Leaflet: information for the patient

Valsartan/Hydrochlorothiazide

Premium Pharma

320 mg/12.5 mg, film-coated tablets EFG

valsartan/hydrochlorothiazide

Read this 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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Valsartan/Hydrochlorothiazide Premium Pharma 320 mg/12.5 mg and what it is used for

2. What you need to know before taking Valsartan/Hydrochlorothiazide Premium Pharma 320 mg/12.5 mg

3. How to take Valsartan/Hydrochlorothiazide Premium Pharma 320 mg/12.5 mg

4. Possible side effects

5. Storage of Valsartan/Hydrochlorothiazide Premium Pharma 320 mg/12.5 mg

6. Contents of the pack and additional information

Valsartán/HidroclorotiazidaPremium Pharmafilm-coated tablets contain two active ingredients known as valsartán and hidroclorotiazida. These components help control high blood pressure (hypertension).

-Valsartánbelongs to a class of medications known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

-Hidroclorotiazidabelongs to a class of medications known as thiazide diuretics. Hidroclorotiazida increases diuresis, which also decreases blood pressure.

Valsartán/HidroclorotiazidaPremium Pharmais used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not take Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12,5 mg:

- If you are allergic (hypersensitive) to valsartan, to hydrochlorothiazide, to derivatives of sulfonamides (substances chemically related to hydrochlorothiazide) or to any of the other components of this medicine (listed in section 6).

- If you are pregnantover 3 months(it is also better to avoid the use of Valsartán/HidroclorotiazidaPremium Pharma320 mg/12,5 mg at the beginning of pregnancy – see Pregnancy section).

- If you have a severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile in the liver (cholestasis).

- If you have a severe kidney disease.

- If you are unable to produce urine (anuria).

- If you are undergoing dialysis.

- If you have lower-than-normal levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment.

- If you have gout.

- If you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskirén.

If any of these situations apply to you, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán/HidroclorotiazidaPremium Pharma320 mg/12,5 mg:

- If you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium, or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.

- If you have low levels of potassium in your blood.

- If you experience severe diarrhea or vomiting.

- If you are taking high doses of a diuretic.

- If you have a severe heart disease.

- If you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. Your doctor may also monitor your kidney function.

- If you have a narrowing of the renal artery.

- If you have recently undergone a kidney transplant.

- If you have primary aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán/HidroclorotiazidaPremium Pharmais not recommended.

- If you have kidney or liver disease.

- If you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when takingValsartan/HidroclorotiazidaPremium Pharma, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.

- If you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

- If you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).

- If you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.

- If you have previously experienced an allergic reaction with the use of another medication of this class to reduce blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.

- If you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur during a period of time ranging from several hours to weeks after taking Valsartan/HidroclorotiazidaPremium Pharma. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have had an allergy to penicillin or sulfonamides previously.

- If you are taking any of the following medications used to treat high blood pressure (hypertension):

(high blood pressure):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

- If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 exposure to the sun and UV rays while takingValsartan/HidroclorotiazidaPremium Pharma.

- If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after takingValsartan/HidroclorotiazidaPremium Pharma, see your doctor immediately.

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

See also the information under the heading “Do not take Valsartán/HidroclorotiazidaPremium Pharma”

- It may cause increased sensitivity to the sun.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking valsartán/hidroclorotiazida in monotherapy.

Children and adolescents

Valsartán/HidroclorotiazidaPremium Pharmais not recommended for use in children and adolescents (under 18 years).

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Valsartán/HidroclorotiazidaPremium Pharmais not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby, see Pregnancy section.

Other medications and Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12,5 mg

Inform your doctor or pharmacist that you are taking, have recently used, or may need to use any other medication.

The effect of treatment with Valsartán/HidroclorotiazidaPremium Pharmamay be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue treatment of one of the medications. This is especially applicable to the following medications:

• Lithium, a medication used to treat some types of psychiatric diseases.
• Medications that may increase the amount of potassium in the blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing medications, or heparin.
• Medications that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
• Some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect ofValsartan/HidroclorotiazidaPremium Pharma.
• Medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics.
• Medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics.
• Medications used to treat gout, such as allopurinol, probenecid, sulfinpirazona.
• Vitamin D therapy and calcium supplements.
• Medications used to treat diabetes (oral antidiabetic medications such as metformin or insulin).
• Other medications to reduce blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskirén (see also the information under the headings “Do not take Valsartan/HidroclorotiazidaPremium Pharma” and “Warnings and precautions”)
• Medications that increase blood pressure, such as norepinephrine or adrenaline.
• Digoxin or other digitalis glycosides (medications used to treat heart problems).
• Medications that may increase blood sugar levels, such as diazoxide or beta-blockers.
• Cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide.
• Pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g.
• Muscle relaxants, such as tubocurarine.
• Anticholinergic medications (medications used to treat a wide range of conditions such as gastrointestinal cramps, urinary retention, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia).
• Amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).
• Colestiramine and colestipol (medications used primarily to treat high levels of lipids in the blood).
• Ciclosporina, a medication used to prevent organ rejection after transplantation.
• Alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery).
• Iodinated contrast media (used for diagnostic imaging tests).

Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12,5 mg with food, drink, and alcohol

You can take Valsartán/HidroclorotiazidaPremium Pharmawith or without food.

Avoid taking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or suspect you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medication.

Generally, your doctor will advise you to stop taking Valsartán/HidroclorotiazidaPremium Pharmabefore becoming pregnant or as soon as you become pregnant, and will advise you to take another medication instead of Valsartán/HidroclorotiazidaPremium Pharma. Valsartán/HidroclorotiazidaPremium Pharmais not recommended for use at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby from that point on.

Inform your doctor if you plan to initiate or are breastfeeding, as Valsartán/HidroclorotiazidaPremium Pharmais not recommended for use during this period. Your doctor may decide to administer a treatment that is more suitable

if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know your reactions to the effects of Valsartán/HidroclorotiazidaPremium Pharma. Like many other medications used to treat high blood pressure, Valsartán/HidroclorotiazidaPremium Pharmamay cause, in rare cases, dizziness and affect concentration.

Always take this medication exactly as your doctor tells you to. This will help you get the best results and reduce the risk of side effects. If you are unsure, consult your doctor or pharmacist.

People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

Your doctor will tell you exactly how many tablets of Valsartán/Hidroclorotiazida Premium Pharma you should take. Depending on how you respond to the treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Valsartán/Hidroclorotiazida Premium Pharma is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take Valsartán/Hidroclorotiazida Premium Pharma with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12.5 mg than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

You can also contact the toxicology information service, phone: 91 562 04 20 (indicating the medication and the amount taken).

If you forget to take Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12.5 mg

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12.5 mg

If you stop taking Valsartán/Hidroclorotiazida Premium Pharma, your high blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

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

Like all medicines, Valsartan/Hidroclorotiazida Premium Pharma320 mg/12.5 mg can cause side effects, although not everyone will experience them

Some side effects may be serious and require immediate medical attention:

- You should visit your doctor immediately if you notice symptoms of angioedema, such as:

- Swelling in the face, tongue, or throat

- Difficulty swallowing

- Urticaria and difficulty breathing

- Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)

- Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)

- Fever, sore throat, increased frequency of infections (agranulocytosis)

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartan/Hidroclorotiazida Premium Pharmaand contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

Uncommon(may affect up to 1 in 100 people)

- Cough

- Low blood pressure

- Dizziness

- Dehydration (with symptoms of thirst, dry mouth and tongue, reduced urine frequency, dark-colored urine, dry skin)

- Muscle pain

- Fatigue

- Numbness or tingling

- Blurred vision

- Ringing or buzzing in the ears

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

- Dizziness

- Diarrhea

- Joint pain

Unknown frequency(cannot be estimated from available data):

- Difficulty breathing

- Severe decrease in urine production

- Low sodium levels in the blood(which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or seizures)

- Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)

- Low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)

- Elevated bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)

- Elevated urea and creatinine levels in the blood (which may indicate abnormal kidney function)

- Elevated uric acid levels in the blood (which, in severe cases, may trigger a gout attack)

- Syncope (fainting)

Side effects observed with valsartan or hydrochlorothiazide alone, but not with Valsartan/Hidroclorotiazida Premium Pharma:

Valsartan

Uncommon(may affect up to 1 in 100 people)

- Dizziness

- Abdominal pain

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

Unknown frequency(cannot be estimated from available data):

- Blisters on the skin (sign of dermatitis herpetiformis)

- Skin rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to the flu

- Skin rash, red-purple patches, fever, itching (signs of vasculitis)

- Low platelet count (sometimes with bleeding or bruising more frequently than usual)

- Elevated potassium levels in the blood (sometimes with muscle spasms or abnormal heart rhythm)

- Allergic reactions (with symptoms such as skin rash, itching, urticaria, difficulty breathing or swallowing, dizziness)

- Swelling mainly of the face and throat, skin rash, itching

- Elevated liver function values

- Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)

- Kidney insufficiency

-Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or seizures)

Hydrochlorothiazide

Very common(may affect more than 1 in 10 people)

- Low potassium levels in the blood

- Elevated lipid levels in the blood

Common(may affect up to 1 in 10 people)

-Low sodium levels in the blood

-Low magnesium levels in the blood

-Elevated uric acid levels in the blood

-Skin rash with itching and other types of rash

-Decreased appetite

-Mild vomiting and nausea

-Dizziness, dizziness when standing up

-Inability to achieve or maintain an erection

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

-Elevated calcium levels in the blood

-Elevated blood sugar levels

-Sugar in the urine

-Worsening of diabetic metabolic state

-Swelling and blisters on the skin (due to increased sensitivity to the sun)

-Constipation, diarrhea, stomach or intestinal discomfort, liver alterations that may appear with yellow skin and eyes.

-Irregular heartbeat

-Headache

-Sleep disturbances

-Depression

-Low platelet count (sometimes with bleeding or bruising under the skin)

-Dizziness

-Numbness or tingling

-Visual disturbances

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

-Inflammation of blood vessels with symptoms such as skin rash, red-purple patches, fever (vasculitis)

-Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)

-Rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)

-Rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)

-Severe stomach pain (pancreatitis)

-Pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)

-Fever, sore throat, or mouth ulcers due to infections (leukopenia)

-Confusion, fatigue, muscle cramps, and spasms, rapid breathing (hypochloremic alkalosis)

Unknown frequency(frequency cannot be estimated from available data)

-Weakness, bruising, and frequent infections (aplastic anemia)

-Significant decrease in urine production (possible signs of renal dysfunction or renal failure)

-Skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)

-Muscle spasms

-Fever (pyrexia)

-Weakness (asthenia)

-Skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of side effects

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

Do not store above 30 ºC. Store in the original packaging to protect it from humidity.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12,5 mg

• The active principles are valsartán and hidroclorotiazida. Each tablet contains 320 mg of valsartán and 12,5 mg of hidroclorotiazida.
• The other components are: microcrystalline cellulose, crospovidona and magnesium stearate.
• The coating of the tablet contains hypromelosa, titanium dioxide (E-171), talc, macrogol PEG 8000 and iron oxide red (E-172).

Appearance of the product and content of the packaging

The coated tablets of Valsartán/Hidroclorotiazida Premium Pharma 320 mg/12,5 mg are oval, convex and light pink in color.

The tablets are presented in packaging, PCTFE/LHD/Aluminum blister with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Premium Pharma SL

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, 2 , Abrunheira, 2710 – 089 Sintra

Portugal

Last review date of this leaflet: February 2025

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/