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.

• Keep this prospect as you may need to read it again
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 6 days.

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

1. Storage of Melatonina Noxarem

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:

• renal insufficiency. Melatonin is not recommended for use if you have a severe kidney disease.
• liver insufficiency. Melatonin is not recommended for use if you have a severe liver disease.
• autoimmune disease (when your body is 'attacked' by your own immune system). Melatonin is not recommended for use in this case.
• cardiovascular disease for which you take an antihypertensive medication. Melatonin is not recommended for use in this case.

The dosing time of melatonin is important. Melatonin should be used as indicated.

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 the components of tobacco smoke may accelerate the breakdown of melatonin 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:

• 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 or hormone replacement therapy), carbamazepine (used in the treatment of epilepsy), and 5- or 8-methoxypsoralen (5 and 8 MOP) (used in the treatment of skin diseases such as psoriasis).
• adrenergic agonists or antagonists (such as certain types of medications used to control blood pressure through vasoconstriction, nasal decongestants, medications that lower blood pressure), opioid agonists or antagonists (such as medicinal products used in the treatment of addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory medications), antidepressants, tryptophan, and alcohol.
• cimetidine (used for the treatment of stomach problems such as ulcers), calcium channel blockers (medications used to treat hypertension and sudden chest pain [angina pectoris], such as nifedipine).
• benzodiazepines and non-benzodiazepine hypnotics (medications used to induce 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, edoxaban (used to prevent blood clotting) – INR may need to be checked more specifically.

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 time for taking melatonin. 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

This medication is not recommended for use during pregnancy. Do not use Melatonina Noxarem if you are breastfeeding.

Driving and operating machinery

Melatonin has a moderate impact 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. In case of 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). On 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 you can take the higher dose on the following 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, since if you take it at the wrong time, melatonin 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 upon treatment completion.

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 somnolence, 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 1,000 people)

• Chest pain

Very rare: (may affect 1 in 1,000 people)

• Loss of consciousness or fainting
• Severe chest pain due to angina
• Feeling one's own heartbeats
• Depression
• Visual problems
• Disorientation
• Vestibular disorder (a sensation of spinning or dizziness)
• Blood in the urine
• Low white blood cell count in the blood
• Low platelet count, increasing the risk of bleeding or bruising
• Psoriasis

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

• Hypersensitivity reaction
• Skin swelling

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 limbs, glucose excretion in the urine, excess protein in the urine, menopausal symptoms, feeling of weakness, liver insufficiency, and weight gain.

Very rare: (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 sexual desire, 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, abdominal discomfort, vomiting, abnormal intestinal sounds, flatulence, excessive saliva production, bad breath, abdominal discomfort, gastric disorder, gastric mucosa inflammation, eczema, hives, hand dermatitis, itchy hives, nail disorder, arthritis, muscle spasms, neck pain, nocturnal cramps, large urine volume, nocturia, prolonged and painful erection, 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 of 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 the 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 principle 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 responsible manufacturer

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

Responsible manufacturer:

Vitabalans Oy

Varastokatu 7-9

13500 Hämeenlinna

Finland

This medicine is authorized in the member states of the European Economic Area (EEA) with the following names:

Dagravit: Finland

Melatonina Noxarem: Spain

Last review date of this leaflet: February 2023

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/