Oxazepam tzf

Package leaflet: Information for the patient

Oksazepam TZF, 10 mg, coated tablets
Oxazepamum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

Oksazepam TZF belongs to the group of benzodiazepine derivatives. It exerts an inhibitory effect on many structures of the central nervous system, especially those involved in regulating emotional processes. The medicine has anxiolytic and weaker hypnotic effects. Oksazepam TZF also has weak skeletal muscle relaxant and anticonvulsant properties.

Indications for use
Short-term and temporary use:

• In anxiety disorders associated with neuroses and other psychosomatic disorders.
• In functional sleep disturbances.

States of tension and anxiety related to everyday problems are not indications for the use of this medicine.

2. Important information before using Oksazepam TZF

When not to use Oksazepam TZF:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in patients with severe respiratory insufficiency or sleep apnoea episodes,
• in patients with severe liver impairment, myasthenia gravis, or acute porphyria,
• in patients experiencing conditions associated with phobias, obsessions, or chronic psychoses,
• in patients with alcohol intoxication,
• with hypnotics or other medicines that depress the central nervous system.

Warnings and precautions
Before starting treatment with Oksazepam TZF, consult your doctor or pharmacist.
If there is no improvement after 7–14 days of treatment, or if symptoms recur, the patient should consult a doctor.

Tolerance
Regular use of Oksazepam TZF for several weeks may lead to reduced effectiveness of the medicine.

Dependence
Treatment with Oksazepam TZF may lead to psychological and physical dependence. The risk increases with higher doses and longer duration of treatment, and is greater in patients who have previously been dependent on alcohol or drugs. Such patients should inform their doctor, as Oksazepam TZF should only be used under strict medical supervision.

Withdrawal symptoms
If physical dependence has developed, abrupt discontinuation of the medicine may lead to withdrawal syndrome. Characteristic symptoms include: headache, muscle pain, intense anxiety and emotional tension, motor restlessness, confusion, disorientation, irritability, and insomnia.
In more severe cases, symptoms may include: loss of reality perception, personality disturbances, hypersensitivity to touch, acoustic and light stimuli, tingling and numbness in limbs, hallucinations, or seizures.

Rebound phenomenon and anxiety
During discontinuation of oksazepam, a rebound phenomenon may occur – worsening of symptoms that originally prompted benzodiazepine use. This may be accompanied by mood changes, anxiety, sleep disturbances, insomnia, and restlessness. Since this phenomenon is associated with abrupt discontinuation, gradual dose reduction is recommended.

Anterograde amnesia
Oksazepam TZF may cause anterograde amnesia. Symptoms typically occur several hours after taking the medicine, especially at high doses. Patients treated with oksazepam for sleep disorders should take oksazepam one hour before bedtime and ensure conditions for uninterrupted 7–8 hours of sleep to minimize the risk of amnesia.

Paradoxical reactions
Oksazepam TZF may cause paradoxical reactions such as: motor restlessness, agitation, irritability, aggression, hostility, nightmares, hallucinations, psychoses, sleepwalking, personality disturbances, and intensified insomnia. These reactions are observed more frequently in elderly patients or those dependent on alcohol.
If such symptoms occur, contact your doctor.

Special patient groups
Benzodiazepines should not be given to children without careful assessment of the necessity, and treatment duration should be limited to a minimum.
In elderly patients (over 65 years), a lower dose is recommended (see section 3 "How to use Oksazepam TZF") due to increased risk of adverse effects in this age group, particularly disturbances in orientation and motor coordination (falls, injuries).
Patients with liver or kidney impairment, or chronic respiratory insufficiency, should inform their doctor before taking Oksazepam TZF. The doctor will determine an individual dosage depending on the degree of organ impairment. Dose reduction is recommended in patients with renal impairment.

Use in depression
Before taking Oksazepam TZF, the patient should inform the doctor about any psychiatric disorders. Using Oksazepam TZF alone in patients with depression may worsen symptoms, including suicidal tendencies.
Oksazepam TZF in patients with porphyria may exacerbate symptoms of the disease. Patients with porphyria should inform their doctor before starting treatment with Oksazepam TZF.
Patients with glaucoma, especially with narrow-angle glaucoma, should consult an ophthalmologist before starting treatment with Oksazepam TZF.

During treatment with Oksazepam TZF and for 3 days after discontinuation, alcoholic beverages should not be consumed.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.

Oksazepam TZF and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines planned for future use.
Oksazepam TZF, when used concomitantly with the following medicines, may enhance their effects or be influenced by them.

The patient should inform the doctor if taking any of the following medicines:

• hypnotics, sedatives, antidepressants, antiepileptics, and other psychotropic medicines,
• general anaesthetics,
• antihistamines (used, for example, in allergy treatment),
• skeletal muscle relaxants, curare and its derivatives (Oksazepam TZF enhances the effect of medicines reducing skeletal muscle tone),
• medicines used in Parkinson's disease (e.g. levodopa) (Oksazepam TZF may weaken their effect),
• antibacterial medicines (e.g. rifampicin),
• antiviral medicines (e.g. zidovudine, ritonavir),
• estrogen-containing contraceptives (may weaken the effect of oksazepam),
• nabilone,
• lofexidine (a medicine used in opium alkaloid dependence),
• tizanidine (a muscle relaxant),
• baclofen (enhances the sedative effect of oksazepam),
• probenecid (may enhance the sedative effect of oksazepam),
• theophylline and caffeine (may weaken the hypnotic effect of oksazepam),
• opioids: concomitant use of Oksazepam 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 even be life-threatening. Therefore, concomitant use of these medicines should only be considered when no other treatment options are available.

If the doctor prescribes Oksazepam TZF together with opioids, the dose and duration of concurrent treatment should be minimized.
The patient should inform the doctor about all opioid medicines being taken and strictly follow the doctor’s dosing instructions. It may be helpful to inform friends or family members about the possibility of these symptoms occurring. If such symptoms occur, contact your doctor.
When opioid analgesics are used concomitantly with oksazepam, euphoria may occur, leading to psychological dependence.

Oksazepam TZF with food, drink, and alcohol
Alcohol consumption during oksazepam treatment enhances the depressant effect on the central nervous system and may lead to paradoxical reactions such as psychomotor agitation and aggressive behaviour.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.

Pregnancy
This medicine should not be used in pregnant women.

Breastfeeding
Oksazepam TZF passes into breast milk and should not be used in women who are breastfeeding.
If administration of Oksazepam TZF to a breastfeeding mother is necessary, breastfeeding should be discontinued.

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

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

3. How to use Oksazepam TZF

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Recommended dose
Adults

• In anxiety disorders - 10 mg to 30 mg, 3 to 4 times daily.
• As an adjunctive treatment and only in justified cases of sleep disturbances - 10 mg to 30 mg one hour before bedtime. Patients taking oxazepam due to sleep disturbances should be advised to ensure conditions allowing for uninterrupted, continuous 7–8 hour sleep after taking the medicine.

Dosing in elderly patients
A dose of 10 mg three times daily is usually recommended.
Dosing in patients with hepatic impairment
Caution is advised when using this medicine. The physician may reduce the dose if the patient develops
liver function disturbances.
Use in children and adolescents
The use of oxazepam is not recommended in this age group.
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 oxazepam treatment should be kept to a minimum by the physician, usually lasting from a few days to 2
weeks. The total treatment period, including the tapering-off phase, should not exceed 4 weeks.
Prolonged use of the medicine may lead to dependence.
In individual cases, after assessing the patient's condition, the physician may decide to extend
the maximum treatment duration.
Method of administration
Tablets should be taken orally, swallowed with a small amount of water.
The physician will initiate treatment with the lowest possible effective doses to control symptoms of anxiety or
insomnia, and if necessary, will gradually increase the dose.
The medicine should be discontinued gradually. This particularly applies to patients who have been taking benzodiazepine derivatives
for a prolonged period. Abrupt discontinuation of oxazepam may result in sleep disturbances
and mood changes, as well as difficulties with concentration and attention. Therefore, the medicine should be tapered off gradually, in a manner individually tailored to each patient.
Taking more than the recommended dose of Oksazepam TZF
Symptoms of oxazepam overdose include drowsiness, confusion, and reduced muscle strength. In cases of significant overdose, coma may occur, accompanied by low blood pressure and respiratory depression. In the event of overdose, vomiting should be induced as soon as possible (provided consciousness is preserved) and medical help should be sought immediately.
The specific antidote is flumazenil.
If a higher than recommended dose of the medicine is taken, seek immediate medical advice from a doctor or
pharmacist.
Missed dose of Oksazepam TZF:
If a dose is missed, take the medicine as soon as possible, provided there is sufficient time before the next scheduled dose, or continue taking the medicine regularly.
Do not take a double dose to make up for a missed dose.
Stopping Oksazepam TZF
If you have any further questions about 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.
The frequency and severity of adverse reactions depend on individual patient sensitivity and the dose used.
Discontinuation of the medicine due to severe adverse reactions with Oksazepam TZF is rare.
Severe adverse reactions
Adverse reactions occurring very rarely (occurring in less than 1 in 10,000 patients):

• anaphylactic reactions: sudden difficulty in breathing or speaking, dizziness, drop in blood pressure, facial or skin redness, urticaria, skin lesions.

Other adverse reactions that may occur during treatment
Adverse reactions occurring frequently (occurring in 1 to 10 out of 00 patients):

• drowsiness, slowed reactions, dizziness, confusion and disorientation, muscle weakness, movement disorders
• blurred or double vision.

Adverse reactions occurring rarely (occurring in 1 to 10 out of 10,000 patients):

• headache
• blood disorders (reduced number of white blood cells and granulocytes in the blood)
• nausea, stomach discomfort, dry mouth.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• loss of appetite
• paradoxical reactions: psychomotor agitation, restlessness and aggression, confusion, hallucinations, nightmares, delusions, psychoses, irritability, inappropriate behaviour
• physical and psychological dependence (even during treatment with oksazepam at therapeutic doses), more frequently in patients abusing alcohol or drugs
• withdrawal symptoms and insomnia (after abrupt discontinuation of treatment)
• emergence of previously existing, undiagnosed depression with suicidal tendencies
• tremor, speech disorders, memory disturbances (anterograde amnesia)
• libido disorders (sexual drive)
• slight decrease in blood pressure
• increased liver enzyme activity, liver function disorders with development of jaundice
• allergic skin reactions (rash, itching, urticaria)
• muscle tremor, muscle flaccidity
• urinary retention, urinary incontinence, menstrual disorders
• fever, swelling, fatigue, general weakness, fainting.

Nervous system disorders occur most frequently at the beginning of treatment and in elderly patients, and usually subside during therapy. If these reactions intensify, consult a doctor. The doctor may reduce the dose, which should decrease the severity and frequency of these symptoms.
Paradoxical reactions occur most frequently after alcohol consumption, in elderly patients, and in patients with psychiatric disorders.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Oksazepam TZF

Keep the medicine out of sight and reach of children.
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.
Store below 25 °C. Keep 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 Oksazepam TZF contains

• The active substance is oxazepam.
• The other ingredients are: tablet core: potato starch, sodium carboxymethyl starch (type A), gelatin, polysorbate 80, talc, magnesium stearate, lactose monohydrate; coating: hypromellose, macrogol 6000

What Oksazepam TZF looks like and contents of the pack
Round, biconvex, film-coated tablets, white or almost white.
Packaging: 20 film-coated tablets (1 blister pack containing 20 tablets) or 50 film-coated tablets (2 blister packs containing 25 tablets each) in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: 22 811-18-14
For more detailed information, please contact the representative of the Marketing Authorisation Holder.