TESEDA 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Teseda, 10 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Teseda and what is it used for
4. Important information before taking Teseda
   1. When not to take Teseda
   2. Warnings and precautions
   3. When to be cautious when taking Teseda
   4. Children and adolescents
   5. Teseda and other medicines
   6. Teseda with food, drink, or alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Teseda contains lactose
5. How to take Teseda
   1. Taking a higher dose of Teseda than recommended
   2. Missing a dose of Teseda
   3. Stopping treatment with Teseda
6. Possible side effects
   1. Reporting side effects
7. How to store Teseda
8. Contents of the pack and other information
   1. What Teseda contains
   2. What Teseda looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: 14.12.2023

Package Leaflet: Information for the Patient

Teseda, 10 mg, Tablets

Temazepam

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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Teseda and what is it used for

The active substance of Teseda is temazepam. Temazepam is a benzodiazepine. This medicine has anxiolytic (anti-anxiety) and sedative (sleep-inducing) properties.
Teseda is used for the short-term treatment of severe anxiety that impairs the patient's functioning, or for the treatment of insomnia in adults.

2. Important information before taking Teseda

When not to take Teseda

• if you are allergic to temazepam or any of the other ingredients of this medicine (listed in section 6);
• if you have severe breathing difficulties (severe respiratory failure) or if you have been diagnosed with pauses in breathing during sleep (sleep apnea syndrome);
• if you have liver function disorders (severe liver failure);
• if other benzodiazepines have not been suitable for you;
• if you have long-term muscle weakness (myasthenia gravis).

Warnings and precautions

Before starting to take Teseda, discuss it with your doctor or pharmacist, as you may experience:

• Tolerance - after a few weeks of taking the medicine, you may notice that it is less effective in relieving symptoms. To avoid the development of tolerance, treatment is short-term, usually not exceeding one month.
• Dependence - taking this type of medicine can lead to dependence. The risk of developing dependence increases with the dose and duration of treatment and is higher in patients with a history of alcohol or drug dependence.
• Memory loss - may occur within a few hours of taking temazepam. To minimize the risk of this side effect, it is recommended, if possible, to ensure that the patient has uninterrupted sleep for 7-8 hours.
• Psychological and paradoxical reactions - temazepam may cause behavioral side effects, such as anxiety, agitation, irritability, aggression, delusions (false beliefs), rage, nightmares, hallucinations, psychosis, inadequate behavior, and other behavioral side effects.

When to be cautious when taking Teseda

Teseda may cause physical and psychological dependence. Patients with a history of alcohol or drug dependence should be aware of the possible symptoms of dependence (including headache, muscle pain, anxiety, confusion, irritability). If necessary, contact your doctor.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age.

Teseda and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription and herbal medicines.
When taken together, the effect of Teseda or other medicines may be altered or side effects may occur. These medicines include:

• antipsychotic medicines
• anxiolytic medicines
• medicines used to treat insomnia (sleeping pills)
• antidepressant medicines
• medicines used to treat epilepsy
• antihistamine medicines (used to treat allergic diseases)
• narcotic painkillers (opioids)
• levodopa (used to treat Parkinson's disease)
• disulfiram (used to treat alcohol dependence)
• cisapride (used to treat gastrointestinal disorders)
• oral contraceptives.

Taking Teseda with opioids (strong painkillers, medicines used for substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening.
Therefore, concurrent use should only be considered when other treatment methods are not possible.
If your doctor has prescribed Teseda with opioids, use the smallest effective dose, and the duration of treatment should be as short as possible.
Tell your doctor about all opioid medicines you are taking and follow the dosage instructions carefully. It may be helpful to inform friends or family about the risk, so they are aware of the symptoms. If these symptoms occur, contact your doctor.
If you are scheduled for surgery under anesthesia, tell your doctor that you are taking Teseda.
Remember to tell your doctor that you are taking Teseda during follow-up visits.

Teseda with food, drink, or alcohol

Take Teseda tablets with a glass of water or other liquid. Tablets can be taken with or without food.
It is not recommended to consume alcohol while taking this medicine, as the sedative effect on the central nervous system may be increased when temazepam and alcohol are taken together.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine. Do not take Teseda during pregnancy and breastfeeding.
If you become pregnant during treatment with Teseda, tell your doctor immediately, as they may decide to change the treatment.

Driving and using machines

Teseda causes drowsiness and reduces the ability to drive and perform tasks that require precision, especially at the beginning of treatment. Therefore, avoid driving and performing precise tasks until you know how the medicine affects you.
A dose (10 mg or 20 mg) taken in the evening usually does not affect performance the next morning.

Teseda contains lactose

Each tablet contains 72.3 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Teseda

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.
The duration of treatment should be as short as possible. Long-term use of Teseda may lead to dependence or the development of tolerance to the medicine (reduced effectiveness of Teseda).
Insomnia
The recommended dose is 10 mg - 20 mg per day, before bedtime. The recommended dose for elderly patients is 10 mg per day. The dose should be taken directly before bedtime. After taking the medicine, the patient should have 7-8 hours of uninterrupted sleep.
The duration of treatment should be only a few days to two weeks and should not exceed 4 weeks (including the period of dose reduction).
Periodic anxiety states
The recommended dose is 10 mg - 30 mg, no more than three times a day. The duration of treatment should not exceed 8 to 12 weeks (including the period of dose reduction).

Taking a higher dose of Teseda than recommended

If you have taken too many tablets by mistake, temazepam may cause central nervous system depression. Symptoms may include drowsiness, disorientation, weakness, lack of coordination or muscle tension, decreased body temperature, decreased blood pressure, breathing difficulties, coma, and in rare cases, death.
When going to the doctor or hospital, take the package of medicine with you.

Missing a dose of Teseda

Take the missed dose as soon as possible. However, if it is almost time for the next dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Teseda

Do not stop taking the medicine suddenly, as unexpected withdrawal symptoms may occur. These symptoms include feelings of anxiety, fear, or nervousness (anxiety), insomnia, and seizures. The dose of the medicine should be gradually reduced.
Stopping treatment with Teseda may also lead to temporary insomnia and anxiety (rebound phenomenon). Mood changes and restlessness may also occur. To avoid these symptoms, the dose of the medicine should be gradually reduced, according to the doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Teseda can cause side effects, although not everybody gets them.
If you experience any of the following symptoms of a severe allergic reaction, stop treatment and contact your doctor (very rare: may affect up to 1 in 10,000 people):

• skin itching, rash, swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing.

Common side effects (may affect up to 1 in 10 people)

• emotional suppression, disorientation;
• drowsiness, decreased alertness, fatigue, or lack of energy.

Uncommon side effects (may affect up to 1 in 100 people)

• restless sleep, nightmares;
• headache, dizziness, difficulty controlling movements (ataxia);
• nausea, dryness of the mucous membranes of the mouth;
• muscle weakness;
• skin reactions, allergic reactions.

Rare side effects (may affect up to 1 in 1,000 people)

• memory loss, psychological reactions, such as restlessness, irritability, aggression, delusions, psychosis, and inadequate behavior;
• withdrawal symptoms (see section "Stopping treatment with Teseda");
• depression.

Very rare side effects (may affect up to 1 in 10,000 people):

• double vision;
• changes in sex drive.

Long-term use of Teseda may lead to the development of tolerance and dependence.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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 provide more information on the safety of this medicine.

5. How to store Teseda

Store in a temperature below 25°C. Store the blister in the outer packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the words "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Medicines should 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 pack and other information

What Teseda contains

• The active substance is temazepam. Each tablet contains 10 mg of temazepam.
• The other ingredients are lactose monohydrate, cornstarch, gelatin, talc, and magnesium stearate.

What Teseda looks like and contents of the pack

White to light yellow, round, approximately 7 mm in diameter, flat, uncoated tablets with a dividing line, marked with ORN73.
Pack sizes: 20 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: 14.12.2023