SUVARTAR H 160mg/12.5mg x 28 tabl
Leaflet: patient information
Suvartar H 160 mg / 12.5 mg film-coated tablets
Suvartar H 160 mg / 25 mg film-coated tablets
Suvartar H 160 mg/12.5 mg film-coated tablets
Suvartar H 160 mg/25 mg film-coated tablets
Valsartan/hydrochlorothiazide ( Valsartan / hydrochlorothiazide )
Read all of this 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 further questions, ask your doctor or pharmacist.
- This medicine is prescribed only and personally for you. Don't leave it to other people. It can harm them, regardless of the fact that the signs of their illness are the same as yours.
- If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet (see item 4).
What this leaflet contains :
1. What Suvartar H is and what it is used for
2. What you need to know before you take Suvartar H
3. How to take Suvartar H
4. Possible side effects
5. How to store Suvartar H
6. Contents of the package and additional information
1. What Suvartar H is and what it is used for
Suvartar H film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both substances help control high blood pressure
(hypertension).
- Valsartan belongs to a group of drugs called "angiotensin II receptor blockers
blockers' and is used to lower high blood pressure. Angiotensin II is a substance that causes blood vessels to constrict, which is found in the body and can cause high blood pressure. Valsartan works by blocking angiotensin II. This causes the blood vessels to widen blood vessels and lowering of
arterial pressure.
- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases the volume of
urine output, which also lowers blood pressure.
Suvartar H is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with the individual substances alone.
High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart and kidneys, and cause stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.
- What you need to know before you take Suvartar H
Do not take Suvartar H
- if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6).
- if you are more than 3 months pregnant (it is better to avoid taking Suvartar H and at the beginning of pregnancy - see the section "Pregnancy and breastfeeding").
- if you have severe liver disease, affecting the small bile ducts in the liver (biliary cirrhosis) leading to blockage of bile in the liver (cholestasis).
- if you have severe kidney disease.
- if you cannot pass urine (anuria).
- if you are being treated with an artificial kidney.
- if you are on dialysis.
- if you have lower than normal levels of potassium or sodium in your blood, or if you have too high levels of calcium in your blood despite treatment.
- if you have gout
- if you suffer from diabetes or impaired kidney function and are being treated with a blood pressure lowering medicine containing aliskiren.
Do not take Suvartar H and consult a doctor if any of the above apply to you.
Warnings and precautions
Talk to your doctor before taking Suvartar H
- if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor needs to monitor your blood potassium levels regularly.
- if you have low levels of potassium in your blood.
- if you have diarrhea or severe vomiting.
- if you are taking high doses of dehydration tablets (diuretics).
- if you have severe heart disease.
- if you suffer from heart failure or have had a heart attack. Follow your doctor's instructions about starting the dose carefully. Your doctor may also test your kidney function.
- if you suffer from renal artery narrowing.
- if you have recently received a new kidney.
- if you suffer from hyperaldosteronism - a disease in which your adrenal glands make too much of the hormone aldosterone. In this case, the use of Suvartar H is not recommended.
- if you have liver or kidney disease.
- if you have ever had swelling, mainly of the face or throat, while taking other medicines (including ACE inhibitors). If you get these symptoms, stop taking Suvartar H and contact your doctor immediately and stop taking it. See also item 4 "Possible side effects"
- if you have fever, rash and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease).
- if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
- if you have had allergic reactions to other blood pressure lowering medicines from this class of medicine (angiotensin II receptor blockers) or if you have an allergy or asthma.
- If you experience problems with visual acuity or eye pain. These may be symptoms of increased pressure in the eyes and may occur after several hours to several weeks of taking Suvartar N. This may lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, your risk of developing this condition is greater.
- may cause increased skin sensitivity when exposed to the sun.
- if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV rays while taking Suvartar H.
- if you are taking any of the following medicines to treat high blood pressure:
- ACE inhibitor (eg enalapril, lisinoril, ramipril), especially if you have kidney problems related to diabetes.
- aliskiren
If any of the conditions described above apply to you, tell your doctor.
Your doctor may check your kidney function, blood pressure and levels of electrolytes (eg potassium) in your blood at certain intervals.
See also the information under "Do not take Suvartar H".
You should tell your doctor if you think you are (or may be) pregnant. Suvartar H is not recommended in early pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).
Children and adolescents
The use of Suvartar H in children and adolescents (under 18 years of age) is not recommended.
Other medicines and Suvartar H
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of the treatment may be affected by taking other medicines at the same time as Suvartar H. It may be necessary for your doctor to change the dosage and/or to take other precautions or, in individual cases, to stop the treatment with some of the medicines. This applies to both prescription and over-the-counter medications, especially:
- lithium - a drug used to treat certain psychiatric disorders
- medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing drugs and heparin.
- medicines that can lower the amount of potassium in the blood, such as diuretics (dehydrators), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
- certain antibiotics (from the rifamycin group), a medicine used against transplant rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Suvartar H.
- Medicines that can cause torsades de pointes (regular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics.
- Medicines that can lower the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics.
- medicines to treat gout, such as allopurinol, probenecid, sulfinpyrazone
- vitamin D and calcium supplements,
- medicines to treat diabetes (oral agents, such as metformin or insulin)
- other medicines to lower blood pressure including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under "Do not take Suvartar H" and "Warnings and precautions")
- medicines that raise blood pressure, such as norepinephrine and adrenaline
- digoxin or other digitalis glycosides (medicines used to treat heart problems)
- medicines that raise blood sugar, such as diazoxide or beta-blockers
- cytotoxic medicines (used to treat cancer) such as methotrexate or cyclophosphamide
- pain relievers such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) and more than 3g of acetylsalicylic acid per day
- muscle relaxants such as tubocurarine
- anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as an adjunct to anaesthesia)
- amantadine (a medicine used to treat Parkinson's disease and also to prevent certain diseases caused by viruses)
- cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
- cyclosporine - a drug used in organ transplants to prevent rejection of the organ
- alcohol, sleeping pills and anesthetics (medicines with a sleeping or pain-relieving effect, used for example during surgical operations)
- iodine-contrast substances (means used in imaging)
Suvartar H with food, drinks and alcohol
You can take Suvartar H with or without food.
Do not drink alcohol before talking to your doctor. Alcohol can cause your blood pressure to drop further and/or increase your risk of feeling dizzy or sick.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
You should tell your doctor if you think you are pregnant or may become pregnant.
Your doctor will usually advise you to stop taking Suvartar H before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Suvartar H. Suvartar H is not recommended during early pregnancy and is not must be taken after the 3rd month as it may cause serious harm to your baby if used after the 3rd month of pregnancy.
Tell your doctor if you are breast-feeding or intend to breast-feed.
Suvartar H is not recommended for nursing mothers and your doctor may prescribe another treatment if you wish to breastfeed, especially if your baby is newborn or born prematurely.
Driving and using machines
Before driving, operating machinery or doing other activities that require full concentration, make sure you know how you react to the effects of Suvartar H. Like many other medicines for high blood pressure, Suvartar H can cause dizziness or affect concentration in some cases .
- How to take Suvartar H
Always take this medicine exactly as your doctor has told you. This will help you get the best results and reduce the risk of side effects. If you are not sure, ask your doctor or pharmacist.
People with high blood pressure do not always recognize the symptoms of this disease. Many of them feel normal. That's why it's important to see your doctor regularly, even when you're feeling well.
Your doctor will tell you exactly how many Suvartar H tablets to take. Depending on how you respond to treatment, your doctor will increase or decrease your dose.
- The recommended dose of Suvartar H is one tablet daily.
- Do not change the dose or stop taking the tablets without consulting your doctor.
- The medicine should be taken at the same time each day, usually in the morning.
- You can take Suvartar H with or without food.
- Swallow the tablet with a glass of water.
If you have taken more than the required dose of Suvartar H
In case of severe dizziness and/or fainting, lie down and contact your doctor immediately. If you accidentally take too much of the medicine, contact your doctor, pharmacist or hospital.
If you forget to take Suvartar H
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you stop taking Suvartar H
Stopping treatment with Suvartar H may make your condition worse. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions related to the use of this medicine, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention:
Tell your doctor immediately if you have symptoms of angioedema, for example:
- swelling of the face, tongue, or throat;
- difficulty swallowing;
- hives and difficulty breathing.
If you experience any of these symptoms, stop taking Suvartar H immediately and contact your doctor as soon as possible.
Other side effects include:
Uncommon, affects 1 to 10 in 1,000 patients
- cough
- low blood pressure
- diminution
- dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark-colored urine, dry skin)
- muscle pain
- fatigue
- numbness or tingling
- blurred vision
- noise (eg whistling, buzzing) in the ears
Very rare, affecting less than 1 in 10,000 patients
- dizziness
- diarrhea
- joint pain
Not known according to available data
- difficulty breathing
- a strong decrease in the volume of urine excreted
- low levels of sodium in the blood (which can cause tiredness, confusion, numbness and/or muscle convulsions in severe cases)
- low levels of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
- low number of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
- increase in bilirubin levels in the blood (which can in severe cases lead to yellowing of the skin and eyes)
- increase in blood nitrogen and blood creatinine (which may be a sign of impaired kidney function)
- increased levels of uric acid in the blood (which in severe cases can cause gout)
- syncope (loss of consciousness)
Ice reactions have been reported with valsartan or hydrochlorothiazide alone :
Valsartan
Uncommon, affects 1 to 10 in 1,000 patients
- dizziness
- stomach ache
Not known according to available data
- a skin rash with or without itching combined with any of the following signs and symptoms: fever, joint pain, muscle aches, swollen lymph nodes, and/or flu-like symptoms
- rash, red-violet spots, fever, itching (symptoms of inflammation of the blood vessels)
- low number of platelets in the blood (sometimes with unusual bleeding or bruising)
- high levels of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)
- allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
- swelling mainly in the area of the face and throat, rash, itching
- increase in liver function indicators
- decrease in hemoglobin and red blood cell count (which together, in severe cases, can lead to anemia)
- kidney failure
- low level of sodium in the blood (may cause tiredness, confusion, numbness and/or muscle convulsions in severe cases)
Hydrochlorothiazide
Very common, affecting more than 1 in 10 patients
- decreased levels of potassium in the blood
- elevated blood lipids
Common, affect 1 to 10 in 100 patients
- decreased sodium levels in the blood
- decreased levels of magnesium in the blood
- high levels of uric acid in the blood
- itchy rash and other types of rash
- decreased appetite
- moderate nausea and vomiting
- dizziness, lightheadedness when standing up
- erectile dysfunction
Rare, affect 1 to 10 in 10,000 patients
- swelling and blistering of the skin (due to increased sensitivity to
the sun)
- high blood calcium levels
- elevated blood sugar
- sugar in the urine
- deterioration of the metabolic state in diabetes
- constipation, diarrhoea, stomach or intestinal discomfort, liver disorders which may appear together with yellowing of the skin or eyes.
- irregular heart rhythm
- headache
- sleep disorders
- bad mood (depression)
- low number of platelets in the blood (sometimes with bleeding or bruising under the skin)
- dizziness
- numbness or tingling
- visual disturbances
Very rare, affecting less than 1 in 10,000 patients
- inflammation of blood vessels with symptoms such as rash, red-purple spots, temperature (vasculitis)
- rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
- severe skin diseases that occur with a rash, reddening of the skin, blistering of the lips, eyes or mouth, peeling of the skin, temperature toxic epidermal necrolysis)
- facial rash combined with joint pain, muscle disorders, high fever (cutaneous lupus erythematosus)
- severe upper stomach pain (pancreatitis)
- difficulty breathing with chills, cough, wheezing, inability to breathe (respiratory distress, including pneumonitis and pulmonary oedema)
- high fever, sore throat, frequent infections (agranulocytosis)
- pale skin, tiredness, inability to breathe, dark urine (haemolytic anemia)
- fever, sore throat or inflammation of the lining of the mouth (leucopenia)
- confusion, tiredness, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)
Not known, according to available data
- weakness, bruising and frequent infections (aplastic anemia)
- severely reduced urine output (possible sign of kidney disorder or kidney failure)
- reduced vision or eye pain due to increased pressure (possible signs of erythema multiforme)
- rash, reddened skin, peeling of the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
- muscle spasms
- fever (pyrexia)
- weakness (asthenia)
- skin and lip cancer (non-melanoma skin cancer)
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Executive Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Suvartar H
- Keep out of the reach of children.
- Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date corresponds to the last day of the specified month.
- Do not store at a temperature above 30°C. Store in original packaging to protect from moisture.
- Do not use Suvartar H if you notice that the packaging is damaged or there are signs of external interference.
- Do not flush the medication down the drain. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Suvartar H contains
- The active substances are valsartan and hydrochlorothiazide.
Suvartar H 160 mg / 12.5 mg film-coated tablets
Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Suvartar H 160 mg / 25 mg film-coated tablets
Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
- The other ingredients are:
Suvartar H 160 mg / 12.5 mg film-coated tablets
Tablet core :
Microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silicon Coating:
hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172)
Suvartar H 160 mg / 25 mg film-coated tablets
Tablet core :
Microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silicon
Coverage:
hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
What Suvartar H looks like and contents of the pack
Suvartar H 160 mg / 12.5 mg film-coated tablets
Dark red, oblong, slightly convex, film-coated tablets, debossed on one side with "HHH" and "CG" on the other side of the tablet.
Suvartar H 160 mg / 25 mg film-coated tablets
Orange-brown, oblong, slightly convex, film-coated tablets, debossed on one side with "HHHH" and "NVR" on the other side of the tablet.
Packs containing 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 280 film-coated tablets.
Not all types of packaging can be put on sale.
License holder
Sandoz dd
Verovškova 57, 1000 Ljubljana, Slovenia
Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek SA
Ul. Podlipie 16, 95-010 Strykow, Poland
Lek SA
Ul. Domaniewska 50c, 02-672 Warsaw, Poland
Lek Pharmaceuticals dd
Verovskova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals dd
Trimlini 2D, 9220 Lendava, Slovenia
Novartis Farma SpA
Via Provinciale Schito 131
I-800058 Torre Annunziata / NA, Italy
SC Sandoz SRL
Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania
This medicinal product is authorized for use in the EEC member states under the following names:
Sweden: Valsartan/Hydrochlorothiazide Sandoz
Austria: Valsartan/HCT Sandoz 160 mg/12.5 mg – Filmtabletten
Valsartan/HCT Sandoz 160 mg/25 mg – Filmtabletten
Belgium: Co-Valsartan Sandoz 160 mg / 12.5 mg filmomhulde tabletten
Co-Valsartan Sandoz 160 mg / 25 mg filmomhulde tabletten
Bulgaria Suvartar H 160 mg/12.5 mg film-coated tablets
Suvartar H 160 mg/25 mg film-coated tablets
Germany: Valsartan HCT Sandoz 160 mg/12.5 mg Filmtabletten
Greece: Valsartan HCT/Sandoz
Spain: Valsartan Hidroclorithiazida Sandoz 160/12.5 mg comprimidos recubiertos con película EFG
Valsartan Hidroclorithiazida Sandoz 160/25 mg comprimidos recubiertos con película EFG
Finland: Valsartan/Hydrochlorothiazide Sandoz 160 mg / 12.5 mg tabletti, kalvovärvementinen
France: Valsartan / Hydrochlorothiazide 160 mg/12.5 mg, compreche pelliculé
Valsartan / Hydrochlorothiazide 160 mg/25 mg, tablet pelliculé
Hungary: Valsartan HCT Sandoz 160/12.5 mg filmtabletta
Valsartan HCT Sandoz 160/25 mg film tablet
Lithuania: Suvartar HCT 160mg/12.5mg plevele dengtos tabletes
The Netherlands: Valsartan/Hydrochloorthiazide Sandoz 160/12.5mg, filmomhulde tabletten
Valsartan/Hydrochlorothiazide Sandoz 160/25mg, filmomhulde tabletten
Norway: Valsartan/Hydrochlorothiazide Sandoz
Poland: Ajudan HCT
Portugal: Valsartan + Hidroclorothiazida Sandoz 160 mg + 12.5 mg Comprimidos
Valsartan + Hidroclorothiazida Sandoz 160 mg + 25 mg Comprimidos
Slovenia: Valsartan/hidrochlorothiazide Lek 160 mg/12.5 mg filmsko obložene tablete
Valsartan/hydrochlorothiazide Lek 160 mg/25 mg filmsko obložene tablete
Date of last revision of leaflet
06/2019
