Sotalol 160mg tablets

Main information

  • Trade name:
  • Sotalol 160mg tablets
  • Dosage:
  • 160mg
  • 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:
  • Sotalol 160mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02040000

Status

  • Source:
  • eMC
  • Last update:
  • 29-01-2019

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sotalol 80mg Tablets

Sotalol 160mg 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 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.

In this leaflet:

What Sotalol Tablets are and what are they used for

What you need to know before you take Sotalol Tablets

How to take Sotalol Tablets

Possible side effects

How to store Sotalol Tablets

Contents of the pack and other information

1.

WHAT SOTALOL TABLETS ARE AND WHAT ARE THEY USED FOR

Sotalol belongs to a group of drugs called beta-adrenergic blocking agents or

"beta-blockers". Sotalol is used to treat irregular heartbeats. This can be caused

by the lower heart chambers (ventricular arrhythmia) or the upper heart chambers

(atrial or superventricular arrhythmias)

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS

Do not take Sotalol Tablets if you:

are allergic to sotalol hydrochloride or any of the other ingredients in this

medicine (listed in 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.

suffer from renal failure (creatinine clearance <10 ml/min)

suffer from a condition causing discolouration (white or purple) of the hands

and feet (Raynaud's syndrome)

suffer from very slow heart beat (bradycardia) including sick sinus syndrome,

or long QT interval.

are suffering from a second or third degree AV heart block unless a functioning

pacemaker is present

are suffering from cardiogenic shock

are being treated with anaesthesia that produces myocardial depression

are suffering from hypotension (except due to arrhythmia)

Warning and precautions

Talk to your doctor or pharmacist before taking Sotalol tablets.

Your doctor may wish to check the level of potassium and magnesium in your

blood before you start taking Sotalol tablets.

Regular blood tests may be required during your treatment with Sotalol tablets.

Please tell your doctor before you start to take your tablets if you:

have a history of allergy reaction

have any kidney problems, as your dose of Sotalol may need to changed.

suffer from liver problems

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 Sotalol tablets.

suffer from diabetes, as it may be necessary to change the dose of insulin or

any other medicines you take to treat your diabetes. Sotalol may also hide or

reduce the warning signs of low levels of sugar in you blood (hypoglycaemia)

have an overactive thyroid, as Sotalol can hide the symptoms or make them

worse if treatment with Sotalol tablets is stopped suddenly.

suffer from psoriasis (a skin disease that causes itchy, red, sore patches of

skin)

are scheduled to have a urine analysis

suffer from myasthenia gravis (muscle weakness)

are pregnant, planning to become pregnant or are breast-feeding

If you need to have surgery, you should tell the doctor or anaesthetist that you are

taking Sotalol tablets as it can affect anaesthetics. You may have to stop taking

Sotalol tablets before surgery and it should be gradually stopped over a period of

one week. Your doctor will tell you if this is necessary.

Other medicines and Sotalol

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:

Drugs for the treatment of high blood pressure, heart failure or an irregular

heartbeat (e.g. digoxin, amiodarone, verapamil, disopyramide, quinidine,

procainamide 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.

Floctafenine (medicine used for the short term treatment of mild to moderate

pain)

Calcium channel blockers e.g. verapamil and diltiazem.

Diuretics (water tablet), corticosteroids, amphotericin IV and some laxatives as

these lower potassium levels.

Clonidine (sometimes used to treat hot flushes or headaches)

Insulin and other oral medicines for diabetes

Tubocurarin a neuromuscular blocker

Beta-receptor stimulant drugs such as salbutamol (used in the treatment of

asthma or emphysema).

Treatment of hypertension (e.g. reserpine, guanethidine or alpha methyldopa)

Treatment of depression, anxiety, nervous disorders and mental disturbances

(e.g. methyldopa)

Treatment of allergies such as hay fever (e.g. antihistamines)

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

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 Sotalol tablets during pregnancy unless your doctor thinks it is

essential.

You should not breastfeed while you are being treated with Sotalol tablets.

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.

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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:

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 Sotalol 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:

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. 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 Sotalol tablets (affecting more than 1 in 100 patients)

include the following:

irregular heartbeat, slow heart beat, heart failure, chest pain, low blood

pressure, swelling, fainting and palpitations.

nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhoea,

cramps.

anxiety, depression, mood changes, headache, light-headedness, dizziness,

general weakness, tiredness, sleeping problems, 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 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 the side effects directly via the yellow card scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play

or Apple App Store.

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

The active substance is sotalol hydrochloride, 80mg or 160mg. Other ingredients

are calcium hydrogen phosphate dihydrate, maize starch, povidone k30, sodium

starch glycollate (type A), talc and magnesium stearate. Sotalol 160mg Tablets

also contain indigo carmine (E132)

What Sotalol Tablets looks like and contents of the pack

Sotalol 80mg Tablets are round, white to off-white, flat, beveled-edged tablets with

breakline on one side.

Sotalol 160mg Tablets are round, blue, flat, beveled edged tablets with breakline

on one side.

The tablets are available in blister packs of 28 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 02/2019