Sental

Package Leaflet: Information for the User

Sental, 3 mg, tablets

Sental, 5 mg, tablets

Melatonin

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

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

Table of Contents of the Leaflet

• 1. What is Sental and what is it used for
• 2. Important information 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 is Sental and what is it used for

The active substance of 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 related to time zone changes in adults. Sleep disorders related to time zone changes are a set of symptoms related to long-distance travel from east to west or from west to east. Sental is recommended for adults traveling across 5 or more time zones, especially in an easterly direction, and especially if they have experienced symptoms of sleep disorders related to time zone changes during previous trips. Travelers crossing 2-4 time zones may also use the medicinal product if necessary.
• Insomnia in children and adolescents (aged 6 to 17 years) with attention deficit hyperactivity disorder (ADHD), when sleep hygiene measures have been insufficient.

2. Important information before taking Sental

When not to take Sental

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

Warnings and precautions

Before starting treatment with Sental, discuss it with your doctor or pharmacist if you have:

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

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

Children and adolescents

Sental should not be used in children under 6 years of age.

Sental and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
These include:

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder),
• Quinolones and rifampicin (used to treat bacterial infections),
• Estrogens (used in contraceptives and hormone replacement therapy)
• Carbamazepine (used to treat epilepsy),
• 5- and 8-methoxypsoralen (5 and 8-MOP) (used to treat skin disorders, such as psoriasis),
• Adrenergic receptor agonists/antagonists (such as certain types of medicines used to control blood pressure by constricting blood vessels, decongestants, 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,
• Benzodiazepine derivatives and other sedatives (such as zaleplon, zolpidem, and zopiclone),
• Thioridazine (used to treat schizophrenia),
• Imipramine (used to treat depression),
• Warfarin (used to prevent blood clotting) - more frequent INR (blood clotting test) monitoring may be necessary.

Taking Sental with food, drink, and alcohol

Food may affect the efficacy of the Sental medicinal product (see "How to take Sental").
It is not recommended to take this medicine with food.
Do not eat for 2 hours before and after planned intake of melatonin.
People with significantly elevated blood sugar levels or diabetes are advised not to eat any meals for at least 3 hours before taking melatonin.
Do not consume alcohol before, during, or after taking Sental, as it reduces the efficacy of Sental.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Sental should not be used during pregnancy.
The Sental medicinal product should not be used during breastfeeding.
Women of childbearing age should use contraception during treatment. Some contraceptive measures may affect the action of Sental; see the section "Sental and other medicines" for further questions, consult your doctor.

Driving and using machines

Sental has a moderate effect on the ability to drive and use machines.
Sental may cause 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 exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Do not eat 2 hours before or 2 hours after the planned intake of melatonin. Swallow the tablets with a glass of water.
Time zone change-related sleep disorders in adults
The recommended dose is one 3 to 5 mg tablet per day, starting from the day of arrival at the destination, for a maximum of 4 days. The maximum daily dose is 5 mg. Sental is recommended for adults traveling across at least 5 time zones, especially in an easterly direction. The medicinal product may also be used by people traveling across 2-4 time zones if necessary.
The timing of melatonin intake is important. The dose should be taken before sleep (local time).
Insomnia in children and adolescents aged 6 to 17 years with ADHD
The initial dose of Sental, as well as any necessary increase to determine the most suitable dose for the patient, is determined by the doctor. The tablet is taken 30-60 minutes before sleep. The maximum daily dose that a patient can take is 5 mg. The use of Sental is appropriate when the smallest effective dose has been determined by the doctor to be 3 mg or 5 mg through the use of other products with lower strength.
Treatment should be regularly monitored by the doctor (recommended at least every 6 months) to confirm that it is still appropriate. Treatment should be discontinued once a year to check if treatment is still necessary.
Sental 5 mg tablet: The score line is only to facilitate breaking the tablet into two halves, should you have difficulty swallowing it whole.

Overdose of Sental

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

Missed dose of Sental

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

Stopping Sental treatment

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

4. Possible side effects

Like all medicines, Sental can cause side effects, although not everybody gets them.
Possible side effects include headache, nausea, loss of appetite, dizziness, daytime sleepiness, and disorientation, both in adults and children. Other side effects that may occur are described below.
Melatonin used in various sleep disorders may cause a range of side effects.
If you experience any of the following serious side effects, stop taking Sental 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 pectoris,
• Palpitations,
• Dizziness (feeling of dizziness or "spinning")

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

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

If you experience any of the following side effects, contact your doctor or seek medical advice:

Uncommon:(may affect up to 1 in 100 people)
Irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, anxiety, migraine, headache, lethargy (fatigue, lack of energy), restlessness associated with increased activity, dizziness, fatigue, high blood pressure, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea (vomiting), changes in blood composition that may cause yellowing of the skin and whites of the eyes, skin inflammation, night sweats, itching, rash, dry skin, limb pain, glucose in the urine, high protein levels in the urine, menopausal symptoms, weakness, 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, depression, mood changes, aggression, excitement, crying, stress symptoms, early morning awakening, increased sexual desire, depressive mood, disorientation, memory disorders, attention disorders, dreamy state, restless legs syndrome (urge to move legs), poor sleep quality, tingling sensation, vision disturbances, eye watering, dizziness when standing or sitting, hot flashes, acid reflux, stomach disorders, mouth blisters, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, flatulence, excessive saliva production, bad breath, abdominal complaints, stomach disorders, stomach inflammation, psoriasis, rash, skin rash, nail disorders, joint inflammation, muscle cramps, neck pain, nocturnal cramps, blood in the urine, excessive urination, nocturia, prolonged painful erection, prostatitis, fatigue, pain, thirst, decreased white blood cell count, decreased platelet count, which increases the risk of bleeding or bruising, increased liver enzyme activity, abnormal electrolyte levels, and abnormal laboratory test results.
Frequency not known:(cannot be estimated from the available data)
Skin swelling or abnormal milk secretion by the breasts.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sental

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 that month.
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 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:
Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Maize starch paste.

What Sental looks like and contents of the pack

3 mg tablets: White, round, biconvex tablet with a logo of 7, 7 mm in diameter.
5 mg tablets: White, capsule-shaped tablet with a score line on one side, 10 mm x 5 mm in size. The score line is only to facilitate breaking the tablet into two halves, should you have difficulty swallowing it whole.
10, 30, 50, or 100 tablets in blisters (PVC/Aluminum).
Not all pack sizes may be marketed.

Marketing authorization holder

Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna, Finland

Manufacturer

Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Melatal
Sweden: Melatan
Poland: Sental

Date of last revision of the leaflet:

• 06.05.2024