LORMETAZEPAM STADA 2 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lormetazepam Stada 2 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. See section 4.

Contents of the pack:

1. What is Lormetazepam Stada and what is it used for
2. What you need to know before you take Lormetazepam Stada
3. How to take Lormetazepam Stada

1. Possible side effects
2. Storing Lormetazepam Stada

1. Pack contents and further information

1. What is Lormetazepam Stada and what is it used for

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

It is indicated for:

• Short-term treatment of insomnia.

• Induction of sleep in pre and postoperative periods

Lormetazepam belongs to a group of hypnotic 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 Stada

Do not take Lormetazepam Stada

• If you are allergic (hypersensitive) to lormetazepam, benzodiazepines, or any of the other components 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
• If you have sleep apnea syndrome (interruption of breathing during sleep).

• In case of acute intoxication with alcohol, hypnotics, analgesics, or medicines 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 failure, as you should receive a lower dose than usual
• If you have liver failure
• If you have severe kidney failure
• Lormetazepam 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 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 the hypnotic effects may be detected.

Dependence

Lormetazepam 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 anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In more severe cases, even depersonalization, derealization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic seizures may occur. Follow your doctor's instructions for administration of lormetazepam 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). The likelihood of a withdrawal/rebound phenomenon is greater after abruptly stopping treatment, so it is recommended to gradually reduce the dose until its definitive suppression. Follow your doctor's recommendations for use and administration instructions for lormetazepam exactly to avoid these symptoms as much as possible.

Amnesia

Lormetazepam 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 may produce restlessness, agitation, irritability, aggression, delirium, rage, 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 discontinue treatment with lormetazepam if these reactions appear.

Tell your doctor if you have depression. Lormetazepam should not be used as the sole treatment for sleep disorders associated with depression.

Lormetazepam should not be used as a first-line treatment for psychotic illness (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 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).

Use of Lormetazepam Stada with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

A potentiation of the effect of lormetazepam may occur when administered concomitantly 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, an increase in the sensation of euphoria may also occur, 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).

Interactions have also been reported with some medicines used in the treatment of arterial hypertension (beta-blockers) and with central nervous system stimulants (methylxanthines).

The concomitant use of lormetazepam and opioids (potent analgesics, substitution therapy medicines, and some cough medicines) increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

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

Tell your doctor about all opioid medicines you are taking and follow your doctor's dosing recommendations closely. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

If you are taking other medicines, consult your doctor.

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 drug or alcohol abuse. The sedative effect can be potentiated when this medicine is administered in combination with alcohol, so it is recommended to avoid consuming 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 plan to become pregnant, consult your doctor before using this medicine.

If, for strict medical reasons, the medicine is administered during the third trimester of pregnancy or during childbirth, it is foreseeable that effects on the newborn may appear, such as hypothermia, hypotonia, and moderate respiratory depression, as well as difficulties during breastfeeding.

Children born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence, which can trigger a 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 is a medicine that produces sleep, so it significantly affects the ability to drive or operate machinery. 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 when starting treatment or if the dose is increased.

Lormetazepam Stada contains lactose

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

Lormetazepam Stada contains sodium

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

3. How to take Lormetazepam Stada

Follow your doctor's instructions for administration of this medicine exactly. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

The recommended dose is:

For short-term treatment of insomnia

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

Administration of 1 mg of lormetazepam (½ tablet of lormetazepam 2 mg) is recommended in a single dose.

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) in case they are necessary for this group of patients.

Use in elderly patients

Administration 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. Therefore, 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 properly, inform your doctor, who may advise you to use a lower dose of lormetazepam.

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

For induction of sleep in pre and postoperative periods

The doses will depend on the patient's age, weight, and general conditions.

Use in adults

Administration of a mean 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) in case they are necessary for this group of patients.

Use in elderly patients

A dose of 1 mg of lormetazepam per day is generally 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 properly, 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 is not life-threatening unless it is combined with other central nervous system depressants (including alcohol). In case of overdose, it should be considered 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, vision disorders, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death may occur.

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 medicine and the amount ingested. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Lormetazepam Stada

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

If you stop taking Lormetazepam Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause 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 are angioedema (swelling), completed or attempted suicide, usually associated with the masking of pre-existing depression.

The most frequently observed adverse reactions in patients treated with lormetazepam 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 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 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, 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 pre-existing depression. In these patients, suicide 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 Adverse Effects

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

5. Storage of Lormetazepam Stada

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

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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, povidone K-25.

Appearance of the Product and Package Contents

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

Other presentations:

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Kern Pharma, S.L.

Polígono Industrial Colón II

C/ Venus 72

08228 Terrassa (Barcelona)

Spain

This prospectus was approved in November 2018

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