Circadin 2mg modified-release tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Melatonin

Disponibil de la:

Flynn Pharma Ltd

Codul ATC:

N05CH01

INN (nume internaţional):

Melatonin

Dozare:

2mg

Forma farmaceutică:

Modified-release tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04010100; GTIN: 5702157141340 5060106551245

Prospect

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.
WHAT IS IN 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 CIRCADIN IS AND WHAT IT IS
USED FOR
The active substance of Circadin,
melatonin, belongs to a natural group
of hormones produced by the body.
Circadin is used on its own for the
short-term treatment of primary
insomnia (persistent difficulty in
getting to sleep or staying asleep, or
poor quality of sleep) in patients
aged 55 years and older. ‘Primary’
means that the insomnia does not
have any identified cause, including
any medical, mental or
environmental cause.
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
Talk to your doctor or pharmacist
before taking Circadin.
–
If you suffer from liver or kidney
problems. No studies on the use of
Circadin in people with liver or
kidney diseases have been
performed, you should speak to
your doctor before taking Circadin
as its use is not recommended.
–
If you have been told by your
doctor that you have an
intolerance to some sugars.
–
If you have been told you suffer
from an autoimmune disease
(where the body is ‘attacked’ by its
own immune system). No studies
on the use of Circadin in people
with auto-immune diseases hav

Caracteristicilor produsului

OBJECT 1
CIRCADIN
Summary of Product Characteristics Updated 07-Jun-2018 | Flynn Pharma
Ltd
1. Name of the medicinal product
Circadin 2 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 2 mg melatonin.
Excipient with known effect: each prolonged-release tablet contains 80
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
White to off-white, round, biconvex tablets
4. Clinical particulars
4.1 Therapeutic indications
Circadin is indicated as monotherapy for the short-term treatment of
primary insomnia characterised by
poor quality of sleep in patients who are aged 55 or over.
4.2 Posology and method of administration
Posology
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and
after food. This dosage may be
continued for up to thirteen weeks.
_Paediatric population_
The safety and efficacy of Circadin in children aged 0 to 18 years has
not yet been established.
No data are available.
_Renal impairment_
The effect of any stage of renal impairment on melatonin
pharmacokinetics has not been studied. Caution
should be used when melatonin is administered to such patients.
_Hepatic impairment_
There is no experience of the use of Circadin in patients with liver
impairment. Published data
demonstrates markedly elevated endogenous melatonin levels during
daytime hours due to decreased
clearance in patients with hepatic impairment. Therefore, Circadin is
not recommended for use in patients
with hepatic impairment.
Method of Administration
Oral use. Tablets should be swallowed whole to maintain prolonged
release properties. Crushing or
chewing should not be used to facilitate swallowing.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
Circadin may cause drowsiness. Therefore the product should be used
with caution if the effects of
drowsiness are likely to be associ