PATIENT INFORMATION LEAFLET

Dyazide® 50mg/25mg Tablets Triamterene/Hydrochlorothiazide

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 any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dyazide® 50mg/25mg Tablets are and what they are used for

2.    Before you take Dyazide® 50mg/25mg Tablets

3.    How to take Dyazide® 50mg/25mg Tablets

4.    Possible side effects

5.    How to store Dyazide® 50mg/25mg Tablets

6.    Further information

1.    What Dyazide® 50mg/25mg Tablets are and what they are used for

Dyazide® 50mg/25mg Tablets belong to a group of medicines called diuretics. They make the kidneys remove water from the body and they have the effect of lowering the blood pressure. Dyazide® 50mg/25mg Tablets are used to treat mild to moderate high blood pressure and they may be used in combination with other medicines.

They can also be used to treat oedema, which is a build-up of fluid in the body. This may occur in many situations, for instance during treatment with steroids, or with liver and kidney problems, or with heart failure (when the heart doesn’t pump efficiently).

2.    Before you take Dyazide® 50mg/25mg Tablets DO NOT take Dyazide® 50mg/25mg Tablets if you:

•    know that you are allergic to triamterene and hydrochlorothiazide or any of the other ingredients of Dyazide® 50mg/25mg Tablets (see section 6 of this leaflet).

•    have a serious liver or kidney disorder (your doctor will advise you)

•    have high levels of potassium in your blood (hyperkalaemia) or high levels of calcium in the blood (hypercalcaemia). Your doctor will advise you.

•    have disease of the adrenal glands causing weakness, weight loss and a deficiency of hormones in the blood (Addison’s disease)

•    have a serious complication of diabetes (diabetic ketoacidosis)

Take special care with Dyazide® 50mg/25mg Tablets and tell your doctor if you have:

•    controlled diabetes

Make sure your doctor is aware of this

Taking other medicines

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

The effects of these medicines may change, especially if you are taking:

Do not use potassium supplements or medicines containing potassium

Pregnancy and breast feeding

You must tell your doctor if you are pregnant or if you think that you are. Usually, your doctor will advise you to take another medicine instead of Dyazide, as Dyazide is not recommended during pregnancy. This is because Dyazide crosses the placenta and its use after the third month of pregnancy may cause potentially harmful foetal and neonatal effects.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Dyazide is not recommended for mothers who are breast-feeding.

Driving and using machines

Dyazide® 50mg/25mg Tablets should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Dyazide® 50mg/25mg Tablets

This medicinal product contains less than 1mmol sodium (23mg) per dose i.e. essentially Sodium - free (0.88mg). This should be taken into consideration by patients on a controlled sodium (salt) diet.

3. How to take Dyazide® 50mg/25mg Tablets

Always take Dyazide® 50mg/25mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide the best dose for you and may change it depending on how you respond to treatment. You may also be given other medicines.

USUAL DOSE:

To treat high blood pressure

Take one tablet each day after breakfast.

To treat fluid retention (oedema):

Take one tablet twice a day after meals. This dose may then be increased by your doctor to as many as four tablets a day, in which case take two tablets after breakfast and your remaining daily dose after lunch.

Do not take more than four tablets a day, as this may increase the side effects you may have. Keep taking Dyazide® 50mg/25mg Tablets even if you feel well. Do not stop taking Dyazide® 50mg/25mg Tablets unless your doctor tells you to.

Your doctor will give you regular blood tests during treatment.

Do not give Dyazide® 50mg/25mg Tablets to children under 12 years.

If you take more Dyazide® 50mg/25mg Tablets than you should:

If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take any remaining tablets and this leaflet with you so that the medical staff know exactly what you have taken.

If you forget to take your Dyazide® 50mg/25mg Tablets:

If you miss a dose, then take it as soon as you remember unless you are within two hours of your next dose. In this case, take the next dose at the normal time. Do not double the next dose to make up for the forgotten one.

4. Possible side effects

Like all medicines, Dyazide® 50mg/25mg Tablets can sometimes cause side effects, although not everybody gets them.

As Dyazide® 50mg/25mg Tablets remove excess water from your body, the number of times that you need to pass urine will increase. This will be most noticeable when you first start taking Dyazide® 50mg/25mg Tablets. Under certain lights you may also notice a blue fluorescence in your urine.

Other side effects may include:

•    feeling sick or being sick, diarrhoea.

•    feeling weak or dizzy and/or have muscle cramps and headaches.

•    feeling thirsty or have a dry mouth.

•    gout (often felt as painful joints, especially of the big toe).

•    Very rarely, some patients may develop a skin rash especially when the skin is exposed to daylight. Some patients may develop a condition known as systemic lupus erythematosus (SLE). This usually causes

•    inflammation or rheumatoid arthritis-like symptoms (pain, stiffness and/or swelling of the joints) and can occur anywhere in the body.

•    Certain other side effects such as changes in the blood levels of chemicals and salts can only be detected by your doctor. To check for this your doctor may occasionally want to do some blood tests.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Dyazide® 50mg/25mg Tablets

Keep out of the reach and sight of children.

Do not use Dyazide® 50mg/25mg Tablets after the expiry date which is stated on the box. If your Tablets are out of date, take them to your pharmacist who will get rid of them safely.

This medicinal product does not require any special storage precautions.

6.    Further information

Each Dyazide® 50mg/25mg Tablet contains 50mg of Triamterene and 25mg of Hydrochlorothiazide.

Dyazide® 50mg/25mg Tablets also contains FD & C Yellow No. 6 (E110), sodium lauryl sulphate, sodium starch glycollate, povidone 30, magnesium stearate and maize starch. This medicinal product contains less than 1mmol sodium (23mg) per dose i.e. essentially Sodium -free (0.88mg).

What Dyazide® 50mg/25mg Tablets look like and contents of the pack

Dyazide® 50mg/25mg Tablets are circular, peach tablets with E93 marked on one side.

They are supplied in blister packs of 15, 30 or 60 tablets.

They are also supplied in securitainers, polyethylene vials or amber glass bottles of 20, 100,

500 or 1000 tablets.

Marketing Authorisation Holder

Mercury Pharmaceuticals Ltd

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Manufacturer

Mercury Pharmaceuticals Ltd

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK This leaflet was last revised in October 2013

Dyazide is a registered trademark of Mercury Pharma Group Ltd.