CIRCADIN 2 mg PROLONGED-RELEASE TABLETS (30 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 pack and other information

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. Storing Circadin
6. Contents of the pack and further 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 falling asleep or staying asleep or poor quality sleep) in patients over 55 years old. "Primary" means that the insomnia is not caused by any known medical, psychiatric or environmental factor.

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 starting treatment with 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 old, as it has not been evaluated in this population and its effects are not known. For administration to children from 2 to 18 years old, 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 using, have recently used or might use 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 having taken 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 plan to become pregnant. 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 having taken some food, 1 or 2 hours before bedtime. This dose may be continued for up to thirteen weeks.

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 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 Circadin

Stopping or prematurely ending treatment does not cause any known harmful 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
• Palpitations
• Depression
• Visual impairment
• Blurred vision
• Disorientation
• Dizziness (feeling of dizziness or that "everything is 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 (tiredness, lack of energy), restlessness associated with increased activity, dizziness, fatigue, 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, limb pain, 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 tearing, 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 and painful erection, 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 experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storing 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 stated.

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 further information

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

Appearance and packaging

Circadin 2 mg prolonged-release tablets are white or almost white, biconvex, round 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:

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 from the representative of the marketing authorisation holder.

België/Belgique/Belgien Takeda Belgium Tel/Tél: +32 2 464 06 11

Takeda-Belgium@takeda.com

Lietuva

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

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RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Luxembourg/Luxemburg

Takeda Belgium

Tél/Tel: +32 2 464 06 11 (BE)

Takeda-Belgium@takeda.com

Ceská republika

RAD Neurim Pharmaceuticals EEC SARL Tel: +44 7563543352 (UK)

e-mail: neurim@neurim.com

Magyarország

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Danmark

Takeda Pharma A/S Tlf: +45 46 77 11 11

Malta

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Deutschland

MEDICE Arzneimittel Pütter GmbH & Co. KG Tel: +49 (0)2371 9370

info@medice.de

Nederland

Takeda Nederland b.v Tel: +31 20 203 5492

medinfoEMEA@takeda.com

Eesti

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Norge

Takeda AS

Tlf: +47 6676 3030

infonorge@takeda.com

Ελλ?δα

TAKEDA ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 6387800

gr.info@takeda.com

Österreich

SANOVA PHARMA GesmbH Tel.: +43 (01) 80104-0

e-mail: sanova.pharma@sanova.at

España

EXELTIS HEALTHCARE, S.L. Tfno: +34 91 7711500

Polska

MEDICE Arzneimittel Pütter GmbH & Co. KG Tel.: + 48-(0)22 642 2673

e-mail: office@medice.pl

France

BIOCODEX

Tél: +33 (0)1 41 24 30 00

e-mail: medinfo@biocodex.com

Portugal

Italfarmaco, Produtos Farmacêuticos, Lda.

Tel. +351 214 342 530

e-mail: geral@itf-farma.pt

Hrvatska

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

România

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Ireland

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Slovenija

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Ísland

Vistor hf.

Simi: +354 535 7000

Slovenská republika

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

Italia

Fidia Farmaceutici S.p.A.

Tel: +39 049 8232222

e-mail: info@fidiapharma.it

Suomi/Finland

Takeda Oy

Puh/Tel: +358 20 746 5000

Κ?προς

RAD Neurim Pharmaceuticals EEC SARL

Τηλ : +33 185149776 (FR)

e-mail: neurim@neurim.com

Sverige

Takeda Pharma AB Tel: +46 8 731 28 00

infosweden@takeda.com

Latvija

RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

United Kingdom (Northern Ireland) RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR)

e-mail: neurim@neurim.com

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