Valsartan/indapamide billev

Package leaflet: Information for the patient

Valsartan/Indapamide Billev, 80 mg + 1.5 mg, modified-release tablets
Valsartan/Indapamide Billev, 160 mg + 1.5 mg, modified-release tablets
Valsartanum + Indapamidum
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Valsartan/Indapamide Billev is and what it is used for

Valsartan/Indapamide Billev contains two active substances: valsartan and indapamide in a single tablet.
Valsartan belongs to a group of medicines called angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effects of angiotensin II. This leads to relaxation of the blood vessels and a reduction in blood pressure.
Indapamide is a diuretic (a "water tablet"). Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it causes only a slight increase in urine production.
This medicine is intended for the treatment of high blood pressure (hypertension) in adults. Your doctor may prescribe Valsartan/Indapamide Billev if you are already taking valsartan and indapamide at the same dose, but as separate tablets.

2. Important information before taking Valsartan/Indapamide Billev

When not to take Valsartan/Indapamide Billev

• if the patient is allergic to valsartan, indapamide, any other sulfonamide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has liver disease or a condition called hepatic encephalopathy (liver problems affecting the brain and central nervous system),
• if the patient is more than 3 months pregnant (it is also advisable to avoid using Valsartan/Indapamide Billev during early pregnancy – see section "Pregnancy and breastfeeding"),
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has severe kidney disease,
• if the patient has low blood potassium levels.

Warnings and precautions
Before starting treatment with Valsartan/Indapamide Billev, discuss with your
doctor or pharmacist:
­ if the patient has liver disease,
­ if the patient has severe kidney disease or is undergoing dialysis,
­ if the patient has renal artery stenosis,
­ in patients who have recently undergone kidney transplantation (received a new kidney),
­ in patients with severe heart disease other than heart failure or myocardial infarction,
­ if the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including angiotensin-converting enzyme (ACE) inhibitors), inform the doctor. If such symptoms occur while taking Valsartan/Indapamide Billev, treatment must be stopped immediately and the medicine must not be taken again. See also section 4 "Possible side effects".
­ in patients taking medicines that increase blood potassium levels, such as:
potassium supplements or potassium-containing salt substitutes, potassium-sparing diuretics, and heparin. Regular monitoring of blood potassium levels may be necessary.
­ in patients with hyperaldosteronism. This is a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. Valsartan/Indapamide Billev is not recommended for patients with hyperaldosteronism.
­ in patients who have lost large amounts of fluid (dehydration) due to diarrhoea, vomiting, or taking high doses of diuretic tablets (water tablets),
­ if the patient is taking any of the following medicines used to treat 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 diabetes,
­ if the patient has gout,
­ if the patient has any heart rhythm disorders,
­ if the patient is scheduled for tests assessing parathyroid function.

During treatment, contact your doctor immediately:
­ if the patient develops abdominal pain, nausea, vomiting, or diarrhoea after taking Valsartan/Indapamide Billev, discuss this with your doctor. The doctor will decide on further treatment. Do not make independent decisions about stopping Valsartan/Indapamide Billev.
­ if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the choroid layer of the eye (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Valsartan/Indapamide Billev. If left untreated, they may lead to permanent vision loss. Patients previously allergic to penicillin or sulfonamides may be at higher risk of developing this condition.
­ if the patient experiences muscle disorders, including muscle pain, tenderness, weakness, or cramps.
Inform the doctor if the patient has photosensitivity reactions.
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood tests to check for low levels of sodium, potassium, or magnesium, and high calcium levels.
Always inform the doctor about pregnancy, suspected pregnancy, or plans to become pregnant. Use of Valsartan/Indapamide Billev is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child (see section "Pregnancy and breastfeeding").

Important information for athletes
Athletes should be aware that this medicine contains an active substance that may result in a positive doping test.

Children and adolescents
Valsartan/Indapamide Billev is not recommended for use in children and adolescents under 18 years of age.

Valsartan/Indapamide Billev and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The effect of the medicine may change if Valsartan/Indapamide Billev is taken simultaneously with certain other medicines. This may require dose adjustments, additional precautions, or in some cases, discontinuation of one of the medicines. This applies to both prescription and over-the-counter medicines.
Inform your doctor if you are taking any of the following medicines, as special precautions may be required:
­ medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, bretylium, dofetilide, digitalis glycosides),
­ medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol, pimozide),
­ bepridil (used to treat angina pectoris, a condition causing chest pain due to coronary artery disease),
­ cisapride, difenoxin (used to treat indigestion),
­ sparfloxacin, moxifloxacin, intravenous erythromycin (antibiotics used to treat bacterial infections),
­ intravenous vinpocetine (used for symptomatic treatment of cognitive disorders in elderly patients, including memory loss),
­ halofantrine (an antiparasitic medicine used to treat certain types of malaria),
­ pentamidine (used to treat certain types of pneumonia),
­ antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, astemizole, terfenadine),
­ non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain (e.g. ibuprofen) or high doses of acetylsalicylic acid,
­ angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure, such as enalapril, lisinopril, etc.),
­ intravenous amphotericin B (used to treat fungal infections),
­ oral corticosteroids used to treat various conditions (including severe asthma and rheumatoid arthritis),
­ stimulant laxatives (e.g. bisacodyl, phenolphthalein, senna alkaloids),
­ baclofen (used to treat disorders such as muscle stiffness in conditions like multiple sclerosis),
­ potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene),
­ metformin (used to treat diabetes),
­ iodinated contrast media (used in X-ray imaging procedures),
­ calcium tablets or other calcium supplements,
­ cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or to treat autoimmune diseases or severe rheumatic or dermatological conditions,
­ tetracosactide (used to treat Crohn's disease),
­ allopurinol (used to treat gout),
­ medicines used to treat addiction (e.g. methadone),
­ lithium (used to treat certain psychiatric conditions),
­ medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
­ certain antibiotics (rifamycin group),
­ antiviral medicines used to treat HIV/AIDS (e.g. ritonavir).

Valsartan/Indapamide Billev with food, drink, and alcohol
Avoid regular consumption of excessive amounts of alcohol while taking Valsartan/Indapamide Billev.
Valsartan/Indapamide Billev may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Always inform the doctor about pregnancy, suspected pregnancy, or plans to become pregnant. The doctor will usually advise stopping treatment with Valsartan/Indapamide Billev before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Valsartan/Indapamide Billev is not recommended during early pregnancy and must not be used in patients who are more than 3 months pregnant, as it may seriously harm the unborn child if used after the third month of pregnancy.

Breastfeeding
Valsartan/Indapamide Billev must not be used during breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines
Before driving, using tools, operating machinery, or performing any activity requiring concentration, the patient should ensure how Valsartan/Indapamide Billev affects them. Like many other medicines used to treat high blood pressure, Valsartan/Indapamide Billev may cause dizziness and affect the ability to concentrate. In such cases, the patient should refrain from driving or performing other activities requiring concentration.

Valsartan/Indapamide Billev contains lactose
If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Valsartan/Indapamide Billev

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose for adults is one tablet of a specified strength per day, preferably in the morning.
Valsartan/Indapamide Billev should be taken at the same time each day.
Tablets may be taken regardless of meals. Swallow them whole with water. Do not crush or chew the tablets.
Taking more Valsartan/Indapamide Billev than recommended
If too many tablets have been taken, contact your doctor or pharmacist immediately.
Very high doses of Valsartan/Indapamide Billev may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, and changes in urine output.
Missing a dose of Valsartan/Indapamide Billev
If a dose of Valsartan/Indapamide Billev is missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
Stopping Valsartan/Indapamide Billev
Stopping treatment with Valsartan/Indapamide Billev may worsen the condition. Since treatment for high blood pressure usually lasts a lifetime, consult your doctor before discontinuing the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

If the patient experiences any of the following adverse reactions, which may be serious, treatment with this medicine must be discontinued immediately and medical advice must be sought without delay:

• Angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, or swelling of the mucous membranes of the throat or airways, leading to breathlessness or difficulty in swallowing. If such symptoms occur, immediate medical attention must be sought. (Very rare – may occur in no more than 1 in 10,000 patients)

• Severe skin reactions, including severe rash, redness of the entire skin surface, intense itching, formation of blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions. (Very rare – may occur in no more than 1 in 10,000 patients)

• Life-threatening irregular, rapid heartbeat. (Frequency unknown – cannot be estimated based on available data)

• Pancreatitis, which may cause severe abdominal and back pain associated with profound malaise. (Very rare – may occur in no more than 1 in 10,000 patients)

• Brain disease caused by liver disorder (hepatic encephalopathy). (Frequency unknown – cannot be estimated based on available data)

• Hepatitis (inflammation of the liver). (Frequency unknown – cannot be estimated based on available data)

If any of these symptoms occur, treatment with Valsartan/Indapamide Billev must be stopped immediately and a doctor must be contacted without delay (see also section 2 "Warnings and precautions").

Other adverse reactions include:

Common (may occur in no more than 1 in 10 patients):

• Low blood potassium levels
• Allergic reactions, mainly dermatological, in individuals predisposed to allergic and asthmatic reactions
• Red, raised rash

Uncommon (may occur in no more than 1 in 100 patients):

• Low blood sodium levels, which may cause dehydration and low blood pressure
• Sensation of spinning (vertigo of labyrinthine origin)
• Cough
• Vomiting
• Abdominal pain
• Small red spots on the skin (petechiae)
• Inability to achieve or maintain erection (erectile dysfunction)
• Fatigue

Rare (may occur in no more than 1 in 1,000 patients):

• Low blood chloride levels
• Low blood magnesium levels
• Exhaustion
• Headache
• Tingling and numbness sensations (paresthesia)
• Nausea
• Constipation
• Dryness of the mouth

Very rare (may occur in no more than 1 in 10,000 patients):

• Changes in blood cell counts, such as thrombocytopenia (reduced number of platelets causing easy bruising and nosebleeds), leukopenia (reduced number of white blood cells, which may lead to unexplained fever, sore throat or other flu-like symptoms; if these occur, contact a doctor), and anemia (reduced number of red blood cells)
• High blood calcium levels
• Irregular heartbeat
• Low blood pressure
• Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• Abnormal liver function
• Kidney disorders (causing symptoms such as fatigue, increased frequency of urination, itching, nausea, swelling of limbs)

Frequency unknown (cannot be estimated from available data):

• Decreased hemoglobin concentration and reduced number of red blood cells in blood (in severe cases may lead to anemia)
• Unexplained reduction in neutrophil count (a type of white blood cell) in blood
• Increased blood potassium levels (in severe cases may cause muscle cramps and heart rhythm disturbances)
• Sudden loss of consciousness (fainting)
• Myopia (short-sightedness)
• Blurred vision
• Visual disturbances
• Impaired vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the choroid layer of the eye [choroidal effusion] or acute angle-closure glaucoma)
• Heart rhythm disturbances visible on ECG
• Purple-red skin lesions, fever, itching (symptoms of vasculitis)
• Increased liver enzyme activity (may indicate liver damage), including increased blood bilirubin levels (in severe cases may cause yellowing of the skin and eyes)
• In patients with systemic lupus erythematosus (an autoimmune disease causing inflammation and damage to joints, tendons, and organs, with symptoms such as skin rash, fatigue, loss of appetite, weight gain, and joint pain), symptoms may worsen
• Cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA light have also been reported
• Skin blisters (sign of bullous dermatitis)
• Rash
• Itching of the skin
• Muscle cramps, weakness, tenderness or pain, particularly if the patient feels unwell or has a high temperature, which may be due to abnormal muscle breakdown
• Increased serum creatinine levels (may indicate impaired kidney function)
• Increased blood glucose levels in diabetic patients
• Increased blood uric acid levels, a substance which may cause or exacerbate gout (pain in one or more joints, especially in the feet)
• Increased liver enzyme activity.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Valsartan/Indapamide Billev

Keep this medicine out of sight and reach of children.
There are no special requirements for the storage of this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack
following: "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Valsartan/Indapamide Billev contains
The active substances in this medicine are valsartan and indapamide.
Valsartan/Indapamide Billev, 80 mg + 1.5 mg, modified-release tablets:
each tablet contains 80 mg of valsartan and 1.5 mg of indapamide.

• Other ingredients:
• Tablet core: microcrystalline cellulose (102), lactose monohydrate (100 and 200), sodium croscarmellose, povidone K30, hypromellose type 4000 cP, magnesium stearate, colloidal anhydrous silica, talc.
• Coating: hypromellose type 2910, titanium dioxide (E 171), macrogol PEG 400, iron oxide, yellow (E 172), iron oxide, red (E 172), talc.

Valsartan/Indapamide Billev, 160 mg + 1.5 mg, modified-release tablets:
each tablet contains 160 mg of valsartan and 1.5 mg of indapamide.

• Other ingredients:
• Tablet core: microcrystalline cellulose (102), lactose monohydrate (100 and 200), sodium croscarmellose, povidone K30, hypromellose type 4000 cP, magnesium stearate, colloidal anhydrous silica, talc.
• Coating: hypromellose type 2910, titanium dioxide (E 171), macrogol PEG 400, iron oxide, yellow (E 172), iron oxide, red (E 172), talc.

What Valsartan/Indapamide Billev looks like and contents of the pack
Valsartan/Indapamide Billev, 80 mg + 1.5 mg, modified-release tablets are coated, round, biconvex, pink in colour. The tablet diameter is approximately 9 mm.
On one side of the tablet, the imprint "CL3" is embossed. The tablet is clearly convex.
Valsartan/Indapamide Billev, 160 mg + 1.5 mg, modified-release tablets are coated, round, biconvex, pink in colour. The tablet diameter is approximately 11 mm.
On one side of the tablet, the imprint "CL4" is embossed. The tablet is clearly convex.
30 or 90 modified-release tablets packed in blisters made of Aluminium/OPA/PVC/Aluminium, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Billev farmacija vzhod d.o.o.
Tržaška cesta 202
1000 Ljubljana
Slovenia

Manufacturer
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

This medicine is authorised in the European Economic Area countries under the following names:
Bulgaria: Валсартан/Индапамид Билев 80 mg/1.5 mg, 160 mg/1.5 mg таблетки с изменено освобождаване
Estonia: Valsartan/Indapamide Billev
Latvia: Valsartan/Indapamide Billev 80 mg/1.5 mg, 160 mg/1.5 mg modificētās darbības tabletes
Poland: Valsartan/Indapamide Billev
Romania: Valsartan/Indapamidă Billev 80 mg/1.5 mg, 160 mg/1.5 mg comprimate cu eliberare modificată
Slovakia: Valsartan/Indapamide Billev 80 mg/1.5 mg, 160 mg/1.5 mg tablety s riadeným uvoľňovaním

For further information about this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]