Leaflet: information for the user

Lormetazepam pensa 1 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, as 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 similar symptoms, 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.

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

2. What you need to know before taking Lormetazepam Pensa

3. How to take Lormetazepam Pensa

4. Possible side effects

5. Storage of Lormetazepam Pensa

6. Contents of the pack and additional information

Lormetazepam Pensa is a medication from the group of hypnotics that promotes sleep: normalizes the time needed to fall asleep and its total duration, while reducing the number of interruptions of the same.

It is indicated for:

• Treatment of short duration insomnia.
• Induction of sleep in pre and postoperative periods.

Lormetazepam Pensa belongs to a group of hypnotic medications called benzodiazepines. Benzodiazepines are only indicated for the treatment of an intense disorder, which limits the patient's activity or subjects them to an important stress situation.

Do not take Lormetazepam Pensa

• if you have myasthenia gravis (a disease characterized by an abnormal degree of 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 respiratory arrest that occur during sleep),
• in case of acute intoxication with alcohol, hypnotics, analgesics, or medications that act on the central nervous system (neuroleptics, antidepressants, lithium),
• if you have severe liver insufficiency,
• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of Lormetazepam Pensa.

Be especially careful with Lormetazepam Pensa

• if you have chronic respiratory insufficiency, as you should receive a lower dose than usual,
• if you have severe renal insufficiency,
• Lormetazepam Pensa should not be used as first-line treatment for psychiatric disease or as a single treatment for anxiety or sleep disorders associated with depression.

Tolerance

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

Dependence

• Lormetazepam Pensa may induce the appearance of 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 substance abuse or alcohol consumption. Abrupt termination of treatment may be accompanied by withdrawal symptoms, such as headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability. Follow exactly the administration instructions for Lormetazepam Pensa indicated by your doctor, in order to avoid, as much as possible, the appearance of these symptoms.

Rebound insomnia and anxiety

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

Amnesia

• Lormetazepam Pensa may induce anterograde amnesia, that is, difficulty remembering recent events. To reduce this risk, you should ensure that you can sleep without interruption for 7-8 hours (see section "4. POSSIBLE ADVERSE EFFECTS").

Psychiatric and paradoxical reactions

• Lormetazepam Pensa may produce restlessness, agitation, irritability, aggression, delirium, anger attacks, 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 suspend treatment with Lormetazepam Pensa if these reactions appear.
• A previous depression before treatment with Lormetazepam Pensa may be masked during treatment with Lormetazepam. In these patients, there is a risk of suicide (see section "4. POSSIBLE ADVERSE EFFECTS").

Use of other medications

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

A potentiating effect of Lormetazepam Pensa may be produced when administered concomitantly with the following medications:

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

Consult your doctor if you are taking other medications.

Use of Lormetazepam Pensa with food and beverages

Benzodiazepines should be used with extreme caution in patients with a history of substance abuse or alcohol consumption. The sedative effect may be potentiated when the product is administered in combination with alcohol, so it is recommended to avoid the use of alcoholic beverages. This should be taken into account especially since it affects the ability to drive or operate machinery (see section "Driving and operating machines").

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

If you are being treated with Lormetazepam and want to become pregnant or suspect that you are, consult your doctor to explain how you should 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 predictable that there may be effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression.

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.

Due to the fact that benzodiazepines pass into breast milk, their use is contraindicated in lactating 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. In addition, the duration of treatment should be the minimum possible. For more information on 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 indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Driving and operating machines

Lormetazepam Pensa is a medication that produces sleep. Do not drive or operate machines 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.

Follow exactly the administration instructions for lormetazepam indicated by your doctor. Consult your doctor or pharmacist if you have doubts. Remember to take your medication.

Your doctor will indicate the duration of your treatment with lormetazepam. Do not discontinue 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. Generally, it varies between a few days and two weeks, with a maximum period, including a gradual dose reduction, of four weeks.

The tablets should be taken with a small amount of liquid a little before going to bed.

Adults

It is recommended to administer 1 lormetazepam Pensa 1 mg tablet or ½ 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 can be increased to 2 mg.

Older adults

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

In older adults, 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 estimate that the action 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 administer a medium/daily dose of 2 mg of lormetazepam (from 0.5 to 3 mg).

Children

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

Older adults and patients at risk

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

Consider reducing the dose for patients with mild or moderate respiratory difficulties or for patients with liver insufficiency.

If you take more lormetazepam Pensa than you should

Overdose does not represent a vital threat unless its administration is combined with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient has ingested multiple products.

Overdosing with benzodiazepines generally manifests itself by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, ataxia (alteration of movement coordination), hypotonia (muscle tone decrease), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death may appear.

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

In case of assistance at a care center, do not forget to bring this prospectus.

If you forgot to take lormetazepam Pensa

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

If you interrupt treatment with lormetazepam Pensa

Upon cessation of administration, the symptoms that led to the use of the medication may reappear, including restlessness, anxiety, insomnia, headaches, and sweating, so your doctor will indicate precisely how to gradually reduce the dose.

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

Like all medicines, Lormetazepam Pensa can cause side effects, although not everyone will experience them.

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

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

Very common:means that it is likely to occur in1 or more of every 10 people,

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

Immune system disorders

Common:Angioedema (inflammatory disease that affects the skin and subcutaneous and submucosal tissue).

Mental and behavioral disorders

Common:Anxiety, decreased libido (sexual desire).

Nervous system disorders

Very common: Headache.

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

Cardiac disorders

Common:Tachycardia (acceleration of heartbeats).

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

Common:Pruritus (itching).

Renal and urinary disorders

Common:Urination disorder.

General disorders and administration site conditions

Common:Weakness, sweating.

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

Dependence:

The administration of Lormetazepam (even at therapeutic doses) may induce the development of physical dependence; withdrawal of treatment may induce the development of a withdrawal or rebound phenomenon (see section “Be careful with Lormetazepam Pensa”). It may produce psychological dependence. Cases of abuse have been reported.

Mental and behavioral disorders

• Rebound insomnia (after interrupting treatment, the same symptoms appear for which it was initiated) (see section “Be careful with Lormetazepam Pensa”).
• Psychiatric and paradoxical reactions: When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium (false ideas that are believed to be true and cannot be proven), outbursts of anger, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), inappropriate behavior, and other changes in behavior may appear. These reactions may be severe and appear more frequently in children and the elderly. (see section “Be careful with Lormetazepam Pensa”).
• Depression: The use of benzodiazepines may mask an existing depression. In these patients, suicides may be triggered.

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 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 numbness, emotional disorder, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (alteration of movement coordination) or double vision. These effects appear predominantly at the beginning of treatment and usually disappear with repeated administration. Occasionally, jaundice (yellow discoloration of mucous membranes and skin) and skin reactions such as urticaria, pruritus, or skin rash have been reported.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the reach and sight of children.

Lormetazepam Pensa does not require special conditions for conservation.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.in case of doubt preguest your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lormetazepam Pensa

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

Appearance of the product and contents of the packaging

Lormetazepam Pensa 1 mg tablets are presented in boxes containing blister packs with 30 tablets (standard pack) and 500 tablets (clinical pack). The tablets are white, round, and scored on one side. The score 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 pack) and 500 tablets (clinical pack).

Only some pack sizes may be marketed.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in February 2016