Candesartan and hydrochlorothiazide Mylan Generics: detailed information

Patient Information Leaflet

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

Candesartan cilexetil and Hydrochlorothiazide
Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Candesartan and Hydrochlorothiazide Mylan Generics is and what it is used for
What you need to know before taking Candesartan and Hydrochlorothiazide Mylan Generics
How to take Candesartan and Hydrochlorothiazide Mylan Generics
Possible side effects
How to store Candesartan and Hydrochlorothiazide Mylan Generics
Contents of the pack and other information

1. What Candesartan and Hydrochlorothiazide Mylan Generics is 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 substances: 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 helps blood vessels to relax and widen, which helps reduce blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as diuretics. It helps the body eliminate water and salts, such as sodium, through the urine. This helps lower blood pressure.

Your 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 should 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 medicines (such as cotrimoxazole). If you are unsure whether this applies to you, ask your doctor
You are more than 3 months pregnant (it is also advisable to avoid Candesartan and Hydrochlorothiazide Mylan Generics in early pregnancy (see section - Pregnancy))
You have severe kidney problems
You have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder)
You continuously have low levels of potassium in the blood despite treatment to increase them
You continuously have high levels of calcium in the blood despite treatment to reduce them
You have previously suffered from gout
You have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If you are unsure whether any 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 have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Candesartan and Hydrochlorothiazide Mylan Generics
You have diabetes or are at risk of developing diabetes
You have heart problems such as heart failure (a weakening of the heart muscle)
You have narrowing of heart valves or thickening of the heart muscle, which may affect blood flow from the heart
You have other liver or kidney problems
You have recently undergone a kidney transplant
You have renal artery stenosis (narrowing of the artery to the kidney)
You have low levels of sodium in the blood, are severely dehydrated, or are vomiting, have recently vomited frequently, or have diarrhoea
You are being treated with high doses of diuretics (medicines that increase urine production) or are urinating excessively
You have a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism)
You have ever had a disease called systemic lupus erythematosus (SLE)
You have low blood pressure
You have had a stroke, heart attack, or suffer from angina (or reduced blood flow to the brain)
You have previously had allergic reactions or asthma
You must inform your doctor if you think you are pregnant (or could become pregnant). Candesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see section Pregnancy)
You are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- Aliskiren
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 increased pressure in the eye and may occur from a few hours to weeks after taking Candesartan and Hydrochlorothiazide Mylan Generics. This may lead to permanent loss of vision if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing such a reaction.

Your doctor may check your kidney function, blood pressure, and levels 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 Generics”.

During treatment

This medicine may affect the results of certain blood tests. If you need to have blood tests, inform your doctor or hospital staff that you are taking this medicine.

If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Mylan Generics. This is because Candesartan and Hydrochlorothiazide Mylan Generics, in combination with certain anaesthetics, may cause excessive lowering of blood pressure.

If you are scheduled for an imaging diagnostic procedure (to visualise parts of your body), inform 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 may increase skin sensitivity to sunlight. If this occurs, do not use sunlamps or tanning booths, and use sunscreen or wear protective clothing when exposed to sunlight.

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 must not be given to children.

Other medicines and Candesartan and Hydrochlorothiazide Mylan Generics

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Candesartan and Hydrochlorothiazide Mylan Generics may affect how some other medicines work, and other medicines may affect Candesartan and Hydrochlorothiazide Mylan Generics.

If you are taking certain medicines, your doctor may need to prescribe periodic blood tests. Your doctor may consider it necessary to adjust your dose and/or take other precautions.

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

Other medicines that help lower blood pressure, including beta-blockers, diazoxide, ACE inhibitors such as enalapril, captopril, lisinopril or ramipril, or aliskiren (see also information in the sections “Do not take Candesartan and Hydrochlorothiazide Mylan Generics” and “Warnings and precautions”)
Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation)
Acetylsalicylic acid (aspirin) (if taking more than 3 g per day) (medicines to relieve pain and inflammation)
Potassium-containing preparations or salt substitutes containing potassium, or other medicines that increase potassium levels in the blood such as heparin (a medicine to thin the blood) or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (a medicine used to treat bacterial infections)
Medicines that may affect potassium levels in the blood [diuretics (medicines that help urinate), laxatives, penicillin (an antibiotic), amphotericin (for treating fungal infections), carbenoxolone (for treating oesophageal diseases or mouth ulcers), steroids such as prednisolone, pituitary hormone (ACTH)]
Calcium supplements or vitamin D
Medicines to lower cholesterol, such as cholestyramine or colestipol
Medicines for diabetes (tablets such as metformin or insulin)
Medicines to control heart rhythm (antiarrhythmics), such as quinidine, disopyramide, amiodarone, sotalol, ibutilide, digoxin
Other medicines that may affect heart rhythm, such as cisapride (for stomach problems), erythromycin, sparfloxacin, pentamidine (antibiotics), halofantrine (for treating malaria), terfenadine (an antihistamine)
Certain antipsychotic medicines that may affect potassium levels in the blood, such as thioridazine, chlorpromazine, trifluoperazine, haloperidol, amisulpride
Lithium (a medicine for mental health conditions)
Medicines for treating cancer such as methotrexate (which may be used to treat other conditions such as psoriasis, arthritis) and cyclophosphamide
Amantadine (for treating Parkinson's disease or severe viral infections)
Barbiturates (sedatives also used to treat epilepsy)
Anticholinergic agents such as atropine and biperiden
Cyclosporine, a medicine used to prevent organ transplant rejection
Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve spastic conditions), amifostine (used in cancer treatment), and certain antidepressants (such as amitriptyline, clomipramine, dosulepin)
Adrenaline or noradrenaline, sometimes used to help increase blood pressure or, occasionally, to treat severe allergic reactions

Candesartan and Hydrochlorothiazide Mylan Generics and alcohol

When Candesartan and Hydrochlorothiazide Mylan Generics is prescribed for you, talk to your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant or could become pregnant. Your doctor will usually advise you to stop taking candesartan cilexetil/hydrochlorothiazide before pregnancy or as soon as you know you are pregnant and will recommend an alternative medicine instead of Candesartan and Hydrochlorothiazide Mylan Generics. Candesartan cilexetil/hydrochlorothiazide is not recommended during pregnancy and must not be taken after the first trimester, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed.

Candesartan and Hydrochlorothiazide Mylan Generics is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you intend to breastfeed, especially if the baby is a newborn or was born prematurely.

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 operate tools or machinery.

Candesartan and Hydrochlorothiazide Mylan Generics contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Candesartan and Hydrochlorothiazide Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.
It is important that you take Candesartan and Hydrochlorothiazide Mylan Generics every day.
The recommended dose is 1 tablet of Candesartan and Hydrochlorothiazide Mylan Generics once daily. You may take Candesartan and Hydrochlorothiazide 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 remember to take it.

If you take more Candesartan and Hydrochlorothiazide Mylan Generics than you should
If you take more Candesartan and Hydrochlorothiazide Mylan Generics than prescribed, contact your doctor or pharmacist immediately for advice. A severe drop in blood pressure may occur, which could cause dizziness, or you may experience increased heart rate or irregular heartbeat, muscle cramps, or in some cases feel very sleepy or experience reduced consciousness.

If you forget to take Candesartan and Hydrochlorothiazide Mylan Generics
Do not take a double dose to make up for the forgotten dose. Simply take the next dose as usual.

If you stop taking Candesartan and Hydrochlorothiazide Mylan Generics
If you stop treatment with Candesartan and Hydrochlorothiazide Mylan Generics, your blood pressure may rise again. For this reason, the risk may increase. Do not stop taking the medicine without first talking to your doctor.

If you have any further questions about 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 which side effects may occur. Some of the side effects of Candesartan and Hydrochlorothiazide Mylan Generics are caused by candesartan cilexetil, while others are caused by hydrochlorothiazide.
If you experience any of the following side effects, stop taking Candesartan and Hydrochlorothiazide Mylan Generics and seek immediate medical help:
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 swelling of the skin (with raised skin rashes),
liver problems, including inflammation of the liver (hepatitis). You may experience fatigue, yellowing of the skin and whites of the eyes, dark urine, pale stools or stomach pain,
breathing difficulties (including lung inflammation and fluid in the lungs),
inflammation of the pancreas. This causes mild to severe stomach pain,
severe skin rash developing rapidly with blisters or peeling of the skin and, possibly, mouth blisters,
onset or worsening of lupus-like reactions (which include 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, increased susceptibility to infections (e.g. sore throat, mouth ulcers), fever or easy bruising or bleeding. This may be due to reduced blood cell production 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, or have cloudy urine or blood in the urine.

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

skin and lip cancer (non-melanoma skin cancer),
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).

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

changes in blood test results:
reduced sodium levels in the blood. If this is severe, you may experience weakness, lack of energy or muscle cramps,
increased or decreased potassium levels 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,
presence of sugar in the urine,
feeling dizzy, lightheaded or weak,
headache,
lung infection (which may include symptoms such as 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 standing up from a sitting or lying position,
loss of appetite, diarrhoea, constipation, gastric irritation,
skin rash, rash caused by light sensitivity.

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

reduced kidney function detectable in blood tests,
difficulty sleeping, depression, restlessness,
tingling or prickling sensations in the arms or legs,
blurred vision for a short period,
abnormal heartbeat,
high temperature (fever),
muscle cramps,
damage to blood vessels causing red or purple spots on the skin,
increased blood urea 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 unwell).

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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 and on the blister after the words
“Exp.”. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6 Contents of the packaging and other information

What Candesartan and Hydrochlorothiazide Mylan Generics contains

The active substances 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 carmellose, glycerol monostearate, hydroxypropylcellulose, lactose monohydrate, maize starch, magnesium stearate, yellow iron oxide (E172). Additionally, the 16 mg/12.5 mg tablets 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.
Candesartan and Hydrochlorothiazide Mylan Generics 16 mg/12.5 mg tablets are peach-coloured, mottled, round, biconvex, with “M” engraved on one side and “CH2” on the other.

Candesartan and Hydrochlorothiazide Mylan Generics is available in blisters containing 28 tablets.
Not all pack sizes may be marketed. Unused material should be disposed of in accordance with local regulations.

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

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

This medicine is authorised in the Member States of the European Economic Area under the
following names:
Germany – Candesartadura plus 8/12,5 mg Tabletten, 16/12,5 mg Tabletten
Italy – Candesartan and hydrochlorothiazide Mylan Generics 8 mg/12.5 mg or 16 mg/12.5 mg