Circadin

Package leaflet: Information for the patient

Circadin 2 mg prolonged-release tablets

Melatonin
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Circadin is 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. How to store Circadin
6. Contents of the pack and other information

1. What Circadin is and what it is used for

The active substance of Circadin, melatonin, 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 in falling asleep or staying asleep, or poor sleep quality) in patients aged 55 years and over.
"Primary" means that no cause for the insomnia has been identified, including any medical, mental, or environmental cause.

2. What you need to know before taking Circadin

Do not take Circadin

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Circadin.

• if you have liver or kidney problems. Studies on the use of Circadin in people with liver or kidney disease have not been conducted; consult your doctor before taking Circadin, as its use is not recommended.
• if your doctor has told you that you have an intolerance to certain sugars.
• if you have been diagnosed with an autoimmune disease (a condition in which the body is "attacked" by its own immune defenses). Studies on Circadin in patients with autoimmune diseases have not been conducted; therefore, consult your doctor before taking Circadin, as its use is not recommended.
• Circadin may cause drowsiness; be cautious if you experience drowsiness, as it may impair your ability to perform activities such as driving.
• Smoking may reduce the effectiveness of Circadin, since components of tobacco smoke can increase the liver's metabolism of melatonin.

Children and adolescents
Do not give this medicine to children aged 0 to 18 years, as it has not been tested and its effects are unknown. In children aged between 2 and 18 years, another melatonin-containing medicine may be more appropriate; please consult your doctor or pharmacist.
Other medicines and Circadin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include:

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralens (used to treat skin diseases, e.g. psoriasis (reddish, scaly patches on the skin)), cimetidine (used to treat stomach problems such as ulcers), quinolones and rifampicin (used to treat bacterial infections), estrogens (used in contraceptives or hormone replacement therapy), and carbamazepine (used to treat epilepsy).
• Adrenergic agonists/antagonists (such as certain medicines used to control blood pressure by constricting blood vessels, nasal decongestants, medicines to lower blood pressure), opioid agonists/antagonists (such as medicines used to treat drug addiction), 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).

Circadin with food, drinks and alcohol
Take Circadin after eating. Do not consume alcohol before, during or after taking Circadin, as it reduces the effectiveness of Circadin.
Pregnancy and breastfeeding
Do not take Circadin if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Circadin may cause drowsiness. If this occurs, you must not drive or operate machinery. If you experience prolonged drowsiness, consult your doctor.
Circadin contains lactose monohydrate
Circadin contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Circadin

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one Circadin tablet (2 mg) taken orally every day after a meal, 1-2 hours before going to bed. This dosage may be maintained for a period of up to thirteen weeks.
The tablet must be swallowed whole. Circadin tablets must not be crushed or split.

If you take more Circadin than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or pharmacist immediately.
If you have taken a dose exceeding the maximum recommended dose, you may experience drowsiness.

If you forget to take Circadin
If you forget to take a tablet, take it as soon as you remember, provided it is before going to bed; otherwise, wait until the time for your next dose and then continue as usual.
Do not take a double dose to make up for the missed dose.

If you stop taking Circadin
There are no known harmful effects associated with interrupting or stopping treatment prematurely. No withdrawal symptoms after discontinuation of Circadin following completion of therapy have been reported.

If you have any doubts about how to use this medicine, consult 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 caused by angina
• Noticeable heartbeats
• Depression
• Changes in vision (including reduction)
• Blurred vision
• Disorientation
• Dizziness (sensation of spinning)
• Presence of red blood cells in the urine
• Reduced number of white blood cells in the blood
• Reduced platelet count, leading to increased bleeding or bruising
• Psoriasis (reddish, scaly patches on the skin)

If any of the following non-serious side effects occur, contact your doctor and/or seek medical advice:

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, hypertension, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in blood composition that may cause yellowing of the skin or eyes, skin inflammation, night sweats, itching, rash, dry skin, pain in extremities, menopausal symptoms, feeling of weakness, presence of glucose in urine, excess protein in urine, abnormalities in liver function tests, and weight gain.

Rare: (may affect up to 1 in 1,000 people)
Herpes zoster (shingles), increased levels of fats in the blood, low serum calcium levels, low sodium levels in the blood, mood changes, aggression, agitation, crying, stress symptoms, early morning awakening, increased libido (increased sexual desire), low mood, memory deficit, attention disorders, dream-like state, restless legs syndrome, poor quality of sleep, tingling sensation, increased tear production, postural dizziness (dizziness upon standing or sitting up), hot flushes, acid reflux, stomach disturbances, mouth ulcers, tongue ulcers, stomach discomfort, vomiting, intestinal noises, intestinal gas, excessive saliva production, bad breath, abdominal pain, stomach disorders, inflammation of the gastric mucosa, eczema, skin rash, hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain, night cramps, prolonged erection which may be painful, inflammation of the prostate, fatigue, pain, thirst, increased urine production, nocturnal urination, increased liver enzymes, abnormalities in blood electrolyte tests, and abnormalities in laboratory test results.

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 effect, including those not listed in this leaflet, please inform your doctor or pharmacist. 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. How to store 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 that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Circadin contains

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

Description of the appearance of Circadin and contents of the pack
Circadin 2 mg prolonged-release tablets are round, biconvex tablets, white to off-white in colour. Each carton contains a blister strip with 7, 20 or 21 tablets, or alternatively two blister strips with 15 tablets each (pack size of 30 tablets). 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: [email protected]

Manufacturer:
Sites responsible for batch release in the European Economic Area (EEA):
Temmler Pharma GmbH & Co. KG
Temmlerstrasse 2
35039 Marburg
Germany
Iberfar Indústria Farmacêutica S.A.
Estrada Consiglieri Pedroso 123
Queluz De Baixo
Barcarena
2734-501
Portugal
Rovi Pharma Industrial Services, S.A.
Vía Complutense, 140
Alcalá de Henares
Madrid, 28805
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium RAD Neurim Pharmaceuticals EEC SARL
Tél/Tel: +32 2 464 06 11 Tel: +33 185149776 (FR)
Email: [email protected] Email: [email protected]

България Luxembourg/Luxemburg
RAD Neurim Pharmaceuticals EEC SARL Takeda Belgium
Tel: +33 185149776 (FR) Tél/Tel: +32 2 464 06 11 (BE)
Email: [email protected] Email: [email protected]

Česká republika Magyarország
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
Email: [email protected] Email: [email protected]

Danmark Malta
Takeda Pharma A/S RAD Neurim Pharmaceuticals EEC SARL
Tlf: +45 46 77 11 11 Tel: +33 185149776 (FR)
Email: [email protected]

Deutschland Nederland
INFECTOPHARM Arzneimittel Takeda Nederland bv
und Consilium GmbH Tel: +31 20 203 5492
Tel: +49 6252 957000 Email: [email protected]
Email: [email protected]

Eesti Norge
RAD Neurim Pharmaceuticals EEC SARL Takeda AS
Tel: +33 185149776 (FR) Tlf: +47 800 800 30
Email: [email protected] Email: [email protected]

Ελλάδα Österreich
TAKEDA ΕΛΛΑΣ Α.Ε. SANOVA PHARMA GesmbH
Tel: +30 210 6387800 Tel.: +43 (01) 80104-0
Email: [email protected] Email: [email protected]

España Polska
EXELTIS HEALTHCARE, S.L. MEDICE Arzneimittel Pütter GmbH & Co. KG
Tfno: +34 91 7711500 Tel.: +48-(0)22 642 2673
Email: [email protected]

France Portugal
BIOCODEX Italfarmaco, Produtos Farmacêuticos, Lda.
Tél: +33 (0)1 41 24 30 00 Tel: +351 214 342 530
Email: [email protected] Email: [email protected]

Hrvatska România
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
Email: [email protected] Email: [email protected]

Ireland Slovenija
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
Email: [email protected] Email: [email protected]

Ísland Slovenská republika
Vistor hf. RAD Neurim Pharmaceuticals EEC SARL
Tel: +354 535 7000 Tel: +33 185149776 (FR)
Email: [email protected]

Italia Suomi/Finland
Fidia Farmaceutici S.p.A. Takeda Oy
Tel: +39 049 8232222 Puh/Tel: +358 20 746 5000
Email: [email protected]

Κύπρος Sverige
RAD Neurim Pharmaceuticals EEC SARL Takeda Pharma AB
Tel: +33 185149776 (FR) Tel: +46 8 731 28 00
Email: [email protected] Email: [email protected]

Latvija United Kingdom (Northern Ireland)
RAD Neurim Pharmaceuticals EEC SARL RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR) Tel: +33 185149776 (FR)
Email: [email protected] Email: [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu