Melatonin Noxarem 3 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Melatonin Noxarem 3 mg tablets

Melatonin Noxarem 5 mg tablets

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

Follow exactly the instructions for administration provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

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

2. What you need to know before taking Melatonin Noxarem

3. How to take Melatonin Noxarem

4. Possible side effects

5. How to store Melatonin Noxarem

6. Contents of the pack and other information

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

The active substance in Melatonin Noxarem is melatonin, which belongs to a group of hormones produced by the body.

Melatonin is used for the short-term treatment of jet lag in adults. Jet lag refers to symptoms caused by time zone changes when travelling across different time zones, either eastward or westward.

You should consult a doctor if your condition worsens or does not improve.

2. 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

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

• 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 condition for which you are taking antihypertensive medication. The use of melatonin is not recommended in this case.

The timing of melatonin dosing is important. Melatonin should be used as directed.

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

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

Children and adolescents

This medicine must not be given to individuals under 18 years of age, as it has not been evaluated in this age group and its effects are unknown.

Other medicines and Melatonina Noxarem

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. These medicines include:

• Fluvoxamine (used in the treatment of depression and obsessive-compulsive disorder), quinolones and rifampicin (used to treat 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 medicines used to control blood pressure via vasoconstriction, nasal decongestants, blood pressure-lowering medicines), opioid agonists or antagonists (such as medicines used in the treatment of drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressant medicines, tryptophan, and alcohol.
• Cimetidine (used to treat stomach problems such as ulcers), calcium channel blockers (medicines used to treat hypertension and sudden chest pain [angina], 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) – INR monitoring may be required for more specific monitoring.

Taking Melatonina Noxarem with food, drinks, and alcohol

Food 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 affect blood glucose control if taken shortly before or after carbohydrate-rich meals. If you have diabetes or significant glucose intolerance, it is advisable to take melatonin at least 3 hours after any meal.

Do not consume alcoholic beverages before, during, or after taking melatonin, as alcohol reduces its effectiveness and may worsen certain symptoms of jet lag (such as headache, morning fatigue, and concentration problems).

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to take Melatonin Noxarem

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 3 mg tablet daily for up to 4 days. You should take the first dose upon arrival at your destination, at the time you usually go to bed (local time). On subsequent days, you should also take the dose at your usual bedtime. If the standard dose of 3 mg does not adequately relieve your symptoms, you may take a 5 mg tablet at local bedtime instead of the 3 mg tablet. You must not take the 5 mg tablet in addition to the 3 mg tablet; instead, you may take the higher dose on subsequent days. The maximum daily dose is 5 mg once daily. You should take the dose that adequately relieves your symptoms for the shortest possible duration.

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, you must not take the tablets before 8:00 p.m. or after 4:00 a.m. The tablets should be taken with a glass of water. It is recommended to avoid eating food 2 hours before or 2 hours after the scheduled time for taking melatonin.

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

If you take more Melatonin Noxarem than you should

In case of overdose or accidental ingestion, especially by a child, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

Taking more than the recommended daily dose may 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 from stopping or ending treatment prematurely. There are no known withdrawal symptoms associated with melatonin use after treatment ends.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Possible adverse effects during short-term use for jet lag are: headache, loss of appetite, dizziness, daytime drowsiness, and disorientation.

Various adverse effects have been reported with the use of melatonin for other disorders.

If you experience any of the following serious adverse 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
• Awareness of your own heartbeat
• Depression
• Vision problems
• Disorientation
• Vertigo (a sensation of dizziness or spinning)
• Presence of 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-serious adverse effects, consult your doctor and/or seek medical advice.

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

Irritability, nervousness, agitation, insomnia, unusual dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, 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, night sweats, itching, rash, dry skin, pain in the limbs, glucose excretion in urine, excess protein in urine, menopausal symptoms, feeling of weakness, liver failure, and weight gain.

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

Shingles (herpes zoster), elevated 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, drowsy state, restless legs syndrome, poor quality of sleep, tingling sensation, watery eyes, dizziness upon standing or sitting, hot flushes, gastroesophageal reflux, stomach disorders, mouth sores, tongue ulcers, stomach discomfort, vomiting, abnormal intestinal noises, flatulence, excessive saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the gastric mucosa, eczema, rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, nocturnal cramps, large volume of urine, nighttime urination, prolonged erection which may be painful, prostate gland enlargement, fatigue, pain, thirst, increased liver enzymes, abnormal blood electrolytes, and abnormal laboratory test results.

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

Swelling of the mouth or tongue, hyperglycemia, and abnormal milk secretion.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Melatonin Noxarem

Keep this medicine out of sight and reach of children.

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

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Melatonin Noxarem

The active substance 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 hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, pregelatinized starch.

Appearance of Melatonin Noxarem and contents of the pack

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

5 mg: white, capsule-shaped tablet with a score 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 tablet bottles (HDPE plastic container and LDPE plastic cap).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Vemedia Manufacturing B.V.

Verrijn Stuartweg 60

1112 AX Diemen

The Netherlands

Local representative: Vemedia Pharma Hispania S.A.
c/ Aragón, 18
08011 Barcelona
Tel. +34 93 453 62 19

Manufacturer:

Vitabalans Oy

Varastokatu 7-9

13500 Hämeenlinna

Finland

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Dagravit: Finland
Melatonin Noxarem: Spain

Date of the most recent review of this leaflet: February 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/