Sotacor 80mg tablets

Main information

  • Trade name:
  • Sotacor 80mg tablets
  • Dosage:
  • 80mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Sotacor 80mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02040000; GTIN: 5012712005308 5012712004080

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 11184/0144
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the patient

Sotacor 80 mg Tablets

Sotalol hydrochloride

Read all of this 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.

What is in this leaflet:

1.

What SOTACOR is and what it is used for

2.

What you need to know before you take SOTACOR

3.

How to take SOTACOR

4.

Possible side effects

5.

How to store SOTACOR

6.

Contents of the pack and other information

1. What SOTACOR is and what it is used for

The name of this medicine is Sotacor . Each tablet contains 80 mg of sotalol hydrochloride as the active

ingredient.

Sotacor belongs to a group of drugs called beta-adrenergic blocking agents or “beta-blockers.”

Sotacor is used to treat irregular heartbeats.

2. What you need to know before you take SOTACOR

Do not take SOTACOR:

if you are

allergic

to sotalol hydrochloride or

any of the other ingredients in this medicine (listed in section

if you suffer from

asthma

, attacks of wheezing or any other lung disease.

if you have a very slow heart beat or

low blood pressure

if you suffer from a condition causing discolouration (white or purple) of the hands and feet (Raynaud’s

syndrome).

if you suffer from any severe

circulation disorders

if you have suffered from

heart disease

(such as untreated heart failure) or had a recent heart attack that your

doctor does

not know about.

if you suffer from a condition called

metabolic acidosis

if you suffer from an untreated tumour of the adrenal gland

if you suffer from

kidney failure

If you are affected by any of the above you should tell your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sotacor.

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.

Regular blood tests may be required during your treatment with Sotacor.

You must tell your doctor:

if you are

pregnant

, planning to become pregnant or are breast-feeding.

if you have any

kidney problems

, as your dose of Sotacor may need to be changed.

if you 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 sugar in your

blood (hypoglycaemia).

if you have an

overactive thyroid

, as Sotacor can hide the symptoms or make them worse if treatment with

Sotacor is stopped suddenly.

if you 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.

if you suffer from

psoriasis

(a skin disease that causes itchy, red, sore patches of skin).

if you suffer from liver problems

If you need 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.

Children

Sotacor is

not recommended

for use in children.

Other medicines and SOTACOR

Tell your doctor if you are taking , have recently taken or might take any other medicines, including those

obtained without a prescription. Some medicines can have an effect on each others actions.

It is especially important that you tell your doctor if you are taking the following medicines:

for the treatment of high blood pressure, heart failure or an irregular heartbeat (e.g. digoxin, amiodarone,

verapamil)

floctafenine (medicine used for the short term treatment of mild to moderate pain)

for the treatment of cert

ain infections

(e.g.

amphotericin B, pentamidine, halofantrine)

steroids

laxatives

clonidine (sometimes used to treat hot flushes or headaches)

for the treatment of hypertension (e.g. reserpine, guanethidine or alpha methyldopa)

for the treatment of diabetes (e.g. metformin or insulin)

for the treatment of asthma and other diseases of the lung (e.g. ventolin inhalers)

for depression, anxiety, nervous disorders and mental disturbances (e.g. methyldopa)

for allergies such as hay fever (e.g. antihistamines)

antibiotics

water tablets (diuretics)

SOTACOR with food, drink and alcohol

Moderate amounts of alcohol will not affect Sotacor, however you should check with your doctor first to see if

drinking is advisable for you.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine

. You should not be given Sotacor during pregnancy unless your doctor

thinks it is essential.

You should not breastfeed while you are being treated with Sotacor.

Driving and using machines

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

operate machinery.

SOTACOR 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 SOTACOR

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

Adults

The recommended daily dose is between 80 mg and 320 mg. Some patients may need up to 640 mg 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.

The dose may be taken either as a single dose or in two divided doses. Check with your 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.

Children

Sotacor is

not recommended for use in children.

If you take more SOTACOR than you should

take

many

tablets contact

your doctor

go to

your

nearest hospital

emergency

department

immediately

and take the tablets and leaflet with you.

If you forget to take SOTACOR

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 a forgotten dose.

If you stop taking SOTACOR

Do not stop taking Sotacor without consulting your doctor. 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 immediately if you get any of the following symptoms: swelling of the face, lips, tongue

and/or throat with difficulty in swallowing or breathing. These may be signs of an allergic reaction and the

tablets will be stopped.

Side effects seen with Sotacor (affecting more than 1 in 100 patients) include the following:

irregular heartbeat, slow heartbeat, 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in

this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

37TU

www.mhra.gov.uk/yellowcard

U37T

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SOTACOR

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the foil blister and carton. The expiry date refers

to the last day of that month

Do not store the tablets above 25°C.

Store in the original package to protect from light.

If you are told to stop taking this medicine, return any unused tablets to your pharmacist.

Do not throw away any

medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer

use. These measures will help protect the environment.

6. Content of the pack and other information

What SOTACOR contains

The active substance is sotalol hydrochloride. Each tablet contains 80 mg sotalol hydrochloride.

The other ingredients are:

colloidal anhydrous silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose and

stearic acid.

What SOTACOR looks like and contents of the pack

Sotacor 80 mg 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 or 30 tablets, respectively.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bristol-Myers Squibb Pharmaceuticals Limited

Uxbridge Business Park

Sanderson Road, Uxbridge

Middlesex UB8 1DH, United Kingdom

Ireland

Bristol-Myers Squibb Holdings Limited

t/a Bristol-Myers Pharmaceuticals,

Swords,

County Dublin, Ireland.

Manufactured by:

FARMEA

10 rue Bouché Thomas

ZAC d’Orgemont

49000 Angers

France

This leaflet was last revised in October 2017