Prospecto: Information for the Patient

Candesartán/Hidroclorotiazida Teva 16 mg/12,5 mg Tablets EFG

Candesartán cilexetilo/ Hidroclorotiazida

Read this prospectus carefully before starting to take this medicine, as it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Candesartán/ Hidroclorotiazida Teva and how it is used

2.What you need to know before starting to take Candesartán/ Hidroclorotiazida Teva

3.How to take Candesartán/ Hidroclorotiazida Teva

4.Possible adverse effects

5.Storage of Candesartán /Hidroclorotiazida Teva

6.Contents of the package and additional information

Your medicine is called Candesartán/Hidroclorotiazida Teva. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active ingredients: 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 makes your blood vessels relax and dilate. This facilitates a decrease in blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes your body to eliminate water and salt, such as sodium, in your urine. This facilitates a decrease in blood pressure.

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

Do not take Candesartán/Hidroclorotiazida Teva

• if you are allergic to candesartán cilexetilo or to 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 you are in this situation, consult your doctor,
• if you are more than 3 months pregnant (it is best to avoid Candesartán/Hidroclorotiazida Teva during the first months of pregnancy - see section 2: Pregnancy and breastfeeding),
• if you have severe kidney disease,
• if you have severe liver disease or biliary obstruction (a problem with the bile flowing from the gallbladder),
• if you have persistent low levels of potassium in the blood,
• if you have persistent high levels of calcium in the blood,
• if you have ever had gout.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medicine that contains aliskirén.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Candesartán/Hidroclorotiazida Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán/Hidroclorotiazida Teva

• 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 had it frequently recently or have diarrhoea,
• if you have a condition called Conn's syndrome (also known as primary aldosteronism),
• if you have ever had a condition called systemic lupus erythematosus (SLE),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you have 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 haemorrhage) or an increase in eye pressure and can occur within a few hours to weeks after taking Candesartán/Hidroclorotiazida Teva. If left untreated, this can lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it,
• inform your doctor if you think you are (or could be) pregnant. Candesartán/Hidroclorotiazida Teva is not recommended for use at the start of pregnancy andshould not be takenif you are more than 3 months pregnant, as it can cause serious harm to your baby when used from that point onwards (see section 2: Pregnancy and breastfeeding).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

• if you are taking an ACE inhibitor together with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see “Taking Candesartán/Hidroclorotiazida Teva with other medicines”).
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartán/Hidroclorotiazida Teva.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartán/Hidroclorotiazida Teva, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure and electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán/Hidroclorotiazida Teva”.

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

If you are to undergo surgery, inform your doctor or dentist that you are taking Candesartán/Hidroclorotiazida Teva. This is because Candesartán/Hidroclorotiazida Teva, in combination with some anaesthetics, can cause a drop in blood pressure.

Candesartán/Hidroclorotiazida Teva may increase your skin's sensitivity to the sun.

Children and adolescents

There is no experience with the use of Candesartán/Hidroclorotiazida Teva in children (under 18 years). Therefore Candesartán/Hidroclorotiazida Teva should not be administered to children.

Use in athletes

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

Taking Candesartán/Hidroclorotiazida Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.Candesartán/Hidroclorotiazida Teva may affect the way some medicines work and some medicines may influence the effect of Candesartán/Hidroclorotiazida Teva. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

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

• other medicines to lower your blood pressure, including beta-blockers and diazoxide.
• anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• aspirin (if you take more than3 gper 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 reduce cholesterol, such as colestipol or colestiramine.
• medicines for diabetes (tablets or insulin).
• medicines to control heart rhythm (antiarrhythmic 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 promote urine production).
• laxatives.
• penicillin or co-trimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics).
• amphotericin (for the treatment of fungal infections).
• lithium (a medicine for mental health problems).
• steroids 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 oesophageal disease or mouth ulcers).
• anticholinergic agents such as atropine and biperiden.
• ciclosporin, a medicine used to prevent organ rejection after transplantation.
• other medicines that may increase the antihypertensive effect such as baclofen (a medicine for muscle spasm relief), amifostine (used in cancer treatment) and some antipsychotic medicines.

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

- If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán/Hidroclorotiazida Teva” and “Warnings and precautions”)

Taking Candesartán/Hidroclorotiazida Teva with food, drinks and alcohol

You can take Candesartán/Hidroclorotiazida Teva with or without food.

• When you are prescribed Candesartán/Hidroclorotiazida Teva, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you are (or could be) pregnant.Your doctor will usually recommend that you stop taking Candesartán/Hidroclorotiazida Teva before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of Candesartán/Hidroclorotiazida Teva. Candesartán/Hidroclorotiazida Teva is not recommended for use at the start of pregnancy, andshould not be takenif you are more than 3 months pregnant,as it can cause serious harm to your baby if used from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartán/Hidroclorotiazida Teva is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Candesartán/Hidroclorotiazida Teva contains lactose

Candesartán/Hidroclorotiazida Teva contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Candesartán/Hidroclorotiazida Teva contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

It is essential to continue taking Candesartán/ Hidroclorotiazida Teva every day.

The recommended doseis one tablet once a day. Swallow the tablet with a glass of water.

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

The groove is onlyfor splitting and facilitating swallowing but not for dividing into equal doses.

If you take more Candesartán/ Hidroclorotiazida Teva than you should

If you take more Candesartán/ Hidroclorotiazida Teva than prescribed by your doctor, consult your doctor or pharmacist immediately for advice.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán/ Hidroclorotiazida Teva

Do not take a double dose to compensate for the missed doses. Simply take the next dose as usual.

If you interrupt treatment with Candesartán/ Hidroclorotiazida Teva
High blood pressure treatment is usually for life, and therefore, do not stop taking this medication without consulting your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects ofCandesartán/ Hidroclorotiazida Tevaare due to candesartán cilexetilo and others are due to hydrochlorothiazide.

Stop taking Candesartán /Hidroclorotiazida Teva and see your doctor immediately if you experience any of the following severe reactions:

Rare (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 white of the eyes)

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

• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• Acute respiratory difficulty (signs include severe difficulty breathing, fever, weakness, and confusion).

Candesartán/ Hidroclorotiazida 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 occurs, inform your doctor. It is possible that your doctor will perform blood tests at regular intervals to check that Candesartán/ Hidroclorotiazida Teva is not affecting your blood (agranulocytosis).

Other possible side 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 experience muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you have kidney problems or heart failure. If severe, you may feel tired, weak, experience irregular heartbeats, or tingling.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache.
• Respiratory infection.

Rare (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 caused by sensitivity to sunlight.

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

• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, or anxiety.
• Tickling or pinching sensations in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• 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 or appearance of rare skin reactions.

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

• Back pain, joint and muscle pain.
• Changes in liver function, including hepatitis. You may feel tired, have yellowing of the skin and the white of the eyes, and experience flu-like symptoms.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Cough.
• Nausea.

Frequency unknown (cannot be estimated from available data)

• Acute myopia.
• Loss of vision or eye pain due to high pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage or acute angle-closure glaucoma).
• SLE and cutaneous lupus (allergic condition that causes fever, joint pain, skin rash that may include redness, blisters, exfoliation, and nodules).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

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

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

Do not usethis medicationafter the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Do not store above 25C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Candesartán/ Hidroclorotiazida Teva Composition

- The active ingredients are candesartan cilexetilo and hidroclorotiazida. Each tablet contains 16 mg of candesartan cilexetilo and 12.5 mg of hidroclorotiazida.

- The other components are: pregelatinized corn starch, povidone K-30, calcium carmelose, poloxamer 188, microcrystalline cellulose, anhydrous lactose (dried by spray drying), magnesium stearate, iron oxide red (E-172).

Appearance of the product and contents of the package

Candesartán /Hidroclorotiazida Teva 16 mg/12.5 mg are light pink tablets, in capsule shape, biconvex, one face 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 face of the tablet is scored.

Candesartán/ Hidroclorotiazida Teva 16 mg/12.5 mgis 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 single-dose blisters (hospital pack).

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible 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 with the following names:

Germany:Candesartancilexetil-ratiopharm comp.

Belgium:Co-Candesartan Teva

Spain:Candesartán /Hidroclorotiazida Teva 16 mg/12.5 mg tablets EFG

France:Candesartan/hydrochlorothiazide TEVA SANTE

Italy:Candesartan e Idroclorotiazide Teva Italia

Netherlands:Candesartan cilexetil/Hydrochlorothiazide Teva

Portugal:Candesartan + Hidroclorotiazida Teva

Sweden:Candesartan/ Hydrochorothiazide Teva.

Last review date of this leaflet: January 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/