Candesartan/Hydrochlorothiazide Viatris 16 mg/12.5 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan/Hydrochlorothiazide Viatris16 mg/12.5 mg film-coated tablets

(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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Candesartan/Hydrochlorothiazide Viatris and what is it used for

Your medicine is called Candesartan/Hydrochlorothiazide Viatris. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. Both work together to lower your blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and widen. This helps to lower your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body get rid of water and salts such as sodium in your urine. This helps to lower your blood pressure.

Your doctor may prescribe Candesartan/Hydrochlorothiazide Viatris if your blood pressure is not adequately controlled with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before you take Candesartan/Hydrochlorothiazide Viatris

Do not takeCandesartan/Hydrochlorothiazide 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 not sure if you are in this situation, consult your doctor.
• If you are more than 3 months pregnant. (It is also preferable to avoid Candesartan/Hydrochlorothiazide Viatris during the first months of pregnancy – see section on Pregnancy).
• If you have severe kidney disease.
• If you have severe liver disease or biliary obstruction (problems with bile leaving the gallbladder).
• If you have persistently low potassium levels in your blood despite treatment to increase potassium.
• If you have persistently high calcium levels in your blood despite treatment to decrease calcium.
• If you have ever had gout.
• If you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Viatris.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartan/Hydrochlorothiazide Viatris if:

• You have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Candesartan/Hydrochlorothiazide Viatris, seek medical attention immediately.
• 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure 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 a narrowing of the heart valves, or a thickening of the heart muscle, which can affect blood flow from the heart.
• You have other liver or kidney problems.
• You have recently had a kidney transplant.
• You have a narrowing of the renal artery.
• You have low sodium levels in your blood, are severely dehydrated, or have vomiting, have had it frequently lately, or have diarrhea.
• You are being treated with high doses of diuretics or urinate frequently.
• You have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• You have ever had a disease called systemic lupus erythematosus (SLE).
• You have low blood pressure.
• You have ever had a stroke, heart attack, or angina (or reduced blood flow to the brain).
• You have ever had an allergy or asthma.
• Tell your doctor if you are pregnant (or think you might be). Candesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.
• If you are taking any of the following medicines to treat high blood pressure:
• • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • Aliskiren.

• 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 an increase in eye pressure, and can occur within hours to weeks after taking Candesartan/Hydrochlorothiazide Viatris. If left untreated, it could lead to total vision loss. Your risk of developing this may be greater if you have previously been allergic to penicillin or sulfonamide.

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 check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See the information under the heading “Do not take Candesartan/Hydrochlorothiazide Viatris”.

During treatment

This medicine may affect the results of certain blood tests. If you need to have a blood test, tell the medical staff or hospital that you are taking this medicine.

Ifyou are going to have surgery, tell your doctor or dentist that you are taking Candesartan/Hydrochlorothiazide Viatris. This is because Candesartan/Hydrochlorothiazide Viatris, in combination with some anesthetics, can cause a significant drop in blood pressure.

If you needto undergo cosmetic surgery (see parts of your body) and must inform the medical staff or hospital that you are taking this medicine. The use of iodine in the material may increase the risk of adverse effects that occur.

Candesartan/Hydrochlorothiazide Viatris may increase the sensitivity of your skin to the sun. If this happens, do not use sunlamps, tanning beds, and use sunscreen or cover up with clothing when in the sun.

Children and adolescents

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

Use in athletes

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

Other medicines and Candesartan/Hydrochlorothiazide Viatris

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

Candesartan/Hydrochlorothiazide Viatris may affect the way other medicines work, and certain medicines may affect the way Candesartan/Hydrochlorothiazide Viatris works. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and angiotensin-converting enzyme inhibitors (ACE inhibitors) such as enalapril, captopril, lisinopril, or ramipril, or aliskiren (see also the information under the headings “Do not take Candesartan/Hydrochlorothiazide Viatris” and “Warnings and precautions”).
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (aspirin) (if you take more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (other medicines to increase potassium levels in the blood, such as heparin (a medicine to thin the blood) or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (a medicine to treat bacterial infections).
• Medicines that may affect the amount of potassium in the blood (medicines such as diuretics), laxatives, penicillin (an antibiotic), amphotericin (for the treatment of fungal infections), carbenoxolone (for the treatment of esophagus problems or oral ulcers), steroids such as prednisolone, pituitary hormone (ACTH).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets, such as metformin or insulin).
• Medicines to control heart rhythm (anti-arrhythmic agents) 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 the treatment of malaria), terfenadine (an antihistamine).
• Certain antipsychotic medicines that may be affected by potassium levels in the blood, such as thioridazine, chlorpromazine, trifluperazine, haloperidol, amisulpride.
• Lithium (a medicine for mental health problems).
• Medicines for the treatment of cancer (such as methotrexate, which may also be used for other conditions, such as psoriasis or arthritis, and cyclophosphamide).
• Amantadine (for the treatment of Parkinson's disease or severe viral infections).
• Barbiturates (a sedative used to treat epilepsy).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Other medicines that may increase the blood pressure-lowering effect, such as baclofen (a medicine to relieve muscle spasms), amifostine (used in cancer treatment), and some antidepressants (such as amitriptyline, clomipramine, dosulepin).
• Adrenaline or noradrenaline, sometimes used to help increase blood pressure or to treat severe allergic reactions.

Using Candesartan/Hydrochlorothiazide Viatris with alcohol

• When Candesartan/Hydrochlorothiazide Viatris is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking candesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of candesartan/hydrochlorothiazide. Candesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan/Hydrochlorothiazide Viatris is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want 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 use tools or machines.

Candesartan/Hydrochlorothiazide Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Candesartan/Hydrochlorothiazide Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important that you take candesartan/hydrochlorothiazide every day. The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water. You can take candesartan/hydrochlorothiazide 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 Candesartan/Hydrochlorothiazide Viatris than you should

If you have taken more candesartan/hydrochlorothiazide than prescribed by your doctor, consult your doctor or pharmacist immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20) indicating the medicine and the amount taken.

You may experience a drop in blood pressure, which can cause you to feel dizzy, or you may notice an increase in heart rate or irregular heartbeats, muscle cramps, or in some cases, you may feel very sleepy or experience a reduction in your level of consciousness.

If you forget to take Candesartan/Hydrochlorothiazide Viatris

Do not takea double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan/Hydrochlorothiazide Viatris

If you stop taking candesartan/hydrochlorothiazide, your blood pressure may increase again. Do notstop taking this medicine without consulting your doctor.

If you have any further questions on 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 all people suffer from them.

It is essential that you know what these adverse effects might be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Viatris may be caused by candesartan cilexetil and others by hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Viatris and go to the doctor immediately if you have any of the followingadverse effects:

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

• Difficulty breathing, swelling of the face, lips, tongue, and/or throat that can cause difficulty swallowing, intense itching of inflamed skin (swollen).
• Liver problems, including liver inflammation (hepatitis). You may notice that you are more tired, yellowing of the skin and the whites of the eyes, dark urine, pale stools, or stomach pain.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• Pancreas inflammation. This causes moderate to severe stomach pain.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Appearance or worsening of existing lupus-like reactions (including 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 the reduction of blood cell production in the bone marrow (bone marrow depression).

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, urinate infrequently or not at all, or have cloudy or bloody urine.
• Acute breathing difficulties (symptoms include severe breathing difficulties, 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 high 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 this situation is severe, you may feel tired, weak, have irregular heartbeats, or tingling.
• An increase in cholesterol or fat, glucose, or uric acid levels in the blood.
  • Presence of glucose in urine.
  • Feeling dizzy or weak.
  • Headache.
  • Lung infection (which may include symptoms such as the common cold, flu).

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

• Low blood pressure. This can cause dizziness or fainting, especially when getting up from a sitting or lying position.

• Lack of appetite, diarrhea, 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, which can be seen in blood tests.
• Difficulty sleeping, depression, or restlessness.
• Tingling or pinching in arms and legs.
• Blurred vision for a short time.
• Abnormal heartbeats.
• High temperature (fever).
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• Increased urea nitrogen or certain proteins (creatinine) in the blood, which can be seen 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, which can be seen in blood tests.
• Cough.

• Nausea.
• Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging, blister, or bottle after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect it from light and moisture.

In HDPE bottles, the validity period is 90 days. Do not extract or swallow the desiccant found in the bottle.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Viatris

The active ingredients 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), cornstarch, yellow iron oxide (E-172), and red iron oxide (E-172). See section 2, "Candesartan/Hydrochlorothiazide Viatris contains lactose".

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide Viatris tablets are peach-colored, speckled, round, biconvex, marked with "M" on one face and "CH2" on the other.

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyCandesartan cilexetil HCT Mylan 16 mg/12.5 mg Tabletten

AustriaCandesartan/HCT Arcana 16 mg/12.5 mg tabletten

BelgiumCo-Candesartan Mylan 16 mg/12.5 mg tabletten

BulgariaCoCandesargen 16 mg/12.5 mg tablets

SpainCandesartan/Hydrochlorothiazide Viatris 16 mg/12.5 mg comprimidos EFG

FranceCandesartan Hydrochlorothiazide Viatris 16 mg/12.5 mg comprimé

LuxembourgCo-Candesartan Mylan 16 mg/12.5 mg comprimés

NetherlandsCandesartan cilexetil/Hydrochlorothiazide Mylan 16 mg/12.5 mg tabletten

PortugalCandesartan + Hydrochlorothiazide Mylan 16 mg/12.5 mg tablets

Date of the last revision of this prospectus:January 2025

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