Candesartan and hydrochlorothiazide Zentiva

Patient Information Leaflet

Candesartan and Hydrochlorothiazide Zentiva 16 mg/12.5 mg tablets

Generic 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The name of the medicine is Candesartan and Hydrochlorothiazide Zentiva 16 mg/12.5 mg tablets.
It is used to treat high blood pressure (hypertension) in adult patients. It contains
two active substances: candesartan cilexetil and hydrochlorothiazide. These work together to
lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes the relaxation and dilation of blood vessels. This helps reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (which help increase urination). This helps the body eliminate water and salts such as sodium through the urine. This contributes to lowering blood pressure.

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

2. What you should know before taking Candesartan and Hydrochlorothiazide Zentiva

Do not take Candesartan and Hydrochlorothiazide Zentiva:

• if you are allergic to candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to sulfonamide medicines. If you are unsure whether this applies to you, consult your doctor;
• if you are more than 3 months pregnant (it is better to avoid using Candesartan and Hydrochlorothiazide Zentiva even in the early stages of pregnancy – see the section on pregnancy);
• if you have severe kidney problems;
• if you have severe liver disease or biliary obstruction (a bile drainage problem from the gallbladder);
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you have persistently low levels of potassium in your blood;
• if you have persistently high levels of calcium in your blood;
• if you have had gout.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Zentiva.
Inform your doctor:

• if you have diabetes;
• if you have heart, liver, or kidney problems;
• if you have recently undergone a kidney transplant;
• if you are vomiting, have recently experienced severe vomiting, or have diarrhea;
• if you have a disorder of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism);
• 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 Zentiva;
• if you have or 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 think you may be pregnant (or if there is a possibility of becoming pregnant), you must inform your doctor. Candesartan and Hydrochlorothiazide Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”);
• 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.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under "Do not take Candesartan and Hydrochlorothiazide Zentiva if:".
Your doctor may want to examine you more frequently and carry out tests if you have any of these conditions.
The active ingredient hydrochlorothiazide may cause an unusual reaction leading to vision loss and eye pain. These could be symptoms of increased pressure in the eye and may occur within hours or weeks after taking Candesartan and Hydrochlorothiazide Zentiva. This may lead to permanent vision loss.
If you are about to undergo surgery, tell your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Zentiva. This is because Candesartan and Hydrochlorothiazide Zentiva, when combined with certain anesthetics, may cause excessive lowering of blood pressure.
Candesartan and Hydrochlorothiazide Zentiva may increase the skin's sensitivity to sunlight.
For athletes: The use of this medicine constitutes doping and may result in a positive anti-doping test.
Children and adolescents
There is no experience with the use of Candesartan and Hydrochlorothiazide Zentiva in children (under 18 years of age). Therefore, Candesartan and Hydrochlorothiazide Zentiva must not be administered to children.
Other medicines and Candesartan and Hydrochlorothiazide Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candesartan and Hydrochlorothiazide Zentiva may affect how other medicines work, and some medicines may affect Candesartan and Hydrochlorothiazide Zentiva. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.
In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• other medicines that help lower blood pressure, including beta-blockers, diazoxide;
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation);
• acetylsalicylic acid (if taking more than 3 g per day) (a medicine to relieve pain and inflammation);
• potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
• calcium or vitamin D supplements;
• cholesterol-lowering medicines such as colestipol or cholestyramine;
• medicines for diabetes (oral tablets or insulin);
• medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers;
• medicines whose action may be influenced by blood potassium levels, such as certain antipsychotic drugs;
• heparin (a medicine to thin the blood);
• medicines that help you urinate (diuretics);
• laxatives;
• penicillin or co-trimoxazole (also known as trimethoprim/sulfamethoxazole) (an antibiotic);
• amphotericin (for treating fungal infections);
• lithium (a medicine for mental health conditions);
• steroids such as prednisolone;
• pituitary hormone (ACTH);
• cancer-treating medicines;
• amantadine (for treating Parkinson's disease or severe viral infections);
• barbiturates (a type of sedative also used to treat epilepsy);
• carbenoxolone (used to treat esophageal disorders or oral ulcers);
• anticholinergic agents such as atropine and biperiden;
• cyclosporine, a medicine used in organ transplants to prevent rejection;
• other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotic medicines.

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Candesartan and Hydrochlorothiazide Zentiva if:" and "Warnings and precautions").

Taking Candesartan and Hydrochlorothiazide Zentiva with food, drinks, and alcohol
When Candesartan and Hydrochlorothiazide Zentiva is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may make you feel weak or dizzy.
Pregnancy, breastfeeding, and fertility
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Your doctor will usually advise you to stop taking Candesartan and Hydrochlorothiazide Zentiva before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Candesartan and Hydrochlorothiazide Zentiva. Candesartan and Hydrochlorothiazide Zentiva is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan and Hydrochlorothiazide Zentiva is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy when taking Candesartan and Hydrochlorothiazide Zentiva. If this happens to you, do not drive or operate tools or machinery.
Candesartan and Hydrochlorothiazide Zentiva contains lactose monohydrate and sodium
Candesartan and Hydrochlorothiazide Zentiva contains lactose monohydrate, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Candesartan and Hydrochlorothiazide Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
It is important to continue taking Candesartan and Hydrochlorothiazide Zentiva every day.

• The recommended dose of Candesartan and Hydrochlorothiazide Zentiva is one tablet daily.
• Swallow the tablet whole with a glass of water. You may take Candesartan and Hydrochlorothiazide Zentiva with or without food.
• Try to take the tablet at the same time each day. This will help you remember to take it.
• The breakline on the tablet is only intended to assist you in splitting the tablet if you have difficulty swallowing it whole.

If you take more Candesartan and Hydrochlorothiazide Zentiva than you should
If you take more Candesartan and Hydrochlorothiazide Zentiva than prescribed by your doctor, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartan and Hydrochlorothiazide Zentiva
Do not take a double dose to make up for the forgotten tablet. Take only the next dose as usual.

If you stop taking Candesartan and Hydrochlorothiazide Zentiva
If you stop treatment with Candesartan and Hydrochlorothiazide Zentiva, your blood pressure may rise again. Therefore, do not stop treatment with Candesartan and Hydrochlorothiazide Zentiva without first talking to your doctor.

If you have any doubts about how to use 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 might be. Some of the side effects of Candesartan and Hydrochlorothiazide Zentiva are caused by candesartan cilexetil, and some are caused by hydrochlorothiazide.
Stop taking Candesartan and Hydrochlorothiazide Zentiva and seek immediate medical help if you experience any of the following allergic reactions:

• 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 swallowing;
• Severe itching of the skin (with raised, itchy bumps).

Candesartan and Hydrochlorothiazide Zentiva may cause a reduction in the number of white blood cells in the blood. Your resistance to infections may decrease, and you may notice fatigue, infection or fever. If this occurs, contact your doctor. Your doctor may occasionally perform blood tests to check whether Candesartan and Hydrochlorothiazide Zentiva has affected your blood (agranulocytosis).
Other possible side effects include:
Common (may affect up to 1 in 10 people)

• Changes in blood test results:

  • Reduced sodium levels in the blood. If this reduction 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 this change is severe, you may experience fatigue, weakness, irregular heartbeat or tingling sensations;
  • Increased levels of cholesterol, glucose or uric acid in the blood.

• Presence of glucose in the urine.

• Dizziness, lightheadedness and weakness.

• Headache.

• Respiratory 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, rash with swelling (urticaria), rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or whites of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling sensations in the arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes mild to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• Reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever or easy bruising.
• Severe skin rash that develops rapidly, with blistering and peeling of the skin, and sometimes in the mouth.
• .

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 liver inflammation (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.

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

• Sudden onset of myopia (short-sightedness).
• Skin and lip cancer (non-melanoma skin cancer).
• Sudden decrease in vision and eye pain (possible signs of acute myopia or secondary acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes which may include redness, blistering, peeling and swelling).

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 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 Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry
date refers to the last day of that month.
No special storage conditions are required for this medicine.
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 Zentiva contains
The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg
of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
The other ingredients are: monohydrate lactose, maize starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate and triethyl citrate.
Description of the appearance of Candesartan and Hydrochlorothiazide Zentiva and contents of the
pack
Candesartan and Hydrochlorothiazide Zentiva tablets are biconvex, white in colour, with a score line on one side and the imprint CH16 on the same side.
Pack sizes: 7, 14, 28, 30, 56, 70, 90 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milan
Italy
Manufacturer:
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
P.O. box 14
Hal Far BBG 07
Malta
Sanofi S.P.A.
Viale Europa, 11
21040 Origgio (VA)
Italy
Zentiva k.s.
U Kabelovny 130
Prague 10 – Dolni Mecholupy 102 37
Czech Republic
This medicinal product is authorised in the European Economic Area Member States
under the following names: