Valsartan/hydrochlorothiazide Pharmakern 160/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Valsartan/Hydrochlorothiazide Pharmakern 160 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 you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Valsartan/Hydrochlorothiazide Pharmakern 160 mg/12.5 mg is and what it is used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Pharmakern 160 mg/12.5 mg
3. How to take Valsartan/Hydrochlorothiazide Pharmakern 160 mg/12.5 mg
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Pharmakern 160 mg/12.5 mg
6. Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Pharmakern 160 mg/12.5 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” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to 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.

Valsartán/Hidroclorotiazida Pharmakern is used to treat high blood pressure that is not adequately controlled with either component alone.

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 also 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 Pharmakern 160 mg/12.5 mg

Do not take Valsartán/Hidroclorotiazida Pharmakern 160 mg/12.5 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 160 mg/12.5 mg in early pregnancy – see Pregnancy section).
• If you have severe liver disease, destruction of 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 160 mg/12.5 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 your potassium levels necessary.
• If you have low levels of potassium 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 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 eye 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 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), especially 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, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV radiation while taking Valsartán/Hidroclorotiazida Pharmakern.
• 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 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 information under the heading “Do not take Valsartán/Hidroclorotiazida Pharmakern”.

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

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 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).

You must inform your doctor if you suspect you are pregnant (or could be). The use of Valsartán/Hidroclorotiazida Pharmakern is not recommended during early pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Other medicines and Valsartán/Hidroclorotiazida Pharmakern 160 mg/12.5 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 when taken 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 particularly important with 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 increase the effect of Valsartán/Hidroclorotiazida Pharmakern.
• 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 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 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 (COX-2) inhibitors and acetylsalicylic acid at doses above 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 anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery).
• Iodinated contrast media (used in diagnostic imaging procedures).

Taking Valsartán/Hidroclorotiazida Pharmakern 160 mg/12.5 mg with food, drink, and alcohol

You may take Valsartán/Hidroclorotiazida Pharmakern 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, breastfeeding, and fertility

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

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

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 it must not be taken after the third month of pregnancy, 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 Valsartán/Hidroclorotiazida Pharmakern is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Before driving a vehicle, operating tools, handling machinery, or engaging in other activities requiring concentration, ensure you are aware of how Valsartán/Hidroclorotiazida Pharmakern affects you. 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 160 mg/12.5 mg

Always take Valsartan/Hydrochlorothiazide Pharmakern exactly as prescribed by your doctor. 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 experience any noticeable symptoms and may feel perfectly well. For this reason, it is very important to keep your scheduled appointments with your doctor, even if you feel fine.

Your doctor will tell you exactly how many tablets of Valsartan/Hydrochlorothiazide Pharmakern you should take. Depending on your response to treatment, your doctor may decide to adjust your dose up or down.

• The recommended dose of Valsartan/Hydrochlorothiazide Pharmakern 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 each 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 160 mg/12.5 mg than you should

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

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

If you forget to take Valsartan/Hydrochlorothiazide Pharmakern 160 mg/12.5 mg

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for 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 160 mg/12.5 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 160 mg/12.5 mg may produce adverse effects, although not everyone will experience them.

Some adverse effects may 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

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

• Vision loss 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 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 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 urine output
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, malaise, 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, lymph node swelling 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 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
• 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 status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders which may appear 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)
• 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 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 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, 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 Valsartán/Hydrochlorothiazide Pharmakern 160 mg/12.5 mg

Keep 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 refers to the last day of the month indicated.

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

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

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

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida Premium Pharma 160 mg/12.5 mg

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

Appearance of the product and contents of the container

Valsartán/Hidroclorotiazida Premium Pharma 160 mg/12.5 mg film-coated tablets are red, oval-shaped tablets, scored on one side.

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

Only certain pack sizes may be marketed.

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 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/