Lorafen

Package leaflet: Information for the patient

Lorafen, 1 mg, coated tablets
Lorafen, 2.5 mg, coated tablets
Lorazepamum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Lorafen is and what it is 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 Lorafen is and what it is used for

Lorafen contains lorazepam as the active substance, which belongs to a group of medicines called benzodiazepines. Lorafen has anxiolytic and hypnotic effects, as well as weaker anticonvulsant and skeletal muscle relaxant properties.
Lorafen is used short-term and on an as-needed basis in the treatment of:

• anxiety of various origins;
• sleep disturbances associated with states of heightened anxiety.

2. Important Information Before Using Lorafen

When not to use Lorafen
Do not use Lorafen if the patient has:

• Hypersensitivity (allergy) to lorazepam or any other benzodiazepine, or to any of the excipients listed in section 6;
• Severe respiratory insufficiency;
• Sleep apnoea syndrome (frequent, brief interruptions in breathing during sleep);
• Severe hepatic or renal insufficiency;
• Narrow-angle glaucoma;
• Myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
• Acute porphyria (a rare metabolic disorder related to blood);
• Alcohol intoxication or intoxication with drugs acting on the central nervous system.

Warnings and precautions
General information regarding effects observed during treatment with benzodiazepines and other drugs with benzodiazepine-like action, which should be considered when using Lorafen.

➢ Tolerance
After several weeks of treatment with Lorafen, its effectiveness may decrease.

➢ Dependence
Prolonged use of lorazepam may lead to psychological and physical dependence. The risk of developing dependence increases with higher doses and longer duration of treatment, and is greater in patients with alcohol or drug dependence, as well as in patients with personality disorders.

➢ Withdrawal symptoms
If Lorafen is abruptly discontinued, withdrawal symptoms may occur, such as: headache, muscle pain, increased anxiety, tension, restlessness, motor agitation, disorientation, sleep disturbances, irritability. In more severe cases, symptoms may include: loss of reality perception, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling and numbness in limbs, hallucinations and delusions, epileptic seizures.

➢ Rebound phenomenon and anxiety
During discontinuation of Lorafen, a transient recurrence of intensified symptoms that led to treatment initiation (so-called "rebound" phenomenon) may occur. These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of such symptoms, gradual dose reduction is recommended.

➢ Anterograde amnesia (inability to remember events after drug administration)
Lorafen may cause anterograde amnesia (difficulty learning and remembering new information – new data are not permanently stored). This condition most commonly occurs within a few hours after drug administration, especially at higher doses. If the physician has prescribed Lorafen once daily, to reduce the risk of anterograde amnesia, it is recommended to take the medication half an hour before bedtime and ensure adequate conditions for uninterrupted sleep lasting 7–8 hours.

➢ Psychiatric and paradoxical reactions
In children and elderly patients, the risk of psychiatric and paradoxical (opposite to expected) reactions is increased, such as: anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disturbances.
If such symptoms occur, contact a physician immediately.

Specific patient groups

➢ Elderly patients should receive lower doses of Lorafen (see section 3), due to increased risk of adverse effects, particularly disturbances in orientation and motor coordination (falls, injuries).

➢ Patients with hepatic or renal insufficiency or chronic respiratory insufficiency should inform their physician about their condition before taking Lorafen.

➢ Use in depression: Before using Lorafen, inform the physician about any psychiatric disorders. Patients with symptoms of depression or anxiety associated with depression should be treated with multiple medications. Administering Lorafen alone to patients with depression may worsen depressive symptoms, including suicidal thoughts.

➢ During benzodiazepine treatment, masked depression may emerge.

➢ Patients dependent on alcohol, narcotics, or drugs should inform their physician about such habits before taking Lorafen, as they have a high risk of developing psychological and physical dependence. This group of patients should use Lorafen under strict medical supervision.

➢ Lorafen in patients with porphyria may exacerbate symptoms of this disease. Patients with porphy游戏副本

3. How to use Lorafen

Lorafen should always be taken exactly as prescribed by the doctor.
If in doubt, consult your doctor.
Adults and children over 12 years of age
For anxiety disorders, the initial dose is usually 2 mg to 3 mg of lorazepam per day, divided into 2 or
3 doses. If necessary, the doctor may increase the dose up to
6 mg per day, in 2 or 3 divided doses.
The doctor will gradually increase the dose, starting with increasing the evening dose. The maximum dose is 10 mg/day.
For sleep disturbances caused by anxiety, the usual dose is 2 mg to 4 mg of lorazepam once daily before bedtime.
Children under 12 years of age
The safety and efficacy of lorazepam in children under 12 years of age have not been established.
Elderly patients
Usually, half the dose recommended for adult patients is sufficient (see section 2, Warnings and
precautions).
Duration of treatment
The duration of treatment will be 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, gradually increase it.
Use of a higher than recommended dose of Lorafen
Symptoms of overdose include disturbances in consciousness, drowsiness, slurred speech. In severe
cases of poisoning, the following may occur: impaired motor coordination, hypotension, muscle weakness,
respiratory depression, coma, and even death.
If a higher than recommended dose of Lorafen has been taken, contact a doctor immediately or go to the nearest hospital emergency department.
The medicine should be brought in its original packaging so that the medical staff can clearly identify which drug was taken.
Missed dose of Lorafen
If a patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken as scheduled.
If a patient forgets to take two or more doses, they should contact their doctor.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Lorafen
Do not stop taking the medicine unless advised by the doctor. Symptoms of the illness may recur. If the doctor decides to discontinue treatment, the dose should be gradually reduced over several days.
If in doubt about how to use the medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of adverse reactions after using the medicine has been 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 based on available data.

Serious adverse reactions

• Occurring rarely:

• confusion, states of excitement and agitation, depression

• yellowing of the skin or whites of the eyes, brown-colored urine – these may be symptoms of jaundice

• Occurring very rarely:

• severe allergic reaction such as itching, swelling of lips or tongue, wheezing, or shortness of breath

• Occurring with unknown frequency:

• depression with suicidal tendencies, anxiety, irritability, hallucinations, nightmares, illusions (seeing or hearing things that are not real), psychosis (loss of contact with reality), unusual behaviors. These disorders most commonly occur after alcohol consumption, in elderly individuals, or in patients with psychiatric disorders.

• coma
  ➢ If any of the above adverse symptoms occur, you should immediately inform your doctor or go to the nearest hospital emergency department.

Other adverse reactions that may occur during treatment with Lorafen
The following adverse reactions occur very commonly:

• Drowsiness, slowed reaction time

The following adverse reactions occur commonly:

• Muscle weakness

The following adverse reactions occur rarely:

• Allergic skin reactions – rashes, itching, hives
• Confusion, emotional disturbances, loss of self-control, impulsiveness, euphoria, sleep disturbances, emergence of previously existing but undiagnosed depression
• Headache, dizziness, disturbances of consciousness and disorientation, lack of motor coordination. These effects most commonly occur at the beginning of treatment, in elderly patients, and usually resolve during continued therapy.
• Memory disturbances, speech difficulties
• Visual disturbances (blurred or double vision)
• Slight decrease in blood pressure
• Nausea, stomach discomfort, dry mouth sensation
• Slight increase in liver enzyme activity, liver function disturbances with development of jaundice (yellowing of the skin and whites of the eyes)

The following adverse reactions occur very rarely:

• Changes in the number of certain blood cells

The following adverse reactions occur with unknown frequency:

• Loss of appetite
• Paradoxical reactions – psychomotor agitation, insomnia, increased excitability and aggression, muscle tremors, seizures. Paradoxical reactions most commonly occur after alcohol consumption, in elderly patients, and in patients with psychiatric disorders.
• Psychological and physical dependence. Patients who abuse alcohol or drugs are more susceptible to developing dependence.
• Withdrawal syndrome after abrupt discontinuation of the medicine
• Impaired motor coordination
• Trembling around the mouth, rhythmic finger tremors, uncontrolled movements, twisting movements of the head, trunk, or face
• Slowed heart rate, chest pain
• Urinary retention, urinary incontinence
• Menstrual disorders, disturbances in sexual drive
• General weakness, fainting

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lorafen

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep 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 stated month.
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 package and other information

What Lorafen contains
The active substance is lorazepam.
Lorafen 1 mg: One coated tablet contains 1 mg of lorazepam.
Other ingredients: 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 coated tablet contains 2.5 mg of lorazepam.
Other ingredients: potato starch, sodium carboxymethyl starch (type A), gelatin, talc,
carmoisine (E-124), magnesium stearate, lactose monohydrate, polyvinyl alcohol,
maltodextrin, sucrose, carmoisine lake (E-124), titanium dioxide, Opaglos 6000

What Lorafen looks like and contents of the pack
Lorafen 1 mg: White, round, biconvex, smooth coated tablets.
Lorafen 2.5 mg: Pink, round, biconvex, smooth coated tablets.
Pack: 25 coated tablets

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: 22 811-18-14

For further information, please contact the representative of the Marketing Authorisation Holder.