Candesartan/Hydrochlorothiazide Teva 16/12.5 mg Tablets

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

Do not take Candesartan/Hydrochlorothiazide Teva

• 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 this applies to you, consult your doctor
• if you are pregnant for more than 3 months (it is also better to avoid Candesartan/Hydrochlorothiazide Teva during the first months of pregnancy - see section 2: Pregnancy and breast-feeding)
• if you have severe kidney disease
• if you have severe liver disease or biliary obstruction (a problem with the release of bile from 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 impairment and are being treated with a blood pressure lowering medicine containing aliskiren

If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Candesartan/Hydrochlorothiazide Teva

• if you are diabetic
• if you have heart, liver or kidney problems
• if you have recently had a kidney transplant
• if you are vomiting, have recently had frequent vomiting 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 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 an increase in pressure in the eye and can occur within hours to weeks after taking Candesartan/Hydrochlorothiazide Teva. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it
• you should inform your doctor if you think you are (or might become) pregnant. Do not take Candesartan/Hydrochlorothiazide Teva if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy
• if you are taking any of the following medicines used to treat high blood pressure:

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

• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines called mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Taking Candesartan/Hydrochlorothiazide Teva with other medicines”)
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartan/Hydrochlorothiazide Teva
• 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 Teva, seek medical attention immediately

Your doctor may check 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 Teva”.

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

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

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

Children and adolescents

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

Athletes

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

Taking Candesartan/Hydrochlorothiazide Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candesartan/Hydrochlorothiazide Teva may affect the way some medicines work and some medicines may affect the way Candesartan/Hydrochlorothiazide Teva works. If you are using certain medicines, your doctor may need to do blood tests from time to time.

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

• Other medicines to lower your blood pressure, including beta-blockers and diazoxide
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, or diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation)
• Acetylsalicylic acid (if you take more than 3 g per day) (medicines to relieve pain and inflammation)
• Potassium supplements or salt substitutes containing 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 certain 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 cancer treatment
• 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 mouth 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 blood pressure-lowering effect, such as baclofen (a medicine to relieve spasms), amifostine (used in cancer treatment), and certain antipsychotic medicines

Your doctor may need to change your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”)

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

You can take Candesartan/Hydrochlorothiazide Teva with or without food.

• When prescribed Candesartan/Hydrochlorothiazide Teva, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Candesartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Candesartan/Hydrochlorothiazide Teva. It is not recommended to take Candesartan/Hydrochlorothiazide Teva during the first few months of pregnancy, and you must not take it if you are more than 3 months pregnant, as it may harm your baby if used after the third month of pregnancy

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to use Candesartan/Hydrochlorothiazide Teva during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is newborn or premature

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Some patients may feel tired or dizzy when taking Candesartan/Hydrochlorothiazide Teva. If this happens to you, do not drive or use tools or machines.

Candesartan/Hydrochlorothiazide Teva contains lactose

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

Candesartan/Hydrochlorothiazide Teva contains sodium

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

3. How to take Candesartan/Hydrochlorothiazide Teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

It is important that you take Candesartan/Hydrochlorothiazide Teva 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 score line is only to facilitate breaking and not to divide into equal doses.

If you take more Candesartan/Hydrochlorothiazide Teva than you should

If you take more Candesartan/Hydrochlorothiazide Teva than your doctor has prescribed, contact your doctor or pharmacist immediately for advice.

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

If you forget to take Candesartan/Hydrochlorothiazide Teva

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

If you stop taking Candesartan/Hydrochlorothiazide Teva

Treatment for high blood pressure is usually for life. Do not stop taking this medicine without talking to 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 Teva are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Teva and go to the doctor immediately if you have any of the following severe reactions:

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

• severe skin itching (with skin rash).

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

• difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat,
• jaundice (yellowing of the skin or the whites of the eyes)

Very Rare (may affect up to 1 in 10,000 people):

• swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing,
• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Candesartan/Hydrochlorothiazide Teva 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 Teva is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (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.
• Headache.
• Respiratory infection.

Uncommon (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)

• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or anxiety.
• 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 bruise easily.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly ulcers in the mouth.
• Worsening of pre-existing lupus erythematosus reactions or appearance of uncommon skin reactions.

Very Rare (may affect up to 1 in 10,000 people)

• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowish color of the skin and the 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, exfoliation, 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, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them 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. Storage of Candesartan/Hydrochlorothiazide Teva

Keep this medicine out of sight and reach of children.

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.

Do not store at a temperature above 25°C.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 Teva

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other components are: pregelatinized starch (derived from corn), povidone K-30, calcium carmellose, poloxamer 188, microcrystalline cellulose, lactose monohydrate (spray-dried), magnesium stearate, red iron oxide (E-172).

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide Teva 16 mg/12.5 mg are light pink, capsule-shaped, biconvex tablets, one side of the tablets is scored and engraved with "C" on the left side of the score and with "16" on the right side of the score. The other side of the tablet is scored.

Candesartan/Hydrochlorothiazide Teva 16 mg/12.5 mg is available in package sizes of 7, 10, 14, 15, 28, 30, 50, 56, 90, 98, 100, 300 tablets; 28 x 1, 50 x 1, 56 x 1, and 98 x 1 unit-dose blisters (hospital packaging).

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 Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

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 Operations Poland Sp. z o.o.

ul. Mogilska 80 31-546, Cracow

Poland

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

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

Germany: Candesartan cilexetil-ratiopharm comp.

Belgium: Co-Candesartan Teva

Spain: Candesartan/Hydrochlorothiazide Teva 16 mg/12.5 mg tablets EFG

France: Candesartan/hydrochlorothiazide TEVA SANTE

Italy: Candesartan and Hydrochlorothiazide Teva Italia

Netherlands: Candesartan cilexetil/Hydrochlorothiazide Teva

Portugal: Candesartan + Hydrochlorothiazide Teva

Sweden: Candesartan/Hydrochlorothiazide Teva.

Date of the last revision of 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/