LORAZEPAM CINFA 5 mg TABLETS

2. What you need to know before taking lorazepam cinfa

Do not take lorazepam cinfa:

• If you are allergic to lorazepam or any of the other components of this medication (listed in section 6).
• If you have ever had an allergic reaction (hypersensitivity) after taking benzodiazepines (the group of medications to which lorazepam belongs).
• 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 uncomfortable breathing).
• If you have sleep apnea (pauses in breathing while sleeping).
• If you have severe liver disease.
• If you are undergoing simultaneous treatment with opioids, barbiturates, neuroleptics, or similar medications.

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 regarding hypnotic effects. It can also lead to dependence. This usually occurs mainly after uninterrupted use of the medication 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 worked for other patients) and never recommended to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment longer than recommended.
• Consult your doctor regularly so that they can decide whether to continue treatment.
• The duration of treatment should be as short as possible.
• Treatment interruption should be done gradually, according to the instructions indicated by your doctor.

Tolerance

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

Amnesia

Benzodiazepines can induce amnesia. This fact occurs more frequently several hours after administration of the medication, so to reduce 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 may reappear or worsen. Additionally, suicidal tendencies in depressive patients may be masked, which should be monitored in these patients.

Taking lorazepam cinfa with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

When lorazepam cinfa 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, hypnotics, anxiolytics/sedatives, antidepressants)
• Medications used to relieve severe pain (narcotic analgesics).
• Medications used to treat convulsions or epileptic seizures (antiepileptic medications).
• Anesthetics and barbiturates (sedatives).
• Medications used to treat allergies (antihistamines).

Similarly, the combined 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 cinfa 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

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. Benzodiazepines and their derivatives have been detected passing through the placenta.

If, on medical recommendation, the product is administered during late pregnancy or at high doses during labor, it is foreseeable that effects on the newborn may appear, such as hypoactivity, hypothermia (decreased body temperature), hypotonia (decreased muscle tone), apnea (periods of lack of breathing), moderate respiratory depression, feeding problems, and metabolic response imbalance to stress from cold.

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 patientsand 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 indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

lorazepam cinfa contains sodium.

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

3. How to take lorazepam cinfa

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

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

The recommended initial dose in anxiety states is 0.5 to 3 mg per day, divided into several doses. This dose may be increased or decreased according to the patient's needs or age and at the discretion of the doctor, not exceeding the maximum recommended dose of 10 mg divided into several doses.

The tablet can be divided into equal doses.

There are 1 mg lorazepam Cinfa tablets to obtain doses lower than 2.5 mg.

The duration of treatment should be as short as possible. The patient should be reevaluated at regular intervals, including the need to continue treatment, especially in those patients who are symptom-free. In general, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal. Your doctor will indicate the dose you should take at each moment.

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

Pediatric Population

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

Elderly Patients and Patients with Renal and/or Hepatic Insufficiency

Elderly patients and patients with renal and/or hepatic insufficiency may respond to lower doses, being sufficient half the adult dose.

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, phone 91 562 04 20, indicating the medication and the amount ingested.

As with other benzodiazepines, overdose does not represent a threat to life, unless taken with other central depressants (including alcohol).

In case of accidental overdose, vomiting should be induced (before one hour) if the patient is conscious.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may be drowsiness, confusion, and lethargy. In more severe cases, ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death may appear.

If you forget to take lorazepam cinfa

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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 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 thoughts 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 (discoordination and speech problems), dizziness.

Frequency not known: Extrapyramidal symptoms: tremor, 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 (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 can produce respiratory tract obstruction that can be fatal), 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 (decreased body temperature).

Investigations

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

As mentioned earlier, withdrawal of the product may cause the reappearance of certain symptoms due to the development of dependence.

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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of lorazepam cinfa

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Lorazepam Cinfa Composition

• The active ingredient is lorazepam. Each tablet contains 5 mg of lorazepam.
• The other components are: lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.

Product Appearance and Packaging Content

Lorazepam Cinfa is presented in the form of white, cylindrical, biconvex, scored tablets with the L5 logo on one side.

It is presented in PVC-PVDC/Aluminum blisters.

Each package contains 20 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:May 2020

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/

You can access detailed and updated information about this medication 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/68478/P_68478.html

QR code at: https://cima.aemps.es/cima/dochtml/p/68478/P_68478.html