Package Leaflet: Information for the User

Lormetazepam Teva 1 mg Tablets EFG

Read this leaflet carefully before you start to take 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.

Lormetazepam Tevacontains 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 a severe disorder, which limits the patient's activity or subjects them to a situation of significant stress.

Do not use Lormetazepam Teva

• If you are allergic to the active ingredient, to benzodiazepines, or to any of the other components of this medication (listed in section 6).
• If you have myasthenia gravis (very weak or tired muscles).
• If you have severe respiratory failure (for example, severe chronic obstructive pulmonary disease).
• If you have sleep apnea (temporary stop in breathing while sleeping).
• In case of acute intoxication with alcohol, sleep medications, 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 long-term treatment, it is recommended that they perform periodic blood tests and liver function tests.
• If you become pregnant during treatment, you must inform your doctor.
• Do not recommend its use in children or adolescents.

If you are being treated with opioids, as it may 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

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

To minimize this risk, please take the following precautions:

• The taking of benzodiazepines will be done only under medical prescription (never because they have been effective in other patients) and never advise others.
• Do not increase, at all, the doses prescribed by the doctor, or prolong the treatment 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 to decide if treatment should continue.

Rebound insomnia and anxiety

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

The abrupt discontinuation of lormetazepam should be avoided and a gradual reduction of the dose should be followed.

Amnesia

Benzodiazepines, including Lormetazepam Teva, may induce amnesia (memory alteration). To minimize this risk, ensure that you will be able to sleep without interruption for 7-8 hours (see section “4. Possible adverse reactions”).

Psychiatric and paradoxical reactions

In the treatment with benzodiazepines, including Lormetazepam Teva, pre-existing depressions may reappear or the depressive state may worsen. Additionally, they may unmask suicidal tendencies in depressed 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 related medications should be reserved for patients for whom alternative treatment options are not possible. If you are prescribed lormetazepam concomitantly with opioids, use the lowest effective dose and the shortest duration of treatment possible.

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

Other medications and Lormetazepam Teva

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

The concomitant use of lormetazepam with opioids (analgesics, medication for substitution therapy, and some antitussives) increases the risk of somnolence, respiratory difficulty (respiratory depression), coma, and may put your life at risk. Due to this, concurrent administration should only be considered when alternative treatments are not possible.

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

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

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

Certain medications may interact with Lormetazepam Teva and make you feel more drowsy than usual. These are 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, barbiturates, 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, prolonging or decreasing its activity.

The effect of muscle relaxants may be potentiated.

Taking Lormetazepam Teva with food, drinks, and alcohol

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

Pregnancy and lactation

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

Pregnancy

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

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

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

Lactation

Lormetazepam Teva should not be used during lactation, 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 pharmacological effects mentioned (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 patients and debilitated patients

Elderly patients 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 relaxation effect, there is a risk of falls and subsequent fractures in elderly patients, especially in patients who get up at night.

Patients with severe renal insufficiency

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

Use in patients with respiratory insufficiency

Lormetazepam is contraindicated in patients with severe respiratory insufficiency.

Use in patients with liver insufficiency

Lormetazepam Teva should be used with caution in patients with severe liver insufficiency and/or encephalopathy.

Loss or bereavement

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

Driving and operating machinery

Lormetazepam Teva is a sleep medication. 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 Teva contains lactose

If your doctor has indicated 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; 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.

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

The treatment should start with the lowest doses and should not exceed the maximum dose.

The recommended dose is 1 mg of lormetazepam per day (1 Lormetazepam Teva tablet) 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 per day (2 Lormetazepam Teva 1 mg tablets).

Use in children and adolescents

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

Older adults, debilitated patients, or patients with cerebral vascular disorders (arteriosclerosis), mild to moderate respiratory insufficiency, and/or renal and/or hepatic insufficiency

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 insufficiency, see section 2.

Do not stop treatment abruptly. Your doctor will indicate the precise way to gradually reduce the dose, as stopping the administration may cause the symptoms that led to the use of the medication to reappear.

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

• The use of benzodiazepines should be made only under medical prescription (never because they have worked in other patients) and never advise them to other people.
• Do not increase the doses prescribed by the doctor at all, nor prolong the treatment longer than recommended.
• Consult the doctor regularly so that they decide whether to continue treatment.

The treatment duration should be as short as possible. In general, it varies between a few days and two weeks, with a maximum period of four weeks, including the gradual dose reduction period.

If you take more Lormetazepam Teva than you should

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

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma.

In moderate cases, symptoms include drowsiness, confusion, lethargy, and dysarthria (language disorders). In more serious cases, ataxia (coordination disorder of movements), paradoxical reactions, central nervous system depression, visual disturbances, hypotonia (muscle tone decrease), hypotension (low blood pressure), respiratory depression (respiratory difficulties), cardiac depression, rarely coma, and very rarely death may appear.

Treatment of overdose

The clinical management of any medication overdose should always take into account the possibility that the patient has ingested multiple products.

After a benzodiazepine overdose, vomiting should be induced (before one hour) if the patient remains conscious. Vomiting should not be induced if there is a risk of aspiration. If the patient is unconscious, gastric lavage should be performed with airway conservation. If gastric lavage does not provide any benefit, 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 (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 taking benzodiazepines chronically or in cases of overdose with cyclic 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 compensate for the missed doses.

If you stop treatment with Lormetazepam Teva

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

If you stop taking lormetazepam, especially if it is done abruptly, changes in mood, anxiety, insomnia, and restlessness, lack of concentration, headaches, and sweating, among others, may appear, so your doctor will indicate the precise way to gradually reduce the dose until you complete your treatment.

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

According to frequencies, they are defined as:

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

- Headache

Frequent(may affect up to 1 in 10 people)

- Anxiety, decreased libido (sexual desire) and bradypsychia.

- Dizziness, sedation, somnolence (drowsiness), altered attention, amnesia, dysarthria (slurred speech), dysgeusia.

- Tachycardia (acceleration of heartbeats)

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

- Pruritus (itching)

- Urinary tract disorder

- Asthenia (lack of strength), excessive sweating, discomfort.

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

-Hypersensitivity

-Syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatremia.

-Visual problems (including double vision and blurred vision)

-Hypotension (decreased blood pressure)

-Respiratory insufficiency, apnea, worsening of sleep apnea, worsening of chronic obstructive pulmonary disease (COPD).

-Increased liver transaminases and increased alkaline phosphatase in blood.

-Allergic dermatitis.

Unknown frequency(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), withdrawal/rebound insomnia syndrome (after interrupting treatment, the same symptoms appear for which treatment was initiated), agitation, aggression, irritability, restlessness, anger attacks, nightmares, abnormal behavior, emotional alterations.

- Confusion, psychomotor delay, decreased level of consciousness, ataxia (alteration of movement coordination), convulsion, tremor, extrapyramidal alterations.

- Nystagmus (involuntary eye movement)

- Urticaria, exanthema (rash).

- Fatigue, muscle weakness, muscle cramps, hypothermia, paradoxical reactions.

Due to the muscle relaxation effect, there is a risk of falls and subsequent 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 System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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.

Lormetazepam Teva does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after “CAD or EXP”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 cornstarch.

Appearance of the product and content of the packaging

Lormetazepam Teva is presented in the form of oral tablets. Each package 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.Thescore serves to divide the tablet into two equal halves.

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid

Spain

Responsible for manufacturing

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4.

50016 Zaragoza

Spain

or

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Industrial Area Areta

Huarte-Pamplona (Navarra)- Spain

Last review date of this leaflet: September 2023

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