Melatonin Aurovitas 2 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Melatonin Aurovitas 2 mg prolonged-release tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Melatonin Aurovitas is and what it is used for
2. What you need to know before taking Melatonin Aurovitas
3. How to take Melatonin Aurovitas
4. Possible side effects
5. How to store Melatonin Aurovitas
6. Contents of the pack and other information

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

The active substance of Melatonin Aurovitas is melatonin, and it belongs to a group of natural hormones produced by the body.

Melatonin is used alone for the short-term treatment of primary insomnia (persistent difficulty in falling asleep or staying asleep, or poor quality of sleep) in patients aged 55 years or older. "Primary" means that the insomnia has no identifiable medical, mental, or environmental cause.

2. What you need to know before taking Melatonin Aurovitas

Do not take Melatonin Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Melatonin Aurovitas:

• If you have liver or kidney problems. Studies on the use of melatonin in people with liver or kidney disease have not been conducted; you should speak with your doctor before taking melatonin, as its use is not recommended.
• If your doctor has told you that you have an intolerance to certain sugars.
• If you have been diagnosed with an autoimmune disease (a condition in which the body is “attacked” by its own immune system). Studies on the use of melatonin in people with autoimmune diseases have not been carried out; therefore, you should talk to your doctor before taking melatonin, as its use is not recommended.
• Melatonin may cause drowsiness; you should be cautious if drowsiness occurs, as it may affect your ability to perform tasks such as driving.
• Tobacco may reduce the effectiveness of melatonin, as components of tobacco smoke can increase the breakdown of melatonin in the liver.

Children and adolescents

This medicine should not be administered to children or adolescents aged 0 to 18 years, as it has not been evaluated in this population and its effects are unknown. For administration to children aged 2 to 18 years, another melatonin-containing medicine may be more appropriate; consult your doctor or pharmacist.

Other medicines and Melatonin Aurovitas

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 to treat depression and obsessive-compulsive disorder), psoralens (used to treat skin diseases such as psoriasis), cimetidine (used to treat stomach problems such as ulcers), quinolones and rifampicin (used to treat bacterial infections), estrogens (used as contraceptives or in hormone replacement therapy), and carbamazepine (used to treat epilepsy).
• Adrenergic agonists and antagonists (such as certain medicines used to control blood pressure by constricting blood vessels, nasal decongestants, or drugs to reduce blood pressure), opioid agonists and antagonists (such as some medicines used in the treatment of drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressants, tryptophan, and alcohol.
• 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).

Taking Melatonin Aurovitas with food, drinks, and alcohol

Take melatonin after eating a meal. Do not drink alcohol before or after taking melatonin or during treatment, as it reduces the effectiveness of melatonin.

Pregnancy and breastfeeding

Do not take melatonin if you are pregnant, think you might be pregnant, intend to become pregnant, or are breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Melatonin Aurovitas may cause drowsiness. If this occurs, you should not drive or operate machinery. Consult your doctor if you experience persistent drowsiness.

Melatonin Aurovitas contains lactose monohydrate

This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Melatonin Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet (2 mg) of melatonin per day, taken orally after food, 1 or 2 hours before bedtime. This dose may be continued for up to thirteen weeks.

Swallow the tablet whole. Melatonin Aurovitas tablets must not be crushed or split.

If you take more Melatonin Aurovitas than you should

If you accidentally take more than the prescribed amount, contact your doctor or pharmacist as soon as possible.

Taking a higher daily dose than recommended may cause drowsiness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Melatonin Aurovitas

If you forget to take the tablet, take it as soon as you remember, before going to bed, or wait until the next scheduled dose and then continue as before.

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

If you stop taking Melatonin Aurovitas

Stopping or ending treatment prematurely does not cause any known harmful effects. The use of melatonin does not cause withdrawal effects 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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop taking the medicine and contact your doctor immediately:

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

• Chest pain

Rare: (may affect up to 1 in 1000 people)

• Loss of consciousness or fainting
• Severe chest pain due to angina
• Awareness of heartbeat
• Depression
• Visual impairment
• Blurred vision
• Disorientation
• Dizziness (sensation of dizziness or spinning)
• Presence of red blood cells in urine
• Decrease in the number of white blood cells in the blood
• Decrease in the number of platelets in the blood, which increases the risk of bleeding or bruising
• Psoriasis

If you experience any of the following non-serious adverse effects, contact your doctor or seek medical assistance:

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

Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity, dizziness, exhaustion, high blood pressure, upper abdominal pain, indigestion, formation of mouth ulcers, dry mouth, nausea, alteration in blood composition that may cause yellowish discoloration of the skin or eyes, skin inflammation, night sweats, itching, skin rash, dry skin, limb pain, menopausal symptoms, feeling of weakness, glucose excretion in urine, excess protein in urine, abnormal liver function, and weight gain.

Rare: (may affect up to 1 in 1000 people)

Herpes, increased concentration of fat molecules in the blood, reduced concentration of calcium in the blood, reduced concentration of sodium in the blood, mood alteration, aggression, agitation, crying, stress symptoms, early morning awakening, increased sexual desire, depressive mood, memory impairment, attention disturbance, dreamy state, restless legs syndrome, poor quality of sleep, prickling sensation, increased tearing, dizziness upon standing or sitting, hot flushes, acid reflux, digestive disturbances, mouth blisters, tongue ulceration, stomach discomfort, vomiting, abnormal intestinal noises, flatulence, excessive salivation, bad breath, abdominal discomfort, stomach disorders, inflammation of the stomach mucosa, eczema, skin rash, hand dermatitis, itchy skin rash, nail abnormalities, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged erection which may be painful, prostate inflammation, fatigue, pain, thirst, increased volume of urine, desire to urinate at night, increased liver enzymes, electrolyte abnormalities in the blood, and laboratory test abnormalities.

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

Hypersensitivity reaction, swelling of the mouth or tongue, skin swelling, and abnormal milk secretion.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. They can also be reported directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Melatonin Aurovitas

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

Store in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Melatonin Aurovitas 2 mg prolonged-release tablets EFG

• The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other components are: Lactose monohydrate, calcium hydrogen phosphate dihydrate, ammonio methacrylate copolymer (Type B), colloidal anhydrous silica, talc, magnesium stearate.

Appearance of the product and contents of the pack

Prolonged-release tablet.

Biconvex, round, white or almost white, uncoated tablets, smooth on both sides.

Melatonin Aurovitas 2 mg prolonged-release tablets EFG are available in blister packs.

Blister pack: 7, 10, 20, 21, 30, 60, 90 and 100 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Melatonin AB 2 mg tabletten met verlengde afgifte/comprimés à libération prolongée/Retardtabletten

France: MELATONINE ARROW LP 2 mg, comprimé à libération prolongée

Germany: Melatonin PUREN 2 mg Retardtabletten

Italy: Melatonina Aurobindo

Portugal: Melatonina Generis

Spain: Melatonin Aurovitas 2 mg prolonged-release tablets EFG

Date of the most recent revision of this leaflet: June 2021

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/).