Candesartan and hydrochlorothiazide Mylan: detailed information

Package leaflet: Information for the patient

Candesartan and Hydrochlorothiazide Mylan 32 mg/12.5 mg tablets, 25 mg tablets

(candesartan cilexetil/hydrochlorothiazide)
Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Candesartan and Hydrochlorothiazide Mylan is and what it is 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 substances: 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 helps blood vessels to relax and widen. This helps lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (tablets that increase urine production). 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 if your blood pressure has not been adequately controlled with candesartan cilexetil or hydrochlorothiazide 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 unsure whether this applies to you, ask your doctor.
if you are more than 3 months pregnant. (It is advisable to avoid using Candesartan and Hydrochlorothiazide Mylan even during early pregnancy - see section on Pregnancy)
if you have severe kidney problems
if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder)
if you have persistently low levels of potassium in your blood despite treatment to increase them
if you have persistently high levels of calcium in your blood despite treatment to reduce them
if you have 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 unsure whether these conditions apply to you, consult 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 have previously had skin cancer or develop 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.
if you have diabetes or are at risk of developing it
if you have other liver or kidney problems
if you have heart problems such as heart failure (weakening of the heart muscle)
if you have narrowing of heart valves or thickening of the heart muscle, which may affect blood flow from the heart
if you have undergone a kidney transplant
if you have renal artery stenosis
if you have low levels of sodium in your blood, are severely dehydrated, or are vomiting, have recently vomited frequently, or have diarrhea
if you are being treated with high doses of diuretics or producing large amounts of urine
if you have a disorder of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism)
if you have had a disease called systemic lupus erythematosus (SLE)
if you suffer from low blood pressure
if you have had a stroke, heart attack, or suffer from angina (or have reduced blood flow to the brain)
if you have ever suffered from allergies or asthma
you must inform your doctor if you suspect (or are planning) a pregnancy. Candesartan cilexetil/hydrochlorothiazide is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may seriously harm the unborn baby if taken during this stage of pregnancy (see section on Pregnancy).
if 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 are taking an ACE inhibitor together with a medicine belonging to a class known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Candesartan and Hydrochlorothiazide Mylan").
if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye and may occur from a few hours to weeks after taking Candesartan and Hydrochlorothiazide Mylan Generics. This may lead to permanent vision loss if untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing such a reaction.

Your doctor may monitor 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”.
During treatment

Your doctor may need to monitor levels of potassium, sodium, magnesium, etc., in your blood during treatment.
This medicine may also affect the results of certain blood tests. If you are due to have a blood test, inform your doctor or hospital staff that you are taking this medicine.
If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Mylan. This is necessary because, when combined with certain anesthetics, candesartan and hydrochlorothiazide may cause a drop in blood pressure or interfere with some drugs used during surgery.
If you are scheduled for an imaging diagnostic procedure (to visualize 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.
This medicine may make your skin more sensitive to sunlight. If this occurs, avoid sunlamps, tanning beds, and use sunscreen or protective clothing when exposed to sunlight.

Other medicines and Candesartan and Hydrochlorothiazide Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Candesartan and Hydrochlorothiazide Mylan may affect the action of certain other medicines, and some medicines may affect Candesartan and Hydrochlorothiazide Mylan. Your doctor may need to adjust your dose and/or take other precautions. If you are taking certain medicines, your doctor may prescribe periodic blood tests.
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, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril, or aliskiren (see also information in the sections “Do not take Candesartan and Hydrochlorothiazide Mylan” and “Warnings and precautions”).
an ACE inhibitor together with certain medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone)
non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation)
acetylsalicylic acid (aspirin) (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation)
potassium supplements or potassium-containing salt substitutes, or medicines that increase potassium levels in the blood such as heparin (a blood-thinning medicine) or co-trimoxazole, also known as trimethoprim/sulfamethoxazole (a medicine used to treat bacterial infections)
medicines that may affect potassium levels in the blood (such as diuretics, laxatives, penicillin (an antibiotic), amphotericin (for treating fungal infections), carbenoxolone (for treating esophageal problems or oral ulcers), steroids such as prednisolone, pituitary hormone (ACTH))
calcium supplements or vitamin D
cholesterol-lowering medicines such as colestipol or cholestyramine
medicines for diabetes (tablets such as metformin or insulin)
medicines to control heart rhythm (antiarrhythmics), such as quinidine, disopyramide, amiodarone, sotalol, ibutilide
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 be affected by blood potassium levels, such as thioridazine, chlorpromazine, trifluoperazine, haloperidol, amisulpride, lithium (a medicine used to treat mental health conditions)
medicines for cancer (such as methotrexate (which may also be used for other conditions such as psoriasis, arthritis) and cyclophosphamide)
amantadine (for treating 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 after organ transplantation to prevent organ rejection
other medicines that may enhance the antihypertensive effect such as baclofen (a medicine used to relieve spasticity), amifostine (used in cancer treatment), and certain antidepressants (such as amitriptyline, clomipramine, dosulepin)
adrenaline or noradrenaline, sometimes used as adjuvants in hypertensive therapy or sometimes for treating severe allergic reactions

Candesartan and Hydrochlorothiazide Mylan and alcohol
If you have been prescribed Candesartan and Hydrochlorothiazide Mylan, talk to your doctor before drinking alcohol.
Alcohol may cause dizziness or fainting.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop treatment with candesartan cilexetil and hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe another medicine instead of Candesartan and Hydrochlorothiazide Mylan. Candesartan cilexetil and hydrochlorothiazide is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may seriously harm your unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan and Hydrochlorothiazide Mylan is not recommended for breastfeeding mothers, and if you wish to continue breastfeeding, your doctor may decide to prescribe an alternative treatment, especially if your baby is newborn or was born prematurely.
Driving and using machines
Some patients may feel tired or dizzy when taking candesartan cilexetil and hydrochlorothiazide. If you experience these effects, do not drive and do not operate tools or machinery.
Candesartan and Hydrochlorothiazide Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, contact him before taking this medicine.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Candesartan and Hydrochlorothiazide Mylan

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

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

If you take more Candesartan and Hydrochlorothiazide Mylan than you should:
If you take more Candesartan and Hydrochlorothiazide Mylan than prescribed by your doctor, contact your doctor or pharmacist immediately. 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:
DO NOT take a double dose to make up for the missed dose. Simply take the next dose as usual.

If you stop taking Candesartan and Hydrochlorothiazide Mylan:
If you stop treatment with Candesartan and Hydrochlorothiazide Mylan, your blood pressure may rise again. For this reason, do not stop taking this medicine without first consulting your doctor.

If you have any questions about the use of this medicine, consult 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 Hydrochlorothiazide Mylan are caused by candesartan cilexetil, while others are caused by hydrochlorothiazide.
Stop taking Candesartan and Hydrochlorothiazide 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)

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

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 the 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 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 may cause tiredness, lack of energy or muscle cramps
increased or decreased levels of potassium in the blood, especially if you already have kidney problems or suffer from heart failure. In severe cases, you may notice fatigue, tiredness, irregular heartbeat or tingling
increased levels of cholesterol or fats, sugar or uric acid in the blood
sugar in the urine
dizziness, lightheadedness or weakness
headache
lung infection (including signs such as common cold, flu-like symptoms)

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

low blood pressure, which may make you feel weak or cause you to faint, especially when standing up from a sitting or lying position
loss 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 sensations in the arms or legs
temporary blurred vision
abnormal heart rhythm
high temperature (fever)
muscle cramps
damage to blood vessels, causing red or purple spots on the skin
increased levels of 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 or muscle pain
changes in liver function detectable in blood tests
cough
nausea (feeling unwell)

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 experience any side effects, 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 following 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister pack, or bottle after the words “EXP.” The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Blister packs: Store in the original packaging.
Bottle packs: Keep the container tightly closed. Do not swallow or remove the desiccant contained in the bottle.
Use within 90 days after first opening.
Do not dispose of medicines via 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 substances are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg/25 mg of hydrochlorothiazide.
The other components are calcium carmellose, glycerol monostearate, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch, yellow iron oxide (E172). Additionally, 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, scored, with "CH" engraved above the break line and "3" below it on one side, and "M" on the other side.
Candesartan and Hydrochlorothiazide Mylan 32 mg/25 mg are peach-coloured, mottled, round, biconvex tablets, scored, with "CH" engraved above the break line and "4" below it on one side, and "M" 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 containing 14, 30, 56 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
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