Lorazepam orion

Package leaflet: Information for the patient

Lorazepam Orion, 2.5 mg, tablets
Lorazepamum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Lorazepam Orion is and what it is used for
2. What you need to know 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 Lorazepam Orion is and what it is used for

Lorazepam Orion is a tranquilizer and anxiolytic agent. 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 the patient is allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has irregular breathing with breathing pauses during sleep (sleep apnoea);
• if the patient has a lung disease causing breathing difficulties;
• if the patient suffers from myasthenia (excessive muscle fatigue, Myasthenia gravis);
• if the patient has severe liver impairment.

Warnings and precautions
Before starting treatment with Lorazepam Orion, discuss with your doctor:

• if the patient has kidney function disorders;
• if the patient has liver function disorders;
• if the patient is debilitated or elderly;
• if the patient has chronic respiratory disorders;
• if the patient has acute narrow-angle glaucoma;
• if there are or have been substance use disorders, drug abuse, or alcohol abuse;
• if the patient has had seizures in the past.

Consult your doctor if the patient is pregnant, planning to become pregnant, breastfeeding,
or if the woman is of childbearing age (see section "Pregnancy and breastfeeding").
Treatment with Lorazepam Orion may lead to dependence.
The use of benzodiazepines (even at therapeutic doses) may lead to physical and psychological dependence. To reduce the risk of dependence, the lowest effective dose should be used for the shortest possible duration. Treatment usually should not last longer than 4 weeks. The need for continuing treatment should be assessed if treatment exceeds 4 weeks, and then regularly, preferably by the same doctor who initiated treatment. The duration of treatment should not exceed 2–3 months at most.
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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Exercise particular caution if the patient is taking the following medicines during treatment with Lorazepam Orion:

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

Concomitant use of these medicines may increase or decrease the effect of lorazepam or increase the risk of adverse effects.
Concomitant use of Lorazepam Orion with opioids (strong analgesics, medicines used in substitution therapy, and some antitussive medicines) increases the risk of sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when alternative treatment options are not possible.
If your doctor has prescribed Lorazepam Orion together with opioids, use the lowest effective dose, and treatment duration should be as short as possible.
Inform your doctor about all opioid medicines the patient is taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the possibility of the above-mentioned symptoms occurring in the patient.
If such symptoms occur, contact your doctor immediately.
Lorazepam Orion with food, drink, and alcohol
Tablets should be taken with liquid. The medicine can be taken with or without food.
Alcohol:
Do not drink alcohol while taking this medicine, as alcohol may alter or intensify the effects of Lorazepam Orion in an unpredictable manner.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Lorazepam Orion should not be used during pregnancy, especially during the first and third trimesters, as lorazepam may have a significant effect on the foetus.
If pregnancy occurs while taking Lorazepam Orion, inform your doctor immediately so that a decision on changing treatment can be made.
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 infant. The doctor will decide whether the patient should take this medicine during breastfeeding or discontinue breastfeeding, taking into account the expected benefits of treatment for the mother and the benefits of breastfeeding for the child.
Driving and operating machinery
Lorazepam Orion has a moderate or marked effect on the ability to drive and perform tasks requiring precision, as it impairs reaction ability and causes sedation, drowsiness, and muscle relaxation. In addition, Lorazepam Orion may cause adverse effects such as dizziness and visual disturbances. Do not drive or operate machinery while under the influence of lorazepam.
Lorazepam Orion contains lactose monohydrate
This medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Lorazepam Orion

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
The dosage and duration of treatment are individually determined for each patient.
Recommended dose:

• In 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, range from 1 to 7.5 mg. The largest dose should be taken before bedtime;
• In insomnia due to anxiety or transient situational stress, the average dose is 1 mg to 2 mg once daily, usually before bedtime;
• In elderly or 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 may be divided into equal doses.
For doses that cannot be achieved using tablets of this strength, after consultation with the 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.
Taking more than the recommended dose of Lorazepam Orion
If an overdose is taken or the medicine is accidentally ingested by a child, contact a doctor or hospital immediately to assess the risk and receive advice on necessary actions.
The following symptoms may occur: drowsiness, confusion, apathy, speech disturbances, unsteady movements, depression, low blood pressure, reduced muscle strength, breathing difficulties, fainting with weak pulse, pallor, bluish discoloration of lips and nails. In rare cases, coma may occur. In very rare cases, Lorazepam Orion poisoning may result in death.
Missed dose of Lorazepam Orion
Do not take a double dose to make up for a missed dose. Skip the missed dose and take the next scheduled dose as planned.
Stopping treatment with Lorazepam Orion
Treatment may only be discontinued or interrupted as directed by the physician.
The doctor may gradually reduce the dose of Lorazepam Orion, especially if high doses have been used or the treatment has been prolonged.
If the patient suddenly stops taking Lorazepam Orion, withdrawal symptoms may occur, such as headache, muscle pain, anxiety, tension, restlessness, depression, insomnia, sweating, dizziness, confusion, and irritability. Furthermore, symptoms previously alleviated by Lorazepam Orion may worsen after abrupt discontinuation.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Important adverse effects that require attention:
If any of the following symptoms occur, stop taking Lorazepam Orion and contact a doctor immediately or go to the emergency department of the nearest hospital:
severe allergic reaction. Symptoms of a severe allergic reaction include:

• rash, itching;
• swelling of the face, lips, mouth and throat, which may cause significant difficulty in swallowing and breathing (angioedema). This is a serious adverse effect. The patient may require urgent medical assistance or hospitalization.

Other possible adverse effects
Very common (occur in more than 1 in 10 people):

• sedation, fatigue, drowsiness;

Common (occur in up to 1 in 10 people):

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

Uncommon (occur in up to 1 in 100 people):

• headache, reduced alertness, emotional blunting;
• visual disturbances (including double vision and blurred vision);
• nausea, gastrointestinal discomfort, change in appetite;
• skin reactions;
• changes in libido, impotence, reduced intensity of orgasm;

Rare (occur in up to 1 in 1,000 people):

• changes in blood morphology (reduction in red blood cells, white blood cells and platelets);
• transient anterograde amnesia and memory disturbances;
• increased bilirubin levels, jaundice, increased liver enzyme activity (aminotransferases, alkaline phosphatase);

Very rare (occur in up to 1 in 10,000 people):

• hypersensitivity reactions and anaphylactic/pseudoanaphylactic reactions;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), decreased blood sodium concentration, low body temperature;
• disinhibition, euphoria, coma, suicidal thoughts or attempts, paradoxical reactions including: anxiety, agitation, excitement, hostility, aggression, anger, sleep disturbances/insomnia, increased sexual drive, hallucinations, extrapyramidal symptoms, tremor, dizziness, speech disorders, seizures, convulsions, coma;
• low blood pressure, decreased blood pressure;
• respiratory depression, apnoea, worsening of sleep apnoea, exacerbation of obstructive pulmonary disease;
• constipation;
• skin allergic reactions, alopecia.

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

• prolonged reaction time;
• concentration disturbances;
• balance disturbances;
• withdrawal syndrome;
• dependence.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Marketing Authorisation Holder or to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Adverse effects can also be reported directly to the Marketing Authorisation Holder.

Reporting adverse effects helps to provide more information on the safe use of this medicine.

5. How to store Lorazepam Orion

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging following “Expiry (EXP)”. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Medicines must 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 packaging and other information

What Lorazepam Orion contains

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

What Lorazepam Orion looks like and contents of the pack

Light yellow, round, flat uncoated tablets with bevelled edges, approximately 8 mm x 3.1 mm in size, marked with the symbol "2,5" embossed on one side and a deep score line on the other side. The tablet can be divided into equal doses.

Packaging:
Soft blister Aluminium/PE or OPA/Aluminium/PVC/Aluminium blister in a cardboard box.
Pack sizes:
Soft blister Aluminium/PE: 10, 20 and 30 tablets.
OPA/Aluminium/PVC/Aluminium blister: 10, 20, 25 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]