Package Leaflet: Information for the User

Lormetazepam Cinfa 2 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 cinfa 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 a severe disorder, which limits the patient's activity or subjects them to a situation of significant stress.

Do not take lormetazepam cinfa

Warnings and precautions

Consult your doctor or pharmacist before starting to take lormetazepam cinfa.

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

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.

Amnesia

Benzodiazepines, including lormetazepam, may induce amnesia (memory alteration). This occurs more frequently after several hours of medication administration, so patients should ensure they sleep uninterrupted for 7-8 hours after taking the tablet.

Dependence and abuse

Treatment with benzodiazepines may cause 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 to the maximum, follow these precautions:

• The taking of benzodiazepines will be done only under medical prescription (never because they have worked 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 taking the medication may reappear, as well as mood changes, anxiety, insomnia, restlessness, and others. Your doctor will indicate precisely how togradually reduce the dose.

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

Psychiatric and paradoxical reactions

In the treatment with benzodiazepines, including lormetazepam, 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 suspended if these reactions appear.

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 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 the elderly, especially in patients who get up at night.

Use in patients with respiratory insufficiency

Lormetazepam is contraindicated in patients with severe respiratory insufficiency.

Use in patients with liver insufficiency

Lormetazepam 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.

Concomitant use of lormetazepam cinfa with other medications

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, substitution therapy medications, and some antitussives) increases the risk of somnolence, respiratory difficulty (respiratory depression), coma, and may put your life at risk. Therefore, 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 your doctor's recommendations carefully on dosage. 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 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 (narcotic analgesics), those used to treat seizures/epileptic attacks (antiepileptics), 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 reducing its activity.

The effect of muscle relaxants may be potentiated.

Concomitant use of lormetazepam cinfa with food, beverages, 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 medication is administered during a late stage of pregnancy, or at high doses during delivery, it is predictable that effects may appear on the newborn, such as hyporeactivity, hypothermia, hypotonia (low muscle tone), apnea (respiratory difficulty), moderate respiratory depression, feeding problems, and metabolic response imbalance to cold stress.

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

Lactation

Lormetazepam 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 neonates whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect any of the mentioned pharmacological effects (including sedation and irritability).

Driving and operating machinery

Lormetazepam is a medication that causes sleepiness. 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 cinfa contains lactose

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

Lormetazepam cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) 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.

Your doctor will inform you of the duration of your treatment with lormetazepam. The treatment duration should be as short as possible.

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

Adults

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

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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 (1 lormetazepam 2 mg tablet).

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 0.5 mg of lormetazepam per day.

The tablet can be divided into equal doses.

For severe respiratory insufficiency, see section 2.

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

If you take more lormetazepam cinfa than you should

The symptoms of benzodiazepine overdose generally manifest 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 (involuntary movement coordination disorders), paradoxical reactions, central nervous system depression, hypotonia, hypotension, respiratory depression, (respiratory difficulties), cardiac depression, coma, and 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, inducing vomiting (before one hour) is recommended if the patient remains conscious. Vomiting should not be induced if there is a risk of aspiration. If the patient is unconscious, a gastric lavage with airway conservation should be performed. 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 treatment for 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take lormetazepam cinfa

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

If you stop treatment with lormetazepam cinfa

Do not stop taking lormetazepam until your doctor tells you to.

If you stop taking lormetazepam, especially if you do so abruptly, mood changes, anxiety, insomnia, and restlessness, lack of concentration, headaches, and sweating, among others, may appear.

Your doctor will explain how to gradually reduce the dose until you complete your treatment.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

According to frequencies, they are defined as:

Very Frequent(may affect more than 1 in 10 patients):

Headache.

Frequent(may affect up to 1 in 10 patients):

Anxiety, libido alterations, and bradypsychia. Dizziness, sedation, somnolence, attention alteration, amnesia, dysarthria (slurred speech), dysgeusia. Tachycardia. Vomiting, nausea, upper abdominal pain, constipation, dry mouth. Pruritus. Urination alterations. Asthenia, hyperhidrosis, discomfort.

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

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. Completed suicide, attempted suicide (due to unmasking of a pre-existing depressant), acute psychosis, hallucination, dependence, drug abuse, depression (unmasking of a pre-existing depression), deception, withdrawal/rebound insomnia syndrome, agitation, aggression, irritability, anger, nightmares, confusion state, delirium, abnormal behavior, emotional disorder, psychomotor delay. Low level of consciousness, ataxia, convulsion, tremor, extrapyramidal alterations. Nystagmus (involuntary eye movement). Urticaria, rash. Muscle weakness, muscle cramps. Fatigue, hypothermia, paradoxical reactions.

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

Reporting 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 medication.

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

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

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection 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 cinfa

• The active ingredient is lormetazepam. Each tablet contains 2 mg of lormetazepam.
• The other components are: microcrystalline cellulose (E-460), lactose monohydrate, sodium laurilsulfate, sodium croscarmellose, magnesium stearate, magnesium carbonate (E-504) and pregelatinized cornstarch.

Appearance of the product and content of the packaging

Lormetazepam cinfa 2 mg is presented in the form of white, cylindrical, biconvex, scored tablets on one side and marked with the code “Z2” on the other.

It is presented in PVC-PVDC/Aluminum blisters. Each package contains 20 or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:July 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68372/P_68372.html

QR code to:https://cima.aemps.es/cima/dochtml/p/68372/P_68372.html