MEDAZEPAM 10 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Medazepam TZF, 10 mg, hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Medazepam TZF and what is it used for
4. Important information before taking Medazepam TZF
   1. When not to take Medazepam TZF
   2. Warnings and precautions
   3. Medazepam TZF and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
5. How to take Medazepam TZF
   1. Adults
   2. Children
   3. If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.
   4. Duration of treatment
   5. Method of administration
   6. Use of a higher than recommended dose of Medazepam TZF
   7. Missing a dose of Medazepam TZF
   8. Stopping treatment with Medazepam TZF
6. Possible side effects
   1. Severe side effects
   2. Other side effects that may occur after treatment with Medazepam TZF
   3. Reporting side effects
7. How to store Medazepam TZF
8. Contents of the packaging and other information
   1. What Medazepam TZF contains
   2. What Medazepam TZF looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

Leaflet accompanying the packaging: patient information

Medazepam TZF, 10 mg, hard capsules

Medazepam

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

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Medazepam TZF and what is it used for

Medazepam TZF contains the active substance medazepam, which belongs to a group of medicines called benzodiazepines. Medazepam TZF has an anxiolytic effect, exhibits moderate muscle relaxant activity, and has a weak sedative and anticonvulsant effect. Indications for use: The medicine is used for short-term treatment:

• of anxiety disorders of various origins, especially in the course of neuroses (particularly organ neuroses);
• of increased mental tension and excitement.

2. Important information before taking Medazepam TZF

When not to take Medazepam TZF

If the patient has:

• hypersensitivity (allergy) to medazepam or other benzodiazepines or any of the excipients of the medicine (listed in section 6);
• severe respiratory failure;
• sleep apnea syndrome (breathing disorders during sleep);
• severe liver failure;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue).

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 taking Medazepam TZF.

• Tolerance: After taking Medazepam TZF for several weeks, its effectiveness may decrease.

• Dependence: Long-term use of Medazepam TZF may lead to psychological and physical dependence. The risk of developing dependence increases with the dose and duration of treatment and is higher in patients who are dependent on 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, agitation, restlessness, disorientation, sleep disturbances, and irritability. In severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, tingling, and numbness of limbs, hallucinations, and delusions, seizures.

• Rebound phenomenon and anxiety: When discontinuing Medazepam TZF, 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): Medazepam TZF 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 Medazepam TZF once a day, to reduce the risk of anterograde amnesia, it is recommended to take the medicine 30 minutes before going to bed and ensure adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

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

Special patient groups

• Elderly patients should receive lower doses of Medazepam TZF (see section 3), due to the possibility of increased side effects, mainly orientation and motor coordination disorders (falls, injuries).

• Patients with liver or kidney failure, or with chronic respiratory failure, should inform their doctor about these diseases before taking Medazepam TZF.

• Patients with closed-angle glaucoma should inform their doctor about this disease.

• Medazepam TZF may exacerbate the symptoms of porphyria in patients with this disease. Patients with porphyria should inform their doctor about this disease before starting treatment.

• Use in depression: Before taking Medazepam TZF, you should inform your doctor about any mental health conditions. Patients with symptoms of depression or anxiety associated with depression should take several medicines at the same time. Administering Medazepam TZF alone to patients with depression may worsen the symptoms of the disease, including suicidal thoughts.

• Patients addicted to alcohol, drugs, or medicines should inform their doctor about these addictions before taking Medazepam TZF. These patients are at high risk of developing psychological and physical dependence. Therefore, this group of patients should take Medazepam TZF only under the strict control of a doctor.

• Taking Medazepam TZF in people who are grieving after the loss of loved ones does not improve their well-being.

Medazepam TZF and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take. You should also inform your doctor if you drink alcohol. 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 health conditions;
• medicines used for insomnia;
• medicines used for allergic diseases that can cause drowsiness;
• medicines used for epilepsy (e.g., carbamazepine, phenytoin, hydantoin);
• medicines used for 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 for Parkinson's disease (e.g., levodopa);
• oral contraceptives;
• alcohol: drinking alcohol while taking Medazepam TZF may enhance its effect and lead to paradoxical reactions, such as psychomotor agitation, aggressive behavior (see section 2. Warnings and precautions).
• opioids: concomitant use of Medazepam TZF and opioids (strong painkillers, medicines used for substitution therapy, some cough medicines) increases the risk of drowsiness, 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 your doctor prescribes Medazepam TZF with opioids, they should limit the dose and duration of concomitant treatment. You should inform your doctor about all the opioid medicines you are taking and strictly follow the doctor's instructions for dosing. It may be helpful to inform your friends or relatives to be aware of the possibility of the above-mentioned 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 plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Medazepam TZF should not be taken during pregnancy. Medazepam passes into breast milk. If it is necessary to administer the medicine, breastfeeding should be discontinued.

Driving and operating machinery

During treatment with Medazepam TZF, you should not drive vehicles or operate machinery. The ability to drive vehicles and operate machinery may be impaired due to the possibility of drowsiness, concentration disorders, or other side effects that reduce concentration (see section 4. Possible side effects). Medazepam TZF contains lactose.If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. Medazepam TZF contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Medazepam TZF

Medazepam TZF should always be taken according to the doctor's instructions. In case of doubts, you should consult a doctor.

Adults

• In anxiety disorders: usually 10 mg to 30 mg per day in 2 or 3 divided doses.
• In conditions of increased tension and excitement: usually 10 mg to 30 mg per day in 2 or 3 divided doses. If necessary, the doctor may increase the dose of the medicine. The dose of medazepam should be increased gradually, starting with an increase in the dose taken in the evening. A maximum of 60 mg per day can be administered.

Children

Medazepam TZF is not recommended for use in children.

If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Duration of treatment

The duration of treatment is determined by the doctor.

Method of administration

Medazepam TZF capsules should be taken orally, before meals, with a small amount of water. The doctor will start treatment with the smallest effective dose and, if necessary, will gradually increase it.

Use of a higher than recommended dose of Medazepam TZF

Symptoms of overdose are impaired consciousness, drowsiness, confusion, 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 Medazepam TZF than recommended, you should immediately consult a doctor or go to the nearest emergency department in a hospital. You should take the medicine in its original packaging, so the medical staff can accurately check which medicine was taken.

Missing a dose of Medazepam TZF

If you forget to take a dose of the medicine, you should take the next dose as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose and take the next one according to the prescription. If you forget to take two or more doses, you should consult a doctor. You should not take a double dose to make up for the missed dose.

Stopping treatment with Medazepam TZF

You should not stop taking the medicine unless it is in accordance with the doctor's instructions. It is possible that the symptoms of the disease will recur. If the doctor decides to discontinue the medicine, the dose should be gradually reduced over several days. If you have any further doubts about taking this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, Medazepam TZF can cause side effects, although not everybody gets them.

Severe side effects

If you experience any of the following side effects, you should immediatelyinform your doctor or go to the nearest emergency department in a hospital.

• Severe allergic reaction in the form of itching, swelling of the lips or tongue, or wheezing, or shortness of breath. These symptoms have been reported very rarely(less than 1 in 10,000 patients).

• Disorientation, excitement, and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses (loss of contact with reality), abnormal behavior. These disorders occur rarely(less than 1 in 1,000 patients) - most often after consuming alcohol, in the elderly, or in patients with mental health conditions.

Other side effects that may occur after treatment with Medazepam TZF

The following side effects occur frequently(less than 1 in 10 patients)

• feeling of drowsiness, dizziness, and slowed reactions may occur during the first few days of treatment in elderly patients and usually disappear during further treatment.

The following side effects occur infrequently(less than 1 in 100 people)

• visual disturbances (blurred, double vision);
• nausea, stomach upset, dry mouth.

The following side effects occur rarely(less than 1 in 1,000 patients)

• changes in the number of some blood cells;
• skin allergic reactions - rash, itching, hives;
• loss of appetite;
• psychological and physical dependence may develop during treatment with therapeutic doses. Sudden discontinuation of treatment may cause withdrawal syndrome. Patients who abuse alcohol or drugs are more prone to developing dependence. During treatment with Medazepam TZF, previously undiagnosed depression may be revealed.
• drowsiness, memory disorders, coordination disorders, speech disorders, changes in libido - these symptoms mainly affect patients taking high doses of the medicine;
• increased intraocular pressure;
• chest pain, breathing difficulties;
• liver function disorders with jaundice (yellowing of the skin, whites of the eyes);
• muscle tremors, muscle weakness, decreased muscle strength;
• urinary retention or incontinence;
• menstrual disorders, breast enlargement in men (gynecomastia).

The following side effects occur very rarely(less than 1 in 10,000 patients)

• involuntary twisting and bending of different parts of the body (dystonia), coordination disorders (ataxia), motor disorders, epilepsy, paranoid symptoms, depersonalization.

The frequency of the following symptoms cannot be determined from the available data

• increased prolactin levels in the blood;
• loss of appetite;
• mild decrease in blood pressure;
• general weakness.

Reporting side effects

If you experience any side effects, including any side effects not listed in the 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the Department} Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Medazepam TZF

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

6. Contents of the packaging and other information

What Medazepam TZF contains

The active substance of the medicine is medazepam. Each hard capsule contains 10 mg of medazepam. The other ingredients are: potato starch, rice starch, gelatin, sodium carboxymethyl starch, magnesium stearate, talc, lactose monohydrate The composition of the capsule shell is: quinoline yellow (E 104), red iron oxide (E 172), titanium dioxide (E 171), gelatin

What Medazepam TZF looks like and what the packaging contains

Opaque yellow capsules, size 3. The contents of the capsules - powder, white to light cream in color. Packaging:20 hard capsules

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna ul. A. Fleminga 2 03-176 Warszawa Phone: 22 811-18-14 In order to obtain more detailed information about this medicine, you should contact the marketing authorization holder.

Date of the last update of the leaflet: