CIRCADIN 2 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Circadin 2 mg Prolonged-Release Tablets

Melatonin

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

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Circadin and what is it used for

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

Circadin is used on its own for the short-term treatment of primary insomnia (persistent difficulty in falling asleep or staying asleep or poor quality sleep) in patients over 55 years of age. "Primary" means that the insomnia does not have any known cause, whether medical, mental or environmental.

2. What you need to know before you take Circadin

Do not take Circadin

• 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 taking Circadin.

• If you have liver or kidney problems. No studies have been conducted on the use of Circadin in people with liver or kidney disease; you should talk to your doctor before taking Circadin, as its use is not recommended.
• If your doctor has told you that you have an intolerance to some 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 Circadin in people with autoimmune diseases; therefore, you should talk to your doctor before taking Circadin, as its use is not recommended.
• Circadin 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 Circadin, 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. For administration to children from 2 to 18 years, another melatonin medicine may be more suitable; consult your doctor or pharmacist.

Taking Circadin 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 medicines 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).

Taking Circadin with food, drinks and alcohol

Take Circadin after you have eaten some food. Do not drink alcohol before, after or while taking Circadin, as it reduces the effectiveness of Circadin.

Pregnancy and breastfeeding

Do not take Circadin if you are pregnant, think you may be pregnant or are planning to have a baby. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Circadin may cause drowsiness. In this case, do not drive or operate machinery. Consult your doctor if you experience persistent drowsiness.

Circadin contains lactose monohydrate

Circadin contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Circadin

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 Circadin per day, taken orally after eating some food, 1 or 2 hours before bedtime. This dose may be continued for up to thirteen weeks.

You should swallow the tablet whole. Circadin tablets should not be crushed or broken in half.

If you take more Circadin 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.

If you forget to take Circadin

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 then continue as before.

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

If you stop taking Circadin

Stopping or ending treatment prematurely does not cause any known adverse effects. The use of Circadin 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 1,000 people)

• Loss of consciousness or fainting
• Severe chest pain due to angina
• Awareness of heartbeats
• Depression
• Visual impairment
• Blurred vision
• Disorientation
• Dizziness (feeling of dizziness or "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, abdominal pain, 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 1,000 people)

Herpes zoster, 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 libido (increased sexual desire), depressive mood, memory impairment, attention alteration, daydreaming, 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 ulcers, tongue ulcers, stomach discomfort, vomiting, abnormal intestinal sounds, gas, excessive saliva production, bad breath, abdominal discomfort, stomach disorders, stomach mucosa inflammation, eczema, skin redness, hand dermatitis, skin redness and itching, nail disorders, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged erection that may be painful, prostate inflammation, fatigue, pain, thirst, increased urine volume, need to urinate at night, increased liver enzymes, blood electrolyte abnormalities 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Circadin

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 refers to the last day of the month shown.

Do not store above 25°C. Store in the original package to protect from light.

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

6. Contents of the pack and other information

Composition of Circadin

The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.

The other ingredients (excipients) are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, colloidal anhydrous silica, talc and magnesium stearate.

Appearance of the product and pack contents

Circadin 2 mg prolonged-release tablets are presented as biconvex, round, white or almost white tablets. Each carton of tablets contains a blister strip with 7, 20 or 21 tablets or a cardboard box with two blister strips with 15 tablets each (30 tablets in total). Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux

75002 Paris

France

Email: regulatory@neurim.com

Manufacturer:

Responsible centres for batch release in the EEA:

Temmler Pharma GmbH & Co. KG

Temmlerstrasse 2

35039 Marburg

Germany

Iberfar - Indústria Farmacêutica S.A.

Rua Consiglieri Pedroso, n.o 121-123 - Queluz de Baixo

Barcarena, 2734-501

Portugal

Rovi Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares

Madrid, 28805

Spain

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:{month YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu