80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg film-coated tablets
valsartan/hydrochlorothiazide
What Valtsu comp is and what it is used for
Valtsu comp film-coated tablets contain two active substances, valsartan and hydrochlorothiazide. Both substances help to control high blood pressure ( hypertension ).
- 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 et.
Valtsu comp 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.
What you need to know before taking Valtsu comp
Do not take Valtsu comp:
- if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide ), or any of the other ingredients of this medicine (listed in section 6).
- if you have been pregnant for more than 3 months (it is also good to avoid Valtsu comp earlier in pregnancy, see the section “Pregnancy and breast-feeding”)
- if you have severe liver disease, destruction of the small bile ducts in the liver ( biliary cirrhosis ) leads to bile accumulating 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 you are being treated with an antihypertensive medicine containing aliskiren
If any of the above apply to you, talk to your doctor, and do not take Valtsu comp.
Warnings and precautions
Talk to your doctor before taking Valtsu comp
- 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 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, Valtsu comp 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 Valtsu comp, stop taking Valtsu comp immediately and never take it again. See also section 4, “Potential 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 or triglyceride levels in the blood
- 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 your vision deteriorates or your eyes hurt. These may be symptoms of fluid accumulation in the eye (between the choroid and sclera) or increased pressure in the eye and may occur within hours to weeks of taking Valtsu comp. It can lead to permanent vision loss if left untreated. If you have previously had an allergic reaction to penicillin or sulfonamides, the risk of this side effect may be higher
- if you are taking any of the following medicines used to treat high blood pressure:- an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.- the aliskiren
- 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 taking Valtsu comp.
- 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 Valtsu comp, seek medical attention immediately.
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 “Don’t take Valtsu comp”.
Valtsu comp can increase the skin’s sensitivity to the sun.
You must tell your doctor if you think you are ( or may become ) pregnant. Valtsu comp is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as the medicine may cause birth defects if used at this stage (see section “Pregnancy and breast-feeding”)
Children and young people
Use of Valtsu comp in children and adolescents (younger than 18 years) is not recommended.
Other medicines and Valtsu comp
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 Valtsu comp 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 are 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, corticosteroids, laxatives, ACTH (a hormone ), carbenoxolone, amphotericin, penicillin G, salicylic acid, and derivatives
- certain antibiotics (rifamycin group), a medicine used to protect against transplant rejection (cyclosporin), or an antiretroviral medicine for HIV /AIDS infection (ritonavir). These medicines can enhance the effect of Valtsu comp
- medicines that can cause “torsades de pointes” (irregular heartbeats) such as antiarrhythmics (medicines for heart problems) and some antipsychotics (for mental illnesses)
- medicines that can reduce the amount of sodium in the blood, e.g. antidepressants, antipsychotics, and antiepileptics
- medicines for gout, e.g. allopurinol, probenecid, sulfinpyrazone
- Vitamin D and calcium supplements
- diabetes medication (oral agents e.g. metformin, or insulin er)
- other antihypertensive drugs, including methyldopa, ACE inhibitors (for example, enalapril, lisinopril, ramipril, etc.), or aliskiren (see also the information under the headings “Do not take Valtsu comp” and “Warnings and precautions”)
- medicines that raise blood pressure, etc., e.g. norepinephrine or adrenaline
- digoxin or other digitalis glycosides (medicines to treat heart problems)
- medicines that can raise blood sugar, e.g. diazoxide or beta-blockers
- cytostatics (drugs against cancer), e.g. methotrexate or cyclophosphamide
- pain relievers, e.g. non-steroidal anti-inflammatory agents ( NSAID ), which include e.g. selective cyclooxygenase 2 inhibitors (Cox 2 inhibitors) and aspirin in doses higher than 3 grams per day
- muscle relaxants, e.g. tubocurarine
- anticholinergic drugs (used to treat several different diseases, e.g. spasmodic pain in the gastrointestinal tract, bladder spasm, asthma, motion sickness, muscle spasms, and Parkinson’s disease, as well as to facilitate anesthesia), such as atropine or biperiden
- amantadine (used in Parkinson’s disease and also to treat or prevent certain diseases caused by viruses)
- cholestyramine and colestipol (medicines used for high blood lipid levels)
- ciclosporin, a medicine used in organ transplants to prevent rejection
- alcohol, sleeping pills, and anesthetics (drugs with a sleep-inducing or anesthetic effect, such as those used in operations)
- iodine contrast agent (used in imaging)
Valtsu comp with food, drink, and alcohol
You can take Valtsu comp with or without food.
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 and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
- You must talk to your doctor if you think you are (or may become) pregnant. Usually, your doctor will suggest that you stop taking Valtsu comp before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Valtsu comp should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it can cause serious birth defects.
Breast-feeding
- Tell your doctor if you are breastfeeding or intend to start breastfeeding.
Valtsu comp is not recommended during breastfeeding and your doctor may choose another 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 a vehicle, use tools or machines, or perform activities that require concentration, make sure you know how Valtsu comp affects you. Like many other medicines for the treatment of high blood pressure, Valtsu comp can rarely cause dizziness and affect the ability to concentrate.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Valtsu comp contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is almost “sodium-free”.
How to take Valtsu comp
Always take this medicine as directed by your doctor, so that you get the best results 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 Valtsu comp tablets to take. Depending on the treatment result, the doctor can raise or lower the dose.
- The recommended dose of Valtsu comp is one tablet per day.
- Do not change the dose or stop the treatment without consulting the doctor.
- The medicine should be taken at the same time every day, usually in the morning.
- You can take Valtsu comp regardless of a meal.
- Swallow Valtsu comp with a glass of water.
- The 160 mg/25 mg tablet can be divided into two equal doses.
If you have taken too much Valtsu comp
If you experience severe dizziness and/or fainting, seek medical attention immediately and lie down.
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Valtsu comp
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 dose.
If you stop taking Valtsu comp
If you stop your treatment with Valtsu comp, 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, although not everybody gets them.
Some side effects can be serious and require immediate medical attention:
You should contact your doctor immediately if you experience symptoms of angioedema, such as:
- swollen face, tongue, or throat
- difficulty swallowing
- hives, difficulty breathing
- serious skin disease causing rash, reddened skin, blisters on lips, eyes, or mouth, scaly skin, fever ( toxic epidermal necrolysis )
- impaired vision or pain in the eyes due to high pressure (may be a sign of fluid accumulation in the eye (between the choroid and sclera) or acute narrow-angle glaucoma )
- fever, sore throat, or frequent infections ( agranulocytosis )
- acute respiratory distress syndrome (signs of this are severe shortness of breath, fever, weakness, and confusion) (frequency: very rare).
These side effects are very rare or occur in an unknown number of users.
If you experience any of these symptoms, stop taking Valtsu comp and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects are:
Uncommon (may affect up to 1 in 100 users)
- cough
- low blood pressure
- dizziness
- dehydration (with symptoms such as thirst, dry mouth, and tongue, decreased urination, dark-colored urine, and dry skin)
- pain in the muscles
- fatigue
- tingling and numbness
- blurred vision
- roaring and 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 sodium levels in the blood (can trigger tiredness, confusion, muscle twitching, and/or seizures in severe cases)
- low level of potassium in the blood (sometimes associated 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)
- blistering of the skin (a sign of bullous dermatitis )
- 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 (sometimes associated with nausea, tiredness, confusion, feeling unwell, and convulsions)
Hydrochlorothiazide
Very common (may affect more than 1 in 10 users)
- low level of potassium in the blood
- increased lipid content in the blood
Common (may affect up to 1 in 10 users)
- low blood sodium
- low level of magnesium in the blood
- high levels of uric acid in the blood
- itchy rashes and other types of rashes
- loss of appetite
- slight nausea and vomiting
- dizziness, fainting when standing up
- inability to get and 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 blood calcium levels
- high blood sugar
- sugar in the urine
- impaired metabolic status in diabetes
- constipation, diarrhea, stomach, and intestinal discomfort, liver disorders (which may appear as 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 and 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, trouble breathing or swallowing, dizziness ( hypersensitivity reaction )
- rash on the face, pain in the joints
- muscle disease
- fever (lupus erythematosus)
- severe pain in the upper part of the stomach; ( pancreatitis )
- breathing difficulties with fever, cough, wheezing/wheezing, and shortness of breath ( respiratory distress with pneumonitis and pulmonary edema )
- pale skin, tiredness, shortness of breath, dark urine ( hemolytic anemia )
- fever, sore throat, or mouth ulcers due to infection ( leukopenia )
- confusion, fatigue, muscle twitching and spasms, rapid breathing (hypochloraemic alkalosis )
- lack of or low levels of various blood cells
Has been reported (occurring in an unknown number of users)
- weakness, bruising and frequent infections ( aplastic anemia )
- drastically reduced urine output (may be a sign of kidney disease or kidney failure )
- rash, reddened skin, blisters on the lips, eyes, or mouth, scaly skin, fever (may be signs of erythema multiforme)
- muscle cramps
- fever ( pyrexia )
- weakness ( asthenia )
- skin and lip cancer (non-melanoma skin cancer)
How to store Valtsu comp
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, can, or blister pack after EXP. The expiration date is the last day of the specified month.
Cans
Store in the original packaging. Moisture sensitive.
Blister packs:
Store at a maximum of 30 °C
Store in the original packaging. Moisture sensitive.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
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.
Valtsu comp 80 mg/12.5 mg: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide .
Valtsu comp 160 mg/12.5 mg: each tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide .
Valtsu comp 160 mg/25 mg: each tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide .
Other ingredients are:
Tablet core:
Microcrystalline cellulose, croscarmellose sodium, povidone (K-30), magnesium stearate
Film coating:
80 mg/12.5 mg: polyvinyl alcohol (partially hydrolyzed), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
160 mg/12.5 mg: polyvinyl alcohol (partially hydrolyzed), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
160 mg/25 mg: polyvinyl alcohol (partially hydrolyzed), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
Appearance and package sizes of the medicine
Valtsu comp 80 mg/12.5 mg is a light orange, oval film-coated tablet (size approx. 5.3 x 10.2 mm).
Valtsu comp 160 mg/12.5 mg is a dark red, oval film-coated tablet (size approx. 6.1 x 15.2 mm).
Valtsu comp 160 mg/25 mg is a brown, oval film-coated tablet, scored on one side (size approx. 5.6 x 14.2 mm). The tablet can be divided into two equal doses.
Blisters:
Packs of 14, 20, 28, 30, 56, 60, 98, 100 film-coated tablets.
Cans:
100, 500 film-coated tablets.
Not all pack sizes may be marketed.
Manufacturer
HBM Pharma sro, Sklabinska 30, 03680 Martin, Slovakia
Merckle GmbH, Ludwig-Merckle-Str. 3, Weiler, 89143 Blaubeuren, Germany
Teva Pharmaceutical Works, 13 Pallagi Street, 4042 Debrecen, Hungary