Candesartan/hydrochlorothiazide Teva 16/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Candesartan/Hydrochlorothiazide Teva 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 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Candesartán/Hydrochlorothiazide Teva is and what it is used for

The name of your medicine is Candesartán/Hydrochlorothiazide Teva. It is used to treat 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 relax and widen your blood vessels. This makes it easier to reduce blood pressure.
• 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 lower blood pressure.

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

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

Do not take Candesartán/Hydrochlorothiazide Teva

• 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/Hydrochlorothiazide Teva 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 kidney failure 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 Candesartán/Hydrochlorothiazide Teva.

Warnings and precautions

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

• if you have diabetes

• if you have heart, liver, or kidney problems

• if you have recently received a kidney transplant

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

• if you have a disorder 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 eye pressure, which may occur within hours to weeks after taking Candesartán/Hydrochlorothiazide Teva. If left 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

• you must inform your doctor if you think you are (or could be) pregnant. The use of Candesartán/Hydrochlorothiazide Teva is not recommended at the beginning of 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 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 of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Taking Candesartán/Hydrochlorothiazide Teva with other medicines”)

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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.

• 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, 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”.

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

Candesartán/Hydrochlorothiazide Teva may increase your skin's sensitivity to sunlight.

Children and adolescents

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

Use in athletes

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

Taking Candesartán/Hydrochlorothiazide Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Candesartán/Hydrochlorothiazide Teva may affect how some medicines work, and some medicines may influence the effect of Candesartán/Hydrochlorothiazide Teva. 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 or vitamin D supplements.
• 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 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 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 serious 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 biperidene.
• Cyclosporine, a medicine used in organ transplants 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 some antipsychotic medicines.

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 the information under the headings “Do not take Candesartán/Hydrochlorothiazide Teva” and “Warnings and precautions”)

Taking Candesartán/Hydrochlorothiazide Teva with food, drinks, and alcohol

You may take Candesartán/Hydrochlorothiazide Teva with or without food.

• When Candesartán/Hydrochlorothiazide Teva is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

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 could be) pregnant. Your doctor will usually advise you to stop taking Candesartán/Hydrochlorothiazide Teva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Candesartán/Hydrochlorothiazide Teva is not recommended early in 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 start. The use of Candesartán/Hydrochlorothiazide Teva is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is 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 performed. Some patients may feel tired or dizzy when taking Candesartán/Hydrochlorothiazide Teva. If this happens to you, do not drive or operate tools or machinery.

Candesartán/Hydrochlorothiazide Teva contains lactose

Candesartán/Hydrochlorothiazide Teva contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Candesartán/Hydrochlorothiazide Teva contains sodium

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

3. How to take Candesartan/Hydrochlorothiazide Teva

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

It is important that you continue taking Candesartan/Hydrochlorothiazide Teva 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 score is intended only for ease of breaking and swallowing, and not for dividing into equal doses.

If you take more Candesartan/Hydrochlorothiazide Teva than you should

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

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

If you stop taking Candesartan/Hydrochlorothiazide Teva
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 are due to candesartán cilexetil, while others are due to hydrochlorothiazide.

Stop taking Candesartán/Hydrochlorothiazide Teva and contact 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 (signs include severe shortness of breath, fever, weakness, and confusion).

Candesartán/Hydrochlorothiazide Teva may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, have an infection, or develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to check whether Candesartán/Hydrochlorothiazide Teva is 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 blood sodium levels. If severe, you may feel weak, lack energy, or experience 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 feel tired, weak, have irregular heartbeats, or experience 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.
• Abnormal heartbeats.
• 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.
• 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 developing 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 experience 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Medicinal Products: 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

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

Do not use this medicine after the expiry date stated on the packaging or blister. 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 you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan/Hydrochlorothiazide Teva

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

Appearance of the medicinal product and contents of the pack

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

Candesartan/Hydrochlorothiazide Teva 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; 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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:

Germany: Candesartancilexetil-ratiopharm comp.
Belgium: Co-Candesartan Teva
Spain: Candesartán /Hidroclorotiazida Teva 16 mg/12,5 mg comprimidos EFG
France: Candesartan/hydrochlorothiazide TEVA SANTE
Italy: Candesartan e Idroclorotiazide Teva Italia
The Netherlands: Candesartan cilexetil/Hydrochlorothiazide Teva
Portugal: Candesartan + Hidroclorotiazida Teva
Sweden: Candesartan/ Hydrochlorothiazide Teva

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/