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Benzthiazide 25mg And Triamterene 50mg Capsules

Document: leaflet MAH BRAND_PL 10972-0018 change

PATIENT INFORMATION LEAFLET

Dytide Capsules

Triamterene 50 mg and Benzthiazide 25 mg

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 Dytide Capsules are and what they are used for

2.    Before you take Dytide Capsules

3.    How to take Dytide Capsules

4.    Possible side effects

5.    How to store Dytide Capsules

6.    Further information

1.    What Dytide Capsules are and what they are used for

Dytide Capsules belong to a group of medicines called diuretics. They help the kidneys remove water from the body. They 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).

2.    Before you take Dytide Capsules DO NOT take Dytide Capsules if you:

•    know that you are allergic to triamterene and benzthiazide or any of the other ingredients of Dytide (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) or high levels of calcium in the blood (hypercalcaemia). 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)

•    have a serious complication of diabetes (diabetic ketoacidosis)

•    are pregnant or breast feeding

Take special care with Dytide Capsules if you have:

•    controlled diabetes

•    a build up of uric acid (gout)

•    problems with your liver or kidneys or pancreas

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 Dytide 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 Dytide Capsules may make your skin more sensitive to light which can lead to rashes on your skin.

It is advisable that you use sun cream to protect your skin as necessary.

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 and non steroidal anti-inflammatories (NSAIDs) such as indomethacin (medicines for pain relief)

•    Antidepressants such as fluoxetine, citalopram, and including Monoamine Oxidase

Inhibitors (MAOIs), eg phenelzine

•    Medicines for severe mental illness such as lithium and Carbamazepine used to treat

epilepsy (fits)

•    Calcium salts, or Vitamin D

•    Corticosteroids to treat inflammatory conditions such as arthritis or asthma

•    Cytotoxics (to treat cancer) and Trilostane used to treat certain cancers and glandular

disorders

•    Other diuretics (“water Capsules”)

•    B-blocker eye drops used to treat glaucoma (e.g. timolol)

•    The contraceptive pill

•    Sympathomimetics used to stimulate the heart, eg dopamine, and to treat asthma, eg

salbutamol

•    Tacrolimus used in transplants to suppress the immune system

•    Theophylline (used to treat breathing problems )

•    Medicines to treat diabetes

•    Other medicines that treat high blood pressure including angiotensin inhibitors

•    Dipyridamole used to thin the blood in the treatment of stroke or heart disease

•    Alprostadl used to treat problems with erection in men

•    Moxisylyte used to treat problems with circulation to the hands

•    Muscle relaxants including Tizanidine used in the treatment of spinal injury and multiple

sclerosis

•    Colestyramine used in the treatment of high blood cholesterol levels Do not use potassium supplements or medicines containing potassium Pregnancy and breast feeding

Dytide 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

Dytide Capsules should not affect your ability to drive or use machinery. However, you may experience weakness or dizziness whilst taking the tablets. if you are affected do not drive or operate machinery.

Important information about some of the ingredients of Dytide Capsules

This medicine contains lactose, which is a sugar. If you have been told by your doctor that you have an intolerance to sugars, contact your doctor before taking this medicine.

3. How to take Dytide Capsules

Always take Dytide 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:

Take three capsules a day, two after breakfast and one after lunch. After the first week of treatment, take the capsules every other day. The dose can be further reduced to one or two capsules every other day, taken after breakfast or after breakfast and lunch.

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

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

Your doctor will give you regular blood tests during treatment.

Do not give Dytide Capsules to children under 12 years.

If you take more Dytide 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 Dytide Capsules:

If you miss taking Dytide 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, Dytide can sometimes cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially a ffecting yo ur w hole b ody) S TOP TA KING you r m edicine an d go to a d octor immediately.

As Dytide Capsules 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 Dytide Capsules. 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.

•    unexplained bruising or bleeding from the nose or gums. Weakness or tingling from your

hands and feet.

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

•    mouth ulcers, malaise, fatigue, unexplained bruising, fever or sore throat may occassionally

occur

•    jaundice (yellowing of the skin or whites of eyes).

•    acute pancreatitis (symptoms include sever pain in your stomach radiating to the back, fever, feeling sick, being sick and loss of appetite).

•    very rarely, some patients may develop a skin rash especially when the skin is exposed to daylight and some patients may develop a condition known as systemic lupus erythematosus

(SLE). This usually causes inflammation or rheumatoid arthritis-like symptoms and can occur anywhere in the body.

Certain other unwanted 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.

5.    How to store Dytide Capsules

Keep out of the reach and sight of children.

Do not use Dytide Capsules after the expiry date which is stated on the box. If your Capsules are out of date, take them to your pharmacist who will get rid of them safely.

Do not store above 30°C. Store in the original package.

6.    Further information

Each Dytide Capsules contains 50mg of trimterene and 25mg of benzthiazide.

Dytide Capsules also contains magnesium stearate, lactose, erythrosine E127, indigocarmine E132, titanium dioxide E171.

What Dytide Capsules look like and contents of the pack

Dytide Capsules are clear, colourless capsules with opaque maroon caps, 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.

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 March 2014.