Valsartan/hydrochlorothiazide Stadafarma 80 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan/Hydrochlorothiazide Stadafarma 80 mg/12.5 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Valsartán/Hidroclorotiazida Stadafarma is and what it is used for

Valsartán/Hidroclorotiazida Stadafarma film-coated tablets contain two active substances known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased 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 output, which also helps lower blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with either component used alone.

High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. Elevated blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. What you need to know before taking Valsartán/Hidroclorotiazida Stadafarma

Do not take Valsartán/Hidroclorotiazida Stadafarma

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is also advisable to avoid using valsartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• if you have severe liver disease, destruction of the small bile ducts in the liver (primary biliary cirrhosis), leading to bile accumulation 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 abnormally 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 renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartán/Hidroclorotiazida Stadafarma

• if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of your potassium levels necessary.

• if you have low potassium levels in your blood.

• if you experience severe diarrhoea 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 renal artery stenosis (narrowing of the artery to the kidney).

• if you have recently undergone a kidney transplant.

• if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, valsartan/hydrochlorothiazide is not recommended.

• if you have kidney or liver disease.

• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking valsartan/hydrochlorothiazide, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.

• if you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).

• if you have diabetes, gout, or high cholesterol or lipid levels in your blood.

• if you have previously had an allergic reaction to another medicine of this class used 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 eye pressure, which may occur from several hours to several weeks after taking valsartan/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. You may be at higher risk if you have previously had an allergy to penicillin or sulphonamides.

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

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

• aliskiren

  • if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking valsartan/hydrochlorothiazide.
  • if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, seek medical attention immediately.

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

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

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Stadafarma”.

Valsartan/hydrochlorothiazide may increase skin sensitivity to sunlight.

The use of valsartan/hydrochlorothiazide is not recommended in children and adolescents (under 18 years of age).

You must inform your doctor if you suspect you are pregnant (or might be). The use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Use in athletes

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

Taking Valsartán/Hidroclorotiazida Stadafarma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken together with certain medicines.

It may be necessary to adjust the dose and/or take additional precautions, or in some cases, discontinue treatment with one of the medicines. This is especially relevant for the following medicines:

• lithium, a medicine used to treat certain psychiatric conditions
• medicines or substances that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan/hydrochlorothiazide.
• medicines that may cause “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medicines for gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines for diabetes (oral antidiabetics such as metformin or insulin)
• other blood pressure-lowering medicines including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Valsartán/Hidroclorotiazida Stadafarma” and “Warnings and precautions”)
• medicines that increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medicines used to treat heart problems)
• medicines that increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses above 3 g
• muscle relaxants such as tubocurarine
• anticholinergic medicines (used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid to anaesthesia)
• amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral infections)
• cholestyramine and colestipol (medicines used to treat high lipid levels in blood)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• alcohol, sleeping medicines and anaesthetics (medicines with sedative or pain-relieving effects used, for example, during surgery)
• iodinated contrast media (used in diagnostic imaging procedures)

Taking Valsartán/Hidroclorotiazida Stadafarma with food, drinks and alcohol

You may take valsartan/hydrochlorothiazide with or without food. Avoid alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

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

Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

• Inform your doctor if you are breastfeeding or planning to breastfeed

The use of valsartan/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment if you plan to breastfeed, especially if your baby is a newborn or was premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you are aware of how valsartan/hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may rarely cause dizziness and affect your ability to concentrate.

Valsartán/Hidroclorotiazida Stadafarma contains sorbitol

80 mg/12.5 mg: This medicine contains 9.25 mg of sorbitol per tablet.

160 mg/25 mg: This medicine contains 18.5 mg of sorbitol per tablet.

Valsartán/Hidroclorotiazida Stadafarma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

Valsartán/Hidroclorotiazida Stadafarma contains lactose

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

3. How to take Valsartán/Hidroclorotiazida Stadafarma

Follow exactly the instructions given by your doctor for taking this medicine. This will help you achieve the best results and reduce the risk of adverse effects. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any symptoms; many feel perfectly normal. For this reason, it is very important to keep your doctor's appointments, even if you feel well.

Your doctor will tell you exactly how many tablets of valsartan/hydrochlorothiazide to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of valsartan/hydrochlorothiazide 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 may take valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Stadafarma 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valsartán/Hidroclorotiazida Stadafarma

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartán/Hidroclorotiazida Stadafarma

If you stop treatment with valsartan/hydrochlorothiazide, your hypertension may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, valsartan/hydrochlorothiazide may cause adverse effects, although not everyone experiences them.

Some adverse effects can be serious and require immediate medical attention:

• You should see your doctor immediately if you notice symptoms of angioedema, such as:

• swelling of the face, tongue or throat

• difficulty swallowing

• hives and difficulty breathing.

• Serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

• Decreased vision or eye pain due to elevated 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 and 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 such as thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g. ringing or buzzing) in the ears

Very rare (may affect less than 1 in 10,000 people):

• dizziness
• diarrhea
• joint pain
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea

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

• difficulty breathing

• severe reduction in urine output

• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)

• 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, may cause yellowing of the skin and eyes)

• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)

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

• syncope (fainting)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan

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

• sensation of spinning
• abdominal pain

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

• blisters on the skin (sign of bullous dermatitis)
• skin rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of inflammation of blood vessels)
• low platelet count (sometimes with more frequent bleeding or bruising than usual)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• 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 test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

Hydrochlorothiazide

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

• low potassium levels in the blood
• increased blood lipids

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
• itchy rash and other types of skin rash
• decreased appetite
• vomiting and mild nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

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

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may occur 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 disturbances

Very rare (may affect less than 1 in 10,000 people):

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including pneumonitis and pulmonary edema)
• 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)
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)

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

• weakness, bruising and frequent infections (aplastic anemia)

• marked decrease in urine production (possible signs of kidney impairment or kidney failure)

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

• muscle cramps

• fever (pyrexia)

• weakness (asthenia)

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Stadafarma

Keep out of the sight and reach of children.

Do not use Valsartan/Hydrochlorothiazide Stadafarma after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of the month indicated after EXP.

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

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and other information

Composition of Valsartan/Hydrochlorothiazide Stadafarma

The active substances are valsartan and hydrochlorothiazide.

One tablet of Valsartan/Hydrochlorothiazide Stadafarma 80 mg/12.5 mg film-coated tablets EFG contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. The other components are:

Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sorbitol (E-420), magnesium carbonate, pregelatinized corn starch, povidone K-30, stearoyl fumarate sodium, sodium lauryl sulfate, crospovidone type A.

Film coating: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171), iron oxide red (E 172).

Appearance of the medicinal product and contents of the pack

Film-coated tablets.

Valsartan/Hydrochlorothiazide Stadafarma 80 mg/12.5 mg film-coated tablets EFG: pink, cylindrical, biconvex tablets.

The tablets are available in packs of 14, 28, 30, 56, 98 and 280 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios CINFA, S.A.

Olaz-Chipi, 10 - Polígono Areta

31620 Huarte (Pamplona)

Spain

or

ZENTIVA k.s.

• Kabelovny 130, 10237, Prague 10

Czech Republic

or

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/