PATIENT INFORMATION LEAFLET

Lormetazepam Stada 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 only. Do not give it to others even if they have the same symptoms as you, 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.

1. Possible side effects
2. Storage of Lormetazepam Stada

1. Contents of the pack and additional information

Lormetazepam 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 postoperative periods

Lormetazepam 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 Stada

• If you are allergic (hypersensitive) to lormetazepam, benzodiazepines, 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 insufficiency
• If you have sleep apnea syndrome (interruption of breathing during sleep).

-In case of acute intoxication with alcohol, hypnotics, analgesics, or medications that act on the central nervous system (neuroleptics, antidepressants, lithium).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lormetazepam:

• If you have chronic respiratory insufficiency, as you should receive a lower dose than usual
• If you have liver insufficiency
• If you have severe renal insufficiency
• Lormetazepam 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 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 with respect to hypnotic effects may be detected.

Dependence

Lormetazepam may induce 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 substance abuse or alcohol consumption. Abrupt termination of treatment may be accompanied by withdrawal symptoms, such as severe anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In severe cases, derealization, depersonalization, hallucinations, paresthesia in the extremities, intolerance to light, sound, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for lormetazepam 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 symptoms that led to the initiation of treatment). The probability of appearance of a withdrawal/rebound phenomenon is higher after abrupt termination of treatment, so it is recommended to gradually reduce the dose until its definitive suppression. Follow exactly the recommendations for use and administration instructions for lormetazepam indicated by your doctor, in order to avoid, as much as possible, the appearance of these symptoms.

Amnesia

Lormetazepam may induce anterograde amnesia, i.e., 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 may produce restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, abnormal and inadequate 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 if these reactions appear.

Inform your doctor if you have depression. Lormetazepam should not be used as a single treatment for sleep disorders associated with depression.

Lormetazepam should not be used as first-line treatment for psychiatric disease (see section 4).

Children and adolescents

Lormetazepam 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 the elderly

Elderly 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 Stada with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those acquired without a prescription.

A potentiation of the effect of lormetazepam may occur when administered concomitantly with the following medications:

• Medications used in the treatment of 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 the risk of psychological dependence.
• Medications used in the treatment of 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).

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 (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all the opioid medications you are taking and follow closely the dosage recommendation of your doctor. It may be helpful to inform friends or relatives about the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Consult your doctor if you are taking other medications.

Taking Lormetazepam Stada with food, drink, and alcohol

During treatment with lormetazepam, avoid alcoholic beverages.

Benzodiazepines should be used with extreme caution in patients with a history of substance abuse or alcohol consumption. The sedative effect may be potentiated when this medication is administered in combination with alcohol, so it is recommended to avoid the consumption 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 machines”).

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, consult your doctor before using this medication.

If, by strict medical necessity, the medication is administered during the third trimester of pregnancy or during delivery, it is predictable that there may be effects on the newborn, such as hypothermia, hypotonia, and moderate respiratory depression, and difficulties during breastfeeding.

Children born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence, which may trigger a 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 machines

Lormetazepam is a medication that induces sleep, so it significantly affects the ability to drive or operate machinery. 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 Stada contains lactose

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

Lormetazepam Stada contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

The recommended dose is:

For the short-term treatment of insomnia

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 small amount of liquid a little before going to bed.

Use in adults

A single dose of 1 mg of lormetazepam (½ tablet of lormetazepam 2 mg) is recommended.

In cases of severe or persistent insomnia, and always according to strict 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 (lormetazepam 1 mg and an oral solution presentation) if necessary for this group of patients.

Use in elderly patients

A dose of 0.5 mg of lormetazepam per day (½ tablet of the lormetazepam 1 mg presentation, as a single dose, is recommended.

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

Use in patients with respiratory problems

If you have mild or moderate difficulty breathing, inform your doctor, who may advise you to use a lower dose of lormetazepam.

Use in patients with liver problems

If your liver does not function well, inform your doctor, who may advise you to use a lower dose of lormetazepam.

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

For the induction of sleep in pre- and postoperative periods

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

Use in adults

A medium dose of 2 mg of lormetazepam per day is recommended. The dose range is 0.5 to 3 mg of lormetazepam per day. One hour before the operation, half of this dose is recommended.

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.

A dose of 0.5 to 1 mg of lormetazepam per day is recommended. One hour before the operation, half of this dose is recommended. There are other presentations of lormetazepam (lormetazepam 1 mg and an oral solution presentation) if necessary for this group of patients.

Use in elderly patients

Generally, a dose of 1 mg of lormetazepam per day is recommended. One hour before the operation, half of this dose is recommended.

Use in patients with respiratory problems

If you have mild or moderate difficulty breathing, inform your doctor, who may advise you to use a lower dose of lormetazepam. One hour before the operation, half of the dose is recommended.

Use in patients with liver problems

If your liver does not function well, inform your doctor, who may advise you to use a lower dose of lormetazepam. One hour before the operation, half of the dose is recommended.

The tablet can be divided into equal doses.

If you take more Lormetazepam Stada 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, consider the possibility that the patient has ingested multiple products.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy (drowsiness); in more serious cases, ataxia (alteration of movement coordination), visual disturbances, hypotonia (muscle tone decrease), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Lormetazepam Stada

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

If you interrupt the treatment with Lormetazepam Stada

Your doctor will indicate the duration of treatment with lormetazepam. Do not suspend treatment before, as you may not achieve the desired effect.

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

Like all medicines, this medicine 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 drowsiness, 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 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 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).

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 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 discontinued (see "Warnings and precautions" section).

- Psychiatric and paradoxical reactions: When using lormetazepam, 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 alterations may appear.

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

Nervous system disorders

- Amnesia:Lormetazepam 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 possible 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date refers to the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Lormetazepam Stada 2 mg tablets

• The active ingredient is lormetazepam. Each tablet contains 2 mg of lormetazepam.

• The other components (excipients) are lactose monohydrate, sodium croscarmellose, magnesium stearate, cornstarch, and povidone K-25.

Appearance of the product and contents of the packaging

Lormetazepam Stada 2 mg tablets are presented in packaging containing blisters with 20 tablets (standard packaging) and 500 tablets (clinical packaging). The tablets are white, round, and scored on one side.

Other presentations:

Lormetazepam Stada 1 mg tablets, which are presented in packaging containing blisters with 30 tablets (standard packaging) and 500 tablets (clinical packaging).

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Kern Pharma, S.L.

Colón II Industrial Estate

Venus 72 Street

08228 Terrassa (Barcelona)

Spain

This leaflet was approved in November 2018

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