Amlodipine Thame 10mg/5ml Oral Solution

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Amlodipine Besilate

제공처:

SYRI Limited, t/a Thame Laboratories

ATC 코드:

C08CA; C08CA01

INN (국제 이름):

Amlodipine Besilate

복용량:

10 mg/5ml

약제 형태:

Oral solution

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Dihydropyridine derivatives; amlodipine

승인 상태:

Not marketed

승인 날짜:

2015-08-21

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE THAME 10MG/5ML ORAL SOLUTION
(amlodipine)
READ ALL OF THESE 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.
The name of your medicine is Amlodipine Thame 10mg/5ml Oral Solution
but it will be referred to as
Amlodipine throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Amlodipine is and what it is used for
2. What you need to know before you take Amlodipine
3. How to take Amlodipine
4. Possible side effects
5. How to store Amlodipine
6. Contents of the pack and other information
1.
WHAT AMLODIPINE IS AND WHAT IT IS USED FOR
Amlodipine contains the active substance amlodipine which belongs to a
group of medicines called
calcium antagonists.
Amlodipine is used to treat high blood pressure (hypertension) or a
certain type of chest pain called
angina, a rare form of which is Prinzmetal’s or variant angina.
In patients with high blood pressure your medicine works by relaxing
blood vessels, so that blood
passes through them more easily. In patients with angina amlodipine
works by improving blood supply
to the heart muscle which then receives more oxygen and as a result
chest pain is prevented. Your
medicine does not provide immediate relief of chest pain from angina.
You must talk to your doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE
DO NOT TAKE AMLODIPINE IF:

You are allergic to amlodipine or any of the other ingredients of this
medicine (listed in section 6) or
to any other calcium antagonists. This may be itching,

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Thame 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine Thame Oral Solution contains the active ingredient,
amlodipine (as amlodipine besilate).
Each 5ml of oral solution contains 10mg amlodipine.
Each ml of oral solution contains 2mg amlodipine.
_Excipients with known effect:_
Each 5ml of oral solution contains 3mg methyl parahydroxybenzoate
(E218) and 5.5g of glycerol (E422).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
A clear, greenish yellow coloured solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal's) angina
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
For oral use.
Measure the prescribed dose from the 2.5-5ml double ended spoon
provided in the pack.
Posology
_Adults_
For both hypertension and angina the usual initial dose is 5mg
(2.5ml).
Amlodipine Thame once daily which may be
increased to a maximum dose of 10mg (5ml) depending on the individual
patient's response.
The higher strength Amlodipine Thame 10mg/5ml Oral Solution is
recommended for use in adults, or when higher
doses are prescribed.
In hypertensive patients, Amlodipine Thame has been used in
combination with a thiazide diuretic, alpha blocker, beta
blocker, or an angiotensin converting enzyme inhibitor. For angina,
Amlodipine Thame may be used as monotherapy
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