Securon Sr
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Securon® SR 240mg Tablets
(verapamil hydrochloride)
Your medicine is called Securon SR 240mg Tablets but will be referred to as Securon SR throughout the remainder of this leaflet.
This medicine is also available in a lower strength: Half Securon SR (120mg).
IMPORTANT INFORMATION
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet as you may need to read it again
• This leaflet provides a summary of the information currently available about Securon SR
• For further information or advice ask your doctor or pharmacist
• This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you
• Tell your doctor or pharmacist if you experience any side effects
Leaflet contents:
1. What is Securon SR and what is it used for?
2. What should you know before taking your tablets?
3. How should you take your tablets?
4. Possible side effects
5. How should you store your tablets?
6. Further information.
1. What is Securon SR and what is it used for?
Securon SR belongs to a group of medicines called calcium channel blockers. Calcium channel blockers change the amount of calcium getting into the muscle cells in your heart and blood vessels. This can change the strength and speed with which your heart beats.
It also opens up the blood vessels so blood can be pumped around the body more easily. This helps more oxygen to get to your heart muscle and can lower your blood pressure.
Securon SR is used to treat hypertension (high blood pressure) and to prevent angina (chest pain) attacks. The tablets may also be prescribed following a heart attack, to prevent another attack occuring.
The active ingredient in Securon SR is verapamil hydrochloride.
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2. What should you know before taking your tablets?
If the answer to any of the following questions is ‘YES’ please tell your doctor or pharmacist BEFORE taking any tablets:
• Are you sensitive (allergic) to verapamil or any of the ingredients in the tablets? (See Section 6)
• Are you pregnant or planning to become pregnant, or are you breast feeding?
• Do you have very low blood pressure?
• Do you have or have you ever suffered from heart problems such as heart failure?
• Do you have an abnormally slow or irregular heart beat?
• Have you recently had a heart attack?
• Do you have liver or kidney problems?
• Do you have or have you ever suffered from heart problems such as heart failure or the heart condition called Wolff-Parkinson-White syndrome?
• Do you have a condition where the nerve to muscle transmission is affected e.g. myasthemia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy?
• Are you being treated with ivabradine (for heart conditions)?
Taking other medicines.
Please tell your doctor or pharmacist if you are taking any medicines with or without a prescription or have recently taken any of the following medicines:
• beta-blockers used to treat high blood pressure and heart conditions (these include atenolol, propranolol and metoprolol)
• alpha blockers used to treat high blood pressure and heart conditions (these include prazosin and terazosin)
• diuretics (also called “water pills”)
• medicines known as “statins” such as atorvastatin, lovastatin, simvastatin used to lower cholesterol levels
• any other medicine for high blood pressure or an abnormal heart beat (arrhythmia) such as quinidine, flecainide, digoxin and digitoxin
• dabigatran (medicine to prevent the formation of blood clots)
• medicines containing ivabradine for the treatment of certain heart diseases
• medicines used to treat depression (including the herbal product St John’s Wort), anxiety or psychosis. These may include imipramine, buspirone and lithium.
• medicines known as immunosuppressants such as ciclosporin, sirolimus, everolimus and tacrolimus. These are used to prevent organ transplant rejection.
• glibenclamide, used to treat certain types of diabetes
• aspirin, a non-steroidal anti-inflammatory painkiller (NSAID) used to relieve pain and reduce fever
• almotriptan, used to treat migraine
• midazolam, used as a sedative or anaesthetic
How should you take your tablets?
• theophylline, used to treat asthma
• doxorubicin, an anti-cancer medicine
• cimetidine, used to treat indigestion or stomach ulcers
• carbamazepine, phenytoin or phenobarbital (phenobarbitone). These medicines are used as anti-convulsants.
• rifampicin, used to treat tuberculosis and other types of infection
• ritonavir, used to treat HIV
• erythromycin, clarithromycin and telithromycin, used to treat certain types of infection
• colchicine or sulfinpyrazone, used to treat gout.
Tell your surgeon or dentist that you are taking Securon SR if surgery is planned as it may affect the anaesthetic used.
Driving and operating machines
Do NOT drive, operate machinery or do anything that requires you to be alert, until you know how the tablets affect you.
Securon SR can make some people feel dizzy, especially when they first start to take the tablets.
Other important information
Do NOT drink grapefruit juice whilst taking your tablets as it can affect the absorption of this medicine. This does not occur with other fruit juices such as orange, apple or tomato juice.
Drinking alcohol
Securon SR will increase the time your body takes to get rid of alcohol. This means that you may not have to drink as much for your blood alcohol levels to be above the legal limit to drive. It will also take you longer to sober up.
Taking Securon SR with food and drink
Your tablets can be taken with a glass of water to help you swallow them. It does not matter if you have eaten, so they can be taken with or without food.
Pregnancy and breast feeding
Please discuss with your doctor if you are pregnant, planning to become pregnant or are breast feeding.
ALWAYS take your tablets exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.
TAKE YOUR TABLETS with a glass of water. You should swallow the tablets without chewing or crushing them. It does not matter if you have not eaten.
The number of tablets that you will need to take will depend on what you are being treated for:
ADULTS:
Hypertension (high blood pressure)
The usual dose is one Securon SR tablet a day. If you have not taken Securon SR before, your doctor may prescribe a lower dose such as a Half
Securon SR 120 mg tablet each day.
The maximum dose to treat high blood pressure is 480 mg each day.
This is usually taken as one Securon SR tablet in the morning and one in the evening, leaving a gap of about 12 hours between each dose.
Angina (chest pain)
The usual starting dose for angina is one Securon SR tablet taken twice a day. You should take one tablet in the morning and one in the evening, with a gap of about 12 hours in between them. Your doctor may prescribe a lower dose according to your symptoms.
Following a heart attack
The usual dose following a heart attack is 360 mg each day. This may be taken as one Securon SR tablet in the morning and a Half Securon SR 120 mg tablet in the evening or as one Half Securon SR 120 mg tablet taken three times a day. The doctor will usually wait at least a week after your heart attack before prescribing these tablets.
CHILDREN:
Securon SR is NOT recommended for children under 12 years of age.
If you take more tablets than prescribed (an overdose) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you.
If you forget to take your tablets take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.
If you stop taking your tablets your condition may get worse. It is important that you keep taking these tablets until your doctor tells you to stop. Do NOT stop just because you feel better.
Other things to remember about Securon SR
• Securon SR may be broken in half if your doctor advises you to do so (e.g. if a lower dose has been prescribed).
• The tablets should NOT be crushed or chewed, as this will affect the modified-release formulation of the product.
Possible side effects
As with all medicines Securon SR can cause side effects, although not everyone will suffer from them.
If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist.
Tell your doctor IMMEDIATELY if you experience any of the following side effects:
• Yellowing of the skin or eyes, a fever or tenderness around the middle. These are signs that your liver may not be functioning as well as usual
• Palpitations, chest pains for the first time or chest pains becoming more frequent, swollen ankles, hot and painful hands or feet
• Swelling of the limbs
• Unexpected wheezing, difficulty breathing, swelling of the mouth, lips or tongue or severe skin rash
The most common side effect is constipation. Other side effects include abnormal heart beat, flushing of the face or neck, headaches, feeling or being sick, abdominal pain or discomfort, dizziness, vertigo, tinnitus (ringing or buzzing in the ears), tiredness, tremor, movement disorders, muscle weakness, aches and pains in the joints and/or muscles, skin rash or itching, a tingling or prickling feeling on the skin, numbness and hair loss. Impotence may occur rarely.
Other side effects might occur if Securon SR is used for a long time. Tell your doctor if you develop swollen gums which start to spread over your teeth, or if your breasts swell (males) or start to produce milk (males and females). These effects are rare and are resolved upon stopping taking the tablets.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
What Securon SR looks like:
Oblong, pale, green, scored and embossed with two Knoll logos (triangles) on one side.
Securon SR is available in packs of 20.
Manufacturer:
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
PL No: 33902/0304 I POM
Leaflet revision date: 16/09/2016
Securon® is a registered trademark of Mylan Healthcare GmbH.
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How should you store your tablets?
Do NOT take your tablets after the ‘use by’ date shown on the carton.
Do not store above 25°C. Store in the original package.
Your tablets should be stored in a safe place out of the sight and reach of children, your medicine could harm them.
If your doctor decides to stop your treatment, return any left over tablets to your pharmacist. Only keep the tablets if your doctor tells you to. Do NOT dispose of leftover tablets carelessly (e.g. down the toilet or in with your general rubbish).
If your medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.
Further information
Each tablet contains 240mg verapamil hydrochloride in a sustained release (slow release) formulation.
Inactive tablet ingredients:
Microcrystalline cellulose, sodium alginate, povidone, magnesium stearate, purified water, hypromellose, macrogol 400, macrogol 6000, talc, titanium dioxide (E171), 1-green lake [quinoline yellow (E104) and indigo carmine (E132)], montan glycol wax