Sotalol 40mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sotalol 40mg Tablets
(sotalol hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass It on to others. It may harm them, even If their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Sotalol Tablets are and what are they used for
2. What you need to know before you take Sotalol Tablets
3. How to take Sotalol Tablets
4. Possible side effects
5. How to store Sotalol Tablets
6. Contents of the pack and other information
1. WHAT SOTALOL TABLETS ARE AND WHAT ARE THEY USED FOR
Sotalol is a 6-adrenoceptor blocker and is used in the treatment of irregular heart beats. These can be cause by the lower heart chambers (Ventricular arrhythmia) or the upper hearts chambers (atrial or superventricular arrhytmias).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS
Do not take Sotalol Tablets if you:
• are allergic (hypersensitive) to or any of the other ingredients in the product (see Section 6)
• suffer from kidney failure or have untreated tumour near your kidney (phaechromocytoma).
• have a history of breathing difficulties due to a narrowing of the airways (bronchospasm)
• suffer from low blood pressure or circulation failure.
• suffer from metabolic acidosis or diabetic ketoacidosis.
• have circulatory problems (e.g. Raynauld's disease)
• suffer from very slow heart beat (bradycardia) including sick sinus syndrome, or long QT interval.
• have a particular heart beat disturbance called Torsade de pointes or heart block.
• have uncontrolled heart failure or Prinzmetal's angina (a form of unstable angina)
• are being treated with verapamil injection
Warning and precautions
Please tell your doctor before you start to take your tablets if you:
• have a history of allergy reaction
• suffer from kidney or liver disease.
• have disturbed salt and water balance (including low potassium or
magnesium)
• are diabetic or have a history of episodes of low blood sugar.
• have any thyroid problem.
• are suffering from psoriasis (a skin condition).
• are scheduled to have a surgery.
• are scheduled to have a urine analysis
• suffer from myasthenia gravis (muscle weakness)
Other medicines and Sotalol
Consult your doctor or pharmacist before starting Sotalol Tablets if you are taking or have recently been taking any of the following medicines:
• Anti-arrhythmic drugs e.g. disopyramide, quinidine, procainamide, amiodarone and bepridil.
• Drug that prolongs QT interval (a type of change in ECG) e.g. phenothiazines or tricyclic antidepressants; terfenadine, astemizole, erythromycin, halofantrine, pentamidine and quinolone antibiotics.
• A medicine called floctafenine.
• Calcium channel blockers e.g. verapamil and diltiazem.
• Diuretics (water tablet), corticosteroids, amphotericin IV and some laxatives as these lower potassium levels.
• Clonidine used for hypertension.
• Digoxin or similar drugs.
• Insulin and other oral medicines for diabetes
• Tubacurarin a neuromuscular blocker.
• Beta-receptor stimulant drugs such as salbutamol (used in the treatment of asthma or emphysema).
Also inform your doctor or pharmacist if you are taking or have recently taken, any other medicine including those that you have bought without prescription.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant or planning to become pregnant. If you are taking Sotalol Tablets do not breast feed your baby and consult your doctor for further advice.
Driving and using machines
Sotalol is not known to have any effect on your ability to drive or use machines. But make sure that you are not having dizziness or fatigue before driving or operating machines.
3. HOW TO TAKE SOTALOL TABLETS
Always take Sotalol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will initiate your treatment with a small dose. Your heart beat and cardiac rhythm will be monitored closely. Your dose may be changed after monitoring your response to the treatment.
The following dose schedule can be recommended:
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Adults:
The initial dose is 80mg per day, administered either singly or as two divided doses. Your doctor may increase your dose gradually allowing 2-3 days between dosing increments.
The most commonly used dosage range is a daily dose of 160 to 320 mg in two divided doses at 12 hours interval.
Some patients may require a daily dose as high as 480-640mg/day. Take your tablets at the same time every day.
Children:
This medicine is not recommended for children.
Patients with kidney problems:
Patients with kidney problems should consult their doctor for the correct dosage. If you take more Sotalol Tablets than you should
Do not take more tablets than your doctor tells you to. If you take too many, go to the nearest hospital casualty department taking the medicine with you or tell your doctor immediately. Take any tablets leftover with you and also the box, as this will allow easier identification of the tablets.
If you forget to take Sotalol Tablets
If you forget to take a dose of Sotalol Tablets, take it as soon as you remember. But if it is almost time for the next dose, do not double up on the dose.
If you stop taking Sotalol Tablets
Do not discontinue your tablets without consulting your doctor. Your doctor may reduce the dose before completely stopping the tablets.
Withdrawal symptoms may occur if Sotalol Tablets abruptly stopped including exacerbation of angina pectoris (a kind of chest pain), arrythmias and in some cases heart attack.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sotalol Tablets can cause side effects, although not everybody gets them. You may suffer an allergic reaction; if any of the following side effects come on soon after taking these tablets, stop the tablets and tell your doctor immediately:
• Sudden wheeziness or tightness in the chest
• Swelling of eyelids, face or lips; with or without a lumpy skin rash ("hives") anywhere on the body
• Unexplained fever
• Feeling faint, especially on standing up
Very common side effects (affecting more than 1 in 10 patients):
• irregular heart beat
• slow heartbeat (especially less than 50 beats per minute)
• abdominal pain
• shortness of breath
• dizziness
• upset stomach
Uncommon side effects (affecting between 1 in 100 to 1 in 1000 patients):
• chest pain
• palpitation
• fainting
• heart failure
• nausea and vomiting
• diarrhoea, wind or cramps
• light-headache
• sleep disturbance
• abnormal taste
• unusual tiredness or weakness
• decreased sexual ability
Rare side effects:
• dry eyes
• blurred vision
• numbness or tingling and/or blue fingers and toes Reporting of side effects
If any of these side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 the medicine
5. HOW TO STORE SOTALOL TABLETS
Keep this medicine out of the sight and reach of children Do not store above 25°C.
Store your tablets in the original package.
This medicine should not be used after the expiry date stated on the pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Sotalol Tablets contains
Each tablet contains sotalol hydrochloride 40mg.
Other ingredients are calcium hydrogen phosphate dihydrate, maize starch, povidone k30, sodium starch glycollate (type A), talc and magnesium stearate.
What Sotalol Tablets looks like and contents of the pack
Sotalol 40 mg Tablets are round, white to off-white, flat, bevelled-edged tablets. The tablets are available in blister packs of 28 and 56 tablets.
Marketing Authorisation Holder and Manufacturer
Milpharm Limited
Ares, Odyssey Business Park,
West End Road, South Ruislip, HA4 6QD, United Kingdom This leaflet was last revised in April 2015