Prospecto: information for the user

Candesartán/Hidroclorotiazida Viatris16 mg/12,5 mg tablets EFG

(Candesartán cilexetilo/hidroclorotiazida)

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isCandesartán/Hidroclorotiazida Viatrisand for what it is used

2.What you need to knowbeforestarting totakeCandesartán/Hidroclorotiazida Viatris

3.How to takeCandesartán/Hidroclorotiazida Viatris

4.Possible adverse effects

5.Storage ofCandesartán/Hidroclorotiazida Viatris

6. Contents of the package and additional information

Your medicine is calledCandesartán/Hidroclorotiazida Viatris. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: 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 makes blood vessels relax and dilate. This makes your blood pressure decrease.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps the body get rid of water and salt, such as sodium, in the urine. This makes your blood pressure decrease.

Your doctor may prescribeCandesartán/Hidroclorotiazida Viatrisif your blood pressure is not controlled adequately with candesartán cilexetilo or hidroclorotiazida alone.

Do not takeCandesartán/Hidroclorotiazida Viatris

• If you are allergic to candesartán, to hidroclorotiazida or to any of the other components of this medicine (listed in section 6).
• If you are allergic to sulfonamides (such as cotrimoxazol). If you are unsure whether you are in this situation, consult your doctor.
• If you are more than 3 months pregnant. (It is also recommended 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 the bile flowing out of the gallbladder).
• If you have persistent low levels of potassium in the blood despite treatment to increase potassium.
• If you have persistent high levels of calcium in the blood despite treatment to decrease calcium.
• If you have ever had gout.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medicine that contains aliskirén.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before takingCandesartán/HidroclorotiazidaViatris

Warnings and precautions

Consult your doctor or pharmacistbefore starting to takeCandesartán/HidroclorotiazidaViatris if:

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartán/Hidroclorotiazida Viatris, go to your doctor immediately.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking candesartán cilexetilo/hidroclorotiazida.
• If you are diabetic or at risk of developing diabetes.
• If you have heart problems, such as heart failure (a weakening of the heart muscle).
• If you have a narrowing of the heart valves, or a thickening of the heart muscle, which may affect blood flow from the heart.
• If you have other liver or kidney problems.
• If you have recently had a kidney transplant.
• If you have a narrowing of the renal artery.
• If you have low levels of sodium in the blood, are very dehydrated or have frequent vomiting, or have diarrhea.
• If you are being treated with high doses of diuretics or urinating frequently.
• If you have a condition called Conn's syndrome (also known as primary aldosteronism).
• 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, myocardial infarction or angina (or reduced blood flow to the brain).
• If you have allergies or asthma.
• Inform your doctor if you are pregnant (or if you suspect you may be). Do not use candesartán/hidroclorotiazida at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).
• If you are taking any of the following blood pressure lowering medicines:
• • An ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a few hours to weeks after takingCandesartán/HidroclorotiazidaViatris. If left untreated, it may lead to total loss of vision. Your risk of developing this may be higher if you have had a previous allergy 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 monitor your kidney function, blood pressure and electrolyte levels in the blood (such as potassium), at regular intervals.

See the 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 staff or hospital that you are taking this medicine.

Before surgery

Inform your doctor or dentist that you are taking Candesartán/Hidroclorotiazida Viatris. This is because Candesartán/Hidroclorotiazida Viatris, in combination with some anesthetics, may cause a large drop in blood pressure.

Before cosmetic surgery

Inform the medical staff or hospital that you are taking Candesartán/Hidroclorotiazida Viatris. The use of iodine in the material may increase the risk of adverse effects that occur.

Candesartán/Hidroclorotiazida Viatris may increase skin sensitivity to the sun. If this occurs, do not use sunbeds, tanning cabins and use sunscreen or cover up with clothing when in the sun.

Children and adolescents

There is no experience with the use ofCandesartán/Hidroclorotiazida Viatrisin children (under 18 years). Therefore,Candesartán/Hidroclorotiazida Viatrisshould not be administered to children.

Use in athletes

This medicine contains hidroclorotiazida which may produce a positive result in doping control tests.

Other medicines and Candesartán/Hidroclorotiazida Viatris

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

Candesartán/Hidroclorotiazida Viatris may affect the way 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 at regular intervals.

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

• Other blood pressure lowering medicines, including beta-blockers, diazoxide and ACE inhibitors (such as enalapril, captopril, lisinopril or ramipril) or aliskirén (see also the 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 (pain and inflammation relievers).
• Aspirin (if you take more than 3 g per day) (pain and inflammation reliever).
• Potassium supplements or salt substitutes containing potassium (other medicines to increase potassium levels in the blood, such as heparin (blood thinner) or cotrimoxazol also known as trimetoprima/sulfametoxazol (bacterial infection treatment).
• Medicines that may affect the amount of potassium in the blood (such as diuretics), laxatives, penicillin (an antibiotic), amphotericin (for fungal infections), carbenoxolone (for esophageal problems or oral ulcers), steroids such as prednisolone, pituitary hormone (ACTH).
• Calcium supplements or vitamin D.
• Cholesterol-lowering medicines, such as colestipol or colestiramine.
• Diabetes medicines (tablets, such as metformin or insulin).
• Medicines to control heart rhythm (antiarrhythmic agents) such as quinidine, disopyramide, amiodarone, sotalol, ibutilide, digoxin.
• Other medicines that may affect heart rhythm, such as cisaprida (for stomach problems), erythromycin, esparfloxacina, pentamidine (antibiotics), halofantrina (for malaria treatment), terfenadine (antihistamine).
• Some 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).
• Cancer medicines (such as methotrexate (also used for other conditions such as, for example, psoriasis, arthritis) and cyclophosphamide).
• Amantadina (for Parkinson's disease treatment or for severe viral infections).
• Barbiturates (a sedative used for epilepsy treatment).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporina, a medicine used to prevent organ transplant rejection.
• Other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for muscle spasms), amifostine (used for cancer treatment) and some antidepressants (such as amitriptyline, clomipramine, dosulepina).
• Adrenaline or noradrenaline, sometimes used to help increase blood pressure or, sometimes, for the treatment of severe allergic reactions.

Use of Candesartán/Hidroclorotiazida Viatris with alcohol

• When prescribedCandesartán/Hidroclorotiazida Viatris, consult your doctor before taking alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually advise you to stop takingcandesartán/hidroclorotiazidabefore becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead ofcandesartán/hidroclorotiazida. It is not recommended to usecandesartán/hidroclorotiazidaduring pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Inform your doctor if you are breastfeeding or about to start. It is not recommended to useCandesartán/Hidroclorotiazida Viatrisduring breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and operating machines

Some patients may feel tired or dizzy when takingcandesartán/hidroclorotiazida. If this occurs to you, do not drive or operate tools or machines

Candesartán/Hidroclorotiazida Viatris contains lactose

If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. It is essential that you continue taking candesartán/hidroclorotiazida every day. The recommended dose is one tablet once a day.

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

Try to take the tablet at the same time every 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, consult your doctor or pharmacist immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested.

You may experience a decrease in blood pressure, which can cause dizziness, or you may notice an increase in heart rate or irregular heartbeats, muscle cramps, or in some cases, excessive sleepiness or a reduction in level of consciousness.

If you forgot to take Candesartán/Hidroclorotiazida Viatris

Do not take a double dose to compensate for the missed dose. Simply take the next dose.

If you interrupt treatment with Candesartán/Hidroclorotiazida Viatris

If you stop taking candesartán/hidroclorotiazida, your blood pressure may increase again. Do not stop taking this medication before consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinemay cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side 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 followingside 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, intense itching of the inflamed skin.
• Liver problems, including inflammation of the liver (hepatitis). You may notice that you are more tired, yellowing of the skin and the white of the eyes, dark urine, pale stools, or stomach pain.
• Respiratory difficulties (including pulmonary inflammation and fluid in the lungs).
• Pancreatitis. 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 erythematosus-like reactions (which include unusual skin reactions, facial rash, joint pain, muscle disorders, and fever).
• 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 easily bruise. This may be due to reduced blood cell production in the bone marrow (bone marrow depression).

Very rare (may affect up to1 in 10,000 people)

• Effects on kidney function, especially if you already have kidney problems or heart failure. You may notice back pain, urinating infrequently or not at all, or having cloudy or bloody urine.
• Acute respiratory distress (symptoms include severe difficulty breathing, 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 hemorrhage) or acute angle-closure glaucoma].

Other possible side effects include:

Frequent (may affect up to 1 in 10 people):

• Changes in blood test results:

-Reduced sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.

-Increased or decreased potassium levels in the blood, especially if you already have kidney problems or heart failure. If severe, you may feel tired, weak, have irregular heartbeats, or experience numbness.

-Increased levels of cholesterol or fats, glucose, or uric acid in the blood.

• Presence of glucose in urine.
• Dizziness or weakness.
• Headache.
• Pulmonary infection (which may include symptoms such as common cold, flu).

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

• Low blood pressure. This may cause dizziness or fainting, especially when getting up from a seated or lying position.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, sun sensitivity reaction.

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

• Effects on kidney function, which may be seen in blood tests.
• Difficulty sleeping, depression, or restlessness.
• Itching or pinching in arms and legs.
• Blurred vision for a short period.
• Irregular heartbeats.
• Fever.
• Muscle cramps.
• Vascular damage causing red or purple spots on the skin.
• Increased urea nitrogen levels in the blood or certain proteins (creatinine) in the blood, which may be seen in blood tests.

Very rare (may affect up to1 in 10,000 people):

• Itching.
• Back pain, joint pain, and muscle pain.
• Changes in liver function, which may be seen in blood tests.
• Cough.
• Nausea.
• Angioedema intestinal: swelling in the intestine that causes 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 side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging, blister pack, or bottle after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

In HDPE bottles, the shelf life is 90 days. Do not remove or ingest the desiccant found in the bottle.

Medications should not be disposed of through drains or trash. Dispose of empty containers and unused medications at the SIGRE drop-off pointat your pharmacy. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment..

Composition of Candesartán/Hidroclorotiazida Viatris

The active ingredients are candesartán cilexetilo and hidroclorotiazida.

Each tablet contains 16 mg of candesartán cilexetilo and 12.5 mg of hidroclorotiazida.

The other components are calcium carmelose, glycerol monoestearate, hydroxypropylcellulose (E-463), lactose monohydrate, magnesium stearate (E-470B), cornstarch, yellow iron oxide (E-172), and red iron oxide (E-172).See section 2, “Candesartán/Hidroclorotiazida Viatris contains lactose”.

Appearance of the product and contents of the package

The Candesartán/Hidroclorotiazida Viatris tablets are peach-colored, speckled, round, biconvex, marked with “M” on one face and “CH2” on the other.

Candesartán/Hidroclorotiazida 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 package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

McDermott Laboratories trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft

H-2900 Komárom

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 medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyCandesartancilexetil 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

SpainCandesartán/Hidroclorotiazida Viatris 16 mg/12.5 mg comprimidos EFG

FranceCandesartan Hydroclorotiazide Viatris 16 mg/12.5 mg comprimé

LuxembourgCo-Candesartan Mylan 16 mg/12.5 mg comprimés

NetherlandsCandesartan cilexetil/Hydrochlorotiazide Mylan 16 mg/12.5 mg tabletten

PortugalCandesartan + Hidroclorotiazida Mylan 16 mg/12.5 mg tablets

Revision date of this leaflet:January2025

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es