Candesartan/Hydrochlorothiazide TevaPharma 32mg/25mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan/Hydrochlorothiazide Tevapharma 32 mg/25 mg film-coated tablets EFG

Candesartan cilexetil/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Candesartan/Hydrochlorothiazide Tevapharma is and what it is used for

Your medicine is called Candesartan/Hydrochlorothiazide Tevapharma. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. Both work together to lower your blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and dilate. This helps to lower your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body get rid of water and salts (like sodium) in your urine. This helps to lower your blood pressure.

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

2. What you need to know before you take Candesartan/Hydrochlorothiazide Tevapharma

Do not take Candesartan/Hydrochlorothiazide Tevapharma

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to sulfonamides. If you are not sure if you are in this situation, consult your doctor,
• if you are more than 3 months pregnant (it is also better to avoid Candesartan/Hydrochlorothiazide Tevapharma during the first months of pregnancy - see section on Pregnancy),
• if you have severe kidney disease,
• if you have severe liver disease or biliary obstruction (problem with bile leaving the gallbladder),
• if you have persistent low potassium levels in your blood,
• if you have persistent high calcium levels in your blood,
• if you have ever had gout,
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Tevapharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartan/Hydrochlorothiazide Tevapharma

• if you are diabetic,
• if you have heart, liver, or kidney problems,
• if you have recently had a kidney transplant,
• if you have been vomiting, have been vomiting frequently lately, or have diarrhea,
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism),
• if you have ever had a disease called systemic lupus erythematosus (SLE),
• if you have had skin cancer or if an unexpected skin lesion appears during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartan/Hydrochlorothiazide Tevapharma,
• if you have low blood pressure,
• if you have ever had a stroke,
• if you have ever had an allergy or asthma,
• 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 can occur within hours to weeks after taking Candesartan/Hydrochlorothiazide Tevapharma. If left untreated, this can lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it,
• tell your doctor if you are pregnant (or think you might be). Candesartan/Hydrochlorothiazide Tevapharma is not recommended during the first months of pregnancy, and you should not take it if you are more than 3 months pregnant, as it can cause serious harm to your baby if used after the third trimester of pregnancy,
• if you are taking any of the following medicines to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren,
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Candesartan/Hydrochlorothiazide Tevapharma, see your doctor immediately.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Candesartan/Hydrochlorothiazide Tevapharma”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan/Hydrochlorothiazide Tevapharma. Your doctor will decide whether to continue treatment. Do not stop taking this medicine on your own.

If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan/Hydrochlorothiazide Tevapharma. This is because Candesartan/Hydrochlorothiazide Tevapharma, in combination with some anesthetics, can cause a drop in blood pressure.

Candesartan/Hydrochlorothiazide Tevapharma may increase your skin's sensitivity to the sun.

Children and adolescents

There is no experience with the use of Candesartan/Hydrochlorothiazide Tevapharma in children and adolescents (under 18 years). Therefore, Candesartan/Hydrochlorothiazide Tevapharma should not be given to children and adolescents.

Athletes

This medicine contains hydrochlorothiazide, which can produce a positive result in doping tests.

Other medicines and Candesartan/Hydrochlorothiazide Tevapharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Candesartan/Hydrochlorothiazide Tevapharma may affect how some medicines work and some medicines may affect how Candesartan/Hydrochlorothiazide Tevapharma works. If you are using certain medicines, your doctor may need to do blood tests from time to time, change your dose, and/or take other precautions.

In particular, tell your doctor if you are using any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, or diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Aspirin (if you take more than 3 g per day) (medicines to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (anti-arrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to increase urine production).
• Laxatives.
• Penicillin or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (antibiotics).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for the treatment of cancer.
• Amantadine (for the treatment of Parkinson's disease or severe viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporin, a medicine used for organ transplants to prevent organ rejection.
• Other medicines that may increase the anti-hypertensive effect, such as baclofen (a medicine for the relief of spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan/Hydrochlorothiazide Tevapharma” and “Warnings and precautions”).

Taking Candesartan/Hydrochlorothiazide Tevapharma with food, drinks, and alcohol

• You can take Candesartan/Hydrochlorothiazide Tevapharma with or without food.
• When you are prescribed Candesartan/Hydrochlorothiazide Tevapharma, consult your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant (or think you might be). Your doctor will usually advise you to stop taking Candesartan/Hydrochlorothiazide Tevapharma before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of Candesartan/Hydrochlorothiazide Tevapharma. Candesartan/Hydrochlorothiazide Tevapharma is not recommended during the first months of pregnancy, and you should not take it if you are more than 3 months pregnant, as it can cause serious harm to your baby if used after the third trimester of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan/Hydrochlorothiazide Tevapharma is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Some patients may feel tired or dizzy when taking Candesartan/Hydrochlorothiazide Tevapharma. If this happens to you, do not drive or use tools or machines.

Candesartan/Hydrochlorothiazide Tevapharma contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Candesartan/Hydrochlorothiazide Tevapharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Candesartan/Hydrochlorothiazide Tevapharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

It is important that you keep taking Candesartan/Hydrochlorothiazide Tevapharma every day.

The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water.

Try to take the tablet at the same time each day. This will help you remember to take it.

The tablet can be divided into equal doses.

If you take more Candesartan/Hydrochlorothiazide Tevapharma than you should

If you take more Candesartan/Hydrochlorothiazide Tevapharma than your doctor prescribed, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan/Hydrochlorothiazide Tevapharma

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan/Hydrochlorothiazide Tevapharma

If you stop taking Candesartan/Hydrochlorothiazide Tevapharma, your blood pressure may increase again. Therefore, do not stop taking Candesartan/Hydrochlorothiazide Tevapharma before consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. It is essential that you know what these adverse effects might be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Tevapharma are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Tevapharma and go to the doctor immediately if you have any of the following 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 can cause difficulty swallowing,
• Severe skin itching (with rash).
• Very rare (may affect up to 1 in 10,000 people): acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Candesartan/Hydrochlorothiazide Tevapharma may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this happens, inform your doctor. Your doctor may perform blood tests from time to time to check that Candesartan/Hydrochlorothiazide Tevapharma is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:
• • A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
  • An increase or reduction in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats, or tingling.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Feeling of dizziness or weakness.
• Headaches

• Respiratory infection

Infrequent (may affect up to 1 in 100 people)

• Low blood pressure. This can cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and 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, or restlessness.
• Tingling or pinching in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Breathing difficulties (including pulmonary inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damaged blood vessels that produce red or purple spots on the skin.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus erythematosus reactions or appearance of uncommon skin reactions.

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 feel tired, have a yellowing of the skin and whites of the eyes, and have flu-like symptoms.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Cough.
• Nausea.

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

• Sudden myopia.
• Vision loss 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).
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Candesartan/Hydrochlorothiazide Tevapharma

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Tevapharma 32 mg/25 mg EFG tablets

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.

• The other components are: lactose monohydrate, cornstarch, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and triethyl citrate.

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide Tevapharma 32 mg/25 mg tablets are oval, biconvex, white or almost white, scored on both sides, and engraved with 32/25 on one side (approx. 7 x 12 mm)

PVC/PDC-Al blister

Package sizes:

7, 14, 15, 20, 28, 30, 56, 60, 90, 98, and 100 tablets.

HDPE bottles:

Package sizes: 30, 100, 250, 500 tablets

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Alabtros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

Or

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate,

Hal Far BBG3000 (Malta)

Or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Or

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava-Komárov

Czech Republic

Or

Teva Operations Poland Sp. z o.o.

Ul. Mogilska 80 31-546, Krakow

Poland

Or

Teva Pharma S.L.U.

C/C nº 4, Polígono Industrial Malpica

50016 Zaragoza

Spain

This medicine is authorizedin the Member States of the European Economic Area under the following names:

Germany: Candesartan-comp. AbZ 32 mg/25 mg Tabletten

Denmark: Candiva comp

Spain: Candesartan Hydrochlorothiazide Tevapharma 32 mg/25 mg EFG tablets

Date of the lastrevisionof this prospectus: January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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