Lorazepam CINFA 1 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
lorazepam cinfa 1 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet; 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What lorazepam cinfa is and what it is used for
- What you need to know before taking lorazepam cinfa
- How to take lorazepam cinfa
- Possible adverse effects
- Storage of lorazepam cinfa
Pack contents and additional information
1. What lorazepam cinfa is and what it is used for
lorazepam cinfa 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 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, anxiety related to surgical and/or diagnostic procedures, and pre-anesthesia.
Sleep disorders.
2. What you need to know before taking lorazepam cinfa
Do not take lorazepam cinfa
- If you are allergic to lorazepam, to benzodiazepines (the group of medicines to which lorazepam belongs), or to any of the other ingredients of this medicine (listed in section 6).
- If you have been diagnosed with myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak or fatigued muscles).
- If you suffer from severe respiratory insufficiency (difficulty breathing or severe chest discomfort).
- If you have sleep apnea (temporary cessation of breathing during sleep).
- If you have a severe liver disease.
Warnings and precautions
Talk to your doctor or pharmacist before starting lorazepam cinfa:
- 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.
- Use in children under 6 years of age is not recommended.
Dependence
Continuous use of benzodiazepines for several weeks may lead to a certain loss of effectiveness regarding hypnotic effects. It may also lead to dependence. This is particularly likely when the medicine is taken continuously for a long period.
To minimize this risk, the following instructions should be observed:
- Benzodiazepines should only be taken under medical prescription (never because they worked for other patients), and you should never recommend them to others.
- Do not increase the dose prescribed by your doctor, nor extend the treatment beyond the recommended duration.
- Consult your doctor regularly so they can decide whether treatment should continue.
- The duration of treatment should be as short as possible.
- Discontinuation of treatment should be gradual, according to your doctor's instructions.
- The use of lorazepam together with opioid medicines may cause profound sedation, respiratory depression, coma, and death.
Tolerance
After continuous use for several weeks, a certain degree of reduced effectiveness regarding hypnotic effects may be observed.
Amnesia
Benzodiazepines may induce amnesia. This is more common several hours after taking the medicine; therefore, to reduce the associated risk, patients should ensure they can sleep uninterrupted for 7–8 hours after taking the tablet.
Psychiatric and paradoxical reactions
When using benzodiazepines, pre-existing depression may reappear or worsen. In addition, suicidal tendencies in depressed patients may be masked and should therefore be closely monitored.
Other medicines and lorazepam cinfa
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.
It should be noted that all benzodiazepines produce depressant effects on the CNS (central nervous system) when administered together with barbiturates or alcohol.
When lorazepam is taken with other medicines acting on the CNS, the combination may make you feel excessively drowsy. These medicines include:
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Medicines used to treat mental illnesses (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
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Medicines used to relieve severe pain and 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 medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.
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However, if your doctor prescribes lorazepam together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
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Inform your doctor about all opioid medicines you are taking and closely follow your doctor’s dosing 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 or epileptic fits (antiepileptic medicines).
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Anaesthetics and barbiturates (sedatives).
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Medicines used to treat allergies (antihistamines).
In addition, 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-asthmatic, bronchodilators).
Taking lorazepam cinfa 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:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
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 demonstrated.
If, on medical advice, the product is administered during late pregnancy or at high doses during delivery, effects on the newborn such as hypoactivity, hypothermia (decreased body temperature), hypotonia (reduced muscle tone), apnea (periods without breathing), moderate respiratory depression, feeding difficulties, and metabolic imbalance in response to cold stress may be expected.
Infants born to mothers who have taken benzodiazepines chronically for several weeks during pregnancy or during the last stage 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 neonates 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 patients, and debilitated patients
Benzodiazepines are not recommended for 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 risk of respiratory depression, such as in patients with chronic obstructive pulmonary disease (COPD) or sleep apnea syndrome.
Driving and using 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.
lorazepam cinfa contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
lorazepam cinfa contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.
3. How to take lorazepam cinfa
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The tablet may be divided into equal doses.
Your doctor will determine the duration of your treatment. Do not stop treatment prematurely, as it may not achieve the desired effect.
Anxiety:
The recommended initial dose for anxiety states is 0.5 to 3 mg daily, divided into several doses, administered orally, with or without food. This dose may be increased or decreased according to the patient's needs or age, at the discretion of the physician.
The duration of treatment should be as short as possible. Your doctor should regularly reevaluate your condition. In general, the total duration of treatment should not exceed 8–12 weeks, including gradual withdrawal.
Insomnia:
Treatment should begin with the lowest recommended dose: 1 mg as a single dose at bedtime, gradually increasing until an effective dose is achieved. The maximum dose of 4 mg must not be exceeded.
In general, the duration of treatment should be as short as possible, ranging from a few days up to two weeks, with a maximum duration of four weeks, including gradual withdrawal of the medication. Your doctor will indicate the dose you should take at each stage.
In certain cases, it may be necessary to extend treatment beyond the recommended period; such a decision can only be made by your doctor.
Use in children
There are no data available in children (under 6 years of age), and therefore, lorazepam is not recommended for use in young children.
Use in elderly patients
In elderly patients, the recommended dose is half a tablet (0.5 mg) per day, which may be gradually adjusted if necessary.
Use in patients with kidney problems
In patients with kidney impairment, the recommended dose is half a tablet (0.5 mg) per day, which may be gradually adjusted if necessary.
Use in patients with liver problems
In patients with liver impairment, the recommended dose is half a tablet (0.5 mg) per day, which may be gradually adjusted if necessary.
If you take more lorazepam cinfa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Telephone: 91 562 04 20), indicating the medication and the amount ingested.
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 may increase the risk of seizures.
If you forget to take lorazepam cinfa
Take your tablet as soon as you remember. Do not take a double dose to make up for missed doses.
If you stop taking lorazepam cinfa
When administration is discontinued, the symptoms that led to starting the medication may reappear, along with 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 give you precise instructions on how to gradually reduce the dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects described below are listed according to their frequency of occurrence:
Very common: May affect more than 1 in 10 people.
Common: May affect up to 1 in 10 people.
Uncommon: May affect up to 1 in 100 people.
Rare: May affect up to 1 in 1,000 people.
Very rare: May affect up to 1 in 10,000 people.
Frequency not known | Cannot be estimated from the 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 reactions (allergic).
Endocrine disorders
Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.
Metabolism and nutrition disorders
Frequency not known: Hyponatremia (lack of sodium).
Psychiatric disorders
Frequent: Confusion, depression, emergence of depression.
Uncommon: Change in libido (sexual desire), decreased orgasms.
Frequency not known: Disinhibition, euforia, suicidal thoughts and attempts, paradoxical reactions such as anxiety, agitation, excitement, hostility, aggressiveness, rage, sleep disturbances/insomnia, increased sexual desire, and hallucinations.
Nervous system disorders
Very frequent: Sensation of breathlessness.
Frequent: 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 disorder.
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 (decreased 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 which can be fatal), skin allergic reactions, alopecia (hair loss).
Musculoskeletal and connective tissue disorders
Frequent: Muscle weakness.
Reproductive system and breast disorders
Uncommon: Impotence.
General disorders and administration site conditions
Very frequent: Sensation of breathlessness.
Frequent: Asthenia (fatigue and tiredness).
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.
Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Lorazepam cinfa storage
Do not store at temperatures above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of lorazepam cinfa
- The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
- The other components are: monohydrate lactose, microcrystalline cellulose (E-460), sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.
Appearance of the product and contents of the pack
lorazepam cinfa is presented as white, cylindrical, biconvex tablets, scored on one side and marked with the code "L1" on the other.
It is packaged in PVC-PVDC/Aluminum blisters.
Each pack contains 25, 50, or 500 tablets (hospital pack).
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) -Spain
Date of the most recent review of this leaflet: July 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68477/P_68477.html
QR code to: https://cima.aemps.es/cima/dochtml/p/68477/P_68477.html