CIRCADIN 2 mg Extended-Release Tablet

Зміст інструкції

1. Circadin 2 mg prolonged-release tablets
   1. What is Circadin and what is it 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. Package contents and other information

Circadin 2 mg prolonged-release tablets

Melatonin

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Circadin and what is it used for

The active ingredient 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
falling asleep or staying asleep, or poor sleep quality), in patients aged 55 years and over. “Primary”
means that no cause has been identified for the insomnia, including a 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 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 have not been conducted on the use of Circadin in people with liver or kidney diseases; 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 certain sugars.
• if you have been told that you suffer from an autoimmune disease (in which the body is “attacked” by its own immune defenses). Studies have not been conducted on Circadin in people with autoimmune diseases, therefore talk to your doctor before taking Circadin, as its use is not recommended.
• Circadin may cause drowsiness; be careful if you experience drowsiness, as this may impair your ability to perform activities such as driving.
• Smoking may reduce the effectiveness of Circadin, as components of tobacco smoke are able to increase the transformation of melatonin by the liver.

Children and adolescents
Do not give this medicine to children between 0 and 18 years of age, as it has not been
tested and its effects are unknown. In children between 2 and 18 years of age, it may be more
appropriate to administer another medicine containing melatonin; ask your doctor or
pharmacist for advice.

Other medicines and Circadin
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, e.g. psoriasis (red and scaly patches of 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).
• Agonists/antagonists adrenergic (such as some types of medicines used to control blood pressure by narrowing blood vessels, nasal decongestants, medicines to lower blood pressure), agonists/antagonists of opioids (such as medicines used to treat drug addiction), inhibitors of prostaglandins (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 are pregnant or are planning a pregnancy, or if
you are breastfeeding. Ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
Circadin may cause drowsiness. In this case, you should not drive or use machines. 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, talk to your doctor before taking this medicine.

3. How to take Circadin

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

If you take more Circadin than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or
pharmacist as soon as possible.
If you have taken a dose of medicine higher than 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, before bedtime, or wait
until it is time to take the next dose, then continue as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Circadin
No adverse effects are known in case of interruption or premature discontinuation of treatment. No
withdrawal symptoms of Circadin are known after completion of therapy.
If you have any further questions on 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 everyone will experience them.
If you suffer from any of the following serious side effects, stop taking the medicine and
immediatelyconsult your doctor:

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
• Vision impairment (including reduced vision)
• Blurred vision
• Disorientation
• Dizziness (feeling of spinning)
• Presence of red blood cells in the urine
• Reduced number of white blood cells in the blood
• Reduced platelets, resulting in increased bleeding or bruising
• Psoriasis (red, scaly patches of skin)

If any of the following non-serious side effects occur, consult 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 the extremities, menopause symptoms, feeling of weakness,
presence of glucose in the urine, excess protein in the 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 levels of calcium
in the serum, low levels of sodium in the blood, mood alterations, aggressiveness, agitation, crying,
stress symptoms, early morning awakening, increased libido (increased sexual desire),
lowered mood, memory impairment, attention disorders, dreamy state, restless legs syndrome, poor sleep quality, sensation of tingling, increased tearing,
postural dizziness (dizziness when assuming an upright or seated position), hot flashes,
acid reflux, stomach disorders, ulcers in the mouth, ulcers on the tongue, stomach discomfort,
vomiting, intestinal noises, flatulence, excessive saliva production, bad breath,
abdominal pain, stomach upset, inflammation of the gastric mucosa, eczema, skin rash,
hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged erection which may be painful, inflammation of the prostate,
fatigue, pain, thirst, increased urine production, nocturia, 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 effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through
the national reporting system detailed in Annex V. By reporting side effects you can
contribute to providing 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 pack after EXP. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original package to protect
the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Circadin contains

• The active ingredient is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other ingredients are: ammonium methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, 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, of colour from
white to off-white. Each pack of tablets contains a blister strip with 7, 20 or 21 tablets or alternatively two blister strips of 15 tablets each (pack of 30 tablets). It is possible that
not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux
75002 Paris
France
e-mail: [email protected]
Manufacturer:
Responsible sites for Batch Release within 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, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Takeda Belgium
Tél/Tel: +32 2 464 06 11
e-mail: [email protected]

Lietuva
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

България
RAD Neurim Pharmaceuticals EEC SARL
Тел: +33 185149776 (FR)
e-mail: [email protected]

Luxembourg/Luxemburg
Takeda Belgium
Tél/Tel: +32 2 464 06 11 (BE)
e-mail: [email protected]

Česká republika
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Magyarország
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

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

Malta
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Deutschland
INFECTOPHARM Arzneimittel
und Consilium GmbH
Tel: +49 6252 957000
e-mail: [email protected]

Nederland
Takeda Nederland bv
Tel: +31 20 203 5492
e-mail: [email protected]

Eesti
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
e-mail: [email protected]

Ελλάδα
TAKEDA ΕΛΛΑΣ Α.Ε.
Τηλ: +30 210 6387800
e-mail: [email protected]

Österreich
SANOVA PHARMA GesmbH
Tel.: +43 (01) 80104-0
e-mail: [email protected]

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

Polska
MEDICE Arzneimittel Pütter GmbH & Co. KG
Tel.: + 48-(0)22 642 2673
e-mail: [email protected]

France
BIOCODEX
Tél: +33 (0)1 41 24 30 00
e-mail: [email protected]

Portugal
Italfarmaco, Produtos Farmacêuticos, Lda.
Tel. +351 214 342 530
e-mail: [email protected]

Hrvatska
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

România
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Ireland
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Slovenija
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Ísland
Vistor hf.
Simi: +354 535 7000

Slovenská republika
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

Italia
Fidia Farmaceutici S.p.A.
Tel: +39 049 8232222
e-mail: [email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: +358 20 746 5000

Κύπρος
RAD Neurim Pharmaceuticals EEC SARL
Τηλ: +33 185149776 (FR)
e-mail: [email protected]

Sverige
Takeda Pharma AB
Tel: +46 8 731 28 00
e-mail: [email protected]

Latvija
RAD Neurim Pharmaceuticals EEC SARL
Tel: +33 185149776 (FR)
e-mail: [email protected]

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