Patient leaflet - SOTACOR 80 MG TABLETS
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.
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1. What SOTACOR is and what it is used for
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2. What you need to know before you take SOTACOR
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3. How to take SOTACOR
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4. Possible side effects
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5. How to store SOTACOR
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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
S Do not take SOTACOR:
- ™ if you are allergic to sotalol hydrochloride or any of the other ingredients in this medicine (listed in ““““ section 6).
- 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 certain 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
If you take too many tablets contact your doctor or 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: www. mhra.gov.uk/yellowcard.
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:
Neon Healthcare Limited
8 The Chase, John Tate Road,
Hertford,
SG13 7NN
United Kingdom
Manufactured by:
FARMEA
10 rue Bouche Thomas
ZAC d’Orgemont
49000 Angers
France
This leaflet was last revised in September 2021
90001798/13