Candesartan/hydrochlorothiazide Viatris 16 mg/12.5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Candesartán/Hidroclorotiazida Viatris 16 mg/12.5 mg tablets EFG

(Candesartan cilexetil/hydrochlorothiazide)

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Candesartán/Hidroclorotiazida Viatris is and what it is used for

Your medicine is called Candesartán/Hidroclorotiazida Viatris. It is used to treat high blood pressure (hypertension). 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 blood vessels to relax and widen, making it easier for your blood pressure to decrease.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps the body get rid of water and salts such as sodium through the urine. This also helps lower your blood pressure.

Your doctor may prescribe Candesartán/Hidroclorotiazida Viatris if your blood pressure is not adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

2. What you need to know before taking Candesartán/Hidroclorotiazida Viatris

Do not take Candesartán/Hidroclorotiazida Viatris

• If you are allergic to candesartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulfonamides (such as cotrimoxazole). If you are unsure whether this applies to you, consult your doctor.
• If you are more than 3 months pregnant. (It is also preferable to avoid Candesartán/Hidroclorotiazida Viatris during the first months of pregnancy – see Pregnancy section).
• If you have severe kidney disease.
• If you have severe liver disease or biliary obstruction (problems with bile drainage from the gallbladder).
• If you have persistently low blood potassium levels despite treatment to increase potassium.
• If you have persistently high blood calcium levels despite treatment to reduce calcium.
• If you have ever had gout.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking Candesartán/Hidroclorotiazida Viatris.

Warnings and precautions

Consult your doctor or pharmacist before starting Candesartán/Hidroclorotiazida Viatris 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/Hidroclorotiazida Viatris, seek medical attention immediately.

• You have had skin cancer or 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking candesartan cilexetil/hydrochlorothiazide.

• You are diabetic or at risk of developing diabetes.

• You have heart problems, such as heart failure (a weakening of the heart muscle).

• You have narrowing of heart valves or thickening of the heart muscle, which may affect blood flow from the heart.

• You have other liver or kidney problems.

• You have recently received a kidney transplant.

• You have renal artery stenosis.

• You have low blood sodium levels, are severely dehydrated, or have recently experienced frequent vomiting or diarrhea.

• You are being treated with high doses of diuretics or urinate very frequently.

• You have a disorder of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).

• You have ever had a condition called systemic lupus erythematosus (SLE).

• You have low blood pressure.

• You have ever suffered a stroke, myocardial infarction, or angina (or reduced blood flow to the brain).

• You have had allergies or asthma.

• Inform your doctor if you are pregnant (or suspect you might be). Candesartán/hydrochlorothiazide is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward (see Pregnancy section).

• You are taking any of the following medicines used to treat high blood pressure (hypertension):

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

• If you experience vision disturbances or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking Candesartán/Hidroclorotiazida Viatris. If untreated, this could lead to complete vision loss. Your risk of developing this may be higher if you have previously had an allergy to penicillin or sulfonamides.

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

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See information under the heading “Do not take Candesartán/Hidroclorotiazida Viatris”.

During treatment

This medicine may affect the results of certain blood tests. If you need any blood tests, inform the medical or hospital staff that you are taking this medicine.

If you are undergoing surgery, inform your doctor or dentist that you are taking Candesartán/Hidroclorotiazida Viatris. This is because Candesartán/Hidroclorotiazida Viatris, in combination with certain anesthetics, may cause a significant drop in blood pressure.

If you need to undergo cosmetic surgery (body contouring) and must inform medical or hospital staff that you are taking this medicine. The use of iodine-containing materials may increase the risk of adverse effects.

Candesartán/Hidroclorotiazida Viatris may increase skin sensitivity to sunlight. If this occurs, avoid sunlamps, tanning beds, and use sunscreen or protective clothing when exposed to sunlight.

Children and adolescents

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

Use in athletes

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

Other medicines and Candesartán/Hidroclorotiazida Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Candesartán/Hidroclorotiazida Viatris may affect how other medicines work, and certain medicines may influence the effect of Candesartán/Hidroclorotiazida Viatris. 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, as your doctor may need to adjust your dose and/or take other precautions:

• Other blood pressure-lowering medicines, including beta-blockers, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril, or ramipril, or aliskiren (see also information under the headings “Do not take Candesartán/Hidroclorotiazida Viatris” and “Warnings and precautions”).
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines for pain and inflammation relief).
• Acetylsalicylic acid (aspirin) (if taking more than 3 g per day) (medicine for pain and inflammation relief).
• Potassium supplements or salt substitutes containing potassium (other medicines that increase potassium levels in blood, such as heparin (a blood thinner), or cotrimoxazole also known as trimethoprim/sulfamethoxazole (medicine for treating bacterial infections)).
• Medicines that may affect blood potassium levels (such as diuretics), laxatives, penicillin (an antibiotic), amphotericin (for treating fungal infections), carbenoxolone (for treating esophageal or oral ulcers), steroids such as prednisolone, pituitary hormone (ACTH).
• Calcium supplements or vitamin D.
• Cholesterol-lowering medicines such as colestipol or cholestyramine.
• Medicines for diabetes (tablets such as metformin or insulin).
• Medicines to control heart rhythm (antiarrhythmics) such as quinidine, disopyramide, amiodarone, sotalol, ibutilide, digoxin.
• Other medicines that may affect heart rhythm, such as cisapride (for stomach problems), erythromycin, sparfloxacin, pentamidine (antibiotics), halofantrine (for treating malaria), terfenadine (antihistamine).
• Certain antipsychotic medicines that may be affected by blood potassium levels, such as thioridazine, chlorpromazine, trifluoperazine, haloperidol, amisulpride.
• Lithium (a medicine for mental health conditions).
• Medicines for cancer treatment (such as methotrexate (which may also be used for other conditions such as psoriasis or arthritis) and cyclophosphamide).
• Amantadine (for treating Parkinson's disease or serious viral infections).
• Barbiturates (a sedative used to treat epilepsy).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Other medicines that may enhance the antihypertensive effect such as baclofen (a medicine for relieving spasms), amifostine (used in cancer treatment), and certain antidepressants (such as amitriptyline, clomipramine, dosulepin).
• Adrenaline or noradrenaline, sometimes used to help increase blood pressure or to treat severe allergic reactions.

Use of Candesartán/Hidroclorotiazida Viatris with alcohol

• When prescribed Candesartán/Hidroclorotiazida Viatris, consult your doctor before consuming alcohol. Alcohol may make you feel weak 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 taking this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking candesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán/hydrochlorothiazide is not recommended during pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Candesartán/Hidroclorotiazida Viatris 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.

Driving and using machines

Some patients may feel tired or dizzy when taking candesartan/hydrochlorothiazide. If this happens to you, do not drive or operate tools or machinery.

Candesartán/Hidroclorotiazida Viatris contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Candesartán/Hidroclorotiazida Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. Consult your doctor or pharmacist if you have any doubts. It is important that you continue taking candesartán/hidroclorotiazida every day. The recommended dose is one tablet once daily.

Swallow the tablet with a glass of water. You may take candesartán/hidroclorotiazida with or without food.

Try to take the tablet at the same time each day, preferably in the morning. This will help you remember to take it.

If you take more Candesartán/Hidroclorotiazida Viatris than you should

If you have taken more candesartán/hidroclorotiazida 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 (telephone 91 562 04 20), indicating the medicine and the amount ingested.

You may experience a drop in blood pressure, which could cause dizziness, or you may notice an increased heart rate or irregular heartbeats, muscle cramps, or in some cases, excessive drowsiness or reduced level of consciousness.

If you forget to take Candesartán/Hidroclorotiazida Viatris

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

If you stop taking Candesartán/Hidroclorotiazida Viatris

If you stop taking candesartán/hidroclorotiazida, your blood pressure may rise again. Do not stop taking this medicine before 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 have 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/Hidroclorotiazida Viatris may be caused by candesartán cilexetilo, and others by hydrochlorothiazide.

Stop taking Candesartán/Hidroclorotiazida Viatris and see your doctor immediately if you experience any of the following adverse effects:

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

• Difficulty breathing, swelling of the face, lips, tongue and/or throat that may cause difficulty swallowing, severe itching of inflamed (swollen) skin.
• Liver problems, including inflammation of the liver (hepatitis). You may notice you are more tired than usual, yellowing of the skin and whites of the eyes, dark urine, pale stools, or stomach pain.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Severe skin reaction that develops rapidly, causing blisters and peeling of the skin, and possibly mouth ulcers.
• Onset or worsening of lupus-like reactions (which may include unusual skin reactions, facial rash, joint pain, muscle disorders, and fever).
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection (e.g., sore throat, mouth ulcers), fever, or bruise easily. This may be due to reduced production of blood cells in the bone marrow (bone marrow suppression).

Very rare (may affect up to 1 in 10,000 people)

• Effects on kidney function, especially if you already have kidney problems or heart failure. You may notice back pain, infrequent or no urination, or cloudy urine or blood in the urine.
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

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 severe, you may experience tiredness, weakness, irregular heartbeat, or tingling sensations.
  • Increased levels of cholesterol or fats, glucose, or uric acid in the blood.
  • Presence of glucose in the urine.
  • Dizziness or weakness.
  • Headache.
  • Lung infection (which may include symptoms such as common cold or flu).

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

• Low blood pressure. This may cause dizziness or fainting, especially when standing up from a sitting or lying position.
• Loss or lack of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, skin reaction caused by sensitivity to sunlight.

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

• Effects on kidney function, detectable in blood tests.
• Difficulty sleeping, depression, or restlessness.
• Tingling or pins and needles in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• High temperature (fever).
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• Increased blood urea nitrogen or certain proteins (creatinine) in the blood, detectable in blood tests.

Very rare (may affect up to 1 in 10,000 people):

• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, detectable in blood tests.
• Cough.
• Nausea.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

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

• Myopia (inability of the eye to focus on distant objects).

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 Viatris

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

Do not use this medicine after the expiry date stated on the container, blister pack, or bottle following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original container to protect from light and moisture.

For HDPE bottles, the shelf life after first opening is 90 days. Do not remove or swallow the desiccant contained in the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan/Hydrochlorothiazide Viatris

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 calcium carmellose, glycerol monostearate, hydroxypropylcellulose (E-463), lactose monohydrate, magnesium stearate (E-470B), maize starch, yellow iron oxide (E-172), and red iron oxide (E-172). See section 2, “Candesartan/Hydrochlorothiazide Viatris contains lactose”.

Nature of the product and pack contents

Candesartan/Hydrochlorothiazide Viatris tablets are peach-coloured, mottled, round, biconvex tablets, marked with “M” on one side and “CH2” on the other.

Candesartan/Hydrochlorothiazide Viatris is available in blisters containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets and in bottles containing 30 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1
Hungary

or

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe
Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352
Germany

or

Viatris Santé
1 Rue de Turin
69007 Lyon
France

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Candesartancilexetil HCT Mylan 16 mg/12,5 mg Tabletten
Austria Candesartan/HCT Arcana 16 mg/12,5 mg tabletten
Belgium Co-Candesartan Mylan 16 mg/12,5 mg tabletten
Bulgaria CoCandesargen 16 mg/12,5 mg tablets
Spain Candesartán/Hidroclorotiazida Viatris 16 mg/12,5 mg comprimidos EFG
France Candesartan Hydroclorotiazide Viatris 16 mg/12,5 mg comprimé
Luxembourg Co-Candesartan Mylan 16 mg/12,5 mg comprimés
Netherlands Candesartan cilexetil/Hydrochlorotiazide Mylan 16 mg/12,5 mg tabletten
Portugal Candesartan + Hidroclorotiazida Mylan 16 mg/12,5 mg tablets

Date of latest review of this leaflet: January 2025

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