Package Insert: Information for the User

LormetazepamKern pharma2 mg tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Lormetazepam Kern Pharma 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.

Lormetazepam Kern Pharma 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 Kern Pharma

• if you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (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, 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 renal failure,
• if you have liver failure
• Lormetazepam Kern Pharma should not be used as a first-line treatment for psychiatric disease or as a single treatment for anxiety or sleep disorders associated with depression.
• Lormetazepam Kern Pharma should be administered with caution to patients with cerebellar or medullary 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 Kern Pharma 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 Kern Pharma indicated by your doctor, in order to avoid, to the extent 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 Kern Pharma indicated by your doctor, in order to avoid, to the extent possible, the appearance of these symptoms.

Amnesia

• Lormetazepam Kern Pharma 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 without interruption for 7-8 hours (see section 4).

Psychiatric and paradoxical reactions

• Lormetazepam Kern Pharma 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 Kern Pharma if these reactions appear.
• Inform your doctor if you have depression. Lormetazepam Kern Pharma should not be used as a single treatment for sleep disorders associated with depression.
• Lormetazepam Kern Pharma should not be used as a first-line treatment for psychiatric disease (see section 4).

Other warnings

• Some patients have developed hematological disorders 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 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 adults.

• Cases of benzodiazepine abuse have been reported.

• 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. In addition, the duration of treatment should be the minimum possible (see section 3).

Use in older adults

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)

Use of Lormetazepam Kern Pharma with other medications

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

A potentiation of the effect of Lormetazepam Kern Pharma may occur when administered concomitantly 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, there may also be an increase in the feeling of euphoria, 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 channel blockers, 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).

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

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

Please inform your doctor about all the opioid medications 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.

Consult your doctor if you are taking other medications.

Use of Lormetazepam Kern Pharma with food, drink, and alcohol

Avoid drinking alcoholic beverages during treatment with Lormetazepam Kern Pharma.

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. 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, as it affects the ability to drive or operate machinery (see section “Driving and operating machinery”).

Pregnancy and breastfeeding

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 Kern Pharma 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 Kern Pharma contains lactose and sodium.

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 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for lormetazepam indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

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 treatment duration 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 small amount of liquid a little before going to bed.

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 can be increased to 2 mg (1 tablet of Lormetazepam Kern Pharma 2 mg).

Senior 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, drowsiness, and fatigue. Therefore, your doctor will indicate the dose that best suits your condition.

Consider reducing the dose in patients with mild or moderate respiratory difficulties or in patients with liver insufficiency.

If you estimate that the action 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 you to comply with the prescribed dose.

If you take more Lormetazepam Kern Pharma 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, take into account the possibility that the patient has ingested multiple products.

Lormetazepam overdose typically manifests by different degrees of central nervous system depression, ranging 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 leaflet.

If you forgot to take Lormetazepam Kern Pharma

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

If you interrupt treatment with Lormetazepam Kern Pharma

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

When stopping administration, the symptoms that led to taking 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 Kern Pharma may 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 Kern Pharma 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 Kern Pharma are headache, sedation, and anxiety.

Very common side effects

(may affect more than 1 in 10 patients)

• Headache

Common side 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 disorder, amnesia, visual disorder, speech disorder, dysgeusia, mental slowing.

• Tachycardia (acceleration of heartbeats).

• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.

• Pruritus (itching).

• Urinary 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 disturbances.

• Confusion, decreased level of consciousness, ataxia (alteration of movement coordination), muscle weakness.

• Urticaria, exanthema (rash).

• Fatigue.

• Falls.

To learn more about 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).

Mental disorders:

Rebound insomnia may appear when the medication is withdrawn (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 and inappropriate behavior, and other conduct disturbances 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 cause anterograde amnesia (difficulty remembering recent events). (See "Warnings and precautions" section).

Reporting 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 Vigilance of Medicinal Products 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 the sight and reach of children.

Lormetazepam Kern Pharma does not require special conditions for conservation.

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 down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointofthepharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Lormetazepam Kern Pharma Composition

• 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 contents of the package

Lormetazepam Kern Pharma 2 mg tablets are presented in boxes containing blister packs with 14, 20, and 30 tablets (standard packs) and 500 tablets (clinical pack). 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 packs) and 500 tablets (clinical pack).

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus 72

08228 Terrassa (Barcelona)

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

SpainLormetazepam Kern Pharma 2 mg tablets

FranceLormétazépam Actavis 2 mg tablets

BelgiumLormetazepam Sandoz 2 mg tablets

LuxembourgLormetazepam Sandoz 2 mg tablets

ItalyLormetazepam Sandoz GmbH

Last review date of this leaflet: July 2021

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