LORMETAZEPAM TEVA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Lormetazepam Teva contains lormetazepam, which belongs to a group of medicines called benzodiazepines. It is indicated for the short-term treatment of insomnia.

Benzodiazepines are only indicated for the treatment of severe disorders that limit the patient's activity or subject them to significant stress.

2. What you need to know before you take Lormetazepam Teva

Do not take Lormetazepam Teva

• If you are allergic to the active substance, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
• If you have myasthenia gravis (very weak or tired muscles).
• If you have severe respiratory failure (e.g., severe chronic obstructive pulmonary disease).
• If you have sleep apnea (temporary cessation of breathing while sleeping).
• In case of acute intoxication with alcohol, sleeping pills, pain relievers, or psychotropic medications (neuroleptics, antidepressants, lithium salts).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lormetazepam Teva.

If any of the following cases apply to you, inform your doctor. Your doctor will take this into account during treatment with lormetazepam.

• If you have spinal or cerebellar ataxia (lack of coordination of movements).
• If you have any liver or kidney disorder.
• If you have closed-angle glaucoma.
• If your doctor has prescribed prolonged treatment, it is advisable to have periodic blood tests and liver function tests.
• If you become pregnant during treatment, you must inform your doctor.
• It is not recommended for use in children or adolescents.

If you are being treated with opioids, as it can cause difficulty breathing, sedation, coma, and even death.

Be aware that you may experience the following reactions:

Tolerance

After continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.

Dependence and abuse

Treatment with benzodiazepines may lead to the development of physical and psychological dependence. This risk increases with dose and duration, but dependence can also occur during short-term treatment with the therapeutic dose range.

To prevent this risk as much as possible, the following precautions must be taken into account:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and never advise them to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
• In patients with a history of drug and/or alcohol abuse, potential abuse of the medication may occur.
• Consult your doctor regularly so that he can decide whether to continue treatment.

Rebound insomnia and anxiety

When administration is stopped, the symptoms that led to the use of the medication may reappear, as well as changes in mood, anxiety, or insomnia, restlessness, among others, so your doctor will indicate the precise way to gradually decrease the dose.

Lormetazepam should not be stopped abruptly and a gradual dose reduction process should be followed.

Amnesia

Benzodiazepines, including Lormetazepam Teva, can induce amnesia (memory impairment). To minimize this risk, you should ensure that you will be able to sleep uninterrupted for 7-8 hours (see section "4. Possible side effects").

Psychiatric and paradoxical reactions

In treatment with benzodiazepines, including Lormetazepam Teva, pre-existing depressions may reappear or worsen. Additionally, they may unmask suicidal tendencies in depressive patients, which should be monitored in these patients.

The medication should be discontinued if these reactions appear.

Risk of concomitant use with opioids

The concomitant use of lormetazepam and opioids may result in sedation, respiratory depression, coma, and death. Due to these risks, the concomitant prescription of sedative medications such as benzodiazepines or opioid-related medications should be reserved for patients for whom alternative treatment options are not possible. If lormetazepam is prescribed concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

Your doctor should closely monitor you for signs and symptoms of respiratory depression and sedation. You should be aware of these symptoms (see "Use of Lormetazepam Teva with other medications").

Other medications and Lormetazepam Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The concomitant use of lormetazepam with opioids (analgesics, substitution therapy medications, and some cough suppressants) increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and can be life-threatening. Due to this, concomitant administration should only be considered when no alternative treatments are possible.

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

Please inform your doctor of all opioids you are taking and carefully follow the dosage recommendations indicated by your doctor. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Alcohol increases the sedative effect of this medication, so it is recommended to avoid alcohol consumption.

Certain medications may interact with Lormetazepam Teva and make you feel more drowsy than expected. These are medications called central nervous system depressants, including those used to treat mental illnesses such as antipsychotics (neuroleptics), hypnotics (anxiolytics, sedatives), antidepressants; those used to relieve strong pain (analgesics, narcotics); medications used to treat convulsions/epileptic seizures (antiepileptic medications), anesthetic medications, barbituric medications, and medications used to treat allergies (sedating antihistamines).

The concomitant administration of lormetazepam with other medications such as theophylline or aminophylline, beta-blockers, cardiac glycosides, oral contraceptives, and some antibiotics may alter the effect of lormetazepam by prolonging or decreasing its activity.

The effect of muscle relaxants may be enhanced.

Taking Lormetazepam Teva with food, drinks, and alcohol

Avoid alcohol consumption during treatment with lormetazepam, as it increases the sedative effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of benzodiazepines, including lormetazepam, appears to be related to a possible increased risk of congenital malformations in the first trimester of pregnancy. Benzodiazepines and their metabolites have been detected crossing the placenta.

If, due to strict medical necessity, the product is administered during late pregnancy or at high doses during labor, withdrawal symptoms may appear in the newborn, such as hypoactivity (reduced activity), hypothermia (reduced body temperature), hypotonia (weak muscle tone), apnea (temporary absence of breathing), respiratory depression, feeding problems, and metabolic response imbalance to cold stress.

Children born to mothers who take benzodiazepines chronically during several weeks of pregnancy or during the last period of pregnancy may develop physical dependence and trigger withdrawal syndrome in the postnatal period.

Breastfeeding

Lormetazepam Teva should not be used during breastfeeding, as benzodiazepines, including lormetazepam, are excreted in breast milk. Cases of sedation and inability to breastfeed have been detected in newborns whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect any of the mentioned pharmacological effects (including sedation and irritability).

Children and adolescents

Benzodiazepines are not indicated in children or adolescents, except for premedication for diagnostic or surgical procedures (anesthesiology, intensive care). In these cases, a single dose of 1 mg is recommended.

Use in elderly and debilitated patients

Elderly and debilitated patients should receive a lower dose, as they are more susceptible to the effects of the medication. Follow your doctor's instructions carefully. Due to the muscle relaxant effect, there is a risk of falls and consequently fractures in elderly patients, especially in patients who get up during the night.

Patient with severe renal impairment

Lormetazepam should be administered with caution in patients with severe renal impairment.

Use in patients with respiratory failure

Lormetazepam is contraindicated in patients with severe respiratory failure.

Use in patients with hepatic impairment

Lormetazepam Teva should be used with caution in patients with severe hepatic impairment and/or encephalopathy.

Grief or loss

In cases of grief or loss, psychological adjustment may be inhibited by benzodiazepines.

Driving and using machines

Lormetazepam Teva is a medication that causes sleepiness. 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 at the start of treatment or if the dose is increased.

Lormetazepam Teva contains lactose

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

Lormetazepam Teva contains sodium

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

3. How to take Lormetazepam Teva 1 mg tablets

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

Your doctor will indicate the duration of your treatment with Lormetazepam Teva. The duration of treatment should be as short as possible.

Treatment should be started with the lowest doses and the maximum dose should not be exceeded.

The recommended dose is 1 mg of lormetazepam daily (1 tablet of Lormetazepam Teva) 15 to 30 minutes before bedtime, administered orally.

The usual dose may be increased at the doctor's discretion in case of severe or persistent insomnia that does not respond to the usual regimen, up to a maximum of 2 mg of lormetazepam daily (2 tablets of Lormetazepam Teva 1 mg).

Use in children and adolescents

Lormetazepam is not indicated for the treatment of insomnia in children and adolescents.

Elderly patients, debilitated patients, or patients with cerebrovascular disorders (arteriosclerosis), mild or moderate respiratory failure, and/or renal and/or hepatic impairment

The dose should be reduced to half a tablet per day (0.5 mg of lormetazepam). Other presentations of lormetazepam are available to achieve this dose.

For severe respiratory failure, see section 2.

Do not interrupt treatment abruptly. Your doctor will indicate the precise way to gradually decrease the dose, as when administration is stopped, the symptoms that led to the use of the medication may reappear.

The use of benzodiazepines can lead to dependence. This occurs mainly after uninterrupted use of the medication for a long time. To prevent this risk as much as possible, the following instructions should be taken into account:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and never advise them to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
• Consult your doctor regularly so that he can decide whether to continue treatment.

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.

If you take more Lormetazepam Teva than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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, lethargy, and dysarthria (speech disorders). In more severe cases, ataxia (alteration of movement coordination), paradoxical reactions, central nervous system depression, vision disorders, hypotonia (decreased muscle tone), hypotension (low blood pressure), respiratory depression (breathing difficulties), cardiac depression, rarely coma, and very rarely death may appear.

Treatment of overdose

Clinical management of overdose with any medication should always consider the possibility that the patient has ingested multiple products.

After a benzodiazepine overdose, vomiting should be induced (within an hour) if the patient is conscious. Vomiting is not recommended if there is a risk of aspiration. If the patient is unconscious, gastric lavage should be performed with preservation of the airway. If gastric emptying does not provide any advantage, activated charcoal should be administered to reduce absorption.

Special attention should be paid to respiratory and cardiovascular functions if the patient requires admission to an intensive care unit for monitoring.

Use of antidote in case of overdose

In hospitalized patients, flumazenil (a benzodiazepine antagonist) may be used as an adjunctive method in the treatment of overdose, but never as a substitute for the method described above. In patients who take benzodiazepines chronically or in cases of overdose with tricyclic antidepressants, special care should be taken when administering flumazenil, as this combination of medications may increase the risk of seizures.

If you forget to take Lormetazepam Teva

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

If you stop taking Lormetazepam Teva

Do not stop treatment with lormetazepam until your doctor tells you to do so.

If you stop taking lormetazepam, especially if it is abrupt, changes in mood, anxiety, insomnia, restlessness, lack of concentration, headache, and sweating, among others, may appear, so your doctor will indicate precisely how to gradually decrease the dose until the end of your treatment.

If you have any other questions about the use of this medication, 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.

According to frequency, they are defined as:

Very Common(may affect more than 1 in 10 people)

• Headache

Common(may affect up to 1 in 10 people)

• Anxiety, decreased libido (sexual desire), and bradypsychia.
• Dizziness, sedation, somnolence (drowsiness), attention disturbance, amnesia, dysarthria (slurred speech), dysgeusia.
• Tachycardia (accelerated heart rate)
• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
• Pruritus (itching)
• Urination disorder
• Asthenia (lack of strength), excessive sweating, discomfort.

Very Rare(may affect up to 1 in 10,000 people)

• Hypersensitivity
• Inappropriate antidiuretic hormone secretion syndrome (SIADH), hyponatremia.
• Visual disturbances (including double vision and blurred vision)
• Hypotension (decreased blood pressure)
• Respiratory failure, apnea, worsening of sleep apnea, worsening of chronic obstructive pulmonary disease (COPD).
• Increased liver transaminases and increased alkaline phosphatase in blood.
• Allergic dermatitis.

Frequency Not Known(cannot be estimated from available data)

• Angioedema, attempted suicide or completed suicide (due to unmasking of pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false perceptions of the senses), dependence, drug abuse, depression (unmasking of pre-existing depression), deception, delirium (false ideas that are believed to be true and cannot be proven), insomnia withdrawal/rebound syndrome (after interrupting treatment, the same symptoms for which it was started appear), agitation, aggression, irritability, restlessness, anger attacks, nightmares, abnormal behavior, emotional disturbances.
• Confusion, psychomotor retardation, decreased level of consciousness, ataxia (alteration of movement coordination), convulsion, tremor, extrapyramidal disturbances.
• Nystagmus (involuntary eye movement)
• Urticaria, exanthema (rash).
• Fatigue, muscle weakness, muscle cramps, hypothermia, paradoxical reactions.

Due to the muscle relaxant effect, there is a risk of falls and consequently fractures in elderly people.

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. Conservation of Lormetazepam Teva

Keep this medicine out of sight and reach of children.

Lormetazepam Teva does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after "CAD or EXP". 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 medicines you no longer need at 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 Teva 1 mg tablets

• The active ingredient is Lormetazepam, 1 mg.

• The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate, magnesium carbonate, and pregelatinized starch (derived from corn).

Appearance of the Product and Package Contents

Lormetazepam Teva is presented in the form of oral tablets. Each package contains 30 tablets. Lormetazepam 1 mg tablets are round, biconvex, white, scored on one side, and marked on the other with the letters Z1. The score serves to divide the tablet into two equal halves.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11,

Albatros Building B, 1st floor,

Alcobendas, 28108, Madrid

Spain

Manufacturer

Teva Pharma, S.L.U.

Malpica Industrial Estate, C/ C, 4.

50016 Zaragoza

Spain

or

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

Huarte-Pamplona (Navarra), Spain

Date of Last Revision of this Prospectus: September 2023

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