SLOW-K 600 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Slow-K® 600mg prolonged-release

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• – Keep this leaflet. You may need to read it again.

• – Ask your pharmacist if you need more information or advice.

• – 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.

This medicine is available using above names but will be referred to as Slow-K throughout this leaflet.

What is in this leaflet

• 1. What Slow-K is and what it is used for

• 2. What you need to know before you take Slow-K

• 3. How to take Slow-K

• 4. Possible side effects

• 5. How to store Slow-K

• 6. Contents of the pack and other information

1. what slow-k is and what it is used for

Slow-K belongs to a group of medicines called potassium supplements.

Slow-K contains potassium and is used to treat or prevent low levels of potassium in your body. Slow-K tablets are prolonged-release tablets which means that the potassium is released slowly from the tablet.

Whilst on this medicine your doctor will want to measure your blood levels of potassium on a regular basis.

2. what you need to know before you take slow-k do not take slow-k:

• – if you are allergic to potassium chloride or any of the other ingredients of this medicine (listed in section 6)

• – if you have been told by your doctor you have kidney failure

• – if you have Addison’s disease (which is a condition where your adrenal gland is not producing enough steroids)

• – if you have recently suffered from severe burns

• – if you suffer from digestive problems or have difficulty swallowing (due to a narrowing or blockage of your gullet (food pipe) or intestines)

• – if you have been told you have metabolic acidosis (a condition caused by increased acid levels in the blood)

• – if you are dehydrated (you may feel thirsty with a dry mouth)

• – if you have high blood potassium levels (which can cause an abnormal heartbeat)

• – if you suffer from a condition called hyporeninaemic hypoaldosteronism (where your body is low on an enzyme called renin and a hormone called aldosterone which normally helps to control your blood pressure)

• – if you are taking certain types of diuretics (water tablets); either potassium-sparing diuretics (e.g. triamterene and amiloride) or aldosterone antagonists (e.g. spironolactone and eplerenone).

Warnings and precautions

Talk to your doctor or pharmacist before taking Slow-K if you: – have had an ostomy (an operation to remove part of your bowels) – suffer from any condition which affects your bowel movements – suffer from heart disease (which may cause chest pain, shortness of breath or ankle swelling)

• – suffer from kidney problems – have or have ever had a stomach ulcer.

Do not give Slow-K to children.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Slow-K.

Other medicines and Slow-K

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking:

• – “water tablets” for high blood pressure and certain heart diseases, e.g. triamterene and amiloride (if you are taking potassium-sparing diuretics, stop taking Slow-K, see the section ‘Do not take Slow-K’)

• – “water tablets” for heart failure and certain liver and kidney problems, e.g. spironolactone and eplerenone (if you are taking aldosterone antagonists, stop taking Slow-K, see the section ‘Do not take Slow-K’)

• – for high blood pressure or heart problems such as captopril or atenolol

• – for treatment of high blood pressure, kidney damage due to diabetes and congestive heart failure such as losartan or valsartan

• – for transplants, rheumatic disease or skin complaints

• – for pain relief or rheumatism such as aspirin or naproxen

• – used to thin the blood

• – for an irregular heartbeat

• – for abdominal or stomach spasms or cramps such as atropine sulphate or hyoscine butylbromide

• – for high blood pressure, e.g. aliskerin

• – for indigestion

Slow-K with food and drink

You must take your tablets with fluid during a meal.

Pregnancy and breast-feeding

Your doctor will only give you Slow-K if you really need it. Slow-K is a prolonged-release tablet, which means it takes a long time to dissolve. When you are pregnant your digestive system works more slowly and so Slow-K tablets take longer to pass through your system. This could mean you do not receive the correct amount of potassium from your Slow-K tablets.

Slow-K should not be taken during breast-feeding unless your doctor considers that the benefits for you are greater than the risks to the child.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Slow-K contains sucrose

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 slow-k

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is 2 to 3 tablets a day. Your doctor will decide when and how to treat you with Slow-K. Your doctor may tell you to take up to 12 tablets a day.

• – The tablets should not all be taken at once but spread out during the day and taken with your meals.

• – Take your tablets with fluid during a meal and whilst sitting upright.

• – Swallow them whole.

• – Do not break or chew them. This is important as the tablets release potassium slowly. If you chew the tablets, this could damage the tablet and let the potassium out too quickly and this could cause stomach problems.

If you take more Slow-K than you should

If you accidentally take too many tablets, or someone else takes your medicine, you should tell your doctor at once or contact your nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor.

If you forget to take Slow-K

Do not worry. If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose.

Do not take a double dose. Then go on as before.

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 everyone gets them.

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Serious side effects

If you experience any of the following side effects, contact your doctor or pharmacist IMMEDIATELY:

• – signs of intestinal bleeding or ulcers such as coughing up blood (however small the amount), blood in your vomit and black stools

• – severe sickness (feeling sick or being sick)

• – constipation

• – swelling of the stomach

• – diarrhoea

• – severe stomach pains.

Other side effects:

• – high blood levels of potassium (which can cause an abnormal heartbeat) – itching and skin rashes (nettle rash).

5. how to store slow-k

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tablet container after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Store in the original package in order to protect from light.

Do not use this medicine if you notice the appearance has changed in any way.

If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to.

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. contents of the pack and other information

What Slow-K contains

The active substance is potassium chloride.

Each tablet contains 600mg potassium chloride equivalent to 315mg potassium or approximately 8mmol potassium ion (K+).

The other ingredients are cetostearyl alcohol, gelatin, magnesium stearate, acacia, yellow iron oxide (E172), red iron oxide (E172), talc, titanium dioxide (E171), carnauba wax and sucrose.

What Slow-K looks like and contents of the pack

Slow-K is a pale orange, round, biconvex tablet with no marking on either side. They are prolonged-release tablets with a sugar-coating.

Slow-K is available in aluminium and PVC blisters in pack sizes of 40 and 100 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by GSK-Gebro Consumer Healthcare GmbH, Bahnhofbichl 13, A-6391 Fieberbrunn, Austria.

Procured from within the EU by Product Licence holder

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middesex, HA1 1XD.

Repackaged by Servipharm Ltd.

PL 20636/3145

Leaflet revision and issue date (Ref) 24.10.18[3]

Slow-K is a trademark of Novartis AG.