Package Insert: Information for the User

LorazepamKern Pharma5 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 read 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 Pharmabelongs to a group of medications known as “short-acting benzodiazepines”. It is indicated for the short-term treatment of anxiety states associated with insomnia, depression, and emotional disturbances.

Do not takeLorazepamKern Pharma

• 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 a benzodiazepine (a group of medications to which lorazepam belongs).
• If you have myasthenia gravis (a neuromuscular autoimmune disease characterized by very weak and tired muscles).
• If you have severe respiratory insufficiency (difficult breathing or severe chest discomfort).
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• If you have severe liver insufficiency.
• If you are being treated simultaneously with opioids, barbiturates, neuroleptics, or similar medications.

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 may 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 may induce an alteration of recent memory; this occurs more frequently after several hours following medication intake, so to minimize the associated risk, ensure that you will be able to sleep uninterrupted for 7-8 hours after taking the tablet (see section 4).
• Benzodiazepines may 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.
• It is recommended to use lower doses in patients with chronic respiratory insufficiency.

Administration in children

Like other benzodiazepines, lorazepam should not be administered to children, unless strictly necessary. The duration of treatment should be the minimum possible.

Administration 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.

Administration of 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 may interact with some medications, especially with central nervous system depressants. A potentiation of the depressive effect on the central nervous system may occur when administered concurrently with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedating antihistamines.

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

Compounds that inhibit certain hepatic enzymes (particularly cytochrome P 450) may potentiate the activity of benzodiazepines.

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

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

Please inform your doctor about all opioid medications you are taking, and follow your doctor's recommended dosage 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.

Inform your doctor or pharmacist if you are taking, or have taken recently, any other medication, even those acquired without a prescription.

Administration of Lorazepam Kern Pharma with food, beverages, and alcohol

Lorazepam should not be administered in combination with alcoholic beverages, as these may potentiate the sedative effect of the medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become 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 discontinuation of treatment.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which may trigger a withdrawal syndrome 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 may 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.

Your doctor will inform you of the duration of your treatment with this medication.

This medication is administered orally. Swallow the tablets with a sufficient amount of liquid.

The recommended dose for anxiety states is 1 to 4 tablets per day, divided into 2 or 3 doses. The highest dose should be taken before sleeping.

It is recommended to start treatment with the lowest recommended dose, gradually increasing it until effective doses are achieved.

The duration of treatment should be as short as possible. Your doctor should regularly reevaluate your situation. 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.

In elderly patients and patients with renal and/or hepatic insufficiency, the recommended dose is 0.5 mg per day, which can be gradually adjusted if necessary.

There are other presentations of lorazepam in the case of needing lower doses of 5 mg of lorazepam.

If you take moreLorazepamKern Pharmathan 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 as different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy. 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 takeLorazepamKern Pharma

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

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

Like all medications,this medicationmay have adverse effects, although not everyone will experience them.

The use of lorazepam, like other benzodiazepines, may produce drowsiness, emotional numbing, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (disruption of the nervous system functions) or diplopia (double vision).

These reactions predominantly occur at the beginning of treatment and generally disappear with continued administration. Occasionally, other adverse effects may occur, such as gastrointestinal disturbances, changes in libido or skin reactions.

Other adverse effects that may occur:

• Anterograde amnesia (recent memory disorder): the risk is higher with increased dosage. Amnestic effects may be associated with inappropriate behavior (see Warnings and Precautions).
• Depression: the use of benzodiazepines may unmask existing depression.
• Psychiatric and paradoxical reactions: restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations. These reactions can be severe and occur more frequently in children and elderly patients.
• Dependence: physical dependence (withdrawal or rebound phenomena upon discontinuing treatment) and/or psychological dependence may occur. Cases of abuse have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for 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.

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 indicated 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 your 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.

Composition of Lorazepam Kern Pharma

• The active ingredient is lorazepam.Each tablet contains 5 mg of lorazepam.
• The other components are lactose, cornstarch, gelatin, talc (E-553b), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

White, round, scored tablet on one face and marked with a “5” on the other.

The tablet can be divided into equal doses.

Each standard package contains 20 tablets and each clinical package contains 500 tablets.

Holder of the marketing authorization and responsible for manufacturing

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 for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.