Propafenone 300mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Propafenone hydrochloride

Dostopno od:

A A H Pharmaceuticals Ltd

Koda artikla:

C01BC03

INN (mednarodno ime):

Propafenone hydrochloride

Odmerek:

300mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02030200

Navodilo za uporabo

medicine. If you or someone else swallows several of
these tablets all together, contact your doctor or nearest
hospital emergency department immediately. Always take
any tablets left over with you and also the box, as this will
allow easier identification of the tablets.
IF YOU FORGET TO TAKE PROPAFENONE HYDROCHLORIDE TABLETS
If you forget to take a dose, take it as soon as you remember.
If it is almost time for your next dose do not take a double
dose to make up for a forgotten dose, just carry on as before.
IF YOU STOP TAKING PROPAFENONE HYDROCHLORIDE TABLETS
It is important that you keep taking these tablets until
your doctor tells you to stop. Don’t stop just because you
feel better. If you stop taking the tablets without your
doctor’s advice, your condition may get worse.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
TELL YOUR DOCTOR OR PHARMACIST IMMEDIATELY IF YOU
EXPERIENCE ANY OF THE FOLLOWING:
•
a rash, itching or skin reddening or other signs of an
allergic reaction such as difficulty breathing. Although
these are rare, they can be serious.
•
yellowing of the skin and/or eyes, as these may be a
sign of liver problems
•
you start to bruise easily or if you develop a very sore throat
with a high fever, as in very rare cases, treatment may affect
the amount of white blood cells and platelets in the blood.
Other side effects with , propafenone hydrochloride
tablets may include:
Very Common side effects (occurring in more than 1 in 10 users):
•
Dizziness
•
Irregular (slow or fast) heart beat
•
Heart palpitations (being aware of your heart beat)
Common side effects (occurring in 1 to 10 users in 100):
•
Anxiety
•
Difficulty sleeping
•
Headache
•
Alteration of taste or a bitter taste
•
Blurred vision
•
Abnormal heart rhythm
•
Shortness of breath
•
Stomach pain
•
Feeling or being sick
•
Diarrhoea
•
Constipatio

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propafenone hydrochloride 300mg Film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300mg propafenone hydrochloride
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white, round, biconvex, film-coated tablets, with score
line on
one side and plain on the other side.
The tablet can be divided in to equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propafenone is indicated for the prophylaxis and treatment of
ventricular
arrhythmias.
Propafenone is also indicated for the prophylaxis and treatment of
paroxysmal
supraventricular
tachyarrhythmias
which
include
paroxysmal
atrial
flutter/fibrillation and paroxysmal re-entrant tachycardia’s
involving the AV
node or accessory bypass tracts, when standard therapy has failed or
is
contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that propafenone therapy should be initiated under
hospital
conditions, by a physician experienced in the treatment of
arrhythmias. The
individual
maintenance
dose
should
be
determined
under
cardiological
surveillance including ECG monitoring and blood pressure control. If
the QRS
interval is prolonged by more than 160msec or the PQ interval is
prolonged by
more than 20%, the dose should be reduced or discontinued until the
ECG
returns to normal limits._ _
_ADULTS_
Initially, 150 mg three times daily increasing at a minimum of
three-day
intervals to 300 mg twice daily and if necessary, to a maximum of 300
mg
three times daily.
The tablets should be swallowed whole and taken with a drink after
food. A
reduction in the total daily dose is recommended for patients below 70
kg
bodyweight.
_ _
_ELDERLY _
No overall differences in safety or effectiveness were observed in
this patient
population, but greater sensitivity of some older individuals cannot
be ruled
out, therefore, these patients should be carefully monitored.
Treatment should
be initiate