Sental

Package leaflet: Information for the user

Sental, 1 mg, tablets
Sental, 2 mg, tablets
Sental, 4 mg, tablets
Melatoninum
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sental is and what it is 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 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 associated with time zone changes in adults. Sleep disturbances related to time zone changes refer to symptoms caused by jet lag during travel across several time zones.
• Insomnia in children and adolescents (aged 6 to 17 years) with attention hyperactivity deficit disorder, i.e. ADHD (Attention Deficit Hyperactivity Disorder), when sleep hygiene measures have proven insufficient.

2. Important information before using Sental

When not to use Sental

• if the patient is allergic to melatonin or 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)

Use of Sental is not recommended in patients with liver disease, kidney disease, or autoimmune disease.
Women of childbearing potential should use contraception during treatment. Some contraceptive agents may affect the action of Sental—see section "Sental with other medicines". For further questions, consult your doctor.

Children and adolescents
This medicine should not be given to children or adolescents under 18 years of age for sleep disturbances related to time zone changes, as its safety and efficacy in this indication are unknown.
This medicine should not be given to children under 6 years of age, as its safety and efficacy are unknown.

Sental with other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Such medicines 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 contraceptives 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 types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, antihypertensive drugs),
• Opioid receptor agonists/antagonists (such as medicines 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) – more frequent monitoring of INR (blood clotting test) may be necessary.
• Beta-blockers (used in the treatment of high blood pressure), as these medicines may reduce the effect of melatonin.
• Nifedipine (used in the treatment of high blood pressure), as melatonin may reduce the effectiveness of nifedipine.
• NSAIDs, such as acetylsalicylic acid and ibuprofen.
• Tobacco smoking may reduce the effectiveness of melatonin.

Taking Sental with food, drink, and alcohol
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 or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Contraception in women of childbearing potential and young women
Women of childbearing potential and young women should use contraception during treatment with Sental. Since some contraceptive agents may increase melatonin levels in the body, the choice of contraceptive method should be discussed with a doctor (see section "Sental with other medicines").

Pregnancy
Sental is not recommended for use during pregnancy. Melatonin crosses the placenta, and there is insufficient information regarding the potential risk to the unborn child.

Breastfeeding
Sental is not recommended during breastfeeding. Melatonin passes into human milk, and a risk to the breastfed infant cannot be excluded.

Driving and using machines
Sental may cause drowsiness and reduce alertness for several hours after administration. Therefore, patients should not drive or operate machinery after taking melatonin.

3. How to take Sental

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Sleep disturbances related to time zone changes in adults
The recommended dose is 1–5 mg once daily for up to 5 days.
The maximum daily dose is 5 mg for 5 days.
The first dose should be taken upon arrival at the destination, at the usual bedtime according to local time. In the following days, the medicine should also be taken at the usual bedtime. Tablets should not be taken before 8:00 PM or after 4:00 AM local time.

Insomnia in children and adolescents aged 6 to 17 years with ADHD
The recommended initial dose is 1–2 mg, taken 30–60 minutes before bedtime.
The dose should be individually adjusted up to a maximum of 5 mg per day, regardless of age.
The lowest effective dose should be used.
Treatment should be regularly reviewed 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.

Method of administration
Tablets should be swallowed with a glass of water.
Food should not be consumed within 2 hours before or 2 hours after taking Sental.

Taking more than the recommended dose of Sental
If an overdose is accidentally taken or if a child accidentally ingests the medicine, always contact a doctor or the nearest hospital immediately to assess the risk and obtain further instructions.
Taking more than the recommended daily dose may cause drowsiness.

Missed dose of Sental
If the patient forgets to take a dose before bedtime and wakes up during the night, the missed dose may be taken no later than 4:00 AM local time.
Do not take a double dose to make up for a missed dose.

Stopping Sental
There is no known harmful effect of interrupting or stopping treatment earlier. No withdrawal symptoms have been reported after discontinuation of Sental.

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.
Potential adverse reactions include headache, nausea, loss of appetite, dizziness, daytime sleepiness, and disorientation, in both adults and children. Other adverse reactions that may occur are described below.
Melatonin used in various sleep disorders may cause a range of adverse reactions.
If any of the following serious adverse reactions occur in a patient, treatment should be discontinued immediately and a doctor should be contacted without delay:

Rare: (may occur in up to 1 in 1,000 patients)

• Loss of consciousness or fainting,
• Severe chest pain due to angina pectoris,

Frequency unknown: (cannot be estimated from the available data)

• Hypersensitivity reaction
• Swelling of the mouth and tongue

If any of the following adverse reactions occur in a patient, contact a doctor and/or seek medical advice:

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

• Irritability, nervousness, restlessness
• Insomnia
• Unusual dreams, nightmares
• Anxiety
• Migraine, headache
• Lethargy (tiredness, lack of energy)
• Restlessness with associated increased arousal
• Dizziness
• Fatigue
• Hypertension
• Abdominal pain
• Chest pain
• Indigestion
• Oral ulceration, dry mouth, nausea
• Blood count changes which may lead to yellowing of the skin or eyes
• Dermatitis
• Night sweats
• Itching, rash, dry skin
• Limb pain
• Presence of glucose in urine
• Proteinuria
• Menopausal symptoms
• Feeling of weakness
• Abnormal liver function
• Weight gain

Rare: (may occur in up to 1 in 1,000 patients)

• Herpes zoster
• Increased blood lipid levels
• Depression
• Mood swings
• Aggression, arousal
• Tearfulness
• Stress symptoms
• Waking up very early in the morning
• Increased sexual drive
• Low mood
• Disorientation
• Memory disturbances
• Attention disturbances
• Feelings of derealization
• Restless legs syndrome
• Poor sleep quality
• Sensation of "pins and needles" and numbness
• Palpitations
• Visual disturbances
• Lacrimation (watery eyes)
• Dizziness (sensation of spinning or "whirling" in the head)
• Dizziness upon sitting or standing
• Hot flushes
• Gastroesophageal reflux disease
• Stomach disorders
• Blisters in the mouth, tongue ulceration
• Gastric discomfort, vomiting
• Abnormal bowel sounds, bloating
• Excessive salivation, bad breath
• Abdominal discomfort
• Stomach disorders
• Gastritis
• Psoriasis
• Eczema
• Skin rash
• Hand dermatitis
• Itchy rash
• Nail disorders
• Arthritis
• Muscle cramps
• Neck pain
• Nocturnal muscle cramps
• Presence of blood in urine
• Increased urine output
• Nocturia
• Prolonged and painful erection
• Prostatitis
• Tiredness
• Pain
• Thirst
• Decreased white blood cell count
• Decreased platelet count, increasing the risk of bleeding or bruising
• Increased liver enzyme activity
• Abnormal blood electrolyte levels
• Abnormal laboratory test results

Frequency unknown: (cannot be estimated from the available data)

• Skin swelling
• Inappropriate milk secretion

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warszawa
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions may also be reported to the marketing authorization holder.

5. How to store Sental tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package following:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.
1 mg tablets in blisters:
Store below 25°C.
Keep in the original packaging to protect from light.
1 mg tablets in bottles, and 2 mg and 4 mg tablets in blisters and bottles:
Keep in the original packaging to protect from light.

6. Contents of the pack and other information

What Sental contains
The active substance is melatonin.
Sental 1 mg tablets: Each tablet contains 1 mg of melatonin.
Sental 2 mg tablets: Each tablet contains 2 mg of melatonin.
Sental 4 mg tablets: Each tablet contains 4 mg of melatonin.
The other ingredients are:
Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Pregelatinized starch (corn).

What Sental looks like and contents of the pack
1 mg tablets: Capsule-shaped tablet, white to beige in colour. The tablet measures 5 mm x 10 mm.
2 mg tablets: Round, convex tablet, white to beige in colour. The tablet has a diameter of 6 mm.
4 mg tablets: Round, convex tablet, white to beige in colour. The tablet has a diameter of 7 mm.
Pack sizes: 10, 30, 50 and 100 tablets in blisters (PVC/Aluminium).
10, 30, 50 and 100 tablets in containers (HDPE container with LDPE cap).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Tel: +48 22 646 6035
E-mail: [email protected]

Manufacturer
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

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