Lorazepam Kern Pharma 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

LorazepamKern Pharma 5 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 other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents:

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 adverse 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 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 take Lorazepam Kern Pharma

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

Warnings and precautions

Consult 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 occur,
• As with 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, abrupt discontinuation of treatment may cause withdrawal symptoms such as headache, 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 stopping the medicine, especially if treatment is discontinued 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 your doctor's instruction,
• 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 that you can 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 for the treatment of anxiety associated with depression (risk of suicide),
• Benzodiazepines should be used with extreme caution in patients who have used or currently use drugs or alcohol,
• Lower doses are recommended in patients with chronic respiratory insufficiency.

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 individuals may be more sensitive to the effects of lorazepam than other adults, and therefore should take a lower dose.

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 depressant effect on the central nervous system may be enhanced when lorazepam is administered together with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedative antihistamines.

In the case of narcotic analgesics, there may also be an increased sensation of euphoria, which could increase psychological dependence.

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

Concomitant use of lorazepam and opioids (strong analgesics, substitution therapy medicines, 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 possible.

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 such symptoms.

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

Taking Lorazepam Kern Pharma with food, drinks, and alcohol

Lorazepam must not be taken together with alcoholic beverages, as alcohol may enhance the sedative effect of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 gradually discontinue treatment.

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

Breastfeeding

Since benzodiazepines pass into breast milk, taking 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, reduced attention, or decreased reaction capacity. 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 before taking this medicine.

3. How to take Lorazepam Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine 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 for anxiety states is 1 to 4 tablets daily, divided into 2 or 3 doses. The highest dose should be taken before going to bed.

Treatment should be initiated with the lowest recommended dose, gradually increasing until effective doses are achieved.

The duration of treatment should be as short as possible. Your doctor should regularly re-evaluate 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.

In elderly patients and patients with renal and/or hepatic impairment, the recommended dose is 0.5 mg per day, with gradual dose adjustment if necessary.

Other lorazepam formulations are available if lower doses than 5 mg of lorazepam are required.

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 telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

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

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy (drowsiness). In more severe cases, ataxia (impaired coordination due to nervous system dysfunction), hypotonia (reduced muscle tone), hypotension, respiratory depression, rarely coma, and very rarely death may occur.

If you forget to take Lorazepam Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone experiences them.

The use of lorazepam, as with other benzodiazepines, may cause drowsiness, emotional blunting, reduced level of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (disturbance of nervous system functions), or diplopia (double vision).

These reactions occur predominantly at the beginning of treatment and usually 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 increases with higher doses. Amnesic effects may be associated with inappropriate behaviors (see Warnings and precautions).
• Depression: the use of benzodiazepines may unmask an underlying depression.
• Psychiatric and paradoxical reactions: restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disturbances. These reactions can be severe and occur more frequently in children and elderly patients.
• Dependence: physical dependence (withdrawal or rebound phenomena upon discontinuation of treatment) and/or psychological dependence may occur. Cases of abuse have been reported.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lorazepam Kern Pharma

Keep this medicine out of 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lorazepam Kern Pharma

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

Appearance of the product and contents of the pack

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

The tablet can be divided into equal doses.

Each standard 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 the most recent revision 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 Medical Devices (AEMPS) http://www.aemps.gob.es/.