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Co-Triamterzide Tablets

Document: leaflet MAH GENERIC_PL 13606-0096 change

Co-Triamterzide Tablets BP

(Co-triamterzide)

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

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

•    If you have any further questions, ask your doctor, or pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Co-triamterzide Tablets are and what they are used for

2.    What you need to know before you take Co-triamterzide Tablets

3.    How to take Co-triamterzide Tablets

4.    Possible side-effects

5.    How to store Co-trimterzide Tablets

6.    Contents of the pack and further information

1.    WHAT CO-TRIAMTERZIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Co-triamterzide Tablets belong to a group of medicines called diuretics. The medicine works by increasing the amount of urine passed by your kidneys, so removing excess water from the body and also reducing blood pressure.

Co-triamterzide Tablets are used for the treatment of high blood pressure and also for the treatment of water retention in heart failure or liver disease.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TRIAMTERZIDE TABLETS

Do not take Co-triamterzide if you:

•    Have had an allergic (hypersensitive) reaction with symptoms of a rash, itching or shortness of breath to triamterene or hydrochlorothiazide or other sulphonamide derived drugs or any excipients (see Section 6)

•    Suffer from kidney failure or liver disease

•    Suffer from uncontrolled diabetes leading to ketoacidosis

•    Suffer from Addison’s disease, an underactive adrenal gland

•    Are already taking potassium supplements or ACE inhibitors (see Section 2, Other medicines and Co-triamterzide)

•    Have been told by your doctor that you have high potassium in your blood.

•    Have been told by your doctor you have high calcium in your blood (Hypercalcaemia).

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before taking these tablets if you:

•    Have been told by your doctor that you have low potassium in your blood

•    Are over 65 years as your doctor may give you a blood test

•    Have kidney problems as you may need a blood test

•    Are already taking NSAIDs (non-steroidal anti-inflammatory drugs) as your doctor may give you a blood test

•    Have    cirrhosis    of the    liver    or reduced liver function

•    Have    gout

•    Have    diabetes

•    Have    pancreatitis

•    Have    systemic    lupus    erythematosus

•    Need a blood test for thyroid function or folic acid levels.

If you are over 65 years old, have kidney problems or are also taking an NSAID (Non-Steroidal Anti-inflammatory Drug) then your doctor will see you regularly to monitor your treatment and you may have to have blood tests.

Other medicines and Co-triamterzide

Are you taking any of the following medicines?

•    Other medicines used for the treatment of high blood pressure (e.g. an “ACE” inhibitor, another thiazide diuretic, loop diuretics, renin inhibitors, “Beta-blocker” or “Alpha-blocker”)

•    Corticosteroids (steroid hormones) or ACTH (adrenocortiocotropic hormone)

•    Potassium supplements

•    Cholestyramine or colestipol (used to help lower cholesterol level)

•    Non-steroidal anti-inflammatory drugs (for the treatment of arthritis and other painful conditions e.g. ibuprofen, aspirin)

•    Medicines for diabetes (e.g. insulin, chlorpropamide)


•    Carbamazepine (to treat epilepsy)

•    Lithium (for the treatment of depression)

•    Medicines for heart failure or palpitations/irregular heart beat

•    Medicines containing calcium or vitamin D (also sometimes called calciferol or ergocalciferol for the treatment of soft bones)

•    Steroid therapy (for the treatment of allergic and inflammatory disorders e.g. prednisolone)

•    Trilostane (for treatment of Chushing’s Syndrome)

•    An ulcer healing drug containing carbenoxolone

•    Ciclosporin or tacrolimus (used to prevent rejection of an organ following transplant)

•    Allopurinol (to treat gout)

•    Toremifene (an artificial hormone)

•    Amphoteracin or fluconazole (to treat fungal infections)

•    Medicines for respiratory diseases (e.g. theophylline)

•    Taking alcohol, barbiturates or narcotics with this medicine may lead to orthostatic hypotension

•    There is an increased risk or arrhythmias associated with certain medicines that when taken with Co-triamterzide may cause electrolyte disturbances such as cardiac glycosides, amisulpride, atomoxetine, pimozide, sotalol, sertindole and thioridazine

•    Cisplatin (used in chemotherapy)

•    Muscle relaxants (such as baclofen and tizanidine)

•    Oestrogen and oral contraceptives (e.g. drospirenone)

•    Antidepressants such as amitriptyline and reboxetine, and also Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine

•    Sympathomimetics used to stimulate the heart, e.g. dopamine and to treat asthma, e.g. salbutamol.

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

If you are already taking another medicine to reduce your blood pressure, your doctor may have reduced the dose of that medicine before you start taking the Co-triamterzide Tablets. If your doctor decides that you should take Co-triamterzide and an ACE inhibitor at the same time, your condition is likely to be checked regularly.

If you see another doctor or go into hospital, tell them what medicines you are taking. This is important if you have an operation because Co-triamterzide can interfere with medicines used during an operation to relax muscles.

Taking Co-triamterzide with food and drink

The tablets should be swallowed with a drink of water after meals.

Pregnancy and breast-feeding

Ask your doctor or pharmacist before taking any medicine during pregnancy and breast-feeding.

Driving and using machines

This medicine may cause some patients to feel weak, dizzy and have headaches. DO NOT drive or operate machinery if it has this effect on you.

Important information about some of the ingredients of Co-triamterzide Tablets

Co-triamterzide Tablets contain Sunset Yellow (E110) which can cause allergic reactions including asthma. Allergy is more common if you already are allergic to aspirin.

These tablets also contain Lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.

3. HOW TO TAKE CO-TRIAMTERZIDE TABLETS

Always take Co-triamterzide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual doses of this medicine are given below. Check with your doctor if you are not sure why you have been prescribed this medicine.

For the treatment of high blood pressure: The usual starting dose is one tablet a day (after breakfast). Your doctor may increase your dose if necessary.

For the treatment of oedema: The usual starting dose is one tablet twice a day, after meals. Your doctor may increase your dose if necessary.

Co-triamterzide Tablets are not recommended for children.

These are the usual doses. Your doctor may prescribe different doses to these. The label on the bottle will tell you what dose you should take and for how long. If you are still not sure ask your doctor or pharmacist.

If you take more Co-triamterzide Tablets than you should

Too many tablets at once may make you unwell. Contact

your doctor or your nearest casualty department at once if you have

taken too many tablets.

If you forgot to take Co-triamterzide Tablets

Do not worry. Take the missed dose as soon as you remember. However, if it is almost time for your next dose, leave out the missed dose and take your next dose at the right time.

Do not take a double dose to make up for a forgotten dose.


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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Co-triamterzide can cause side effects, although not everybody gets them.

If you experience any of the following for the first time after starting to take this medicine, STOP taking the tablets and tell your doctor immediately, these may be signs of an allergic reaction:

•    Serious allergic reaction - signs may include skin rashes, itching or hives, swelling of the face, lips, tongue or other parts of the body, difficulty breathing, feeling faint or dizzy.

•    Serious skin reactions such as Toxic Epidermal Necrolysis. Symptoms include flu like symptoms e.g. fever, cough, sore throat and runny nose for 2-3 days which develops into excessive peeling of the skin.

•    Other serious reactions include Systemic Lupus Erythmatous where symptoms include swollen or aching joints, skin rash which is usually on the face, weight change, sun or light sensitivity, hair loss and ulcers which usually occur in the mouth or the nose.

Other unwanted effects which may occur are:

•    Feeling sick (nausea), being sick (vomiting), dry mouth, severe abdominal pain (acute pancreatitis), diarrhoea, stomach discomfort.

•    Muscle cramps.

•    Weakness, thirst, fever.

•    This medicine can cause increased blood levels of cholesterol, and also a waste product produced by the body called urea, which may lead to gout. It can also alter the blood levels of minerals such as sodium, calcium and potassium. These will

be picked up in a blood test by your doctor.

•    Rash, sensitivity of the skin to sunlight or artificial light (photosensitivity).

•    Inflammation of the blood vessels (vasculitis - symptoms include fever, weight loss, fatigue, a rapid pulse and aches and pains that are difficult to pinpoint).

•    Gout (attacks of pain or swelling in more than one joint).

•    Metabolic acidosis (where the body produces excessive acid). Symptoms of metabolic acidosis include chest pain, pounding heat beat (palpitations) and headache.

•    Glucose in the urine (Glycosuria).

•    Increased levels of sugar in the blood (hyperglycaemia).

•    Kidney failure which is reversible on stopping this medicine, due to a disorder known as interstitial nephritis or acute interstitial nephritis (a disorder where spaces between the kidney tubules become swollen or inflamed). Reversible kidney failure can also occur due to an interaction between triamterene and some NSAIDs. Kidney or urinary stones.

•    Changes in the types and numbers of blood cells. These will be picked up during a blood test by your doctor.

•    Breathing difficulties including inflammation of lung tissue with a fever and cough (pneumonitis and interstitial pneumonitis), build up of fluid in the lungs (pulmonary oedema).

•    Headache, restlessness and dizziness.

•    Temporary blurring of vision and yellowing of vision (xanthopsia).

•    Thickening of the blood vessel walls (Vasculitis necrotising) symptoms include fever, chills, tiredness, weight loss, abnormal skin tissue, muscle and joint pain and tingling in the body.

•    Low blood volume (hypovolaemia).

•    Lowering of blood pressure.

•    Swelling in the mouth (Sialoadenitis).

•    Yellowing of the skin and/or whites of the eyes (Jaundice).

•    Serum sickness. This is a type of allergic reaction with symptoms such as rashes, itching, joint pain fever, swollen lymph nodes and tiredness.

•    Your urine may look blue under certain light.

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 CO-TRIAMTERZIDE TABLETS Keep out of the sight and reach of children.

Store below 25°C. Store in the original container.

Do not use Co-triamterzide Tablets after the expiry date which is


stated on the label. The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Co-triamterzide Tablets contains

The active substances are 50mg of triamterene and 25mg of hydrochlorothiazide as the active ingredients (together known as Co-triamterzide).

The other ingredients are:    Lactose

Modified cellulose gum Povidone

Microcrystalline cellulose Magnesium stearate Purified stearate Purified talc Sunset yellow (E110)

What Co-triamterzide Tablets look like and contents of the pack

Description:

Co-triamterzide Tablets are round and peach coloured, with a break line on one side and a pestle and mortar logo on the other side.

Contents of pack: Blister pack

The tablets are supplied to your pharmacist in packs containing 28, 30, 50, 100, or 500 tablets, who will then provide you with the required number of tablets as prescribed by your doctor (not all pack sizes may be marketed).

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Marketing Authorisation Holder and Manufacturer:

MA Holder:

Co-Pharma Limited

Unit 4, Metro Centre,

Tolpits Lane, Watford,

Herts. UK,

WD18 9SS Tel: 01923 255580 Fax: 01923 255581

Manufacturer:

Haupt Pharma Berlin GmbH,

Gradestrafle 13 Moosrosenstrafle 5and Britzer Damm 120

12347 Berlin

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Not applicable

This leaflet was last revised in 07/2015


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