Lormetazepam Pensa 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patientuser

Lormetazepam Pensa 2 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Lormetazepam Pensa is a hypnotic medicine that promotes sleep: it normalizes the time required to fall asleep and the total duration of sleep, while reducing the number of sleep interruptions.

It is indicated for:

• Short-term treatment of insomnia.
• Sleep induction in pre- and post-operative periods.

Lormetazepam Pensa belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's daily activities or cause considerable stress.

2. What you need to know before starting to take Lormetazepam Pensa

Do not take Lormetazepam Pensa

• if you have myasthenia gravis (a disease characterized by the appearance of abnormal muscle weakness),
• if you have severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease),
• if you have sleep apnea syndrome (a condition characterized by brief episodes of breathing cessation occurring during sleep),
• in case of acute intoxication with alcohol, hypnotics, analgesics, or medications acting on the central nervous system (neuroleptics, antidepressants, lithium),
• if you have severe hepatic insufficiency,
• if you are allergic (hypersensitive) to the active substance or to any of the other components of Lormetazepam Pensa.

Special precautions with Lormetazepam Pensa

• if you have chronic respiratory insufficiency, as you should receive a lower than usual dose;
• if you have severe renal impairment;
• Lormetazepam Pensa must not be used as first-line treatment for psychotic illness, nor as monotherapy for anxiety or sleep disorders associated with depression.

Tolerance

• After continuous use for several weeks, a certain degree of reduced efficacy regarding hypnotic effects may be observed.

Dependence

• Lormetazepam Pensa may lead to physical and psychological dependence. The risk of dependence increases with dose and duration of treatment, and is also higher in patients with a history of drug or alcohol abuse. Abrupt discontinuation of treatment may be accompanied by withdrawal symptoms such as headache, muscle pain, marked anxiety, tension, restlessness, confusion, and irritability. Follow exactly the administration instructions for Lormetazepam Pensa provided by your doctor in order to minimize, as much as possible, the occurrence of these symptoms.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient recurrence of the symptoms that led to initiating treatment). This episode may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. The likelihood of developing a withdrawal/rebound syndrome is greater after abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until treatment is completely discontinued. Follow exactly the usage recommendations and administration instructions for Lormetazepam Pensa provided by your doctor in order to minimize, as much as possible, the occurrence of these symptoms.

Amnesia

• Lormetazepam Pensa may cause anterograde amnesia, that is, difficulty in remembering recent events. To reduce this risk, you should ensure that you are able to sleep uninterrupted for 7–8 hours (see section “4. POSSIBLE ADVERSE EFFECTS”).

Psychiatric and paradoxical reactions

• Lormetazepam Pensa may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders causing reduced mental function). Your doctor will discontinue treatment with Lormetazepam Pensa if such reactions occur.
• Pre-existing depression may be masked during treatment with Lormetazepam Pensa. In these patients, there is a risk of suicide (see section “4. POSSIBLE ADVERSE EFFECTS”).

Use of other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might stop using any other medicines, including those obtained without a prescription.

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

• Antipsychotics (neuroleptics, medicines used in the treatment of psychiatric disorders)
• Hypnotics (medicines that improve sleep onset and duration)
• Anxiolytics/sedatives (medicines used to treat anxiety)
• Antidepressants (medicines used to treat depression)
• Opioid analgesics (certain medicines that reduce pain). With these medicines, an increased feeling of euphoria may also occur, which could increase psychological dependence
• Antiepileptics (medicines used in the treatment of epilepsy)
• Anaesthetics (medicines generally used during surgical procedures to reduce pain and/or consciousness)
• Sedating antihistamines (medicines mainly used to treat allergic symptoms)
• Calcium channel blockers (medicines used to treat cardiovascular diseases)
• Oral contraceptives (medicines used to prevent pregnancy)
• Certain antibiotics (medicines used to treat certain infections)
• Levo-dopa and its combinations (a medicine for the treatment of Parkinson's disease)

If you are taking other medicines, consult your doctor.

Use of Lormetazepam Pensa with food and drinks

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol use. The sedative effect may be enhanced when the product is taken together with alcohol; therefore, consumption of alcoholic beverages should be avoided. This is particularly important as it affects the ability to drive or operate machinery (see section “Driving and use of machines”).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

If you are being treated with Lormetazepam and wish to become pregnant or suspect you may be pregnant, consult your doctor, who will advise you on how to discontinue treatment.

If, due to strict medical necessity, the medicine is administered during the third trimester of pregnancy or at high doses during childbirth, effects in the newborn such as hypothermia, hypotonia, and moderate respiratory depression may be expected.

Infants born to mothers who chronically take benzodiazepines during the last trimester of pregnancy may develop physical dependence and experience withdrawal symptoms in the postnatal period.

Since 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 careful medical assessment of the need for such treatment. In addition, the duration of treatment should be as short as possible. For further information on use in patients under 18 years of age, see section “3. HOW TO TAKE LORMETAZEPAM PENSA”.

Use in elderly patients

Elderly patients should receive a lower than the usual dose. Your doctor will recommend the most appropriate dosage regimen. (See section “3. HOW TO TAKE LORMETAZEPAM PENSA”).

Important information about some of the ingredients of Lormetazepam Pensa

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

Driving and use of machines

Lormetazepam Pensa 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 particular attention at the beginning of treatment or when increasing the dose.

3. How to take Lormetazepam Pensa

Follow exactly the dosing instructions for lormetazepam as given by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will indicate how long your treatment with lormetazepam should last. Do not stop treatment prematurely, as it may not achieve the desired effect.

Short-term treatment of insomnia

The duration of treatment should be as short as possible. In general, it ranges from a few days to two weeks, with a maximum period—including gradual dose reduction—of four weeks.

The tablets should be taken with some liquid shortly before going to bed.

Adults

It is recommended to take ½ tablet of Lormetazepam Pensa 2 mg as a single dose.

In cases of severe or persistent insomnia, and always according to medical judgment, the dose may be increased to 2 mg (1 tablet of Lormetazepam Pensa 2 mg).

Elderly patients

A daily dose of ¼ tablet (0.5 mg lormetazepam) as a single dose is recommended.

In elderly individuals, benzodiazepines may be associated with an increased risk of falls due to possible muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will determine the dose best suited to your condition.

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

Induction of sleep in pre- and post-operative periods

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

Adults

A recommended average daily dose of 2 mg lormetazepam (range: 0.5 to 3 mg) is advised.

Children

A recommended dose of 0.5 to 1 mg lormetazepam/day (¼ to ½ tablet of Lormetazepam Pensa 2 mg) is advised.

Elderly patients and patients at risk

A daily dose of 1 mg is generally recommended. One hour before surgery, half of this dose is recommended.

Dose reduction should be considered in patients with mild or moderate breathing difficulties or in those with hepatic insufficiency.

If you take more Lormetazepam Pensa than you should

Overdose is not usually life-threatening unless it is combined with other central nervous system depressants (including alcohol). In cases of overdose, consider the possibility that the patient may have ingested multiple substances.

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, and lethargy; in more severe cases, ataxia (impaired coordination of movement), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death may occur.

In case of accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone 91 562 04 20 immediately, indicating the medication and amount taken.

If you go to a medical facility, do not forget to bring this leaflet with you.

If you forget to take Lormetazepam Pensa

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

If you stop taking Lormetazepam Pensa

When stopping treatment, the symptoms that led to taking the medicine may reappear, and restlessness, anxiety, insomnia, headache, and sweating may occur. Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lormetazepam Pensa may cause adverse effects, although not everyone experiences them.

If the dosage is not adjusted to the individual patient's condition, adverse effects due to excessive sedation and muscle relaxation may occur.

The meaning of the frequencies of the adverse effects listed below is as follows:

Very common: means that 1 or more out of every 10 people are likely to experience them.

Common: means that between 1 and 10 out of every 100 people are likely to experience them.

Immune system disorders

Common: Angioedema (inflammatory condition affecting the skin and subcutaneous and submucosal tissues).

Psychiatric disorders

Common: Anxiety, decreased libido (sexual desire).

Nervous system disorders

Very common: Headache.

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

Cardiac disorders

Common: Tachycardia (increased heart rate).

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

Common: Pruritus (itching).

Renal and urinary disorders

Common: Urinary disturbance.

General disorders and administration site conditions

Common: Asthenia (lack of strength), sweating.

For further information on the following points, see section “Take special care with Lormetazepam Pensa”.

Dependence:

Administration of Lormetazepam (even at therapeutic doses) may lead to physical dependence; discontinuation of treatment may lead to withdrawal or rebound phenomena (see section “Take special care with Lormetazepam Pensa”). Psychological dependence may also occur. Cases of abuse have been reported.

Psychiatric disorders

• Rebound insomnia (after stopping treatment, the same symptoms for which treatment was initiated reappear) (see section “Take special care with Lormetazepam Pensa”).
• Psychiatric and paradoxical reactions: When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggressiveness, delirium (false beliefs accepted as true and impossible to disprove), rage attacks, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate behavior, and other behavioral disturbances may occur. These reactions can be severe and occur more frequently in children and elderly patients (see section “Take special care with Lormetazepam Pensa”).
• Depression: The use of benzodiazepines may mask pre-existing depression. In such patients, suicidal behavior may be triggered.

Nervous system disorders

• Amnesia: Anterograde amnesia (difficulty in remembering recent events) may occur with therapeutic doses, with risk increasing at higher doses. Amnesic effects may be associated with inappropriate behaviors (see section “Take special care with Lormetazepam Pensa”).

Adverse reactions in other organs and systems

The following adverse reactions have been reported with the use of Lormetazepam Pensa: daytime drowsiness, emotional blunting, emotional disturbance, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movement), or double vision. These effects predominantly occur at the beginning of treatment and usually diminish with repeated administration. Jaundice (yellowing of mucous membranes and skin) and cutaneous adverse reactions such as urticaria, pruritus, or skin rash have been reported occasionally.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 via 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 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, 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 Pensa

• The active substance is lormetazepam. Each tablet contains 2 mg of lormetazepam.
• The other components are: monohydrate lactose, sodium croscarmellose, magnesium stearate, maize starch, povidone K-25.

Appearance of the product and contents of the pack

Lormetazepam Pensa 2 mg tablets are presented in boxes containing blister packs with 20 tablets (standard pack) and 500 tablets (clinical pack). The tablets are white, round, and scored on both sides. The score mark is intended to divide the tablet into two equal parts.

Other presentations:

Lormetazepam Pensa 1 mg tablets, presented in boxes containing blister packs with 30 tablets (standard pack) and 500 tablets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible

Kern Pharma, S.L.

Colón II Industrial Estate

C/ Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in February 2016