Lorazepam Orion

Package Leaflet: Information for the Patient

Lorazepam Orion, 2.5 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.
• 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, including those not listed in this leaflet, please inform your 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. The active substance is lorazepam, which belongs to a group of medicines 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 you are allergic to lorazepam, benzodiazepines or any of the other ingredients of this medicine (listed in section 6);
• if you have irregular breathing with pauses in breathing during sleep (sleep apnea);
• if you have a lung disease that causes breathing difficulties;
• if you have myasthenia gravis (a condition characterized by excessive muscle weakness);
• if you have severe liver failure.

Warnings and precautions

Before starting to take Lorazepam Orion, discuss with your doctor:

• if you have kidney problems;
• if you have liver problems;
• if you are weak or elderly;
• if you have chronic respiratory problems;
• if you have acute narrow-angle glaucoma;
• if you have or have had problems with drug or alcohol abuse;
• if you have had seizures in the past;

Consult your doctor if you are pregnant, planning to have a baby, or breastfeeding, or if you are of childbearing age (see section "Pregnancy and breastfeeding").

Taking Lorazepam Orion may lead to dependence.

The use of benzodiazepines (even at therapeutic doses) may lead to physical and psychological dependence. To minimize the risk of dependence, use the lowest effective dose of Lorazepam Orion for the shortest possible period. Treatment should not 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 duration of treatment should not exceed a maximum of 2-3 months.

Children and adolescents

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

Lorazepam Orion and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Be particularly careful if you are taking the following medicines while taking Lorazepam Orion:

• other medicines that have a sedative effect on the central nervous system (e.g., antipsychotics, anxiolytics, antidepressants, hypnotics, sedatives, anesthetics, opioid analgesics, antihistamines with sedative effects);
• antiepileptic drugs (e.g., phenobarbital, hydantoin, barbiturates, and valproic acid);
• drugs used in addiction therapy (lofexidine and disulfiram);
• drugs used to treat gastrointestinal disorders (cisapride); antibiotics (rifampicin);
• muscle relaxants (baclofen and tizanidine);
• anti-asthmatic drugs (theophylline and aminophylline) and caffeine;
• antihypertensive drugs, vasodilators, and diuretics;
• nabilone (an antiemetic drug);
• probenecid (used to treat gout).

Taking these medicines together with lorazepam may increase or decrease the effect of lorazepam or increase the risk of side effects.
Taking Lorazepam Orion with opioids (strong painkillers, substitution therapy drugs, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible.
If your doctor has prescribed Lorazepam Orion with opioids, use the lowest effective dose, and the treatment duration should be as short as possible.
Tell your doctor about all opioid medicines you are taking, and strictly follow your doctor's dosage instructions. It may be helpful to inform friends or relatives about the possibility of the above-mentioned symptoms occurring in you.
If such symptoms occur, contact your doctor.

Lorazepam Orion with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Do not take Lorazepam Orion during pregnancy, especially in the first and last trimesters, as lorazepam may have a significant impact on the fetus.
If you become pregnant while taking Lorazepam Orion, inform your doctor immediately so that he can decide on a change of treatment.
Women of childbearing age must use effective contraception during treatment.
The active substance of Lorazepam Orion passes into breast milk and may cause drowsiness and feeding difficulties in the breastfed child. Your doctor will decide whether you should take this medicine while breastfeeding or stop breastfeeding, taking into account the expected benefits of treatment for the mother and the benefits of breastfeeding for the child.

Driving and using machines

Lorazepam Orion has a moderate to significant impact 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. Do not drive or operate machinery while under the influence of lorazepam.

Lorazepam Orion contains lactose monohydrate

The medicine contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Lorazepam Orion

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.
The dosage and duration of treatment are determined individually for each patient.
Recommended dose:

• for the treatment of anxiety states, the average daily dose is 2 to 3 mg of lorazepam, 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 a day, usually before bedtime;
• in elderly and debilitated patients, the recommended initial dose is 1 mg per day, divided into two doses. The dose should be carefully adjusted according to the patient's needs and tolerance.

The tablet can be divided into equal doses.
For doses that cannot be obtained using tablets of this strength, after consulting your doctor, it is recommended to use another available strength of Lorazepam Orion (1 mg).

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 medicine by a child, contact your doctor or hospital for advice on the risk and the actions to be taken.
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, paleness, blue discoloration of the lips and fingernails. In rare cases, coma has been observed. In very rare cases, Lorazepam Orion overdose can cause death.

Missed dose of Lorazepam Orion

Do not take a double dose to make up for a missed dose. Miss the missed dose and take the next planned dose.

Stopping treatment with Lorazepam Orion

Treatment may only be stopped or interrupted according to your doctor's instructions.
Your doctor may gradually decrease the dose of Lorazepam Orion, especially if high doses or long-term treatment is used.
If you suddenly stop taking Lorazepam Orion, you may experience withdrawal symptoms, such as headaches, muscle pain, anxiety, tension, restlessness, depression, insomnia, sweating, dizziness, confusion, and irritability. Additionally, after sudden discontinuation of the medicine, the symptoms that the medicine is intended to alleviate may worsen.
If you have any further questions about 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.

Important side effects to look out for:

If you experience any of the following symptoms, stop taking Lorazepam Orion and contact your doctor or go to the emergency department of your nearest hospital immediately:
severe allergic reaction. Symptoms of a severe allergic reaction include:

• rash, itching;
• swelling of the face, lips, mouth, and throat, which may cause difficulty in swallowing and breathing (angioedema). This is a serious side effect. You may need urgent medical attention or hospitalization.

Other possible side effects

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

• sedation, fatigue, drowsiness;

Common (occurring in up to 1 in 10 patients):

• ataxia, disorientation, depression, unveiling of depression, dizziness;
• muscle weakness, asthenia (chronic fatigue);

Uncommon (occurring in up to 1 in 100 patients):

• headaches, decreased alertness, emotional numbing;
• 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 patients):

• changes in blood cell count (decreased red blood cells, white blood cells, and platelets);
• transient anterograde amnesia and memory disorders;
• increased bilirubin levels, jaundice, increased liver enzyme activity (aminotransferases, alkaline phosphatase);

Very rare (occurring in up to 1 in 10,000 patients):

• hypersensitivity reactions and anaphylactic/anaphylactoid reactions;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), decreased sodium levels in the blood, low body temperature;
• 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, extrapyramidal symptoms, tremors, dizziness, speech disturbances, seizures, convulsions, coma;
• 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):

• prolonged reaction time;
• concentration disorders;
• balance disorders;
• withdrawal syndrome;
• dependence;

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the regulatory authority or to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lorazepam Orion

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lorazepam Orion contains

• The active substance is lorazepam. One tablet contains 2.5 mg of lorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, potassium polacrylate, yellow iron oxide (E 172), and magnesium stearate.

What Lorazepam Orion looks like and contents of the pack

Light yellow, round, flat tablets with beveled edges, approximately 8 mm x 3.1 mm in size, with the symbol "2.5" embossed on one side and a deep break line on the other side. The tablet can be divided into equal doses.
Packaging:
Soft aluminum/PE blister or OPA/Aluminum/PVC/Aluminum blister in a cardboard box.
Pack sizes:
Soft aluminum/PE blister: 10, 20, and 30 tablets.
OPA/Aluminum/PVC/Aluminum blister: 10, 20, 25, and 30 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Importer:

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer:

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For more information about this medicine, 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:02.09.2022