Clonidine (Teva)

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Clonidine hydrochloride 25ug

Saadav alates:

Teva Pharma (New Zealand) Limited

INN (Rahvusvaheline Nimetus):

Clonidine hydrochloride 25 µg

Annus:

25 mcg

Ravimvorm:

Tablet

Koostis:

Active: Clonidine hydrochloride 25ug Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified talc Sodium starch glycolate

Ühikuid pakis:

Blister pack, PVC/Al, 112 tablets

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

PCAS Finland Oy

Näidustused:

The prophylactic management of migraine or recurrent vascular headaches in adult patients. The management of vasomotor conditions commonly associated with the menopause and characterised by flushing.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 112 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2012-07-12

Infovoldik

CONSUMER MEDICINE INFORMATION
CLONIDINE (TEVA)
Clonidine hydrochloride 25 microgram tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Clonidine
(Teva).
This leaflet answers some common questions about Clonidine (Teva). It
does
not contain all the available information. The most up-to-date
Consumer
Medicine Information can be downloaded from www.medsafe.govt.nz.
Reading this leaflet does not take the place of talking to your doctor
or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of
you taking Clonidine (Teva) against the benefits this medicine is
expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT CLONIDINE (TEVA) IS USED FOR
Clonidine (Teva) contains a medicine called clonidine. This belongs to
a
group of medicines called vasodilators. Vasodilators widen the blood
vessels
and this helps the blood to flow more easily.
Clonidine (Teva) tablets are used to prevent migraine attacks and
similar
types of headache. It is also used to prevent hot flushes that may
occur in
women during the menopause (change of life).
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Clonidine (Teva) is available only with a doctor's prescription.
Clonidine (Teva) is not addictive.
BEFORE YOU TAKE CLONIDINE (TEVA)
Clonidine (Teva) is not suitable for everyone.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CLONIDINE (TEVA) IF YOU:
•
you
are
allergic
to
any
medicine
containing
clonidine
or
any
of
the
ingredients listed at the end of this leaflet
•
you have certain heart problems, such as irregular/slow heartbeat
•
you are already taking other medicines that contain clonidine.
DO NOT TAKE IT AFTER THE EXPIRY DATE (‘EXP.’ AS PER CARTON AND
BLISTER
PRINTED ON THE PACK.
If you take it after the expiry date has passed, it may not work

Toote omadused

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CLONIDINE (Teva) 25 microgram tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clonidine hydrochloride 25 micrograms.
Excipient with known effect:
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off-white circular tablet, engraved with ‘CD 25’ on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prophylactic management of migraine or recurrent vascular
headaches in adult patients.
The management of vasomotor conditions commonly associated with
menopause and characterised by
flushing.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
_Adults (including elderly patients) _
Therapy should be started with one tablet twice daily (morning and
evening).
If there is no relief after two weeks the dosage can be gradually
increased to 3 tablets twice daily.
Duration of treatment will depend on the frequency and severity of
attacks. It may take 2 - 4 weeks
until Clonidine (Teva) is fully effective.
Note: Clonidine (Teva) is not suitable for clearing acute migraine
headaches.
Special populations
_Renal impairment _
Clonidine should be used with caution in patients with renal
insufficiency. Careful monitoring of
blood pressure is required.
Paediatric population
The safety and efficacy of clonidine in children and adolescents have
not been established.
4.3
CONTRAINDICATIONS
Clonidine (Teva) should not be used in patients with known
hypersensitivity to the active ingredient
or other components of the product, and in patients with severe
bradyarrhythmia resulting from either
sick sinus syndrome or AV blocks of 2nd or 3rd degree.
In case of rare hereditary conditions that may be incompatible with an
excipient of the product (see
section 4.4 Special warnings and precautions for use) the use of the
product is contraindicated.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
At doses higher than those recommended above, clonidine is an
effective antihypertensive agent.
Caution should be observed