Oksazepam Tzf

Package Leaflet: Information for the Patient

Oksazepam TZF, 10 mg, Coated Tablets

Oxazepam

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Oksazepam TZF belongs to the group of benzodiazepine derivatives. It acts by inhibiting many structures of the central nervous system, mainly those related to the regulation of emotional processes.
The drug has an anxiolytic effect and a weaker sedative effect. Oksazepam TZF also has a weak muscle relaxant and anticonvulsant effect.

Indications

For short-term use:

• In anxiety disorders accompanying neuroses and other psychosomatic disorders.
• In sleep disorders of a functional nature.

States of tension and anxiety related to everyday problems are not an indication for the use of the drug.

2. Important information before taking Oksazepam TZF

When not to take Oksazepam TZF:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in patients with severe respiratory failure, with sleep apnea attacks,
• in patients with severe liver failure, with myasthenia, with acute porphyria,
• in patients with phobic states, obsessions or chronic psychoses,
• in patients with alcohol intoxication,
• with sleeping pills or other drugs that act by inhibiting the central nervous system.

Warnings and precautions

Before starting treatment with Oksazepam TZF, discuss it with your doctor or pharmacist.
If after 7-14 days of treatment there is no improvement or the symptoms recur, the patient should consult a doctor.

Tolerance

Regular use of Oksazepam TZF for several weeks may lead to a decrease in the effectiveness of its action.

Dependence

Taking Oksazepam TZF may lead to psychological and physical dependence. The risk increases with the increase in dose and duration of treatment and is higher in patients who have been dependent on alcohol or drugs. Therefore, these patients should inform their doctor, as they may use Oksazepam TZF only under their strict control.

Withdrawal symptoms

In the event of physical dependence, sudden withdrawal of the drug may lead to the occurrence of a withdrawal syndrome. The characteristic symptoms of this syndrome are: headache, muscle pain, very severe anxiety and emotional tension, restlessness, confusion, disorientation, irritability, insomnia.
In more severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to touch, acoustic and light stimuli, tingling and numbness of limbs, hallucinations or seizures.

Rebound phenomenon and anxiety

During the withdrawal of oxazepam, a rebound phenomenon may occur - an exacerbation of the symptoms that were the reason for the use of benzodiazepines. This may be accompanied by mood changes, anxiety or sleep disturbances, insomnia, and restlessness. Since this phenomenon is related to the sudden withdrawal of the drug, it is recommended to gradually reduce its dose.

Anterograde amnesia

Oksazepam TZF may cause anterograde amnesia. Symptoms most often occur a few hours after taking the medicine, especially in high doses. Patients treated with oxazepam for sleep disorders should be informed to limit the risk of amnesia, take oxazepam one hour before sleep and have conditions for continuous, uninterrupted 7-8 hours of sleep.

Paradoxical reactions

Oksazepam TZF may cause paradoxical reactions, including: restlessness, excitement, irritability, aggression, hostility, nightmares, hallucinations, psychoses, lunacy, personality disorders, increased insomnia. These reactions are much more common in elderly patients or those dependent on alcohol.
In the event of such symptoms, you should contact your doctor.

Special patient groups

Benzodiazepines should not be given to children without careful assessment of the need for these drugs, and the treatment time should be limited to a minimum.
In elderly patients (over 65 years), it is recommended to use a lower dose (see section 3 "How to take Oksazepam TZF"), due to the increased risk of adverse reactions in this age group, mainly orientation and motor coordination disorders (falls, injuries).
Patients with liver or kidney failure, with chronic respiratory failure before taking Oksazepam TZF should inform their doctor about these diseases. The doctor will determine the dosage individually for each patient, depending on the degree of organ failure. It is recommended to reduce the dose in patients with kidney failure.

Use in depression

Before taking Oksazepam TZF, the patient should inform their doctor about any mental illnesses they have. The use of Oksazepam TZF alone in patients with depression may exacerbate its symptoms, including suicidal tendencies.
Oksazepam TZF in patients with porphyria may exacerbate the symptoms of this disease. Patients with porphyria before starting treatment with Oksazepam TZF should inform their doctor about this disease.
Patients with glaucoma, especially with a narrow angle of filtration, before starting treatment with Oksazepam TZF should consult an ophthalmologist.
During treatment with Oksazepam TZF and up to 3 days after its completion, you should not drink any alcoholic beverages.
You should consult your doctor, even if the above warnings relate to situations that have occurred in the past.

Oksazepam TZF and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.
Oksazepam TZF taken at the same time as the following medicines may enhance the effect of these medicines or these medicines may affect the effect of Oksazepam TZF.
The patient should tell the doctor if they are taking the following medicines:

• sleeping pills, sedatives, antidepressants, antiepileptics, and other psychotropic drugs,
• general anesthetics,
• antihistamines (used to treat, for example, allergies),
• muscle relaxants, curare and its derivatives (Oksazepam TZF enhances the effect of muscle relaxants),
• drugs used to treat Parkinson's disease (e.g., levodopa) (Oksazepam TZF may weaken their effect),
• antibiotics (e.g., rifampicin),
• antiviral drugs (e.g., zidovudine, ritonavir),
• contraceptives containing estrogens (may weaken the effect of oxazepam),
• nabilone,
• lofexidine (a drug used in opioid dependence),
• tizanidine (a muscle relaxant),
• baclofen (enhances the sedative effect of oxazepam),
• probenecid (may enhance the sedative effect of oxazepam),
• theophylline and caffeine (may weaken the sedative effect of oxazepam).
• opioids: concomitant use of Oksazepam TZF and opioids (strong painkillers, drugs used in 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 drugs can only be considered when other treatment options are not possible.

If, however, the doctor prescribes Oksazepam TZF together with opioids, they should limit the dose and duration of concomitant treatment..
The patient should inform the doctor about all opioid medications they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives so that they are aware of the possibility of these symptoms. In the event of such symptoms, you should contact your doctor.
In the case of concomitant use of opioid analgesics with oxazepam, euphoria may occur, leading to psychological dependence.

Oksazepam TZF with food and drink and alcohol

Consuming alcohol during treatment with oxazepam enhances the depressive effect on the central nervous system and may lead to the occurrence of paradoxical reactions, such as psychomotor excitement, aggressive behavior.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
The drug should not be used in pregnant women.
Breastfeeding
Oksazepam TZF passes into breast milk, should not be used in breastfeeding women.
If it is necessary to administer Oksazepam TZF to a breastfeeding mother, breastfeeding should be discontinued.

Driving and using machines

During treatment with Oksazepam TZF, do 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 adverse reactions that reduce concentration (see section 4 "Possible side effects").

Oksazepam TZF contains lactose.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
Oksazepam contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Oksazepam TZF

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Recommended dose

Adults

• In anxiety disorders - 10 mg to 30 mg 3 to 4 times a day.
• Supportively and only in justified cases of sleep disorders - 10 mg to 30 mg one hour before sleep. Patients taking oxazepam for sleep disorders should be informed to have conditions for continuous, uninterrupted 7-8 hours of sleep after taking the medicine.

Dosing in elderly patients
Usually, a dose of 10 mg 3 times a day is recommended.
Dosing in patients with liver failure
Caution is recommended when using this medicine. The doctor may reduce the dose in case of liver function disorders in the patient.

Use in children and adolescents

Oxazepam is not recommended for use 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.

Treatment duration

The treatment time with oxazepam should be limited by the doctor to a minimum, usually ranging from a few days to 2 weeks. The total treatment time, including the period of gradual withdrawal of the medicine, should not exceed 4 weeks.
Longer use of the medicine may cause symptoms of dependence.
In individual cases, after assessing the patient's condition, the doctor may decide to extend the maximum treatment time.

Method of administration

Tablets should be taken orally, with a small amount of water.
The doctor will start treatment with the lowest effective doses to control anxiety or insomnia symptoms and, if necessary, will gradually increase them.
The medicine should be withdrawn gradually. This applies especially to patients taking benzodiazepine derivatives for a longer period. Sudden withdrawal of oxazepam may cause sleep and mood disorders, concentration and attention disorders. Therefore, the medicine should be withdrawn gradually, in a manner tailored to each patient.

Using a higher than recommended dose of Oksazepam TZF

Symptoms of oxazepam overdose are drowsiness, confusion, muscle weakness. In the case of significant overdose, coma may occur with a decrease in blood pressure and circulatory collapse. After an overdose, vomiting should be provoked as soon as possible (provided that the patient is conscious) and contact a doctor.
The specific antidote is flumazenil.
In the event of taking a higher than recommended dose of the medicine, you should immediately consult a doctor or pharmacist.

Missing a dose of Oksazepam TZF:

In the event of a missed dose, the medicine should be taken as soon as possible, if the time to the next dose is long enough, or continue regular intake of the medicine.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Oksazepam TZF

In case of any further doubts related to the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency and severity of side effects depend on the individual patient's sensitivity and the size of the dose used. Withdrawal of the medicine due to severe side effects after taking Oksazepam TZF is rare.

Severe side effects

Side effects that occurvery rarely(occurring in less than 1 in 10,000 patients):

• anaphylactic reactions: sudden breathing difficulties, speech difficulties, dizziness, blood pressure drop, flushing of the face or skin, urticaria, skin changes.

Other side effects that may occur during treatment

Side effects that occuroften(occurring in 1 to 10 out of 100 patients):

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

Side effects that occurrarely(occurring in 1 to 10 out of 10,000 patients):

• headache
• blood disorders (decreased white blood cell and granulocyte count in the blood)
• nausea, stomach upset, dry mouth.

Side effectsof unknown frequency(frequency cannot be estimated from available data):

• loss of appetite
• paradoxical reactions: psychomotor restlessness, excitement and aggression, confusion, hallucinations, psychoses, lunacy, personality disorders, increased insomnia
• physical and psychological dependence (even during treatment with oxazepam in therapeutic doses), more often in patients who abuse alcohol or drugs
• withdrawal symptoms and insomnia (after sudden cessation of treatment)
• unmasking of previously existing, undiagnosed depression with suicidal tendencies
• tremors, speech disorders, memory disorders (anterograde amnesia)
• libido disorders (sexual drive)
• mild decrease in blood pressure
• increased liver enzyme activity, liver function disorders with jaundice
• allergic skin reactions (rash, itching, urticaria)
• muscle tremors, muscle weakness
• urinary retention, urinary incontinence, menstrual disorders
• fever, swelling, fatigue, general weakness, fainting.

Nervous system disorders occur most often at the beginning of treatment, in elderly patients, and usually disappear during therapy. If these reactions worsen, you should consult your doctor. The doctor may reduce the dose, which should reduce the severity and frequency of these symptoms.
Paradoxical reactions most often occur after consuming alcohol, in elderly patients, and in patients with mental illnesses.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 gather more information on the safety of the medicine.

5. How to store Oksazepam TZF

Keep the medicine out of the 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 specified month.
Store below 25°C. Store in the original packaging to protect from light and moisture.
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 does Oksazepam TZF contain

• 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 what the pack contains

Round, biconvex, coated tablets, white or almost white in color.
Packaging:20 coated tablets (1 blister pack of 20) or 50 coated tablets (2 blister packs of 25) in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: