Catapres Tablets 100 micrograms

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

CLONIDINE HYDROCHLORIDE

から入手可能:

Boehringer Ingelheim Limited

ATCコード:

C02AC; C02AC01

INN（国際名）:

CLONIDINE HYDROCHLORIDE

投薬量:

0.1 milligram(s)

医薬品形態:

Tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Imidazoline receptor agonists; clonidine

認証ステータス:

Marketed

承認日:

1979-04-01

情報リーフレット

xxxxxx-xxx
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
• 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 gets
troublesome or serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What CATAPRES Tablets are and what
they are used for
2. Before you take CATAPRES Tablets
3. How to take CATAPRES Tablets
4. Possible side effects
5. How to store CATAPRES Tablets
6. Further information
1.
WHAT CATAPRES TABLETS ARE AND
WHAT THEY ARE USED FOR
CATAPRES Tablets contain a medicine
called clonidine. This belongs to a group
of medicines called antihypertensives.
CATAPRES is used to lower high blood
pressure (to treat hypertension).
2.
BEFORE YOU TAKE CATAPRES
TABLETS
DO NOT TAKE CATAPRES IF:
• You are pregnant, likely to get pregnant
or are breast-feeding
• You are allergic (hypersensitive) to
clonidine or any of the other
ingredients of CATAPRES (see section
6: Further information)
• You have a slow heart rate due to heart
problems
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
using CATAPRES.
TAKE SPECIAL CARE WITH CATAPRES
Check with your doctor or pharmacist
before taking CATAPRES if:
• You have Raynaud’s disease (a problem
with circulation to the fingers and toes)
or other blood circulation problems,
including circulation to the brain
• You have heart or kidney problems
• You have or have ever had depression
• You have constipation
• You have a nerve disorder that causes
your hands and feet to feel different
(‘altered sensation’) or low blood
pressure when you stand up
If you are not sure if any of the above
apply to you, talk to your doctor

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Catapres Tablets 100 micrograms.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains clonidine hydrochloride 100 micrograms.
For excipients see 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, round, flat, bevel-edged tablets impressed with the motif
01C on one side and the Boehringer Ingelheim
symbol on the reverse.
01C
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Catapres tablets are indicated for the treatment of hypertension that
has failed to respond adequately to other anti-
hypertensives.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults only:
The usual initial dosage is 0.05 to 0.10 mg three times daily with
subsequent gradual increments to the level of optimal
control generally in the daily dose range of
0.3 to 1.2 mg in divided doses although higher levels may be required.
Should clonidine be added to other anti-hypertensive therapy dosage of
the latter should be gradually reduced as the
clonidine is introduced.
Patients undergoing anaesthesia should continue their Catapres
treatment before, during and after anaesthesia using oral
or intravenous administration according to individual circumstances.
_PAEDIATRIC POPULATION:_
There is insufficient evidence 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.
_RENAL INSUFFICIENCY:_
Dosage must be adjusted
- according to the individual antihypertensive response which can show
high variability in patients with renal
insufficiency
- according to the degree of renal impairment
4.3 CONTRAINDICATIONS
Catapres should not be used in children (please refer to section 4.4
Special Warnings and Precautions for Use) or 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
block of 2nd or 3rd degree.
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