Valsartan/hydrochlorothiazide Pharmakern 320/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 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, consult 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 you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg is and what it is used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg
3. How to take Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg
6. Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg is and what it is used for

Valsartán/Hidroclorotiazida Pharmakern 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” that 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 diuresis, which also lowers blood pressure.

Valsartán/Hidroclorotiazida Pharmakern is used to treat high blood pressure that is not adequately controlled with 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, leading 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 Pharmakern 320 mg/25 mg

Do not take Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg:

• If you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is also advisable to avoid using Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg in early pregnancy – see section Pregnancy).
• 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 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 Pharmakern 320 mg/25 mg:

• If you are taking potassium-sparing medicines, 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 artery to the kidney (renal artery stenosis).
• 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, Valsartán/Hidroclorotiazida Pharmakern 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 Valsartán/Hidroclorotiazida Pharmakern, 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 triglyceride 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 intraocular pressure, which may occur from several hours to weeks after taking Valsartán/Hidroclorotiazida Pharmakern. If untreated, this may lead to permanent vision loss.

Your risk of developing this condition may be higher 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 and UV exposure while taking Valsartán/Hidroclorotiazida Pharmakern.
• If you have had respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop severe shortness of breath or difficulty breathing after taking Valsartán/Hidroclorotiazida Pharmakern, seek medical attention immediately.

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 Pharmakern”

• It may cause increased skin sensitivity to sunlight.

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 monotherapy without medical advice.

Children and adolescents

The use of Valsartán/Hidroclorotiazida Pharmakern is not recommended in children and adolescents (under 18 years of age).

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. The use of Valsartán/Hidroclorotiazida Pharmakern is not recommended during early pregnancy (first 3 months) and must not be used after the third month of pregnancy, as it may cause serious harm to your baby – see section Pregnancy.

Other medicines and Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment with Valsartán/Hidroclorotiazida Pharmakern may be altered if taken together with certain medicines. Your doctor may need to adjust your dose and/or take other 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 that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or 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 enhance the effect of Valsartán/Hidroclorotiazida Pharmakern.
• 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 used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
• Therapeutic vitamin D and calcium supplements.
• Medicines used to treat 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 Pharmakern” 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 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 various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion 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 medicines, and anesthetics (medicines with sedative or pain-relieving effects used, for example, during surgery).
• Iodinated contrast agents (used in diagnostic imaging procedures).

Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg with food and drink

You may take Valsartán/Hidroclorotiazida Pharmakern with or without food.

Avoid drinking 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

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

Generally, your doctor will advise you to stop taking Valsartán/Hidroclorotiazida Pharmakern before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Valsartán/Hidroclorotiazida Pharmakern is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby when used from that point onward.

Inform your doctor if you plan to start or are currently breastfeeding, as Valsartán/Hidroclorotiazida Pharmakern 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 the infant is a newborn or premature.

Driving and using machines

Before driving, 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/Hidroclorotiazida Pharmakern. Like many other medicines used to treat high blood pressure, Valsartán/Hidroclorotiazida Pharmakern may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg

Always take this medicine exactly as your doctor has told you. This will help you achieve the best results and reduce the risk of side effects. If in doubt, consult your doctor or pharmacist.

People with high blood pressure often do not notice any signs of the condition and 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 Pharmakern to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Valsartan/Hydrochlorothiazide Pharmakern is one tablet daily.
• 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 Pharmakern with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg than you should

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

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

You may also contact the toxicology information service at telephone number: 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg

If you miss 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 Valsartan/Hydrochlorothiazide Pharmakern 320 mg/25 mg

If you discontinue treatment with Valsartan/Hydrochlorothiazide Pharmakern, 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, Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg may produce 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 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)

• 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 Valsartán/Hidroclorotiazida Pharmakern 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 of 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 up to 1 in 10,000 people)

• dizziness
• diarrhea
• joint pain

Frequency not known (frequency 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, discomfort, 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 in the blood (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

Adverse effects observed with valsartan or hydrochlorothiazide separately, but not observed with Valsartán/Hidroclorotiazida Pharmakern:

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 presenting 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 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 blood vessel inflammation)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle cramps or 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 lead to 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
• 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)

• swelling and blisters on the skin (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, diarrhea, stomach or intestinal discomfort, liver disorders which 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 disturbances

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

(vasculitis)

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)
• 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)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)

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

• weakness, bruising and frequent infections (aplastic anemia)
• marked decrease in urine production (possible signs of kidney impairment or renal 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, pharmacist, or nurse, 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 Pharmakern 320 mg/25 mg

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

Keep out of 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 that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other components are: microcrystalline cellulose, crospovidone and magnesium stearate.
• The tablet film coating contains hypromellose, titanium dioxide (E-171), talc, macrogol PEG 8000 and yellow iron oxide (E-172).

Appearance of the product and contents of the container

Valsartán/Hidroclorotiazida Pharmakern 320 mg/25 mg film-coated tablets are oval-shaped, biconvex and light yellow in colour.

The tablets are supplied in containers and in PCTFE/LHD/Aluminum blisters containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

Portugal

Date of latest review of this leaflet: February 2025

Detailed and up-to-date 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/