LORAZEPAM PENSA 1 mg TABLETS

2. What you need to know before taking Lorazepam Pensa

Do not take Lorazepam Pensa:

• If you are allergic to lorazepam or any of the other components of this medication (listed in section 6).
• If you are allergic to benzodiazepines (the group of medications to which lorazepam belongs).
• If you have been diagnosed with Myasthenia Gravis (an autoimmune neuromuscular disease characterized by very weak or tired muscles).
• If you have severe respiratory failure (difficult breathing or severe chest discomfort).
• If you have sleep apnea (pauses in breathing for short periods while sleeping).
• If you have a severe liver disease.

Warnings and Precautions

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

• If you have altered liver function.
• If your doctor has prescribed prolonged treatment, it is advisable to have periodic blood tests and liver function tests.
• If you become pregnant during treatment, you should inform your doctor.
• It is not recommended for use in children under 6 years of age.

Children

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

Tolerance

After continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.

Dependence

Continuous use of benzodiazepines for several weeks may lead to some loss of efficacy with respect to hypnotic effects. It may also lead to dependence. This usually occurs mainly after uninterrupted use of the medication for a long time. To prevent this risk as much as possible, the following instructions should be taken into account:

• The use of benzodiazepines will only be done under medical prescription(never because they have worked for other patients) and never recommend them to other people.
• Do not increase the prescribed dosesin any way, nor prolong the treatment for longer than recommended.
• Regularly consult your doctor so that they can decide whether to continue treatment.
• The interruption of treatment should be done gradually, according to the instructions indicated by your doctor.

• The duration of treatment should be as shortas possible.
• The use of lorazepam together with opioid-type medications can cause deep sedation, respiratory depression, coma, and death.

Amnesia

Benzodiazepines can induce amnesia. This occurs more frequently after several hours after administration of the medication, so to reduce the associated risk, patients should ensure they sleep uninterruptedly for 7-8 hours after taking the tablet.

Psychiatric and Paradoxical Reactions

In treatment with benzodiazepines, pre-existing depressions or worsening of the depressive state may reappear. Additionally, suicidal tendencies in depressive patients may be masked, which should be monitored in these patients.

Elderly and Debilitated Patients

Elderly and debilitated patients should receive a lower dose since they are more susceptible to the effects of the drug.

Use in Patients with Respiratory Failure

Lower doses are recommended in patients with chronic respiratory failure due to the associated risk of respiratory depression, such as in patients with chronic obstructive pulmonary disease (COPD) or sleep apnea syndrome.

Other Medications and Lorazepam Pensa

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

It should be noted that all benzodiazepines produce depressant effects on the central nervous system (CNS), if administered together with barbiturates or alcohol. When lorazepam is taken with other medications that act on the CNS, the combination can make you feel more drowsy than expected. These medications include:

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

• Drugs used to relieve strong pain and potent analgesics, medications for substitution therapy (treatment of opioid addiction), and some medications for cough (narcotic analgesics and opioids). The use of lorazepam together with opioid-type medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes lorazepam together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all opioid medications you are taking and closely follow your doctor's dose recommendation. It may be helpful to inform friends or family members so they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.
• Drugs used to treat seizures/epileptic attacks (antiepileptic medications).
• Anesthetic drugs.
• Barbiturate drugs (sedatives).
• Drugs used to treat allergies (antihistamines).

Similarly, the concomitant administration of lorazepam with other medications may alter the effect of lorazepam, prolonging or decreasing its activity. These medications 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 can be taken with or without food.

Alcohol increases the sedative effect of this medication, so it is recommended to avoid consuming alcoholic beverages.

Pregnancy and Breastfeeding

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

Pregnancy:

Discuss with your doctor if you are or plan to become pregnant.

The use of benzodiazepines appears to be related to a possible increased risk of congenital malformations in the first trimester of pregnancy. It has been detected that benzodiazepines and their derivatives pass through the placenta.

If the product is administered during late pregnancy or at high doses during labor, it is foreseeable that effects on the newborn may appear, such as hypoactivity, hypothermia (decrease in body temperature), hypotonia (decrease in muscle tone), apnea (period of lack of breathing), moderate respiratory depression, feeding problems, and metabolic response imbalance to stress from cold.

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

Breastfeeding:

This medication should not be used during breastfeeding, as benzodiazepines are excreted in breast milk. Cases of sedation and inability to breastfeed have been detected in newborns whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect any of the mentioned pharmacological effects (sedation and irritability).

Driving and Using Machines

Lorazepam may alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Lorazepam Pensa contains Lactose and Sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to Take Lorazepam Pensa

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment. Do not suspend treatment before, as it may not have the desired effect.

The recommended dose in adults is half a tablet or 1 tablet (0.5 or 1 mg of lorazepam) 2 to 3 times a day, which means a maximum of 3 mg of lorazepam, administered orally, with or without food. This dose may be increased or decreased according to the needs or age of the patient, and at the discretion of the doctor.

If you take more Lorazepam Pensa than you should

Although intoxication with benzodiazepines is very rare, if you have taken more lorazepam than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Phone: 91 562 04 20.

The most frequent symptoms of intoxication are excessive drowsiness, confusion, or coma.

Treatment of overdose includes induction of vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and adequate patient control. Flumazenil may be used as an antidote. In patients who take benzodiazepines chronically, special care should be taken when administering flumazenil, as this combination of drugs may increase the risk of seizures.

If you forget to take Lorazepam Pensa

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

If you interrupt treatment with Lorazepam Pensa

When stopping administration, the symptoms that led you to take the medication may reappear, as well as restlessness, muscle pain, anxiety, tension, unease, confusion, and irritability, insomnia, lack of concentration, headache, sweating, depression, rebound phenomena, derealization (unreal or unfamiliar perception of the immediate environment), dizziness, depersonalization (disconnection from reality), involuntary movements, nausea, vomiting, diarrhea, loss of appetite, tremors, abdominal cramps, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia (excessive stimulation), short-term memory loss, and hyperthermia (increase in body temperature), so your doctor will indicate precisely how to gradually decrease the dose.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people experience them.

The following side effects are described 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 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)

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 platelets), agranulocytosis (decrease in neutrophils, a type of white blood cell), and pancytopenia (significant decrease in all blood cells).

Immune System Disorders

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

Endocrine Disorders

Frequency not known: Inappropriate antidiuretic hormone secretion syndrome.

Metabolism and Nutrition Disorders

Frequency not known: Hyponatremia (lack of sodium).

Psychiatric Disorders

Common: Confusion, depression, unveiling of depression.

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

Frequency not known: Disinhibition, euphoria, suicidal ideas and attempts, paradoxical reactions such as anxiety, agitation, excitement, hostility, aggression, fury, sleep disturbances/insomnia, sexual desire, and hallucinations.

Nervous System Disorders

Very common: Sedation, drowsiness.

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

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

Eye Disorders

Frequency not known: Visual problems (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 can produce a blockage of the airways that can be fatal), allergic reactions on the skin, 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, withdrawal of the product may cause the reappearance of certain symptoms due to the development of dependence.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package 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 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 Lorazepam Pensa

Do not store above 25°C.

Keep this medication out of 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Lorazepam pensa

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

Appearance of the Product and Container Content

Lorazepam pensa is presented in the form of white, cylindrical, biconvex, scored tablets, marked with the code “L1”. They can be divided into equal halves.

Each container 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 Last Revision of this Prospectus:December 2020

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