Signopam

Package leaflet: Information for the patient

SIGNOPAM, 10 mg, tablets
Temazepam
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Signopam is and what it is 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 Signopam is and what it is used for

Signopam contains the active substance temazepam, which belongs to a group of medicines called benzodiazepines. Temazepam has hypnotic, sedative, and anxiolytic properties. It also exhibits weak anticonvulsant activity and skeletal muscle relaxation.
Signopam is used on a short-term and temporary basis:

• for the treatment of severe sleep disorders when insomnia causes significant exhaustion in the patient;
• for premedication – preparation for surgical procedures and uncomfortable diagnostic examinations.

2. Important information before using Signopam

When not to use Signopam
Do not use Signopam if the patient has:

• hypersensitivity to temazepam or any of the other ingredients of this medicine (listed in section 6);
• severe respiratory insufficiency regardless of cause;
• severe hepatic insufficiency;
• sleep apnoea syndrome;
• myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
• intoxication with alcohol or drugs acting on the central nervous system.

Warnings and precautions
Before starting treatment with Signopam, discuss it with your doctor or pharmacist.
General information regarding effects observed during benzodiazepine treatment, which should be considered when using Signopam.

➢ Tolerance
After several weeks of using Signopam, its effectiveness may decrease.

➢ Dependence
Long-term use of Signopam may lead to psychological and physical dependence. The risk of developing dependence increases with higher doses and longer duration of treatment, and is greater in patients with drug or alcohol dependence or those with personality disorders.

➢ Withdrawal symptoms
If the drug is abruptly discontinued, withdrawal symptoms may occur, such as: headache, muscle pain, increased anxiety, tension, restlessness, motor agitation, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of reality perception, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling and numbness in limbs, hallucinations and delusions, epileptic seizures.

➢ Rebound phenomenon and anxiety
During discontinuation of Signopam, a transient recurrence of intensified symptoms that were the reason for initiating treatment may occur (so-called "rebound" phenomenon). These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these symptoms, your doctor will recommend gradually reducing the dose.

➢ Anterograde amnesia (inability to remember events after taking the drug)
Signopam may cause anterograde amnesia (difficulty learning and remembering new information – new data are not permanently stored). This condition most commonly occurs within a few hours after administration, especially at high doses. If your doctor has prescribed Signopam once daily, to reduce the risk of anterograde amnesia, it is recommended to take the medicine half an hour before going to bed and ensure appropriate conditions for continuous, uninterrupted sleep lasting 7–8 hours.

➢ Psychological and paradoxical reactions
In children and elderly patients, the risk of abnormal and paradoxical (opposite to expected) psychological reactions increases, such as: anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, and behavioral disturbances.
If such symptoms occur, contact your doctor immediately.

Special patient groups
➢ Elderly patients should receive lower doses of Signopam (see section 3), due to the increased risk of adverse effects, particularly disturbances in orientation and motor coordination (falls, injuries).
➢ Patients with hepatic or renal insufficiency or chronic respiratory insufficiency should inform their doctor about these conditions before taking Signopam.
➢ Use in depression
Before using Signopam, inform your doctor about any psychiatric disorders. Patients with symptoms of depression or anxiety associated with depression should be treated with multiple medications. Administering Signopam alone to patients with depression may worsen depressive symptoms, including suicidal thoughts.
➢ During benzodiazepine treatment, masked depression may become apparent.
➢ Patients with alcohol, drug, or medication dependence should inform their doctor about these addictions before taking Signopam. These patients have a high risk of developing psychological and physical dependence. Therefore, this group of patients should use Signopam only under strict medical supervision.
➢ Use of Signopam in individuals grieving the loss of loved ones does not improve well-being.

Signopam and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is particularly important if you are taking any of the following medicines or drinking alcohol:

• fluvoxamine, fluoxetine, and other medicines used to treat psychiatric disorders;
• medicines used for insomnia;
• medicines used for allergic conditions that may cause drowsiness;
• medicines used for epilepsy (e.g. carbamazepine, phenytoin, hydantoin);
• strong analgesics (e.g. morphine);
• opioids: concomitant use of Signopam and opioids (strong painkillers, medicines used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may even be life-threatening. Therefore, simultaneous use of these medicines should only be considered when no other treatment options are available.

If your doctor prescribes Signopam together with opioids, the dose and duration of concomitant treatment should be limited.
The patient should inform the doctor about all opioid medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the possible occurrence of the mentioned symptoms. If such symptoms occur, contact your doctor immediately.

Alcohol
Drinking alcohol while taking Signopam may enhance its effects and lead to paradoxical reactions such as: strong psychomotor excitation, aggressive behavior (see section 2; Warnings and precautions).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Pregnancy
Signopam should not be taken during pregnancy.

Breastfeeding
Signopam passes into human milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery
During treatment with Signopam, do not drive or operate machinery.
The ability to drive and operate machinery may be impaired due to possible drowsiness, concentration disturbances, or other adverse effects that reduce concentration (see section 4. Possible side effects).

Signopam contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to use Signopam

This medicine should always be taken as directed by the physician.
In case of doubt, consult your doctor.

Adults
Sleep disorders: usually 10 mg to 20 mg taken half an hour before bedtime. In individual
cases, when these doses are ineffective, the doctor may increase the dose up to a maximum of 40 mg
per day.
Preparation for surgical procedures and uncomfortable diagnostic examinations: usually
20 mg to 40 mg as a single dose, taken 30 to 60 minutes before the surgical procedure
or diagnostic examination.

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

Patients with impaired kidney and/or liver function
Patients with impaired liver and/or kidney function should inform their doctor about these
conditions. The doctor will adjust the dosage according to the degree of organ impairment.

Elderly patients
Elderly patients are more sensitive to medicines acting on the central nervous system.
When using Signopam in this patient group, it is recommended to administer the lowest
effective dose. The dose should not exceed half the dose recommended for adult patients.

If during treatment 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 will be 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 lowest effective dose and, if necessary, gradually increase it.

Overdose of Signopam
Symptoms of overdose include disturbances of consciousness, drowsiness, slurred speech. In severe
cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness,
respiratory depression, coma.

In case of overdose of Signopam, seek immediate medical attention by contacting a doctor or going to the nearest hospital emergency department. Bring the medicine in its original packaging so that the medical staff can clearly identify which medicine was taken.

Missed 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 missed dose should be skipped and the next dose taken as scheduled. If the patient forgets to take two or more doses, they should contact their doctor.

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

Stopping treatment with Signopam
Do not discontinue the medicine unless instructed by the doctor. There may be a recurrence of disease symptoms. If the doctor decides to discontinue treatment, the dose may be gradually reduced over several days.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions
If any of the following adverse symptoms occur, you should immediately
contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reaction in the form of itching, swelling of lips or tongue, or wheezing or shortness of breath. These symptoms have been reported very rarely (less than 1 in 10,000 patients).
• Disorientation, states of excitement and agitation, depression with suicidal tendencies, anxiety, irritability, hallucinations, nightmares, illusions (seeing or hearing things that are not real), psychoses (loss of contact with reality), unusual behaviour. These disorders most commonly occur after alcohol consumption and in elderly patients. The frequency of these symptoms cannot be determined from available data.

Other adverse reactions that may occur during treatment with Signopam
The following adverse reactions occur commonly (less than 1 in 10 patients):

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

The following adverse reactions occur rarely (less than 1 in 1,000 patients):

• Changes in the count of certain blood cells
• Nausea, gastrointestinal discomfort, dry mouth sensation

The frequency of occurrence of the following symptoms cannot be determined from available data
(frequency unknown):

• Skin rashes, itching, urticaria
• Loss of appetite
• During treatment with temazepam, previously existing undiagnosed depression may become apparent
• Memory disturbances, motor coordination disturbances, speech disturbances, changes in libido
• Decreased blood pressure
• Slight increase in liver enzyme activity, disturbances in liver function with jaundice (yellowing of the skin and whites of the eyes)
• Urinary retention, urinary incontinence
• General weakness, fainting

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Signopam

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry (EXP). The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
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 Signopam contains

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

What Signopam looks like and contents of the pack
White or almost white, flat-faced, biconvex tablets with the imprint "S" on one side.
Pack size: 20 tablets
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22 811-18-14
For further information, please contact the representative of the Marketing Authorisation Holder.