Package leaflet: Information for the patient

Senaxa PR, 2 mg, prolonged-release tablets
Melatoninum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
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. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

The active substance in Senaxa PR, melatonin, belongs to a group of natural hormones
produced by the human body.
Senaxa PR is used alone in the short-term treatment of primary insomnia
(persistent difficulty in falling asleep or maintaining sleep continuity, or poor sleep quality) in
patients aged 55 years and older. "Primary" means that insomnia has no identified cause,
including medical, psychological, or environmental causes.

2. Important information before taking Senaxa PR

When not to take Senaxa PR

if the patient is allergic to melatonin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Senaxa PR, discuss this with your doctor or pharmacist.

If the patient has impaired kidney or liver function. Studies on the use of Senaxa PR in patients with liver or kidney disease have not been conducted; the patient should consult a doctor before taking this medicine, as its use is not recommended in such cases.
If the patient has been diagnosed with intolerance to certain sugars.
If the patient has been diagnosed with an autoimmune disease (a condition in which the body's immune system attacks the body itself). Studies on the use of Senaxa PR in patients with autoimmune diseases have not been conducted; therefore, the patient should consult a doctor before starting this medicine, as its use is not recommended in such cases.
Senaxa PR may cause drowsiness; caution should be exercised if drowsiness affects the patient, as it may impair the ability to perform certain activities, such as driving.
Smoking may reduce the effectiveness of Senaxa PR, as components of tobacco smoke may accelerate the breakdown of melatonin in the liver.

Children and adolescents
Do not use this medicine in children and adolescents aged 0 to 18 years, as it has not been tested in this patient group and its effect is unknown. Another melatonin-containing medicine may be more suitable for use in this age group. Consult a doctor or pharmacist.

Senaxa PR and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used by the patient, as well as any medicines the patient plans to take. These include:

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

Taking Senaxa PR with food, drink, and alcohol
Senaxa PR should be taken after a meal. Do not consume alcohol before, during, or after taking Senaxa PR, as it reduces the effectiveness of the medicine.

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

Driving and operating machinery
Senaxa PR may cause drowsiness. In such a case, driving or operating machinery should be avoided. If drowsiness persists, consult a doctor.

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

3. How to take Senaxa PR

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult 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 may be continued for up to thirteen weeks.
The tablet should be swallowed whole. Do not crush or split Senaxa PR tablets.

Taking more Senaxa PR than recommended
If you have taken too much of this medicine, contact your doctor or pharmacist immediately.
Taking more than the recommended daily dose may cause drowsiness.

If you forget to take Senaxa PR
If you miss a dose, take the next tablet at bedtime when you remember, or wait until the next scheduled dose and then continue your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping Senaxa PR
There are no known harmful effects of stopping or prematurely discontinuing treatment. No withdrawal symptoms have been observed after stopping treatment with Senaxa PR.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur in a patient, the medicine should be discontinued immediately and medical advice must be sought without delay:

Uncommon: (may affect up to 1 in 100 patients)

Chest pain

Rare: (may affect up to 1 in 1000 patients)

Loss of consciousness or fainting
Severe chest pain due to angina pectoris
Palpitations
Depression
Visual disturbances
Blurred vision
Disorientation
Dizziness
Presence of red blood cells in urine
Decreased number of white blood cells in blood
Decreased number of platelets, increasing 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
Skin swelling

If any of the following non-serious adverse reactions occur, consult a doctor and/or seek medical advice:

Uncommon: (may affect up to 1 in 100 patients)
Irritability, nervousness, restlessness, insomnia, unusual dreams, nightmares, anxiety, migraine, headache, lethargy, restlessness associated with increased activity, dizziness, fatigue, somnolence, high blood pressure, upper abdominal pain, indigestion, oral ulceration, dry mouth, nausea, blood abnormalities which may cause yellowing of the skin and whites of the eyes, skin inflammation, night sweats, itching, rash, dry skin, limb pain, menopausal symptoms, weakness, glucose excretion in urine, excessive protein in urine, abnormal liver function, and weight gain.

Rare: (may affect up to 1 in 1000 patients)
Shingles, high levels of blood lipids, low serum calcium levels, low blood sodium levels, mood changes, aggression, agitation, crying, tension symptoms, early morning awakening, increased libido (increased sexual drive), depressive mood, memory disturbances, attention disturbances, dream-like state, restless legs syndrome, poor quality of sleep, tingling sensation, watery eyes, dizziness upon standing or sitting, hot flushes, gastroesophageal reflux disease, gastric disturbances, oral blisters, tongue ulceration, upset stomach, vomiting, unusual bowel sounds, flatulence, excessive salivation, bad breath, abdominal discomfort, stomach disorders, gastric mucosal inflammation, rash, skin eruption, hand dermatitis, itchy rash, nail plate abnormalities, joint inflammation, muscle cramps, neck pain, nocturnal cramps, prolonged erection which may be painful, prostatic inflammation, feeling of exhaustion (fatigue), pain, thirst, excessive urination, nocturia, elevated liver enzyme activity, abnormal blood electrolyte levels, and abnormal laboratory test results.

Frequency not known: (frequency cannot be estimated from the available data)
Abnormal milk secretion from breasts.

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

5. How to store Senaxa PR

Keep this medicine out of 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 stated month.
Do not store above 25°C. Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What the medicine 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 available as white or off-white, round, biconvex tablets with a diameter of 8.0 ± 0.3 mm.
The medicine is supplied in blisters made of PVC/PVDC/Aluminium, packed in cardboard boxes.
The pack contains 7, 20, 21 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14 A
05-170 Zakroczym
Tel. +48 22 785 27 60
This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Malta: Senaxa PR, 2 mg prolonged-release tablets
Poland: Senaxa PR