CO-DIOVAN 80 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Co-Diován 80mg/12.5mg film-coated tablets

Valsartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this 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 leaflet. See section 4.

Contents of the pack and other information:

1. What is Co-Diován and what is it used for
2. What you need to know before you take Co-Diován
3. How to take Co-Diován
4. Possible side effects
5. Storing Co-Diován
6. Contents of the pack and other information

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

Co-Diován film-coated tablets contain 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, resulting in increased 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.

Co-Diován 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 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 Co-Diován

Do not takeCo-Diován

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

• if you are pregnant for more than 3months(in any case, it is best to avoid taking this medicine also at the beginning of your pregnancy – see section Pregnancy).
• 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 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 failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of these situations apply to you, tell your doctor and do not take Co-Diován.

Warnings and precautions

Consult your doctor

• 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 check your potassium levels.
• 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 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 undergone a kidney transplant.
• if you have hyperaldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Co-Diován 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 Co-Diován, stop treatment with Co-Diován 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-Diován. Your doctor will decide whether to continue treatment. Do not stop taking Co-Diován on your own.
• 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 high triglycerides in your blood.
• if you have previously had an allergic reaction with the use of another medicine of 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 may occur during a period of time ranging from several hours to weeks after taking Co-Diován. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing it if you have previously had an allergy to penicillin or sulfonamides.

• if you are taking any of the following medicines 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. Treatment with hydrochlorothiazide, especially 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-Diován.
• 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 Co-Diován, seek medical attention immediately.

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

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

Co-Diován may cause increased sensitivity of the skin to the sun.

Co-Diován is not recommended for use in children and adolescents (under 18 years of age).

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Your doctor will normally advise you to stop taking Co-Diován before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine to lower your blood pressure instead. Co-Diován is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby; see section Pregnancy.

Using Co-Diován with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of treatment with Co-Diován may be altered if it is taken with certain other 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 illnesses
• medicines or substances that can increase the amount of potassium in the blood, including potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (of the rifampicin group), a medicine used to prevent rejection in a transplant (cyclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir); these medicines may increase the effect of Co-Diován
• medicines that can induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics and some antipsychotics
• medicines that can 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 Co-Diován” 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 can 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 nonsteroidal 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 (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)
• colestipol and cholestyramine (medicines primarily used to treat high lipid levels in the blood)
• cyclosporin, a medicine used to prevent organ rejection in transplants
• alcohol, sleeping pills, and anesthetics (sedative or pain-relieving medicines used, for example, in surgery)
• iodinated contrast media (used in diagnostic imaging tests)

Taking Co-Diován with food, drinks, and alcohol

Avoid drinking alcohol until you have talked to your doctor. Alcohol can further lower your blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy and breastfeeding

• Tell 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 Co-Diován before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine to lower your blood pressure instead. Co-Diován is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby; see section Pregnancy.

• Tell your doctor if you are about to start or are breastfeeding, as Co-Diován is not recommended for women during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know how Co-Diován affects you. Like many other medicines used to treat high blood pressure, Co-Diován can, in rare cases, cause dizziness and affect your ability to concentrate.

3. How to take Co-Diován

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

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 Co-Diován tablets to take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of Co-Diován 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 Co-Diován with or without food.
• Swallow the tablet with a glass of water.

If you take more Co-Diován than you should

If you notice a strong feeling of 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Co-Diován

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 Co-Diován

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

If you have any further questions on 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 fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Fever, sore throat, increased frequency of infections (agranulocytosis)
• Severe respiratory distress, fever, weakness, and confusion (acute respiratory distress)

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Co-Diován and contact your doctor immediately (see also section 2 "Warnings and Precautions").

Other adverse effects include:

Uncommon(may affect up to 1 in 10 people):

• 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 1,000 people):

• dizziness
• diarrhea
• joint pain

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

• breathing difficulties
• 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 the skin and eyes to turn yellow)
• 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)
• fainting (syncope)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartán

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

• feeling of rotation
• abdominal pain

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

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

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

• blisters on the skin (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, red-purple spots, fever, itching (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 red blood cell percentage in the blood (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 people):

• low potassium levels in the blood
• increased 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
• skin rash with itching and other types of rash
• decreased appetite
• mild nausea and vomiting
• 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 sun sensitivity)
• 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 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 less than 1 in 10,000 people):

• vasculitis with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• breathing difficulties 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)

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

• 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)
• skin and lip cancer (non-melanoma skin cancer)

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 (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Co-Diován

• Keep out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• 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. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the 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 ofCo-Diován

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.
• The tablet coating contains: hypromellose, macrogol 8000, talc, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171).

Appearance of the Product and Package Contents

The film-coated tablets of Co-Diován 80 mg/12.5 mg are oval, light orange in color with the mark "HGH" on one side and "CG" on the other.

The tablets are available in blister packs of 14 tablets, 28 tablets in a calendar pack, 30 tablets, 56 tablets, 98 tablets in a calendar pack, or 280 tablets. Also available are single-dose blister packs of 56x1, 98x1, or 280x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Manufacturer

Novartis Farma – Produtos Farmacêuticos, S.A.

Avenida Professor Doutor Cavaco Silva, n.° 10E (Taguspark, Porto Salvo)

Oeiras Parish. 2740 255

Portugal

Novartis Farma S.p.A.

Via Provinciale, Schito131

80058 Torre Annunziata / NA

Italy

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma GmbH

Roonstrasse 25

DE-90429 Nuremberg

Germany

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

Novartis Pharma nv

Medialaan 40/Bus 1

BE-1800 Vilvoorde

Belgium

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

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

12 km National Road

Athens-Lamia. GR-14451. Metamorphoses

Greece

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

Novartis s.r.o.

Na Pankráci 1724/129

CZ-140 00 Prague 4, Nusle

Czech Republic

Novartis Poland Sp. zo.o.

ul. Marynarska 15

02-674 Warsaw

Poland

Novartis Pharma S.A.S.

8-10 rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

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

Date of the last revision of this leaflet:02/2022

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