CLONIDINE HYDROCHLORIDE 25 Microgram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-09-2016
Summary of Product characteristics
(SPC)
15-09-2016
Active ingredient:
CLONIDINE HYDROCHLORIDE
Available from:
Auden Mckenzie (Pharma Division) Ltd
ATC code:
N02CX02
INN (International Name):
CLONIDINE HYDROCHLORIDE
Dosage:
25 Microgram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other antimigraine preparations
Authorization status:
Transfer Pending
Authorization date:
2008-12-12
Patient Information leaflet
1
DCP: UK/H/1448/001/DC
PACKAGE LEAFLET
2
PATIENT INFORMATION LEAFLET
/…/
25 MICROGRAM TABLETS
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.
DO NOT PASS IT ON TO OTHERS. IT MAY
HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS
YOURS.
IF ANY OF THE SIDE EFFECTS BECOME SERIOUS, OR IF YOU NOTICE
ANY SIDE EFFECTS NOT LISTED IN THIS
LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET:
1. What is /…/ and what is it used for?
2. Before you take /…/ 25 microgram Tablets
• _Do not take _/…/ _25 microgram Tablets… _
• _Other things to do or know before you
take the tablets _
• _Taking other medicines _
• _Pregnancy and breast feeding _
• _Driving and using machines _
• _Important information
about some of the ingredients in _/…/ _25 microgram Tablets _
_ _
3. How to take /…/ 25 microgram Tablets
• _Usual recommended dose _
• _If you forget to take a dose _
• _If you take too many tablets _
_ _
4. Possible side effects
5. How to store /…/ 25 microgram Tablets
6. Further information
1. WHAT IS /…/ AND WHAT IS IT USED FOR?
/…/ 25 microgram Tablets belong to a group
of medicines called ‘vasodilators’, which cause
widening of the blood vessels and therefore an increase in blood
flow.
Your doctor has prescribed /…/ 25
microgram Tablets for you to prevent attacks of migraine
and similar types of headache. The tablets are
also used to prevent hot flushes that may occur
in women during the menopause (‘change of life’).
2. BEFORE YOU TAKE /…/ 25 MICROGRAM TABLETS
DO NOT TAKE /…/ 25 MICROGRAM TABLETS:
• if you t
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonidine Hydrochloride 25 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clonidine hydrochloride 25 micrograms.
_Excipients:_
Clonidine Hydrochloride 25 microgram Tablets contain 48 mg lactose monohydrate per tablet.
For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white circular tablet, engraved with ‘CD 25’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
a) The prophylactic management of migraine or recurrent vascular headache.
b) The management of vasomotor conditions commonly associated with the menopause and characterised by flushing.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults over 18 years:_
Initially 2 tablets twice daily. If after two weeks there has been no remission, increase to 3 tablets twice daily.
The duration of treatment depends upon the severity of the condition.
If symptoms continue to occur the patient should be informed that it may take 2 - 4 weeks until Clonidine
Hydrochloride 25 microgram Tablets are fully effective.
_Children and Adolescents:_
There is insufficient information for the application of Clonidine in children and adolescents younger than 18 years.
Therefore the use of Clonidine is not recommended in paediatric subjects under 18 years.
_Elderly:_
No specific information on the use of this product in the elderly is available.
_PATIENTS WITH RENAL IMPAIRMENT_
Clonidine Hydrochloride should be used with caution in patients with renal insufficiency. Careful monitoring of blood
pressure is required.
4.3 CONTRAINDICATIONS
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/08/2016_
_CRN 2179813_
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