CO-ZIDOCAPT 50/25 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CO-ZIDOCAPT 50/25 MG TABLETS

1. 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.

2. 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 anti-diabetic 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 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.

If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Co-zidocapt.
If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Co-zidocapt. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.
If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Co-zidocapt, seek medical attention immediately.

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 AntiInflammatory 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 the dose is changed or if you drink alcohol. If this is experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Co-zidocapt contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take co-zidocapt

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

These tablets are to be taken orally as a single dose in the morning.
These tablets should be taken independently of meals and with a generous amount of fluid.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

The recommended dose for adults is:

The usual dose is one tablet daily.

Elderly patients

The dose should be kept as low as possible to achieve adequate blood pressure control. In some patients, Co-zidocapt 25/12.5mg may be sufficient.

Patients with severe kidney problems:

Co-zidocapt is not recommended.

Use in children

Do not give this medicine to children.

If you take more Co-zidocapt than you should

If you accidentally take too many tablets, contact your doctor or nearest emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

The symptoms of overdose are: increased urine output, imbalance of fluids in the body, severely low blood pressure, loss of consciousness including coma, fits, loss of movement, irregular heartbeat, slowing of the heartbeat, kidney failure.

If you forget to take Co-zidocapt

Take it as soon as you remember, unless it is nearly time for your next dose.

If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Co-zidocapt

It is important that you keep taking Co-zidocapt for as long as your doctor has told you to. Do not stop taking the tablets even though you may feel better. Do not stop or change your treatment before talking to your doctor.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Co-zidocapt and seek medical advice immediately if you develop the following symptoms:

Allergic reactions: swelling of the hands, face, feet, eyelids, lips, tongue, throat, difficulty breathing, itching, dizziness (Anaphylaxis)
Blistering of the skin (Toxic Epidermal Necrolysis/Pemphigus), mouth, eyes or genitals (Stevens-Johnson Syndrome)
Fever, general ill feeling, itching, joint aches, multiple skin lesions (Erythema Multiforme)
Swelling of the deeper layers of the skin, caused by a build-up of fluid (Angioedema).

Common Side Effects (may affect up to 1 in 10 people):

Sleep disorders
Loss of taste and/or dry mouth
Dizziness or lightheadedness
Dry, persistent cough (this should stop after stopping treatment with Co-zidocapt)
Shortness of breath (Dyspnoea)
Feeling or being sick (Nausea/Vomiting)
Upset stomach and/or stomach pain
Diarrhoea
Constipation
Itching with or without a rash (Pruritus)
Skin rashes
Hair loss (Alopecia)
Stomach ulcer.

Uncommon Side Effects (may affect up to 1 in 100 people):

Faster heart beat (Tachycardia/Tachyarrhythmia)
Chest pain (Angina Pectoris)
Feeling your heartbeat (Palpitations)
Low blood pressure (Hypotension)
Tingling or numbness in the fingers, toes, ears or nose (Raynauds Syndrome)
Reddening of the face (Flushing) or paling of the skin (Pallor)
Chest pain
Feeling tired (Fatigue)
Generally unwell (Malaise)
Headache
Tingling or numbness in the hands or feet (Paraesthesia).

Rare Side Effects (may affect up to 1 in 100 people):

Loss of appetite (Anorexia)
Drowsiness
Inflammation and/or ulcers in the mouth (Stomatitis)
Swelling of the wall of the bowels (Intestinal Angioedema)
Kidney problems including kidney failure and inflammation of the kidneys (Interstitial Nephritis)
Passing urine less frequently (Oliguria)
Passing urine more frequently (Polyuria).

Very Rare Side Effects (may affect less than 1 in 10,000 people):

Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (Pancytopenia), especially in patients suffering from kidney problems
Reduction in red blood cells which may cause pale skin and feeling of tiredness (Anaemia)
Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (Aplastic Anaemia)
Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (Haemolytic Anaemia)
Reduction in blood platelets, which increases the risk of bleeding or bruising (Thrombocytophenia)
Swollen/enlarged lymph nodes (Lymphadenopathy)
Auto-immune diseases and/or positive ANA-titres (a positive ANA, [Anti-Nuclear Antibody] titer can be the indication of a variety of diseases or conditions. This test is often used to diagnose auto-immune diseases, especially lupus
High levels of blood potassium which can cause abnormal heart rhythm (Hyperkalaemia)
Low blood sugar (Hypoglycaemia)
Increased acidity in the blood (Acidosis)
Confusion
Depression
Stroke (Cerebrovascular Accident [CVA])
Insufficient blood supply to the brain (Cerebrovascular Insufficiency)
Feeling faint (Syncope)
Blurred vision
Heart abruptly stops beating (Cardiac Arrest)
The blood supply being pumped by the heart muscle needs oxygen (Cardiogenic Shock)
Shortness of breath or difficulty in breathing (Bronchospasm/Allergic Alveolitis)
Cold-like symptoms: sneezing, itchiness, blocked/runny nose (Rhinitis)
Collective symptoms of cough, fever, difficulty breathing, and sweating at night (Eosinophilic Pneumonia)
Inflammation or infection of the tongue (Glossitis)
Inflammation of the pancreas (Pancreatitis)
Liver failure or other liver disorders including Jaundice (yellowing of skin and eyes)
Skin rashes with the formation of wheals (Urticaria)
Abnormal sensitivity of the skin to sunlight (Photosensitivity)
Skin disorders (Erythroderma/Exfoliative Dermatitis)
Muscle and/or joint pain (Myalgia/Arthralgia)
Protein in the urine (Nephrotic Syndrome/Proteinuria)
Inability to maintain an erection (Impotence)
Excessive development of the male breast (Gynaecomastia)
Fever
Frequent wheezing, breathlessness, stomach pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (Eosinophilia)
Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (Hyponatraemia)
Increase of urea or creatinine in the blood (may be a sign of kidney problems)
Decrease in levels of haemoglobin (a protein that transports oxygen) in the blood
Decrease in levels of haematocrit (a blood test [as part of a complete blood count] that measures

the percentage of red blood cells [depending on the number and size of red blood cells] of the volume of whole blood)

Increased Erythrocyte Sedimentation Rate [ESR] (a blood screening test that indirectly measures how much inflammation is in the body)
Weight loss
Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Other side effects (frequency not known)

Serum sickness (a type of delayed allergic reaction)
Inflammation of the salivary glands (Sialadentitis)
Abnormal condition of the bone marrow in which it is unable to produce normal amounts of red blood cells, white blood cells, and platelets leaving the immune system in a weakened state and vulnerable to infection (Bone Marrow Depression)
High blood sugar levels (Hyperglycaemia)
Glucose in the urine (Glycosuria)
Abnormally high level of uric acid in the blood (Hyperuricaemia)
Imbalance of fluids in the body. Symptoms include dry mouth, thirst, weakness, tiredness, drowsiness, restlessness, muscle pain, cramps, being/feeling sick (Electrolyte Imbalance)
Increased level of fats (cholesterol and triglyceride) in your blood
Restlessness
Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Eye disorders including objects appear yellow (Xanthopsia), nearsightedness in vision (Acute Myopia), sudden eye pain, red eyes and reduced vision caused by pressure inside the eye rising quickly (Acute Angle-Closure Glaucoma)
Feeling of dizziness or „spinning“ (Vertigo)
Low blood pressure which may cause dizziness, light-headedness or fainting on standing up (Postural Hypotension)
Inflammation and damage of the blood vessel walls that also affects the skin (Necrotising Angiitis)
Inflammation of the blood vessels often with skin rash (Vasculitis)
Inflammation of the lung (Pneumonitis) or an excess collection of watery fluid in the lungs

(Pulmonary Oedema)

Condition which causes joint pain, skin rashes and fever (Lupus Erythematosus)
Muscle spasm
Skin rash resulting from bleeding into the skin (Purpura)
General weakness
Skin and lip cancer (Non-melanoma skin cancer).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store co-zidocapt

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last date of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What Co-zidocapt contains:

Each 25/12.5mg tablet contains 25mg of Captopril and 12.5mg of Hydrochlorothiazide
Each 50/25mg tablet contains 50mg of Captopril and 25mg of Hydrochlorothiazide

The other ingredients are: lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose and stearic acid.

What Co-zidocapt looks like and contents of the pack:

Co-zidocapt 25/12.5mg are white to off-white, round tablets with an approximate diameter of 7mm with a score notch
Co-zidocapt 50/25mg are white to off-white, round tablets with an approximate diameter of 10mm with a score notch

Co-zidocapt is available in:

Co-zidocapt Tablets are available in packs of: 20, 28, 50 or 100 tablets.

Not all pack sizes may be marketed.

Product Licence Numbers

Co-zidocapt 25/12.5mg Tablets – PL 20416/0576
Co-zidocapt 50/25mg Tablets – PL 20416/0577