LORMETAZEPAM KERN PHARMA 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

LormetazepamKern Pharma2 mg Tablets EFG

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 any 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 signs of illness 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.

Contents of the pack:

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

1. What is Lormetazepam Kern Pharma and what is it used for

Lormetazepam Kern Pharma is a medicine belonging to the group of hypnotics that promotes sleep: it normalizes the time needed to fall asleep and the total duration, while reducing the number of interruptions.

It is indicated for:

• Short-term treatment of insomnia.

Lormetazepam Kern Pharma belongs to a group of medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of intense disorders that limit the patient's activity or subject them to significant stress.

2. What you need to know before you take Lormetazepam Kern Pharma

Do not take Lormetazepam Kern Pharma

• 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 Kern Pharma:

• 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 Kern Pharma 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 Kern Pharma 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 Kern Pharma 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 Kern Pharma exactly to avoid these symptoms as much as possible.

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 likelihood of a withdrawal/rebound syndrome is greater after abrupt cessation of 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 Kern Pharma exactly to avoid these symptoms as much as possible.

Amnesia

• Lormetazepam Kern Pharma 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 Kern Pharma may produce restlessness, agitation, irritability, aggression, delirium, rage 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 discontinue treatment with Lormetazepam Kern Pharma if these reactions appear.
• Tell your doctor if you have depression. Lormetazepam Kern Pharma should not be used as the sole treatment for sleep disorders associated with depression.
• Lormetazepam Kern Pharma 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 to perform repeated treatments.

• Although hypotension is rare, 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 the elderly.

• There have been reports of benzodiazepine abuse.

• It should be used with caution in patients with narrow-angle glaucoma.

Children and adolescents

Lormetazepam Kern Pharma 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. 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).

Using Lormetazepam Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use other medicines.

The effect of Lormetazepam Kern Pharma may be enhanced 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, there may also be an increase in the sensation of euphoria, which can 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 produce ataxia.

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

The concomitant use of lormetazepam and opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medicine with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

If you are taking other medicines, consult your doctor.

Using Lormetazepam Kern Pharma with food, drink, and alcohol

During treatment with Lormetazepam Kern Pharma, 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 especially taken into account as 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, for strict medical reasons, the medicine is administered during the third trimester of pregnancy or at high doses during childbirth, it is likely that effects on the newborn, such as hypothermia, hypotonia, and moderate respiratory depression, may appear.

Children born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence and experience 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 Kern Pharma is a medicine that produces sleep. Do not drive or use machines if you feel somnolent 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 Kern Pharma contains lactose and sodium.

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 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Lormetazepam Kern Pharma

Follow your doctor's instructions for administration of lormetazepam exactly. Consult your doctor or pharmacist if you have doubts. Remember to take your medicine.

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.

Adults

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

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

Elderly patients

It is recommended to administer 0.5 mg of lormetazepam per day (1 tablet of Lormetazepam Kern Pharma 0.5 mg or ½ tablet of Lormetazepam Kern Pharma 1 mg) as a single dose.

In elderly patients, benzodiazepines may be associated with a higher risk of falls due to muscle weakness, dizziness, somnolence, and fatigue. Therefore, your doctor will indicate the dose that best suits your condition.

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

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

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

If you take more Lormetazepam Kern Pharma 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 somnolence to coma. In moderate cases, symptoms include somnolence, 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 attend a medical center, do not forget to bring this leaflet.

If you forget to take Lormetazepam Kern Pharma

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

If you stop taking Lormetazepam Kern Pharma

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

When discontinuing administration, the symptoms that led to the taking of the medicine may reappear, and restlessness, anxiety, insomnia, headache, and sweating may occur, 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 Kern Pharma 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 alteration, 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 Kern Pharma are angioedema (swelling), completed suicide, or attempted suicide, usually associated with the masking of pre-existing depression.

The most frequently observed adverse reactions in patients treated with Lormetazepam Kern Pharma 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 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 (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 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 demonstrated), 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 Kern Pharma 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 Kern Pharma, reactions such as restlessness, agitation, irritability, aggression, delirium (false ideas that are believed to be true and cannot be demonstrated), anger attacks, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), abnormal inappropriate behavior, and other changes in behavior may appear.

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

Nervous System Disorders

• Amnesia: Lormetazepam Kern Pharma may produce anterograde amnesia (difficulty remembering recent events). (See "Warnings and Precautions" section).

Reporting 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 it 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. Storage of Lormetazepam Kern Pharma

Keep out of sight and reach of children.

Lormetazepam Kern Pharma does not require special storage conditions.

Do not use Lormetazepam Kern Pharma 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 drains or into 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. Package Contents and Additional Information

Composition of Lormetazepam Kern Pharma

• The active ingredient is lormetazepam. Each tablet contains 2 mg of lormetazepam.
• The other components are: lactose monohydrate, sodium croscarmellose, magnesium stearate, cornstarch, povidone K-25.

Appearance of the Product and Package Contents

Lormetazepam Kern Pharma 2 mg tablets are presented in boxes containing blister packs with 14, 20, and 30 tablets (standard packages) and 500 tablets (clinical package). The tablets are white, round, and scored on both sides. The score serves to divide the tablet into two equal halves.

Other presentations:

Lormetazepam Kern Pharma 1 mg tablets, which are presented in boxes containing blister packs with 14 and 30 tablets (standard packages) and 500 tablets (clinical package).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus 72

08228 Terrassa (Barcelona)

Manufacturer:

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus 72

08228 Terrassa (Barcelona)

Lek Pharmaceuticals d.d.

Verovskova ulica 57

SI - 1526 Ljubljana, Slovenia

Arrow Génériques

26 avenue Tony Garnier

69007 Lyon, France

This medication is authorized in the member states of the European Economic Area under the following names:

Spain Lormetazepam Kern Pharma 2 mg tablets

France Lormétazépam Actavis 2 mg tablets

Belgium Lormetazepam Sandoz 2 mg tablets

Luxembourg Lormetazepam Sandoz 2 mg tablets

Italy Lormetazepam Sandoz GmbH

Date of the Last Revision of this Prospectus: July 2021

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