VALSARTAN/HYDROCHLOROTHIAZIDE CINFAMED 320mg/12.5mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan/Hydrochlorothiazide Cinfamed 320 mg/12.5 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Valsartan/Hydrochlorothiazide Cinfamed and what is it used for
2. What you need to know before you take Valsartan/Hydrochlorothiazide Cinfamed
3. How to take Valsartan/Hydrochlorothiazide Cinfamed
4. Possible side effects
5. Storage of Valsartan/Hydrochlorothiazide Cinfamed
6. Package Contents and Further Information

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

Valsartan/Hydrochlorothiazide Cinfamed contains two active substances called valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also decreases 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 of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

2. What you need to know before you take Valsartan/Hydrochlorothiazide Cinfamed

Do not take Valsartan/Hydrochlorothiazide Cinfamed

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), peanuts, or soy, or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant(in any case, it is better to avoid taking this medicine also at the start of your pregnancy - see section Pregnancy and Breastfeeding),
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile in the liver (cholestasis),
• if you have severe kidney disease,
• if you are unable to produce urine (anuria),
• if you are undergoing dialysis,
• if you have low potassium or sodium levels in your blood, or if your blood calcium levels are higher than normal despite treatment,
• if you have gout,
• if you have diabetes or kidney insufficiency and are being treated with a medicine to lower blood pressure that contains aliskiren.

If any of these situations apply to you,tell your doctor and do not take valsartan/hydrochlorothiazide.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Valsartan/Hydrochlorothiazide Cinfamed

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan/Hydrochlorothiazide Cinfamed
• if you are using potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels
• if you have low potassium levels in your blood
• if you experience severe diarrhea or vomiting
• if you are taking high doses of a diuretic
• if you have severe heart disease
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function
• if you have narrowing of the kidney artery
• if you have recently had a kidney transplant
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartan/Hydrochlorothiazide Cinfamed is not recommended
• if you have kidney or liver disease
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan/hydrochlorothiazide, stop treatment with valsartan/hydrochlorothiazide immediately and never take it again. See also section 4 “Possible side effects”
• if you have fever, rash, and joint pain, which can be signs of systemic lupus erythematosus (a known autoimmune disease)
• if you have diabetes, gout, high cholesterol or triglyceride levels in your blood
• if you have previously had an allergic reaction with the use of another medicine in this class to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a time frame ranging from several hours to a week after taking valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously been allergic to penicillin or sulfonamides.
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide Cinfamed, see your doctor immediately.

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

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

See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide Cinfamed”.

Valsartan/Hydrochlorothiazide Cinfamed may cause increased sensitivity of the skin to the sun.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Valsartan/Hydrochlorothiazide Cinfamed is not recommended for use at the start of pregnancy (first 3 months), and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy and Breastfeeding).

Children and Adolescents

Valsartan/Hydrochlorothiazide Cinfamed is not recommended for use in children and adolescents (under 18 years of age).

Use in Athletes:This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Taking Valsartan/Hydrochlorothiazide Cinfamed with Other Medicines

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

The effect of treatment with Valsartan/Hydrochlorothiazide Cinfamed may be altered if taken with certain medicines. Your doctor may need to change your dose and/or take other precautions or, in some cases, stop treatment with one of the medicines. This is especially applicable to the following medicines:

• lithium, a medicine used to treat certain types of psychiatric disorders
• medicines or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin
• medicines that may decrease the amount of potassium in the blood, such as diuretics (medicines to urinate), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.

• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan/Hydrochlorothiazide Cinfamed.
• medicines that may induce “torsades de pointes” (irregular heartbeats), such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines for treating diabetes (insulin or oral antidiabetics such as metformin)

• other medicines for lowering blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide Cinfamed” 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 medicines for pain such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in doses above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat a wide range of disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases)
• cholestyramine and colestipol (medicines primarily used to treat high lipid levels in the blood)
• cyclosporin, a medicine used to prevent organ rejection in transplants

• alcohol, sleeping medicines, and anesthetics (medicines with a sedative effect or for pain used, for example, in the case of surgery)
• iodinated contrast media (used in diagnostic imaging tests)

Taking Valsartan/Hydrochlorothiazide Cinfamed with Food, Drinks, and Alcohol

Avoid taking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the possibility of dizziness and weakness.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

• You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.Your doctor will normally advise you to stop taking Valsartan/Hydrochlorothiazide Cinfamed before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another anti-hypertensive medicine instead. Valsartan/Hydrochlorothiazide Cinfamed is not recommended for use at the start of pregnancy, and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby.
• Tell your doctor if you are about to start or are breastfeeding, as Valsartan/Hydrochlorothiazide Cinfamed is not recommended for women during this period. Your doctor may decide to administer a treatment that is more suitable if you wish to breastfeed, especially to newborns or premature babies.

Driving and Using Machines

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

Valsartan/Hydrochlorothiazide Cinfamed contains Lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Valsartan/Hydrochlorothiazide Cinfamed contains Sodium.

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

Valsartan/Hydrochlorothiazide Cinfamed contains Soybean Lecithin.

This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

3. How to Take Valsartan/Hydrochlorothiazide Cinfamed

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

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

If you take more Valsartan/Hydrochlorothiazide Cinfamed than you should

If you notice a strong dizziness and/or fainting, lie down and contact your doctor immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan/Hydrochlorothiazide Cinfamed

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 Cinfamed

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• You should visit your doctor immediately if you notice symptoms of angioedema, such as:
• • swelling of the face, tongue, or pharynx
  • difficulty swallowing
  • hives and difficulty breathing.
• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high pressure (possible signs of acute angle-closure glaucoma)
• Fever, sore throat, increased frequency of infections (agranulocytosis)

These adverse effects are very rare (may affect up to 1 in 10,000 patients) or of unknown frequency (cannot be estimated from available data)

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 patients)

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced urination frequency, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

Unknown frequency(cannot be estimated from available data)

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

• feeling of rotation
• abdominal pain

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

• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency(cannot be estimated from available data)

• skin blisters (sign of bullous dermatitis)
• skin rash with or without itching along with any of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• skin rash, redness, blisters on the lips, eyes, or mouth, skin peeling, fever (symptoms of vasculitis)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; skin rash; itching
• elevated liver function values
• decrease in hemoglobin and hematocrit levels (which, in severe cases, can cause anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

Hydrochlorothiazide:

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

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

Common(may affect up to 1 in 10 patients)

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood

• skin rash with itching and other types of rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• inability to achieve or maintain an erection

Rare(may affect up to 1 in 1,000 patients)

• swelling and blisters on the skin (due to increased sensitivity to the sun)
• 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 changes that 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 up to 1 in 10,000 patients)

• vasculitis with symptoms such as skin rash, red-purple spots, fever
• reactions of hypersensitivity (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing, with fever, cough, wheezing, shortness of breath (breathing difficulties 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 respiratory distress (signs include severe breathing difficulties, fever, weakness, and confusion).

Unknown frequency(cannot be estimated from available data)

• skin and lip cancer (non-melanoma skin cancer)
• 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]
• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine production (possible signs of kidney disorder or kidney failure)
• skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasms
• fever (pyrexia)
• weakness (asthenia)

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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Cinfamed

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

Blister packs: Do not store above 30°C.

Bottles: No special storage conditions are required.

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

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

6. Package Contents and Additional Information

Composition of Valsartan/Hydrochlorothiazide Cinfamed

The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silica, polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, soy lecithin (E-322), red iron oxide, and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Valsartan/Hydrochlorothiazide Cinfamed is presented in the form of film-coated tablets, pink in color, oval, biconvex, with the inscription "V" on one side and "H" on the other.

Valsartan/Hydrochlorothiazide Cinfamed tablets are available in blister packs containing 28 or 280 (clinical packaging) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Actavis Limited Bulebel Industrial Estate Zejtun ZTN 3000 Malta

or

BALKANPHARMA DUPNITSA AD

3, Samokovsko Shosse Str. 2600

Dupnitsa

Bulgaria

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet: February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75382/P_75382.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75382/P_75382.html