LORAZEPAM CINFA 1 mg TABLETS

2. What you need to know before taking lorazepam cinfa

Do not take lorazepam cinfa

• If you are allergic to lorazepam, benzodiazepines (the group of medications to which lorazepam belongs), or any of the other components of this medication (listed in section 6).
• 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 breathing or severe chest discomfort).
• If you have sleep apnea (pauses in breathing for short periods while sleeping).
• If you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take lorazepam cinfa:

• If you have altered liver function.
• If your doctor has prescribed 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.

Dependence

Continuous 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 usually occurs mainly after uninterrupted use of the medication for a long time.

To minimize this risk, 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 recommended to other people.
• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• Regularly consult your doctor to decide if treatment should be continued.
• The duration of treatment should be as short as possible.
• Discontinuation of treatment should be done gradually, according to the instructions indicated by your doctor.
• The use of lorazepam with opioid-type medications can cause deep sedation, respiratory depression, coma, and death.

Tolerance

After continuous use for several weeks, some degree of loss of efficacy with respect to hypnotic effects may be detected.

Amnesia

Benzodiazepines can induce amnesia. This fact occurs more frequently several hours after administration of the medication, so to minimize the associated risk, patients should ensure they sleep uninterruptedly for 7-8 hours after taking the tablet.

Psychiatric and paradoxical reactions

In 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 medications and lorazepam cinfa

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

When lorazepam is taken with other medications that act on the CNS, the combination can make you feel more drowsy than necessary. These medications include:

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

• Medications used to relieve strong pain and potent analgesics, medications for substitution therapy (treatment of opioid addiction), and some medications for cough (narcotic analgesics and opioids). The use of lorazepam 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 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 your doctor's dose recommendation. It may be helpful to inform friends or family members so they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.
• Medications used to treat convulsions or epileptic seizures (antiepileptic medications).
• Anesthetics and barbiturates (sedatives).
• Medications used to treat allergies (antihistamines).

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

• Clozapine (treatment of schizophrenia).
• Valproate (treatment of epilepsy and bipolar disorders).
• Probenecid (treatment of gout).
• Theophylline or aminophylline (anti-asthmatics, bronchodilators).

Taking lorazepam cinfa 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:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

If, on medical recommendation, the product is administered during a late stage of pregnancy or at high doses during childbirth, it is foreseeable that effects on the newborn such as hypoactivity, hypothermia (drop 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 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 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 patients, 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 patients and debilitated patients should receive a lower dose, as they are more susceptible to the effects of the medication.

Use in patients with respiratory failure

Lower doses are recommended 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 capacity. 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.

lorazepam cinfa contains lactose.

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

lorazepam cinfa contains sodium.

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

3. How to take lorazepam cinfa

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

The tablet can be divided into equal doses.

Your doctor will indicate the duration of your treatment. Do not stop treatment before it is finished, as it may not have the desired effect.

Anxiety:

The recommended initial dose in anxiety states is 0.5 to 3 mg per day, divided into several doses, 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.

The duration of treatment should be as short as possible. Your doctor should regularly reassess your situation. 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 in a single dose at bedtime, gradually increasing until the effective dose is achieved. The maximum dose should not exceed 4 mg.

In general, the duration of treatment should be as short as possible, ranging from a few days 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 time.

In certain cases, it may be necessary to prolong treatment beyond the recommended period; this decision can only be made by your doctor.

Use in children

There is no data available in children (under 6 years of age), and therefore, the prescription of lorazepam is not recommended for young children.

Use in elderly patients

In elderly patients, the recommended dose is half a tablet (0.5 mg) per day, which can be gradually adjusted if necessary.

Use in patients with kidney problems

In patients with kidney problems, the recommended dose is half a tablet (0.5 mg) per day, which can be gradually adjusted if necessary.

Use in patients with liver problems

In patients with liver problems, the recommended dose is half a tablet (0.5 mg) per day, which can be gradually adjusted if necessary.

If you take more lorazepam cinfa than you should

In case of overdose or accidental ingestion, consult 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 poisoning are: excessive drowsiness, confusion, or coma.

Treatment of overdose includes induction of vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and proper patient control. Flumazenil can be used as an antidote. In patients who take benzodiazepines chronically, special care should be taken when administering flumazenil, as this combination of medications can 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 forgotten doses.

If you stop taking lorazepam cinfa

When stopping the administration, the symptoms that led to the taking of the medication 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, 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 body 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.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects are described in relation 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.

Disorders of the Blood and Lymphatic System

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).

Disorders of the Immune System

Frequency not known: Hypersensitivity and anaphylactic/anaphylactoid reactions (allergic).

Endocrine Disorders

Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.

Metabolic and Nutritional Disorders

Frequency not known: Hyponatremia (lack of sodium).

Psychiatric Disorders

Common: Confusion, depression, unmasking of depression.

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

Frequency not known: Disinhibition, euphoria, suicidal thoughts and attempts, paradoxical reactions such as anxiety, agitation, excitement, hostility, aggression, fury, sleep disturbances/insomnia, sexual desire, and hallucinations.

Disorders of the Nervous System

Very common: Feeling of suffocation.

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

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

Ocular Disorders

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

Disorders of the Ear and Labyrinth

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).

Disorders of the Skin and Subcutaneous Tissue

Frequency not known: Angioedema (swelling under the skin of the tongue, glottis, or larynx that can cause respiratory obstruction that can be fatal), allergic skin reactions, alopecia (hair loss).

Musculoskeletal and Connective Tissue Disorders

Common: Muscle weakness.

Disorders of the Reproductive System and Breast

Uncommon: Impotence.

General Disorders and Administration Site Conditions

Very common: Feeling of suffocation.

Common: Asthenia (fatigue and tiredness).

Frequency not known: Hypothermia (decrease in body temperature).

Investigations

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

As previously indicated, withdrawal of the product may cause the reappearance of certain symptoms as a consequence of dependence.

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

5. Conservation of Lorazepam Cinfa

Do not store at a temperature above 25°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the drains or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lorazepam Cinfa

• The active ingredient is lorazepam. Each tablet contains 1 mg of lorazepam.
• The other components are: lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the Product and Package Contents

Lorazepam Cinfa is presented in the form of white, cylindrical, biconvex tablets, scored on one side and marked with the code "L1" on the other.

It is presented in PVC-PVDC/Aluminum blisters.

Each package contains 25, 50, or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:July 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). 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