Senaxa Pr

Package Leaflet: Information for the Patient

Senaxa PR, 2 mg, prolonged-release tablets

Melatonin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Senaxa PR and what is it used for

The active substance of Senaxa PR, melatonin, belongs to a group of natural hormones produced by the human body.
Senaxa PR is used alone for the short-term treatment of primary insomnia (persistent difficulties falling asleep or staying asleep, or poor quality sleep) in patients aged 55 and over. "Primary" means that the insomnia is not caused by any known medical, psychiatric, or environmental factor.

2. Important information before taking Senaxa PR

When not to take Senaxa PR

• if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Senaxa PR, discuss it with your doctor or pharmacist.

• If you have kidney or liver problems. There have been no studies on the use of Senaxa PR in people with liver or kidney disease; you should consult your doctor before taking this medicine, as its use is not recommended in such cases.
• If you have been diagnosed with intolerance to some sugars.
• If you have been diagnosed with an autoimmune disease (in which the body is attacked by its own immune system). There have been no studies on the use of Senaxa PR in people with autoimmune diseases; therefore, you should consult your doctor before taking this medicine, as its use is not recommended in such cases.
• Senaxa PR may cause drowsiness; be careful if drowsiness affects you, as it may impair your ability to perform certain activities, such as driving.
• Smoking may reduce the effectiveness of Senaxa PR, as tobacco smoke components may accelerate the breakdown of melatonin in the liver.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it has not been tested in this patient group and its effects are unknown. Another melatonin-containing medicine may be more suitable for this age group. Consult your doctor or pharmacist.

Senaxa PR and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. These include:

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralens (used to treat skin disorders such as psoriasis), cimetidine (used to treat stomach disorders such as ulcers), quinolones and rifampicin (used to treat bacterial infections), estrogens (used in contraceptive pills and hormone replacement therapy), and carbamazepine (used to treat epilepsy).
• Adrenergic receptor agonists/antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, decongestants, and blood pressure-lowering medicines), opioid receptor agonists/antagonists (such as medicines used to treat drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory medicines), antidepressants, tryptophan, and alcohol.
• Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, such as zaleplon, zolpidem, and zopiclone).
• Thioridazine (used to treat schizophrenia) and imipramine (used to treat depression).

Taking Senaxa PR with food, drink, and alcohol

Take Senaxa PR after a meal. Do not drink alcohol before, during, or after taking Senaxa PR, as it reduces the effectiveness of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Senaxa PR may cause drowsiness. In this case, do not drive or operate machinery. If drowsiness persists, consult your doctor.

Senaxa PR contains lactose monohydrate

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

3. How to take Senaxa PR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Senaxa PR is one tablet (2 mg) taken orally once daily after a meal, 1-2 hours before bedtime. This dose can be continued for up to 13 weeks.
Swallow the tablet whole. Do not crush or break Senaxa PR tablets.

Taking more Senaxa PR than recommended

If you take more than the recommended dose, contact your doctor or pharmacist immediately.
Taking more than the recommended daily dose of Senaxa PR may cause drowsiness.

Missing a dose of Senaxa PR

If you miss a dose, take the next tablet before bedtime when you remember, or wait until it is time for your next dose and then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Senaxa PR

No harmful effects have been reported if treatment with Senaxa PR is stopped or interrupted prematurely. No withdrawal symptoms have been observed after stopping treatment with Senaxa PR.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Senaxa PR can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Senaxa PR and contact your doctor immediately:
Uncommon: (may affect up to 1 in 100 people)

• Chest pain

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

• Loss of consciousness or fainting
• Severe chest pain due to angina
• Palpitations
• Depression
• Visual disturbances
• Blurred vision
• Disorientation
• Dizziness
• Presence of red blood cells in urine
• Decreased white blood cell count
• Decreased platelet count, which may increase the risk of bleeding or bruising
• Psoriasis

Frequency not known: (frequency cannot be estimated from the available data)

• Hypersensitivity reaction
• Swelling of the lips or tongue
• Swelling of the skin

If you experience any of the following non-serious side effects, contact your doctor or pharmacist:
Uncommon: (may affect up to 1 in 100 people)
Irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, anxiety, migraine, headache, lethargy, restlessness, dizziness, fatigue, drowsiness, high blood pressure, abdominal pain, nausea, vomiting, changes in blood composition that may cause yellowing of the skin and eyes, skin rash, night sweats, itching, rash, dry skin, limb pain, menopausal symptoms, weakness, glucose in urine, high protein levels in urine, abnormal liver function, and weight gain.
Rare: (may affect up to 1 in 1,000 people)
Shingles, high levels of fat particles in the blood, low calcium levels in the blood, low sodium levels in the blood, mood changes, aggression, excitement, crying, tension, early morning awakening, increased libido, depressive mood, memory disorders, attention disorders, dreamy state, restless legs syndrome, poor quality sleep, tingling sensation, tearing, dizziness when standing or sitting, hot flashes, gastroesophageal reflux disease, stomach disorders, mouth ulcers, tongue ulcers, stomach upset, vomiting, unusual bowel sounds, gas, excessive salivation, bad breath, abdominal complaints, stomach disorders, gastritis, rash, skin rash, itching rash, nail changes, joint inflammation, muscle cramps, neck pain, nocturnal cramps, prolonged erection that may cause pain, prostatitis, fatigue, pain, thirst, excessive urination, nocturia, increased liver enzyme activity, abnormal electrolyte levels in the blood, and abnormal laboratory test results.
Frequency not known: (frequency cannot be estimated from the available data)
Abnormal milk secretion from the breasts.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 Senaxa PR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package to protect from light.
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 Senaxa PR contains

• The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other ingredients (excipients) are: ammonio methacrylate copolymer (type B), calcium hydrogen phosphate dihydrate, lactose monohydrate, colloidal anhydrous silica, talc, and magnesium stearate.

What Senaxa PR looks like and contents of the pack

Senaxa PR 2 mg prolonged-release tablets are white or almost white, round, biconvex tablets with a diameter of 8.0 ± 0.3 mm.
Senaxa PR is available in blisters of PVC/PVDC/Aluminum packed in a cardboard box.
The pack contains 7, 20, 21, or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14 A
05-170 Zakroczym
Phone: +48 22 785 27 60

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Malta: Senaxa PR, 2 mg prolonged-release tablets
Poland: Senaxa PR

Date of last revision of the package leaflet: