MELATONIN ARROTEX 2 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Melatonin Arrotex 2 mg prolonged-release tablets EFG

Melatonin

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 Melatonin Arrotex is and what it is used for.
2. What you need to know before you take Melatonin Arrotex.
3. How to take Melatonin Arrotex.
4. Possible side effects.
5. Storage of Melatonin Arrotex
6. Contents of the pack and further information.

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

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

Melatonin Arrotex 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 over 55 years of age. "Primary" means that the insomnia has no identifiable cause, whether medical, mental, or environmental.

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

Do not take Melatonin Arrotex

• 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 Arrotex

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

Using Melatonin Arrotex with other medicines

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 addictions), 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 Arrotex with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Do not take Melatonin Arrotex if you are pregnant, think you may be pregnant, or plan to become pregnant, or if you are breastfeeding. Talk to your doctor or pharmacist before using this medicine.

Driving and using machines

Melatonin Arrotex may cause drowsiness. In that case, do not drive or operate machinery. Talk to your doctor if you experience continuous drowsiness.

Melatonin Arrotex contains lactose monohydrate

Melatonin Arrotex contains lactose monohydrate. If your doctor has told you that you have intolerance to certain sugars, talk to them before taking this medicine.

3. How to take Melatonin Arrotex

Follow exactly the administration instructions of this medicine given 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 Arrotex 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 Arrotex tablets should not be crushed or broken in half.

If you take more Melatonin Arrotex than you should

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

Taking a dose higher than the recommended daily dose may cause drowsiness.

If you forget to take Melatonin Arrotex

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 Arrotex

Stopping or premature termination of treatment does not cause any known harmful effects. The use of Melatonin Arrotex does not cause withdrawal effects after treatment is finished.

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 seek medical attention:

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, dreamy state, restless legs syndrome, poor quality sleep, 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 upset, 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, swelling of the skin, and abnormal milk secretion.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Melatonin Arrotex

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

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

This medicine does not require any special storage conditions. Keep in the original package to protect from light.

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

6. Contents of the pack and further information

Composition of Melatonin Arrotex

• The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other ingredients (excipients) are lactose monohydrate, calcium hydrogen phosphate dihydrate, ammonio methacrylate copolymer, talc, silica, anhydrous colloidal, and magnesium stearate.

Appearance of the product and pack contents

Melatonin Arrotex 2 mg prolonged-release tablets are presented as biconvex, round, white or almost white tablets. Each carton contains 7, 20, 21, or 30 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Arrotex Pharmaceuticals Limited

70 Sir John Rogerson's Quay,

Dublin 2,

Ireland

Manufacturer:

Eurofins PROXY Laboratories B.V.

Archimedesweg 25

2333 CM LEIDEN

THE NETHERLANDS

This medicine is authorised in the Member States of the European Economic Area under the following names:

United Kingdom Melatonin Mylan 2mg Prolonged-release Tablets

Poland Melatonina Arrotex

Spain Melatonina Arrotex 2 mg Comprimidos de Liberacion Prolongada EFG

Date of last revision of this package leaflet:September 2018