LORMETAZEPAM 1 mg Tablets

2. What you need to know before taking Lormetazepam Pensa

N

Be especially careful with Lormetazepam Pensa

• Lormetazepam Pensa 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.

Tolerance

• After continuous use for several weeks, a certain degree of loss of efficacy regarding the hypnotic effects may be detected.

Dependence

• Lormetazepam Pensa may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also higher in patients with a history of drug or alcohol abuse. The abrupt cessation of treatment may be accompanied by withdrawal symptoms, such as headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability. Follow your doctor's instructions for administering Lormetazepam Pensa exactly to avoid these symptoms as much as possible.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of the symptoms that led to the initiation of treatment). This episode may be accompanied by other reactions, such as mood changes, anxiety, or sleep disorders and restlessness. The likelihood of a withdrawal/rebound syndrome is higher after abruptly stopping treatment, so it is recommended to gradually decrease the dose until its definitive suppression. Follow your doctor's recommendations for use and administration instructions for Lormetazepam Pensa exactly to avoid these symptoms as much as possible.

Amnesia

• Lormetazepam Pensa may induce anterograde amnesia, i.e., difficulty remembering recent events. To minimize this risk, you should ensure that you can sleep uninterrupted for 7-8 hours (see section "4. Possible Side Effects").

Psychiatric and paradoxical reactions

• Lormetazepam Pensa may produce restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate 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 Pensa if these reactions appear.
• A pre-existing depression may be masked during treatment with Lormetazepam. In these patients, there is a risk of suicide (see section "4. Possible Side Effects").

Use of other medications

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

The effect of Lormetazepam Pensa may be enhanced when administered concomitantly with the following medications:

• Antipsychotics (neuroleptics, medications used to treat psychiatric disorders)
• Hypnotics (medications that improve sleep onset and duration)
• Anxiolytics/sedatives (medications used to treat anxiety)
• Antidepressants (medications used to treat depression)
• Narcotic analgesics (certain medications that reduce pain). With these medications, an increased sensation of euphoria may also occur, which can increase psychological dependence
• Antiepileptics (medications used to treat epilepsy)
• Anesthetics (medications used generally in surgical interventions to reduce pain and/or consciousness)
• Sedating antihistamines (medications used primarily to treat allergic symptoms)
• Calcium antagonists (medications used to treat cardiovascular diseases)
• Oral contraceptives (medications used to prevent pregnancy)
• Certain antibiotics (medications used to treat certain infections)
• Levodopa and its combinations (medication for the treatment of Parkinson's disease)

If you are taking other medications, consult your doctor.

Use of Lormetazepam Pensa with food and beverages

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be enhanced when the product is administered in combination with alcohol; therefore, it is recommended to avoid the use of alcoholic beverages. This should be particularly taken into account as 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 medication.

As a general precaution, you should not use Lormetazepam during pregnancy, childbirth, or breastfeeding.

If you are being treated with Lormetazepam and want to become pregnant or suspect that you are pregnant, consult your doctor so that they can explain how to stop treatment.

If, for strict medical reasons, the medication is administered during the third trimester of pregnancy or at high doses during childbirth, it is likely that effects on the newborn, such as hypothermia, hypotonia, and moderate respiratory depression, may appear.

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

Because benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Use in 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 it by the doctor. Additionally, the duration of treatment should be as short as possible. For more information on the use in patients under 18 years, see section "3. How to take Lormetazepam Pensa".

Use in the elderly

Elderly patients should receive a lower dose than usual. Your doctor will recommend the most suitable dosage. (See section "3. How to take Lormetazepam Pensa").

Important information about some of the components of Lormetazepam Pensa

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

Driving and using machines

Lormetazepam Pensa is a medication that produces sleep. 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 you increase the dose.

3. How to take Lormetazepam Pensa

Follow your doctor's instructions for administering Lormetazepam exactly. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate the duration of your treatment with Lormetazepam. Do not stop treatment before it is completed, as it may not have the desired effect.

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.

Adults

It is recommended to take 1 tablet of Lormetazepam Pensa 1 mg or ½ tablet of the alternative presentation of Lormetazepam Pensa 2 mg, in a single dose.

In cases of severe or persistent insomnia, and always according to medical criteria, the dose may be increased to 2 mg.

Elderly patients

It is recommended to take ½ tablet per day (0.5 mg of Lormetazepam), as a single dose.

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.

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

Induction of sleep in pre- and post-operative periods

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

Adults

It is recommended to take a medium dose of 2 mg of Lormetazepam per day (from 0.5 to 3 mg).

Children

It is recommended to take a dose of 0.5 to 1 mg of Lormetazepam per day (from ½ to 1 tablet of Lormetazepam Pensa 1 mg).

Elderly patients and patients at risk

It is generally recommended to take a dose of 1 mg per day. One hour before the operation, it is recommended to take half of these doses.

A dose reduction should be considered for patients with mild or moderate breathing difficulties or those with liver failure.

If you take more Lormetazepam Pensa than you should

Overdose is not life-threatening unless the administration is combined with other central nervous system depressants (including alcohol). In case of overdose, it should be taken into account 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, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death may occur.

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

When attending a medical center, do not forget to bring this package leaflet.

If you forget to take Lormetazepam Pensa

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

If you stop treatment with Lormetazepam Pensa

When stopping administration, the symptoms that led to the initiation of treatment may reappear, and restlessness, anxiety, insomnia, headache, and sweating may occur, so your doctor will indicate exactly how to gradually decrease the dose. If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Lormetazepam Pensa may cause side effects, although not everyone will experience them.

If the dosage is not adapted to the individual conditions of each patient, side effects due to excessive sedation and muscle relaxation may appear.

The meaning of the frequencies of the side effects shown below is as follows:

Very common:means that it is likely to occur in 1 or more out of every 10 people,

Common:means that it is likely to occur in between 1 and 10 out of every 100 people.

Immune system disorders

Common: Quincke's edema (inflammatory disease affecting the skin and subcutaneous and submucous tissue).

Psychiatric disorders

Common: Anxiety, decreased libido.

Nervous system disorders

Very common: Headache.

Common: Dizziness, sedation, somnolence, attention disorder, amnesia, visual disturbance, speech disorder, dysgeusia, slowed thinking.

Cardiac disorders

Common: Tachycardia.

Gastrointestinal disorders

Common: Vomiting, nausea, upper abdominal pain, constipation, dry mouth.

Skin and subcutaneous tissue disorders

Common: Pruritus.

Renal and urinary disorders

Common: Micturition disorder.

General disorders and administration site conditions

Common: Asthenia, sweating.

For more information on the following points, see section "Be especially careful with Lormetazepam Pensa".

Dependence:

The administration of Lormetazepam (even at therapeutic doses) may induce the development of physical dependence; stopping treatment may induce the development of a withdrawal or rebound phenomenon (see section "Be especially careful with Lormetazepam Pensa"). Psychological dependence may occur. Cases of abuse have been reported.

Psychiatric disorders

• Rebound insomnia (after stopping treatment, the same symptoms for which it was initiated reappear) (see section "Be especially careful with Lormetazepam Pensa").
• Paradoxical psychiatric reactions: When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral changes may occur. These reactions may be severe and occur more frequently in children and the elderly. (See section "Be especially careful with Lormetazepam Pensa").
• Depression: The use of benzodiazepines may mask a pre-existing depression. In these patients, there is a risk of suicide.

Nervous system disorders

• Amnesia: Anterograde amnesia (difficulty remembering recent events) may develop when using therapeutic doses, with a higher risk when increasing the dose. Amnestic effects may be associated with inappropriate behavior (see section "Be especially careful with Lormetazepam Pensa").

Disorders of other organs and systems

With the administration of Lormetazepam Pensa, the following adverse reactions have been reported: daytime somnolence, emotional bluntness, emotional disorder, decreased alertness, confusion, fatigue, headache, vertigo, muscle weakness, ataxia, or double vision. All these effects occur predominantly at the beginning of treatment and usually disappear with repeated administration. Occasionally, jaundice and adverse skin reactions such as urticaria, pruritus, or skin rash have been reported.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting of side effects

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

5. Storage of Lormetazepam Pensa

Keep out of the reach and sight of children.

Lormetazepam Pensa does not require special storage conditions.

Do not use Lormetazepam Pensa after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lormetazepam Pensa

• The active ingredient is lormetazepam. Each tablet contains 1 mg of lormetazepam.
• The other ingredients are: lactose monohydrate, sodium croscarmellose, magnesium stearate, corn starch, povidone K-25.

Appearance of the Product and Package Contents

Lormetazepam Pensa 1 mg tablets are presented in boxes containing blister packs with 30 tablets (standard packaging) and 500 tablets (clinical packaging). The tablets are white, round, and scored on one side. The score line serves to divide the tablet into two equal halves.

Other Presentations:

Lormetazepam Pensa 2 mg tablets, which are presented in boxes containing blister packs with 20 tablets (standard packaging) and 500 tablets (clinical packaging).

Only certain package sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in February 2016