Melatonin pharma nord

Package leaflet: Information for the user

Melatonina Pharma Nord, 3 mg, coated tablets
Melatoninum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if symptoms worsen, consult your doctor.

Table of contents:

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

1. What Melatonina Pharma Nord is and what it is used for

Melatonina Pharma Nord contains the active substance melatonin. Melatonina Pharma Nord may be used for the short-term treatment of symptoms associated with jet lag in adults. Symptoms of jet lag include sleep disturbances, daytime fatigue, malaise, mild mood disturbances, irritability, and gastrointestinal disturbances.

How Melatonina Pharma Nord works
Melatonin is a hormone naturally produced by the body that helps regulate the body's day/night biological rhythm. Travel across time zones can disrupt this biological rhythm, leading to symptoms of jet lag. The severity and type of symptoms may vary between individuals, but generally, the more time zones crossed, the more pronounced and longer-lasting the symptoms. Melatonina Pharma Nord may help restore the normal day/night rhythm and relieve jet lag symptoms.

If there is no improvement after 5 days, or if you feel worse, you should contact your doctor.

2. Important information before taking Melatonina Pharma Nord

When not to take Melatonina Pharma Nord

• 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 Melatonina Pharma Nord, discuss with your doctor or pharmacist:

• if the patient has epileptic seizures. Melatonin may increase the frequency of seizures, for example in patients with epilepsy
• if the patient has an autoimmune disease (conditions in which the body is "attacked" by its own immune system)
• if the patient has diabetes or impaired glucose tolerance, as this medicine may increase blood glucose levels. If the patient has diabetes, they should ensure not to take this medicine 2 hours before a meal, and after a meal, should wait at least 3 hours before taking the medicine.
• if the patient has moderate or severe liver function impairment or severe kidney function impairment
• if the patient smokes cigarettes. Smoking may reduce the effectiveness of Melatonina Pharma Nord, as components of cigarette smoke may increase the breakdown of melatonin in the liver
• if the patient has hypertension and is taking medication for high blood pressure. Melatonin may reverse the beneficial effects of antihypertensive drugs
• This medicine may cause drowsiness. Caution is advised if the patient experiences drowsiness, as it may adversely affect the ability to perform activities such as driving vehicles.

Children and adolescents
This medicine must not be given to children and adolescents aged 0 to 18 years, as the safety and efficacy of the medicine in short-term treatment of symptoms related to time zone change have not been established.
Melatonina Pharma Nord and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

• Fluvoxamine (used in the treatment of depression and obsessive-compulsive disorders), because fluvoxamine may enhance the effect of melatonin.
• Psoralens (used in the treatment of skin diseases, e.g. psoriasis), because psoralens may enhance the effect of melatonin.
• Cimetidine (used in the treatment of stomach disorders, such as ulcers), because cimetidine may enhance the effect of melatonin.
• Estrogens (used in contraceptives or hormone replacement therapy), because estrogens may enhance the effect of melatonin.
• Quinolones (used in the treatment of bacterial infections), because quinolones may enhance the effect of melatonin.
• Rifampicin (used in the treatment of bacterial infections), because rifampicin may reduce the effect of melatonin.
• Carbamazepine (used in the treatment of epilepsy), because carbamazepine may reduce the effect of melatonin.
• Warfarin (used as a medicine to reduce blood clotting), because melatonin may interfere with the action of warfarin.
• Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, e.g. midazolam, temazepam and zaleplon, zolpidem, zopiclone), because melatonin may enhance the sedative effect of these medicines and may enhance some of the adverse effects of zolpidem (morning drowsiness, nausea, confusion).

Melatonina Pharma Nord with food and alcohol

• This medicine should not be taken with food (see section 3).
• Alcohol may disrupt sleep and worsen some symptoms caused by time zone change (e.g. headache, morning fatigue, concentration problems); therefore, it is recommended not to consume alcohol while taking Melatonina Pharma Nord.
• Consuming alcohol while taking this medicine may cause increased drowsiness.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Melatonina Pharma Nord is not recommended for use during pregnancy. Melatonin crosses the placenta, and there is insufficient information regarding the potential risk to the unborn child.
Women of childbearing potential must use an effective method of contraception during treatment with this medicine.
Breastfeeding
Use of Melatonina Pharma Nord is not recommended in breastfeeding women. Melatonin passes into human milk and risk to the breastfed infant cannot be excluded.
Fertility
Use of Melatonina Pharma Nord is not recommended in women and men planning to have children, as there is insufficient information on the effect of melatonin on fertility in women and men.
Driving and operating machinery
Melatonina Pharma Nord may cause drowsiness and reduce alertness for several hours after administration. Therefore, this medicine should not be taken before driving or operating machinery.
Melatonina Pharma Nord contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Melatonina Pharma Nord

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
The recommended dose for adults and elderly patients is 1 tablet once daily,
for a maximum of 5 days. If the effect of Melatonina Pharma Nord is insufficient, 2 tablets
may be taken simultaneously the following evening. The dose that adequately relieves
symptoms should be taken for the shortest possible duration.
The first dose should be taken upon arrival at the destination, at the usual bedtime.
Subsequent doses should also be taken at bedtime. Do not take the tablets before 8:00 PM or
after 4:00 AM.
The tablets should be swallowed whole with water or another liquid (e.g. milk, fruit juice).
It is recommended to avoid food intake for at least 2 hours before and at least 2 hours after
taking Melatonina Pharma Nord. If the patient has impaired glucose tolerance or
diabetes, it is best not to take Melatonina Pharma Nord for at least 3 hours after a meal.
Melatonina Pharma Nord 3 mg may be taken for a maximum of 16 treatment periods in a given year.
Taking more than the recommended dose of Melatonina Pharma Nord
If a patient has taken more than the recommended dose of Melatonina Pharma Nord and feels unwell,
they should contact a physician, hospital, or pharmacist.
The most common symptoms of overdose include drowsiness, headache, dizziness, and nausea.
Missing a dose of Melatonina Pharma Nord
If a patient misses a dose at bedtime and wakes up during the night, the missed dose may be taken,
but not later than 4:00 AM.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Melatonina Pharma Nord
If a patient stops taking this medicine, it will not have harmful effects or cause withdrawal symptoms.
If you have any further questions about the use of this medicine, consult your
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following adverse reactions occur in a patient, treatment with the medicine should be discontinued and the patient should immediately contact a doctor:
Uncommon adverse reactions (may occur in no more than 1 in 100 treated patients)

• Chest pain

Rare adverse reactions (may occur in no more than 1 in 1,000 treated patients)

• Decrease in the number of white blood cells in the blood
• Decrease in the number of platelets, increasing the risk of bleeding or bruising
• Disorientation
• Fainting
• Vision disturbances, including blurred vision
• Palpitations (awareness of heart beating)
• Blood (red blood cells) in urine

Frequency unknown (frequency cannot be estimated from available data)

• Severe allergic reaction causing swelling of the tongue or oral mucosa

Other adverse reactions
If any of the following other adverse reactions occur in a patient, contact a doctor or pharmacist:
Common adverse reactions (may occur in no more than 1 in 10 people)

• Headache
• Drowsiness

Uncommon adverse reactions (may occur in no more than 1 in 100 people)

• Irritability, nervousness, anxiety, unusual dreams, restlessness
• Dizziness
• High blood pressure
• Abdominal pain, epigastric pain, indigestion, mouth ulcers, dry mouth, nausea
• Itching, rash, dry skin
• Presence of sugar in urine, presence of protein in urine
• Malaise
• Weight gain

Rare adverse reactions (may occur in no more than 1 in 1,000 people)

• High levels of certain fat particles (triglycerides) in blood
• Mood changes, aggression, increased libido
• Memory disturbances, restless legs syndrome, tingling and numbness sensations
• Watery eyes
• Hot flushes
• Vomiting, flatulence, excessive salivation, bad breath, inflammation of the stomach mucosa
• Nail disorders
• Joint inflammation, muscle cramps
• Passing large amounts of urine
• Prolonged erection, which may be painful, inflammation of the prostate gland
• Thirst
• Abnormal electrolyte levels in blood

Frequency unknown (frequency cannot be estimated from available data)

• Hypersensitivity reactions
• High blood glucose levels
• Galactorrhea (also in men)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C
PL-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 Melatonina Pharma Nord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP. The expiry date refers to the last day of the stated month.
• There are no special temperature storage requirements for this medicine.
• This medicine should be stored in its original packaging to protect it 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 will help protect the environment.

6. Contents of the packaging and other information

What Melatonina Pharma Nord contains

• The active substance is melatonin. Each tablet contains 3 mg of melatonin.
• Other components are: Tablet core: microcrystalline cellulose (type 101), microcrystalline cellulose (type 102), maltodextrin, colloidal anhydrous silica, magnesium stearate, sodium croscarmellose. Tablet coating: hypromellose (type 2910)

What Melatonina Pharma Nord looks like and contents of the pack
Round, biconvex, coated tablet, white or almost white. Size 7.5 mm.
Pack: blister pack containing 10 or 30 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharma Nord ApS
Tinglykke 4-6
6500 Vojens
Denmark

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Pharma Nord sp. z o.o.
ul. Zwoleńska 24C
04-761 Warsaw
Phone: 022 615 27 22
Email: [email protected]

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Belgium Melatonine Pharma Nord 3 mg comprimés pélliculés / filmomhulde tabletten / Filmtabletten