LORAZEPAM VIR 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lorazepam Vir 1 mg tablets

Contents of the pack:

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

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

Lorazepam Vir 1 mg is a tranquilizer-anxiolytic (prevents nervousness and anxiety) that acts without influencing the normal activities of the individual. It complements antidepressive therapy and can be combined with antidepressant medications and other psychotropic drugs.

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 pre-anesthesia.

-Sleep disorders.

2. What you need to know before taking Lorazepam Vir

Do not take Lorazepam Vir:

• If you are allergic to the active substance, to benzodiazepines (the group of medicines to which lorazepam belongs) or to any of the other components of this medicine.
• 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 or troublesome breathing).
• If you have sleep apnea (breathing stop for short periods of time 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 altered liver function.
• If your doctor has prescribed you 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 in children under 6 years of age unless strictly necessary; the duration of treatment should be as short as possible.

Dependence

The continued use of benzodiazepines for several weeks can lead to some loss of efficacy with respect to hypnotic effects. It can also lead to dependence. This mainly occurs after uninterrupted use of the medicine 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 been effective in other patients) and never recommend them to other people.
• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• Consult your doctor regularly so that he decides if the treatment should be continued.
• The duration of the treatment should be as short as possible.
• The interruption of the treatment should be done gradually, according to the instructions indicated by your doctor.

The use of lorazepam together with opioid-type medications can 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 can induce amnesia. This fact occurs more frequently after several hours after the administration of the medicine, so, to reduce the associated risk, patients should ensure that they sleep uninterruptedly for 7-8 hours after taking the tablet.

Psychiatric and paradoxical reactions

In the 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.

Other medicines and Lorazepam Vir

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines.

It should be taken into account that all benzodiazepines produce depressant effects on the CNS (central nervous system) if administered together with barbiturates or alcohol.

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

• Drugs used for the treatment of mental disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
  • Drugs used to relieve strong pain and potent analgesics
  • Medicines for substitution therapies (treatment of opioid addiction) and some cough medicines (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 the recommended dose of your doctor. It may be helpful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

• Drugs used for the treatment of seizures/epileptic attacks (antiepileptic drugs).
• Anesthetic drugs.
• Barbituric drugs (sedatives).
• Drugs used for the treatment of allergies (antihistamines).

Similarly, the concomitant administration of lorazepam with other medicines can alter the effect of lorazepam by prolonging or decreasing 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 Vir with food, drinks, and alcohol

Lorazepam can be taken with and 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:

Tell your doctor if you are or plan to become pregnant.

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

If the product is administered during a late phase of pregnancy, or at high doses during delivery, it is foreseeable that effects on the newborn 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 due to cold may appear.

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 medicine 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).

Use in children, elderly, and debilitated patients:

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

It is recommended to use lower doses 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.

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 ability. 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.

Important information about some of the components of Lorazepam Vir

This medicine does not contain lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lorazepam Vir

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

Your doctor will indicate the duration of your treatment. Do not stop treatment before, as it may not have 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 needs or age of the patient and at the doctor's discretion.

If you take more Lorazepam Vir than you should

Although intoxication with benzodiazepines 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 drowsiness, confusion, or coma.

Treatment of overdoseincludes induction of vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and adequate control of the patient. 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 can increase the risk of seizures.

If you forget to take Lorazepam Vir

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

If you stop taking Lorazepam Vir

When stopping the administration, the symptoms that led you to take the medicine may reappear, as well as restlessness, muscle pain, anxiety, tension, unease, confusion, and irritability, insomnia, lack of concentration, headache, sweating, depression, rebound phenomena, depersonalization (disconnection from reality), dizziness, derealization (unreal or unknown perception of the immediate environment), 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 doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are described according to their frequency of appearance 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

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 (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, unmasking 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: Feeling of suffocation.

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

Frequency not known: Extrapyramidal symptoms: tremors, dysarthria (difficulty articulating words), headache, convulsions; 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.

Vascular disorders

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

Respiratory, thoracic, and mediastinal disorders

Frequency not known: Respiratory failure, apnea, worsening of sleep apnea.

Worsening of chronic obstructive pulmonary disease (COPD).

Gastrointestinal disorders

Uncommon: Nausea.

Frequency not known: Constipation.

Hepatobiliary disorders

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

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 skin reactions, alopecia (hair loss).

Frequency not known: Allergic skin reactions, alopecia (hair loss).

Musculoskeletal and connective tissue disorders

Common: Muscle weakness.

Reproductive system and breast disorders

Uncommon: Impotence.

General disorders and administration site conditions

Very common: Feeling of suffocation.

Common: Asthenia (fatigue, tiredness)

Frequency not known: Hypothermia (decrease in body temperature)

Investigations

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

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 suffer is serious 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lorazepam Vir

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton, after “EXP”. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the cartons and any remaining medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Lorazepam Vir Composition

• The active ingredient is lorazepam.
• The other components are: microcrystalline cellulose, talc, and magnesium stearate.

Product Appearance and Packaging Content

Lorazepam Vir 1 mg is presented in boxes containing 25, 30 or 50 tablets

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

28923 Alcorcón (Madrid), Spain

Date of the Last Revision of this Leaflet:March 2022.

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