Melatonin Noxarem 5 mg 10 tablets

Melatonin Noxarem 5 mg 10 tablets

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

Follow the instructions for taking the medicine exactly as given 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 further information, ask your pharmacist.

If you experience side effects, please contact your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.

You should consult a doctor if you get worse or do not improve after 6 days.

Contents of the package leaflet

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

2. What you need to know before you start taking Noxarem Melatonin

3. How to take Noxarem Melatonin

4.  Possible side effects

5. Storage of Melatonin Noxarem

6. Contents of the pack and additional information

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

The active substance in Noxarem Melatonin 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 the time difference when travelling across different time zones, in either an easterly or westerly direction.

A doctor should be consulted if it worsens or does not improve.

2. What you need to know before you start taking Melatonin Noxarem

Do not take Melatonin Noxarem:

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking this medicine if you suffer from:

kidney failure. The use of melatonin is not recommended if you have severe kidney disease.

liver failure. Melatonin is not recommended if you have liver disease.

autoimmune disease (when the body is "attacked" by its own immune system). Melatonin is not recommended in this case.

cardiovascular condition for which you take 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 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 can speed up the breakdown of melatonin in the liver.

Children and adolescents

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

Other medicines and Noxarem Melatonin

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

Fluvoxamine (used in the treatment of depression and obsessive compulsive disorder), quinolones and rifampicin (used in the treatment of bacterial infections), oestrogens (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 by 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 drugs), antidepressant medicines, tryptophan and alcohol.

Cimetidine (used to treat stomach problems such as ulcers), calcium channel blockers (medicines used to treat high blood pressure 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 may need to be checked more specifically.

Taking Noxarem Melatonin 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 of taking melatonin. Melatonin may alter blood glucose control if taken shortly before or after carbohydrate-rich meals. If you have diabetes or any significant glucose intolerance, you should ideally take melatonin at least 3 hours after any meal.

Do not drink 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 breast-feeding

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

Driving and using machines

Melatonin has a moderate influence on the ability to drive and use machines. 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 melatonin.

3. How to take Melatonin Noxarem

Follow the instructions for taking the medicine exactly as given in this leaflet or as directed by your doctor or pharmacist. If you are in any doubt, ask your doctor or pharmacist.

The recommended dose is one 3 mg tablet a day for up to 4 days. You should take the first dose when you arrive at your destination at your usual bedtime (local time). On the following days, you should also take the dose at your normal bedtime. If the standard 3 mg dose does not relieve your symptoms adequately, you can take a 5 mg tablet at your local bedtime instead of the 3 mg tablet. You should not take the 5 mg tablet in addition to the 3 mg tablet, but 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 relieves your symptoms adequately for the shortest period of time.

The time at which you take melatonin is important, because if you take it at the wrong time, melatonin can cause drowsiness and delay adaptation to local time. Therefore, you should 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 time for taking melatonin.

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

If you take more Melatonin Noxarem than you should

In case of overdose or accidental ingestion, or if accidentally swallowed by a child, consult your doctor or pharmacist immediately or call the Poisons Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

Taking more than the recommended daily dose may make you feel drowsy.

If you forget to take Noxarem Melatonin

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

If you stop taking Noxarem Melatonin

There are no known harmful effects from stopping or terminating treatment early. There are no known withdrawal symptoms from the use of melatonin after the end of treatment.

If you have any other questions 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 sleepiness and disorientation.

A number of adverse 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.

Rare: (may affect 1 in 100 people)

Chest pain

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

Loss of consciousness or fainting

Severe chest pain due to angina

Feeling your own heart beat

Depression

Vision problems

Disorientation

vertigo (a feeling 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

Of unknown frequency: (cannot be estimated from 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.

Rare: (may affect 1 in 100 people)

Irritability, nervousness, agitation, insomnia, strange dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), agitation associated with increased activity, dizziness, tiredness, high blood pressure, 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 extremities, glucose excretion in the urine, excess protein in the urine, menopausal symptoms, feeling of weakness, liver failure and weight gain.

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

Shingles, high levels of fatty acid molecules in the blood, mood swings, aggression, agitation, crying, stress symptoms, waking up too early, increased sex drive, depressed mood, memory problems, inattention, drowsiness, restless legs syndrome, poor quality sleep, tingling sensation, watery eyes, dizziness when getting up or sitting down, hot flushes, gastro-oesophageal reflux, stomach disorders, mouth sores, tongue sores, upset stomach, vomiting, abnormal bowel sounds, wind, excessive saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of gastric mucosa, eczema, rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, night cramps, large volume of urine, night-time urination, prolonged erection which may be painful, swollen prostate gland, tiredness, pain, thirst, increased liver enzymes, abnormal blood electrolytes and abnormal lab results.

Of unknown frequency: (cannot be estimated from available data)

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

Reporting side effects

If you experience any side effects, please tell your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. Storage of Melatonin Noxarem

Keep out of the sight and reach of children.

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

Store in the original carton in order to protect from light.

Medicines should not be flushed down the drain or thrown away. Deposit containers and medicines that you do not need at the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help to protect the environment.

6. Package contents and additional information

Composition of Noxarem Melatonin

The active substance is melatonin.

Each 3 mg tablet contains 3 mg melatonin.

Each 5 mg tablet contains 5 mg melatonin.

The other ingredients are:

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

What Noxarem Melatonin looks like and contents of the pack

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

5 mg: white, capsule-shaped tablet with a slit on one side, 10 mm x 5 mm. The tablet can be divided into equal doses.

10, 30 and 50 tablets in blister packs (PVC/Al) or in a tablet bottle (HDPE plastic container and LDPE plastic cap).

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Responsible Manufacturer

Marketing Authorisation Holder:

Vemedia Manufacturing B.V.

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