Candesartan/hydrochlorothiazide Teva-Ratio 16/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Candesartán/Hydrochlorothiazide Teva-ratio 16 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, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Candesartán/Hidroclorotiazida Teva-ratio is and what it is used for

The name of your medicine is Candesartán/Hidroclorotiazida Teva-ratio. 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. This makes it easier for blood pressure to decrease.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps your body eliminate water and salts such as sodium through urine. This helps reduce blood pressure.

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

2. What you need to know before taking Candesartán/Hidroclorotiazida Teva-ratio

Do not take Candesartán/Hidroclorotiazida 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 unsure whether this applies to you, consult your doctor,
• if you are more than 3 months pregnant (it is also advisable to avoid Candesartán/Hidroclorotiazida Teva-ratio 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 bile drainage from 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 renal impairment 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 Candesartán/Hidroclorotiazida Teva-ratio.

Warnings and precautions

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

• if you have diabetes,
• if you have heart, liver, or kidney problems,
• if you have recently received a kidney transplant,
• if you are experiencing vomiting, have had frequent vomiting recently, 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 condition called systemic lupus erythematosus (SLE),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you have had allergies or asthma,
• if you experience vision loss 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 Candesartán/Hidroclorotiazida Teva-ratio. 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,
• you must inform your doctor if you think you are (or might be) pregnant. Candesartán/Hidroclorotiazida Teva-ratio is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from that stage onward (see section 2: Pregnancy and breastfeeding),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskiren,
• if you are taking an ACEI together with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Taking Candesartán/Hidroclorotiazida Teva-ratio with other medicines”),
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Candesartán/Hidroclorotiazida Teva-ratio,
• if you have previously experienced breathing 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 Candesartán/Hidroclorotiazida Teva-ratio, 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 Candesartán/Hidroclorotiazida Teva-ratio”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán/Hidroclorotiazida Teva-ratio. 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 Candesartán/Hidroclorotiazida Teva-ratio. This is because Candesartán/Hidroclorotiazida Teva-ratio, in combination with certain anesthetics, may cause a drop in blood pressure.

Candesartán/Hidroclorotiazida Teva-ratio may increase skin sensitivity to sunlight.

Children and adolescents

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

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

Taking Candesartán/Hidroclorotiazida Teva-ratio with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Candesartán/Hidroclorotiazida Teva-ratio may affect how some medicines work, and some medicines may influence the effect of Candesartán/Hidroclorotiazida Teva-ratio. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

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

• Other medicines to lower your blood pressure, including beta-blockers and diazoxide.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines for pain and inflammation relief).
• Acetylsalicylic acid (if taking more than 3 g per day) (medicines for pain and inflammation relief).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in blood).
• Calcium supplements or vitamin D.
• Cholesterol-lowering medicines 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 to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines).
• Amphotericin (for treating fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson’s disease or severe viral infections).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Carbenoxolone (for treating esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used in organ transplants to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relieving spasms), amifostine (used in cancer treatment), and certain antipsychotics.

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

• if you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also information under the headings “Do not take Candesartán/Hidroclorotiazida Teva-ratio” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida Teva-ratio with food, drinks, and alcohol

You may take Candesartán/Hidroclorotiazida Teva-ratio with or without food.

• When prescribed Candesartán/Hidroclorotiazida Teva-ratio, consult your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Your doctor will generally advise you to stop taking Candesartán/Hidroclorotiazida Teva-ratio before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán/Hidroclorotiazida Teva-ratio is not recommended during early pregnancy and must not be taken 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 planning to start. Candesartán/Hidroclorotiazida Teva-ratio is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using 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-ratio. If this happens to you, do not drive or operate tools or machinery.

Candesartán/Hidroclorotiazida Teva-ratio contains lactose

Candesartán/Hidroclorotiazida Teva-ratio contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Candesartán/Hidroclorotiazida Teva-ratio contains sodium

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

3. How to take Candesartán/Hydrochlorothiazide Teva-ratio

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking Candesartán/Hydrochlorothiazide Teva-ratio 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 intended only for splitting the tablet to facilitate swallowing, but not for dividing it into equal doses.

If you take more Candesartán/Hydrochlorothiazide Teva-ratio than you should

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

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 medication and the amount ingested.

If you forget to take Candesartán/Hydrochlorothiazide Teva-ratio

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

If you stop taking Candesartán/Hydrochlorothiazide Teva-ratio

Treatment for high blood pressure is usually lifelong, and therefore you should not stop taking this medicine without 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 will experience them.

It is important that you are aware of the possible adverse effects. Some of the adverse effects of Candesartán/Hydrochlorothiazide Teva-ratio are due to candesartan cilexetil, while others are due to hydrochlorothiazide.

Stop taking Candesartán/Hydrochlorothiazide Teva-ratio and see your doctor immediately if you experience any of the following serious reactions:

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

• Severe itching of the skin (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 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 may cause difficulty swallowing,
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Candesartán/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 occurs, inform your doctor. Your doctor may perform blood tests periodically to check that Candesartán/Hydrochlorothiazide Teva-ratio 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 blood sodium levels. If severe, you may feel weak, lack energy, or have 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 tiredness, weakness, irregular heartbeat, or tingling sensations.
  • An increase in blood cholesterol, glucose, or uric acid levels.

• Presence of glucose in urine.

• Dizziness or weakness.

• Headache.

• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhoea, 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 restlessness.
• Tingling or prickling sensations in arms and legs.
• Blurred vision for a short period of time.
• Irregular 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.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, 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)

• 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 whites of the eyes, and flu-like symptoms.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
• Cough.
• Nausea.

Frequency not known (cannot be estimated from available data)

• Sudden myopia.
• Loss of vision 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, skin rashes which may include redness, blisters, peeling, and lumps).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 Teva-ratio

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

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.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán/Hydrochlorothiazide Teva-ratio

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

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

Appearance of the medicine and contents of the pack

Candesartán/Hydrochlorothiazide Teva-ratio 16 mg/12.5 mg are light pink, capsule-shaped, biconvex tablets. One side of the tablets is scored, with the letter "C" engraved to the left of the score and "16" to the right. The other side of the tablet is also scored.

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

Only certain pack sizes may be commercially available.

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:

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 Kraków
Poland

Or

PLIVA Croatia Ltd.
Prilaz baruna Filipovica 25, 10000 Zagreb
Croatia

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

Germany: Candesartan comp. AbZ
Spain: Candesartán/Hydrochlorothiazide Teva-ratio 16 mg/12.5 mg tablets EFG

Date of the most recent review of this leaflet: January 2025

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76319/P_76319.html

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