CANDESARTAN 8 mg /12.5 Mg Coated Tablet

Зміст інструкції

1. Candesartan and Hydrochlorothiazide Mylan Generics 8 mg/12.5 mg tablets, 16 mg/12.5 mg tablets
   1. What is Candesartan and Hydrochlorothiazide Mylan Generics and what it is used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide Mylan Generics
   3. How to take Candesartan and Idroclorotiazide Mylan Generics
   4. Possible side effects
   5. How to store Candesartan and Hydrochlorothiazide Mylan Generics

Candesartan and Hydrochlorothiazide Mylan Generics 8 mg/12.5 mg tablets, 16 mg/12.5 mg tablets

Candesartan cilexetil and Hydrochlorothiazide

Generic medicine

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

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

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

• Candesartan cilexetil belongs to a group of medicines known as angiotensin II receptor antagonists. It causes blood vessels to relax and widen, which helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines known as diuretics. It helps the body to eliminate water and salts, such as sodium, in the urine. This helps to lower blood pressure.

The doctor may prescribe Candesartan and Hydrochlorothiazide Mylan Generics if your blood pressure
has not been adequately controlled by candesartan cilexetil or hydrochlorothiazide alone.

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

Do not take Candesartan and Hydrochlorothiazide Mylan Generics if:

• You are allergic to candesartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• You are allergic to sulfonamide-based medicines (such as, for example, cotrimoxazole). If you are not sure if this applies to you, ask your doctor
• You are pregnant for more than 3 months (it is also better to avoid Candesartan and Hydrochlorothiazide Mylan Generics at the beginning of pregnancy (see section - Pregnancy)).
• You have severe kidney problems.
• You suffer from severe liver disease or bile duct obstruction (a problem with the drainage of bile from the gallbladder) Page 1 of 8
• You have persistently low levels of potassium in your blood despite treatment to increase them
• You have persistently high levels of calcium in your blood despite treatment to decrease them
• You have suffered from gout
• 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 whether one or more of the above conditions apply to you, contact your doctor or pharmacist before starting to take Candesartan and Hydrochlorothiazide Mylan Generics.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Mylan Generics, 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 Generics
• Yousuffer from diabetes or are at risk of developing diabetes
• Youhave heart problems such as heart failure (a weakening of the heart muscle)
• Youhave a narrowing of the heart valves, or a thickening of the heart muscle, which may affect blood flow from the heart.
• Youhave other problems with the liver or kidneys
• Youhave recently had a kidney transplant
• Youhave a narrowing of the renal artery
• Youhave low levels of sodium in your blood, are very dehydrated or have been vomiting a lot recently, or have diarrhea
• Youare being treated with high doses of diuretics (medicines that increase urine production) or are urinating a lot
• Yousuffer from a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism)
• Youhave ever had a disease called systemic lupus erythematosus (SLE)
• Youhave low blood pressure
• Youhave had a stroke, heart attack or suffer from angina (or reduced blood flow to the brain)
• Youhave ever had allergic reactions or asthma in the past
• Youshould tell your doctor if you think you may be pregnant (or could become pregnant). Candesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and should not be used after the third month of pregnancy, as it can cause serious harm to your baby if used during this period (see the Pregnancy section).
• Youare taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes
• Aliskiren
• 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 from a few 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 more at 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.
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See also the information in the section “Do not take Candesartan and Hydrochlorothiazide Mylan Generics”.

During treatment
This medicine may affect the result of some blood tests. Ifyou are going to have blood tests, tell your doctor or hospital staff that you are taking this medicine.

Ifyou are going to have surgery, tell your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Mylan Generics. This is because Candesartan and Hydrochlorothiazide Mylan Generics, in combination with some anesthetics, can cause an excessive drop in blood pressure.

Ifyou 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 imaging diagnostics may increase the risk of side effects.
Candesartan and Hydrochlorothiazide Mylan Generics can cause an increase in the sensitivity of the skin to the sun. If this happens, do not use sunbeds, tanning booths and use sunscreen or wear clothes when exposed to the sun.

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

Other medicines and Candesartan and Hydrochlorothiazide Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
Candesartan and Hydrochlorothiazide Mylan Generics can affect how some other medicines work and other medicines can have an effect on Candesartan and Hydrochlorothiazide Mylan Generics.
If you are using certain medicines, your doctor may need to prescribe you periodic blood tests. The doctor may need to change the dose and/or take other precautions.
In particular, tell your doctor if you are taking any of the following medicines:

• other medicines that help to reduce blood pressure, including beta-blockers, diazoxide, ACE inhibitors, such as enalapril, captopril, lisinopril or ramipril or aliskiren (see also the information in the sections “Do not take Candesartan and Hydrochlorothiazide Mylan” and “Warnings and precautions”).
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (medicines for relieving pain and inflammation)
• acetylsalicylic acid (aspirin) (if you take more than 3 g per day) (medicines for relieving pain and inflammation)
• potassium preparations or salt substitutes containing potassium or other medicines that increase the amount of potassium in the blood such as heparin (a medicine for thinning the blood) or cotrimoxazole also known as trimethoprim / sulfamethoxazole (a medicine used to treat bacterial infections).
• medicines that can affect the amount of potassium in the blood [medicines that help you urinate (diuretics), laxatives, penicillin (an antibiotic), amphotericin (for treating fungal infections), carbenoxolone (for treating diseases of the esophagus or mouth 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, digoxin
• other medicines that can affect the heart rhythm, such as cisapride (for stomach problems), erythromycin, sparfloxacin, pentamidine (antibiotics), alofantrine (for the treatment of malaria), terfenadine (antihistamine)
• some antipsychotic medicines that can affect potassium levels in the blood such as thioridazine, chlorpromazine, trifluoperazine, haloperidol, amisulpride
• lithium (a medicine for mental health problems)
• medicines for treating cancer such as methotrexate (which can be used to treat other conditions such as psoriasis, arthritis) and cyclophosphamide
• amantadine (for the treatment of Parkinson's disease or severe viral infections)
• barbiturates (sedatives also used to treat epilepsy)
• anticholinergic agents such as atropine and biperidene
• cyclosporine, a medicine used to prevent rejection after an organ transplant
• other medicines that can lead to an increase in the antihypertensive effect, such as baclofen (a medicine for relieving spastic states), amifostine (used in cancer treatment) and some antidepressant medicines (such as amitriptyline, clomipramine, dosulepine)
• adrenaline or noradrenaline, sometimes used to help increase blood pressure or, sometimes, for the treatment of severe allergic reactions.

Candesartan and Hydrochlorothiazide Mylan Generics with alcohol
When you are prescribed Candesartan and Hydrochlorothiazide Mylan Generics talk to your doctor before drinking alcohol. Alcohol can make you feel faint or dizzy.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should tell your doctor if you think you may be pregnant or if you could become pregnant. Usually your doctor will advise you to stop taking candesartan cilexetil/hydrochlorothiazide before the start of pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Candesartan and Hydrochlorothiazide Mylan Generics. Candesartan cilexetil/hydrochlorothiazide is not recommended in pregnancy and should not be taken after the first trimester, as it can cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
Candesartan and Hydrochlorothiazide Mylan Generics is not recommended in breastfeeding mothers and your doctor may choose another treatment for you if you intend to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Some people may experience fatigue or dizziness during treatment with candesartan cilexetil/hydrochlorothiazide. If this happens to you, do not drive and do not use tools or machines.

Candesartan and Hydrochlorothiazide Mylan Genericscontainslactose.
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
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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 Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
It is important that you take Candesartan and Idroclorotiazide Mylan Generics every day.
The recommended dose is 1 tablet of Candesartan and Idroclorotiazide Mylan Generics once a
day. You can take Candesartan and Idroclorotiazide Mylan Generics with or without food.
Try to take the tablet at the same time each day, usually in the morning. This will help you to
remember to take it.

If you take more Candesartan and Idroclorotiazide Mylan Generics than you should
If you take more Candesartan and Idroclorotiazide Mylan Generics than you have been prescribed, contact
your doctor or pharmacist immediately for advice. A significant drop in blood
pressure may occur, which can 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 Generics
Donot take a double dose to make up for a forgotten dose. Simply take the next
dose as usual.

If you stop taking Candesartan and Idroclorotiazide Mylan Generics
If you stop taking Candesartan and Idroclorotiazide Mylan Generics, your blood pressure
may rise again. For this reason it may increase. Donot stop taking the medicine without
first talking to your doctor.
If you have any further questions regarding 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 the side effects can be. Some of the side effects of Candesartan and Idroclorotiazide Mylan Generics are caused by candesartan cilexetil,
while others are caused by hydrochlorothiazide.

If any of the following side effects occur, stop taking Candesartan and
Idroclorotiazide Mylan Generics and seek immediate medical attention:
Rare (may affect up to 1 in 1,000 people)

• difficulty breathing, swelling of the face, lips, tongue and/or throat, which can cause difficulty swallowing,
• severe skin swelling (with raised rashes),
• liver problems, including inflammation of the liver (hepatitis). You may experience fatigue, yellowing of the skin and the whites of the eyes, dark urine, pale stools or stomach pain
• difficulty breathing (including lung inflammation and fluid in the lungs)
• inflammation of the pancreas. This causes moderate to severe stomach pain
• severe rash that develops rapidly with blisters or peeling skin and, possibly, blisters in the mouth

Pag. 5 of 8

• appearance or worsening of reactions similar to lupus erythematosus (which includes the appearance of unusual skin reactions, facial rash, joint pain, muscle disorders and fever),
• reduction in the number of red blood cells, white blood cells or platelets. You may experience fatigue, an increased susceptibility to infections (e.g. sore throat, mouth ulcers), fever or easy bruising or bleeding. This may be due to reduced production of blood cells in the bone marrow (bone marrow suppression).

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

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

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

• skin and lip cancer (non-melanoma skin cancer) decreased 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) Other possible side effects are:Common (may affect up to 1 in 10 people):
• changes in blood test results:
• reduced amount of sodium in the blood. If this is severe, you may experience weakness, lack of energy or muscle cramps
• increase or decrease in the amount of potassium in the blood, especially if you already have kidney problems or heart failure. If these effects are severe, you may experience fatigue, weakness, irregular heartbeat and tingling
• increased cholesterol or fats, sugar or uric acid in the blood
• sugar in the urine
• feeling dizzy/lightheaded or weak
• headache
• lung infection (which may include signs such as a common cold, flu-like symptoms).

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

• low blood pressure. This may make you feel weak or dizzy, especially when getting up from a sitting or lying position
• loss or lack of appetite, diarrhea, constipation, stomach irritation
• rash, rash caused by sensitivity to light.

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

• reduced kidney function detectable in blood tests
• difficulty sleeping, depression, agitation
• feeling of 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 causing red or purple spots on the skin
• increased azotemia 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 and muscle pain
• changes in liver function, detectable in blood tests
• cough
• nausea (feeling sick). Pag. 6 of 8

Frequency not known (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, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, on the blister after the wording
“Scad.” (Expiry). The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Store in the original packaging to protect the medicine from light and moisture.
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.

6Contents of the pack and other information
What Candesartan and Hydrochlorothiazide Mylan Generics contains
The active ingredients are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 8 mg/16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
The excipients are: calcium carboxymethylcellulose, glycerol monostearate, hydroxypropylcellulose, lactose
monohydrate, corn starch, magnesium stearate, yellow iron oxide (E172). In addition, the tablets from
16 mg/12.5 mg also contain red iron oxide (E172).

What Candesartan and Hydrochlorothiazide Mylan Generics looks like and contents of the pack
Candesartan and Hydrochlorothiazide Mylan Generics 8 mg/12.5 mg tablets are yellow, mottled,
round, biconvex with “M” engraved on one side and “CH1” on the other side.
Candesartan and Hydrochlorothiazide Mylan Generics 16 mg/12.5 mg tablets are peach-colored,
mottled, round, biconvex with “M” engraved on one side and “CH2” on the other side.
Candesartan and Hydrochlorothiazide Mylan Generics is available in blisters of 28 tablets.
Not all pack sizes may be marketed. Unused material should be
disposed of according to local regulations.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer responsible for batch release:
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
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Generics [UK] Limited
Station Close, Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany –Candesartadura plus 8/12.5 mg Tablets, 16/12.5 mg Tablets

Italy– Candesartan e idroclorotiazide Mylan Generics 8 mg/12.5 mg or 16 mg/12.5 mg
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