Package leaflet: Information for the patient

Teseda, 10 mg, tablets
Temazepamum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Teseda is and what it is used for
Important information before taking Teseda
How to take Teseda
Possible side effects
How to store Teseda
Contents of the pack and other information

1. What Teseda is and what it is used for

The active substance in Teseda is temazepam. Temazepam is a benzodiazepine. This medicine has anxiolytic (anti-anxiety) and sedative properties (causes drowsiness).
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 using Teseda

When not to use Teseda

if the patient is allergic to temazepam or any of the other ingredients of this medicine (listed in section 6);
if the patient has serious breathing difficulties (severe respiratory insufficiency) or has been diagnosed with breathing pauses during sleep (sleep apnoea syndrome);
if the patient has liver function disorders (severe hepatic insufficiency);
if certain other benzodiazepines have not been suitable for the patient;
if the patient has long-term muscle weakness (myasthenia).

Warnings and precautions
Before starting treatment with Teseda, discuss this with your doctor or pharmacist, as the patient may experience:

Tolerance – after several weeks of treatment, the patient may notice that the medicine becomes less effective in relieving symptoms. To avoid the development of tolerance, treatment should be short-term and usually should not last longer than one month.
Dependence – using this type of medicine may lead to dependence. The risk of developing dependence increases with higher doses and longer treatment duration, and is greater in patients with a history of alcohol or drug dependence.
Memory loss – may occur within a few hours after taking temazepam. To reduce the risk of this effect, it is recommended, whenever possible, to ensure the patient has continuous, uninterrupted sleep lasting 7–8 hours.
Psychological and paradoxical reactions – temazepam may cause behavioural adverse effects such as anxiety, agitation, irritability, aggression, delusions (false beliefs), rage, nightmares, hallucinations, psychoses, inappropriate behaviour, and other behavioural adverse effects.

When to exercise caution when using Teseda
Teseda may cause physical and psychological dependence. Patients with a history of alcohol or drug dependence should pay attention to possible symptoms of dependence (including headache, muscle pain, anxiety, confusion, irritability). If necessary, contact your doctor.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Teseda and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines and herbal products.
When used concomitantly, the effect of Teseda or other medicines may be altered or adverse effects may occur. These include:

antipsychotic medicines
anxiolytics
medicines used to treat insomnia (sleeping pills)
antidepressants
medicines used to treat epilepsy
antihistamines (used to treat allergic conditions)
narcotic painkillers (opioids)
levodopa (used in the treatment of Parkinson's disease)
disulfiram (used in the treatment of alcohol dependence)
cimetidine (used to treat gastrointestinal disorders)
oral contraceptives.

Concomitant use of Teseda with opioids (strong painkillers, medicines used in substitution treatment of addiction, and some cough suppressants) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.
If your doctor has prescribed Teseda together with opioids, use the lowest effective dose, and the duration of treatment should be as short as possible.
Inform your doctor about all opioid medicines the patient is taking and strictly follow dosing instructions. It may be helpful to inform friends or family about the risks so they are aware of the symptoms mentioned. If these symptoms occur, contact your doctor.
If the patient is scheduled for surgery under anaesthesia, inform the doctor about the use of Teseda.
Remember to inform your doctor about the use of Teseda during all future medical visits.
Teseda with food, drink or alcohol
Teseda tablets should be taken with a glass of water or another liquid. Tablets may be taken with or without food.
Alcohol consumption is not recommended during treatment with this medicine, as the combined use of temazepam and alcohol may increase their central nervous system depressant effects.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. Teseda must not be used during pregnancy or while breastfeeding.
If the patient becomes pregnant during treatment with Teseda, she should inform her doctor immediately, as the doctor may decide to change the treatment.
Driving and using machines
Teseda causes drowsiness and impairs the ability to drive and perform tasks requiring precision, especially at the beginning of treatment. Therefore, driving and performing precise tasks should be avoided until the patient's response to the medicine is known. A dose (10 mg or 20 mg) taken in the evening usually does not affect performance levels the following morning.
Teseda contains lactose
Each tablet contains 72.3 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to use the medicine Teseda

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The break line on the tablet is intended only to facilitate breaking it for easier swallowing.
The duration of treatment should be as short as possible. Prolonged use of Teseda may
lead to dependence or development of tolerance (reduced effectiveness of Teseda).

Insomnia
The recommended dose is 10 mg – 20 mg per day, taken before bedtime. The recommended dose for
elderly patients is 10 mg per day. The dose should be taken immediately before going to bed.
After taking the medicine, the patient should ensure 7–8 hours of uninterrupted sleep.
The duration of treatment should be only a few days up to two weeks and should not
exceed 4 weeks (including the tapering-off period).

Intermittent anxiety states
The recommended dose is 10 mg – 30 mg, not more than three times daily. The duration of treatment should
not exceed 8 to 12 weeks (including the tapering-off period).

Use of a higher than recommended dose of Teseda
If a patient accidentally takes an excessive amount of tablets, temazepam may cause
central nervous system depression. Symptoms may include drowsiness, disorientation,
weakness, lack of muscle coordination or muscle tone, decreased body temperature,
reduced arterial blood pressure, breathing difficulties, coma, and in rare cases, death.
When going to a doctor or hospital, bring the medicine package with you.

Missed 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 use a double dose to make up for a missed dose.

Stopping the use of Teseda
Do not stop using the medicine abruptly, as withdrawal symptoms may occur unexpectedly.
These symptoms include feelings of unease, fear, or restlessness (anxiety), insomnia, and seizures.
The dose should be gradually reduced.
Stopping the use of Teseda may also lead to temporary insomnia and recurrence of anxiety
("rebound" phenomenon). Mood changes and motor restlessness may also occur. To avoid
these symptoms, the dose should be gradually reduced according to the physician's instructions.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms of a severe allergic reaction occur, treatment must be discontinued and medical advice must be sought immediately (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.

Frequent adverse effects (may affect up to 1 in 10 people):

emotional blunting, disorientation;
drowsiness, reduced alertness, fatigue or lack of energy.

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

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

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

memory loss, psychiatric reactions such as restlessness, irritability, aggression, hallucinations, psychoses and inappropriate behaviour;
withdrawal symptoms (see section "Discontinuing Teseda");
depression.

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

double vision;
changes in sexual drive.

Prolonged use of Teseda may lead to the development of tolerance and dependence.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Teseda

Store below 25°C. Keep 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 stated month.
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 pack and other information

What Teseda contains

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

What Teseda looks like and contents of the pack
White to slightly yellowish, round, flat, uncoated tablets approximately 7 mm in diameter, with bevelled edges, a division line and marked with ORN73.
Pack size: 20 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]