Prospecto: Information for the User

Candesartán/Hidroclorotiazida Tevapharma 32 mg/12,5 mg Tablets EFG

Candesartán cilexetilo/ hidroclorotiazida

Read this prospectus carefully before starting to take the 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 must 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 Tevapharma and how it is used

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

3.How to take Candesartán/ Hidroclorotiazida Tevapharma

4.Possible adverse effects

5.Storage of Candesartán /Hidroclorotiazida Tevapharma

6. Contents of the package and additional information

Your medicine is called Candesartán/Hidroclorotiazida Tevapharma. 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 helps to lower blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps your body to get rid of water and salt, such as sodium, in your urine. This helps to lower blood pressure.

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

Do not take Candesartán/Hidroclorotiazida Tevapharma

• 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 Tevapharma during the first months of pregnancy - see Pregnancy section),
• if you have severe kidney disease,
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of 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 failure 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 Tevapharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán/Hidroclorotiazida 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 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 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartán/Hidroclorotiazida Tevapharma,
• 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 may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to weeks after taking Candesartán/Hidroclorotiazida Tevapharma.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,
• inform your doctor if you are pregnant (or if you suspect you may be). Candesartán/Hidroclorotiazida Tevapharma is not recommended for use at the start of pregnancy, andshould not be takenif you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

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

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

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

Children and adolescents

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

Use in athletes

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

Other medicines and Candesartán/Hidroclorotiazida Tevapharma

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

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

• other medicines to lower your blood pressure, including beta-blockers, diazoxide and the so-called 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).
• Acetylsalicylic acid, (if you take more than3 gper day) (medicines to relieve pain and inflammation).
• Supplements of potassium or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• Supplements of calcium 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 elimination).
• Laxatives.
• Penicillin ortrimethoprim/sulfamethoxazole(antibiotics).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Cancer medicines.
• Amantadine (for the treatment of Parkinson's disease or for severe viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for the treatment of oesophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, 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 muscle spasms), amifostine (used in cancer treatment) and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán/Hidroclorotiazida Tevapharma” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida Tevapharma with food, drinks and alcohol

• You can take Candesartán/Hidroclorotiazida Tevapharma with or without food.
• When you are prescribed Candesartán/Hidroclorotiazida Tevapharma, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Candesartán/Hidroclorotiazida Tevapharma is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Some patients may feel tired or dizzy when taking Candesartán/Hidroclorotiazida Tevapharma. If this happens to you, do not drive or operate tools or machines.

Candesartán/Hidroclorotiazida Tevapharma contains lactose

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

Candesartán/Hidroclorotiazida Tevapharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “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 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 every day. This will help you remember to take it.

The tablet can be divided into equal doses.

If you take more Candesartán/ Hidroclorotiazida Tevapharma than you should

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

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

If you forget to take Candesartán/ Hidroclorotiazida Tevapharma

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

If you interrupt treatment with Candesartán/ Hidroclorotiazida Tevapharma

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. It is important that you know which side effects could occur. Some side effects ofCandesartán/ Hidroclorotiazida Tevapharmaare due to candesartán cilexetilo and others are due to hydrochlorothiazide.

Stop taking Candesartán /Hidroclorotiazida Tevapharma and see 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 skin itching (with skin rash).
• Rare (may affect up to 1 in 10,000 people): Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Candesartán/ Hidroclorotiazida 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 occurs, inform your doctor. Your doctor may perform blood tests at regular intervals to check that Candesartán/ Hidroclorotiazida Tevapharma 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 have muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If severe, you may feel tired, weak, have irregular heartbeats, or experience numbness.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.

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

• Respiratory infection

Occasional (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)

• Jaundice (yellowing of the skin and white 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 anxiety.
• Itching or prickling 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 reactions or appearance of rare 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 inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.

Frequency unknown (cannot be estimated from available data)

• Sudden nearsightedness.
• Loss of vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage or acute angle-closure glaucoma).
• SLE (systemic and cutaneous lupus erythematosus) (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 or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 medicine.

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

This medication does not require special conditions for conservation.

Do not use this medicationafter 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 down the drain or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Candesartán/ Hidroclorotiazida Tevapharma 32 mg/12,5 mg tablets EFG

- The active ingredients are candesartan cilexetilo and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetilo and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the package

Candesartán /Hidroclorotiazida Tevapharma 32 mg/12,5 mg tablets are oval, biconvex, white or almost white, scored on both faces, and engraved with 32/12 on one face (approx 7 x 12 mm)

Blister PVC/PDC-Al

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 commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing:

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

Or

Siegfried Malta Ldt.

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 with the following names:

Germany:Candesartan- comp. AbZ 32 mg/12,5 mg Tabletten

Denmark:Candiva comp

Spain:Candesartan Hidroclorotiazida Tevapharma 32 mg/12,5mg tablets EFG

Last revision date of this leaflet: January 2022

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/