MELATONIN AUROVITAS 2 mg PROLONGED RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Melatonin Aurovitas 2 mg prolonged-release tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the package leaflet:

1. What is Melatonin Aurovitas and what is it used for
2. What you need to know before you take Melatonin Aurovitas
3. How to take Melatonin Aurovitas
4. Possible side effects
5. Storage of Melatonin Aurovitas
6. Package contents and further information

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

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

Melatonin is used on its own for the short-term treatment of primary insomnia (persistent difficulty falling asleep or staying asleep or poor quality sleep) in patients aged 55 years or over. "Primary" means that the insomnia is not caused by any known medical, mental, or environmental factor.

2. What you need to know before you take Melatonin Aurovitas

Do not take Melatonin Aurovitas

• If you are allergic to melatonin or 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. No studies have been conducted on the use of melatonin in people with liver or kidney disease; you should talk to 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 told that you have an autoimmune disease (where the body is "attacked" by its own immune system). No studies have been conducted on the use of melatonin in people with autoimmune diseases; therefore, you should talk to your doctor before taking melatonin as its use is not recommended.
• Melatonin can cause drowsiness; you should be careful if you experience drowsiness, as it may affect your ability to perform tasks such as driving.
• Smoking can reduce the effectiveness of melatonin, as the components of tobacco smoke can increase the breakdown of melatonin in the liver.

Children and adolescents

This medicine should not be given to children or adolescents from 0 to 18 years, as it has not been evaluated in this population and its effects are not known. For administration to children from 2 to 18 years, another melatonin medicine may be more suitable; consult your doctor or pharmacist.

Other medicines and Melatonin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 types of medications used to control blood pressure by constricting blood vessels, nasal decongestants, or medications to reduce blood pressure), opioid agonists and antagonists (such as some medications 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).

Using Melatonin Aurovitas with food, drinks, and alcohol

Take melatonin after you have eaten some food. Do not drink alcohol before, after, or during melatonin administration, as it reduces the effectiveness of melatonin.

Pregnancy and breastfeeding

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

Driving and using machines

Melatonin Aurovitas can cause drowsiness. In that case, do 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 told 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 administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet (2 mg) of melatonin per day, taken orally after eating some food, 1 or 2 hours before bedtime. This dose may be extended for a maximum of thirteen weeks.

Swallow the tablet whole. Melatonin Aurovitas tablets should not be crushed or broken in half.

If you take more Melatonin Aurovitas than you should

If you accidentally take more medicine than you should, go to your doctor or pharmacist as soon as possible.

Taking a higher dose than recommended per day may cause drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 bedtime, or wait until the next 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 prematurely ending treatment does not cause any known adverse effects. The use of melatonin does not cause withdrawal effects after treatment ends.

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.

If you experience any of the following serious side 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 pectoris
• Awareness of heartbeat
• Depression
• Visual impairment
• Blurred vision
• Disorientation
• Dizziness (feeling of dizziness or "everything spinning")
• Presence of red blood cells in the urine
• Decreased number of white blood cells in the blood
• Decreased number of platelets in the blood, which increases the risk of bleeding or bruising
• Psoriasis

If you experience any of the following non-serious side effects, contact your doctor or pharmacist:

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

Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (fatigue, lack of energy), restlessness associated with increased activity, dizziness, exhaustion, high blood pressure, pain in the upper abdomen, indigestion, mouth ulcers, dry mouth, nausea, alteration of blood composition that may cause a yellowish tint to the skin or eyes, skin inflammation, night sweats, itching, skin rash, dry skin, pain in the limbs, menopausal symptoms, feeling of weakness, glucose in the urine, excess protein in the 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 calcium concentration in the blood, reduced sodium concentration in the blood, mood alteration, aggression, agitation, crying, stress symptoms, waking up early, increased sexual desire, depressive mood, memory impairment, attention alteration, daydreaming, restless legs syndrome, poor sleep quality, sensation of pins and needles, increased tear production, dizziness when standing up or sitting down, hot flashes, acid reflux, digestive disorders, mouth blisters, tongue ulcers, stomach discomfort, vomiting, abnormal intestinal sounds, gas, excessive saliva production, bad breath, abdominal discomfort, stomach disorders, stomach mucosa inflammation, eczema, skin rash, hand dermatitis, itchy skin rash, nail disorders, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged and painful erection, prostate inflammation, fatigue, pain, thirst, increased urine volume, need to urinate at night, increased liver enzymes, electrolyte abnormalities in the blood, and laboratory test abnormalities.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency website: www.notificaRAM.es. By reporting side 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 package to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further 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 ingredients are: Lactose monohydrate, calcium hydrogen phosphate dihydrate, ammonio methacrylate copolymer (Type B), colloidal anhydrous silica, talc, magnesium stearate.

Appearance of the product and package contents

Prolonged-release tablet.

White or almost white, biconvex, round tablets, without coating, smooth on both sides.

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 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 medicine is authorised 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: Melatonina Aurovitas 2 mg comprimidos de liberación prolongada EFG

Date of last revision of this package leaflet:June 2021

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/).