Candesartan/hydrochlorothiazide TevaPharma 32 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Candesartan/Hydrochlorothiazide Tevapharma 32 mg/12.5 mg tablets EFG

Candesartan cilexetil/hydrochlorothiazide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Candesartán/Hidroclorotiazida Tevapharma is and what it is used for

Your medicine is called Candesartán/Hidroclorotiazida Tevapharma. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: candesartán cilexetilo and hidroclorotiazida. Both work together to lower blood pressure.

• Candesartán cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It helps relax and widen your blood vessels, which makes it easier to reduce blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps your body get rid of water and salts such as sodium through your urine. This helps reduce blood pressure.

Your doctor may prescribe Candesartán/Hidroclorotiazida Tevapharma if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

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

Do not take Candesartan/Hydrochlorothiazide Tevapharma

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor,
• if you are more than 3 months pregnant (it is also best to avoid Candesartan/Hydrochlorothiazide Tevapharma during the first months of pregnancy – see Pregnancy section),
• if you have severe kidney disease,
• if you have severe liver disease or biliary obstruction (a problem with bile leaving the gallbladder),
• 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 ever had gout,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Tevapharma.

Warnings and precautions

Consult your doctor or pharmacist before starting Candesartan/Hydrochlorothiazide Tevapharma

• if you have diabetes,

• if you have heart, liver, or kidney problems,

• if you have recently received a kidney transplant,

• if you have vomiting, have had frequent vomiting recently, or have diarrhea,

• if you have a disorder 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 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/Hydrochlorothiazide Tevapharma,

• if you have low blood pressure,

• if you have ever had a stroke,

• if you have had allergies 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 eye pressure, which may occur within hours to weeks after taking Candesartan/Hydrochlorothiazide Tevapharma. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition,

• inform your doctor if you are pregnant (or suspect you might be). Candesartan/Hydrochlorothiazide Tevapharma is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section),

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskiren,

• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Candesartan/Hydrochlorothiazide Tevapharma, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., 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 undergoing surgery, inform your doctor or dentist that you are taking Candesartan/Hydrochlorothiazide Tevapharma. This is because Candesartan/Hydrochlorothiazide Tevapharma, in combination with certain anesthetics, may cause a drop in blood pressure.

Candesartan/Hydrochlorothiazide Tevapharma may increase skin sensitivity to sunlight.

Children and adolescents

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

Use in athletes

This medicine contains hydrochlorothiazide, which may produce positive results in doping tests.

Other medicines and Candesartan/Hydrochlorothiazide Tevapharma

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Candesartan/Hydrochlorothiazide Tevapharma may affect how some medicines work, and some medicines may influence the effect of Candesartan/Hydrochlorothiazide Tevapharma. If you are taking certain medicines, your doctor may need to perform blood tests periodically, adjust your dose, and/or take other precautions.

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

• Other blood pressure-lowering medicines, including beta-blockers, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (medicines used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines used to increase potassium levels in 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 (antiarrhythmics), such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, such as certain antipsychotics.
• Heparin (a medicine used to thin the blood).
• Diuretics (medicines that increase urine output).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine used for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (used to treat Parkinson's disease or serious 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 biperidene.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine used to relieve muscle spasms), amifostine (used in cancer treatment), and certain antipsychotics.
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartan/Hydrochlorothiazide Tevapharma” and “Warnings and precautions”).

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

• You may take Candesartan/Hydrochlorothiazide Tevapharma with or without food.
• When prescribed Candesartan/Hydrochlorothiazide Tevapharma, consult your doctor before consuming alcohol. Alcohol may cause dizziness or lightheadedness.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Candesartan/Hydrochlorothiazide Tevapharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan/Hydrochlorothiazide Tevapharma is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Candesartan/Hydrochlorothiazide Tevapharma is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using 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 operate tools or machinery.

Candesartan/Hydrochlorothiazide Tevapharma contains lactose

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

Candesartan/Hydrochlorothiazide Tevapharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Candesartan/Hydrochlorothiazide Tevapharma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is one tablet once daily.

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 may be divided into equal doses.

If you take more Candesartan/Hydrochlorothiazide Tevapharma than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartan/Hydrochlorothiazide Tevapharma

Do not take a double dose to make up for missed doses. Simply take the next dose as scheduled.

If you stop taking Candesartan/Hydrochlorothiazide Tevapharma
If you stop taking Candesartan/Hydrochlorothiazide Tevapharma, your blood pressure may rise again. Therefore, do not stop taking Candesartan/Hydrochlorothiazide Tevapharma without first consulting your doctor.

If you have any further questions about 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 everyone experiences them. It is important that you are aware of what these adverse effects might be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Tevapharma are due to candesartan cilexetil, while others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Tevapharma and contact your doctor immediately if you experience 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 may cause difficulty swallowing,
• severe itching of the skin (with skin rash),
• very rare (may affect up to 1 in 10,000 people): acute breathing difficulty (symptoms include severe shortness of breath, 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 develop a fever. If this occurs, inform your doctor. Your doctor may perform periodic blood tests 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 blood sodium levels. If severe, you may feel weak, lack energy, or experience muscle cramps.
  • An increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling sensations.
  • An increase in blood cholesterol, glucose, or uric acid levels.

• Presence of glucose in urine.

• Dizziness or weakness.

• Headaches.

• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction due to 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 pins and needles sensations in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeat.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have infections, fever, or bruise easily.
• Severe skin reaction developing rapidly, causing blisters and peeling of the skin, and possibly mouth ulcers.
• Worsening of pre-existing lupus-like 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 yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Cough.
• Nausea.

Frequency not known (cannot be estimated from available data)

• Sudden onset of myopia.
• Vision loss 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)).
• Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, and skin rashes that may include redness, blisters, peeling, and lumps).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Tevapharma

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container or blister pack. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan/Hydrochlorothiazide Tevapharma 32 mg/12.5 mg tablets EFG

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the container

Candesartan/Hydrochlorothiazide Tevapharma 32 mg/12.5 mg tablets are oval, biconvex, white or almost white tablets, scored on both sides and engraved with "32/12" on one side (approx 7 x 12 mm).

PVC/PdC-Al blister

Pack sizes:

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

HDPE bottles:

Pack sizes: 30, 100, 250, 500 tablets

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor
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
The 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 medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Candesartan- comp. AbZ 32 mg/12.5 mg Tabletten
Denmark: Candiva comp
Spain: Candesartan Hidroclorotiazida Tevapharma 32 mg/12.5 mg comprimidos EFG

Date of the latest revision of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/