Co-Diovan 320 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Co-Diován 320 mg/12.5 mg film-coated tablets

Valsartan/hydrochlorothiazide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Co-Diován 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, resulting in 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.

Co-Diován is used to treat high blood pressure that is not adequately controlled with either active substance 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 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 Co-Diován

Do not take Co-Diován

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to 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 during the early stages of pregnancy – see Pregnancy section).

• if you have severe liver disease, destruction of the small bile ducts in the liver (primary 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 an antihypertensive medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor

• 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 it necessary to monitor your potassium levels regularly.

• 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 renal artery.

• 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, Co-Diován 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 Co-Diován, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.

• if you develop abdominal pain, nausea, vomiting, or diarrhoea 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, 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 loss of vision 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 Co-Diován. If left 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), 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking Co-Diován.

• if you have previously had respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop 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 blood electrolyte levels (e.g., potassium) at regular intervals.

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

Co-Diován may cause increased skin sensitivity to sunlight.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Co-Diován is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby. See Pregnancy section.

Taking Co-Diován with other medicines

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

The effect of Co-Diován treatment may be altered when taken together 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 particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders
• medicines or substances that may increase blood potassium levels. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and 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 Co-Diován
• 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 for treating diabetes (insulin or oral antidiabetics such as metformin)
• 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 Co-Diován” 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 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anaesthesia)
• 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 Co-Diován with food, drinks, and alcohol

Avoid drinking alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Co-Diován before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Co-Diován is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

• Inform your doctor if you plan to start or are currently breastfeeding, as Co-Diován is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if you have a newborn or premature infant.

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 Co-Diován affects you. Like many other medicines used to treat high blood pressure, Co-Diován may rarely 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 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 symptoms and may feel completely normal. For this reason, it is very important to keep your doctor's appointments, even if you feel well.

Your doctor will tell you exactly how many Co-Diován tablets you should 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 daily.
• 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 may 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 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 may also contact the toxicology information service at phone number 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 treatment with Co-Diován, your hypertension may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further 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 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 pharynx

• difficulty swallowing

• hives and difficulty breathing

• Serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (toxic skin 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 breathing difficulty, 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-Diovány 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 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 less than 1 in 10,000 people):

• dizziness
• diarrhea
• joint pain

Frequency not known (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, muscle fasciculations and/or seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, 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 (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may 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 people):

• sensation of spinning
• abdominal pain

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

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

Frequency not known (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, swollen lymph nodes and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet count (sometimes with more frequent bleeding or bruising than usual)
• high potassium levels in the blood (sometimes with muscle spasms, 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 lead to 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

Uncommon (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 that may occur 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):

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• 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)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty including 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 twitching and spasms, rapid breathing (hypochloremic alkalosis)

Frequency not known (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 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Co-Diovan

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container. The expiry date refers to 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. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Co-Diován

• The active substances 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, red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171).

Appearance of the product and contents of the pack

• The Co-Diován 320 mg/12.5 mg film-coated tablets are oval-shaped, bevelled-edged, pink in colour, with the imprint “NVR” on one side and “HIL” on the other.

• The tablets are supplied in blister packs containing 7 tablets, 14 tablets, 28 tablets in calendar packs, 56 tablets, 98 tablets in calendar packs or 280 tablets. Also available are single-dose perforated blister packs of 56x1, 98x1 or 280x1 tablets.

Only certain 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

IT-80058 Torre Annunziata / NA

Italy

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

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

The Netherlands

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

Date of the most recent review of this leaflet: 02/2022

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