Package Leaflet: Information for the User

Lorazepam Cinfa 5 mg Tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

lorazepam cinfa is a tranquilizer-anxiolytic (prevents nervousness and anxiety) that is used for:

• The short-term treatment of all anxiety states associated with insomnia, depression, emotional disturbances, and linked to surgical and/or diagnostic procedures, and in preanesthesia.

Benzodiazepines are only indicated for the treatment of an intense disorder, which limits the patient's activity or subjects them to an important stressful situation

Do not take lorazepam cinfa:

• If you are allergic to lorazepam or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction (hypersensitivity) after taking benzodiazepines (a group of medicines 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 insufficiency (difficult breathing or severe chest discomfort).
• If you have sleep apnea (temporary stoppage of breathing while sleeping).
• If you have a severe liver disease.
• If you are being treated simultaneously with opioids, barbiturates, neuroleptics, or similar medicines.

Warnings and precautions

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

• If you have impaired liver function.

• If your doctor has prescribed a long-term treatment, it is recommended that they perform periodic blood tests and liver function tests (liver function).
• If during treatment you become pregnant, inform your doctor.
• It is not recommended for use in children under 6 years old.

Dependence

The continued use of benzodiazepines for several weeks may lead to a certain loss of efficacy with respect to hypnotic effects. It may also lead to dependence. This is mainly the case after taking the medicine continuously for a long time. To prevent this risk as much as possible, the following instructions should be taken into account:

• Benzodiazepines should only be taken under medical prescription (never because they have worked in other patients) and never advise others to take them.
• Do not increase the prescribed doses at all, or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if the treatment should continue.
• The duration of treatment should be as short as possible.
• The treatment should be discontinued gradually, according to the instructions indicated by your doctor.

Tolerance

After continued use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.

Amnesia

Benzodiazepines may induce amnesia. This occurs more frequently after several hours have passed since the administration of the medicine, so patients should ensure that they sleep uninterrupted for 7-8 hours after taking the tablet.

Psychiatric and paradoxical reactions

In the treatment with benzodiazepines, pre-existing depressions may reappear or the depressive state may worsen. In addition, the suicidal tendencies of depressed patients may be masked, which should be monitored in these patients.

Taking lorazepam cinfa with other medicines

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

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

When lorazepam cinfa is taken with other medicines that act on the CNS, the combination may make you feel more drowsy than usual. These medicines include:

• Medicines used to treat mental illnesses (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medicines used to relieve strong pain (narcotic analgesics).
• Medicines used to treat seizures or epilepsy (antiepileptic medicines).
• Anesthetics and barbiturates (sedatives).
• Medicines used to treat allergies (antihistamines).

Similarly, the concurrent 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 (antiasmatic, 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

If, on medical advice, the product is administered during a late stage of pregnancy, or at high doses during delivery, it is predictable that they may appear effects on the newborn such as hyporeactivity, hypothermia (decrease in body temperature), hypotonia (decrease in muscle tone), apnea (period of lack of breathing), moderate respiratory depression, feeding problems, and metabolic imbalance in response to cold stress.

Children born to mothers who take benzodiazepines chronically for 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 neonates 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 for children under 6 years old, 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 drug.

Use in patients with respiratory insufficiency

It is recommended to use lower doses 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 operating machinery

Lorazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is 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 indicated that you have an intolerance to certain sugars, consult with him before taking this medicine.

Lorazepam cinfa contains sodium.

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

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

Your doctor will indicate the duration of your treatment. Do not discontinue treatment beforehand, as it may not exert 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 healthcare professional, not exceeding the maximum recommended dose of 10 mg divided into several doses.

The tablet can be divided into equal doses.

There are lorazepam Cinfa tablets of 1 mg 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 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 time.

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

No data are available in children (under 6 years) and therefore, lorazepam is not recommended for young children.

Geriatric patients and patients with renal and/or hepatic insufficiency

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

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

Like other benzodiazepines, overdose does not represent a life-threatening situation, unless taken with other central depressants (including alcohol).

In case of accidental overdose, induce vomiting (within an hour) if the patient is conscious.

Benzodiazepine overdose typically manifests by different degrees of central nervous system depression, ranging from somnolence to coma. In moderate cases, symptoms may include somnolence, confusion, and lethargy (drowsiness). In more serious cases, ataxia (disruption of nervous system functions), hypotonia (abnormal muscle tone), hypotension, respiratory depression, rarely coma, and very rarely death may occur.

If you forgot to take lorazepam cinfa

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Very commonMay affect more than 1 in 10 people.

CommonMay affect up to 1 in 10 people.

UncommonMay affect up to 1 in 100 people.

RareMay affect up to 1 in 1,000 people.

Very rareMay affect up to 1 in 10,000 people.

Frequency not knownCannot be estimated from available data.

Blood and lymphatic system disorders

Frequency not known:Thrombocytopenia (decreased platelets in the blood),agranulocytosis (decreased neutrophils, a type of white blood cell), and pancitopenia (significant decrease in all blood cells).

Immune system disorders

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

Endocrine disorders

Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.

Metabolism and nutrition disorders

Frequency not known: Hyponatremia (low sodium levels).

Mental and behavioural disorders

Common: Confusion, depression, depression unmasking

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

Frequency not known: Dissociation, 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: Sensation of choking.

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

Frequency not known: Extrapyramidal symptoms: tremor, dysarthria (difficulty articulating words), headache, convulsions, 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 (low blood pressure).

Respiratory, thoracic and mediastinal disorders

Frequency not known: Respiratory insufficiency, 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: Icterus (yellowing of the white of the eye and skin).

Skin and subcutaneous tissue disorders

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

Musculoskeletal and connective tissue disorders

Common: Muscle weakness.

Reproductive and breast disorders

Uncommon: Impotence.

General disorders and administration site conditions

Very common: Sensation of choking.

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

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

Do not store at a temperature above 30°C.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 contents

Lorazepam cinfa is presented in the form of white, cylindrical, biconvex, scored, and with logo L5 on one face tablets.

Each package contains 20 or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:May 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your 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 to:https://cima.aemps.es/cima/dochtml/p/68478/P_68478.html