Lorazepam Orion

Package Leaflet: Information for the Patient

Lorazepam Orion, 1 mg, Tablets

Lorazepam

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lorazepam Orion and what is it used for
• 2. Important information before taking Lorazepam Orion
• 3. How to take Lorazepam Orion
• 4. Possible side effects
• 5. How to store Lorazepam Orion
• 6. Contents of the pack and other information

1. What is Lorazepam Orion and what is it used for

Lorazepam Orion is a sedative and anxiolytic medication. The active substance is lorazepam, which belongs to a group of medications called benzodiazepines.
Lorazepam Orion is used for the short-term treatment of severe, disabling anxiety in adults.

2. Important information before taking Lorazepam Orion

When not to take Lorazepam Orion:

• if the patient is allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medication (listed in section 6)
• if the patient has irregular breathing with pauses in breathing during sleep (sleep apnea);
• if the patient has a lung disease that causes breathing difficulties
• if the patient has myasthenia gravis (a chronic disease that causes varying levels of weakness in the skeletal muscles)
• if the patient has severe liver failure.

Warnings and precautions

Before starting to take Lorazepam Orion, the patient should discuss the following with their doctor:

• if the patient has kidney problems
• if the patient has liver problems
• if the patient is weak or elderly
• if the patient has chronic respiratory problems
• if the patient has acute narrow-angle glaucoma
• if the patient has a history of drug or alcohol abuse
• if the patient has a history of seizures.

Tolerance

The patient should talk to their doctor if they notice that the effect of the tablets has decreased after taking them for a few weeks (development of tolerance to the medication).

Taking Lorazepam Orion may lead to dependence.

The use of benzodiazepines can lead to physical and psychological dependence. To minimize the risk of dependence, the patient should take the smallest effective dose of Lorazepam Orion for as short a time as possible. Treatment should not usually last longer than 4 weeks.
The need for continued treatment should be assessed if the treatment duration exceeds 4 weeks, and then regularly, preferably by the same doctor who started the treatment. The treatment duration should not exceed a maximum of 2-3 months.

Abuse

A known risk associated with the use of this type of medication (benzodiazepines) is their abuse (see section 4). Abuse of this medication can lead to overdose and death.
The patient should always follow the doctor's instructions regarding dosage. This medication may be sought after by people who abuse prescription medications, and it should be stored in a place inaccessible to others. Any unused leftovers of the medication should be returned to a pharmacy that accepts them.

Children and adolescents

Lorazepam Orion should not be used in children and adolescents under 18 years of age.

Lorazepam Orion and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The patient should be particularly cautious if they are taking the following medications while taking Lorazepam Orion:

• other medications that have a sedative effect on the central nervous system (e.g., antipsychotic, anxiolytic, antidepressant, sleep-inducing, sedative, anesthetic, opioid pain-relieving medications, antihistamines with a sedative effect)
• antiepileptic medications (e.g., phenobarbital, hydantoin, barbiturates, and valproic acid)
• medications used in addiction therapy (lofexidine and disulfiram)
• medications used to treat gastrointestinal disorders (cisapride)
• antibiotics (rifampicin)
• muscle relaxants (baclofen and tizanidine)
• asthma medications (theophylline and aminophylline) and caffeine
• blood pressure medications, vasodilators, and diuretics
• nabilone (an antiemetic medication)
• probenecid (used to treat gout).

Taking Lorazepam Orion with opioids (strong pain-relieving medications, substitution therapy medications, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered if other treatment options are not possible.
If the doctor has prescribed Lorazepam Orion together with opioids, the patient should take the smallest effective dose, and the treatment duration should be as short as possible.
The patient should tell their doctor about all opioid medications they are taking and strictly follow the doctor's instructions. It may be helpful to inform friends or family members about the possibility of the patient experiencing the above-mentioned symptoms. If such symptoms occur, the patient should contact their doctor.
Taking these medications together with lorazepam may increase or decrease the effect of lorazepam or increase the risk of side effects.

Lorazepam Orion with food, drink, and alcohol

The tablets should be taken with a liquid. The medication can be taken with or without food.
Alcohol:
The patient should not drink alcohol while taking this medication, as alcohol may change or enhance the effect of Lorazepam Orion in an unpredictable way.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medication.
Lorazepam Orion should not be used during pregnancy, especially in the first and last trimester, as lorazepam may have a serious effect on the fetus.
If the patient becomes pregnant while taking Lorazepam Orion, they should immediately inform their doctor so that they can decide on a change of treatment.
The active substance of Lorazepam Orion passes into breast milk. Therefore, the medication should not be used during breastfeeding, unless the expected benefits outweigh the risk to the child.

Driving and using machines

Lorazepam Orion has a moderate to significant effect on the ability to drive and perform tasks that require precision, as it impairs the ability to react, causes sedation, drowsiness, and muscle relaxation. Additionally, Lorazepam Orion may cause side effects such as dizziness and vision disturbances. The patient should not drive or operate machinery while under the influence of lorazepam.

Lorazepam Orion contains lactose.

This medication contains 63.75 mg of lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

3. How to take Lorazepam Orion

This medication should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dosage and treatment duration are determined individually for each patient.
Recommended dose:

• for the treatment of anxiety states, the average daily dose is 2 to 3 mg, divided into several doses. The daily dose may, however, vary from 1 to 7.5 mg. The largest dose should be taken before bedtime
• for insomnia due to anxiety or transient stress, the average dose is 1 to 2 mg once daily, usually before bedtime
• for elderly or weak patients, the recommended daily dose is 1 mg per day, divided into two doses; the dose should be carefully adjusted to the patient's needs and tolerance. The tablet can be divided into equal doses.

Use in children and adolescents

The safety and efficacy of lorazepam in children and adolescents have not been established. Lorazepam Orion should not be used in children and adolescents under 18 years of age.

Overdose of Lorazepam Orion

In case of overdose or accidental ingestion of the medication by a child, the patient should contact their doctor or hospital to get an opinion on the risk and advice on what actions to take.
The following symptoms may occur: drowsiness, confusion, apathy, speech disorders, unsteady gait, depression, low blood pressure, decreased muscle strength, breathing difficulties, fainting with a weak pulse, pallor, and cyanosis. In rare cases, coma has been observed. In very rare cases, overdose of Lorazepam Orion can be fatal.

Missed dose of Lorazepam Orion

The patient should not take a double dose to make up for a missed dose. They should skip the missed dose and take the next scheduled dose.

Stopping treatment with Lorazepam Orion

Treatment may only be stopped or interrupted according to the doctor's instructions.
The doctor may gradually decrease the dose of Lorazepam Orion, especially if high doses are used or for a longer period.
If the patient suddenly stops taking Lorazepam Orion, they may experience withdrawal symptoms, such as headaches, muscle pain, anxiety, tension, restlessness, depression, insomnia, sweating, dizziness, confusion, and irritability. Additionally, the symptoms that the medication is intended to alleviate may worsen.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Lorazepam Orion can cause side effects, although not everybody gets them.

Important side effects to look out for:

The patient should stop taking Lorazepam Orion and immediately contact their doctor if they experience symptoms of a severe allergic reaction, anaphylaxis, or angioedema, such as:

• rash, itching
• swelling of the face, lips, mouth, and throat, which may cause significant difficulties in swallowing and breathing. These are severe but very rare side effects (may occur in up to 1 in 10,000 people). The patient may require emergency medical attention or hospitalization.

Other possible side effects

Very common (occurring in more than 1 in 10 people):

• sedation, fatigue, drowsiness. Common (occurring in up to 1 in 10 people):
• ataxia, disorientation, depression, unveiling of depression, dizziness;
• muscle weakness, asthenia. Uncommon (occurring in up to 1 in 100 people):
• headaches, decreased alertness, emotional suppression
• vision disturbances (including double vision and blurred vision)
• nausea, gastrointestinal disorders, changes in appetite
• skin reactions
• changes in libido, impotence, decreased orgasm. Rare (occurring in up to 1 in 1,000 people):
• changes in blood morphology (decreased red blood cell count, white blood cell count, and platelet count);
• transient anterograde amnesia and memory disturbances
• increased bilirubin levels, jaundice, increased liver enzyme activity (aminotransferases, alkaline phosphatase). Very rare (occurring in up to 1 in 10,000 people):
• hypersensitivity reactions
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyponatremia, hypothermia
• tremors, dizziness, speech disturbances, seizures, lack of inhibition, euphoria, coma, suicidal thoughts or attempts, paradoxical reactions, including: anxiety, agitation, excitement, hostility, aggression, anger, sleep disturbances/insomnia, increased sexual drive, hallucinations
• decreased concentration, balance disturbances
• low blood pressure, decreased blood pressure
• respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease
• constipation
• allergic skin reactions, hair loss.

Frequency not known (frequency cannot be estimated from the available data)

• medication abuse, dependence on the medication, withdrawal syndrome

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the competent authority or to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to store Lorazepam Orion

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the blister pack and outer packaging after: EXP. The expiration date refers to the last day of the specified month.
The medication should not be stored above 25°C.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lorazepam Orion contains

• The active substance of Lorazepam Orion is lorazepam. One tablet contains 1 mg of lorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, potassium polacrylate, and magnesium stearate.

What Lorazepam Orion looks like and contents of the pack

White or almost white, round, flat tablets with beveled edges, with the symbol "1" embossed on one side and a deep score line on the other side.
Packaging:
Soft blisters made of aluminum/PE in a cardboard box.
Pack sizes: 20, 25, 30, 50, or 100 tablets. Not all pack sizes may be marketed.
Aluminum-aluminum blisters in a cardboard box.
Pack sizes: 20, 25, 30, 50, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Importer:

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information about this medication, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:06/2024