Lorazepam Kern Pharma 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lorazepam Kern Pharma 1 mg tablets EFG

Read the entire leaflet carefully before you start taking 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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. How to store Lorazepam Kern Pharma
6. Contents of the pack and other information

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

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

• All anxiety states.
• Neuroses.
• Psychic tension and hyperemotionality.
• Sleep disorders.
• As an adjunct in all medical conditions whose progression involves anxiety components.

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

Do not take Lorazepam Kern Pharma

• If you are allergic to lorazepam or to 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 insufficiency.
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• If you have severe hepatic insufficiency.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 reduced effectiveness regarding hypnotic effects may be observed.
• Like other benzodiazepines, treatment with lorazepam may lead to physical and psychological dependence; the risk of dependence increases with dose and duration of treatment and is higher in patients who have used or currently use drugs or alcohol. Once physical dependence has developed, abruptly stopping treatment may cause withdrawal symptoms such as headaches, muscle pain, marked anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormally acute hearing), tingling and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or seizures.
• After discontinuation of the medicine, especially if treatment is stopped abruptly, rebound insomnia and anxiety, mood changes, and restlessness may occur; 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); do not prolong treatment without medical advice.
• Benzodiazepines may cause impairment of recent memory; this occurs more frequently several hours after taking the medicine, so to reduce the associated risk, you should ensure you will be able to sleep uninterrupted for 7–8 hours after taking the tablet (see section 4).
• Benzodiazepines may cause psychiatric and paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, treatment should be discontinued. These reactions are more frequent in children and elderly patients.
• Benzodiazepines should not be used alone to treat anxiety associated with depression (suicide risk).
• Benzodiazepines should be used with maximum caution in patients who have used or currently use drugs or alcohol.

Children and adolescents

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

Use in elderly patients

As with other benzodiazepines, elderly individuals may be more sensitive to the effects of Lorazepam than younger adults, and therefore should take a lower dose.

Use in patients with respiratory insufficiency

Lower doses are also recommended in patients with chronic respiratory insufficiency due to the 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

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

As with other benzodiazepines, lorazepam may interact with certain medicines, especially central nervous system depressants. The combined use of lorazepam with the following medicines may enhance the central nervous system depressant effect, leading to excessive drowsiness:

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

When narcotic analgesics are used together with lorazepam, there may also be an increased feeling of euphoria, which could increase the risk of psychological dependence.

Concomitant administration of lorazepam with other medicines such as clozapine, valproate, probenecid, theophylline, or aminophylline may alter the effect of lorazepam, either prolonging or reducing its activity.

The concomitant use of lorazepam and opioids (strong analgesics, medications for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may even be fatal. Therefore, concomitant use should only be considered when no other treatment options are available.

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

Please inform your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they can monitor for the symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

Taking Lorazepam Kern Pharma with food, drinks, and alcohol

Lorazepam should not be taken with alcoholic beverages, as alcohol may enhance the sedative effect of the medicine, which could impair your ability to drive or operate machinery.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are taking lorazepam and plan to become pregnant or have confirmed pregnancy, you should contact your doctor to discuss discontinuation of treatment.

Infants born to mothers who take benzodiazepines chronically during the last stage of pregnancy may develop physical dependence and may experience withdrawal symptoms in the postnatal period.

Breastfeeding

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

Driving and using machines

Lorazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or slow reaction times. These effects are 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 medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take Lorazepam Kern Pharma

Follow exactly the instructions for administration of this medicine as given 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) taken 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 physician's discretion.

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

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

Insomnia

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

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

If you feel that the effect 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 may lead to dependence. This occurs mainly after prolonged, uninterrupted use of the medicine. To minimize this risk as much as possible, the following instructions should be observed:

• Benzodiazepines should only be taken on medical prescription (never because they worked in other patients), and you should never recommend them to others.
• Under no circumstances should you increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.
• Consult your doctor regularly so that he or she can decide whether treatment should continue. The duration of treatment should be as short as possible.
• When stopping treatment, the symptoms that led to taking the medicine may reappear, along with restlessness, anxiety, insomnia, difficulty concentrating, headache, and sweating. Therefore, your doctor will give you precise instructions on how to gradually reduce the dose.

If you take more Lorazepam Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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

Treatment includes inducing vomiting or gastric lavage, general supportive measures, adequate respiratory support, monitoring of vital signs, and appropriate patient management.

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 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 achieve the desired effect.

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

4. Possible adverse effects

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

The following are the adverse drug reactions listed according 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 (reduced blood platelets), agranulocytosis (reduction in neutrophils, a type of white blood cell), and pancytopenia (marked reduction in all blood cells).

Nervous system disorders

• Very common: Sedation, somnolence, sensation of suffocation.
• Common: Ataxia (a disorder of the central nervous system causing muscle weakness and speech difficulties, among other symptoms), confusion, depression, unmasking of depression, dizziness.
• Very rare: The effect of benzodiazepines on the central nervous system is dose-dependent, with more pronounced central nervous system depression at higher doses. Extrapyramidal symptoms, tremor, vertigo, visual disturbances (double vision and blurred vision), dysarthria (slurred speech), headache, seizures (fits); amnesia, disinhibition, euphoria, coma, suicidal thoughts and attempts, somnolence. Paradoxical reactions such as anxiety, agitation, excitement, hostility, aggressiveness, rage, sleep disturbances/insomnia, increased libido, and hallucinations.

Cardiac disorders

• Very rare: Hypotension (reduced blood pressure).

Respiratory, thoracic and mediastinal disorders

• Very rare: Respiratory failure, apnea, worsening of sleep apnea. This effect on the respiratory system is dependent on the dose of benzodiazepines, being greater at higher doses; worsening of chronic obstructive pulmonary disease (a chronic lung disorder resulting in airflow obstruction in the lungs).

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: Skin allergic reactions, alopecia (hair loss).

Reproductive system and breast disorders

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

General disorders

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Lorazepam Kern Pharma

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

Do not store at temperatures above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lorazepam Kern Pharma

• The active substance is lorazepam.
• The other components are lactose, gluten-free corn starch, gelatin, talc (E-553b), anhydrous colloidal silicon dioxide, and magnesium stearate.

Appearance of the product and contents of the pack

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

Each standard 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 most recent review of this leaflet: October 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.