LORAZEPAM KERN PHARMA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lorazepam Kern Pharma 1 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 is Lorazepam Kern Pharma and what is it 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 is Lorazepam Kern Pharma and what is it used for

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

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

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

Do not take Lorazepam Kern Pharma

• If you are allergic to lorazepam or any of the other ingredients of this medicine (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 failure.
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• If you have severe liver failure.

Warnings and precautions

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

• If you have altered 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.
• 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, sudden interruption 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 (tingling sensation) and muscle cramps, intolerance to light, sounds, and physical contact, hallucinations, or convulsions.
• After withdrawal of the medicine, especially if the medication is interrupted 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 indication.
• Benzodiazepines may induce an alteration of recent memory; this occurs more frequently after several hours after taking the medicine, so, to minimize 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.

Children and adolescents

As with other benzodiazepines, lorazepam should not be administered to children, unless it is 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 them.

Taking in elderly patients

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

Taking in patients with respiratory failure

It is also recommended to use lower doses in patients with chronic respiratory failure 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 medicines

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

As with other benzodiazepines, lorazepam may interfere with some medicines, especially central nervous system depressants. A potentiation of the depressant effect on the central nervous system may occur, producing more somnolence than expected, when lorazepam is administered together with:

• medicines used to treat mental illnesses (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants)
• medicines used to relieve severe pain (narcotic analgesics)
• medicines used to treat convulsions or epileptic seizures (antiepileptic medicines)
• Anesthetics and barbiturates
• medicines used to treat allergies (sedating antihistamines)

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

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

The concomitant use of lorazepam and opioids (strong pain relievers, medicines for substitution therapy, and some cough medicines) increases the risk of somnolence, breathing difficulties (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 medicine together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendation closely. It may be useful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Taking Lorazepam Kern Pharma with food, drinks, and alcohol

Lorazepam should not be administered in combination with alcoholic beverages, as they can potentiate the sedative effect of the medicine, which can affect the ability to drive or operate machinery.

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 plan to become pregnant or have confirmed that you are pregnant, 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 be triggered in the postnatal period.

Breastfeeding

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

Driving and using machines

Lorazepam may alter your ability to drive or operate machinery, as it can cause somnolence, reduce your attention, or reduce your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines 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 the administration instructions of this medicine exactly as indicated by your doctor. If in 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 duration of treatment should be as short as possible. Your doctor will reassess 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 evolution.

Insomnia

The recommended dose in the treatment of insomnia is 1 tablet (1 mg) per day, administered 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 think the action of Lorazepam Kern Pharma is too strong or too weak, tell your doctor or pharmacist. Take the tablets with a sufficient amount of liquid.

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

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and never advise them to other people.
• Never increase the prescribed doses, nor prolong treatment for longer than recommended.
• Consult your doctor regularly so that he can decide whether to continue treatment. The duration of treatment should be as short as possible.
• When stopping administration, the symptoms that led you to take the medicine may reappear, as well as restlessness, anxiety, insomnia, lack of concentration, headache, and sweating, so your doctor will indicate precisely how to gradually reduce 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

The most frequent symptoms of poisoning are somnolence, confusion, or coma. In moderate cases, the symptoms may be somnolence, confusion, and lethargy (drowsiness). In more severe cases, the following symptoms may occur: ataxia (disorder of the central nervous system functions), hypotonia (muscle tone lower than normal), hypotension, respiratory depression, rarely coma, and very rarely death.

Treatment includes inducing vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and adequate 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 make up for forgotten doses.

If you stop taking Lorazepam Kern Pharma

Your doctor will indicate the duration of your treatment with Lorazepam Kern Pharma. Do not stop treatment before, as it may not have the desired effect.

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

4. Possible side effects

Like all medicines, Lorazepam Kern Pharma can have side effects, although not everybody gets them.

The following adverse reactions are described 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 (decrease in blood platelets), agranulocytosis (decrease in neutrophils, a type of white blood cell), and pancytopenia (significant decrease in all blood cells).

Nervous system disorders

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

Cardiac disorders

• Very rare: Hypotension (decrease in 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, being greater at higher doses of benzodiazepines; worsening of chronic obstructive pulmonary disease (COPD).

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

• Very rare: Allergic skin reactions, alopecia (hair loss).

Reproductive system and breast disorders

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

General disorders

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you experience side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.

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 Lorazepam Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lorazepam Kern Pharma

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

Appearance of the product and packaging contents

White, round, biconvex tablets with a notch on both sides.

Each normal pack contains 25 or 50 tablets, and each clinical pack contains 100 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the 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/.