LORMETAZEPAM KERN PHARMA 1 mg TABLETS

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 higher 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 start 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 higher after abrupt cessation of treatment, so it is recommended to gradually decrease the dose until its final 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 cause restlessness, agitation, irritability, aggression, delirium, 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 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 for repeated treatments.

• Although hypotension is rare, benzodiazepines should be administered with caution in patients for whom a decrease in blood pressure could lead to cardiovascular or cerebrovascular complications. 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 the elderly

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 might 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, an increase in the sensation of euphoria may also occur, 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 cause ataxia.

Interactions have also been reported with some medicines used to treat 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 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 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 causes sleepiness. Do not drive or use machines if you feel sleepy 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 any 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 (1 tablet of Lormetazepam Kern Pharma 1 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.

Elderly patients

It is recommended to administer 0.5 mg of lormetazepam per day (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, sleepiness, 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 1 mg does not allow the prescribed dose to be fulfilled.

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 sleepiness to coma. In moderate cases, symptoms include sleepiness, 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 treatment, the symptoms that led to the taking of the medicine may reappear, and anxiety, insomnia, headache, and sweating may occur. Therefore, your doctor will indicate precisely how to gradually decrease 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 a 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, drowsiness (sopor), attention disorder, amnesia, visual disorder, speech disorder, dysgeusia, mental slowing.
• Tachycardia (acceleration of heartbeats).
• 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 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 proven), anger attacks, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), abnormal 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 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 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 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 at the SIGRE Point in 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 1 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 1 mg tablets are presented in boxes containing blister packs with 14 and 30 tablets (standard packages) and 500 tablets (clinical package). The tablets are white, round, and scored on one side. The score serves to divide the tablet into two equal halves.

Other presentations:

Lormetazepam Kern Pharma 2 mg tablets, which are presented in boxes containing blister packs with 14, 20, 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 1 mg tablets

France Lormétazépam Actavis 1 mg tablets

Belgium Lormetazepam Sandoz 1 mg tablets

Luxembourg Lormetazepam Sandoz 1 mg tablets

Italy Lormetazepam Sandoz GmbH

United Kingdom Lormetazepam 1 mg tablets

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/