Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Premium Pharma 160 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, ask your doctor or pharmacist.

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

- If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Valsartan/Hydrochlorothiazide Premium Pharma 160 mg/12.5 mg and what it is used for

2. What you need to know before taking Valsartan/Hydrochlorothiazide Premium Pharma 160 mg/12.5 mg

3. How to take Valsartan/Hydrochlorothiazide Premium Pharma 160 mg/12.5 mg

4. Possible side effects

5. Storage of Valsartan/Hydrochlorothiazide Premium Pharma 160 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 medicines 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 medicines 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 160 mg/12,5 mg:

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

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

- If you have a severe liver diseaseorsmall bile duct destruction in the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).

- If you have a severe kidney disease.

- If you cannotproduce 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 affect you, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán/HidroclorotiazidaPremium Pharma:

- 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 need 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 experience these symptoms when taking Valsartan/HidroclorotiazidaPremium Pharma, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.

- 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 hemorrhage) or increased eye pressure, which can 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 previously been allergic to penicillin or sulfonamides.

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

(high blood pressure):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. 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 sun exposure and UV rays while taking Valsartan/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) 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).

Inform your doctor if you suspect you are pregnant (or may be). Valsartán/HidroclorotiazidaPremium Pharmais not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant over 3 months, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Other medications and Valsartán/Hidroclorotiazida Premium Pharma 160 mg/12,5 mg

Inform your doctor or pharmacist if you are using, have used recently, 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 particularly applicable to the following medications:

• Lithium, a medication used to treat certain 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 (medications to urinate), 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 of Valsartan/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 to treat gout, such as allopurinol, probenecid, sulfinpirazona
• Vitamin D therapy and calcium supplements
• Medications 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 epinephrine
• 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
• Medications for pain, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g
• Relaxants, such as tubocurarine
• Anticholinergic medications (medications used to treat a wide range of disorders 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 aids, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)
• Contrast agents containing iodine (used for diagnostic imaging tests)

Taking Valsartán/Hidroclorotiazida Premium Pharma 160 mg/12,5 mg with food, drink, and alcohol

You can take Valsartán/HidroclorotiazidaPremium Pharmawith or without food.

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

Pregnancy, breastfeeding, and fertility

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

• Inform your doctor if you suspect you are pregnant (or may be)

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 at the beginning of pregnancy, and it should not be taken if you are pregnant over 3 months, as it may cause serious harm to your baby if used during this period.

• Inform your doctor if you are breastfeeding or plan to start

Valsartán/HidroclorotiazidaPremium Pharmais not recommended for use in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is newborn or premature.

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 Valsartán/Hidroclorotiazida Premium Pharma 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 again.

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 160 mg/12.5 mg than you should

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

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.

If you forget to take Valsartán/Hidroclorotiazida Premium Pharma 160 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 160 mg/12.5 mg

If you stop taking Valsartán/Hidroclorotiazida Premium Pharma, your 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, Valsartán/Hidroclorotiazida Premium Pharma160 mg/12.5 mg may 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 Valsartán/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 in the ears (e.g., tinnitus or buzzing)

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

- Dizziness

- Diarrhea

- Joint pain

Unknown frequency(the 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 in the blood (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 the skin and eyes to turn yellow)

- 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 Valsartán/Hidroclorotiazida Premium Pharma:

Valsartan

Uncommon(may affect up to 1 in 100 people)

- Dizziness

- Abdominal pain

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

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

Unknown frequency(the 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 spots, fever, itching (symptoms 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)

- Renal 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)

- Swelling and blisters on the skin (due to increased sensitivity to the sun)- Elevated calcium levels in the blood

- Elevated blood sugar levels

- Sugar in the urine

- Worsening of diabetic metabolic state

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

- Irregular heartbeat

- Headache

- Sleep disturbances

- Depression

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

- Numbness or tingling

- Visual disturbances

Rare(may affect fewer than 1 in 10,000 people)

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

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

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

- Skin 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(the 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 Vigilance 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.

.

Keep out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C. Store in the original packaging to protect it from moisture.

Do not use Valsartán/Hidroclorotiazida Premium Pharma if you observe that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Valsartán/Hidroclorotiazida Premium Pharma 160 mg/12,5 mg

• The active principles are valsartan and hidroclorotiazida. Each tablet contains 160 mg of valsartan and 12.5 mg of hidroclorotiazida.
• The other components are: microcrystalline cellulose, crospovidone, and magnesium stearate.
• The coating of the tablet contains hypromellose, titanium dioxide (E-171), macrogol PEG 8000, and iron oxide red (E-172).

Appearance of the product and contents of the packaging

The film-coated tablets of Valsartán/Hidroclorotiazida Premium Pharma 160 mg/12,5 mg are oval-shaped, red in color, and scored on one side.

They are presented in PCTFE/LHD/Aluminum blisters containing 18, 28, 30, 56, 98, and 280 tablets.

Only some sizes of packaging may be commercially marketed.

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.

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