SOTACOR 80MG TABLETS

Active substance: SOTALOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
The dose may be taken either as a single dose or in two divided doses. You can check with the doctor
or pharmacist if you are not sure.
For the first few weeks after you start your Sotacor treatment your doctor will need to see you regularly
to check on your response and may need to adjust the dose to one that suits you.

PATIENT INFORMATION LEAFLET

Sotacor 80 mg Tablets
Sotalol hydrochloride

Sotacor is not recommended for use in children.

Please read this leaflet carefully before you are given your medicine
This leaflet provides a summary of the information available on your medicine
Keep this leaflet. You may need to read it again.
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 you want to know more or are not sure ask your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

l

If you take more Sotacor than you should

l

If you take too many tablets contact your doctor or go to your nearest hospital emergency treatment
immediately and take the tablets and leaflet with you.

l

l

If you forget to take Sotacor

l

If you forget to take a dose, do not worry, just take it as soon as you remember unless it is nearly time
for your next dose then you should miss the forgotten dose and continue as before. Do not take a
double dose to make up for the forgotten dose.

4. Possible side effects
Like all medicines Sotacor can cause unwanted effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following symptoms swelling of the face, lips,
tongue and/or throat with difficult in swallowing or breathing. These may be signs of an allergic
reaction and the tablets will be stopped.
Side effects seen with Sotacor tablets (affecting more than 1 in 100 patients) include the following:
Irregular heartbeat, slow heart beat, heart failure, chest pain, low blood pressure, difficulty in breathing,
swelling, fainting and palpitations.
Nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhoea, cramps.
Anxiety depression, mood changes, headache, light-headedness, dizziness, general weakness,
tiredness, problems with vision, sleeping, tingling in feet and hands (pins and needles).
Sexual dysfunction, fever, rash, hearing problems, problems with vision, changes in the way things
taste.
Patients taking this type of medicine have complained of cold and/or blue fingers and toes, worsening
of aches in their legs when walking, skin rash or dry eyes.
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 immediately. It will help if you make a note of what you experienced,
when it started and how long it lasted.

In this leaflet:
1. What Sotacor tablets are and what they are used for
2. Before you take your medicine
3. Taking your medicine
4. Possible side effects
5. How to store your medicine
6. Further Information

l

1. What SOTACOR tablets are and what they are used for

l
l

l

The name of this medicine is Sotacor tablets. Each tablet contains 80mg of sotalol hydrochloride as
the active ingredient.
Sotacor tablets belong to a group of drugs called beta-adrenergic blocking agents or “Beta-Blockers.”
Sotacor tablets are used to treat irregular heartbeats.

2. Before you take your medicine
Do not take this medicine if you:
l
l

5. How to store your medicine

l
l

Do not store the tablets above 25°C.
Store in the original packaging to protect from light.
Please check the expiry date of the product, shown on the blister foil and carton and do not use after
the month stated.

l
l

l

Keep your medicines out of the reach and sight of children.
If you are told to stop taking this medicine, return any unused tablets to your pharmacist.

6. Further Information
What Sotacor tablets contain
The active ingredient in Sotacor tablets is sotalol hydrochloride 80 mg. The other ingredients are:
colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline
cellulose and stearic acid.

What Sotacor tablets look like and contents of the pack
Sotacor 80mg tablets are white in colour, round, biconvex, with a break bar on each side. The tablets
are supplied in blister packs of 14 a strip, or 10 a strip, and come in packs containing 28 0r 30 tablets,
respectively.

Pag. 3

l
l

Are allergic to any of the ingredients in Sotacor.
Suffer from asthma, attacks of wheezing or any other lung disease.
Have a very slow heart beat or low blood pressure.
Suffer from a condition causing discoloration (white or purple) of the hands and feet (Raynaud’s
syndrome).
Suffer from any severe circulation disorders.
Have suffered from heart disease (such as untreated heart failure) or had a recent heart attack that
your doctor dose not know about.
Suffer from a condition called metabolic acidosis.
Suffer from an untreated tumour of the adrenal gland
Suffer from kidney failure.

If you are affected by any of the above you should tell your doctor before taking this medicine. Your
doctor may wish to check the level of potassium and magnesium in your blood before you start taking
Sotacor. Patients with low levels should not take Sotacor tablets.
Regular blood tests may be required during your treatment with Sotacor.
Sotacor is not recommended for use in children.

You must tell your doctor if you:
l
l
l

Are pregnant, planning to become pregnant or are breastfeeding.
Have any kidney problems, as your dose of Sotacor may need to be changed.
Suffer from diabetes, as it may be necessary to change the dose of insulin or any other medicines
you take to treat your diabetes. Sotacor may also hide or reduce the warning signs of low levels of

Pag. 1

l

l

l

sugar in your blood (hypoglycaemia).
Have an overactive thyroid, as Sotacor can hide the symptoms or make them worse if treatment
with Sotacor is stopped suddenly.
Suffer from, or have recently suffered from diarrhoea, or if you have recently had severe diarrhoea,
or an attack that lasted a long time. This is because it can affect the levels of potassium and
magnesium in the body, and you may not be able to take Sotacor.
Suffer from psoriasis (a skin disease that causes itchy, red, sore patches of skin).

If any of the above applies to you, tell your doctor before you take the tablets.

If you are due to have surgery
You should tell the doctor or anaesthetist that you are taking Sotacor as it can affect anaesthetics. You
may have to stop taking Sotacor before surgery and it should be gradually stopped over a period of
one week. Your doctor will tell you if this is necessary.

Marketing Authorisation Holder and Manufacturer
Manufactured by:
Emcure Pharmaceuticals Limited
P-2, I.T.B.T. Park
Phase II, MIDC
Hinjwadi
Pune 411057, India
Marketing Authorisation Holder:
UK
Bristol-Myers Squibb Holdings Limited
t/a Bristoly-Myers Pharmaceuticals
Uxbridge Business Park
Sanderson Road, Uxbridge
Middlesex UB8 1DH, United Kingdom

Eire
Bristol-Myers Squibb Holdings Limited
t/a Bristol-Myers Pharmaceuticals
Swords
County Dublin
Ireland

Taking Sotacor tablets with other medicines
Always tell your doctor about other medicines you may be taking or have recently taken including those
obtained without a prescription. Some medicines can have an effect on each others action.
It is especially important that you tell your doctor if you are taking medicines for:
High blood pressure, heart failure or an irregular heartbeat (eg digoxin, amiodarone, verapamil)
Diabetes (eg metformin or insulin)
Asthma and other diseases of the lung (eg ventolin inhalers)
Depression, anxiety, nervous disorders and mental disturbances (eg methyldopa)
Allergies such as hayfever (eg antihistamines)

Last revised: March 2011

l
l
l
l
l

Or if you are taking:
A medicine called clonidine (sometimes used to treat hot flushes or headaches).
Steroids
Laxatives
Antibiotics
Water tablets (diuretics)
l
l
l
l
l

Pregnancy and Breastfeeding
Make sure you tell your doctor if you are pregnant or planning to become pregnant. You should not be
given Sotacor tablets during pregnancy unless your doctor thinks it is essential.
You should not breatfeed while you are being treated with Sotacor tablets.

Taking with Food and Drink
Moderate amounts of alcohol will not affect Sotacor, however you should check with your doctor first
to see if drinking is advisable for you.

Driving or operating machinery
Sotacor does not usually affect your ability to drive. However, if you feel light-headed or dizzy, do not
drive or operate machinery.

Important information about some of the ingredients in Sotacor
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.

3. How to take your medicine
Always take Sotacor exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. Do not stop taking Sotacor without consulting your doctor.
The usual daily dose is between 80 mg and 320mg. Some patients may need up to 640mg a day or
sometimes the doctor may prescribe a different dose from these. Lower doses are often used for elderly
patients or those with kidney disease.
Tablets should be swallowed whole with a glass of water and can be taken with or without food.

510230041IN03
RT01

Pag. 2

Pag. 4

BACK

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)