Prospect: Information for the User
Melatonina Noxarem 3 mg Tablets
Melatonina Noxarem 5 mg Tablets
Read this prospect carefully before starting to take this medicine, as it contains important information for you.
Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.
1.What is Melatonina Noxarem and what it is used for
2.What you need to know before starting to take Melatonina Noxarem
3.How to take Melatonina Noxarem
4.Possible adverse effects
6.Contents of the package and additional information
The active ingredient of Melatonina Noxarem is melatonin, which belongs to a group of hormones produced by the body.
Melatonin is used for the short-term treatment of time zone shift (jet lag) in adults. Time zone shift orjet lagrefers to the symptoms caused by the time difference whentraveling across different time zones, east or west.
You should consult a doctor if it worsens or does not improve.
Do not take Melatonina Noxarem:
-if you are allergic to melatonin or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication if you suffer from:
The dosing time of melatonin is important. Melatonin should be used as directed.
Melatonin may cause drowsiness. If you experience drowsiness, be careful, as it may impair your ability to do things like drive.
Smoking may reduce the effectiveness of melatonin, as tobacco smoke components may accelerate melatonin breakdown in the liver.
Children and adolescents
This medication should not be administered to minors under 18 years of age, as it has not been evaluated in this age group and its effects are unknown.
Other medications and Melatonina Noxarem
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. These medications include:
Taking Melatonina Noxarem with food, drinks, and alcohol
Foods may alter the effectiveness of melatonin. It is recommended not to consume food 2 hours before or 2 hours after the scheduled melatonin intake time. Melatonin may alter blood glucose control if taken shortly before or after carbohydrate-rich meals. If you have diabetes or significant glucose intolerance, it is best to take melatonin at least 3 hours after any meal.
Do not consume alcoholic beverages before, during, or after taking melatonin, as it reduces its effectiveness and may worsen certain symptoms of time zone disorder (such as headaches, morning fatigue, concentration problems).
Pregnancy and breastfeeding
Use of this medication is not recommended during pregnancy. Do not use Melatonina Noxarem if you are breastfeeding.
Driving and operating machinery
Melatonin has a moderate effect on the ability to drive and operate machinery. Melatonin may cause drowsiness, among other things. Alertness (vigilance) may be affected for several hours after taking melatonin. Do not drive or operate machinery after taking melatonina.
Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is one 3 mg tablet per day for a maximum of 4 days. You should take the first dose upon arrival at your destination at the time you normally go to bed (local time). In the following days, you should also take the dose at the time you normally go to bed. If the standard dose of 3 mg does not adequately alleviate your symptoms, you can take one 5 mg tablet at local bedtime instead of the 3 mg tablet. Do not take the 5 mg tablet in addition to the 3 mg tablet, but rather take the higher dose on subsequent days. The maximum daily dose is 5 mg once a day. You should take the dose that adequately alleviates your symptoms for the shortest period.
The time at which you take melatonin is important,as taking it at the wrong time may cause drowsiness and delay adaptation to local time. Therefore, do not take the tablets before 20:00 hours or after 04:00 hours. The tablets should be taken with a glass of water. It is recommended not to consume food 2 hours before or 2 hours after the scheduled melatonin intake time.
The 5 mg Melatonina Noxarem tablet can be divided into equal doses.
If you take more Melatonina Noxarem than you should
In case of overdose or accidental ingestion, or if a child accidentally ingests them, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
Taking more than the recommended daily dose may cause drowsiness.
If you forgot to take Melatonina Noxarem
Do not take a double dose to compensate for the missed dose.
If you interrupt treatment with Melatonina Noxarem
No adverse effects are known for interrupting or terminating treatment before time. No withdrawal symptoms are known after melatonin use is discontinued.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects in short-term use for time zone shift are: headache, loss of appetite, dizziness, daytime drowsiness, and disorientation.
Various side effects have been reported when using melatonin for other disorders.
If you experience any of the following severe side effects, stop taking the medicine and consult your doctor immediately.
Rare:(may affect 1 in 100 people)
Uncommon:(may affect 1 in 1,000 people)
Frequency not known:(cannot be estimated from available data)
If you experience any of the following non-severe side effects, consult your doctor and/or seek medical advice.
Rare:(may affect 1 in 1,000 people)
Irritability, nervousness, agitation, insomnia, rare dreams, nightmares, anxiety, migraine, headache, lethargy (fatigue, lack of energy), agitation associated with increased activity, dizziness, fatigue, hypertension, abdominal pain, indigestion, mouth ulcers, dry mouth, nausea, changes in blood composition that may cause yellowing of the skin or eyes, skin inflammation, nocturnal sweating, itching, hives, dry skin, pain in the extremities, glucose excretion in the urine, excess protein in the urine, menopausal symptoms, feeling of weakness, liver insufficiency, and weight gain.
Uncommon:(may affect 1 in 1,000 people)
Herpes zoster, high levels of fatty acid molecules in the blood, mood changes, aggression, agitation, crying, stress symptoms, waking up very early, increased sex drive, depressive state, memory problems, lack of attention, somnolent state, restless legs syndrome, poor sleep quality, tingling sensation, watery eyes, dizziness when standing or sitting, hot flashes, gastroesophageal reflux, gastrointestinal disorders, mouth sores, tongue ulcers, stomach discomfort, vomiting, abnormal intestinal sounds, flatulence, excessive saliva production, bad breath, abdominal discomfort, gastric disorder, gastric mucosa inflammation, eczema, hives, hand dermatitis, hives with itching, nail disorder, arthritis, muscle spasms, neck pain, nocturnal cramps, large urine volume, nocturnal urination, prolonged erection that may be painful, prostate gland inflammation, fatigue, pain, thirst, increased liver enzymes, abnormal electrolytes in the blood, and abnormal laboratory results.
Frequency not known:(cannot be estimated from available data)
Swelling of the mouth or tongue, hyperglycemia, and abnormal milk secretion.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box (EXP). The expiration date is the last day of the month indicated.
Store in the original packaging to protect it from light.
Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.
Composition of Melatonina Noxarem
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 components are:
Calcium dihydrogen phosphate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, pregelatinized starch.
Appearance of Melatonina Noxarem and contents of the packaging
3 mg: white, round, convex tablet with the logo 7, 7 mm in diameter.
5 mg: white capsule-shaped tablet with a groove on one side, dimensions 10 mm x 5 mm.The tablet can be divided into equal doses.
10, 30 and 50 tablets in blisters (PVC/Al) or in a bottle for tablets (HDPE plastic container and LDPE plastic cap)
Only some packaging sizes may be marketed.
Marketing authorization holder and manufacturer responsible
Marketing authorization holder:
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
Netherlands
Local representative:
Vemedia Pharma Hispania S.A.
c/ Aragón, 182
08011 Barcelona
Tel. +34 93 453 62 19
Manufacturer responsible:
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland
This medicine is authorized in the European Economic Area (EEA) member states with the following names:
Dagravit: Finland
Melatonina Noxarem: Spain
Last review date of this leaflet: February 2023
Other sources of information
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.