MELATONIN NOXAREM 5 mg TABLETS

2. What you need to know before taking Melatonin Noxarem

Do not take Melatonin Noxarem:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if you suffer from:

• renal insufficiency. The use of melatonin is not recommended if you have severe kidney disease.
• hepatic insufficiency. The use of melatonin is not recommended if you have liver disease.
• autoimmune disease (when the body is "attacked" by its own immune system). The use of melatonin is not recommended in this case.
• cardiovascular disease for which you are taking antihypertensive medication. The use of melatonin is not recommended in this case.

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

Melatonin can cause drowsiness. If you experience drowsiness, you should be careful, as it can impair your ability to perform tasks such as driving.

Smoking can reduce the effectiveness of melatonin, as the components of tobacco smoke can accelerate the breakdown of melatonin in the liver.

Children and adolescents

This medicine 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 medicines and Melatonin Noxarem

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. These medicines 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 medicines used to control blood pressure through vasoconstriction, nasal decongestants, medicines that lower blood pressure), opioid agonists or antagonists (such as medicinal products used in the treatment of drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory medicines), antidepressants, tryptophan, and alcohol.
• Cimetidine (used for the treatment of stomach problems such as ulcers), calcium channel blockers (medicines used to treat hypertension and sudden chest pain [angina pectoris], such as nifedipine).
• Benzodiazepines and non-benzodiazepine hypnotics (medicines 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) – it may be necessary to check the INR more specifically.

Taking Melatonin Noxarem with food, drinks, and alcohol

Food can 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 can 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 has the potential to worsen certain symptoms of jet lag (such as headache, morning fatigue, concentration problems).

Pregnancy and breastfeeding

The use of this medicine is not recommended during pregnancy. You should not use Melatonin Noxarem if you are breastfeeding.

Driving and using machines

Melatonin has a moderate influence on the ability to drive and use machines. Melatonin can cause drowsiness, among other things. Alertness (vigilance) may be affected for several hours after taking melatonin. Do not drive or operate machinery after taking melatonin.

3. How to take Melatonin Noxarem

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 subsequent days, you should also take the dose at the time you normally go to bed. If the standard dose of 3 mg does not alleviate your symptoms adequately, you can take a 5 mg tablet at the 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 subsequent days. The maximum daily dose is 5 mg once a day. You should take the dose that alleviates your symptoms adequately during the shortest period.

The time at which you take melatonin is important, as taking it at the wrong time can cause drowsiness and delay adaptation to local time. Therefore, you should not take the tablets before 8:00 PM or after 4:00 AM. 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 time for taking melatonin.

The 5 mg Melatonin Noxarem tablet can be divided into equal doses.

If you take more Melatonin Noxarem than you should

In case of overdose or accidental ingestion, or if a child accidentally ingests it, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

Taking more than the recommended daily dose can cause drowsiness.

If you forget to take Melatonin Noxarem

Do not take a double dose to make up for the forgotten dose.

If you stop taking Melatonin Noxarem

No harmful effects are known if you stop or finish the treatment prematurely. No withdrawal symptoms are known due to the use of melatonin after finishing the treatment.

If you have any other 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.

Possible side effects in short-term use for jet lag 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 serious side effects, stop taking the medicine and consult 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 due to angina
• Feeling your own heartbeats
• Depression
• Vision problems
• Disorientation
• Dizziness (a feeling of dizziness or "spinning")
• Blood in the urine
• Low white blood cell count in the blood
• Low platelet count, which increases the risk of bleeding or bruising
• Psoriasis

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

• Hypersensitivity reaction
• Swelling of the skin

If you experience any of the following non-serious side effects, consult your doctor and/or seek medical advice.

Uncommon:(may affect up to 1 in 100 people)

Irritability, nervousness, agitation, insomnia, strange 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 could cause yellowing of the skin or eyes, skin inflammation, night sweats, itching, rash, dry skin, pain in the limbs, glucose in the urine, excess protein in the urine, menopausal symptoms, feeling of weakness, liver failure, and weight gain.

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

Shingles, 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 up or sitting down, hot flashes, gastroesophageal reflux, stomach disorders, mouth sores, tongue ulcers, stomach upset, vomiting, abnormal intestinal noises, gas, excessive saliva production, bad breath, abdominal discomfort, gastric disorder, gastric mucosa inflammation, eczema, rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, nocturnal cramps, large amount of urine, nocturia, prolonged erection that can be painful, prostate gland inflammation, fatigue, pain, thirst, increased liver enzymes, abnormal blood electrolytes, and abnormal laboratory results.

Frequency not known:(cannot be estimated from the 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 not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Melatonin Noxarem

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton (EXP). The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Melatonin 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 ingredients are:

Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, pregelatinized starch.

Appearance of Melatonin Noxarem and package contents

3 mg: white, round, convex tablet with the logo 7, 7 mm in diameter.

5 mg: white, capsule-shaped tablet with a score line on one side, 10 mm x 5 mm in size. 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 pack sizes may be marketed.

Marketing authorization holder and 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

Manufacturer:

Vitabalans Oy

Varastokatu 7-9

13500 Hämeenlinna

Finland

This medicine is authorized in the Member States of the European Economic Area (EEA) under the following names:

Dagravit: Finland

Melatonin Noxarem: Spain

Date of the last revision 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 Health Products (AEMPS): http://www.aemps.gob.es/