VALSARTAN/HYDROCHLOROTHIAZIDE PREMIUM PHARMA 80/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg Film-Coated Tablets EFG

valsartan/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 and other information

1. What Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg is and what it is used for
2. What you need to know before you take Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg
3. How to take Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg
6. Pack contents and further information

1. What Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg is and what it is used for

Valsartan/Hydrochlorothiazide Premium Pharma film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs 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 narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases blood pressure.

Valsartan/Hydrochlorothiazide Premium Pharma is 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 can lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg

Do not take Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg:

• If you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, to sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant for more than 3 months (it is also recommended to avoid the use of Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg at the start of pregnancy – see section Pregnancy).
• If you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile in the liver (cholestasis).
• If you have severe kidney disease.
• If you are unable to produce urine (anuria).
• If you are undergoing dialysis.
• If you have low 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 failure and are being treated with a medicine to reduce blood pressure that contains aliskiren.

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 Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg:

• If you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly check 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 severe heart disease.
• If you have heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
• If you have narrowing of the kidney artery.
• If you have recently undergone a kidney transplant.
• If you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartan/Hydrochlorothiazide Premium Pharma is 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Valsartan/Hydrochlorothiazide Premium Pharma, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.
• If you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (a known autoimmune disease).
• If you have diabetes, gout, high cholesterol or triglyceride levels in your blood.
• If you have previously experienced an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.
• If you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a time frame of several hours to weeks after taking Valsartan/Hydrochlorothiazide Premium Pharma. If left untreated, this can lead to permanent vision loss.

You may be at greater risk of developing it if you have previously been allergic to penicillin or sulfonamides.

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

• 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, they could be symptoms of
• If 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 Valsartan/Hydrochlorothiazide Premium 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 shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Premium Pharma, seek medical attention 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 Valsartan/Hydrochlorothiazide Premium Pharma”

• It may cause increased sensitivity of the skin to the sun.

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

Children and adolescents

The use of Valsartan/Hydrochlorothiazide Premium Pharma is not recommended in children and adolescents (under 18 years of age).

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

• You must inform your doctor if you suspect you are pregnant (or might be)

Normally, your doctor will advise you to stop taking Valsartan/Hydrochlorothiazide Premium Pharma before becoming pregnant or as soon as you become pregnant, and will advise you to take another medicine instead of Valsartan/Hydrochlorothiazide Premium Pharma. The use of Valsartan/Hydrochlorothiazide Premium Pharma is not recommended at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used after the third month of pregnancy.

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

The use of Valsartan/Hydrochlorothiazide Premium Pharma is not recommended 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 using machines

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how you react to the effects of Valsartan/Hydrochlorothiazide Premium Pharma. Like many other medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide Premium Pharma can, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg

Always take Valsartan/Hydrochlorothiazide Premium Pharma exactly as your doctor has told you. This will help you to 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 signs 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 Valsartan/Hydrochlorothiazide Premium Pharma tablets to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

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

If you take more Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg than you should

If you notice a strong 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan/Hydrochlorothiazide Premium Pharma 80 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 missed doses.

If you stop taking Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg

If you stop your treatment with Valsartan/Hydrochlorothiazide Premium Pharma, your hypertension may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg can cause adverse effects, although not all people suffer from them.

Some adverse effects can 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 pharynx
• difficulty swallowing
• hives 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 effusion) or acute angle-closure glaucoma)

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

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide Premium Pharmaand contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other adverse 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 urination frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

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

• difficulty breathing
• severe decrease in diuresis
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, or abnormal heart rhythm)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, can trigger a gout attack)
• syncope (fainting)

Adverse effects observed with valsartan or hydrochlorothiazide alone, but not observed with Valsartan/Hydrochlorothiazide Premium Pharma:

Valsartan

Uncommon(may affect up to 1 in 100 people)

• feeling of rotation
• 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.

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

-blisters on the skin (sign of bullous dermatitis)

• skin rash with or without itching along with any of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of vasculitis)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle spasms or abnormal heart rhythm)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat, skin rash, itching
• elevated liver function values
• decrease in hemoglobin levels and reduction of red blood cell percentage in the blood (which, in severe cases, can cause anemia)
• renal failure

-low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

Hydrochlorothiazide

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

• low potassium levels in the blood
• increased lipids in the blood

Common(may affect up to 1 in 10 people)

-low sodium levels in the blood

-low magnesium levels in the blood

-high 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 sun sensitivity)

-high calcium levels in the blood

-high sugar levels in the blood

-sugar in the urine

-worsening of diabetic metabolic state

• constipation, diarrhea, stomach or intestinal discomfort, liver changes that may appear along with yellowing of the skin and eyes)
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)

-dizziness

-tingling or numbness

-vision changes

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

• vasculitis with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• acute difficulty breathing (signs include severe difficulty breathing, fever, weakness

• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• rash on the face, joint pain
• muscle disorders
• fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching, and spasms, rapid breathing (hypochloremic alkalosis)

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

• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of kidney disorder or kidney 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 and lip cancer (non-melanoma skin cancer)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. 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 Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg

Keep out of sight and reach of children.

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

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

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

Do not use Valsartan/Hydrochlorothiazide Premium Pharma if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, crospovidone, and magnesium stearate.
• The tablet coating contains hypromellose, titanium dioxide (E-171), macrogol PEG 8000, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

The film-coated tablets of Valsartan/Hydrochlorothiazide Premium Pharma 80 mg/12.5 mg are oval and pink in color.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Premium Pharma SL

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

Portugal

Date of the Last Revision of this Leaflet:February 2025.

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