CANDESARTAN 32 mg /12,5 Mg Tabletka Powlekana

Treść ulotki

1. What is Candesartan and Hydrochlorothiazide Mylan and what is it used for
2. What you need to know before taking Candesartan and Hydrochlorothiazide Mylan
3. How to take Candesartan and Idroclorotiazide Mylan
4. Possible side effects
5. How to store Candesartan and Hydrochlorothiazide Mylan
6. Package Contents and Other Information

Candesartan and Hydrochlorothiazide Mylan 32 mg/ 12.5 mg tablets
Candesartan and Hydrochlorothiazide Mylan 32 mg/ 25 mg tablets
(candesartan cilexetil/hydrochlorothiazide)
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Candesartan and Hydrochlorothiazide Mylan is and what it is used for
• 2. What you need to know before you take Candesartan and Hydrochlorothiazide Mylan
• 3. How to take Candesartan and Hydrochlorothiazide Mylan
• 4. Possible side effects
• 5. How to store Candesartan and Hydrochlorothiazide Mylan
• 6. Contents of the pack and other information.

1. What is Candesartan and Hydrochlorothiazide Mylan and what is it used for

The name of this medicine is Candesartan and Hydrochlorothiazide Mylan. It is used to treat high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to reduce blood pressure.

• Candesartan cilexetil belongs to a group of medicines known as angiotensin II receptor antagonists. It causes blood vessels to relax and widen. This helps to lower blood pressure.
• Hydrochlorothiazide belongs to a group of drugs called diuretics (tablets that promote diuresis). It helps the body to eliminate water and salts, such as sodium, present in the urine. This helps to lower blood pressure.

Your doctor may prescribe Candesartan and Hydrochlorothiazide Mylan if your blood pressure has not been adequately controlled with candesartan cilexetil or hydrochlorothiazide administered alone.

2. What you need to know before taking Candesartan and Hydrochlorothiazide Mylan

Do not take Candesartan and Hydrochlorothiazide Mylan:

• if you are allergic to candesartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamide medicines (such as cotrimoxazole). If you are not sure if this applies to you, ask your doctor.
• If you are pregnant for more than 3 months. (it is best to avoid the use of Candesartan and Hydrochlorothiazide Mylan even during the early stages of pregnancy - see the section Pregnancy)
• if you have severe kidney problems
• if you have a severe liver disease or bile obstruction (a problem with the drainage of bile from the gallbladder)
• if you consistently have low levels of potassium in your blood despite being treated to increase them
• if you consistently have high levels of calcium in your blood despite being treated to reduce them
• if you have suffered from gout
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren.

If you are not sure if these conditions apply to you, talk to your doctor or pharmacist before
taking Candesartan and Hydrochlorothiazide Mylan.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Mylan:

• if you havehad skin cancer in the past or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartan and Hydrochlorothiazide Mylan
• if you havediabetes or are at risk of developing it
• if you haveother problems with your liver or kidneys
• if you haveheart problems such as heart failure (a weakening of the heart muscle)
• if you havea narrowing of the heart valves or a thickening of the heart muscle that may affect blood flow from the heart
• if you havehad a kidney transplant
• if you havea narrowing of the renal artery
• if you havelow levels of sodium in your blood, are very dehydrated or have been vomiting, have recently vomited a lot or have diarrhoea
• if you arebeing treated with high doses of diuretics or pass large amounts of urine
• if you havea disease of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism)
• if you have hada disease called systemic lupus erythematosus (SLE)
• if you sufferfrom low blood pressure
• if you have hada stroke, a heart attack or if you suffer from angina (or experience reduced blood flow to the brain)
• if you haveever suffered from allergies or asthma
• you must tellyour doctor if you suspect (or are planning) a pregnancy. Candesartan cilexetil/Hydrochlorothiazide is not recommended during the early stages of pregnancy and the product should not be taken if you are pregnant for more than 3 months as, if taken at that time of pregnancy, it could seriously harm the baby (see the section pregnancy)
• if you are takingany of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril) especially if you have kidney problems related to diabetes
• Aliskiren
• if you are takingan ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used for the treatment of heart failure (see “Other medicines and Candesartan and Hydrochlorothiazide Mylan”).
• If you have 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 in pressure in the eye and can occur within hours to weeks after taking Candesartan and Hydrochlorothiazide Mylan Generics. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing it.

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 the information in the section “Do not take Candesartan and Hydrochlorothiazide Mylan”.

During treatment

• The doctor may need to check the levels of potassium, sodium and magnesium etc. in the blood during treatment.
• This medicine may also affect the result of some blood tests. If you are going to have a blood test, tell your doctor or hospital staff that you are taking this medicine.
• If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Mylan. This is necessary because, when combined with some anesthetics, candesartan and hydrochlorothiazide can cause a drop in blood pressure or interfere with some medicines used during surgery.
• If you are going to have a diagnostic imaging procedure (to visualize parts of your body) tell your doctor or hospital staff that you are taking this medicine. The use of iodine in diagnostic imaging may increase the risk of side effects.
• This medicine may make your skin more sensitive to sunlight. If this happens, do not use sunbeds, tanning beds and use sunscreen or cover up with clothing when exposed to the sun.

Other medicines and Candesartan and Hydrochlorothiazide Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Candesartan and Hydrochlorothiazide Mylan can affect the activity of some other medicines and some
medicines can have an effect on Candesartan and Hydrochlorothiazide Mylan. Your doctor may
need to change the dose and/or take other precautions. If you are being treated with
some medicines, your doctor may prescribe blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines:

• other medicines that help to lower blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril or aliskiren (see also the information in the section “Do not take Candesartan and Hydrochlorothiazide Mylan” and “Warnings and precautions”).
• An ACE inhibitor together with some medicines for treating heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines for relieving pain and inflammation)
• acetylsalicylic acid (aspirin) (if you take more than 3 g per day), (medicine for relieving pain and inflammation)
• potassium supplements or salt substitutes containing potassium or medicines that increase potassium levels in the blood such as heparin (a medicine for thinning the blood) or co- trimoxazole also known as trimethoprim/sulfamethoxazole (a medicine used to treat bacterial infections).
• medicines that can affect the amount of potassium in the blood (medicines such as diuretics, laxatives, penicillin (an antibiotic), amphotericin (for the treatment of fungal infections), carbenoxolone (for the treatment of problems with the esophagus, or oral ulcers), steroids such as prednisolone, pituitary hormone (ACTH).
• calcium or vitamin D supplements.
• medicines for lowering cholesterol, such as colestipol or colestyramine
• medicines for diabetes (tablets such as metformin or insulin)
• medicines for controlling the heartbeat (antiarrhythmics), such as quinidine, disopyramide, amiodarone, sotalol, ibutilide
• other medicines that can affect the heartbeat such as cisapride (for stomach problems), erythromycin, sparfloxacin, pentamidine (antibiotics), halofantrine (for the treatment of malaria), terfenadine (antihistamine).
• some antipsychotic medicines that can be affected by potassium levels in the blood such as thioridazine, chlorpromazine, trifluperazine, haloperidol, amisulpride, lithium (a medicine for the treatment of mental health problems)
• medicines for treating cancer (such as methotrexate (which can also be used for other conditions such as psoriasis, arthritis) and cyclophosphamide)
• amantadine, (for the treatment of Parkinson's disease or severe viral infections)
• barbiturates (a type of sedative also used to treat epilepsy)
• anticholinergic agents such as atropine and biperiden
• cyclosporine, a medicine used in case of organ transplantation to prevent organ rejection
• other medicines that can strengthen the antihypertensive effect such as baclofen (a medicine for relieving spasticity), amifostine (used in cancer treatment) and some antidepressant medicines (such as amitriptyline, clomipramine, dosulepin).
• adrenaline, or noradrenaline, sometimes used as adjuvants in hypertension therapy or, sometimes, for the treatment of severe allergic reactions.

Candesartan and Hydrochlorothiazide Mylan with alcohol
If you are prescribed Candesartan and Hydrochlorothiazide Mylan, talk to your doctor before drinking alcohol.
Alcohol can cause you to faint or feel dizzy.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you suspect (or are planning) a pregnancy. Usually your doctor will advise you to stop treatment with candesartan cilexetil and hydrochlorothiazide before you
become pregnant or as soon as pregnancy is confirmed and will prescribe another medicine for
you to use instead of Candesartan and Hydrochlorothiazide Mylan. Candesartan cilexetil and Hydrochlorothiazide is not
recommended during pregnancy and should not be taken if you are pregnant for more than 3 months as,
if taken after the third month of pregnancy, it could seriously harm your baby.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Candesartan and
Hydrochlorothiazide Mylan is not recommended for mothers who are breastfeeding and if you want
to continue breastfeeding your baby your doctor may decide to prescribe alternative treatment.

Driving and using machines
Some patients may feel tired or dizzy when taking candesartan cilexetil and
hydrochlorothiazide. If these effects occur, do not drive and do not use any tools or
machinery.

Candesartan and Hydrochlorothiazide Mylan contains lactose
If you have been diagnosed with an intolerance to some sugars, such as lactose, contact your doctor
before taking this medicine.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

3. How to take Candesartan and Idroclorotiazide Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist. It is important that you take Candesartan and
Idroclorotiazide Mylan every day. The recommended dose of Candesartan and Idroclorotiazide Mylan is
one tablet once a day.
Swallow the tablet with a glass of water. You can take Candesartan and Idroclorotiazide Mylan with or
without food.
Try to take the tablet every day at the same time, usually in the morning. This will help you to
remember to take it.

Use in children and adolescents
There is no experience regarding the use of candesartan cilexetil and hydrochlorothiazide in children (under 18
years of age). Therefore, the use of Candesartan and Idroclorotiazide Mylan is not recommended in children.
The score line is not intended for breaking the tablet.

If you take more Candesartan and Idroclorotiazide Mylan than you should:
If you take more Candesartan and Idroclorotiazide Mylan than prescribed by your doctor, contact your
doctor or pharmacist immediately. A significant drop in blood pressure may occur,
which may cause dizziness, or an increase in heart rate or irregular heartbeat, muscle cramps, or in some cases you may feel very sleepy or experience a
reduction in consciousness.

If you forget to take Candesartan and Idroclorotiazide Mylan:
DO NOTtake a double dose to make up for a missed dose .Simply take the
next dose as usual.

If you stop taking Candesartan and Idroclorotiazide Mylan:
If you stop taking Candesartan and Idroclorotiazide Mylan, your blood pressure may
rise again. For this reason, do notstop taking this medicine without first
consulting 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 that you are aware of what these side effects may be. Some side effects of Candesartan and Idroclorotiazide Mylan are caused by candesartan
cilexetil, while others are caused by hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide Mylan and contact your doctor immediately if you experience any of the following allergic reactions:
Rare (may affect up to 1 in 1,000 people)

• difficulty breathing, swelling of the face, lips, tongue and/or throat which may cause difficulty swallowing, severe skin itching (with bumps)
• liver problems, including inflammation of the liver (hepatitis). You may notice tiredness, yellowing of the skin and the whites of your eyes, dark urine, pale stools or stomach pain
• difficulty breathing (due to fluid in the lungs and swelling of the lungs)
• inflammation of the pancreas. This can cause moderate to severe stomach pain
• severe skin rash developing rapidly with blisters or peeling of the skin and, possibly, blisters in the mouth
• development or worsening of pre-existing lupus-like reactions (including signs such as rash on the face, joint pain, muscle disorders and fever)
• reduction in red blood cells, white blood cells or platelets. You may experience tiredness, more frequent infections (e.g. sore throat, mouth ulcers), fever, bruising or bleeding. This may be due to reduced production of blood cells in the bone marrow (bone marrow depression)

Very rare (may affect up to 1 in 10,000 people)

• kidney failure, especially if you already have kidney problems or heart failure. You may experience back pain, little or no urination, cloudy urine or blood in your urine.

Frequency not known (the frequency cannot be estimated from the available data)

• skin cancer and lip cancer (non-melanoma skin cancer)
• blurred vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Other possible side effects include:
Common (may affect up to 1 in 10 people):

• changes in blood test results:
• low levels of sodium in the blood. In severe cases this can cause fatigue, lack of energy or muscle cramps
• increase or decrease in potassium levels in the blood, especially if you have kidney problems or heart failure. In severe cases, you may notice tiredness, fatigue, irregular heartbeat or tingling.
• increased levels of cholesterol or fats, sugar or uric acid in the blood
• sugar in the urine
• feeling dizzy/lightheaded or weak
• headache
• lung infection (including symptoms such as the common cold, flu-like symptoms)

Not common (may affect up to 1 in 100 people):

• low blood pressure, which can make you feel weak or faint, especially when getting up from a sitting or lying position.
• loss or lack of appetite, diarrhoea, constipation, stomach irritation
• skin rash, rash caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people):

• reduced kidney function detectable in blood tests
• difficulty sleeping, depression, restlessness
• tingling or prickling in the arms or legs
• blurred vision for a short period
• irregular heartbeat
• high temperature (fever)
• muscle cramps
• damage to blood vessels, resulting in red or purple spots on the skin
• increased urea in the blood or certain proteins (creatinine) in the blood detectable in blood tests

Very rare (may affect up to 1 in 10,000 people):

• itching
• back pain, joint or muscle pain
• changes in your liver function identifiable in blood tests
• cough
• nausea (feeling sick)

Frequency not known (the frequency cannot be estimated from the available data)

• myopia (inability of the eye to focus on distant objects)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Candesartan and Hydrochlorothiazide Mylan

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 packaging, on the blister or on the
bottle after the words “EXP.” The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.

Blister packs:Store in the original packaging.

Bottle packs:Keep the container tightly closed. Do not ingest or remove
the desiccant contained in the bottle.
Use within 90 days after first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Candesartan and Hydrochlorothiazide Mylan contains
The active ingredients are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg/25 mg of hydrochlorothiazide.
The other ingredients are calcium carmellose, glycerol monostearate, hydroxypropylcellulose, lactose
monohydrate, magnesium stearate, corn starch, yellow iron oxide (E172). In addition, the 32
mg/25 mg tablets also contain red iron oxide (E172).

Description of the appearance of Candesartan and Hydrochlorothiazide Mylan and package contents
Candesartan and Hydrochlorothiazide Mylan 32 mg/12.5 mg are yellow, mottled,
round, biconvex tablets with “CH” imprinted above the score line and with "3" imprinted below
the same on one side and with "M" imprinted on the other side.
Candesartan and Hydrochlorothiazide Mylan 32 mg/25 mg are peach-colored, mottled,
round, biconvex tablets with “CH” imprinted above the score line and with "4" imprinted below
the same on one side and with "M" imprinted on the other side.
Candesartan and Hydrochlorothiazide Mylan is available in blisters containing 10, 14, 15, 28, 56 or 98
tablets, in calendar packs containing 14, 28 or 56 tablets and in plastic bottles of 14, 30, 56 or
90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A. Via vittor Pisani 20, 20124 Milano, Italy

Manufacturer:
McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany– Candesartancilexetil/HCT Mylan 32 mg/ 12.5 mg, 32 mg/ 25 mg Tablets

Greece- Candesartan + Hydrochlorothiazide /Mylan 32mg/12.5mg, 32mg/25mg Tablet

Italy– Candesartan e Idroclorotiazide Mylan

Portugal– Candesartan + Hidroclorotiazida Mylan

Spain– Candesartán/Hidroclorotiazida MYLAN 32 mg/12.5 mg, 32 mg/ 25 mg comprimidos EFG