SIGNOPAM 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. SIGNOPAM, 10 mg, tablets
   1. Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Signopam and what is it used for
4. Important information before taking Signopam
   1. When not to take Signopam
   2. Warnings and precautions
   3. Signopam and other medicines
   4. Pregnancy and breastfeeding
   5. Pregnancy
   6. Breastfeeding
   7. Driving and using machines
   8. Signopam contains lactose monohydrate
5. How to take Signopam
   1. Adults
   2. Children
   3. Patients with renal and/or hepatic impairment
   4. Elderly patients
   5. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
   6. Duration of treatment
   7. Method of administration
   8. Taking a higher dose of Signopam than recommended
   9. Missing a dose of Signopam
   10. The patient should not take a double dose to make up for a missed dose.
   11. Stopping treatment with Signopam
6. Possible side effects
   1. Severe side effects
   2. Other side effects that may occur during treatment with Signopam
   3. Reporting side effects
7. How to store Signopam
8. Contents of the pack and other information
   1. What Signopam contains
   2. What Signopam looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last revision of the leaflet:

Leaflet attached to the packaging: patient information

SIGNOPAM, 10 mg, tablets

Temazepam

Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Signopam and what is it used for

Signopam contains the active substance temazepam, which belongs to a group of medicines called benzodiazepines. Temazepam has sedative, calming, and anxiolytic properties. It also has a weak anticonvulsant effect and relaxes skeletal muscle tension. Signopam is used for short-term treatment:

• for severe sleep disorders when insomnia causes significant exhaustion in the patient;
• for premedication - preparation for surgical procedures and stressful diagnostic tests.

2. Important information before taking Signopam

When not to take Signopam

If the patient has:

• an allergy to temazepam or any of the other ingredients of this medicine (listed in section 6);
• severe respiratory failure, regardless of the cause;
• severe liver failure;
• sleep apnea syndrome;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue);
• alcohol or drug intoxication or poisoning with central nervous system depressants.

Warnings and precautions

Before starting treatment with Signopam, the patient should discuss it with their doctor or pharmacist. General information about the effects observed after benzodiazepine treatment, which should be taken into account when using Signopam.

➢ Tolerance: After taking Signopam for several weeks, its effectiveness may decrease.

➢ Dependence: Long-term use of Signopam may lead to psychological and physical dependence. The risk of developing dependence increases with the dose and duration of treatment and is higher in patients who are dependent on drugs, alcohol, or have personality disorders.

➢ Withdrawal symptoms: In case of sudden withdrawal of the medicine, the patient may experience withdrawal symptoms, such as headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, and irritability. In severe cases, the following may occur: loss of reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations, and delusions, seizures.

➢ Rebound phenomenon and anxiety: When discontinuing Signopam, a transient recurrence of intensified symptoms may occur, which were the reason for taking the medicine (so-called rebound phenomenon). These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these symptoms, the doctor will recommend a gradual reduction of the dose.

➢ Anterograde amnesia (inability to remember events after taking the medicine): Signopam may cause anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored). This condition usually occurs within a few hours of taking the medicine, especially in high doses. If the doctor has prescribed Signopam once a day, to reduce the risk of anterograde amnesia, it is recommended to take the medicine half an hour before going to bed and ensuring adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

➢ Psychotic and paradoxical reactions: In children and the elderly, the risk of abnormal psychotic and paradoxical reactions (opposite to expected) increases, such as anxiety, excitement, irritability, aggression, anger, fury, delusions, nightmares, hallucinations, psychoses, behavioral disorders. If such symptoms occur, the patient should immediately contact their doctor.

Special patient groups

➢ Elderly patients should receive lower doses of Signopam (see section 3), due to the possibility of increased side effects, mainly disorientation and coordination disorders (falls, injuries).

➢ Patients with liver or kidney failure or chronic respiratory failure should inform their doctor about these conditions before taking Signopam.

➢ Use in depression: Before taking Signopam, the patient should inform their doctor about any mental illnesses. Patients with symptoms of depression or anxiety associated with depression should take several medicines simultaneously. Administering Signopam to patients with depression may exacerbate depressive symptoms, including suicidal thoughts.

➢ During benzodiazepine treatment, masked depression may be revealed.

➢ Patients with a history of alcohol, drug, or medication dependence should inform their doctor about these addictions before taking Signopam. These patients are at high risk of developing psychological and physical dependence. Therefore, this group of patients should take Signopam only under strict medical supervision.

➢ Taking Signopam in people who are grieving after the loss of loved ones does not improve their well-being.

Signopam and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

This is especially important if the patient is taking any of the following medicines or drinking alcohol:

• fluvoxamine, fluoxetine, and other medicines used to treat mental illnesses;
• medicines used to treat insomnia;
• medicines used to treat allergic diseases that may cause drowsiness;
• medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin); strong painkillers (e.g., morphine);
• opioids: concomitant use of Signopam and opioids (strong painkillers, 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 medicines can only be considered if other treatment options are not possible.

If the doctor prescribes Signopam with opioids, they should limit the dose and duration of concomitant treatment. The patient should inform their 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 to be aware of the possibility of these symptoms. If such symptoms occur, the patient should contact their doctor.

Alcohol: drinking alcohol while taking Signopam may enhance its effect and lead to paradoxical reactions, such as severe psychomotor excitement, aggressive behavior (see section 2; Warnings and precautions).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

Signopam should not be taken during pregnancy.

Breastfeeding

Signopam passes into human milk. If the medicine needs to be administered, breastfeeding should be discontinued.

Driving and using machines

During treatment with Signopam, the patient should not drive vehicles or operate machines. The ability to drive vehicles or operate machines may be impaired due to the possibility of drowsiness, impaired concentration, or other side effects that reduce concentration (see section 4. Possible side effects).

Signopam contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Signopam

This medicine should always be taken according to the doctor's recommendations. If in doubt, the patient should consult their doctor.

Adults

Sleep disorders:usually, 10 mg to 20 mg is taken half an hour before bedtime. In individual cases, when these doses are not effective, the doctor may increase the dose up to a maximum of 40 mg per day.

Preparation for surgical procedures and stressful diagnostic tests:usually, 20 mg to 40 mg is taken as a single dose 30 to 60 minutes before the surgical procedure or diagnostic test.

Children

The safety and efficacy of Signopam in children have not been established.

Patients with renal and/or hepatic impairment

Patients with hepatic and/or renal impairment should inform their doctor about these conditions. The doctor will adjust the dosage of the medicine according to the degree of impairment of the affected organ.

Elderly patients

Elderly patients are more sensitive to central nervous system depressants. When using Signopam in this group of patients, the smallest effective dose is recommended. The dose should not exceed half of the recommended dose for adults.

If 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 treatment is determined by the doctor.

Method of administration

Signopam tablets should be taken orally, with a small amount of water. The doctor will start treatment with the smallest effective dose and, if necessary, will gradually increase it.

Taking a higher dose of Signopam than recommended

Symptoms of overdose are impaired consciousness, drowsiness, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma. If a higher dose of Signopam than recommended is taken, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital. The patient should take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken.

Missing a dose of Signopam

If the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose according to the recommended schedule. If the patient forgets to take two or more doses, they should contact their doctor.

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Signopam

The patient should not stop treatment with Signopam unless it is in accordance with the doctor's recommendation. It is possible that the symptoms of the disease will recur. If the doctor decides to discontinue treatment, the dose of the medicine may be gradually reduced over several days. If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Signopam can cause side effects, although not everybody gets them.

Severe side effects

If any of the following side effects occur, the patient should immediately inform their doctor or go to the nearest emergency department in a hospital:

• Severe allergic reaction, such as itching, swelling of the lips or tongue, or wheezing, or shortness of breath. These symptoms have been reported very rarely (less than 1 in 10,000 patients).
• Disorientation, excitement, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses (loss of contact with reality), abnormal behavior. These disorders usually occur after alcohol consumption and in elderly patients. The frequency of these symptoms cannot be determined based on available data.

Other side effects that may occur during treatment with Signopam

The following side effects are common (less than 1 in 10 patients)

• Drowsiness, dizziness, slowed reactions may occur during the first few days of treatment in elderly patients and usually disappear during continued treatment.
• Visual disturbances (blurred, double vision)

The following side effects are rare (less than 1 in 1,000 patients)

• Changes in the number of some blood cells
• Nausea, stomach upset, dry mouth

The frequency of the following symptoms cannot be determined based on available data (frequency unknown).

• Rashes, itching, hives
• Lack of appetite
• During treatment with temazepam, previously undiagnosed depression may be revealed
• Memory disorders, coordination disorders, speech disorders, changes in libido
• Low blood pressure
• Slight increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin, whites of the eyes)
• Urinary retention, incontinence
• General weakness, fainting

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Signopam

The medicine should be stored out of sight and reach of children. Do not use the medicine after the expiration date stated on the packaging (EXP). The expiration date refers to the last day of the specified month. Store in a temperature below 25°C. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Signopam contains

• The active substance of the medicine is temazepam. One tablet contains 10 mg of temazepam.
• The other ingredients are: potato starch, rice starch, gelatin, talc, magnesium stearate, lactose monohydrate.

What Signopam looks like and what the pack contains

White or almost white, flat, beveled tablets with the inscription "S" on one side.

Packaging:20 tablets

Marketing authorization holder and manufacturer

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

Date of the last revision of the leaflet: