Candesartan НСТ 32 mg / 12,5 mg. 30 tablets

1. What Candesartan HCT Actavis is and what it is used for
The name of your medicine is Candesartan HCT Actavis tablets. It is used to treat high blood pressure (hypertension) in adults and contains two active substances: candesartan cilexetil and hydrochlorothiazide. They work together to lower your blood pressure.

Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists, which cause blood vessels to relax and widen, thereby helping to lower your blood pressure.

Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets) and helps your body to get rid of excess water and salts, such as sodium, in your urine. This helps to lower your blood pressure.
Your doctor may prescribe Candesartan HCT Actavis if your blood pressure is not controlled enough with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before you take Candesartan HCT Actavis
Do not take Candesartan HCT Actavis:
if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
if you are allergic to sulphonamides. If you are not sure if this applies to you, please ask your doctor.
if you are more than 3 months pregnant (it is also better to avoid Candesartan HCT Actavis in early pregnancy - see pregnancy section).
if you have severe kidney problems.
if you have severe liver disease or gallbladder obstruction (a problem with the drainage of bile from the gallbladder).
if you have persistently low levels of potassium in your blood.
if you have persistently low levels of calcium in your blood.
if you have ever had gout.
if you have diabetes or impaired kidney function and are being treated with a blood pressure lowering medicine containing aliskiren.
If you are not sure if any of the above applies to you, please talk to your doctor or pharmacist before taking Candesartan HCT Actavis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan HCT Actavis:

if you have diabetes

if you have heart, liver or kidney problems

if you have recently had a kidney transplant

if you are vomiting, have recently had severe vomiting or have diarrhoea

if you have a disease of the adrenal gland called Conn’s syndrome (also called

primary hyperaldosteronism)

if you have ever had a disease called systemic lupus erythematosus (SLE)

if you have low blood pressure

if you have ever had a stroke

if you have ever had allergies or asthma

if you experience decreased vision or pain in your eye. These may be symptoms of fluid buildup in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may occur within hours to weeks of taking Candesartan HCT Actavis. This may lead to permanent loss of vision if left untreated. If you have previously had an allergy to penicillin or sulphonamides, you may be at higher risk of developing this complication if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren
if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV rays while taking Candesartan HCT Actavis.
if you have had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartan HCT Actavis, seek medical help immediately.
Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood.

See also the information under the heading “Do not take Candesartan Actavis”.

You must tell your doctor if you think you are (or might be) pregnant. Candesartan Actavis is 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).

If you have any of these conditions, your doctor may want you to see him more often and do some tests.

If you are going to have an operation, tell your doctor or dentist that you are taking Candesartan Actavis. This is because when Candesartan Actavis is combined with some anaesthetics, it can cause a drop in blood pressure.

Candace
Candesartan HCT Actavis may cause increased sensitivity of the skin to the sun.

Children and adolescents
There is no experience with the use of Candesartan HCT Actavis in children (under 18 years of age). Therefore, Candesartan HCT Actavis should not be given to children.

Other medicines and Candesartan HCT Actavis
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Candesartan HCT Actavis can affect the way some medicines work and some medicines can have an effect on Candesartan HCT Actavis. If you are taking certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell your doctor if you are taking any of the following medicines:

Other medicines that lower blood pressure, including beta-blockers, diazoxide and angiotensin converting enzyme (ACE) inhibitors, e.g. enalapril, captopril, lisinopril or ramipril
Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation)
Acetylsalicylic acid (if you take more than 3 g each day) (medicine to relieve pain and inflammation)
Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood)
Supplements containing calcium or vitamin D
Cholesterol-lowering medicines, e.g. colestipol or cholestyramine
Medicines to treat diabetes (tablets or insulin)
Medicines to control heart rate (antiarrhythmics), e.g. digoxin and beta-blockers
Medicines that may be affected by blood potassium levels, e.g. some antipsychotic medicines
Heparin (a medicine for thinning the blood)
Water tablets (diuretics)
Laxatives
Penicillin (an antibiotic)
Amphotericin (a medicine for fungal infections)
Lithium (a medicine for mental problems)
Steroids, e.g. prednisolone
Pituitary hormone (ACTH)
Medications for treating cancer
Amantadine (a medicine for Parkinson's disease or serious infections caused by viruses)
Barbiturates (a type of sedative medicine also used to treat epilepsy)
Carbenoxolone (a medicine for treating esophageal disease or mouth ulcers) Anticholinergics, e.g. atropine and biperiden
Cyclosporin - a medicine used in organ transplants to prevent organ rejection
Other medicines that may increase the antihypertensive effect, e.g. baclofen (a medicine for relieving spastic conditions), amifostine (used to treat cancer) and some antipsychotic medicines.
Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan HCT Actavis” and “Warnings and precautions”)
Candesartan HCT Actavis with food and drink
You can take Candesartan HCT Actavis with or without food.

When you are prescribed Candesartan HCT Actavis, ask your doctor before drinking alcohol. Alcohol may make you feel weak or dizzy.

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 or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Candesartan HCT Actavis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan HCT Actavis. Candesartan HCT Actavis is 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 after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or planning to breast-feed. Candesartan HCT Actavis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Driving and using machines
Some people may feel tired or dizzy when taking Candesartan HCT Actavis. If you are affected in this way, do not drive or use any tools or machines.

Candesartan HCT Actavis contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Candesartan HCT Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.

3. How to take Candesartan HCT Actavis
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
It is important to take Candesartan HCT Actavis every day.

The recommended dose of Candesartan HCT Actavis is one tablet once a day.
once a day.
Swallow the tablet with water.
Try to take your tablet at the same time each day. This will help you remember to take it.
If you take more Candesartan HCT Actavis than you should
If you take more Candesartan HCT Actavis than your doctor has prescribed, talk to your doctor or pharmacist straight away.

If you forget to take Candesartan HCT Actavis
Do not take a double dose to make up for a forgotten tablet. Just take the next dose as usual.

If you stop taking Candesartan HCT Actavis
If you stop taking Candesartan HCT Actavis, your blood pressure may increase again. Therefore, do not stop taking Candesartan HCT Actavis without first 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. It is important to know what these side effects may be. Some of the side effects of Candesartan HCT Actavis are caused by candesartan cilexetil and some by hydrochlorothiazide.

Stop taking Candesartan HCT Actavis and seek medical help immediately if you experience any of the following:
difficulty breathing, with or without swelling of the face, lips, tongue and/or throat
swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
severe itching of the skin (with raised rash)
very rare (may affect up to 1 in 10,000 people): acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).
Candesartan HCT Actavis may cause a decrease in the number of white blood cells. Your resistance to infections may be reduced and you may get tiredness, infection or fever. If this happens, contact your doctor. Your doctor may occasionally do blood tests to check whether Candesartan HCT Actavis has had any effect on your blood (agranulocytosis).

Other possible side effects are:
Common (may affect up to 1 in 10 people)
Changes in blood test results:
Reduced sodium in the blood. If severe, you may feel weak, lack of energy or muscle cramps
Increased or decreased potassium in the blood, especially if you already have kidney problems or heart failure. If severe, you may feel tired, weak, irregular heartbeat or tingling
Increased cholesterol, sugar or uric acid in the blood
Sugar in the urine
Feeling dizzy/lightheaded or weak
Headache
Respiratory tract infection
Uncommon (may affect up to 1 in 100 people)
Low blood pressure. This may make you feel weak or dizzy Loss of appetite, diarrhoea, constipation, stomach irritation
Skin rash, raised rash (urticaria), rash caused by sensitivity to light.
Rare (may affect up to 1 in 1,000 people)
Jaundice (yellowing of the skin or whites of the eyes). If this happens to you, contact your doctor immediately.
Effects on how your kidneys work, especially if you have kidney problems or heart failure.
Difficulty sleeping, depression, anxiety
Tingling or prickling in the hands or feet
Blurred vision for a short time
Improper heart rhythm
High temperature (fever)
Inflammation of the pancreas. This causes moderate to severe stomach pain.
Muscle spasms
Damage to blood vessels, leading to red or purple spots on the skin.
Decrease in red or white blood cells or platelets. You may experience tiredness, infection, fever or easy bruising.
Severe rash that develops rapidly, with blistering or peeling of the skin and possibly blistering in the mouth.
Worsening of existing lupus-like reactions or development of unusual skin reactions.
Very rare (may affect up to 1 in 10,000 people)
Swelling of the face, lips, tongue and/or throat
Itching
Back pain, joint and muscle pain
Changes in liver function, including inflammation of the liver (hepatitis). You may experience tiredness, yellowing of the skin and whites of the eyes and flu-like symptoms.
Cough
Nausea
Not known (frequency cannot be estimated from the available data)
Sudden nearsightedness
Reduced vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Diarrhea
5. How to store Candesartan HCT Actavis
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Tablet packaging:
Expiry date after first opening the tablet packaging: 6 months.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Candesartan HCT Actavis contains
The active substances are candesartan cilexetil and hydrochlorothiazide.
Candesartan HCT Actavis 8 mg/12.5 mg - each tablet contains 8 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.
Candesartan HCT Actavis 16 mg/12.5 mg - each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.
Candesartan HCT Actavis 32 mg/12.5 mg - each tablet contains 32 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.
Candesartan HCT Actavis 32 mg/25 mg - each tablet contains 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, corn starch, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate and triethyl citrate.
What Candesartan HCT Actavis looks like and contents of the pack
Candesartan HCT Actavis 8 mg/12.5 mg tablets are white, round, biconvex tablets with a score line on one side and engraved with CH8 on the same side. Candesartan HCT Actavis 16 mg/12.5 mg tablets are white, round, biconvex tablets with a score line on one side and engraved with CH16 on the same side. Candesartan HCT Actavis 32 mg/12.5 mg tablets are white, oval, biconvex tablets, measuring 12 mm x 7 mm, with a score line on the other side.

 

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