Medazepam tzf

Package leaflet: information for the patient

Medazepam TZF, 10 mg, hard capsules
Medazepamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any questions or doubts.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, 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 Medazepam TZF is and what it is 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 pack and other information

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

Medazepam TZF contains medazepam as the active substance, which belongs to a group of medicines called benzodiazepines. Medazepam TZF has anxiolytic properties and shows moderate skeletal muscle relaxant effects. Its hypnotic and anticonvulsant effects are weak.

Indications
The medicine is used on a short-term and temporary basis:

• in anxiety states of various origins, particularly in neuroses (especially somatoform neuroses);
• in states of increased psychological tension and agitation.

2. Important information before using Medazepam TZF

When not to use Medazepam TZF
Do not use if the patient has:

• hypersensitivity (allergy) to medazepam or to any other benzodiazepine or to any of the excipients listed in section 6;
• severe respiratory insufficiency;
• sleep apnoea syndrome (breathing disorders during sleep);
• severe hepatic insufficiency;
• myasthenia gravis (a disease causing muscle weakness and excessive fatigue).

Warnings and precautions
General information regarding effects observed with benzodiazepines and other drugs with similar action, which should be considered when using Medazepam TZF.

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

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

➢ Withdrawal symptoms
If Medazepam TZF is stopped abruptly, withdrawal symptoms may occur, such as: headache, muscle pain, increased anxiety, tension, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of reality, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling and numbness of limbs, hallucinations and delusions, epileptic seizures.

➢ Rebound phenomenon and anxiety
During discontinuation of Medazepam TZF, a transient return of intensified symptoms that led to treatment initiation may occur (so-called "rebound" phenomenon). 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 taking the drug)
Medazepam TZF may cause anterograde amnesia (difficulty in learning and memorizing new information – new data are not permanently stored). This condition usually occurs within a few hours after administration, especially at higher doses. If the physician has recommended taking Medazepam TZF once daily, to reduce the risk of amnesia, it is recommended to take the medicine 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, agitation, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disturbances.
If such symptoms occur, contact the physician immediately.

Special patient groups

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

➢ Patients with hepatic or renal impairment, or with chronic respiratory insufficiency, should inform the physician about these conditions before taking Medazepam TZF.

➢ Patients with closed-angle glaucoma should inform the physician about this condition.

➢ Medazepam TZF in patients with porphyria may exacerbate symptoms of this disease. Patients with porphyria should inform the physician before starting treatment.

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

➢ Patients addicted to alcohol, narcotics or drugs should inform the physician about these dependencies before taking Medazepam TZF. These patients are at high risk of developing psychological and physical dependence. Therefore, this group of patients should use Medazepam TZF only under strict medical supervision.

➢ Use of Medazepam TZF in individuals grieving the loss of a loved one does not improve well-being.

Medazepam TZF and other medicines
Inform the physician about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Also inform the physician if the patient drinks alcohol.
This is particularly important if the patient is taking any of the following medicines or consuming alcohol:

• fluvoxamine, fluoxetine, and other medicines used in the treatment of psychiatric disorders;
• medicines used for insomnia;
• medicines used in allergic conditions that may cause drowsiness;
• medicines used in epilepsy (e.g. carbamazepine, phenytoin, hydantoin);
• medicines used in peptic ulcer disease (e.g. cimetidine, omeprazole, cisapride);
• rifampicin (a medicine used in tuberculosis treatment);
• ketoconazole (an antifungal medicine);
• medicines used for general anaesthesia;
• strong analgesics (e.g. morphine, codeine);
• skeletal muscle relaxants (e.g. baclofen);
• medicines used in Parkinson’s disease (e.g. levodopa);
• oral contraceptives;
• alcohol: drinking alcohol while taking Medazepam TZF may enhance its effects and lead to paradoxical reactions such as psychomotor agitation and aggressive behaviour (see section 2. Warnings and precautions).
• opioids: concomitant use of Medazepam TZF and opioids (strong analgesics, medicines used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when no other treatment options are available.

However, if the physician prescribes Medazepam TZF together with opioids, the dose and duration of concomitant treatment should be limited.
The patient should inform the physician about all opioid medicines being taken and strictly follow the physician’s dosing instructions. It may be helpful to inform friends or family members about the possibility of developing the above-mentioned symptoms. If such symptoms occur, contact the physician immediately.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a physician or pharmacist before using this medicine.
Medazepam TZF should not be used during pregnancy.
Medazepam passes into breast milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery
During treatment with Medazepam TZF, patients should not drive or operate machinery.
The ability to drive and operate machinery may be impaired due to possible occurrence of drowsiness, concentration disturbances, or other adverse effects that reduce concentration (see section 4. Possible adverse effects).

Medazepam TZF contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.
Medazepam TZF contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Medazepam TZF

Medazepam TZF must always be taken as directed by the physician.
In case of doubt, consult your doctor.

Adults

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

Children
Medazepam TZF is not recommended for use in children.

If during treatment the patient feels that the effect of the medicine is too strong or too weak, they should consult their 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 lowest effective dose and, if necessary, gradually increase it.

Use of a higher than recommended dose of Medazepam TZF
Symptoms of overdose include disturbances of consciousness, drowsiness, confusion, and slurred speech. In severe cases of poisoning, the following may occur: motor incoordination, hypotension, muscle weakness, respiratory depression, coma, and even death.

In case of ingestion of a higher than recommended dose of Medazepam TZF, seek immediate medical attention by contacting a doctor or going to the nearest hospital emergency department. Bring the medicine in its original packaging so that medical staff can accurately identify which medicine was taken.

Missed dose of Medazepam TZF
If the 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 scheduled dose, the missed dose should be skipped and the next dose taken according to the prescribed schedule. If the patient misses two or more doses, they should contact their doctor.

Do not take a double dose to make up for a missed dose.

Discontinuation of Medazepam TZF
Do not stop taking the medicine unless instructed by the doctor. There is a possibility of recurrence of disease symptoms. If the doctor decides to discontinue treatment, the dose should be gradually reduced over several days.

If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following adverse symptoms occur, you should immediately
contact your doctor or go to the nearest hospital emergency department.
➢ Severe allergic reaction presenting as itching, swelling of the lips or tongue, or wheezing
or difficulty breathing. These symptoms have been reported very rarely (less than 1 in 10,000 patients).
➢ Disorientation, excitement and agitation, depression with suicidal tendencies, anxiety,
irritability, hallucinations, nightmares, illusions (seeing or hearing things that do not exist),
psychoses (loss of contact with reality), unusual behaviour. These disorders occur
rarely (less than 1 in 1,000 patients) – most frequently after alcohol consumption, in elderly patients or in patients with psychiatric disorders.
Other adverse reactions that may occur during treatment with Medazepam TZF
The following adverse reactions occur frequently (less than 1 in 10 patients)

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

The following adverse reactions occur uncommonly (less than 1 in 100 people)

• visual disturbances (blurred or double vision);
• nausea, gastrointestinal discomfort, dry mouth.

The following adverse reactions occur rarely (less than 1 in 1,000 patients)

• changes in the number of certain blood cells;
• skin allergic reactions – rash, itching, urticaria;
• loss of appetite;
• psychological and physical dependence may develop during treatment at therapeutic doses. Abrupt discontinuation of treatment may lead to withdrawal syndrome. Patients who abuse alcohol or drugs are more susceptible to developing dependence. Treatment with Medazepam TZF may unmask previously existing, undiagnosed depression.
• drowsiness, memory disturbances, motor coordination disorders, speech disturbances, changes in libido – these symptoms mainly affect patients taking high doses of the medicine;
• increased intraocular pressure;
• chest pain, difficulty breathing;
• liver function disorders with jaundice (yellowing of the skin and whites of the eyes);
• muscle tremors, muscle flaccidity, decreased muscle strength;
• urinary retention or incontinence;
• menstrual disorders, breast gland enlargement in men (gynaecomastia).

The following adverse reactions occur very rarely (less than 1 in 10,000 patients)

• involuntary twisting and bending of various body parts (dystonia), disturbances in body motor coordination (ataxia), motor disorders, seizures, paranoid symptoms, depersonalisation.

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

• increased blood levels of the hormone prolactin;
• loss of appetite;
• slight decreases in blood pressure;
• generalised weakness.

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 Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products {current address, telephone number and fax number of the above Department}.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Medazepam TZF

Keep out of the sight and reach of children.
Store below 25 °C. Keep in the original packaging to protect from light.
Do not use this 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. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

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

What Medazepam TZF looks like and contents of the pack
Opaque yellow hard capsules size number 3.
The contents of the capsules: powder ranging from white to light cream.
Pack size: 20 hard capsules

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 on this medicinal product, please contact the Marketing Authorisation Holder.