Lorazepam Vir 1 mg tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Lorazepam Vir 1 mg tablets
Read the entire patient information leaflet carefully before you start taking this medicine, as it contains important information for you.
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Package leaflet contents:
- What Lorazepam Vir is and what it is used for
- What you need to know before taking Lorazepam Vir
- How to take Lorazepam Vir
- Possible side effects
- How to store Lorazepam Vir
- Contents of the pack and other information
1. What Lorazepam Vir is and what it is used for
Lorazepam Vir 1 mg is an anxiolytic tranquilizer (prevents nervousness and anxiety) that acts without interfering with the individual's normal activities. It appropriately complements antidepressant therapy and may be combined with antidepressant medications and other psychotropic drugs.
Lorazepam Vir 1 mg 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 preanesthesia.
- Sleep disorders.
2. What you need to know before starting to take 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 ingredients of this medicine.
- 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 (temporary pauses in 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 impaired liver function.
- If your doctor has prescribed long-term treatment, periodic blood tests and liver function tests are advisable.
- If you become pregnant during treatment, inform your doctor immediately.
- Its use is not recommended in children under 6 years of age.
Children
Benzodiazepines are not recommended for use in children under 6 years of age unless strictly necessary; treatment duration should be as short as possible.
Dependence
Continuous use of benzodiazepines over several weeks may lead to a certain loss of efficacy regarding hypnotic effects. It may also lead to dependence. This occurs mainly after prolonged, uninterrupted use of the medicine. To minimize this risk as much as possible, the following instructions should be observed:
- Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients), and you should never recommend them to others.
- Do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.
- Consult your doctor regularly so they can decide whether treatment should continue.
- Treatment duration should be as short as possible.
- Discontinuation of treatment should be gradual, following your doctor's instructions.
The use of lorazepam together with opioid-type medicines may cause profound sedation, respiratory depression, coma, and death.
Tolerance
After continuous use for several weeks, a certain degree of reduced efficacy regarding hypnotic effects may be observed.
Amnesia
Benzodiazepines may cause amnesia. This is more likely to occur several hours after administration of the medicine; therefore, to reduce the associated risk, patients should ensure they 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, which requires careful monitoring in such patients.
Other medicines and Lorazepam Vir
Inform your doctor or pharmacist if you are using, have recently used, 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 with other medicines that act on the CNS, the combination may make you feel more drowsy than usual. These medicines include:
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Medicines used to treat mental disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
- Medicines used to relieve severe pain and analgesics
- strong analgesics, medicines for substitution therapy (treatment of opioid addiction), and some cough medicines (narcotic analgesics and opioids). The use of lorazepam together with opioid-type medicines increases the risk of drowsiness, difficulty breathing (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 dosage 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.
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Medicines used to treat seizures/epileptic attacks (antiepileptic medicines).
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Anaesthetic medicines.
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Barbiturate medicines (sedatives).
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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-asthma, bronchodilators).
Taking Lorazepam Vir 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 breastfeeding
Consult your doctor or pharmacist before using any medicine.
Pregnancy:
Inform your doctor if you are or plan 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. Passage of benzodiazepines and their metabolites across the placenta has been observed.
If, on medical advice, the medicine is administered during late pregnancy or at high doses during labor, effects on the newborn such as hypoactivity, hypothermia (decreased body temperature), hypotonia (reduced muscle tone), apnea (periods of no breathing), moderate respiratory depression, feeding difficulties, and metabolic imbalance in response to cold stress may be expected.
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.
Breastfeeding
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 newborns whose mothers were being treated with benzodiazepines. These newborns should be monitored for any of the pharmacological effects mentioned (sedation and irritability).
Use in children, elderly, and debilitated patients:
Benzodiazepines are not recommended for use in children under 6 years of age unless strictly necessary; treatment duration should be as short as possible. Elderly and debilitated patients should receive a lower dose, as they are more susceptible to the drug's effects.
Use in patients with respiratory insufficiency
Lower doses are recommended 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 use of machines
Lorazepam may impair your ability to drive or operate machinery, as it may 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.
Important information about some of the ingredients of Lorazepam Vir
This medicine does not contain lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Lorazepam Vir
Follow exactly the administration instructions given by your physician. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the duration of your treatment. Do not stop treatment prematurely, as it may not achieve the desired effect.
The recommended dose in adults is ½ or 1 tablet (0.5 or 1 mg of lorazepam) 2 to 3 times daily, meaning 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, at the physician'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 have, contact your doctor or pharmacist immediately or contact the Toxicology Information Service at telephone: 915 620 420.
The most frequent symptoms of intoxication are: excessive drowsiness, confusion, or coma.
Treatment of overdose includes induction of 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 should be exercised when administering flumazenil to patients who take benzodiazepines chronically, as this combination of drugs may increase the risk of seizures.
If you forget to take Lorazepam Vir
Do not take a double dose to make up for missed doses.
If you stop taking Lorazepam Vir
When administration is discontinued, the symptoms that led to taking the medicine may reappear, as well as 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 (detachment 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 precisely instruct you on how to gradually reduce the dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.
The adverse effects listed below are categorized according to their frequency in treated patients:
Very common: Affects at least 1 in 10 patients
Common: Affects at least 1 in 100 patients
Uncommon: Affects at least 1 in 1,000 patients
Rare: Affects at least 1 in 10,000 patients
Very rare: Affects less than 1 in 10,000 patients
Frequency not known: Cannot be estimated from available data
Blood and lymphatic system disorders
Frequency not known: Thrombocytopenia (reduced blood platelets), agranulocytosis (reduction in neutrophils, a type of white blood cell), and pancytopenia (marked reduction in all blood cells).
Immune system disorders
Frequency not known: Hypersensitivity and anaphylactic/anaphylactoid (allergic) reactions.
Endocrine disorders
Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.
Metabolism and nutrition disorders
Frequency not known: Hyponatremia (low sodium levels).
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, aggression, rage, sleep disturbances/insomnia, increased sexual desire, and hallucinations.
Nervous system disorders
Very common: Sensation of breathlessness
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.
Vascular disorders
Frequency not known: Hypotension (low 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 may cause airway obstruction and can be fatal), skin allergic reactions, alopecia (hair loss).
Frequency not known: Skin allergic 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: Sensation of breathlessness
Common: Asthenia (weakness, fatigue)
Frequency not known: Hypothermia (decreased body temperature)
Investigations
Frequency not known: Increased bilirubin, increased transaminases, and increased alkaline phosphatase (liver enzymes).
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 effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Package contents and additional information
Composition of Lorazepam Vir
- The active substance is lorazepam.
- The other components are: microcrystalline cellulose, talc and magnesium stearate.
Appearance of the medicinal product and contents of the pack
Lorazepam Vir 1 mg is available in cartons 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 most recent revision of this leaflet: March 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/