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Dytac 50mg Capsules

Document: leaflet MAH BRAND_PL 10972-0017 change

MercuryPharma

PATIENT INFORMATION LEAFLET

Dytac® 50mg Capsules

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 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 Dytac 50mg Capsules are and what they are used for

2.    Before you take Dytac 50mg Capsules

3.    How to take Dytac 50mg Capsules

4.    Possible side effects

5.    How to store Dytac 50mg Capsules

6.    Further information

1. What Dytac 50mg Capsules are and what they are used for

Dytac 50mg Capsules belong to a group of medicines called diuretics. They help the kidneys remove water from the body. Dytac 50mg Capsules act by stopping potassium being lost from the body. The capsules are 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, with liver and kidney problems or with heart failure (when the heart doesn’t pump efficiently).

Dytac 50mg Capsules can be used with another type of diuretic which normally allows potassium to be lost from the body. This combination increases the amount of water being removed and prevents potassium loss at the same time.

2. Before you take Dytac 50mg Capsules

DO NOT take Dytac 50mg Capsules if you:

•    know that you are allergic to triamterene or any of the other ingredients of Dytac 50mg Capsules (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 have (hyperkalaemia). Your doctor will advise you.

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

•    you are allergic to Sulphonamides, a type of antibiotic

Take special care with Dytac 50mg Capsules if you have:

•    diabetes mellitus

•    a build up of uric acid (gout)

•    problems with your liver or kidneys or pancreas

•    you know that you have a folic acid deficiency

•    you suffer from hyperplasia of the prostate (enlarged prostate)

•    you have had a heart attack

•    you are taking other medicines for your heart or your blood pressure. Your doctor may decide to alter the amount of the dose of these once you start taking Dytac 50mg Capsules

•    you have difficulty passing urine

•    you have been told by your doctor that you have an intolerance to some sugars.

If any of the above applies to you, make sure your doctor is aware of this.

If you are having any laboratory tests, please let your doctor know you are taking Dytac 50mg Capsules as they may affect the results.

Your doctor may monitor your blood, especially if you are elderly, have problems with your kidneys or also being treated with certain pain killers.

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:

•    Analgesics (medicines for pain relief e.g. Indometacin) or muscle relaxants

•    Medicines for severe mental illness such as lithium

•    Potassium salts

•    Chlorpropamide, used for controlling blood glucose

•    Medicines used in organ transplant patients e.g. tacrolimus, ciclosporin

•    Trilostane, a medicine used in treating hormonal problems

•    Other diuretics (“water Capsules”)

•    Drugs used to treat high blood pressure and heart conditions especially the group of drugs known as beta blockers and ACE inhibitors

•    Potassium-conserving drugs, including ACE inhibitors

•    Antibiotics

•    Antiepileptic agents such as phenobarbitol, phenytoin and carbamazepine

•    Anticoagulants such as warfarin

•    Drugs that alter your hormones including the contraceptive pill and some anticancer medications.

Patients should note that smoking tobacco can reduce the effect of Dytac 50mg Capsules.

Large amounts of glychyrrizin which is contained in liquorice can effect how well Dytac 50mg Capsules works. If you are unsure ask your doctor for advice.

Pregnancy and breast feeding:

Dytac 50mg Capsules should not be used during pregnancy unless your doctor decides it is necessary. You should not continue to breastfeed your baby if you need to take this medicine.

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

Driving and using machines:

Dytac 50mg Capsules should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Dytac 50mg Capsules:

This medicine contains lactose, which is a sugar. 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 Dytac 50mg Capsules

Always take Dytac 50mg Capsules 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:

When given alone, the usual dose is from 3 to a maximum of 5 Dytac 50mg Capsules a day. Take after breakfast and one after lunch. After the first week of treatment, take the Capsules every other day.

When Dytac 50mg Capsules are given with another diuretic, less doses of each medicine should be taken.

If you are elderly, your doctor may give you a lower dose.

Keep taking Dytac 50mg Capsules even if you feel well. Do not stop taking Dytac 50mg Capsules unless your doctor tells you to.

Your doctor will give you regular blood tests during treatment.

Do not give Dytac 50mg Capsules to children under 12 years.

If you take more Dytac 50mg Capsules than you should:

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

If you forget to take your Dytac 50mg Capsules:

If you miss taking Dytac 50mg Capsules in the morning, then take it as soon as you remember and carry on taking the Capsules as normal on the following morning. Do not take more than one dose at a time.

4. Possible side effects

Like all medicines, Dytac 50mg Capsules can cause side effects, although not everybody gets them. If you have any of these side effects, go back to your doctor straight away.

If you suffer cramps, feel dizzy, have aching muscles or swollen, painful joints after taking Dytac 50mg Capsules, go back to your doctor straight away.

If a rash develops, stop taking Dytac 50mg Capsules and speak to your doctor immediately.

Common side effects (occur in 1-10 of every 100 patients)

•    headache, dry mouth and feeling thirsty

•    passing a lot of urine

•    sometimes your urine may look slightly blue in colour, this is nothing to worry about.

Uncommon side effects (occur in 1-10 of every 1,000 patients)

•    restlessness and tiredness

•    dizziness or vertigo

•    tingling sensations (paraesthesias)

•    nausea and diarrhoea

•    skin rashes, unexpected bruising

•    changes to blood-sugar levels, gout, visual problems, low blood pressure, changes in blood chemistry, unusual heart beats (arrhythmias)

•    bowel problems (incontinence), problems passing urine

•    kidney stones.

Very rare side effects (occur in less than 10,000 patients)

•    damaged hearing

•    anaemia (particularly if your diet is poor)

•    increased sensitivity to light

•    affect on your immune system, making you feel very tired and prone to minor illnesses such as coughs, colds or infections

•    liver and kidney problems and pancreatitis.

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.

5. How to store Dytac 50mg Capsules

Keep this medicine out of the sight and reach of children.

Do not use Dytac 50mg Capsules after the expiry date which is stated on the box. The expiry date refers to the last day of that month. If your Capsules are out of date, take them to your pharmacist who will get rid of them safely.

Store in a dry place.

6. Further information

Each Dytac 50mg Capsule contains 50mg of triamterene.

Dytac 50mg Capsules also contain magnesium stearate, lactose, black iron oxide E172, erythrosine E127, titanium dioxide E171, gelatin.

What Dytac 50mg Capsules look like and contents of the pack:

Dytac 50mg Capsules are opaque, maroon-coloured Capsules containing yellow granular powder.

They are supplied in blister packs of 30 Capsules, or amber glass bottles of 30 Capsules.

They are also supplied in polyethylene vials containing 250 Capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer:

Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK. This leaflet was last revised in December 2013    100011/LF/2

Mercury Pharma Group Ltd is licensed to use the registered trade mark Dytac.