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PATIENT INFORMATION LEAFLET

Kalspare® tablets

(chlortalidone, triamterene)

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 your 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 Kalspare tablets are and what they are used for

2.    Before you take Kalspare tablets

3.    How to take Kalspare tablets

4.    Possible side effects

5.    Howto store Kalspare tablets

6.    Further information

1. WHAT KALSPARE TABLETS ARE AND WHAT THEY ARE USED FOR

Kalspare tablets contain the active ingredients chlortalidone and triamterene. The tablets increase the amount of urine passed while limiting the amount of potassium lost into the urine.

Kalspare tablets are used to treat mildly or moderately raised blood pressure or to reduce swelling of the feet and legs when this is due to fluid collecting under the skin, or to reduce fluid which has collected in the abdomen because of damage to the liver (this is called ascites).

2. BEFORE YOU TAKE KALSPARE TABLETS

Do not take Kalspare tablets if you:

•    are allergic (hypersensitive) to chlortalidone, triamterene, other sulphonamide based drugs or any of the other ingredients of Kalspare tablets (see section 6).

•    have worsening kidney failure

•    are taking lithium (anti-depressant)

•    have high blood potassium levels (hyperkalaemia)

•    are taking other potassium sparing drugs, such as spironolactone or amiloride

This medicine should not be used in children.

Take special care with Kalspare tablets Tell you doctor if you:

•    have severe kidney disease

•    worsening liver disease or reduced liver function

•    are taking potassium supplements (for treatment of low blood potassium)

•    suffer from diabetes

•    are pregnant or breastfeeding

•    are about to undergo surgery (Kalspare tablets may interact with surgery medicines)

Your doctor will monitor your blood salt levels during your treatment.

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with Kalspare tablets:

•    potassium supplements

•    lithium, (used in the management of manic depression, mania, some types of depression, aggressive behaviour and intentional self-harm)

•    barbiturates (sleeping medicine)

•    narcotics or alcohol (strong painkillers)

•    tubocurarine (medicines used during surgery)

•    other high blood pressure medication (antihypertensive)

•    other diuretics (increase urine production)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Kalspare tablets with food and drink

Do not drink alcohol when taking Kalspare tablets.

Kalspare tablets should be taken after breakfast.

Pregnancy and breast-feeding

If you are pregnant, likely to become pregnant or are breast-feeding, you must inform your doctor. Some ingredients of Kalspare tablets may harm your unborn child or your breastfeeding baby. Your doctor will prescribe Kalspare tablets for you only if they are essential.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Kalspare tablets should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Kalspare

This medicine contains lactose. If you have been told that you have intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains the colouring agent sunset yellow, which may cause allergic reactions.

This medicine contains sodium propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

3. HOW TO TAKE KALSPARE TABLETS

Always take your medicine as your doctor has instructed.

Do not give Kalspare tablets to children

Dosage

A typical dose is one tablet daily after breakfast.

If necessary the dose may be increased to two tablets once daily after breakfast.

Elderly patients may require lower dosage.

If you take more Kalspare tablets than you should

If you suspect that you or someone else has taken an overdose of Kalspare tablets contact your doctor or go to the emergency department of your local hospital immediately. Always take the container with you, even if empty.

If you forget to take Kalspare tablets

Take that dose as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Kalspare tablets can cause side effects, although not everybody gets them.

Kalspare tablets can rarely cause metabolic acidosis which causes rapid breathing and reduced heart function.

If you believe this is happening to you then inform your doctor immediately.

Kalspare tablets may rarely cause allergic reactions. Symptoms may include swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty in swallowing or difficulty breathing. You should contact a doctor immediately if you experience any of these side effects.

The following side effects have been reported:

•    nausea

•    mouth dryness

•    constipation

•    leg cramps

•    headache

•    dizziness

•    fatigue

•    onset or aggravation of gout

•    onset or aggravation of diabetes

•    decreased blood iodine

•    anaemia (resulting in shortness of breath, weakness and fatigue)

•    jaundice (yellowing of the skin and whites of the eyes)

•    allergic reaction causing inflammation of the kidney

Kalspare tablets may lead to increased blood potassium (hyperkalaemia). The symptoms of this are pins and needles, fatigue, muscle weakness (or paralysis), and abnormally slow heart and shock.

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.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE KALSPARE TABLETS

Keep Kalspare tablets out of the reach and sight of children.

Do not store your tablets above 25“C.

Do not use Kalspare tablets after the expiry date printed on the pack.

6. FURTHER INFORMATION

What Kalspare tablets contains

The active ingredients are 50mg chlortalidone BP and 50mg triamterene BP

The inactive ingredients are lactose, starch, ST A RX 1500 starch, microcrystalline cellulose , sodium starch glycollate, magnesium stearate, hypromellose, polyethylene glycol 4000, polyethylene glycol 400, antifoam, sodium propyl hydroxybenzoate, camauba wax, titanium dioxide E17I, sunset yellow E110.

Product licence holder:

DHP Healthcare Ltd, Maidstone, Kent, ME15 9RS, United Kingdom Manufacturer:

Farmalabor - Produtos Farmaceuticos, S.A.

Zona Industrial de Condeixa-a-Nova 3150-194 Condeixa-a-Nova Portugal

This leaflet was last approved in May 2015

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