PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Co-zidocapt 25/12.5mg & 50/25mg Tablets

(Captopril + Hydrochlorothiazide)

□ What Co-zidocapt is and what it is used for

Co-zidocapt Tablets contain a combination of Captopril and Hydrochlorothiazide (HCT). Captopril is one of a group of medicines known as ACE (Angiotensin-Converting Enzyme) Inhibitors. These work by expanding your blood vessels making it easier for your heart to pump blood to your body. Hydrochlorothiazide (HCT) is one of a group of medicines known as Diuretics. These work by increasing the volume of urine you produce, therefore reducing the water content of your blood and in turn the volume of blood circulating in your body.

Captopril + Hydrochlorothiazide Tablets (referred to as Co-zidocapt throughout this leaflet) are used for the treatment of mild to moderate high blood pressure (hypertension) in patients who have been stabilised on the individual medicines given in the same proportions. The combination tablet of Captopril and Hydrochlorothiazide is particularly suitable for older patients and those patients requiring lower doses. By combining lower doses than might be required if each component were used alone, side effects can be minimised.

What you need to know before you take Co-zidocapt

Do not take Co-zidocapt if:

■    You are allergic to Captopril, Hydrochlorothiazide, other ACE Inhibitors, other Sulphonamides or any of the other ingredients of this medicine (listed in Section 6)

■    You are more than 3 months pregnant (It is also better to avoid Co-zidocapt in early pregnancy - see Pregnancy section)

■    You have suffered from swelling of the deeper layers of the skin, caused by a build-up of fluid linked to previous treatment with an ACE Inhibitor (angioedema)

■    You are prone to or have a history of red, itchy swelling of the eyes, lips, tongue, throat or hands (hereditary/idiopathic angioneurotic oedema)

■    You suffer from severe kidney problems

■    You suffer from severe liver problems

■    You have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor before taking Co-zidocapt:

■    If you are due to have a surgical operation. You should make sure that the anaesthetist is aware you are taking Co-zidocapt

■    If you are due to take an anti-doping test, a bentiromide test, thyroid tests or a urine test for acetone (see "Other medicines and Co-zidocapt")

■    If you are suffering from dehydration as a result of diuretic treatment, low salt diet, diarrhoea, vomiting (being sick) or dialysis. Symptoms of dehydration include: dry mouth, thirst, weakness, lack of energy, drowsiness, restlessness, muscle pain or cramps, low blood pressure (hypotension), decreased production of urine (oliguria), faster heartbeat (tachycardia) feeling (nausea) or being sick (vomiting)

■    If you suffer from heart failure or other heart problems

■    If you suffer from a condition that affects the circulation of blood to the brain

■    If you suffer from kidney problems or narrowing of the arteries in the kidneys

■    If you are black as black patients receiving ACE inhibitor treatment have been reported to have a higher incidence of angioedema (swelling of the deeper layers of the skin, caused by a build-up of fluid) than in non-black patients. Additionally, Co-zidocapt may be less effective in lowering blood pressure in black patients than in non-black patients

■    Patients with a history of angioedema (swelling of the deeper layers of the skin, caused by a build-up of fluid) unrelated to ACE inhibitor treatment may be at increased risk of developing angioedema while taking Co-zidocapt

■    If you are currently suffering from a dry, persistent cough (this will usually go after stopping treatment with Co-zidocapt)

■    If you suffer from liver problems

■    If you have high levels of potassium in the blood (hyperkalaemia), are currently taking potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes or other medicines associated with increases in potassium (e.g. heparin) (see "Other medicines and Co-zidocapt")

■    If you are diabetic, especially if you take oral antidiabetic medicines or insulin (see "Other medicines and Co-zidocapt")

■    If you suffer from collagen vascular disease (disease where problems with the immune system cause inflammation or weakness of collagen [connective tissue])

■    If you are receiving treatment to reduce your immune response

■    If you are taking allopurinol &/or procainamide (see "Other medicines and Co-zidocapt")

■    If you show signs of infection e.g. sore throat, fever

■    If you are receiving treatment to reduce the effects of an allergy to a bee or wasp sting

■    If you are on dialysis, especially with high-flux dialysis membranes

■    If you are having treatment to remove high levels of cholesterol by a procedure called Low-Density Lipoprotein (LDL) apheresis with dextran sulphate

■    If you are currently taking corticosteroids or ACTH [Adreno CorticoTropic Hormone] (see "Other medicines and Co-zidocapt")

■    If you have high levels of calcium in the blood (hypercalcaemia)

■    If you have an abnormally low level of magnesium in the blood (hypomagnesaemia)

■    If you have a history of allergic reactions or suffer from bronchial asthma

■    If you suffer from Systemic Lupus Erythematosus (long-term inflammation of skin)

■    If you are taking lithium (see "Other medicines and Co-zidocapt")

■    If you are taking any of the following medicines used to treat high blood pressure:

o    an angiotensin II receptor blocker (ARBs) (also

known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. o    aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.

potassium) in your blood at regular intervals. See also information under the heading "Do not take Co-zidocapt”

You must tell your doctor if you think you are (or might become) pregnant. Co-zidocapt tablets are not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (See Pregnancy section).

Other medicines and Co-zidocapt

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription. This includes herbal medicines.

Medicines which may interact or be affected by with Co-zidocapt:

■    If you are due to have a surgical procedure. You should make sure that the anaesthetist is aware you are taking Co-zidocapt

■    Clonidine, a medicine used to treat high blood pressure

■    Medicines used to increase frequency of urination e.g. spironolactone, triamterene, amiloride (Potassium-Sparing Diuretics), Thiazide Diuretics such as bendrofluazide and Loop Diuretics such as torasemide

■    Potassium-containing supplements or salt substitutes

■    Medicines used to treat high blood pressure such as propranolol (Beta Blockers), verapamil (Calcium Channel Blockers) and doxazosin (Alpha Blockers)

■    Medicines used to treat angina and heart failure e.g. nitroglycerine, other nitrates and other Vasodilators (medicines used to widen the blood vessels)

■    Medicines used to treat depression such as imipramine (Tricyclic Antidepressants)

■    Medicines used to treat mood disorders e.g. lithium (Anti-Psychotics)

■    Allopurinol, a medicine used to treat gout

■    Procainamide, a medicine used to treat irregular heartbeats (Cardiac Glycosides)

■    Medicines used to treat cancer such as cyclophosphamide (Cytostatics)

■    Medicines used to reduce the body's immunity when receiving organ transplant e.g. ciclosporin (Immunosuppressants)

■    Medicines used to treat serious allergic reaction (anaphylaxis) such as epinephrine (Adrenaline) (Sympathomimetics)

■    Medicines used to treat diabetes e.g. insulin, sulphonylurea (Antidiabetics)

■    Amphotericin B, a medicine used to treat fungal infections

■    Carbenoxolone, a medicine used to treat inflammation of the gullet and oral ulcers

■    Medicines used to reduce inflammation such as prednisolone (Corticosteroids)

■    Corticotropin (AdrenoCorticoTropic Hormone - ACTH)

■    Medicines used to treat constipation e.g. senna (Stimulant Laxative)

■    Cholestyramine, Colestipol, medicines used to lower cholesterol. (Co-zidocapt should be taken at least 1 hour before or 4-6 hours after taking these medicines)

■    Tubocurarine, a muscle relaxant

■    Medicines known to induce Torsades de Pointes such as erythromycin. This may include some Anti-Arrhythmics such as amiodarone and some Anti-Psychotics such as chlorpromazine

■    Carbamazepine, a medicine used to treat epileptic seizures

■    Medicines used to treat certain rheumatic disorders e.g. indomethacin (Non-Steroidal Anti-Inflammatory Drugs

- NSAIDs)

■    Medicines associated with increases in serum potassium e.g. heparin

Your doctor may need to change your dose and/or to take other precautions:

■    If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Co-zidocapt " and "Warnings and precautions")

Tests

■    Hydrochlorothiazide (HCT) contained in this medicine could produce a positive analytical result in an anti-doping test

■    Hydrochlorothiazide (HCT) contained in this medicine may cause diagnostic interference of a Bentiromide Test

■    Hydrochlorothiazide (HCT) contained in this medicine may affect thyroid tests

■    Captopril contained in this medicine may cause a false-positive urine test for acetone

Co-zidocapt and alcohol

During treatment with Co-Zidocapt, it is advisable not to drink alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Your doctor will normally advise you to stop taking Co-zidocapt before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Co-zidocapt. Co-zidocapt is not recommended during pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Treatment with Co-zidocapt is not recommended whilst breast-feeding premature or new-born infants.

In the case of an older baby, the use of Co-zidocapt may be considered if the treatment is necessary for the mother and the child is observed for any adverse side effects.

If Co-zidocapt is used during breast feeding, doses should be kept as low as possible.

An allergy (hypersensitivity) to sulphonamide-derived medicines, lower level of potassium in the blood than normal (hypokalaemia) and yellowing of the skin and/or the whites of the eyes (jaundice) might occur.

Driving and using machines

The ability to drive and use machines may be reduced,

This is more likely to occur at the start of treatment, when

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