VERAPAMIL MYLAN 80 verapamil hydrochloride 80mg tablet HDPE bottle

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Osta se nyt

Pakkausseloste Pakkausseloste (PIL)
24-08-2020
Valmisteyhteenveto Valmisteyhteenveto (SPC)
24-08-2020

Aktiivinen ainesosa:

verapamil hydrochloride

Saatavilla:

Alphapharm Pty Ltd

Valtuutuksen tilan:

Registered

Pakkausseloste

                                VERAPAMIL MYLAN
_contains the active ingredient verapamil hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Verapamil Mylan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Verapamil Mylan
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT VERAPAMIL MYLAN
IS USED FOR
Verapamil Mylan tablets are used to
treat:
•
high blood pressure, also called
hypertension
•
angina (chest pain)
•
some types of arrhythmias
(irregular heartbeats).
Verapamil Mylan belongs to a group
of medicines called calcium
antagonists or calcium channel
blockers. These medicines work by
opening up blood vessels, causing
blood pressure to fall and letting
more blood and oxygen reach the
heart. Calcium channel blockers also
help control an irregular heartbeat.
Verapamil Mylan does not change
the amount of calcium in your blood
or bones. Calcium in your diet or in
calcium supplements will not
interfere with the way Verapamil
Mylan works.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VERAPAMIL MYLAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE VERAPAMIL MYLAN IF
YOU HAVE AN ALLERGY TO:
•
medicines containing verapamil
hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue
or other parts of the body
•
Rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE:
•
low blood pressure (hypotension)
•
certain 
                                
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Valmisteyhteenveto

                                AUSTRALIAN PRODUCT INFORMATION
VERAPAMIL MYLAN
_Verapamil hydrochloride tablet_
_ _
1
NAME OF THE MEDICINE
Verapamil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verapamil hydrochloride is a calcium ion influx inhibitor (slow
channel blocker or calcium ion antagonist).
Each tablet contains 40 mg or 80 mg of verapamil hydrochloride as the
active ingredient.
Excipients with known effect: sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Verapamil hydrochloride is a white or almost white, odourless,
crystalline powder.
VERAPAMIL MYLAN 40 mg is available as a pale yellow, film coated
tablet, marked “VL/40” on one side,
“G” on the other.
VERAPAMIL MYLAN 80 mg tablet is available as a orange/yellow, film
coated tablet, marked “VL/80” on one
side, “G” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Hypertension
•
Angina of effort
•
Angina at rest
•
Vasospastic angina (including Prinzmetal's variant angina)
•
Tachyarrhythmias including paroxysmal supraventricular tachycardia
•
Atrial fibrillation and atrial flutter with rapid ventricular
response.
4.2
DOSE AND METHOD OF ADMINISTRATION
The individual dose and frequency of dosing should be determined in
accordance with the indication and
individual patient response.
ADULTS
The usual starting dose is one 80 mg tablet two or three times daily.
The maintenance dose may be adjusted to
two 80 mg tablets two or three times daily.
Usual maintenance dose: 160 mg twice daily.
CHILDREN
Dose range 40 to 360 mg per day in two or three divided daily doses
according to age and response.
VERAPAMIL MYLAN – PRODUCT INFORMATION
2
ELDERLY, IMPAIRED RENAL FUNCTION
The recommended daily dosage is usually well tolerated.
IMPAIRED HEPATIC FUNCTION
Caution should be exercised when initiating therapy since the
pharmacological action of verapamil hydrochloride
may be increased or prolonged by hepatic insufficiency.
4.3
CONTRAINDICATIONS
Verapamil HCl is contraindicated in:
•

                                
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