Sental

Patient Information Leaflet

Sental, 3 mg, tablets
Sental, 5 mg, tablets
Melatonin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Sental is and what it is used for

The active substance in Sental, melatonin, belongs to a group of natural hormones produced by the human body.
Melatonin helps regulate the day-night rhythm in the body.
Sental is indicated for:

• Short-term treatment of sleep disorders due to jet lag in adults. Sleep disturbances due to jet lag are a set of symptoms related to long-distance travel from east to west or west to east. Sental is recommended for adults travelling across five or more time zones, particularly in an easterly direction, especially if they have previously experienced jet lag symptoms during earlier trips. Travellers crossing 2–4 time zones may also use this medicinal product as needed.
• Insomnia in children and adolescents (aged 6 to 17 years) with attention deficit hyperactivity disorder (ADHD), when sleep hygiene measures have proven insufficient.

2. Important information before using Sental

When not to use Sental

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

Warnings and precautions
Before starting treatment with Sental, consult your doctor or pharmacist if the patient has:

• epilepsy
• kidney disease
• liver disease
• diabetes or impaired glucose tolerance, as this medicine may increase blood glucose levels
• autoimmune disease (a condition in which the body is “attacked” by its own immune system)

The use of Sental is not recommended in patients with liver or kidney disease, or autoimmune disease.
Smoking may reduce the effectiveness of Sental, as components of tobacco smoke may increase the breakdown of melatonin by the liver.
Women of childbearing age should use contraception during treatment. Some contraceptive agents may affect the action of Sental; see section "Sental and other medicines". For further questions, consult your doctor.

Children and adolescents
Sental must not be used in children under 6 years of age.

Sental and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

These include:

• Fluvoxamine (used in the treatment of depression and obsessive-compulsive disorder),
• Quinolones and rifampicin (used in the treatment of bacterial infections),
• Estrogens (used in contraceptive agents and hormone replacement therapy),
• Carbamazepine (used in the treatment of epilepsy),
• 5- and 8-methoxypsoralens (5 and 8-MOP) (used in the treatment of skin disorders such as psoriasis),
• Adrenergic receptor agonists/antagonists (such as certain drugs used to control blood pressure by constricting blood vessels, nasal decongestants, antihypertensive drugs),
• Opioid receptor agonists/antagonists (such as drugs used in the treatment of drug addiction),
• Prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs),
• Antidepressants,
• Tryptophan,
• Benzodiazepine derivatives and other hypnotics (such as zaleplon, zolpidem, and zopiclone),
• Thioridazine (used in the treatment of schizophrenia),
• Imipramine (used in the treatment of depression),
• Warfarin (used to prevent blood clotting) – closer monitoring of INR (a blood clotting test) may be necessary.

Taking Sental with food, drink, and alcohol
Food may affect the efficacy of Sental (see “How to take Sental”).
It is not recommended to take this medicine with food.
Food should not be consumed within 2 hours before or after the planned intake of melatonin.
Patients with significantly elevated blood glucose levels or diabetes are advised not to consume any meals for at least 3 hours before taking melatonin.
Do not consume alcohol before, during, or after taking Sental, as it reduces the effectiveness of Sental.

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.
The use of Sental during pregnancy is not recommended.
Sental must not be used during breastfeeding.
Women of childbearing age should use contraception during treatment. Some contraceptive agents may affect the action of Sental; see section "Sental and other medicines". For further questions, consult your doctor.

Driving and using machines
Sental has a moderate influence on the ability to drive and operate machinery.
Sental may cause, among others, drowsiness. It may affect alertness for several hours after taking melatonin. Do not drive or operate machinery after taking melatonin.

3. How to take Sental
This medicine should always be taken according to the instructions given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Do not consume food 2 hours before or 2 hours after the planned time of melatonin intake. Swallow the tablet with a glass of water.

Sleep disturbances related to time zone changes in adults
The recommended dose is one 3 to 5 mg tablet per day, starting on the day of arrival at the destination, for up to 4 days. The maximum daily dose is 5 mg. Sental is recommended for travel across at least 5 time zones, especially eastward travel. The medicine may also be used as needed by individuals travelling across 2–4 time zones.

The timing of melatonin intake is important. The dose should be taken before bedtime (local time).

Insomnia in children and adolescents aged 6 to 17 years with ADHD
The initial dose of Sental, as well as any necessary dose increase to determine the most appropriate dose for the patient, must be determined by the doctor. Take the tablet 30–60 minutes before bedtime. The maximum daily dose a patient may take is 5 mg. Sental may be used when the lowest effective dose has been established by the doctor at 3 mg or 5 mg through the use of other lower-strength products.

Treatment should be regularly monitored by a doctor (at least once every 6 months) to confirm its continued appropriateness. Treatment should be interrupted once a year to assess whether continued treatment is still necessary.

Sental 5 mg tablet: The score line is only for ease of swallowing if the patient has difficulty swallowing the tablet whole.

Taking more than the recommended dose of Sental
In case of accidental overdose or if a child has accidentally taken the medicine, always contact your doctor or nearest hospital to assess the risk and obtain further instructions.
Taking more than the recommended daily dose may cause drowsiness.

If you miss a dose of Sental
Do not take a double dose to make up for a missed dose.

Stopping Sental
There are no known harmful effects of interrupting or stopping treatment earlier. No withdrawal symptoms have been observed after discontinuation of Sental treatment.

If you have any further questions about 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 experiences them.
Potential adverse effects include headache, nausea, loss of appetite, dizziness, daytime sleepiness, and disorientation, in both adults and children. Other adverse effects that may occur are described below.
Melatonin used in various sleep disorders may cause a range of adverse effects.
If any of the following serious adverse effects occur in a patient, treatment should be discontinued and immediate medical advice should be sought:

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,
• Palpitations (awareness of heartbeat),
• Dizziness (feeling of dizziness or "spinning")

Frequency unknown: (cannot be estimated from available data)

• Hypersensitivity reaction
• Swelling (edema) of the lips or tongue

If any of the following adverse effects occur in a patient, contact 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 (tiredness, lack of energy), restlessness associated with increased activity, dizziness, fatigue, high blood pressure, upper abdominal pain, indigestion, oral ulceration, dry mouth, nausea, changes in blood composition which may cause yellowing of the skin and whites of the eyes, skin inflammation, night sweats, itching, rash, dry skin, limb pain, glucose excretion in urine, excessive protein in urine, menopausal symptoms, weakness, abnormal liver function, and weight gain.

Rare: (may affect up to 1 in 1000 patients)
Shingles, high levels of fat molecules in the blood, depression, mood changes, aggression, agitation, crying, stress symptoms, waking up early in the morning, increased sexual drive, depressive mood, disorientation, memory disturbances, attention disorders, dreamy state, restless legs syndrome (urge to move legs), poor sleep quality, tingling and numbness sensations, visual disturbances, tearing of the eyes, dizziness upon standing or sitting, hot flushes, acid reflux, gastrointestinal disturbances, blisters in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, flatulence, excessive saliva production, bad breath, abdominal discomfort, gastric disturbances, gastritis (inflammation of the stomach lining), psoriasis, rash, skin eruption, hand dermatitis, itchy rash, nail disorders, joint inflammation, muscle cramps, neck pain, nocturnal cramps, presence of blood in urine, passing large amounts of urine, nocturia (urination at night), prolonged painful erection, prostatitis (inflammation of the prostate gland), fatigue, pain, thirst, decreased white blood cell count, decreased platelet count (increasing the risk of bleeding or bruising), increased liver enzyme activity, abnormal blood electrolyte results, and abnormal laboratory test results.

Frequency unknown: (cannot be estimated from available data)
Skin swelling or abnormal milk secretion from the breasts.

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.: 22 49 21 301
Fax: 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 this medicine.

5. How to store the medicine Sental

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging following:
EXP. The expiry date refers to the last day of the stated month.
Store 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Sental contains
The active substance is melatonin.
Sental 3 mg tablets: Each tablet contains 3 mg of melatonin.
Sental 5 mg tablets: Each tablet contains 5 mg of melatonin.
The other ingredients are:
Dibasic calcium phosphate dihydrate, Microcrystalline cellulose, Magnesium stearate, Anhydrous colloidal silica,
Pregelatinized corn starch.

What Sental looks like and contents of the pack
3 mg tablets: white, round, convex tablets with the logo 7, 7 mm in diameter.
5 mg tablets: white capsule-shaped tablets with a score line on one side, 10 mm x 5 mm in size. The score line facilitates splitting the tablet if the patient has difficulty swallowing it whole.
Packaged in blisters (PVC/Aluminium) containing 10, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna, Finland

Manufacturer
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

This medicinal product is authorised in the European Economic Area member states under the following names:
Denmark: Melatal
Sweden: Melatan
Poland: Sental
06.05.2024