Product Information for the Patient

Melatonina Aurovitas 2 mg Extended-Release Tablets EFG

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

-Keep this product information, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What is Melatonina Aurovitas and how is it used

2.What you need to know before starting to take Melatonina Aurovitas

3.How to take Melatonina Aurovitas

4.Possible adverse effects

5.Storage of Melatonina Aurovitas

6.Contents of the package and additional information

The active ingredient of Melatonina 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 falling asleep or staying asleep or poor sleep quality) in patients 55 years of age or older. “Primary” means that the insomnia has no identified cause, whether medical, mental, or environmental.

Do not take Melatonina Aurovitas

- If you are allergic to melatonin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Melatonina Aurovitas:

• If you have liver or kidney problems. There have been no studies on the use of melatonin in people with liver or kidney diseases; you should talk to your doctor before taking melatonin as its use is not recommended.
• If your doctor has told you that you have intolerance to certain sugars.
• If you have been told that you have an autoimmune disease (where your body is "attacked" by your own immune system). There have been no studies 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 may cause drowsiness; you should be careful if you experience drowsiness, as it may affect your ability to perform tasks such as driving.
• Tobacco may reduce the effectiveness of melatonin, as the components of cigarette smoke may increase the breakdown of melatonin in the liver.

Children and adolescents

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

Other medications and Melatonina Aurovitas

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

• Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), psoralens (used for the treatment of skin diseases, such as psoriasis), cimetidine (used for the treatment of stomach problems, such as ulcers), quinolones and rifampicin (used for the treatment of bacterial infections), estrogens (used as contraceptives or in hormone replacement therapy) and carbamazepine (used for the treatment of 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 addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory drugs), antidepressants, tryptophan, and alcohol.
• Benzodiazepines and non-benzodiazepine hypnotics (medications used to induce sleep, such as zaleplon, zolpidem, and zopiclone).
• Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).

Use of Melatonina Aurovitas with food, drinks, and alcohol

Take melatonin after having eaten some food. Do not drink alcohol or take melatonin before, during, or after its 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 medication.

Driving and operating machinery

Melatonina Aurovitas may cause drowsiness. In that case, do not drive or operate machinery. Consult your doctor if you experience continuous drowsiness.

Melatonina Aurovitas contains lactose monohydrate

This medication contains lactose monohydrate. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as 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 having eaten some food, 1 or 2 hours before going to bed. This dose may be prolonged for a maximum of thirteen weeks.

Swallow the tablet whole. Melatonina Aurovitas tablets should not be crushed or split in half.

If you take more Melatonina Aurovitas than you should

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

Taking a dose higher than the recommended dose for each day may cause drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Melatonina Aurovitas

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Melatonina Aurovitas

Interrupting or prematurely terminating treatment does not cause any known harmful effects. Melatonin use does not cause withdrawal effects after treatment completion.

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

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

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

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

• Chest pain

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

• Loss of consciousness or fainting
• Intense chest pain due to angina pectoris
• Perception of heartbeats
• Depression
• Visual deterioration
• Blurred vision
• Disorientation
• Dizziness (sensation of spinning or dizziness)
• Presence of red blood cells in the urine
• Decreased white blood cell count in the blood
• Decreased platelet count in the blood, increasing the risk of bleeding or bruising
• Psoriasis

If you experience any of the following non-serious side 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 (fatigue, lack of energy), restlessness associated with increased activity, dizziness, exhaustion, high blood pressure, upper abdominal pain, indigestion, formation of ulcers in the mouth, dry mouth, nausea, alteration of blood composition that may cause a yellowish discoloration of the skin or eyes, skin inflammation, nocturnal sweating, itching, skin rash, dry skin, pain in the extremities, menopausal symptoms, feeling of weakness, glucose excretion 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 in the middle of the night, increased libido, depressive mood, memory deterioration, attention alteration, dreamy state, restless legs syndrome, poor sleep quality, prickling sensation, increased tearing, dizziness when standing up or sitting down, hot flashes, acid reflux, digestive disturbances, mouth blisters, tongue ulceration, 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 alterations, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged and painful erection, prostate inflammation, fatigue, pain, thirst, increased urine volume, nocturnal urination, increased liver enzymes, blood electrolyte abnormalities, and laboratory test abnormalities.

Unknown frequency:(cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus.You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofMelatonina Aurovitas 2 mg prolonged-release tablets

-The active ingredient is melatonin. Each prolonged-release tabletcontains 2 mg of melatonin.

-The other components are: Lactose monohydrate, calcium dihydrogen phosphate, ammonium methacrylate copolymer (Type B), anhydrous colloidal silica, talc, magnesium stearate.

Appearance of the product and contents of the pack

Prolonged-release tablet.

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

Melatonina Aurovitas 2 mg prolonged-release tablets EFG is available in blisters.

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

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation 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 responsible

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorised in the Member States of the European Economic Area with the following names:

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

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

Alemania:MelatoninPUREN 2 mg Retardtabletten

Italia:MelatoninaAurobindo

Portugal:Melatonina Generis

España:MelatoninaAurovitas 2 mg comprimidos de liberación prolongada EFG

Last review date of this leaflet:June 2021

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).