Package Insert: Information for the User

Lorazepam Kern Pharma 1 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lorazepam Kern Pharma belongs to a group of medications called “short-acting benzodiazepines”. It is indicated for the treatment of:

• All anxiety states.
• Neurosis.
• Psychic tensions and hyperemotivity.
• Sleep disorders.
• As a complement in all medical processes in which there are components of anxiety.

Do not take Lorazepam Kern Pharma

• If you are allergic to lorazepam or any of the other components of this medication (listed in section 6), or if you have ever had an allergic reaction (hypersensitivity) after taking a benzodiazepine.
• If you have myasthenia gravis (very weak and tired muscles).
• If you have severe respiratory insufficiency.
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• If you have severe liver insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lorazepam Kern Pharma.

• If you have impaired liver or kidney function.
• If you have narrow-angle glaucoma.
• After continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.
• Like other benzodiazepines, treatment with lorazepam can cause physical and psychological dependence; the risk of dependence increases with dose and duration of treatment and is higher in patients who have consumed or consume drugs or alcohol. Once physical dependence has developed, abrupt discontinuation of treatment may cause withdrawal symptoms, such as headaches, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormal sharpness of hearing), paresthesia, and cramps in the extremities, intolerance to light, sounds, and physical contact, hallucinations, or convulsions.
• After discontinuation of the medication, especially if it is stopped abruptly, rebound insomnia and anxiety, mood changes, and restlessness may occur; therefore, it is recommended to gradually reduce the dose before discontinuing treatment.
• The duration of treatment should be as short as possible (see section 3) and should not be prolonged without your doctor's indication.
• Benzodiazepines can induce a recent memory alteration; this occurs more frequently after several hours after taking the medication, so to reduce the associated risk, ensure that you can sleep uninterrupted for 7-8 hours after taking the tablet (see section 4).
• Benzodiazepines can produce psychiatric and paradoxical reactions, such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, treatment should be discontinued. These reactions are more frequent in children and elderly patients.
• Benzodiazepines should not be used alone for the treatment of anxiety associated with depression (suicide risk).
• Benzodiazepines should be used with maximum caution in patients who have consumed or consume drugs or alcohol.

Children and adolescents

Like other benzodiazepines, lorazepam should not be administered to children, unless strictly necessary. The duration of treatment should be as short as possible. There are no data available in children under 6 years, and therefore, its administration is not recommended in this age group.

Treatment in elderly patients

Like other benzodiazepines, elderly patients may be more sensitive to the effects of Lorazepam than other adults, so they should take a lower dose.

Treatment in patients with respiratory insufficiency

It is also 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.

Taking Lorazepam Kern Pharma with other medications

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

Like other benzodiazepines, lorazepam can interact with certain medications, especially those that depress the central nervous system. A potentiation of the depressive effect on the central nervous system can occur, resulting in excessive drowsiness, when lorazepam is taken with:

• medications used for the treatment of mental illnesses (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants)
• medications used to relieve strong pain (narcotic analgesics)
• medications used for the treatment of seizures or epilepsy (antiepileptic medications)
• Anesthetics and barbiturates
• medications used for the treatment of allergies (sedating antihistamines)

In the case of narcotic analgesics, an increase in the sensation of euphoria may also occur, which can increase the risk of psychological dependence.

The concomitant administration of lorazepam with other medications such as clozapine, valproate, probenecid, theophylline, or aminophylline may alter the effect of lorazepam, prolonging or reducing its activity.

The concomitant use of lorazepam and opioids (strong analgesics, medication for substitution therapy, and some medications for cough) increases the risk of drowsiness, respiratory depression, coma, and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medication together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Please 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 mentioned symptoms. Contact your doctor when you experience these symptoms.

Taking Lorazepam Kern Pharma with food, beverages, and alcohol

Lorazepam should not be taken in combination with alcoholic beverages, as they can potentiate the sedative effect of the medication, affecting your ability to drive or operate machinery.

Pregnancy, lactation, and fertility

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

Pregnancy

If you are taking lorazepam and plan to become pregnant or have confirmed pregnancy, you should contact your doctor to proceed with the withdrawal of treatment.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, and a withdrawal syndrome may occur in the postnatal period.

Lactation

Due to the fact that benzodiazepines pass into breast milk, it is recommended to avoid taking this medication during lactation.

Driving and operating machinery

Lorazepam may impair your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction time. The occurrence 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 Kern Pharma contains lactose

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

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

Anxiety

The usual dose of Lorazepam Kern Pharma is half a tablet (0.5 mg) 2 to 3 times a day, administered orally. This dose may be increased or decreased according to the patient's needs or age, and always at the discretion of the doctor.

The treatment duration 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.

In certain cases, it may be necessary to prolong treatment beyond the recommended period. This decision can only be made by your doctor, after weighing your progress.

Insomnia

The recommended dose for insomnia treatment is 1 tablet (1 mg) per day, taken at bedtime.

In elderly patients and patients with renal and/or hepatic insufficiency, the recommended dose is half a tablet (0.5 mg) of Lorazepam Kern Pharma per day, which can be gradually adjusted if necessary.

If you estimate that the action of Lorazepam Kern Pharma is too strong or too weak, inform your doctor or pharmacist. Swallow the tablets with a sufficient amount of liquid.

The use of benzodiazepines can lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize this risk, the following instructions should be taken into account:

• The use of benzodiazepines should only be under medical prescription (never because they have worked for other patients) and never advise them to others.
• Do not increase, under any circumstances, the doses prescribed by the doctor, nor prolong the treatment longer than recommended.
• Consult the doctor regularly for them to decide if treatment should continue. The treatment duration should be as short as possible.
• When stopping administration, symptoms that led to taking the medication may reappear, as well as restlessness, anxiety, insomnia, lack of concentration, headaches, and sweating, so your doctor will indicate precisely how to gradually decrease the dose.

If you take more Lorazepam Kern Pharma 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.

The most frequent symptoms of intoxication are drowsiness, confusion, or coma. In moderate cases, symptoms may be drowsiness, confusion, and lethargy (drowsiness). In more serious cases, ataxia (disruption of the nervous system functions), hypotonia (lower than normal muscle tone), hypotension, respiratory depression, rarely coma, and very rarely death may appear.

Treatment includes inducing vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring vital signs, and proper patient control.

If you forget to take Lorazepam Kern Pharma

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 Kern Pharma

Your doctor will indicate the duration of your treatment with Lorazepam Kern Pharma. Do not discontinue treatment prematurely, as it may not produce the desired effect.

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

Like all medicines, Lorazepam Kern Pharma may have side effects, although not everyone will experience them.

The following describes the drug-related adverse reactions 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)

Blood and lymphatic system disorders

• Very rare: Thrombocytopenia (decreased platelets in the blood), agranulocytosis (decreased neutrophils, a type of white blood cell), and pancytopenia (significant decrease in all blood cells).

Nervous system disorders

• Very common: Sedation, drowsiness, sensation of choking.
• Common: Ataxia (a central nervous system disorder that causes muscle weakness and speech problems among other symptoms), confusion, depression, depression unmasking, dizziness.
• Very rare: The effect of benzodiazepines on the central nervous system is dose-dependent, with more severe central nervous system depression at high doses. Extrapyramidal symptoms, tremor, vertigo, visual problems (double vision and blurred vision), dysarthria (slurred speech), headache, seizures (crises); Amnesia, disinhibition, euphoria, coma, suicidal thoughts and attempts, drowsiness. Paradoxical reactions such as anxiety, agitation, excitement, hostility, aggression, fury, sleep disturbances/insomnia, sexual desire, and hallucinations.

Cardiac disorders

• Very rare: Hypotension (decreased blood pressure).

Respiratory, thoracic, and mediastinal disorders

• Very rare: Respiratory failure, apnea, worsening of sleep apnea. This effect on the respiratory system is dose-dependent, with greater effects at higher doses of the medication; worsening of chronic obstructive pulmonary disease (a chronic lung disorder that results in a blockage of airflow in the lungs).

Gastrointestinal disorders

• Uncommon: Nausea.
• Very rare: Constipation, increased bilirubin, jaundice (yellowing of the white of the eye and skin), increased transaminases, and increased alkaline phosphatase (liver enzymes).

Skin and subcutaneous tissue disorders

• Very rare: Skin allergic reactions, alopecia (hair loss).

Reproductive and mammary system disorders

• Uncommon: Change in libido, impotence, decreased orgasms.

General disorders

• Common: Asthenia (fatigue and weakness) and muscle weakness.
• Very rare: Hypersensitivity reactions and anaphylactic/anaphylactoid reactions (allergies), hyponatremia (sodium deficiency), hypothermia (decreased body temperature), syndrome of inappropriate antidiuretic hormone secretion (hormonal disorder).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

If you experience adverse effects, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus.

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

Do not store at a temperature above 30°C.

Do not use Lorazepam Kern Pharma after the expiration date indicated 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 medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lorazepam Kern Pharma

• The active ingredient is lorazepam.
• The other components are lactose, cornstarch without gluten, gelatin, talc (E-553b), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

White, round, biconvex, and scored on both sides.

Each standard package contains 25 or 50 tablets and each clinical package contains 100 tablets.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: October 2020

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