Candesartan/Hydrochlorothiazide Teva-Ratio 32mg/25mg Tablets

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

Do not take Candesartan/Hydrochlorothiazide Teva-ratio

• 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 Teva-ratio during the first months of pregnancy - see section 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 Teva-ratio.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartan/Hydrochlorothiazide Teva-ratio

• if you are diabetic,
• if you have heart, liver or kidney problems,
• if you have recently had a kidney transplant,
• if you have vomiting, have had it 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 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 Teva-ratio. If left untreated, this can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it,
• tell your doctor if you are pregnant (or think you may be). Candesartan/Hydrochlorothiazide Teva-ratio is not recommended during the first trimester 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:

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

• aliskiren,

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 Teva-ratio”.

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

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

Children and adolescents

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

Use in athletes

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

Other medicines and Candesartan/Hydrochlorothiazide Teva-ratio

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Candesartan/Hydrochlorothiazide Teva-ratio may affect the way some medicines work and some medicines may affect the way Candesartan/Hydrochlorothiazide Teva-ratio 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).
• Acetylsalicylic acid (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 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 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 blood pressure-lowering effect, such as baclofen (a medicine to relieve spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.

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

Candesartan/Hydrochlorothiazide Teva-ratio with food, drinks, and alcohol

• You can take Candesartan/Hydrochlorothiazide Teva-ratio with or without food.
• When Candesartan/Hydrochlorothiazide Teva-ratio is prescribed for you, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant (or think you may be). Your doctor will normally advise you to stop taking Candesartan/Hydrochlorothiazide Teva-ratio 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-ratio. Candesartan/Hydrochlorothiazide Teva-ratio is not recommended during the first trimester 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 about to start breastfeeding. Candesartan/Hydrochlorothiazide Teva-ratio 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 using any medicine.

Driving and using machines

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

Candesartan/Hydrochlorothiazide Teva-ratio 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 Teva-ratio 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 Teva-ratio

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

It is important that you continue to take Candesartan/Hydrochlorothiazide Teva-ratio 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 Teva-ratio than you should

If you take more Candesartan/Hydrochlorothiazide Teva-ratio 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 Teva-ratio

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

If you stop taking Candesartan/Hydrochlorothiazide Teva-ratio

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

If you have any other 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 all people suffer from them. It is essential that you know what these adverse effects could be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Teva-ratio are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Teva-ratio and go to the doctor immediately if you have any of the following allergic 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 Teva-ratio 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-ratio 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 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.
• Damage to 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)

• 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.
• Cough.
• Nausea.

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

• Sudden onset of myopia.
• Loss of vision 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 or pharmacist, even if it is a possible adverse effect that is not listed 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 Teva-ratio

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 drains or into the trash. 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 Teva-ratio 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, sodium croscarmellose, magnesium stearate, and triethyl citrate.

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide Teva-ratio 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, 10, 14, 20, 28, 30, 56, 60, 70, 90, 98, 100 tablets.

HDPE bottles:

Package sizes: 30, 100, 500 tablets

Not all 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:

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

Or

Balkanpharma-Dupnitsa AD

3-Samokovsko Shosse Str.,

Dupnitsa 2600, Bulgaria

This medicine is authorized in the member states of the European Economic Area under the following names:

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

Austria: Candesartan/HCT ratiopharm 32 mg/25 mg Tabletten

Spain: Candesartan Hydrochlorothiazide Teva-ratio 32 mg/25 mg EFG tablets

Finland: Candexitil Comp 32 mg/25 mg tablets

Italy: CANDESARTAN and IDROCLOROTIAZIDE DOC Generici 32mg+25mg compresse

Luxembourg: Candesartan-comp. ratiopharm 32 mg/25 mg Tabletten

Portugal: Candesartan + Hydrochlorothiazide ratiopharm

Date of the last revision of this prospectus: February 2022

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/