Lorazepam Pensa 1 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Lorazepam pensa 1 mg tablets EFG

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

Leaflet contents

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

1. What Lorazepam pensa is and what it is used for

Lorazepam is an anxiolytic tranquilizer (prevents nervousness and anxiety) that acts without interfering with the individual's normal activities. It appropriately complements antidepressant therapy and can be combined with antidepressant medications and other psychotropic drugs.

Lorazepam is used in the following cases:

• Short-term treatment of all states of anxiety and tension, whether associated or not with functional or organic disorders, including anxiety associated with depression, anxiety related to surgical and/or diagnostic procedures, and pre-anesthesia.
• Sleep disorders.

2. What you need to know before starting to take Lorazepam pensa

Do not take Lorazepam pensa:

• If you are allergic to lorazepam or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to benzodiazepines (the group of medicines to which lorazepam belongs).
• If you have been diagnosed with Myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak or fatigued muscles).
• If you have severe respiratory insufficiency (difficulty breathing or severe chest discomfort).
• If you have sleep apnea (short periods of stopped breathing during sleep).
• If you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lorazepam pensa.

• If you have impaired liver function.
• If your doctor has prescribed a long-term treatment, it is advisable to have periodic blood tests and liver function tests (the liver).
• If you become pregnant during treatment, you must inform your doctor.
• Its use is not recommended in children under 6 years of age.

Children

Benzodiazepines are not recommended in children under 6 years of age unless strictly necessary. The duration of treatment should be as short as possible.

Development of tolerance and dependence, withdrawal reactions, and drug/medication abuse

You may experience a reduction in the effectiveness of this medicine (tolerance) after continuous use. This medicine is recommended for short-term treatment only.

Treatment with this medicine also increases sensitivity to the effects of alcohol and other medicines that affect brain activity. Therefore, consult your doctor if you consume alcohol or are using such medicines.

Dependence

The use of benzodiazepines, including Lorazepam pensa, may lead to dependence. The risk of dependence increases with higher doses and prolonged use. It is also increased in individuals with a history of alcohol or drug/medication abuse, and in patients with significant personality disorders.

You should inform your doctor if:

• You have taken or are currently taking any drugs,

• You regularly consume alcohol, or in the past frequently consumed large amounts of alcohol,

• You have previously or currently have a desire to take large amounts of medication,

• You suffer from a personality disorder (e.g., difficulty interacting with other people or coping with certain life situations, even if you were not always aware of these problems).

In principle, benzodiazepines should only be used for short periods and should be discontinued gradually. You and your doctor should agree on how long you will take the medicine before starting treatment.

If you stop taking the medicine suddenly or reduce the dose rapidly, withdrawal reactions may occur. Do not stop taking this medicine abruptly. Seek advice from your doctor on how to discontinue treatment.

Some withdrawal reactions may be potentially life-threatening.

Withdrawal reactions may range from mild depressive mood and insomnia to a severe syndrome with muscle and abdominal cramps, vomiting, sweating, tremors, and seizures. The most severe withdrawal signs and symptoms, including potentially fatal reactions, may include: delirium tremens, depression, hallucinations, mania, psychosis, epileptic seizures, and suicidal tendencies. Seizures/epileptic seizures may be more frequent in patients with pre-existing seizure disorders or in those taking other medicines that lower the seizure threshold, such as antidepressants.

Other withdrawal reactions have also been reported: headache, anxiety, restlessness, tension, confusion, irritability, depressed mood, dizziness, feelings of detachment or alienation from oneself and the external world, heightened perception of noise, tinnitus, tingling and numbness in the extremities, increased sensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, nausea, loss of appetite, diarrhoea, panic attacks, muscle pain, states of excitement, increased awareness of heartbeat (palpitations), rapid heartbeat (tachycardia), sensation of losing balance, exaggerated reflexes, inability to recall recent events, and increased body temperature.

The symptoms for which this medicine was prescribed may also reappear for a brief period (rebound phenomenon).

Do not give lorazepam to family members or friends. Keep this medicine in a safe place so that it does not harm others.

Amnesia

Benzodiazepines may cause amnesia. This is more likely to occur several hours after taking the medicine; therefore, to reduce the associated risk, patients should ensure they can sleep uninterrupted for 7–8 hours after taking the tablet.

Psychiatric and paradoxical reactions

When treating with benzodiazepines, pre-existing depression may reappear or worsen. In addition, suicidal tendencies in depressed patients may be masked and should therefore be closely monitored.

Elderly and debilitated patients

Elderly and debilitated patients should receive a lower dose, as they are more susceptible to the effects of the medicine.

Use in patients with respiratory insufficiency

Lower doses are recommended in patients with chronic respiratory insufficiency due to the risk of respiratory depression, for example in patients with chronic obstructive pulmonary disease (COPD) or sleep apnoea syndrome.

Other medicines and Lorazepam pensa

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

It should be noted that all benzodiazepines produce central nervous system (CNS) depressant effects when administered together with barbiturates or alcohol.

When lorazepam is taken together with other medicines that act on the CNS, the combination may make you feel more drowsy than expected. These medicines include:

• Medicines used to treat mental disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).

• Medicines used to relieve severe pain and strong analgesics, medicines for substitution therapy (treatment of opioid addiction), and some cough medicines (narcotic analgesics and opioids). Using lorazepam together with opioid-type medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are available.

• However, if your doctor prescribes lorazepam together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.

• Inform your doctor about all opioid medicines you are taking and closely follow your doctor’s dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• Medicines used to treat seizures/epileptic attacks (antiepileptic medicines).

• Anaesthetic medicines.

• Barbiturate medicines (sedatives).

• Medicines used to treat allergies (antihistamines).

Likewise, the concomitant administration of lorazepam with other medicines may alter the effect of lorazepam, prolonging or reducing its activity. These medicines include:

• Clozapine (treatment of schizophrenia).

• Valproate (treatment of epilepsy and bipolar disorders).

• Probenecid (treatment of gout).

• Theophylline or aminophylline (anti-asthmatics, bronchodilators).

Taking Lorazepam pensa with food, drinks, and alcohol

Lorazepam may be taken with or without food.

Alcohol increases the sedative effect of this medicine; therefore, consumption of alcoholic beverages is not recommended.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

Inform your doctor if you are pregnant or intend to become pregnant.

The use of benzodiazepines appears to be associated with a possible increased risk of congenital malformations during the first trimester of pregnancy. It has been shown that benzodiazepines and their metabolites cross the placenta.

If, on medical advice, this product is administered during the late stages of pregnancy or at high doses during labor, effects on the newborn may be expected, such as hypoactivity, hypothermia (decreased body temperature), hypotonia (reduced muscle tone), apnea (periods of absent breathing), moderate respiratory depression, feeding difficulties, and impaired metabolic response to cold stress.

Infants born to mothers who have chronically taken benzodiazepines for several weeks during pregnancy or during the final period of pregnancy may develop physical dependence and experience withdrawal symptoms in the postnatal period.

Lactation:

This medicine should not be used during breastfeeding, as benzodiazepines are excreted in breast milk. Cases of sedation and inability to suckle have been reported in neonates whose mothers were undergoing treatment with benzodiazepines. These newborns should be monitored for any of the pharmacological effects mentioned (sedation and irritability).

Driving and Machine Use

Lorazepam may impair your ability to drive or operate machinery, as it can cause drowsiness, reduce attention, or decrease reaction capacity. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Lorazepam Pensa contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

3. How to take Lorazepam pensa

The dose and duration of treatment should be adjusted according to your individual condition. Your doctor will advise you on the appropriate dose, the number of times per day you should take the medicine, and how long you should take it, so that you receive the lowest effective dose for the shortest possible time. Do not change or exceed the prescribed dose. To discontinue treatment, the dose should be gradually reduced after consulting your doctor. This reduces the risk of withdrawal reactions, which may be potentially fatal in some cases (see section 2).

Always follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine how long you should take this medicine. Do not stop treatment prematurely, as it may not achieve the desired effect.

The recommended dose for adults is half a tablet or 1 tablet (0.5 or 1 mg of lorazepam) 2 to 3 times a day, meaning a maximum of 3 mg of lorazepam per day, administered orally, with or without food.

Duration of treatment

Your doctor will determine the duration of your treatment. You will be prescribed the lowest effective dose for the shortest possible time, as there is a risk of becoming addicted (dependent). Your doctor will regularly review your treatment.

Stopping treatment or reducing the dose must be done gradually and under medical supervision to avoid withdrawal reactions (see section 2).

If you take more Lorazepam pensa than you should

Although benzodiazepine overdose is very rare, if you have taken more lorazepam than prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20.

The most common symptoms of overdose are excessive drowsiness, confusion, or coma.

Treatment of overdose includes inducing vomiting or gastric lavage, general supportive measures, adequate respiration, monitoring of vital signs, and appropriate patient management. Flumazenil may be used as an antidote. Special caution must be exercised when administering flumazenil to patients who have been taking benzodiazepines chronically, as this combination may increase the risk of seizures.

If you forget to take Lorazepam pensa

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

If you stop taking Lorazepam pensa

Do not stop taking this medicine abruptly unless you suspect a serious adverse reaction, as the dose must be reduced gradually. Your doctor will advise you on how to discontinue treatment. If you think you are experiencing a serious adverse reaction, speak to your doctor immediately.

If you stop taking this medicine or reduce the dose suddenly, you may experience withdrawal symptoms or temporary rebound symptoms (see section 2).

When treatment is discontinued, the symptoms that led to starting the medicine may reappear, along with restlessness, muscle pain, anxiety, tension, agitation, confusion, irritability, insomnia, difficulty concentrating, headache, sweating, depression, rebound phenomena, derealization (unreal or unfamiliar perception of the immediate environment), dizziness, depersonalization (feeling detached from reality), involuntary movements, nausea, vomiting, diarrhea, loss of appetite, tremor, abdominal cramps, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia (excessive stimulation), short-term memory loss, and hyperthermia (increased internal body temperature). Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects are listed below according to their frequency of occurrence in treated patients:

Very common: at least 1 in 10 patients.

Common: at least 1 in 100 patients.

Uncommon: at least 1 in 1,000 patients.

Rare: at least 1 in 10,000 patients.

Very rare: less than 1 in 10,000 patients.

Frequency not known: cannot be estimated from the available data.

General disorders and administration site conditions

Very common: Feeling of suffocation.

Common: Asthenia (fatigue, tiredness).

Frequency not known: Hypothermia (decrease in body temperature), withdrawal syndrome.

Vascular disorders

Frequency not known: Hypotension (decrease in blood pressure).

Gastrointestinal disorders

Uncommon: Nausea.

Frequency not known: Constipation.

Hepatobiliary disorders

Frequency not known: Jaundice (yellowing of the whites of the eyes and skin).

Blood and lymphatic system disorders

Frequency not known: Thrombocytopenia (decrease in blood platelets), agranulocytosis (decrease in neutrophils, a type of white blood cell), and pancytopenia (marked decrease in all blood cells).

Immune system disorders

Frequency not known: Hypersensitivity and anaphylactic/anaphylactoid reactions (allergic reactions).

Endocrine disorders

Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.

Metabolism and nutrition disorders

Frequency not known: Hyponatremia (lack of sodium).

Psychiatric disorders

Common: Confusion, depression, emergence of depression.

Uncommon: Change in libido (sexual desire), decreased orgasms.

Frequency not known: Disinhibition, euphoria, suicidal thoughts and attempts, paradoxical reactions such as anxiety, agitation, excitement, hostility, aggressiveness, rage, sleep disturbances/insomnia, increased sexual desire, and hallucinations; drug/medication abuse, drug/medication dependence.

Nervous system disorders

Very common: Sedation, somnolence.

Common: Ataxia (motor incoordination and speech problems), dizziness.

Frequency not known: Extrapyramidal symptoms: tremor, dysarthria (difficulty articulating words), headache, seizures, amnesia, coma, attention/concentration disturbances, balance disorders.

Eye disorders

Frequency not known: Visual disturbances (double vision and blurred vision).

Ear and labyrinth disorders

Frequency not known: Vertigo.

Reproductive system and breast disorders

Uncommon: Impotence.

Respiratory, thoracic and mediastinal disorders

Frequency not known: Respiratory failure, apnea, worsening of sleep apnea. Worsening of chronic obstructive pulmonary disease (COPD).

Skin and subcutaneous tissue disorders

Frequency not known: Angioedema (swelling under the skin of the tongue, glottis, or larynx that may cause airway obstruction which can be fatal), skin allergic reactions, alopecia (hair loss).

Musculoskeletal and connective tissue disorders

Common: Muscle weakness.

Investigations

Frequency not known: Increased bilirubin, increased transaminases, and increased alkaline phosphatase (liver enzyme).

As indicated above, discontinuation of the product may lead to the recurrence of certain symptoms due to the development of dependence.

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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Lorazepam pensa

Do not store above 25°C.

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

Do not use this medicine after the expiry date stated on the container 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. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lorazepam pensa

• The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose (E-460), sodium croscarmellose, sodium lauryl sulphate and magnesium stearate.

Nature of the product and contents of the pack

Lorazepam pensa is presented as white, cylindrical, biconvex, scored tablets marked with the code "L1". The tablets can be divided into equal halves.

Each pack contains 25 or 50 tablets in PVC-PVDC/aluminum blisters.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra)

Spain

Date of the most recent review of this leaflet: September 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/