Prospecto: information for theuser

Co-Vals 320mg/12,5mg coated tablets

Valsartán/hidroclorotiazida

Read this prospectus carefully before starting to take thismedicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to other people, even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceadverse effectsconsultyour doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Co-Vals and for what it is used

2.What you need to know before starting to take Co-Vals

3.How to take Co-Vals

4.Possible adverse effects

1. Storage of Co-Vals
2. Contents of the package and additional information

Co-Vals film-coated tablets contain two active ingredients known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medications 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 constrict, resulting in an increase in blood pressure. Valsartan acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medications known as thiazide diuretics. Hydrochlorothiazide increases diuresis, which also decreases blood pressure.

Co-Vals 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 cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not takeCo-Vals

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or to any of the other components of this medication (listed in section 6).

• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have a severe liver disease, destruction of small bile ducts in the liver (biliary cirrhosis) leading to a buildup of bile in the liver (cholestasis).
• if you have a severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing dialysis.
• if you have lower than normal 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 kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

If any of these situations affect you, inform your doctor and do not take Co-Vals.

Warnings and precautions

Consult your doctor before starting to take Co-Vals

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in the blood, such as heparin. Your doctor may consider it necessary to control your potassium levels regularly.
• if you have low levels of potassium in your blood.
• if you experience severe diarrhea or vomiting.
• if you are taking high doses of a diuretic.
• if you have a severe heart disease.
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. Your doctor may also monitor your renal function.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Co-Vals 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 medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Co-Vals, stop taking it immediately and never take it again. See also section 4 “Possible side effects”
• if you experience abdominal pain, nausea, vomiting or diarrhea after taking Co-Vals. Your doctor will decide whether to continue treatment. Do not stop taking Co-Vals on your own.
• if you have fever, skin rash and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
• if you have previously experienced an allergic reaction with the use of another medication of this class to lower blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and may occur within a few hours to a week after taking Co-Vals. If not treated, this may lead to permanent vision loss. You may have a higher risk of developing it if you have previously been allergic to penicillin or sulfonamides.
• if you are taking any of the following medications used to treat 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 if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Co-Vals.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Co-Vals, see your doctor immediately.

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

See also the information under the heading “Do not take Co-Vals”.

Co-Vals may cause increased sensitivity to the sun.

Co-Vals is not recommended for use in children and adolescents (under 18 years old).

If you are pregnant, if you suspect you may be pregnant or if you plan to become pregnant, inform your doctor. Co-Vals is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy as it may cause serious harm to your baby, see Pregnancy section.

Use of Co-Vals with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

The effect of treatment with Co-Vals may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric disorders
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications and heparin
• medications that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.
• some antibiotics (rifampicin group), a medication used to protect against rejection in a transplant (ciclosporin) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Co-Vals
• medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medications used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medications used to treat diabetes (insulin or oral antidiabetic medications such as metformin)
• other medications used to lower blood pressure, including metildopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Co-Vals” and “Warnings and precautions”)
• medications that increase blood pressure, such as norepinephrine or adrenaline
• digoxin or other digitalis glycosides (medications used to treat heart problems)
• medications that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as an aid to anesthesia)
• amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses)
• colestiramine and colestipol (medications used primarily to treat high levels of lipids in the blood)
• ciclosporin, a medication used to prevent organ rejection after transplant
• alcohol, sleep medications and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery)
• iodinated contrast media (used for diagnostic imaging tests)

Taking Co-Vals 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 risk of dizziness and weakness.

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant, if you suspect you may be pregnant or if you plan to become pregnant.Generally, your doctor will advise you to stop taking Co-Vals before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Co-Vals is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

• Inform your doctor if you are planning to start or are breastfeedingas Co-Vals is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools or operating machinery, or engaging in other activities that require concentration, make sure you know your reactions to the effects of Co-Vals. Like many other medications used to treat high blood pressure, Co-Vals may cause, in rare cases, dizziness and affect concentration.

Always take this medication exactly as your doctor tells you to.This will help you get the best results and reduce the risk of side effects.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 tablets of Co-Vals you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Co-Vals is one tablet per day.
• Do not change the dose or interrupt treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take Co-Vals with or without food.
• Swallow the tablet with a glass of water.

If you take more Co-Vals 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 can also contact the toxicology information service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Co-Vals

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

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

If you interrupt treatment with Co-Vals

If you stop taking Co-Vals, your high blood pressure may worsen. Do not stop taking the medication unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

• Swelling in the face, tongue, or throat
• 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 fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma]
• Fever, sore throat, increased frequency of infections (agranulocytosis)

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop takingCo-Valsand contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side 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 urine frequency, dark-colored urine, dry skin)
• Muscle pain
• Fatigue
• Tickling or numbness
• Blurred vision
• Noises (e.g. ringing or buzzing) in the ears

Rare (may affect fewer than 1 in 10,000 people):

• Dizziness
• Diarrhea
• Joint pain

Unknown 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, muscle fasciculations, and/or convulsions)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• Low white blood cell count in the blood (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 the skin and eyes to turn yellow)
• Increased levels of urea nitrogen and creatinine in the blood (which may indicate abnormal kidney function)
• Increased levels of uric acid in the blood (which, in severe cases, may trigger a gout attack)
• Syncope (fainting)

The following side effects have been observed with valsartan or hydrochlorothiazide-containing medications separately:

Valsartan

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

• Vertigo
• Abdominal pain

Rare(may affect fewer than 1 in 10,000 people):

• Intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Unknown frequency (cannot be estimated from available data):

• Blisters on the skin (sign of dermatitis bullosa)
• Rash with or without itching, accompanied by one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or symptoms similar to the flu
• Rash, red-purple spots, fever, itching (signs 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 rash, itching, hives, difficulty breathing or swallowing, dizziness)
• Swelling mainly of the face and throat; rash; itching
• Increased liver function values
• Decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• Renal insufficiency
• Low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or convulsions)

Hidroclorotiazida

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

• Low potassium levels in the blood
• Increased levels of lipids in the blood

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
• Rash with itching and other types of rash
• Loss of 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 people):

• 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 alterations that may appear with yellow skin and eyes
• Irregular heartbeat
• Headache
• Sleep disturbances
• Depression
• Low platelet count (sometimes with bleeding or bruising under the skin)
• Dizziness
• Tickling or numbness
• Visual disturbances

Rare (may affect fewer than 1 in 10,000 people):

• Inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• Rash, joint pain, muscle pain, fever (lupus erythematosus)
• Severe stomach pain (pancreatitis)
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

• Difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• Pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• Fever, sore throat, or mouth ulcers due to infections (leukopenia)
• Confusion, fatigue, muscle fasciculations, and spasms, rapid breathing (hypochloremic alkalosis)

Unknown frequency (cannot be estimated from available data):

• Skin cancer and lip cancer (non-melanoma skin cancer)
• Weakness, bruises, and frequent infections (aplastic anemia)
• Significant reduction in urine production (possible signs of renal impairment or renal failure)
• 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 side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.
• Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medicines should not be thrown into the sewers or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofCo-Vals

• The active principles are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.
• The tablet coating contains: hypromellose, macrogol 4000, talc, iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171).

Appearance of the product and content of the container

• The valsartan and hydrochlorothiazide film-coated tablets, Co-Vals 320 mg/12.5 mg, are oval-shaped, with beveled edges, pink in color, with the imprint “NVR” on one face and “HIL” on the other.

• The tablets are presented in blister packs with 28 tablets in a calendar pack.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

TOWA PHARMACEUTICAL EUROPE, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet:December 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/