LORAFEN 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lorafen, 1 mg, scored tablets
3. Lorafen, 2.5 mg, scored tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
4. What is Lorafen and what is it used for
5. Important information before taking Lorafen
   1. When not to take Lorafen
   2. Warnings and precautions
   3. Other medicines and Lorafen
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Lorafen 1 mg contains excipients with known effects:
   7. Lorafen 2.5 mg contains excipients with known effects:
6. How to take Lorafen
   1. Adults and children over 12 years
   2. Children under 12 years
   3. Elderly patients
   4. Duration of treatment
   5. Method of administration
   6. Taking a higher dose of Lorafen than recommended
   7. Missing a dose of Lorafen
   8. Stopping treatment with Lorafen
7. Possible side effects
   1. Severe side effects
   2. Other side effects that may occur after treatment with Lorafen
   3. Reporting side effects
8. How to store Lorafen
9. Contents of the pack and other information
   1. What Lorafen contains
   2. What Lorafen looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

Lorafen, 1 mg, scored tablets

Lorafen, 2.5 mg, scored tablets

Lorazepam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Lorafen and what is it used for

Lorafen contains the active substance lorazepam, which belongs to a group of medicines called benzodiazepines. Lorafen has anxiolytic, sedative, and weaker anticonvulsant and muscle relaxant effects. Lorafen is used for short-term treatment of:

• anxiety of various origins;
• sleep disorders associated with anxiety.

2. Important information before taking Lorafen

When not to take Lorafen

If the patient has:

• hypersensitivity (allergy) to lorazepam or other benzodiazepines or any of the excipients of the medicine (listed in section 6);
• severe respiratory failure;
• sleep apnea syndrome (frequent, short pauses in breathing during sleep);
• severe liver and kidney failure;
• glaucoma with a narrow angle of vision;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue);
• acute porphyria (a rare metabolic disorder related to blood);
• alcohol or drug intoxication.

Warnings and precautions

General information about the effects observed after treatment with benzodiazepines and other medicines with similar effects to benzodiazepines, which should be taken into account when using Lorafen.

Tolerance: After taking Lorafen for several weeks, its effectiveness may decrease.

Dependence: Long-term use of lorazepam can lead to psychological and physical dependence. The risk of dependence increases with the dose and duration of treatment and is higher in patients addicted to alcohol or drugs, as well as in patients with personality disorders.

Withdrawal symptoms: In case of sudden withdrawal of the medicine, the patient may experience withdrawal symptoms, such as headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations, and delusions, epileptic seizures.

Rebound phenomenon and anxiety: When discontinuing Lorafen, a transient recurrence of intensified symptoms that were the reason for taking the medicine (so-called rebound phenomenon) may occur. These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these symptoms, it is recommended to gradually reduce the dose of the medicine.

Anterograde amnesia (inability to remember events after taking the medicine): Lorafen may cause anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored). This condition usually occurs within a few hours of taking the medicine, especially in high doses. If the doctor has prescribed taking Lorafen once a day, to reduce the risk of anterograde amnesia, it is recommended to take the medicine half an hour before going to bed and ensuring adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

Psychological and paradoxical reactions: In children and the elderly, the risk of abnormal psychological and paradoxical reactions (opposite to expected) increases, such as anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disorders. If such symptoms occur, you should contact your doctor immediately.

Specific patient groups:

Patient with impaired liver or kidney function or with chronic respiratory failure should inform their doctor about their condition before taking Lorafen.

Patients with depression: Before taking Lorafen, patients should inform their doctor about any mental illnesses. Patients with symptoms of depression or anxiety associated with depression should take several medicines at the same time. Administering Lorafen to patients with depression may exacerbate symptoms of depression, including suicidal thoughts.

Patients addicted to alcohol, drugs, or medicines should inform their doctor about these addictions before taking Lorafen, as they are at high risk of developing psychological and physical dependence. This group of patients should take Lorafen under close medical supervision.

Other medicines and Lorafen

Tell your doctor about all medicines you are taking or have recently taken, as well as medicines you plan to take. This is especially important if you are taking any of the following medicines or drinking alcohol:

• fluvoxamine, fluoxetine, and other medicines used to treat mental illnesses
• medicines used to treat insomnia
• medicines used to treat allergic diseases that can cause drowsiness
• medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin)
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine, omeprazole, cisapride)
• rifampicin (a medicine used to treat tuberculosis)
• ketoconazole (an antifungal medicine)
• medicines used for general anesthesia
• strong painkillers (e.g., morphine, codeine)
• muscle relaxants (e.g., baclofen)
• medicines used to treat Parkinson's disease (e.g., levodopa)
• oral contraceptives
• alcohol: drinking alcohol while taking Lorafen may enhance its effect and lead to paradoxical reactions, such as psychomotor excitement, aggressive behavior (see section 2, Warnings and precautions).
• opioids: concomitant use of Lorafen and opioids (strong painkillers, medicines used for substitution therapy, some cough medicines) increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered when other treatment options are not possible. If the doctor prescribes Lorafen concomitantly with opioids, it should be in a limited dose and for the shortest possible duration of concomitant treatment. The patient should inform the doctor about all opioid medicines being taken and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform friends or relatives to be aware of the possibility of these symptoms. If such symptoms occur, you should contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lorafen should not be taken during pregnancy. Lorafen passes into breast milk. If there is a need to administer the medicine, breastfeeding should be discontinued.

Driving and using machines

Do not drive or operate machinery while taking Lorafen. The ability to drive or operate machinery may be impaired due to the possibility of somnolence, decreased concentration, or other adverse effects that reduce concentration (see section 4, Possible side effects).

Lorafen 1 mg contains excipients with known effects:

• lactose and sucrose: if you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
• sodium: less than 1 mmol (23 mg) of sodium per scored tablet, which means the medicine is considered "sodium-free".

Lorafen 2.5 mg contains excipients with known effects:

• lactose and sucrose: if you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
• cochineal red (E 124), which may cause allergic reactions.
• sodium: less than 1 mmol (23 mg) of sodium per scored tablet, which means the medicine is considered "sodium-free".

3. How to take Lorafen

Always take Lorafen exactly as your doctor has told you. If you are not sure, ask your doctor.

Adults and children over 12 years

For anxiety disorders, the usual initial dose is 2 mg to 3 mg of lorazepam per day in 2 or 3 divided doses, and then, if necessary, the doctor will increase the dose to 6 mg per day in 2 or 3 divided doses. The dose of lorazepam will be increased gradually, starting with an increase in the evening dose. The maximum dose is 10 mg per day.

Children under 12 years

The safety and efficacy of lorazepam in children under 12 years have not been established.

Elderly patients

Usually, half of the recommended dose for adults is sufficient (see section 2, Warnings and precautions).

Duration of treatment

The duration of treatment is determined by the doctor.

Method of administration

Lorafen tablets should be swallowed with a small amount of water. The doctor will start treatment with the lowest effective dose and, if necessary, will gradually increase it.

Taking a higher dose of Lorafen than recommended

Symptoms of overdose are impaired consciousness, somnolence, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma, and even death. If you have taken a higher dose of Lorafen than recommended, you should immediately contact your doctor or go to the nearest emergency department in a hospital. You should take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken.

Missing a dose of Lorafen

If you miss a dose, you should take the next dose as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose and take the next dose as scheduled. If you miss two or more doses, you should contact your doctor. Do not take a double dose to make up for a missed dose.

Stopping treatment with Lorafen

Do not stop taking Lorafen unless your doctor tells you to. It is possible that the symptoms of the disease will recur. If the doctor decides to stop treatment, the dose of the medicine should be gradually reduced over several days. In case of doubts about taking the medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, Lorafen can cause side effects, although not everybody gets them. The frequency of side effects occurring after taking the medicine is defined as follows: very common- occurs in more than 1 in 10 people; common- occurs in less than 1 in 10 people; uncommon- occurs in less than 1 in 100 people; rare- occurs in less than 1 in 1,000 people; very rare- occurs in less than 1 in 10,000 people; frequency not known- cannot be estimated from the available data.

Severe side effects

• occurring rarely:
• disorientation, excitement, and agitation, depression
• jaundice, dark urine - these may be symptoms of liver disease
• occurring very rarely:
• severe allergic reaction with symptoms such as itching, swelling of the lips or tongue, or wheezing and shortness of breath
• occurring with unknown frequency:
• depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses (loss of contact with reality), abnormal behavior. These disorders most often occur after consuming alcohol and in elderly patients or patients with mental illnesses.
• coma. If any of the above side effects occur, you should immediatelyinform your doctor or go to the nearest emergency department in a hospital.

Other side effects that may occur after treatment with Lorafen

The following side effects occur very commonly:

• sleepiness, slowed reactions

The following side effects occur commonly:

• muscle weakness

The following side effects occur rarely:

• allergic skin reactions - rashes, itching, hives
• disorientation, emotional disturbances, lack of self-control, impulsiveness, euphoria, sleep disturbances, revelation of previously existing but unrecognized depression
• headache and dizziness, impaired consciousness and disorientation. These effects most often occur at the beginning of treatment, in elderly patients, and usually disappear during continued treatment.
• memory disorders, speech disorders
• vision disorders (blurred, double vision)
• mild decrease in blood pressure
• nausea, stomach discomfort, dry mouth
• mild increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin, whites of the eyes).

The following side effects occur very rarely:

• change in the number of some blood cells

The following side effects occur with unknown frequency:

• loss of appetite
• paradoxical reactions - psychomotor anxiety, insomnia, increased excitability and aggression, muscle tremors, seizures. Paradoxical reactions most often occur after consuming alcohol, in elderly patients, and in patients with mental illnesses.
• psychological and physical dependence. Patients who abuse alcohol or drugs are more prone to developing dependence.
• withdrawal syndrome after sudden discontinuation of the medicine
• coordination disorders
• tremors around the mouth, rhythmic finger tremors, uncontrolled movements, twisting of the head, torso, face.
• slow heart rate, chest pain
• urinary retention, incontinence
• menstrual disorders, sexual desire disorders
• general weakness, fainting

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 the medicine.

5. How to store Lorafen

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

6. Contents of the pack and other information

What Lorafen contains

The active substance of the medicine is lorazepam. Lorafen 1 mg: one scored tablet contains 1 mg of lorazepam. The other ingredients are potato starch, sodium carboxymethyl starch (type A), gelatin, talc, magnesium stearate, lactose monohydrate, polyvinyl alcohol, maltodextrin, sucrose, titanium dioxide, Opaglos 6000. Lorafen 2.5 mg: one scored tablet contains 2.5 mg of lorazepam. The other ingredients are potato starch, sodium carboxymethyl starch (type A), gelatin, talc, cochineal red (E-124), magnesium stearate, lactose monohydrate, polyvinyl alcohol, maltodextrin, sucrose, cochineal red lake (E-124), titanium dioxide, Opaglos 6000.

What Lorafen looks like and contents of the pack

Lorafen, 1 mg: white, round, biconvex, smooth scored tablets. Lorafen, 2.5 mg: pink, round, biconvex, smooth scored tablets. Packaging:25 scored tablets

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, phone: 22 811-18-14. For more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the package leaflet: