Package Leaflet: Information for the User

Lorazepam Cinfa 1 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.

Contents of the pack and additional information

lorazepam cinfa is a tranquilizer-anxiolytic (prevents nervousness and anxiety) that acts without influencing normal activities of the individual. It complements antidepressive therapy appropriately and can be combined with antidepressant medications and other psychopharmaceuticals.

Lorazepam is used in the following cases:

• Treatmentfor short-termof all states of anxiety and tension associated or not with functional or organic disorders, including anxiety associated with depression and that linked to surgical and/or diagnostic procedures, and in preanesthesia.

Sleep disorders.

Do not take lorazepam cinfa

• 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.

Warnings and precautions

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

• If you have liver function impairment.
• 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 you become pregnant during treatment, 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 medication continuously 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 be made only under medical prescription (never because they have been effective in other patients) and never advise them to other people.
• Do not increase the prescribed doses at all, or prolong the 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.
• The interruption of treatment should be done gradually, according to the instructions indicated by your doctor.
• The use of lorazepam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.

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 medication, 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.

Other medications and lorazepam cinfa

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

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 is taken with other medications that act on the CNS, the combination may 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 relievestrong 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 sedation, difficulty breathing (respiratory depression), coma, and may 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 together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all the opioid medications you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.
• Medications used to treat seizures or epilepsy (antiepileptic medications).
• Sedatives and barbiturates.
• Medications used to treat allergies (antihistamines).

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

• Clozapine (treatment of schizophrenia).
• Valproate (treatment of epilepsy and bipolar disorders).
• Probenecid (treatment of gout).
• Theophylline or aminophylline (antiasmatics, 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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, at the doctor's recommendation, 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 response imbalance to cold stress.

Newborns born to mothers who take benzodiazepines chronically for several weeks during pregnancy or during the last stage 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 neonates whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect 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 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 medication.

Use in patients with respiratory insufficiency

It is recommended to use lower doses 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 operating machinery

Lorazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease attention, or decrease 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 them before taking this medication.

Lorazepam cinfa contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) 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.

The tablet can be divided into equal doses.

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

Anxiety:

The recommended initial dose for 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 patient's needs or age and at the doctor's discretion.

The duration of treatment should be as short as possible. Your doctor should reevaluate your situation regularly. In general, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal.

Insomnia:

Treatment should start with the lowest recommended dose, 1 mg in a single dose at bedtime, gradually increasing it until an effective dose is achieved. Do not exceed the maximum dose of 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. 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; such a decision can only be made by your doctor.

Use in children

No data is available for children (under 6 years) and therefore, lorazepam should not be prescribed to 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 Toxicological 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.

The treatment of overdose includes inducing vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and proper patient control. Flumazenil may be used as an antidote. In patients taking benzodiazepines chronically, special care should be taken when administering flumazenil, as this combination of medications may increase the risk of seizures.

If you forgot to take lorazepam cinfa

Take your tablet as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with lorazepam cinfa

Upon cessation of administration, the symptoms that led to taking the medication may reappear, as well as restlessness, muscle pain, anxiety, tension, irritability, insomnia, lack of concentration, headache, sweating, depression, rebound phenomena, derealization (perception of the immediate environment as unreal or unknown), 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 internal body temperature),so your doctor will indicate precisely how to gradually decrease the dose.

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

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

The following side effects are described in relation to their frequency of occurrence:

Very commonCan affect more than 1 in 10 people.

CommonCan affect up to 1 in 10 people.

UncommonCan affect up to 1 in 100 people.

RareCan affect up to 1 in 1,000 people.

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

Blood and lymphatic system disorders

Frequency not known:Thrombocytopenia (decreased platelet count in the blood), agranulocytosis (decreased neutrophil count, 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 reactions).

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 unmasked.

Uncommon:Decreased libido (sex drive), decreased orgasms.

Frequency not known:Disinhibition, 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:Vestibular disorders.

Vascular disorders

Frequency not known: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 can cause respiratory tract obstruction, which 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:Fatigue and asthenia.

Frequency not known:Low 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.

Do not store at a temperature above 25°C.

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

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.

Medications 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

Product appearance and packaging contents

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

It is presented in PVC-PE-PVDC/Aluminum blisters.

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) -Spain

Last review date of this leaflet:July 2021

Detailed information about 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 about 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/68477/P_68477.html

QR code to:https://cima.aemps.es/cima/dochtml/p/68477/P_68477.html