. Follow your doctor's instructions for administration of Lormetazepam Normon exactly to avoid, as much as possible, the appearance of these symptoms.

Rebound insomnia and anxiety

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

Amnesia

• Lormetazepam Normon may induce anterograde amnesia, i.e., difficulty remembering recent events; this occurs more frequently in the first hours after taking the medicine, 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, fits of rage, 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 discontinue treatment with Lormetazepam Normon if these reactions appear.
• Inform your doctor if you have depression. Lormetazepam Normon should not be used as the sole treatment for sleep disorders associated with depression.
• Lormetazepam Normon should not be used as a first-line treatment for psychotic illness (see section 4).

Other warnings

• Some patients have developed blood dyscrasias, and some have experienced an increase in liver enzymes while taking benzodiazepines. It is recommended to perform periodic hematological and liver function tests when clinically necessary for repeated treatments.

• Although hypotension is only rarely produced, benzodiazepines should be administered with caution in patients for whom a decrease in blood pressure could produce cardiovascular or cerebrovascular complications. This is especially important in elderly individuals.

• There have been reports of benzodiazepine abuse.

• 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 treatment by the doctor. Additionally, the duration of treatment should be as short as possible (see section 3).

Use in elderly patients

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

Other medicines and Lormetazepam Normon

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

The effect of Lormetazepam Normon may be enhanced when administered with the following medicines:

• Medicines used in the treatment of psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medicines used to relieve severe pain (narcotic analgesics). With these medicines, there may also be an increase in the sensation of euphoria, which can increase psychological dependence.
• Medicines used in the treatment of epilepsy (antiepileptics).
• Anesthetics.
• Medicines used in the treatment of allergic symptoms (sedating antihistamines).
• Medicines used in the treatment of cardiovascular diseases (calcium antagonists, cardiac glycosides).
• Medicines used in the treatment of 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 medicines used in the treatment of arterial hypertension (beta-blockers) and with central nervous system stimulants (methylxanthines).

If you are taking other medicines, consult your doctor.

Using 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 administered in combination with alcohol; therefore, 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 using 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 childbirth, it is foreseeable that effects on the newborn may appear, 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.

Breastfeeding

Since benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Driving and using machines

Lormetazepam Normon is a medicine that produces sleep. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if you increase the dose.

Lormetazepam Normon contains lactose and sodium.

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Lormetazepam Normon

Follow your doctor's instructions for administration exactly. In case of 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 treatment before, as it may not have the desired effect.

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

The tablets should be taken with a little liquid shortly before bedtime.

Use in adults

It is recommended to administer 1 mg of lormetazepam (1 tablet of Lormetazepam Normon 1 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.

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 failure.

If you think the effect 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 failure.

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

There are other presentations of lormetazepam in case Lormetazepam 1 mg does not allow the prescribed dose to be met.

If you take more Lormetazepam Normon than you should

Overdose is not life-threatening unless it 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.

Overdose with benzodiazepines is generally manifested by different 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 (alteration of movement coordination), hypotonia (decrease in muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death.

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

If you go to an assistance center, do not forget to bring this leaflet.

If you forget to take Lormetazepam Normon

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

If you stop treatment with Lormetazepam Normon

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

When stopping treatment, the symptoms that led to the initiation of treatment may reappear, and restlessness, anxiety, insomnia, headache, and sweating may appear, so the doctor will indicate precisely how to gradually reduce the dose.

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

4. Possible Adverse Effects

Like all medications, Lormetazepam Normon can produce adverse effects, although not all people suffer from them.

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

At the beginning of treatment, drowsiness, emotional changes, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (alteration of movement coordination), or double vision may appear. All these effects appear 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 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 Frequent Adverse Effects

(may affect more than 1 in 10 patients)

• Headache

Frequent Adverse Effects

(may 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, drowsiness (lethargy), attention disorder, amnesia, visual disorder, speech disorder, dysgeusia, mental slowing.
• Tachycardia (accelerated heart rate).
• Vomiting, nausea, pain in the upper abdomen, constipation, dry mouth.
• Pruritus (itching).
• Urination disorder.
• Asthenia (lack of strength), excessive sweating.

Adverse Effects of Unknown Frequency

(cannot be estimated from available data)

• Suicide attempt or completed suicide (masking of a pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false perceptions of the senses), dependence, depression (masking of a 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 changes.
• 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).

Psychiatric Disorders:

Rebound insomnia may appear when withdrawing the medication (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 changes in behavior 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 produce anterograde amnesia (difficulty remembering recent events). (See "Warnings and Precautions" section).

Reporting of Adverse Effects

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

5. Conservation of Lormetazepam NORMON

Keep out of the 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 thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of Lormetazepam Normon

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

Appearance of the Product and Content of the Packaging

Lormetazepam Normon 1 mg tablets are presented in a packaging of 30 tablets, each containing 1 mg of lormetazepam. The tablets are white or slightly cream-colored, round, and scored.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus: June 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

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