80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg film-coated tablets
valsartan / hydrochlorothiazide
What Valsartan/Hydrochlorothiazide Krka is and what it is used for
Valsartan/Hydrochlorothiazide Krka film-coated tablets contain two active substances, valsartan and hydrochlorothiazide . Both substances help control high blood pressure.
- Valsartan belongs to a group of drugs called “angiotensin-II receptor blockers” and is used to lower high blood pressure. Angiotensin II is a substance found in the body that constricts the blood vessels, which increases blood pressure et. Valsartan works by inhibiting the effect of angiotensin II. This leads to vessels dilating and blood pressure falling.
- Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics (also called diuretics). Hydrochlorothiazide increases urine production, which also lowers blood pressure, etc.
Valsartan/Hydrochlorothiazide Krka is used to treat high blood pressure that cannot be lowered sufficiently with just one of the substances.
High blood pressure increases the load on the heart and blood vessels. If left untreated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. A lowering of blood pressure et to a normal level reduces the risk of these diseases.
Valsartan and hydrochlorothiazide contained in Valsartan/Hydrochlorothiazide Krka may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Valsartan/Hydrochlorothiazide Krka
Do not take Valsartan/Hydrochlorothiazide Krka
- if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide ), or any other ingredient in this medicine (listed in section 6).
- during the last 6 months of pregnancy (even earlier during pregnancy it is good to avoid Valsartan/Hydrochlorothiazide Krka, see section “Pregnancy and breast-feeding”).
- if you have severe liver disease; the destruction of the small bile ducts in the liver ( biliary cirrhosis ) leads to a build-up of bile in the liver (cholestasis).
- if you have severe kidney disease
- if you cannot produce urine (anuria).
- if you are being treated with an artificial kidney.
- if your potassium or sodium level in the blood is lower than normal or if the calcium level in the blood is higher than normal despite treatment.
- if you have gout.
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
If any of the above applies to you, you should not take this medicine. Talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Valsartan/Hydrochlorothiazide Krka:
- if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase the amount of potassium in the blood, for example, heparin. Your doctor may need to check the amount of potassium in your blood regularly.
- if you have low levels of potassium in your blood.
- if you have diarrhea or severe vomiting.
- if you take high doses of water-reducing tablets ( diuretics ).
- if you have a serious heart condition.
- if you have heart failure or have had a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function.
- if you have a narrowing of the renal arteries.
- if you have recently had a kidney transplant (received a new kidney).
- if you have hyperaldosteronism. This is a disease in which your adrenal glands produce too much of the hormone aldosterone. If this applies to you, Valsartan/Hydrochlorothiazide Krka should not be used.
- if you have liver or kidney disease.
- if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors ), talk to your doctor. If these symptoms occur while taking Valsartan/Hydrochlorothiazide Krka, stop taking Valsartan/Hydrochlorothiazide Krka immediately and never take it again. See also section 4, “Possible side effects”.
- if you have a fever, rash, and joint pain, which may be signs of systemic lupus erythematosus ( SLE, a so-called autoimmune disease).
- if you have diabetes, gout, high cholesterol levels, or high blood lipids.
- if you have had an allergic reaction when using other blood pressure-lowering agents belonging to this drug group ( angiotensin II receptor blockers) or if you have allergies or asthma.
- if you experience impaired vision or eye pain. These may be symptoms of fluid accumulation in the eye (between the choroid and sclera) or an increase in pressure in the eye and may occur within hours to weeks of taking Valsartan/Hydrochlorothiazide Krka. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.
- it can increase the skin’s sensitivity to the sun.
- if you have had skin cancer or if you get an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while using Valsartan/Hydrochlorothiazide Krka.
- if you have previously had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or severe breathing problems after taking Valsartan/Hydrochlorothiazide Krka, seek medical attention immediately.
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- the aliskiren
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Valsartan/Hydrochlorothiazide Krka”.
If any of these apply to you, talk to your doctor.
If you think you are pregnant or become pregnant during treatment, contact your doctor.
Valsartan/Hydrochlorothiazide Krka is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may then cause birth defects (see “Pregnancy and breast-feeding”).
Children and young people
Use of Valsartan/Hydrochlorothiazide Krka in children or adolescents (younger than 18 years) is not recommended.
Other medicines and Valsartan/Hydrochlorothiazide Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The treatment effect can be affected if Valsartan/Hydrochlorothiazide Krka is taken together with certain other medicines. It may be necessary to change the dose, take other precautions or, in some cases, stop treatment with one of the drugs. This applies in particular to the following medicines:
- lithium, a medicine used to treat certain types of mental illness
- medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs, and heparin
- medicines that can reduce the amount of potassium in the blood, e.g. diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
- certain antibiotics (rifamycin group), a medicine used to protect against transplant rejection (ciclosporin), or an antiretroviral medicine for HIV /AIDS infection (ritonavir). These medicines can increase the effect of Valsartan/Hydrochlorothiazide Krka
- medicines that can cause “torsades de pointes” (irregular heart rhythm), e.g. antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
- medicines that can reduce the amount of sodium in the blood, e.g. antidepressants, antipsychotics, antiepileptics
- medicines for gout, e.g. allopurinol, probenecid, sulfinpyrazone
- therapeutic vitamin D and calcium supplements
- diabetes medications (oral agents, eg metformin or insulin er)
- other antihypertensive drugs including methyldopa
- medicines to increase blood pressure et, e.g. norepinephrine or adrenaline
- digoxin or other digitalis glycosides (medicines used to treat heart problems)
- medicines that increase blood sugar, e.g. diazoxide or beta-blockers
- cytotoxic drugs (used to treat cancer), e.g. methotrexate or cyclophosphamide
- pain relievers such as non-steroidal anti-inflammatory drugs ( NSAIDs ), including selective cyclooxygenase 2 inhibitors (COX 2 inhibitors) and aspirin more than 3 grams
- muscle relaxants, e.g. tubocurarine
- anticholinergic drugs (agents for the treatment of a variety of disorders, such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid to anesthesia )
- amantadine (an agent used to treat Parkinson’s disease and also to treat or prevent certain diseases caused by viruses )
- cholestyramine and colestipol (medicines usually used for high levels of lipids (fats) in the blood)
- ciclosporin, a medicine used in organ transplants to prevent rejection
- alcohol, sleeping pills, and anesthetics (drugs with a sleeping or pain-relieving effect used, for example, during surgery)
- iodinated contrast agent (agent used in imaging studies)
- if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Valsartan/Hydrochlorothiazide Krka” and “Warnings and precautions”).
Valsartan/Hydrochlorothiazide Krka with food, drink, and alcohol
You can take Valsartan/Hydrochlorothiazide Krka regardless of meals.
Avoid drinking alcohol until you have spoken to your doctor. Alcohol can lower blood pressure further and/or increase the risk of you becoming dizzy or fainting.
Pregnancy, breastfeeding, and fertility
Consult a doctor or pharmacist before using this medicine.
Pregnancy
If you think you are pregnant or become pregnant during treatment, contact your doctor.
Your doctor will usually suggest that you stop taking Valsartan/Hydrochlorothiazide Krka before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Valsartan/Hydrochlorothiazide Krka should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breastfeeding or intend to start breastfeeding.
Valsartan/Hydrochlorothiazide Krka is not recommended during breastfeeding and your doctor may choose a different treatment for you if you wish to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
Driving ability and use of machinery
Before you drive, use tools or machines or perform activities that require concentration, make sure you know how Valsartan/Hydrochlorothiazide Krka affects you. Like many other medicines for the treatment of high blood pressure, Valsartan/Hydrochlorothiazide Krka can rarely cause dizziness and affect concentration.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Valsartan/Hydrochlorothiazide Krka contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is next to “sodium-free”.
How to use Valsartan/Hydrochlorothiazide Krka
Always take this medicine as directed by your doctor or pharmacist. It will give the best result and reduce the risk of side effects. Ask your doctor or pharmacist if you are unsure.
People with high blood pressure often do not experience any symptoms of this. Many feel as usual. It is therefore important that you go to your doctor’s appointments as planned, even if you feel well.
Your doctor will tell you how many Valsartan/Hydrochlorothiazide Krka tablets to take. Depending on the treatment result, the doctor can raise or lower the dose.
- The usual dose of Valsartan/Hydrochlorothiazide Krka is one tablet per day
- Do not change the dose or stop treatment without consulting a doctor
- The medicine should be taken at the same time every day, usually in the morning
- You can take Valsartan/Hydrochlorothiazide Krka regardless of meals
- Swallow the tablet with a glass of water
If you have used too much Valsartan/Hydrochlorothiazide Krka
If you experience severe dizziness and/or fainting, lie down and contact a doctor immediately.
If you have ingested too much medicine or if, for example, a child has ingested the drug by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Valsartan/Hydrochlorothiazide Krka
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, then skip the missed dose.
Do not take a double dose to make up for a missed tablet.
If you stop using Valsartan/Hydrochlorothiazide Krka
If you stop your treatment with Valsartan/Hydrochlorothiazide Krka, your high blood pressure may get worse. Do not stop taking your medicine unless your doctor tells you to stop.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, but not everybody gets them.
Some side effects can be serious and require immediate medical attention:
- Contact a doctor immediately if you experience symptoms of angioedema, such as:
- swollen face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
- Severe skin disease causing rash, redness, blisters on the lips, eyes, or mouth, peeling, fever ( toxic epidermal necrolysis )
- Decreased vision or pain in the eyes due to high pressure (possible sign of fluid accumulation in the eye (between the choroid and the sclera) or acute narrow-angle glaucoma )
- Fever, sore throat, more frequent infections ( agranulocytosis )
- Acute respiratory distress syndrome (signs of this are severe shortness of breath, fever, weakness, and confusion)
These side effects are very rare or occur in an unknown number of users.
If you get any of these symptoms, stop taking Valsartan/Hydrochlorothiazide Krka and contact your doctor immediately (see section 2 “Warnings and precautions”).
Other side effects include:
Uncommon (may affect up to 1 in 100 users)
- cough
- low blood pressure
- dizzy
- dehydration (with symptoms such as thirst, dry mouth, and tongue, rarely needing to empty the bladder, dark-colored urine, and dry skin)
- pain in the muscles
- fatigue
- tingling and numbness
- blurred vision
- buzzing or buzzing in the ears
Very rare (may affect up to 1 in 10,000 users)
- dizziness
- diarrhea
- pain in the joints
Has been reported (occurring in an unknown number of users)
- difficulty breathing
- significantly reduced urine output
- low blood sodium (which can trigger tiredness, confusion, muscle twitching, and/or seizures in severe cases)
- low level of potassium in the blood (sometimes with muscle weakness, muscle cramps, and abnormal heart rhythm)
- low level of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infection, weakness)
- increased level of bilirubin in the blood (which in severe cases can cause yellow skin and yellow eyes)
- increased values of urea nitrogen and creatinine in the blood (which may indicate impaired kidney function)
- the increased uric acid level in the blood (which in severe cases can trigger gout )
- syncope (fainting)
The following side effects have been reported for products containing valsartan or hydrochlorothiazide:
Valsartan
Uncommon (may affect up to 1 in 100 users)
- sensation of spinning
- pain in the abdomen
Has been reported (occurring in an unknown number of users)
- skin rash with or without itching along with any of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms
- rash, purple-red spots, fever, itching (symptoms of inflammation of the blood vessels)
- low platelet counts (sometimes with unusual bleeding or bruising)
- high level of potassium in the blood (sometimes with muscle cramps, abnormal heart rhythm)
- allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or difficulty swallowing, and dizziness)
- swelling, especially in the face and throat, rash, itching
- elevated liver function values
- reduced hemoglobin value and reduced proportion of red blood cells in the blood ( both can cause anemia in severe cases ).
- kidney failure
- low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching, and/or seizures in severe cases)
Hydrochlorothiazide
Very common (may affect more than 1 in 10 users)
- low level of potassium in the blood
- elevated lipid values in the blood
- Common (may affect up to 1 in 10 users)
- low level of sodium in the blood
- low level of magnesium in the blood
- high level of uric acid in the blood
- itchy rashes and other types of rashes
- decreased appetite
- slight nausea and vomiting
- dizziness, fainting when standing up
- inability to get or maintain an erection
Rare (may affect up to 1 in 1,000 users)
- swelling and blistering of the skin (due to increased sensitivity to the sun)
- high level of calcium in the blood
- high blood sugar level
- sugar in the urine
- deterioration of metabolic diabetes condition
- constipation, diarrhea, discomfort in the stomach and intestines, and liver disorders which can occur together with yellow skin and yellow eyes
- irregular heartbeats
- headache
- sleep disorders
- low mood (depression)
- low platelet counts (sometimes with bleeding or bruising under the skin)
- dizziness
- tingling or numbness
- visual disturbances
Very rare (may affect up to 1 in 10,000 users)
- inflammation of the blood vessels with symptoms such as rash, red-purple-red spots, fever ( vasculitis )
- rash, itching, hives, difficulty breathing or swallowing, dizziness ( hypersensitivity reaction )
- rash on the face, joint pain, muscle disease, fever (lupus erythematosus)
- severe pain in the upper part of the stomach ( pancreatitis )
- difficulty breathing with fever, cough, wheezing, and shortness of breath (shortness of breath including pneumonitis and pulmonary edema)
- pale skin, tiredness, shortness of breath, dark urine ( hemolytic anemia )
- fever, sore throat, or mouth sores due to infection ( leukopenia )
- confusion, fatigue, muscle twitching and spasms, rapid breathing (hypochloraemic alkalosis )
Has been reported (occurring in an unknown number of users)
- skin and lip cancer (Non- melanoma skin cancer)
- weakness, bruising and frequent infections ( aplastic anemia )
- severely reduced urine output (possible signs of kidney disease or kidney failure )
- skin rash, redness, blisters on the lips, eyes, or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
- muscle cramp
- fever ( pyrexia )
- weakness ( asthenia )
How to store Valsartan/Hydrochlorothiazide Krka
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30°C.
Store in the original packaging. Light sensitive. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are valsartan and hydrochlorothiazide .Each Valsartan/Hydrochlorothiazide Krka 80 mg/12.5 mg film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide .Each Valsartan/Hydrochlorothiazide Krka 160 mg/12.5 mg film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide .Each Valsartan/Hydrochlorothiazide Krka 160 mg/25 mg film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide .Each Valsartan/Hydrochlorothiazide Krka 320 mg/12.5 mg film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide .Each Valsartan/Hydrochlorothiazide Krka 320 mg/25 mg film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide .
- Other ingredients in the tablet are microcrystalline cellulose, lactose monohydrate, magnesium stearate (E470b), croscarmellose sodium, povidone K25, and anhydrous colloidal silicon dioxide in the tablet core as well as hypromellose, titanium dioxide (E171), macrogol 4000, red iron oxide (E172) – only in 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, and 320 mg/12.5 mg tablets, yellow iron oxide (E172) – only in 80 mg/12.5 mg, 160 mg/25 mg and 320 mg/ 25 mg tablets – in the film coating. See section 2 “Valsartan/Hydrochlorothiazide Krka contains lactose and sodium”.
Appearance and package sizes of the medicine
Valsartan/Hydrochlorothiazide Krka 80 mg/12.5 mg film-coated tablets are pink, oval, and biconvex tablets.
Valsartan/Hydrochlorothiazide Krka 160 mg/12.5 mg film-coated tablets are red-brown, oval, and biconvex tablets.
Valsartan/Hydrochlorothiazide Krka 160 mg/25 mg film-coated tablets are light brown, oval, and biconvex tablets.
Valsartan/Hydrochlorothiazide Krka 320 mg/12.5 mg film-coated tablets are pink, oval, and biconvex tablets.
Valsartan/Hydrochlorothiazide Krka 320 mg/25 mg film-coated tablets are pale yellow, oval, biconvex tablets.
The tablet can be divided into two equal parts.
Valsartan/Hydrochlorothiazide Krka 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg film-coated tablets are supplied in packs of 14, 28, 30, 56, 60, 84, 90, 98, 280, 56 x 1, 98 x 1 and 280 x 1 film-coated tablets in blisters.
Valsartan/Hydrochlorothiazide Krka 320 mg/12.5 mg and 320 mg/25 mg film-coated tablets are supplied in packs of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 280, 56×1, 98×1 and 280×1 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany.
KRKA-POLSKA Sp. z o. o., ul. Równoległa 5, 02-235 Warsaw, Poland