LORAZEPAM KERN PHARMA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lorazepam Kern Pharma 5 mg tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Lorazepam Kern Pharma is and what it is used for
2. What you need to know before taking Lorazepam Kern Pharma
3. How to take Lorazepam Kern Pharma
4. Possible side effects
5. Storage of Lorazepam Kern Pharma
6. Contents of the pack and further information

1. What Lorazepam Kern Pharma is and what it is used for

Lorazepam Kern Pharma belongs to a group of medicines called "short-acting benzodiazepines". It is indicated for the short-term treatment of anxiety states associated with insomnia, depression, and emotional disturbances.

2. What you need to know before taking Lorazepam Kern Pharma

Do not takeLorazepamKern Pharma

• 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 a benzodiazepine (the group of medicines to which lorazepam belongs).
• If you suffer from myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak and tired muscles).
• If you suffer from severe respiratory failure (difficult breathing or severe chest discomfort).
• If you suffer from sleep apnea syndrome (interruption of breathing during sleep).
• If you suffer from severe liver failure.
• 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 Kern Pharma:

• If you have impaired liver or kidney function.
• If you suffer from narrow-angle glaucoma.
• After continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.
• As with other benzodiazepines, treatment with lorazepam may cause physical and psychological dependence; the risk of dependence increases with the dose and duration of treatment and is greater in patients who have consumed or consume drugs or alcohol. Once physical dependence has developed, abrupt discontinuation of treatment can 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 acuteness of hearing), paresthesia, and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or convulsions.
• After withdrawal of the medicine, especially if the medication is stopped abruptly, rebound insomnia and anxiety, mood changes, and restlessness may appear; therefore, it is recommended to gradually reduce the dose before stopping treatment.
• The duration of treatment should be as short as possible (see section 3) and should not be prolonged without your doctor's advice.
• Benzodiazepines may cause an alteration of recent memory; this occurs more frequently after several hours after taking the medicine, so to reduce the associated risk, you should 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, rage, 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 (risk of suicide).
• Benzodiazepines should be used with maximum caution in patients who have consumed or consume drugs or alcohol.
• Lower doses are recommended in patients with chronic respiratory failure.

Use in children

As with other benzodiazepines, lorazepam should not be administered to children unless strictly necessary. The duration of treatment should be as short as possible.

Use in elderly patients

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

Taking Lorazepam Kern Pharma with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

As with other benzodiazepines, lorazepam may interfere with some medicines, especially central nervous system depressants. The depressant effect on the central nervous system may be potentiated when administered together 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 can increase psychological dependence.

Compounds that inhibit certain liver enzymes (particularly cytochrome P450) may potentiate the activity of benzodiazepines.

Concomitant use of lorazepam and opioids (strong analgesics, substitution therapy medications, and some cough medications) increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and can be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes this medicine together 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 dosage recommendation closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

TakingLorazepam Kern Pharmawith food, drinks, and alcohol

Lorazepam should not be taken in combination with alcoholic beverages, as they can potentiate the sedative effect of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are taking lorazepam and are planning to become pregnant or have confirmed that you are pregnant, you should contact your doctor to discontinue treatment.

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

Breastfeeding

Since benzodiazepines pass into breast milk, this medicine should be avoided during breastfeeding.

Driving and using machines

Lorazepam may affect your ability to drive or operate machinery, as it can cause somnolence, reduce your attention, or reduce your reaction time. The appearance of these effects is more likely at the start 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Lorazepam Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with this medicine.

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

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

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

The duration of treatment should be as short as possible. Your doctor should regularly reassess 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 evolution.

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 case lower doses of 5 mg of lorazepam are needed.

If you take moreLorazepam Kern Pharmathan 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 medicine and the amount ingested.

As with other benzodiazepines, overdose is not life-threatening unless taken with other central depressants (including alcohol).

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

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

If you forget to takeLorazepam Kern Pharma

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use of lorazepam, like other benzodiazepines, may cause somnolence, emotional bluntness, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or diplopia.

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

Other side effects that may occur:

• Anterograde amnesia (recent memory disorder): the risk is greater when increasing the dose. 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, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disorders. These reactions can be severe and occur more frequently in children and elderly patients.
• Dependence: physical dependence (withdrawal or rebound phenomena when treatment is stopped) and/or psychological dependence may occur; see Warnings and precautions. Cases of abuse have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lorazepam Kern Pharma

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lorazepam Kern Pharma

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

Appearance of the product and pack contents

White, round, scored tablet with a "5" marked on one side.

The tablet can be divided into equal doses.

Each normal pack contains 20 tablets and each clinical pack contains 500 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this package leaflet: October 2020

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