Sotalol 80mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOTALOL 40 mg, 80 mg & 160 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.
WHAT IS IN THIS LEAFLET
1. What Sotalol is and what it is used for
2. What you need to know before you take Sotalol
3. How to take Sotalol
4. Possible side effects
5. How to store Sotalol
6. Contents of the pack and other information
1. WHAT SOTALOL IS AND WHAT IT IS USED FOR
Sotalol belongs to a group of medicines called beta-blockers. It can be used to treat problems affecting the beat of your heart (arrhythmias, tachycardia).
If you are not sure why you have been prescribed this medicine then please ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL
Do not take Sotalol and tell your doctor if you:
• are allergic to Sotalol or any of the other ingredients in this medicine (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath
• have a history of asthma, wheezing or other lung diseases
• have any of the following heart problems:
- second or third degree heart block (conditions which may make you feel dizzy or light-headed, tired or prone to collapses)
- very slow or very uneven heart beats
- a problem (common in the elderly) related to poor control of the working of the heart (sick sinus syndrome)
- severe blood circulation problems
- low blood pressure (hypotension) which can make you feel dizzy or light-headed
• have severe kidney problems
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sotalol.
You will not be given Sotalol if you:
• have a sudden and rapid fall in blood pressure (cardiogenic shock)
• have heart failure which is not under control (signs include breathlessness and swollen ankles)
• have high blood pressure caused by a tumour on the adrenal gland which has not been treated. This is called phaeochromocytoma
• have increased levels of acid in your blood (metabolic acidosis)
You will not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sotalol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sotalol if you:
• have or have had heart problems (including heart failure, first degree heart block, heart attack or uneven heart beats) or have low levels of potassium or magnesium in your blood (possibly due to severe diarrhoea), as your doctor may do some tests on your heart and blood before giving you this medicine
• suffer from blood circulation problems (Raynaud’s phenomenon)
• have a skin problem called psoriasis
• have a history of allergic reactions or need anti-allergic treatment e.g. following a wasp or bee sting
• have a thyroid problem, as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by this medicine
• have kidney problems, as you will be given a lower dose of this medicine
• have diabetes, as symptoms of low blood sugar levels (hypoglycaemia) may be hidden by this medicine.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sotalol.
Operations and tests
Tell your doctor, dentist or nurse you are taking Sotalol if you:
• are going to have an operation or an anaesthetic
• are going to have any blood or urine tests.
Other medicines and Sotalol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Sotalol can affect the way some medicines work. Also some medicines can affect the way Sotalol works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• medicines to treat asthma or other lung diseases, such as theophylline
• medicines to treat irregular or uneven heartbeat, such as amiodarone, disopyramide, procainamide, flecainide, quinidine
• medicines to treat high blood pressure or chest pain, such as diltiazem, verapamil, bepridil, nifedipine, ivabradine, ranolazine, nitrates such as glyceryl trinitrate
• medicines to treat high blood pressure, such as captopril (ACE inhibitors), doxazosin and prazosin (alpha-blockers), furosemide and hydrochlorothiazide (diuretics), hydralazine, moxonidine, guanethidine, reserpine, methyldopa, diazoxide, candersatan
• digoxin to treat heart failure
• clonidine to treat high blood pressure or migraine. Do not stop taking clonidine unless your doctor tells you to. If you have to stop taking clonidine, your doctor will tell you how to
• moxisylyte to treat blood circulation problems like Raynaud’s disease medicines for stimulating the heart, such as adrenaline, noradrenaline or dobutamine
• medicines to treat diabetes, such as gliclazide, tolbutamide or insulin
• medicines for pain and swelling, such as ibuprofen or indometacin
• ergotamine used for migraine
• medicines to treat anxiety, depression or mental health problems, such as diazepam, temazepam, amitriptyline, imipramine, phenelzine, chlorpromazine, thioridazine, pimozide, sertindole, amisulpride, sulpiride, haloperidol, zuclophenthixol
• droperidol, dolasetron or tropisetron to treat or prevent nausea and vomiting
• levodopa to treat Parkinson’s disease
• muscle relaxants such as baclofen, tizanidine or tubocurarine
• medicines to treat malaria, such as mefloquine, halofantrine, artemether and lumefantrine
• antibiotics such as erythromycin (by injection), sparfloxacin or moxifloxacin
• pentamidine to treat lung infections
• amphotericin (by injection) to treat fungal infections
• aldesleukin to treat cancer
• antihistamines such as astemizole, terfenadine or mizolastine to treat allergies
• oestrogens used for contraception or hormone replacement therapy (HRT)
• steroids such as hydrocortisone or prednisolone to treat swelling and allergies
• pilocarpine to help produce more saliva and tears
• medicines to treat constipation (laxatives)
• carbenoxolone to treat ulcers
• cisapride to treat heartburn or reflex disease
• tolterodine to treat urinary problems
• alprostadil for problems maintaining an erection
• atomoxetine to treat Attention Deficit Hyperactive Disorder (ADHD)
• cough or cold remedies bought over the counter
• floctafenine, a pain relieving medicine belonging to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs)
Sotalol with food and drink
Moderate amounts of alcohol will not affect Sotalol, however you should check with your doctor first to see if drinking is advisable for you.
Pregnancy and breast-feeding
If you are pregnant or plan to become pregnant speak to your doctor before taking Sotalol. Its effect in pregnancy is not known but some beta-blockers can affect the growth of the unborn baby.
Do not breast-feed your baby unless you have spoken to your doctor first as Sotalol can pass into your breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy or tired while taking Sotalol. If this happens, do not drive or use any tools or machines and tell your doctor.
3. HOW TO TAKE SOTALOL
Always take Sotalol tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Sotalol tablets should be swallowed whole with a glass of water and can be taken with or without food.
Adults
The usual starting dose is 80 mg a day, either as a single dose or in two divided doses at 12 hour intervals.
After 2-3 days your doctor may increase the dose. Most people need 160-320 mg a day, in two divided doses at 12 hour intervals. Some patients may require doses as high as 480 to 640 mg a day but these doses should only be given under specialist supervision.
Patients with kidney problems
If you have kidney problems, your doctor will give you a lower dose than stated above.
Use in children
Sotalol must not be given to children.
If you take more Sotalol than you should
If you take more Sotalol than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take Sotalol
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sotalol
If you suddenly stop taking Sotalol your condition may worsen. Your doctor will reduce your dose slowly over 2 weeks.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sotalol can cause side effects, although
not everybody gets them.
If you get any of the following side effects, STOP
TAKING Sotalol and tell your doctor immediately or go
to the nearest hospital emergency department:
• an allergic reaction to Sotalol which may cause any kind of skin rash, swelling of the face, lips, tongue or throat, sudden wheezing, fluttering or tightness of the chest or collapse
• difficulty in breathing, especially if you have a history of asthma, wheezing or other lung diseases.
• slowing of the heartbeat, an irregular heart rhythm or missed beats (palpitations), heart failure (signs include breathlessness and swollen ankles)
• low blood pressure (hypotension) which can make you feel dizzy or light-headed
• fainting, feeling faint or light-headed
• poor blood circulation making the fingers and toes cold, numb and pale (Raynaud’s phenomenon)
• worsening of cramp-like pains in the lower leg on walking
• bleeding or bruising more easily or purplish marks on the skin
• feeling thirstier than usual, feeling unusually tired or passing more urine than usual, as Sotalol may be affecting the amount of glucose (sugar) in your blood, which can lead to diabetes.
Tell your doctor if you get any of these side effects:
• feeling depressed or anxious, mood changes
• loss of touch with reality (psychosis)
• problems sleeping
• headache, feeling dizzy or light-headed
• tingling or numbness in the arms and legs
• abnormal taste
• dry eyes, changes in eyesight
• hearing problems, a feeling of dizziness or spinning (vertigo)
• feeling sick (nausea), being sick (vomiting), stomach pain or discomfort, diarrhoea, wind, indigestion
• skin rash, worsening of psoriasis (dry flaky skin)
• hair loss
• muscle cramps
• chest pain
• feeling tired or weak, fever
• a build-up of excess fluid in the body (oedema) causing swelling of the hands, arms, legs and ankles
• changes in sex drive (libido).
Taking Sotalol may lead to an increase in the risk of heart rhythm disorders especially torsades de pointes. Your doctor may want to monitor you.
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 SOTALOL
Keep out of the sight and reach of children.
Do not use the tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
There are no special storage requirements for this medicine.
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 contain
The active substance is sotalol hydrochloride.
The other ingredients are calcium hydrogen phosphate dihydrate, maize starch, povidone, sodium starch glycollate, talc and magnesium stearate. The 160 mg tablets also contain indigo carmine (E132).
What Sotalol tablets look like and contents of the pack
The 40 mg tablets are round white to off-white tablets with the Chatfield logo engraved on one side and a break line and SOT40 on the other side.
The 80 mg tablets are round white to off-white tablets with the Chatfield logo engraved on one side and a break line and SOT80 on the other side.
The 160 mg tablets are round blue tablets with the Chatfield logo engraved on one side and a break line and SOT160 on the other side.
All three strengths of Sotalol tablets come in blister packs of 14, 15, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, PC. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London, SW5 9JQ, UK
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 11/2016.
CL0150-0151-0152/O/PIL/CL2
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„ , , Sotalol 40, 80 & Product: 160 mg Tablets MA Holder: Chelonia |
Printing Colours: | Black |
Non-Printing Colours: | Profile |
Chelonia HEALTHCARE Final Preparation Date For Submission: 04/11/2016 |
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PL No.: 33414/0150-0152 |
Packing Site Technical Approval: 00/00/0000 Authority Approval Date: Latest Implementation Deadline: 00/00/0000 | ||
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Pack Size: All Packs |
Dimensions: 148 x 297 mm | ||
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Livery: Chelonia |
Created By: DTawde | ||
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Manufacturer: -Market: UK Component: Leaflet |
Artwork Code: CL0150-0151-0152/O/PIL/CL2 |
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