Co-diovan

Patient Information Leaflet

Co-Diovan 160 mg + 25 mg film-coated tablets
Valsartanum + Hydrochlorothiazidum
Please read all of this leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Co-Diovan is and what it is used for
2. What you need to know 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 Co-Diovan is and what it is used for

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

• Valsartan belongs to a group of medicines known as “angiotensin II receptor antagonists”, which help control high blood pressure. Angiotensin II is a substance produced in the human body that 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.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases urine output, which also helps lower blood pressure.

Co-Diovan is used to treat high blood pressure that cannot be adequately controlled with either of the individual components alone.
High blood pressure increases the workload on the heart and arteries. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. Information before using Co-Diovan

When not to use Co-Diovan:

• if the patient has a known allergy (hypersensitivity) to valsartan, sulfonamide derivatives (chemicals similar to hydrochlorothiazide), or to any of the other ingredients of this medicine (see section 6);
• if the patient is in the third month of pregnancy or beyond (it is also better to avoid using Co-Diovan during early pregnancy – see pregnancy section);
• if the patient has severe liver disease, injury to the small bile ducts in the liver (biliary cirrhosis), resulting in bile accumulation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to produce urine (anuria);
• if the patient is undergoing dialysis with an artificial kidney;
• if the patient has low levels of potassium and sodium in the blood, or high levels of calcium in the blood, despite treatment;
• in patients with gout;
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, this medicine must not be used
and the patient should contact their doctor.
Warnings and precautions
Tell your doctor:

• if the patient is 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 blood potassium levels by the doctor may be necessary;
• if the patient has low potassium levels in the blood;
• if the patient has diarrhoea or severe vomiting;
• if the patient is taking high doses of diuretics;
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. The patient should carefully follow the doctor's instructions regarding the initial dose. The doctor may also check the patient's kidney function;
• if the patient has renal artery stenosis;
• if the patient has recently received a kidney transplant;
• if the patient has hyperaldosteronism; a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. If this condition is present, Co-Diovan should not be used;
• if the patient has liver or kidney disease;
• if the patient has previously experienced swelling of the tongue and face due to an allergic reaction, known as angioedema, after taking another medicine (including ACE inhibitors), inform the doctor. If such symptoms occur while taking Co-Diovan, the patient must stop taking Co-Diovan immediately and must never use it again. See also section 4, “Possible side effects”;
• if the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Co-Diovan, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Co-Diovan;
• if the patient develops fever, rash, or joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease);
• if the patient has diabetes, gout, high cholesterol, or high triglyceride levels in the blood;
• if the patient has previously had allergic reactions after taking other blood pressure-lowering medicines from this class (angiotensin II receptor antagonists), or if the patient has allergies or asthma;
• if the patient experiences vision disturbances 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 intraocular
pressure, which may occur from a few hours to several weeks after starting
treatment with Co-Diovan. Without treatment, these symptoms may lead to
complete vision loss. If the patient previously had an allergy to penicillin or sulfonamides,
they may be at increased risk of developing these symptoms;

• if the patient is taking any of the following medicines for high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
  • aliskiren;
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Co-Diovan, protect the skin from sunlight and UV radiation;
• if the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Co-Diovan, seek immediate medical help.

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading “When not to use Co-Diovan”.
The medicine may increase skin sensitivity to sunlight.
Co-Diovan is not recommended for use in children and adolescents (under 18 years of age).
Inform the doctor if the patient thinks she is pregnant (or might become pregnant).
Co-Diovan is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used during this stage of pregnancy (see pregnancy section).

Co-Diovan with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Taking Co-Diovan with certain other medicines may affect treatment. Dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders;
• medicines or substances that may increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• medicines that may decrease potassium levels in the blood, such as diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Co-Diovan;
• medicines that may cause “torsade de pointes” (irregular heartbeat), such as antiarrhythmic medicines (used to treat heart conditions) and certain antipsychotic medicines;
• medicines that may decrease sodium levels in the blood, such as antidepressants, antipsychotics, anticonvulsants;
• 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, angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under “When not to use Co-Diovan” and “Warnings and precautions”);
• medicines that may increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other cardiac glycosides (medicines used to treat heart conditions);
• medicines that may increase blood glucose levels, such as diazoxide and beta-blockers;
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g;
• muscle relaxants such as tubocurarine;
• anticholinergic medicines (used to treat various conditions such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an adjunct during anaesthesia);
• amantadine (a medicine used to treat Parkinson’s disease and to treat and prevent certain viral infections);
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
• cyclosporine, a medicine used in organ transplant patients to prevent transplant rejection;
• alcohol, sedatives, and anaesthetics (medicines with sedative or pain-relieving effects, used e.g. during surgical procedures);
• iodine-containing contrast agents (used in imaging procedures).

Co-Diovan with food, drink, and alcohol
Avoid consuming alcohol until consulting with a doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness and fainting.

Pregnancy and breastfeeding

• Tell your doctor if you think you are pregnant (or might become pregnant). The doctor will usually advise stopping Co-Diovan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Co-Diovan is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond the third month of pregnancy.
• Inform your doctor if you are breastfeeding or plan to breastfeed. Co-Diovan is not recommended for breastfeeding mothers; the doctor may choose another treatment for patients who plan to breastfeed, especially if the infant is a newborn or premature.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any other tasks requiring concentration, each patient should determine how Co-Diovan affects them. Like other medicines used to treat high blood pressure, Co-Diovan may cause dizziness in some patients and may adversely affect the ability to concentrate.

3. How to use Co-Diovan

Co-Diovan should always be taken exactly as prescribed by your doctor. Following these instructions helps achieve the best results and reduces the risk of adverse effects.
If you have any doubts, you should contact your doctor or pharmacist again.
People with high blood pressure often do not notice any symptoms and many feel quite well. For this reason, it is especially important to attend regular check-ups with your doctor, even if you feel well.
Your doctor will prescribe the exact number of Co-Diovan tablets you should take. Your doctor may decide to increase or decrease the dose, depending on your response to treatment.

• The recommended dose of Co-Diovan is one tablet daily.
• Do not change the dose or stop treatment without consulting your doctor.
• The medicine should be taken at the same time each day, usually in the morning.
• Co-Diovan may be taken with or without food.
• Swallow the tablet with a glass of water.

Taking more Co-Diovan than prescribed
If you experience severe dizziness and/or fainting, lie down immediately and contact your doctor without delay.
If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital immediately.

If you forget to take Co-Diovan
If you miss 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 a forgotten tablet.

If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects may be serious and require immediate medical attention:

• Seek medical advice if symptoms of angioedema occur, such as:
• swelling of the face, tongue or throat,
• difficulty swallowing,
• hives and breathing difficulties,
• severe skin diseases causing rash, redness of the skin, formation of blisters on the lips, eyes or oral mucosa, skin peeling, fever (toxic epidermal necrolysis),
• worsening of vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the uvea—the layer surrounding the eye—or excessive fluid buildup between the choroid and sclera—or acute angle-closure glaucoma),
• fever, sore throat, frequent infections (agranulocytosis),
• acute 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 any of these symptoms occur, stop taking Co-Diovan immediately and contact your doctor (see also section 2. "Warnings and precautions").
Other side effects include:
Not common (may affect up to 1 in 100 people):

• cough,
• low blood pressure,
• feeling of emptiness in the head,
• dehydration (with sensation of thirst, dryness of the mouth and tongue, infrequent urination, dark urine color, dry skin),
• muscle pain,
• feeling of fatigue,
• tingling or numbness,
• blurred vision,
• noises (e.g. ringing, buzzing) in the ears.

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

• dizziness,
• diarrhoea,
• joint pain.

Frequency unknown (frequency cannot be estimated from available data):

• breathing difficulties,
• significantly reduced urine output,
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle twitching, and/or seizures in severe cases),
• low potassium levels in the blood (sometimes associated with muscle weakness, muscle cramps, heart rhythm disturbances),
• 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 may, in rare cases, cause yellowing of the skin and eyes),
• increased blood urea nitrogen and increased creatinine levels in the blood (which may indicate impaired kidney function),
• increased uric acid levels in the blood (which may, in rare cases, trigger gout),
• fainting.

The following side effects have been reported after administration of medicines containing either valsartan or hydrochlorothiazide alone:
Valsartan
Not common (may affect up to 1 in 100 people):

• sensation of spinning (vertigo),
• abdominal pain.

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

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

Frequency unknown (frequency cannot be estimated from available data):

• blisters on the skin (symptoms of bullous dermatitis),
• skin rash with or without itching, occurring with one or more of the following objective and subjective symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms,
• rash, purple-red spots, fever, itching (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, breathing difficulties or swelling, dizziness),
• swelling, mainly of the face and throat; rash; itching,
• increased liver enzyme activity,
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (both factors may cause anemia in severe cases),
• kidney failure,
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle twitching 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,
• itchy rash and other types of skin rash,
• decreased appetite,
• mild nausea and vomiting,
• dizziness/fainting upon standing,
• inability to achieve or maintain erection.

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

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

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

• vasculitis with symptoms such as rash, purple-red spots, fever,
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions),
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus),
• severe upper 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, tremor and muscle cramps, rapid breathing (hypochloremic alkalosis).

Frequency not known (frequency cannot be estimated from 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, formation of blisters on the lips, eyes or oral mucosa, skin peeling, fever (possible symptoms of erythema multiforme),
• muscle cramps,
• fever,
• weakness (asthenia),
• malignant tumors of the skin and lips (non-melanoma skin cancer).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Co-Diovan

• Keep the medicine out of the sight and reach of children.
• Do not use Co-Diovan after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• Do not use Co-Diovan if the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Co-Diovan contains
The active substances in Co-Diovan are valsartan and hydrochlorothiazide.
Each coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Excipients: colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, talc, red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171).

What Co-Diovan looks like and contents of the pack
Oval, brown-orange coated tablets, printed with "HXH" on one side and "NVR" on the other.
Tablets are available in packs containing 14 or 28 tablets (calendar pack).
Not all pack sizes may be marketed.

Marketing Authorisation 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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Novartis Pharma GmbH
Jakov-Lind-Straße 5, Top 3.05
1020 Wien
Austria
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
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
FR-92500 Rueil-Malmaison
France

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