Package Leaflet: Information for the User

Lorazepam Vir 1 mg Tablets

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

2. What you need to know before taking Lorazepam Vir

3. How to take Lorazepam Vir

4. Possible side effects

5. Storage of Lorazepam Vir

6. Contents of the pack and additional information

Lorazepam Vir 1 mg is 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 Vir 1 mg is used in the following cases:

-Short-term treatment of all anxiety and tension states, 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 Vir:

- If you are allergic to the active ingredient, to benzodiazepines (the group of medications to which lorazepam belongs) or to any of the other components of this medication.

- 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 Vir

- If you have liver function impairment.

- If your doctor has prescribed a prolonged treatment, it is recommended that they perform periodic blood tests and liver function tests (liver function).

- If you become pregnant during treatment, inform your doctor.

- Lorazepam is not recommended for 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.

Dependence

The continued 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 the uninterrupted intake of the medication for a long time. To prevent this risk as much as possible, the following instructions should be taken into account:

- The intake of benzodiazepines will be madeonly under medical prescription(never because they have been effective in other patients) and never recommend them to others.

- Do not increase the prescribed dosesby the doctor, nor prolong the treatment longer than recommended.

- Consult your doctor regularly so that they can decide whether to continue treatment.

- The duration of treatment should be the shortestpossible.

- The interruption of treatment should be made in agradualway, according to the instructions indicated by your doctor.

The use of lorazepam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.

Tolerance

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

Amnesia

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

Psychiatric and paradoxical reactions

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

Other medications and Lorazepam Vir

Inform your doctor or pharmacist if you are using, have used recently, or may need to take other medications.

All benzodiazepines produce depressive effects on the CNS (central nervous system) if administered together 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).
• - Strong pain-relieving medications and analgesics
• potent, medications for addiction treatment (opioid addiction treatment) and some medications for cough (narcotic analgesics and opioids). The use of lorazepam with opioid-type medications increases the risk of sedation, respiratory depression, coma, and may be potentially fatal. Therefore, 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 the opioid medications you are taking and follow your doctor's dose recommendation 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).

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 Vir 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

Consult your doctor or pharmacist before using any 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, according to medical recommendation, the product is administered during a late stage of pregnancy, or at high doses during delivery, it is predictable that they may appear effects on the newborn such as hyporeactivity, 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 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 since benzodiazepines are excreted in breast milk. Cases of sedation and inability to breastfeed have been detected in neonates whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect any of the pharmacological effects mentioned (sedation and irritability).

Use in children, elderly, and debilitated patients:

Benzodiazepines are not recommended for children under 6 years old unless absolutely necessary; the duration of treatment should be the minimum possible. The elderly and debilitated patients should receive a lower dose since 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.

Driving and operating machinery

Lorazepam may alter your ability to drive or operate machinery since it may cause drowsiness, decrease your attention, or decrease your 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.

Important information about some of the components of Lorazepam Vir

This medication does not contain lactose.

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

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

Your doctor will inform you of the duration of your treatment. Do not discontinue treatment beforehand, as it may not produce the desired effect.

The recommended dose in adults is ½ 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 patient's needs or age and at the doctor's discretion.

If you take more Lorazepam Vir than you should

Although benzodiazepine intoxication is very rare, if you have taken more Lorazepam Vir than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 915 620 420.

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

Treatment of overdoseincludes 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 combination of medications may increase the risk of seizures.

If you forgot to take Lorazepam Vir

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

If you interrupt treatment with Lorazepam Vir

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 inform you precisely how to gradually decrease the dose.

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

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

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

Very commonAt least 1 in 10 patients

CommonAt least 1 in 100 patients

UncommonAt least 1 in 1,000 patients

RareAt least 1 in 10,000 patients

Very rareLess than 1 in 10,000 patients

Frequency unknown Cannot be estimated from available data

Blood and lymphatic system disorders

Frequency unknown: Thrombocytopenia (decrease in blood platelets), agranulocytosis (decrease in neutrophils, a type of white blood cell), and pancitopenia (significant decrease in all blood cells).

Immune system disorders

Frequency unknown: Hypersensitivity reactions and anaphylactic/anaphylactoid reactions (allergic).

Endocrine disorders

Frequency unknown: Syndrome of inappropriate antidiuretic hormone secretion.

Metabolism and nutrition disorders

Frequency unknown: Hyponatremia (sodium deficiency).

Mental and behavioral disorders

Common: Confusion, depression, depression unmasking

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

Frequency unknown: Disinhibition, euphoria, suicidal ideas and attempts, paradoxical reactions such as anxiety, agitation, excitement, hostility, aggression, fury, sleep alterations/insomnia, sexual desire, and hallucinations.

Nervous system disorders

Very common: Feeling of choking.

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

Frequency unknown:Extrapyramidal symptoms: tremor, dysarthria (difficulty articulating words), headache, convulsions; amnesia, coma, attention/concentration alterations, balance disorder.

Eye disorders

Frequency unknown: Visual problems (double vision and blurred vision).

Ear and labyrinth disorders

Frequency unknown: Vertigo.

Vascular disorders

Frequency unknown: Hypotension (decreased blood pressure).

Respiratory, thoracic, and mediastinal disorders

Frequency unknown: Respiratory insufficiency, apnea, worsening of sleep apnea.

Worsening of chronic obstructive pulmonary disease (COPD).

Gastrointestinal disorders

Uncommon: Nausea.

Frequency unknown: Constipation.

Hepatobiliary disorders

Frequency unknown: Icterus (yellowing of the white of the eye and skin).

Skin and subcutaneous tissue disorders

Frequency unknown: 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).

Frequency unknown: Skin allergic reactions, alopecia (hair loss).

Musculoskeletal and connective tissue disorders

Common: Muscle weakness.

Reproductive and breast disorders

Uncommon: Impotence.

General disorders and administration site conditions

Very common: Feeling of choking.

Common: Asthenia (fatigue, tiredness)

Frequency unknown: Hypothermia (decrease in body temperature)

Investigations

Frequency unknown: Increase in bilirubin, increase in transaminases, and increase in alkaline phosphatase (liver enzymes).

As mentioned earlier, withdrawal of the product may cause the reappearance of certain symptoms as a result of the development of dependence.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects 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:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight 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.

No special storage conditions are required.

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 unused packaging and medications. By doing so, you will help protect the environment..

Composition of Lorazepam Vir

- The active ingredient is lorazepam.

- The other components are: microcrystalline cellulose, talc, and magnesium stearate.

Appearance of the product and content of the packaging

Lorazepam Vir 1 mg is presented in boxes containing 25 or 50 tablets

Holder of the marketing authorization and responsible for manufacturing

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Industrial Park Urtinsa II

28923 Alcorcón (Madrid), Spain

Date of the last review of this leaflet:March 2022.

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