Circadin 2 mg comprimidos de liberacion prolongada (30 comprimidos)

Patient Information Leaflet: Circadin 2 mg prolonged-release tablets

Melatonin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Table of Contents:

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

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

Circadin is used alone for the short-term treatment of primary insomnia (persistent difficulty falling asleep or staying asleep or poor sleep quality) in patients over 55 years old. “Primary” means that the insomnia has no identified cause, whether medical, mental, or environmental.

Do not take Circadin

• if you are allergic to melatonin or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Circadin.

• If you have liver or kidney problems. There have been no studies 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 intolerance to certain sugars.
• If you have been told that you have an autoimmune disease (when your body is "attacked" by your own immune system). There have been no studies 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 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.

Taking Circadin with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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).

Taking Circadin with food, drinks, and alcohol

Take Circadin after eating some food. Do not drink alcohol or take it before, during, or after 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 medication.

Driving and operating machinery

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

Circadin contains lactose monohydrate

Circadin 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. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet (2 mg) of Circadin per day, taken orally after eating, 1 or 2 hours before bedtime. This dose may be prolonged for a maximum of 13 weeks.

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

If You Take More Circadin 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.

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 scheduled dose and continue as usual.

Do not take a double dose to make up for the missed dose.

If You Interrupt Treatment with Circadin

Stopping or prematurely terminating treatment does not cause any known adverse effects. Circadin use does not cause withdrawal effects after treatment is completed.

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

Like all medicines, this medicine can 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:

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
• Intense chest pain due to angina
• 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, 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,

sensation 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 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 at night, increased libido (increased sexual desire), depressive mood, memory deterioration, attention alteration, dreamy state, restless legs syndrome, poor sleep quality, sensation of pinpricks, increased tearing, dizziness upon standing or sitting, hot flashes, acid reflux, digestive alterations, mouth ulceration, tongue ulceration, 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 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.

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

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

Reporting of adverse effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAnexo V.By reporting adverse 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.

Do not use this medication after the expiration date that appears on the packaging after (CAD). The expiration date is the last day of the month indicated.

Do not store above 25 C. Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

• The active ingredient is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other components (excipients) are type B ammonium methacrylate copolymer, calcium dihydrogen phosphate, lactose monohydrate, colloidal anhydrous silica, talc, and magnesium stearate.

Appearance of the product and contents of the pack

Circadin 2 mg prolonged-release tablets are presented as biconvex, round, white or off-white tablets. Each pack of tablets contains a strip

blister with 7, 20 or 21 tablets or a cardboard pack with two blister strips containing 15 tablets each (30 tablets in total). Only some pack sizes may be marketed.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux

75002 Paris France

Email:regulatory@neurim.comManufacturer:

Responsible sites 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 request more information about this medicine by contacting the local representative of the marketing authorization holder

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

Takeda-Belgium@takeda.com

Lietuva

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

e-mail: neurim@neurim.com

??????

RAD Neurim Pharmaceuticals EEC SARL Te?: +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

TakedaAS

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

Last review date of this leaflet:{month YYYY}

Other sources of information

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