MELATONINA 3 mg Tabletka

Treść ulotki

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

Melatonina Noxarem 3 mg tablets, 5 mg tablets

Melatonina

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Melatonina Noxarem and what is it used for

The active ingredient of Melatonina Noxarem, melatonin, belongs to a group of natural hormones produced
by the body.
Melatonina Noxarem is used for the short-term treatment of jet lag in adults. By jet lag we mean the symptoms caused by the time difference during the crossing of different time
zones (when travelling east or west).

2. What you need to know before you take Melatonina Noxarem

Do not take Melatonina Noxarem:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonina Noxarem if you suffer from:

• kidney impairment. If you have a serious kidney disease, the use of Melatonina Noxarem is not recommended.
• liver impairment. If you have a liver disease, the use of Melatonina Noxarem is not recommended.
• autoimmune diseases (where the body is “attacked” by its own immune system). In this case the use of melatonin is not recommended.
• cardiovascular condition for which you are taking an antihypertensive medicine. In this case the use of melatonin is not recommended.

The timing of melatonin administration is important. Melatonina Noxarem must be used
according to the instructions.
Melatonina Noxarem may cause drowsiness. Therefore, you should be careful if you experience some
drowsiness, as this may impair your ability to perform activities such as driving.
Smoking may reduce the effectiveness of Melatonina Noxarem, as the components of tobacco smoke may
promote the degradation of melatonin by the liver.

Children and adolescents
This medicine should not be given to children under 18 years of age as it has not been
tested in these patients and its effects are not known.

Other medicines and Melatonina Noxarem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. These medicines include:

• Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), quinolones and rifampicin (used for the treatment of bacterial infections), estrogens (used in contraceptives or for hormone replacement therapy), carbamazepine (used in the treatment of epilepsy), and 5-methoxipsoralene or 8-methoxipsoralene (5-MOP or 8-MOP, used in the treatment of skin diseases such as psoriasis).
• Agonists/antagonists adrenergic (such as some types of medicines used to control blood pressure by narrowing blood vessels, nasal decongestants, medicines that lower blood pressure), agonists/antagonists opioid (such as medicines used in the treatment of drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressants, tryptophan and alcohol.
• Cimetidine (used for the treatment of stomach problems such as ulcers), calcium channel blockers (medicines used for the treatment of high blood pressure and sudden chest pain [angina pectoris], such as nifedipine).
• Benzodiazepines and non-benzodiazepine hypnotics (medicines used to promote sleep such as zaleplon, zolpidem and zopiclone).
• Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
• Warfarin and other anticoagulants, e.g. dabigatran, rivaroxaban, apixaban and edoxaban (used to prevent blood clots). In this case, it may be necessary to check the INR more specifically.

Melatonina Noxarem with food, beverages and alcohol
Food may affect the effectiveness of Melatonina Noxarem. It is recommended not to eat 2 hours
before or 2 hours after taking melatonin. Do not drink alcohol before, during or after taking
Melatonina Noxarem, as alcohol reduces the effectiveness of Melatonina Noxarem and may worsen
some symptoms of jet lag (e.g. headache, morning fatigue, reduced concentration).

Pregnancy and breastfeeding
Melatonina Noxarem is not recommended during pregnancy. Melatonina Noxarem should not be used
during breastfeeding.

Driving and using machines
Melatonina Noxarem moderately impairs the ability to drive and operate machines.
Melatonin can cause, among other things, drowsiness. Attention may be impaired
for several hours after taking melatonin. Do not drive or operate machinery after taking
melatonin.

3. How to take Melatonina Noxarem

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one 3 mg tablet per day for a maximum of 4 days. The first dose should be
taken upon arrival at your destination, at your usual bedtime (according to local time). Also
the dose of the following days should be taken at your usual bedtime. If the standard dose of
3 mg does not provide adequate relief from symptoms, you can take a 5 mg tablet instead of the
3 mg tablet at the local time of bedtime. The 5 mg tablet should not be taken in addition to
the 3 mg tablet, but a higher dose can be taken on subsequent days. The maximum daily dose
is 5 mg once a day. The dose that provides adequate relief from symptoms should be taken for the
shortest possible period of time.
The timing of melatonin administration is important, as if taken at the wrong time,
melatonin may cause drowsiness and delay adaptation to local time. Therefore, the tablets should not
be taken before 8:00 PM or after 4:00 AM. The tablets should be swallowed with a
glass of water. It is recommended not to eat food 2 hours before or 2 hours after the time of taking
melatonin.
Contact your doctor if you do not feel better or if you feel worse after 6 days.
The Melatonina Noxarem 5 mg tablet can be divided into equal doses.

If you take more Melatonina Noxarem than you should
If you have taken an excessive dose of the medicine or if a child has accidentally taken this
medicine, always contact your doctor or hospital to assess the risks and receive further instructions.
Taking a dose higher than the recommended daily dose may cause drowsiness.

If you forget to take Melatonina Noxarem
Do not take a double dose to make up for a missed dose.

If you stop taking Melatonina Noxarem
No negative effects are known caused by stopping or early discontinuation of treatment. The use
of Melatonina Noxarem does not cause any known withdrawal symptoms once treatment is finished.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible adverse reactions of short-term melatonin use for jet lag are headache, nausea,
loss of appetite, dizziness, daytime sleepiness and disorientation.
Melatonin, when used for other disorders, has been observed to cause a wide variety of adverse effects.
If you experience any of the following serious side effects, stop taking the medicine 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 caused by angina
• Perception of your own heartbeat
• Depression
• Impaired vision
• Disorientation
• Vertigo (dizziness or “spinning sensation”)
• Blood in the urine
• Decreased number of white blood cells in the blood
• Decreased number of platelets in the blood, which increases the risk of bleeding or bruising
• Psoriasis

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

• Hypersensitivity reaction
• Swelling of the skin

If you experience any of the following non-serious side effects, contact your doctor and/or seek medical
attention:

Uncommon(may affect up to 1 in 100 people):
Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy
(fatigue, lack of energy), restlessness associated with hyperactivity, dizziness, fatigue, elevated blood
pressure, abdominal pain, indigestion, mouth ulceration, dry mouth, nausea,
changes in blood composition that can cause yellowing of the skin or eyes,
skin inflammation, night sweats, itching, rash, dry skin, pain in the extremities,
glucose excretion in the urine, excess protein in the urine, menopause symptoms, weakness, abnormal liver
function and weight gain.

Rare(may affect up to 1 in 1,000 people):
Herpes zoster, high levels of fat molecules in the blood, mood changes, aggressiveness, agitation,
bursts of crying, stress symptoms, early morning awakening, increased sexual drive, depressed mood,
memory impairment, attention disorders, dreamlike state, restless legs syndrome, poor sleep quality,
tingling sensation, watery eyes, dizziness when standing up or sitting down, hot flashes,
acid reflux, stomach disorders, blister formation in the mouth, tongue ulceration, stomach pain,
vomiting, abnormal abdominal noises, intestinal gas, excessive saliva production, bad breath,
abdominal discomfort, gastric disorders, inflammation of the stomach lining, eczema, rash,
hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms,
neck pain, nocturnal cramps, large urine volumes, need to urinate during the night, prolonged and potentially
painful erection, inflammation of the prostate, fatigue, pain, thirst, increased
liver enzymes, electrolyte abnormalities in the blood and laboratory test abnormalities.

Frequency not known(frequency cannot be estimated from the available data):
Swelling of the mouth or tongue and abnormal milk secretion.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Melatonina Noxarem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Melatonina Noxarem contains
The active ingredient is melatonin.
Each 3 mg tablet contains 3 mg of melatonin.
Each 5 mg tablet contains 5 mg of melatonin.
The other ingredients are:
Dihydrate calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, pregelatinized
starch.

Description of the appearance of Melatonina Noxarem and contents of the pack
3 mg: white, round, convex tablet with logo 7, diameter of 7 mm.
5 mg: white capsule-shaped tablet with a score line on one side, dimensions 10 mm x 5 mm. The
tablet can be divided into equal doses.
30, 50 tablets in blisters (PVC/Al) or in a tablet container (HD-PE plastic container and
LD-PE plastic closure).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
Netherlands

Manufacturer:
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Melatonin Noxarem: Finland
Noxarem Melatonine: Belgium, Luxembourg
Noxarem Mélatonine: France
Melatonina Noxarem: Portugal

Melatonina Noxarem 3 mg tablets, 5 mg tablets

Melatonina

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 6 days.

Contents of this leaflet:

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

2. What is Melatonina Noxarem and what is it used for

The active ingredient of Melatonina Noxarem, melatonin, belongs to a group of natural hormones produced
by the body.
Melatonina Noxarem is used for the short-term treatment of jet lag in adults. By jet lag we mean the symptoms caused by the time difference during the crossing of different time
zones (travelling east or west).
Consult your doctor if you do not feel better or if you feel worse.

4. What you need to know before taking Melatonina Noxarem

Do not take Melatonina Noxarem:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonina Noxarem if you suffer from:

• kidney impairment. If you have severe kidney disease, the use of Melatonina Noxarem is not recommended.
• liver impairment. If you have liver disease, the use of Melatonina Noxarem is not recommended.
• autoimmune diseases (in which the body is “attacked” by its own immune system). In this case, the use of melatonin is not recommended.
• cardiovascular condition for which you are taking an antihypertensive medicine. In this case, the use of melatonin is not recommended.

The timing of melatonin administration is important. Melatonina Noxarem must be used
according to the instructions.
Melatonina Noxarem may cause drowsiness. Therefore, you should be careful if you experience some
drowsiness, as this may impair your ability to perform activities such as driving.
Smoking may reduce the effectiveness of Melatonina Noxarem, as components of tobacco smoke may
promote the degradation of melatonin by the liver.

Children and adolescents
This medicine should not be given to children under 18 years of age as it has not been
tested in these patients and its effects are unknown.

Other medicines and Melatonina Noxarem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. These medicines include:

• Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), quinolones and rifampicin (used for the treatment of bacterial infections), estrogens (used in contraceptives or for hormone replacement therapy), carbamazepine (used in the treatment of epilepsy), and 5-methoxypsoralen or 8-methoxypsoralen (5-MOP or 8-MOP, used in the treatment of skin diseases such as psoriasis).
• Agonists/antagonists adrenergic (such as some types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, medicines that lower blood pressure), opioid agonists/antagonists (such as medicines used in the treatment of drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressants, tryptophan and alcohol.
• Cimetidine (used for the treatment of stomach problems such as ulcers), calcium channel blockers (medicines used for the treatment of high blood pressure and sudden chest pain [angina pectoris], such as nifedipine).
• Benzodiazepines and non-benzodiazepine hypnotics (medicines used to promote sleep such as zaleplon, zolpidem and zopiclone).
• Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
• Warfarin and other anticoagulants, e.g. dabigatran, rivaroxaban, apixaban and edoxaban (used to prevent blood clots). In this case, it may be necessary to monitor the INR more specifically.

Melatonina Noxarem with food, beverages and alcohol
Food may affect the effectiveness of Melatonina Noxarem. It is recommended not to eat 2 hours
before or 2 hours after taking melatonin. Do not drink alcohol before, during or after taking
Melatonina Noxarem, as alcohol reduces the effectiveness of Melatonina Noxarem and may worsen
some symptoms of jet lag (e.g. headache, morning fatigue, reduced concentration).

Pregnancy and breastfeeding
Melatonina Noxarem is not recommended during pregnancy. Melatonina Noxarem should not be used
during breastfeeding.

Driving and using machines
Melatonina Noxarem moderately impairs the ability to drive and use machines. Melatonin can cause, among other things, drowsiness. The state of attention may be impaired
for several hours after taking melatonin. Do not drive or use machines after taking
melatonin.

5. How to take Melatonina Noxarem

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one 3 mg tablet per day for a maximum of 4 days. The first dose should be
taken upon arrival at your destination, at your usual bedtime (according to local time). Also
the dose for the following days should be taken at your usual bedtime. If the standard dose of
3 mg does not provide adequate relief from symptoms, you can take a 5 mg tablet instead of the
3 mg tablet at the local time of bedtime. The 5 mg tablet should not be taken in addition
to the 3 mg tablet, but a higher dose can be taken in the following days. The maximum daily dose
is 5 mg once a day. The dose that provides adequate relief from symptoms should be taken for the
shortest possible period of time.
The timing of melatonin administration is important, as if it is taken at the wrong time,
melatonin may cause drowsiness and delay adaptation to local time. Therefore, the tablets should not
be taken before 8:00 PM or after 4:00 AM. The tablets should be swallowed with a
glass of water. It is recommended not to eat food 2 hours before or 2 hours after the time of taking
melatonin.
Contact your doctor if you do not feel better or if you feel worse after 6 days.
The Melatonina Noxarem 5 mg tablet can be divided into equal doses.

If you take more Melatonina Noxarem than you should
If you have taken an excessive dose of the medicine or if a child has accidentally taken this
medicine, always contact your doctor or hospital to assess the risks and receive further instructions.
Taking a dose higher than the recommended daily dose may cause drowsiness.

If you forget to take Melatonina Noxarem
Do not take a double dose to make up for a missed dose.

If you stop taking Melatonina Noxarem
No negative effects are known to be caused by stopping or prematurely interrupting treatment. The use
of Melatonina Noxarem does not cause any known withdrawal symptoms once treatment is finished.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible adverse reactions of short-term melatonin use for jet lag are headache, nausea,
loss of appetite, dizziness, daytime sleepiness and disorientation.
Melatonin, when used for other disorders, has been observed to cause a wide variety of adverse effects.
If you experience any of the following serious side effects, stop taking the medicine 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 caused by angina
• Awareness of your heartbeat
• Depression
• Impaired vision
• Disorientation
• Dizziness (vertigo or “spinning sensation”)
• Blood in the urine
• Decreased number of white blood cells in the blood
• Decreased number of platelets in the blood, which increases the risk of bleeding or bruising
• Psoriasis

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

• Hypersensitivity reaction
• Swelling of the skin

If you experience any of the following non-serious side effects, contact your doctor and/or seek medical
attention:

Uncommon(may affect up to 1 in 100 people):
Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy
(tiredness, lack of energy), restlessness associated with hyperactivity, dizziness, fatigue, elevated blood
pressure, abdominal pain, indigestion, mouth ulceration, dry mouth, nausea,
changes in blood composition that can cause yellowing of the skin or eyes,
skin inflammation, night sweats, itching, rash, dry skin, pain in the extremities,
glucose excretion in the urine, excess protein in the urine, menopause symptoms, weakness, abnormal liver
function and weight gain.

Rare(may affect up to 1 in 1,000 people):
Herpes zoster, high levels of fat molecules in the blood, mood changes, aggressiveness, agitation,
bursts of crying, stress symptoms, early morning awakening, increased sexual drive, depressed mood,
memory impairment, attention disorders, dreamlike state, restless legs syndrome, poor sleep quality, tingling
sensation, tearing of the eyes, dizziness when standing up or sitting down, hot flashes,
acid reflux, stomach disorders, blistering in the mouth, ulceration of the tongue, stomach pain,
vomiting, abnormal abdominal noises, flatulence, excessive saliva production, bad breath,
abdominal discomfort, gastric disorders, inflammation of the stomach lining, eczema, rash,
hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms,
neck pain, nighttime cramps, large urine volumes, need to urinate during the night, prolonged and potentially
painful erection, inflammation of the prostate, fatigue, pain, thirst, increased
liver enzymes, electrolyte abnormalities in the blood and laboratory test abnormalities.

Frequency not known(frequency cannot be estimated from the available data):
Swelling of the mouth or tongue and abnormal milk secretion.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Melatonina Noxarem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Melatonina Noxarem contains
The active ingredient is melatonin.
Each 3 mg tablet contains 3 mg of melatonin.
Each 5 mg tablet contains 5 mg of melatonin.
The other ingredients are:
Dihydrate calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, pregelatinized
starch.

Description of the appearance of Melatonina Noxarem and contents of the pack
3 mg: white, round, convex tablet with logo 7, diameter of 7 mm.
5 mg: white capsule-shaped tablet with a score line on one side, dimensions 10 mm x 5 mm. The
tablet can be divided into equal doses.
10 tablets in blisters (PVC/Al) or in a tablet container (HD-PE plastic container and
LD-PE plastic closure).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
Netherlands

Manufacturer:
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Melatonin Noxarem: Finland
Noxarem Melatonine: Belgium, Luxembourg
Noxarem Mélatonine: France
Melatonina Noxarem: Portugal