Package Leaflet: Information for the Patient

Lorazepam pensa 5 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

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

2. What you need to know before you start taking Lorazepam pensa

3. How to take Lorazepam pensa

4. Possible side effects

5. Storage of Lorazepam pensa

6. Contents of the pack and additional information

Lorazepamis a tranquilizer-anxiolytic (prevents nervousness and anxiety) that acts without influencing normal activities of the individual. It complements antidepressive therapy appropriately and can be combined with antidepressant medications and other psychopharmaceuticals.

Lorazepam is used in the following cases:

• Treatment atshort-termfor all states of anxiety and tension, associated or not with functional or organic disorders, including anxiety associated with depression and that linked to surgical and/or diagnostic procedures, and in preanesthesia.
• Sleep disorders.

Do not take Lorazepam pensa:

• If you are allergic to lorazepam or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to benzodiazepines (a 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 insufficiency (difficult breathing or severe chest discomfort).
• If you have sleep apnea (temporary stoppage of breathing 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 liver function impairment.
• If your doctor has prescribed a long-term treatment, it is recommended that they perform periodic blood tests and liver function tests (liver).
• If you become pregnant during treatment, inform your doctor.
• It is not recommended for use in children under 6 years old.

Children:

Benzodiazepines are not recommended for children under 6 years old unless absolutely necessary. The duration of treatment should be the minimum 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 a certain loss of efficacy with respect to hypnotic effects. It may also lead to dependence. This is mainly due to uninterrupted long-term use of the medication. To minimize this risk, follow the instructions below:

• Benzodiazepines should be takenonly under medical prescription(never because they have worked for other patients) and never advise others to take them.
• Do not increase the prescribed doses, nor prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if treatment should be continued.
• Treatment should be discontinued in agradualmanner, according to the instructions indicated by your doctor.

• The duration of treatment should be asshortas possible.
• Use of lorazepam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.

Amnesia:

Benzodiazepines may induce amnesia. This occurs more frequently after several hours have passed since the administration of the medication, so patients should ensure they sleep uninterrupted for 7-8 hours after taking the tablet.

Psychiatric and paradoxical reactions:

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

Older adults and debilitated patients:

Older adults and debilitated patients should receive a lower dose as they are more susceptible to the effects of the medication.

Use in patients with respiratory insufficiency:

It is recommended to use lower doses in patients with chronic respiratory insufficiency 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 taken recently, or may need to take any other medication.

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

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

• Medications used to relieve strong pain and potent analgesics, medication for addiction therapy (opioid addiction treatment) and some cough medications (narcotic analgesics and opioids). The use of lorazepam with opioid-type medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may 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 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 follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
• Medications used to treat seizures/epileptic attacks (antiepileptic medications).
• Anesthetic medications.
• Barbiturate medications (sedatives).
• Medications used to treat allergies (antihistamines).

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

• Clozapine (treatment of schizophrenia).
• Valproate (treatment of epilepsy and bipolar disorders).

• Probenecid (treatment of gout).
• Theophylline or aminophylline (antiasmatic, bronchodilator medications).

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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

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

The use of benzodiazepines appears to be related to a possible increase in the risk of congenital malformations in the first trimester of pregnancy. Benzodiazepines and their derivatives have been detected passing through the placenta.

If, on medical advice, the product is administered during a late stage of pregnancy, or at high doses during delivery, it is predictable that they may cause effects on the newborn such as hyporeactivity, hypothermia (decrease in body temperature), hypotonia (muscle tone decrease), apnea (period of lack of breathing), moderate respiratory depression, feeding problems, and metabolic response imbalance to cold stress.

Children born to mothers who take benzodiazepines chronically for several weeks during 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 neonates whose mothers were under benzodiazepine treatment. These newborns should be monitored to detect any of the pharmacological effects mentioned (sedation and irritability).

Driving and operating machinery:

Lorazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease attention, or decrease reaction time. The appearance of these effects is 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 medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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

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

Your doctor will indicate the duration of your treatment. Do not discontinue treatment beforehand, as it may not achieve the desired effect.

The recommended dose in adultsis half a tablet or 1 tablet (0.5 or 1 mg of lorazepam) 2 to3 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 patient's needs or age, and at the doctor's discretion.

If you take more Lorazepam pensa than you should

Although benzodiazepine overdose is very rare, if you have taken more lorazepamthan you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service. Phone: 91 562 04 20.

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

Overdose treatmentincludes inducing vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and proper patient control. Flumazenil may be used as an antidote. In patients taking benzodiazepines chronically, special care should be taken when administering flumazenil, as this association of medications may increase the risk of seizures.

If you forgot to take Lorazepam pensa

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

If you discontinue treatment with Lorazepam pensa

Upon discontinuation, the symptoms that led to taking the medication may reappear, as well as restlessness, muscle pain, anxiety, tension, unease, confusion, irritability, insomnia, lack of concentration, headache, sweating, depression, rebound phenomena, derealization (perception of the immediate environment as unreal or unknown), 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 the body's internal 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.

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

The following side effects are described according to their frequency of appearance in patients treated:

Very commonin at least 1 in 10 patients.

Commonin at least 1 in 100 patients.

Uncommonin at least 1 in 1,000 patients.

Rarein at least 1 in 10,000 patients.

Very rareless than 1 in 10,000 patients.

Frequency not knowncannot be estimated from available data.

General disorders and administration site conditions

Very common: Dyspnea (shortness of breath).

Common: Fatigue (asthenia).

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: Icterus (yellowing of the whites of the eyes and skin).

Haematological 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 reactions and anaphylactic/anaphylactoid reactions (allergic).

Endocrine disorders

Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.

Metabolism and nutrition disorders

Frequency not known: Hyponatremia (sodium deficiency).

Mental and behavioural disorders

Common: Confusion, depression, depression unmasked.

Uncommon: Decreased 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, somnolence.

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

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

Eye disorders

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

Ear and labyrinth disorders

Frequency not known: Vertigo.

Reproductive and breast disorders

Uncommon: Impotence.

Respiratory, thoracic and mediastinal disorders

Frequency not known: Respiratory insufficiency, 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 cause respiratory tract obstruction that 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 mentioned earlier, 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 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 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.

Do not store at a temperature above 30ºC .

Keep this medication out of the 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lorazepam pensa

- The active ingredient is lorazepam. Each tablet contains 5 mg of lorazepam.

- The other components (excipients) are:monohydrate lactose, microcrystalline cellulose (E-460), sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and content of the packaging:

Lorazepam pensais presented in the form of white, cylindrical, biconvex, scored, and with logo L5 on one of the faces. It can be divided into two equal halves.

Each package contains 20 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)

Spain

Date of the last review of this leaflet:December 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/