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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.

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

Leaflet contents:

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

1. What Valsartan/Hydrochlorothiazide SUN is and what it is used for

Valsartan/Hydrochlorothiazide SUN 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 production, which also lowers blood pressure.

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

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to 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 conditions.

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

Do not take Valsartán/Hidroclorotiazida SUN:

??if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or to any of the other components of Valsartán/Hidroclorotiazida SUN (listed in section 6).

??if you are more than 3 months pregnant. (In any case, it is better to avoid taking Valsartán/Hidroclorotiazida SUN even at the beginning of pregnancy – see Pregnancy section).

??if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).

??if you have severe kidney disease.

??if you are unable to urinate (anuria).

??if you are undergoing dialysis.

??if you have abnormally low levels of potassium or sodium in the 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, inform your doctor and do not take Valsartán/Hidroclorotiazida SUN.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Valsartán / Hidroclorotiazida tablets:

• If you have previously experienced respiratory 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 Valsartán/Hidroclorotiazida SUN, seek medical attention immediately.
• if you are taking potassium-sparing medications, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.

??if you have low blood potassium levels.

??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 renal artery.

??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 medications (including ACE inhibitors), inform your doctor. If you experience these symptoms while taking Valsartán / Hidroclorotiazida tablets, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.

??if you have fever, skin rash, and joint pain, which could be signs of systemic lupus erythematosus (SLE, a known autoimmune disease).

??if you have diabetes, gout, or high cholesterol or lipid levels in the 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 intraocular pressure, which may occur within a period ranging from several hours to one week after taking Valsartán/Hidroclorotiazida. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

??if you are taking any of the following medicines used to treat high blood pressure:

o “ACE inhibitors” such as enalapril, lisinopril, etc.

o aliskiren

• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Valsartán/Hidroclorotiazida 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 on your own.

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

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

Valsartán/Hidroclorotiazida may cause increased skin sensitivity to sunlight.

Inform your doctor if you think you might be pregnant or plan to become pregnant. The use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby (see Pregnancy section).

Children and adolescents

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

Tests

Use of Valsartán/Hidroclorotiazida may result in a positive anti-doping test.

Taking Valsartán/Hidroclorotiazida 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 when taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, discontinue treatment with one of the medicines. This is particularly applicable to the following medicines:

??lithium, a medicine used to treat certain psychiatric conditions

??medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin

??medicines that may decrease blood potassium levels, such as diuretics (medicines to increase urination), 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 Valsartán / Hidroclorotiazida tablets

??medicines that may induce “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 to treat gout, such as allopurinol, probenecid, sulfinpyrazone

??therapeutic vitamin D and calcium supplements

??medicines to treat diabetes (insulin or oral antidiabetics such as metformin)

??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 SUN” and “Warnings and precautions”)

??medicines that may increase blood pressure, such as noradrenaline or adrenaline

??digoxin or other digitalis glycosides (medicines used to treat heart problems)

??medicines that may 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 exceeding 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, travel sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia)

??amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases)

??cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)

??cyclosporine, a medicine used to prevent rejection of transplanted organs

??alcohol, sleeping pills, and anesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery)

??iodinated contrast media (used in diagnostic imaging procedures)

Taking valsartán/hydrochlorothiazide with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

??You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine instead of valsartan/hydrochlorothiazide.

The use of valsartan/hydrochlorothiazide is not recommended at the beginning of pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that time.

Breastfeeding:

??Inform your doctor if you are planning to breastfeed or are currently breastfeeding

Valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

3. How to take Valsartán/Hidroclorotiazida SUN

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

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

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

• The usual 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 SUN 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Valsartán/Hidroclorotiazida SUN

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 SUN

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, this medicine may cause adverse effects, although not everyone will experience 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 pharynx
?? difficulty swallowing
?? hives and difficulty breathing.

• Severe skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Sudden onset of reduced distance vision (acute myopia), decreased vision or eye pain due to high 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 SUN and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other possible 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-coloured urine, dry skin)
?? muscle pain
?? fatigue
?? tingling or numbness
?? blurred vision
?? noises (e.g. ringing or buzzing) in the ears

Very rare (may affect up to 1 in 10,000 people)
?? dizziness
?? diarrhoea
?? joint pain

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be estimated from available data)
?? difficulty breathing
?? severe decrease in urine output
?? low sodium levels in the blood (which may cause fatigue, confusion, muscle fasciculations and/or seizures in severe cases)
?? 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 valsartan or hydrochlorothiazide used separately:

Valsartan

Uncommon (may affect up to 1 in 100 people)
?? sensation of spinning
?? abdominal pain

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

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency 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 increased bleeding or bruising)
  ?? 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
  ?? Increased liver function test values
  ?? Decreased haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anaemia)
  ?? 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 lipid levels

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 skin rash and other types of rash
?? decreased appetite
?? mild vomiting and 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 state
?? constipation, diarrhoea, stomach or intestinal discomfort, liver disorders which 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
?? 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 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 oedema)
? fever, sore throat, increased frequency of infections (agranulocytosis)
? pale skin, fatigue, shortness of breath, dark-coloured urine (haemolytic anaemia)
? confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloraemic alkalosis)
? Acute respiratory difficulty (symptoms include severe breathing problems, fever, weakness and confusion).

Frequency not known (frequency cannot be estimated from available data)
? weakness, bruising and frequent infections (aplastic anaemia)
? 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)

Reporting of adverse effects:

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

5. Storage of Valsartan / Hydrochlorothiazide SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice the packaging is damaged or shows signs of tampering.

This medicine does not require special storage conditions regarding temperature. Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide SUN 80 mg/12.5 mg

Valsartan/Hydrochlorothiazide SUN contains two active substances: Valsartan and hydrochlorothiazide.

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other components are the following excipients:

Tablet core: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, talc, magnesium stearate and pregelatinized maize starch.

Tablet coating: hydroxypropyl cellulose, hypromellose and titanium dioxide (E171).

Nature of the product and pack contents

Valsartan/Hydrochlorothiazide SUN 80 mg/12.5 mg film-coated tablets are white or almost white, oval-shaped, measuring 12.5 x 6.0 mm, marked with "VH 1" on one side and smooth on the other.

Available pack sizes contain 10, 14, 20, 28, 30, 56, 90, 98, 100 or 280 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer

TERAPIA S.A.
124 Fabricii Street,
400632 Cluj Napoca
Romania

Or

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132 JH Hoofddorp,
The Netherlands

Local representative

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 – Barcelona, Spain
Tel.: +34 93 342 7890

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Valsartan COMP BASICS 80mg/12,5mg Filmtabletten
Spain: Valsartán Hidroclorotiazida SUN 80 mg/12,5 mg comprimidos recubiertos con película EFG
Italy: Valsartan e Idroclorotiazide SUN 80 mg/12,5 mg compresse rivestite con film

Date of the most recent review of this leaflet: January 2025

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