Co-diovan

Leaflet attached to the packaging: information for the user

Co-Diovan 160 mg + 25 mg film-coated tablets

Valsartan + Hydrochlorothiazide

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Co-Diovan and what is it used for
• 2. Important information before taking Co-Diovan
• 3. How to take Co-Diovan
• 4. Possible side effects
• 5. How to store Co-Diovan
• 6. Contents of the pack and other information

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

Co-Diovan film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a group of medicines called “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance produced in the human body, which causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the action of angiotensin II. As a result, blood vessels dilate and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases the amount of urine, which also lowers blood pressure.

Co-Diovan is used to treat high blood pressure, which cannot be controlled by taking each of the components separately.

2. Important information before taking Co-Diovan

When not to take Co-Diovan:

• if the patient has been diagnosed with hypersensitivity (allergy) to valsartan, sulfonamide derivatives (chemical substances similar to hydrochlorothiazide) or any of the other components of this medicine (see section 6);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Co-Diovan in early pregnancy - see the section on pregnancy);
• if the patient has severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis), resulting in bile stagnation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to produce urine (anuria);
• if the patient is being dialyzed using an artificial kidney;
• if the patient has decreased potassium and sodium levels in the blood or increased calcium levels in the blood, despite treatment;
• in patients with gout;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren

If any of the above conditions are met, the medicine should not be taken and a doctor should be consulted.

Warnings and precautions

The patient should inform their doctor:

• if they are taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin. Regular monitoring of potassium levels in the blood by a doctor may be necessary;
• if they have low potassium levels in the blood;
• if they have diarrhea or severe vomiting;
• if they are taking high doses of diuretics;
• if they have severe heart disease;
• if they have heart failure or have had a heart attack. The doctor should be careful when prescribing the initial dose of Co-Diovan. The doctor may also check the patient's kidney function;
• if they have narrowing of the renal artery;
• if they have had a kidney transplant;
• if they have hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone. If this disease is present in the patient, taking Co-Diovan is not recommended;
• if they have liver or kidney disease;
• if they have ever had swelling of the tongue and face due to an allergic reaction, known as angioedema, after taking another medicine (including ACE inhibitors), they should tell their doctor. If such symptoms occur while taking Co-Diovan, the patient should stop taking Co-Diovan immediately and never take it again. See also section 4. “Possible side effects”;
• if they experience abdominal pain, nausea, vomiting, or diarrhea after taking Co-Diovan, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Co-Diovan on their own;
• if they have a fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease);
• if they have diabetes, gout, high cholesterol, or high triglycerides in the blood;
• if they have had allergic reactions to other blood pressure-lowering medicines from this group of medicines (angiotensin II receptor antagonists) or if they have an allergy or asthma;
• if they have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in the eye and may occur within a few hours to a few weeks after starting treatment with Co-Diovan. Without treatment, the symptoms may lead to complete loss of vision. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;

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

Co-Diovan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.

• lithium, a medicine used to treat certain mental illnesses;
• medicines or substances that may increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• medicines that may decrease potassium levels in the blood, such as diuretics (diuretics), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (from the rifampicin group), a medicine used to prevent transplant rejection (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Co-Diovan;
• medicines that may cause “torsades de pointes” (irregular heart rhythm), such as anti-arrhythmic medicines (used to treat heart diseases) and certain antipsychotic medicines;
• medicines that may decrease sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• medicines used to treat diabetes (oral medicines, such as metformin or insulin);
• other blood pressure-lowering medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the heading “When not to take Co-Diovan” and Warnings and precautions);
• medicines that increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other digitalis glycosides (medicines used to treat heart diseases);
• medicines that may increase blood sugar levels, such as diazoxide and beta-adrenergic blockers;
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• painkillers, such as non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g;
• muscle relaxants, such as tubocurarine;
• anticholinergic medicines (used to treat various disorders, such as gastrointestinal spasms, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct during anesthesia);
• amantadine (a medicine used to treat Parkinson's disease and to treat and prevent certain viral diseases);
• cholestyramine and colestipol (medicines used mainly to treat high lipid levels in the blood);
• cyclosporin, a medicine used in patients with a transplanted organ to prevent rejection;
• alcohol, sleeping pills, and anesthetics (medicines that have a sedative or analgesic effect, used, for example, during surgical procedures);
• contrast agents containing iodine (used in imaging tests).

Co-Diovan with food, drink, and alcohol

The patient should avoid consuming alcohol until they have consulted their doctor. Alcohol may cause further lowering of blood pressure and (or) increase the risk of dizziness and fainting.

Pregnancy and breastfeeding

• The patient should tell their doctor if they think they are pregnant (or may become pregnant)The doctor will usually advise the patient to stop taking Co-Diovan before becoming pregnant or as soon as they find out they are pregnant, and will recommend taking a different medicine instead of Co-Diovan. Co-Diovan is not recommended in early pregnancy and should not be taken by pregnant women after the 3rd month of pregnancy, as it may seriously harm the baby if taken after the 3rd month of pregnancy.
• The patient should inform their doctor if they are breastfeeding or plan to breastfeedCo-Diovan is not recommended for breastfeeding mothers; the doctor may choose a different treatment for the patient who plans to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Before driving, using tools, operating machinery, or performing other activities that require concentration, the patient should determine how Co-Diovan affects them. Like other medicines used to treat high blood pressure, Co-Diovan may cause dizziness and adversely affect concentration.

3. How to take Co-Diovan

Co-Diovan should always be taken as directed by the doctor. This will help to achieve the best results and minimize the risk of side effects.

• The recommended dose of Co-Diovan is one tablet per day.
• The patient should not change the dose or stop treatment without consulting their doctor.
• The medicine should be taken at the same time every day, usually in the morning.
• Co-Diovan can be taken with or without food.
• The tablet should be swallowed with a glass of water.

Overdose of Co-Diovan

If the patient experiences severe dizziness and (or) fainting, they should lie down and contact their doctor immediately.

Missed dose of Co-Diovan

If the patient misses a dose, they should take it as soon as they remember. If it is already time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Diovan can cause side effects, although not everybody gets them.

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

• The patient should consult their doctor if they experience symptoms of angioedema, such as:
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing,
• severe skin diseases causing rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (toxic epidermal necrolysis),
• worsening vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma),
• fever, sore throat, frequent infections (agranulocytosis),
• severe respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)

The above side effects are very rare or their frequency is unknown.

If the patient experiences any of these symptoms, they should stop taking Co-Diovan immediately and consult their doctor (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 feelings of thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin),
• muscle pain,
• fatigue,
• tingling or numbness,
• blurred vision,
• ringing in the ears (e.g., hissing, buzzing).

Rare (may affect up to 1 in 1,000 people):

• dizziness,
• diarrhea,
• joint pain.

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

• breathing difficulties,
• significantly reduced urine output,
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) seizures in severe cases),
• low potassium levels in the blood (which may be accompanied by muscle weakness, muscle cramps, heart rhythm disturbances),
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers caused by infections, weakness),
• increased bilirubin levels in the blood (which may, in rare cases, cause yellowing of the skin and eyes),
• increased urea and creatinine levels in the blood (which may indicate impaired kidney function),
• increased uric acid levels in the blood (which may, in rare cases, cause gout),
• fainting.

The following side effects have been reported with the use of valsartan or hydrochlorothiazide alone:

Valsartan

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

• vertigo,
• abdominal pain.

Rare (may affect up to 1 in 1,000 people):

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

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

• blisters on the skin (symptoms of bullous dermatitis),
• rash with itching or without, accompanied by some of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and (or) flu-like symptoms,
• rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (symptoms of vasculitis),
• low platelet count (sometimes with unexplained bleeding or bruising),
• high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disturbances),
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing, or swelling; dizziness),
• swelling, mainly of the face and throat; rash; itching,
• increased liver enzyme activity,
• decreased hemoglobin and hematocrit levels in the blood (both of which may, in severe cases, cause anemia),
• kidney failure,
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) seizures in severe cases).

Hydrochlorothiazide

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

• low potassium levels in the blood;
• increased lipid levels 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,
• itching rash and other types of rash,
• decreased appetite,
• mild nausea and vomiting,
• dizziness or fainting when standing up,
• erectile dysfunction.

Rare (may affect up to 1 in 1,000 people):

• swelling and blistering of the skin (due to increased sensitivity to the sun),
• high calcium levels in the blood,
• high blood sugar levels,
• presence of sugar in the urine,
• worsening of metabolic disorders in diabetes,
• constipation, diarrhea, discomfort in the stomach or intestines, liver disorders, which may occur with yellowing of the skin and eyes,
• irregular heartbeat,
• headache,
• sleep disorders,
• low mood (depression),
• low platelet count (sometimes with bleeding or bruising),
• dizziness,
• tingling or numbness,
• vision disturbances.

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

• vasculitis with symptoms such as rash, red-purple spots, fever,
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions),
• rash on the face, joint pain, muscle disorders, fever (symptoms of lupus erythematosus),
• severe abdominal pain (pancreatitis),
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary edema),
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia),
• fever, sore throat, or mouth ulcers due to infection (leukopenia),
• confusion, fatigue, tremors, and muscle cramps, rapid breathing (hypochloremic alkalosis).

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

• weakness, bruising, and frequent infections (aplastic anemia),
• significantly reduced urine output (possible symptoms of impaired kidney function or kidney failure),
• rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (possible symptoms of erythema multiforme),
• muscle cramps,
• fever,
• weakness (asthenia),
• malignant skin and lip tumors (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to store Co-Diovan

• The medicine should be stored out of sight and reach of children.
• Co-Diovan should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• The medicine should not be stored at temperatures above 30°C. It should be stored in its original packaging to protect it from moisture.
• Co-Diovan should not be taken if the packaging is damaged or if there are signs of attempted opening.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Co-Diovan contains

The active substances in Co-Diovan are valsartan and hydrochlorothiazide.

One film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

The other ingredients are: colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, macrogol 4000, talc, iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172), titanium dioxide (E 171).

What Co-Diovan looks like and contents of the pack

Oval, brown-orange film-coated tablets with the inscription HXH on one side and NVR on the other.

The tablets are available in packs of 14 or 28 tablets (calendar pack).

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Poland Sp. z o.o.

ul. Marynarska 15

02-674 Warszawa

tel. +48 22 375 48 88

Manufacturer/Importer

Novartis Farma S.p.A.

Via Provinciale Schito 131

IT-80058 Torre Annunziata/NA

Italy

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10, Top 3.05

1020 Wien

Austria

Novartis Pharma nv

Medialaan 40/Bus 1

BE-1800 Vilvoorde

Belgium

Novartis (Hellas) S.A.C.I.

12 km National Road Athens-Lamia

GR-14451 Metamorphoses

Greece

Novartis Farma-Produtos Farmacêuticos S.A.

Avenida Professor Doutor Cavaco Silva nº10E

Taguspark

Porto Salvo, 2740-255

Portugal

Novartis Pharma B.V.

Haaksbergweg 16,

1101 BX Amsterdam

Netherlands

Novartis Finland Oy

Metsäneidonkuja 10

FI-02130 Espoo

Finland

Novartis Hungária Kft.

Bartók Béla út 43-47.

1114 Budapest,

Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 04/2025