Candesartan/hydrochlorothiazide Teva-Ratio 32 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Candesartán/Hydrochlorothiazide Teva-ratio 32 mg/25 mg tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 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

Your medicine is called 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 to reduce blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps your body eliminate 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 candesartán cilexetilo or hidroclorotiazida alone.

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

Do not take Candesartán/Hydrochlorothiazide Teva-ratio

• if you are allergic to candesartan cilexetil or 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 this applies to you, consult your doctor,
• if you are more than 3 months pregnant (it is also best to avoid Candesartán/Hydrochlorothiazide Teva-ratio during the first months of pregnancy – see Pregnancy section),
• if you have severe kidney disease,
• if you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder),
• if you have persistently low blood potassium levels,
• if you have persistently high blood calcium levels,
• 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/Hydrochlorothiazide Teva-ratio.

Warnings and precautions

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

• if you have diabetes,

• if you have heart, liver, or kidney problems,

• if you have recently undergone a kidney transplant,

• if you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea,

• if you have an adrenal gland disorder 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 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/Hydrochlorothiazide 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 condition,

• inform your doctor if you are pregnant (or suspect you might be). Use of Candesartán/Hydrochlorothiazide Teva-ratio is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from that point onward (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,

• aliskiren,

  • 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 rays while taking Candesartán/Hydrochlorothiazide Teva-ratio.
  • if you have previously experienced respiratory 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/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 Candesartán/Hydrochlorothiazide Teva-ratio”.

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

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

Children and adolescents

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

Use in athletes

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

Other medicines and Candesartán/Hydrochlorothiazide Teva-ratio

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

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and angiotensin-converting enzyme (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 taking more than 3 g per day) (medicines to relieve pain and inflammation).

• Potassium supplements or salt substitutes containing potassium (medicines to increase blood potassium levels).

• Calcium or vitamin D supplements.

• Medicines to lower 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 some antipsychotic medicines.

• 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 treatment of fungal infections).

• Lithium (a medicine for mental health disorders).

• Steroids such as prednisolone.

• Pituitary hormone (ACTH).

• Medicines for cancer treatment.

• Amantadine (for treatment of Parkinson’s disease or serious viral infections).

• Barbiturates (a type of sedative, also used to treat epilepsy).

• Carbenoxolone (for treatment of esophageal disease or oral ulcers).

• Anticholinergic agents such as atropine and biperidene.

• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.

• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relief of muscle 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 information under the headings “Do not take Candesartán/Hydrochlorothiazide Teva-ratio” and “Warnings and precautions”)

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

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking Candesartán/Hydrochlorothiazide Teva-ratio before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Candesartán/Hydrochlorothiazide Teva-ratio is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third trimester of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Candesartán/Hydrochlorothiazide Teva-ratio is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you intend to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Candesartán/Hydrochlorothiazide Teva-ratio contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Candesartán/Hydrochlorothiazide Teva-ratio contains sodium

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

3. How to take Candesartan/Hydrochlorothiazide Teva-ratio

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

It is important that you continue taking Candesartan/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 tablet may 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 prescribed by your doctor, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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 as scheduled.

If you stop taking Candesartan/Hydrochlorothiazide Teva-ratio

If you stop taking Candesartan/Hydrochlorothiazide Teva-ratio, your blood pressure may rise again. Therefore, do not stop taking Candesartan/Hydrochlorothiazide Teva-ratio without first 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 everybody gets them. It is important that you are aware of what these adverse effects might 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 see a 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 itching of the skin (with skin rash).
• very rare (may affect up to 1 in 10,000 people): acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

Candesartan/Hydrochlorothiazide Teva-ratio may cause a decrease in white blood cells. Your resistance to infections may be reduced and you may feel tired, have an infection or fever. If this happens, inform your doctor. Your doctor may carry out 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 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 levels of cholesterol, glucose or uric acid in the blood.

• Presence of glucose in urine.

• Dizziness or weakness.

• Headaches.

• 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)

• 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 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.
• 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 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)

• 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 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 onset of 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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.

This medicine does not require any special storage conditions.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, 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 Candesartan/Hydrochlorothiazide Teva-ratio 32 mg/25 mg tablets EFG

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.

• The other components are: monohydrate lactose, corn starch, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate and triethyl citrate.

Appearance of the product and contents of the container

Candesartan/Hydrochlorothiazide Teva-ratio 32 mg/25 mg tablets are oval, biconvex, white or almost white tablets, scored on both sides and engraved with "32/25" on one side (approx 7 x 12 mm).

PVC/PDC-Al blister packs

Pack sizes:

7, 10, 14, 20, 28, 30, 56, 60, 70, 90, 98, 100 tablets.

HDPE bottles:

Pack sizes: 30, 100, 500 tablets.

Only some 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:

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
The 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 medicinal product 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 Hidroclorotiazida Teva-ratio 32 mg/25 mg comprimidos EFG
Finland: Candexitil Comp 32 mg/25 mg tabletti
Italy: CANDESARTAN e IDROCLOROTIAZIDE DOC Generici 32mg+25mg compresse
Luxembourg: Candesartan-comp. ratiopharm 32 mg/25 mg Tabletten
Portugal: Candesartan + Hidroclorotiazida ratiopharm

Date of the most recent revision 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 packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75761/P_75761.html

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