Melatonina Pharma Nord

Leaflet attached to the packaging: information for the user

Melatonin Pharma Nord, 3 mg, coated tablets

Melatonin

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

Melatonin Pharma Nord contains the active substance melatonin. Melatonin Pharma Nord can be used for the short-term treatment of symptoms related to jet lag in adults. Jet lag symptoms include sleep disturbances, daytime fatigue, tiredness, mild mental disorders, irritability, and gastrointestinal disorders.
How Melatonin Pharma Nord works
Melatonin is a hormone produced by the body that synchronizes the body's day/night biological rhythm. Traveling across time zones can disrupt the biological rhythm, causing jet lag symptoms. The symptoms and their severity may vary from person to person, but they are usually more severe and last longer the more time zones crossed. Melatonin Pharma Nord can help restore the normal day/night rhythm and alleviate symptoms.
If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

2. Important information before taking Melatonin Pharma Nord

When not to take Melatonin Pharma Nord

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

(listed in section 6).

Warnings and precautions

Before starting treatment with Melatonin Pharma Nord, the patient should discuss with their doctor or pharmacist:

• if the patient has epilepsy. Melatonin may increase the frequency of seizures, for example, in patients with epilepsy
• if the patient has an autoimmune disease (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 make sure not to take this medicine within 2 hours before a meal, and after a meal, they should wait at least 3 hours before taking the medicine.
• if the patient has moderate or severe liver or kidney function disorders
• if the patient smokes. Smoking may reduce the effectiveness of Melatonin Pharma Nord, as tobacco smoke components may increase the breakdown of melatonin in the liver
• if the patient has high blood pressure and is taking medications for it. Melatonin may reverse the beneficial effect of blood pressure-lowering medications
• This medicine may cause drowsiness. The patient should be cautious if they feel drowsy, as it may adversely affect their ability to perform tasks such as driving.

Children and adolescents

This medicine should not be given to children and adolescents from 0 to 18 years of age, as the safety and efficacy of the medicine for the short-term treatment of jet lag symptoms have not been established.

Melatonin Pharma Nord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

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

Melatonin Pharma Nord with food and alcohol

• This medicine should not be taken with food (see section 3).
• Alcohol may disrupt sleep and worsen some jet lag symptoms (such as headache, morning fatigue, concentration disorders), so it is recommended not to consume alcohol while taking Melatonin Pharma Nord.
• Consuming alcohol while taking this medicine may cause increased drowsiness.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Melatonin Pharma Nord is not recommended for pregnant women. Melatonin passes through the placenta, and there is not enough information about the risk it may pose to the unborn child.
Women of childbearing age must use effective contraception while taking this medicine.
Breastfeeding
Melatonin Pharma Nord is not recommended for breastfeeding women. Melatonin passes into human milk, and the risk to the breastfed child cannot be excluded.
Fertility
Melatonin Pharma Nord is not recommended for women and men planning to have a child, as there is not enough information about the effect of melatonin on female and male fertility.

Driving and using machines

Melatonin Pharma Nord may cause drowsiness and reduced alertness for several hours after taking. Therefore, the patient should not take this medicine before driving or operating machinery.

Melatonin Pharma Nord contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Melatonin Pharma Nord

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults and the elderly is 1 tablet taken once a day, for a maximum of 5 days. If the effect of Melatonin Pharma Nord is insufficient, 2 tablets can be taken together the next evening. The dose that sufficiently alleviates symptoms should be taken for the shortest possible period.
The first dose should be taken after arriving at the destination at the usual time of going to bed. Subsequent doses should also be taken at the usual time of going to bed. The patient should not take the tablets before 8:00 PM or after 4:00 AM.
The tablets should be swallowed whole and washed down with water or another liquid (such as milk, fruit juice).
It is recommended not to eat for at least 2 hours before and at least 2 hours after taking Melatonin Pharma Nord. If the patient has impaired glucose tolerance or diabetes, it is best not to take Melatonin Pharma Nord for at least 3 hours after a meal.
Melatonin Pharma Nord 3 mg can be taken for a maximum of 16 treatment periods per year.

Taking a higher dose of Melatonin Pharma Nord than recommended

If the patient has taken a higher dose of Melatonin Pharma Nord than recommended and does not feel well, they should contact their doctor, hospital, or pharmacist.
The most common symptoms of overdose are drowsiness, headache, dizziness, and nausea.

Missing a dose of Melatonin Pharma Nord

If the patient misses a dose and wakes up during the night, they can take the missed dose, but not later than 4:00 AM.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Melatonin Pharma Nord

If the patient stops taking this medicine, it will not have a harmful effect or cause withdrawal symptoms.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Melatonin Pharma Nord can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following side effects, they should stop taking the medicine and immediatelycontact their doctor:
Uncommon side effects(may affect up to 1 in 100 people treated)

• Chest pain

Rare side effects(may affect up to 1 in 1,000 people treated)

• Decreased white blood cell count
• Decreased platelet count, which may increase the risk of bleeding or bruising
• Disorientation
• Fainting
• Visual disturbances, including blurred vision
• Palpitations
• Blood in the urine

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

• Severe allergic reaction causing swelling of the tongue or mucous membranes of the mouth

Other side effects

If the patient experiences any of the following side effects, they should contact their doctor or pharmacist:
Common side effects(may affect up to 1 in 10 people)

• Headache
• Drowsiness

Uncommon side effects(may affect up to 1 in 100 people)

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

Rare side effects(may affect up to 1 in 1,000 people)

• High levels of certain fat particles (triglycerides) in the blood
• Mood changes, aggression, increased libido
• Memory disorders, restless legs syndrome, feeling of tingling and numbness
• Lacrimation
• Hot flashes
• Vomiting, flatulence, excessive salivation, bad breath, stomach inflammation
• Nail disorders
• Arthritis, muscle cramps
• Excessive urination
• Prolonged erection, which may be painful, prostatitis
• Thirst
• Abnormal electrolyte levels in the blood

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

• Hypersensitivity reactions
• High blood sugar levels
• Galactorrhoea (also in men)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides.
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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Melatonin Pharma Nord

• The medicine should be stored out of sight and reach of children.
• Do not use the medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.
• There are no special storage instructions for the medicine.
• The medicine should be stored in its original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Melatonin Pharma Nord contains

• The active substance of the medicine is melatonin. Each tablet contains 3 mg of melatonin.
• The other ingredients 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 Melatonin Pharma Nord looks like and contents of the pack

Round, biconvex, coated, white or almost white tablet. Size: 7.5 mm.
Packaging: blister pack containing 10 or 30 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharma Nord ApS
Tinglykke 4-6
6500 Vojens
Denmark
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Pharma Nord sp. z o.o.
ul. Zwoleńska 24C
04-761 Warsaw
tel.: 022 615 27 22
email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium
Melatonine Pharma Nord 3 mg film-coated tablets / filmomhulde tabletten / Filmtabletten