Candesartan/hydrochlorothiazide Teva-Ratio 8/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Candesartan/Hydrochlorothiazide Teva-ratio 8 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 others, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Candesartan/Hydrochlorothiazide Teva-ratio is and what it is used for
2. What you need to know before taking Candesartan/Hydrochlorothiazide Teva-ratio
3. How to take Candesartan/Hydrochlorothiazide Teva-ratio
4. Possible side effects
5. How to store Candesartan/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 for the treatment of high blood pressure (hypertension) in adult patients. It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It helps your blood vessels to relax and widen, which makes it easier for blood pressure to decrease.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body get rid of water and salts such as sodium through your urine. This helps reduce blood pressure.

Your doctor may prescribe Candesartán/Hidroclorotiazida Teva-ratio if your blood pressure has not been adequately controlled with either candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking 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 unsure whether this applies to you, consult your doctor,
• if you are more than 3 months pregnant (it is also advisable to avoid Candesartan/Hydrochlorothiazide 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 flow 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 the above apply to you, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Teva-ratio.

Warnings and precautions

Consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Teva-ratio

• if you have diabetes,
• if you have heart, liver, or kidney problems,
• if you have recently had 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 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, which may occur within hours to weeks after taking Candesartan/Hydrochlorothiazide Teva-ratio. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at increased risk,
• you must inform your doctor if you think you are (or might be) pregnant. Candesartan/Hydrochlorothiazide 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 for 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 ACE inhibitor together with a medicine belonging to the class known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Taking Candesartan/Hydrochlorothiazide 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Candesartan/Hydrochlorothiazide 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 Candesartan/Hydrochlorothiazide 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 Candesartan/Hydrochlorothiazide Teva-ratio”.

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

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan/Hydrochlorothiazide Teva-ratio. This is because Candesartan/Hydrochlorothiazide Teva-ratio, in combination with certain anesthetics, may cause a drop in blood pressure.

Candesartan/Hydrochlorothiazide Teva-ratio may increase skin sensitivity to sunlight.

Children and adolescents

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

Use in athletes

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

Taking Candesartan/Hydrochlorothiazide 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. Candesartan/Hydrochlorothiazide Teva-ratio may affect how some medicines work, and some medicines may influence the effect of Candesartan/Hydrochlorothiazide 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, or diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if taking 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 reduce cholesterol, 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 (used to treat fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (used to treat Parkinson's disease or serious viral infections).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Carbenoxolone (used to treat esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve muscle spasms), amifostine (used in cancer treatment), and certain antipsychotics.

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

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

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

You may take Candesartan/Hydrochlorothiazide Teva-ratio with or without food.

• When prescribed Candesartan/Hydrochlorothiazide Teva-ratio, consult your doctor before consuming alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may 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 usually advise you to stop taking Candesartan/Hydrochlorothiazide Teva-ratio before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan/Hydrochlorothiazide 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 after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartan/Hydrochlorothiazide 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 on the effects on the ability to drive and use machines have been conducted. Some patients may feel tired or dizzy when taking Candesartan/Hydrochlorothiazide Teva-ratio. If this happens to you, do not drive or operate tools or machinery.

Candesartan/Hydrochlorothiazide Teva-ratio contains lactose

Candesartan/Hydrochlorothiazide Teva-ratio contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him 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 considered "sodium-free".

3. How to take Candesartán/Hydrochlorothiazide Teva-ratio

Follow exactly the instructions for use of this medicine as given 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 ease of breaking and swallowing, but not for dividing the tablet 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, contact 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 medicine 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 must 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 experiences them.

It is important that you are aware of what these adverse effects could be. Some of the adverse effects of Candesartán/Hydrochlorothiazide Teva-ratio are due to candesartán cilexetilo, and 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 rash).

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

• Breathing difficulties, 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 from time to time to check that Candesartán/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 decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this condition is severe, you may feel tired, weak, have irregular heartbeats, or tingling sensations.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.

• 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.
• Abnormal heartbeats.
• Breathing difficulties (including pulmonary 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.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection or fever, or bruise easily.
• Severe skin reaction that develops rapidly, causing blisters and peeling of the skin, and possibly mouth ulcers.
• Worsening of pre-existing lupus-like reactions or development 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, and 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, talk to your doctor or pharmacist, even if they are adverse effects 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 containers and unused medicines at a pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

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

Appearance of the medicinal product and contents of the pack

Candesartán/Hydrochlorothiazide Teva-ratio 8 mg/12.5 mg are white or almost white, capsule-shaped, biconvex tablets. One side of the tablets is scored and marked with a "C" to the left of the score and an "8" to the right of the score. The other side of the tablet is scored.

Candesartán/Hydrochlorothiazide Teva-ratio 8 mg/12.5 mg is available in pack sizes of 7, 10, 14, 15, 28, 30, 50, 56, 90, 98, 100, 300 tablets; and in unit-dose blisters (hospital pack) of 28 x 1, 50 x 1, 56 x 1, and 98 x 1.

Only certain pack sizes may be marketed.

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
The 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 medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Candesartan comp. AbZ
Spain: Candesartán/Hydrochlorothiazide Teva-ratio 8 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 medicinal product 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 medicinal product by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76322/P_76322.html

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