Oxazepam Espefa

Package Leaflet: Information for the Patient

OXAZEPAM ESPEFA, 10 mg, 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What Oxazepam Espefa is and what it is used for

Oxazepam Espefa is a short-acting benzodiazepine derivative with anxiolytic, sedative, hypnotic, and anticonvulsant effects. It acts on the limbic system, hypothalamus, and thalamus.
Indications for use:

• anxiety states;
• anxiety associated with depression;
• excitement associated with acute alcoholic withdrawal syndrome.

States of tension and anxiety associated with everyday problems are not an indication for the use of this medicine.
medicine.

2. Important information before taking Oxazepam Espefa

When not to take Oxazepam Espefa:

• if you are allergic to the active substance, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver failure;
• in the case of drug, narcotic, or alcohol dependence;
• if you have severe respiratory failure, sleep apnea syndrome;
• in the case of acute alcohol poisoning, poisoning with sleeping pills, opioids, antipsychotic drugs (neuroleptics, antidepressants, lithium salts);
• if you have been diagnosed with myasthenia gravis (muscle weakness);
• in women during pregnancy and breastfeeding, as well as in children under 6 years of age.

Warnings and precautions

Before starting treatment with Oxazepam Espefa, discuss it with your doctor.

• The medicine is not intended for the primary treatment of psychotic disorders and depression, it should not be used as monotherapy in patients with depression or psychotic disorders.
• The medicine should be used with special caution in patients with respiratory disorders, porphyria.
• In elderly and debilitated patients, the dose should be reduced.
• Prolonged use and sudden discontinuation of therapy should be avoided.
• Oxazepam Espefa, when administered in therapeutic doses, may cause anterograde amnesia, the risk of its occurrence increases with increasing doses.
• Paradoxical reactions may also occur, such as states of acute excitement, hallucinations, psychosis, and euphoric states.
• Oxazepam Espefa should be used with caution in patients in whom a decrease in blood pressure could lead to cardiac complications.
• The medicine should be used with caution in patients with liver or kidney function disorders. During treatment, liver function and blood morphology should be monitored.
• Regular use may lead to the development of tolerance to the medicine, i.e., a decrease in its effectiveness.
• In patients with a history of alcohol or drug dependence, oxazepam should be used with great caution.
• Taking Oxazepam Espefa may lead to physical and psychological dependence. If it is stopped suddenly, withdrawal symptoms may occur, such as irritability, nervousness, difficulty falling asleep, anxiety, fear, and rarely seizures and abdominal pain, loss of sense of reality, increased sweating.

Oxazepam Espefa 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.
Concomitant administration of oxazepam with other medicines that have a depressant effect on the central nervous system (e.g., anesthetics, antidepressants, antipsychotics, sedatives, antihistamines, antihypertensives) increases both the sedative effect of oxazepam and the effect of these medicines. During concomitant use of oxazepam and opioid analgesics, severe euphoria may occur, leading to increased psychological dependence.
Muscle relaxants may also enhance the sedative effect of oxazepam.
Theophylline and caffeine may weaken the sedative effect of benzodiazepines (including oxazepam).
Oxazepam administered concomitantly with medicines used to treat parkinsonism (e.g., levodopa) may weaken their effect.
During treatment with oxazepam, you should avoid drinking alcohol, as individual cases of paradoxical reactions have been reported.

Oxazepam Espefa with food and drink

Taking Oxazepam Espefa with food and drink does not affect the absorption of the medicine.

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.
The safety of oxazepam in pregnant women has not been established.
Oxazepam Espefa is contraindicated in pregnancy, especially in the first and third trimester.
Administration of benzodiazepines during pregnancy may cause fetal damage.
Prolonged use of oxazepam in pregnant women may cause withdrawal syndrome in the newborn. Administration of the medicine in the late stage of pregnancy or during delivery may cause hypothermia, hypotension, respiratory disorders, apnea, and weakness of the sucking reflex in the newborn.
Oxazepam and its metabolites pass into breast milk, so you should not take the medicine while breastfeeding.

Driving and using machines

While taking Oxazepam Espefa, do not drive vehicles or operate machinery, as it may cause impairment of psychophysical fitness. The ability to drive vehicles and operate mechanical devices may be limited due to drowsiness, impaired concentration, or other possible side effects that reduce concentration (see section 4 "Possible side effects").

Oxazepam Espefa contains lactose and sucrose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Oxazepam Espefa

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor.
The medicine should be taken orally, regardless of meals.
Recommended dose:
The dose should be adjusted individually. The smallest possible dose (especially in elderly, debilitated patients, and patients with low serum albumin levels) should be used to avoid excessive sedation (sedation).
Adults: the dose and dosing regimen depend on individual sensitivity and clinical symptoms.
Mild to moderate anxiety: 10 mg to 20 mg 3 to 4 times a day.
Severe anxiety: 20 mg to 30 mg 3 to 4 times a day, with a higher dose at bedtime.
In elderly or debilitated patients, with reduced body weight, hypotension, circulatory or respiratory failure, or muscle weakness, the smallest effective dose (usually 10 mg 3 times a day) is recommended.
In the evening, do not take a tablet immediately after a meal, due to delayed action and possible fatigue and concentration disorders the next morning.
Excitement associated with acute alcoholic withdrawal syndrome: 20 mg to 30 mg administered 3 or 4 times a day.
In acute cases, a single dose or several doses should be taken over several days.
Treatment duration
Your doctor will limit the treatment time with oxazepam to a minimum. Usually, it is from a few days to 2 weeks. After two weeks of taking oxazepam, your doctor will reassess the indications for further use of the medicine. The total treatment duration, including the tapering period, should not exceed 4 weeks. Longer use of the medicine may cause dependence.

Use in children and adolescents

Oxazepam Espefa should not be used in children under 6 years of age. In children and adolescents between 6 and 18 years of age, oxazepam is not recommended due to the lack of dosing recommendations for this age group.

Overdose of Oxazepam Espefa

If you have taken more than the recommended dose of the medicine, seek medical attention immediately.
Symptoms of mild poisoning include: drowsiness, confusion, lethargy, ataxia (coordination disorders), dysarthria (slurred speech), hypotonia, dyskinesia (involuntary repetitive movements); rarely, short-term loss of consciousness.
Symptoms of severe poisoning (especially when combined with alcohol) include: depression of respiratory and cardiovascular function, coma, and even death.

Missed dose of Oxazepam Espefa

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

Stopping treatment with Oxazepam Espefa

Do not stop taking the medicine on your own. Your doctor will decide on gradual dose reduction.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxazepam Espefa can cause side effects, although not everybody gets them.
The frequency and severity of side effects depend on individual patient sensitivity and the dose of the medicine. Discontinuation of the medicine due to side effects is rare.
The frequency of possible side effects listed below is as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

Nervous system disorders
Common: drowsiness, slowed reactions, dizziness, confusion and disorientation, muscle weakness, coordination disorders.
Rare: headache.
These effects occur most often at the beginning of treatment, in elderly patients, and usually disappear during continued therapy. If these reactions are severe, a suitable dose reduction usually reduces their severity and frequency.
Unknown frequency: dysarthria (slurred speech) with slurred and improper pronunciation, memory disorders (anterograde amnesia), libido disorders. The risk of these side effects is higher with higher doses of the medicine.
Eye disorders
Common: blurred double vision.
Skin and subcutaneous tissue disorders
Unknown frequency: allergic reactions.
Gastrointestinal disorders
Unknown frequency: dyspepsia (indigestion).
If dyspepsia occurs, the dose should be reduced or the medicine discontinued.
Renal and urinary disorders
Unknown frequency: urinary retention, incontinence.
Musculoskeletal and connective tissue disorders
Unknown frequency: muscle tremors, muscle weakness.
Blood and lymphatic system disorders
Unknown frequency: leukopenia, thrombocytopenia, and agranulocytosis.
Immune system disorders
Unknown frequency: anaphylactic reactions.
Hepatobiliary disorders
Unknown frequency: liver function disorders, jaundice.
Reproductive system and breast disorders
Unknown frequency: menstrual disorders.
Metabolic and nutritional disorders
Unknown frequency: loss of appetite.
Vascular disorders
Unknown frequency: slight decrease in blood pressure.
General disorders and administration site conditions
Unknown frequency: general weakness, fainting.
Psychiatric disorders
Unknown frequency: paradoxical reactions - psychomotor anxiety, excitement, and aggression, confusion, hallucinations, nightmares, delusions, psychosis, irritability, inappropriate behavior.
Paradoxical reactions most often occur after alcohol consumption, in elderly patients, and in patients with mental illnesses.
Physical and psychological dependence may develop during treatment with oxazepam in therapeutic doses. Sudden discontinuation of treatment may cause withdrawal symptoms such as seizures, tremors, abdominal colic, and muscle cramps, insomnia, vomiting, and excessive sweating and insomnia.
Patients who abuse alcohol or drugs are more prone to developing dependence.
During treatment with oxazepam, previously undiagnosed depression with suicidal tendencies may be revealed.
Additionally, the following may occur: stupor, disorientation, fever, and euphoria.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Oxazepam Espefa

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a temperature 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 Oxazepam Espefa contains

• The active substance of the medicine is oxazepam. One tablet contains 10 mg of oxazepam.
• The other ingredients (excipients) are: lactose monohydrate, potato starch, sucrose, povidone, calcium stearate.

What Oxazepam Espefa looks like and contents of the pack

The pack contains 1 blister pack of 10 tablets or 2 blister packs of 10 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J.Lea 208

• 30 - 133 Kraków, Poland tel. 12 639 27 27

Manufacturer

Joint-Stock Company "Olainfarm"
5 Rupnicu Str., Olaine
LV - 2114 Latvia

Information for the blind and visually impaired: 800-007-777

Date of last revision of the leaflet:01.03.2023