Lormetazepam Teva 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lormetazepam Teva 1 mg tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Lormetazepam Teva is and what it is 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 disturbances that significantly impair the patient's daily activities or cause considerable stress.

2. What you need to know before using Lormetazepam Teva

Do not use 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 suffer from severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease).
• If you have sleep apnea (temporary breathing stops during sleep).
• In case of acute intoxication with alcohol, sleeping medications, pain relievers, or psychotropic medicines (neuroleptics, antidepressants, lithium salts).

Warnings and precautions

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

If any of the following apply to you, inform your doctor. Your doctor will take them 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 long-term treatment, periodic blood tests and liver function tests are advisable.
• If you become pregnant during treatment, you must inform your doctor.
• Use in children and adolescents is not recommended.
• If you are being treated with opioids, as this may cause breathing difficulties, sedation, coma, and even death.

Please be aware that you may experience the following reactions:

Tolerance

After continuous use for several weeks, a certain degree of reduced effectiveness regarding hypnotic effects may occur.

Dependence and abuse

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

To minimize this risk as much as possible, the following precautions should be observed:

• Benzodiazepines should only be taken under medical prescription (never because they worked in other patients), and you should never recommend them to others.
• Do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended time.
• In patients with a history of drug and/or alcohol abuse, there may be potential for medication abuse.
• Consult your doctor regularly so they can decide whether treatment should continue.

Rebound insomnia and anxiety

When treatment is stopped, symptoms that led to taking the medicine may reappear, along with mood changes, anxiety, insomnia, restlessness, and others. Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

Abrupt discontinuation of lormetazepam should be avoided, and a gradual dose reduction process should be followed.

Amnesia

Benzodiazepines, including Lormetazepam Teva, may cause amnesia (memory impairment). This is more likely to occur several hours after taking the medicine; therefore, to reduce the associated risk, patients should ensure they can sleep uninterrupted for 7–8 hours after taking the tablet.

Psychiatric and paradoxical reactions

During treatment with benzodiazepines, including Lormetazepam Teva, pre-existing depression may reappear or worsen. In addition, suicidal tendencies in depressed patients may be unmasked, which should be closely monitored.

The medicine should be discontinued if these reactions occur.

Risk of concomitant use with opioids

Concomitant use of lormetazepam and opioids may result in sedation, respiratory depression, coma, and death. Due to these risks, concomitant prescription of sedative medicines such as benzodiazepines or opioid-related medicines 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 alert to these symptoms (see “Use of Lormetazepam Teva with other medicines”).

Other medicines and Lormetazepam Teva

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

The concomitant use of lormetazepam with opioids (analgesics, medications for substitution therapy, and some antitussives) increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, co-administration should only be considered when no alternative treatment options are available.

However, if your doctor prescribes lormetazepam together with opioids, the dosage and duration of simultaneous treatment should be strictly limited as directed by your doctor.

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

Alcohol increases the sedative effect of this medicine; therefore, alcohol consumption should be avoided.

Certain medicines may interact with Lormetazepam Teva and make you feel more drowsy than usual. These are medicines known as central nervous system depressants, including those used to treat mental disorders such as antipsychotics (neuroleptics), hypnotics (anxiolytics, sedatives), antidepressants; those used to relieve severe pain (analgesics, narcotics), drugs used to treat seizures/epileptic attacks (antiepileptic drugs), anesthetic medicines, barbiturates, and medicines used to treat allergies (sedating antihistamines).

The concomitant administration of lormetazepam with other medicines such as theophylline or aminophylline, beta-blockers, cardiac glycosides, oral contraceptives, and some antibiotics may alter lormetazepam's effect by prolonging or reducing 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 medicine.

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 medicine.

Pregnancy

The use of benzodiazepines, including lormetazepam, appears to be associated with a possible increased risk of congenital malformations during the first trimester of pregnancy. Passage of benzodiazepines and their metabolites across the placenta has been detected.

If administration of the product is required on strict medical grounds during late pregnancy, or at high doses during labour, withdrawal symptoms may occur in the newborn such as hypoactivity (reduced activity), hypothermia (lowered body temperature), hypotonia (weak muscle tone), apnea (temporary absence of breathing), respiratory depression, feeding difficulties, and impaired metabolic response to cold stress.

Infants born to mothers who have taken benzodiazepines chronically for several weeks during pregnancy or in the final stages of pregnancy may develop physical dependence and may experience withdrawal syndrome in the postnatal period.

Breastfeeding

Lormetazepam Teva must not be used during breastfeeding, as benzodiazepines, including lormetazepam, are excreted in breast milk. Cases of sedation and inability to suckle have been reported in newborns whose mothers were receiving benzodiazepine treatment. Such newborns should be monitored for signs of the pharmacological effects mentioned (including sedation and irritability).

Children and adolescents

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

Use in elderly individuals and debilitated patients

Elderly individuals and debilitated patients should receive a reduced 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 individuals, particularly in those who get up during the night.

Patients with severe renal impairment

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

Use in patients with respiratory insufficiency

Lormetazepam is contraindicated in patients with severe respiratory insufficiency.

Use in patients with hepatic impairment

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

Loss or bereavement

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

Driving and using machines

Lormetazepam Teva is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or if you notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

Lormetazepam Teva contains lactose

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

Lormetazepam Teva contains sodium

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

3. How to use Lormetazepam Teva

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

Treatment should begin with the lowest dose, and the maximum dose must not be exceeded.

Adults:

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

The usual dose may be increased at the physician's discretion in cases of severe or persistent insomnia unresponsive to the standard 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 those with cerebrovascular disorders (arteriosclerosis), mild to moderate respiratory insufficiency, and/or renal and/or hepatic impairment

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

For severe respiratory insufficiency, see section 2.

Do not stop treatment abruptly. Your doctor will advise you on the proper way to gradually reduce the dose, as symptoms that led to taking the medicine may reappear upon discontinuation.

The use of benzodiazepines may lead to dependence. This mainly occurs after prolonged, uninterrupted use of the medicine. To minimize this risk as much as possible, the following instructions should be observed:

• Benzodiazepines should only be taken under medical prescription (never because they worked in other patients), and should never be recommended to others.
• Do not increase the prescribed dose or extend treatment beyond the recommended duration.
• Consult your doctor regularly so they can determine whether treatment should continue.

The treatment duration should be as short as possible. Generally, it ranges from a few days to 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915 620 420, indicating the medicine and the amount ingested.

Overdose with benzodiazepines generally manifests as varying 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 serious cases, ataxia (impaired coordination of movements), paradoxical reactions, central nervous system depression, visual disturbances, hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression (breathing difficulties), cardiac depression, rarely coma, and very rarely death may occur.

Treatment of overdose

The clinical management of any drug overdose should always consider the possibility that the patient may have ingested multiple substances.

After a benzodiazepine overdose, vomiting should be induced (within one hour) if the patient is conscious. Inducing vomiting is not recommended if there is a risk of aspiration. If the patient is unconscious, gastric lavage should be performed with airway protection. If gastric emptying is not beneficial, activated charcoal should be administered to reduce absorption.

Special attention should be paid to respiratory and cardiovascular functions. Hospitalization in an intensive care unit may be required for monitoring.

Use of antidote in case of overdose

In hospitalized patients, flumazenil (a benzodiazepine antagonist) may be used as an adjunctive treatment for overdose, but never as a substitute for the methods described above. Particular caution is required when administering flumazenil to patients on chronic benzodiazepine therapy or in cases of overdose involving cyclic antidepressants, as this combination may increase the risk of seizures.

If you forget to take Lormetazepam Teva

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

If you stop taking Lormetazepam Teva

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

If you stop taking lormetazepam, especially abruptly, you may experience mood changes, anxiety, insomnia, restlessness, difficulty concentrating, headache, and sweating, among other symptoms. Therefore, your doctor will precisely instruct you on how to gradually reduce the dose until treatment is completed.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

According to frequency, they are defined as follows:

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 bradylalia.
• Dizziness, sedation, somnolence (drowsiness), attention disturbance, dysarthria (slurred speech), dysgeusia.
• Tachycardia (increased heart rate)
• Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
• Pruritus (itching)
• Urinary disorders
• Asthenia (lack of energy), excessive sweating, malaise.

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

• Hypersensitivity
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatremia.
• Visual disturbances (including double vision and blurred vision)
• Hypotension (decrease in 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, suicide attempt or completed suicide (due to unmasking of pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, drug abuse, depression (unmasking of pre-existing depression), confusion, delirium (false beliefs held as true and impossible to disprove), withdrawal/insomnia rebound syndrome (after stopping treatment, the same symptoms for which treatment was initiated reappear), agitation, aggressiveness, irritability, restlessness, rage attacks, nightmares, abnormal behavior, emotional disturbances.
• Confusion, psychomotor retardation, decreased level of consciousness, ataxia (impaired coordination of movement), convulsion, tremor, extrapyramidal disorders.
• 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 individuals.

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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lormetazepam Teva

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

Lormetazepam Teva does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lormetazepam Teva 1 mg tablets

• The active substance 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 (from corn).

Appearance of the medicine and contents of the pack

Lormetazepam Teva is presented as tablets for oral administration. Each pack contains 30 tablets. Lormetazepam 1 mg tablets are round, biconvex, white tablets, scored on one side and marked on the other with the letters Z1. The score line is intended to facilitate breaking the tablet into two equal parts.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid

Spain

Manufacturer

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

or

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Poligono Industrial Areta

Huarte-Pamplona (Navarra) - Spain

Date of the most recent revision of this leaflet: October 2025

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68373/P_68373.html