80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg film-coated tablets
Valsartan/hydrochlorothiazide
What Valsartore Comp is and what it is used for
Valsartore Comp 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 et.
Valsartore 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 heart attack. A lowering of blood pressure et to a normal level reduces the risk of these diseases.
The valsartan and hydrochlorothiazide contained in Valsartore Comp may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Valsartore Comp
Do not use Valsartore Comp
- 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).
- if you are pregnant: Pregnant women should not use Valsartore Comp during the last 6 months of pregnancy (Even earlier in pregnancy it is good to avoid Valsartore Comp, see Pregnancy and breast-feeding).
- if you have severe liver disease, destruction of the small bile ducts in the liver ( biliary cirrhosis ) leading 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 taking Valsartore 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, Valsartore 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 Valsartore Comp, stop taking Valsartore Comp immediately and never take it again. See also section 4, “Possible side effects”
- if you have 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 high 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 you experience a visual impairment 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 Valsartore Comp. 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 taking Valsartore Comp
- 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 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 Valsartore Comp, seek medical attention immediately.
If any of the above apply to you, talk to your doctor.
Your doctor may need to check your kidney function, blood pressure and the amount of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Valsartore Comp”.
Children and young people
Use of Valsartore Comp in children and adolescents (younger than 18 years) is not recommended.
If you think you are pregnant ( or become pregnant ) during treatment, contact your doctor. Valsartore Comp is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding.
Other medicines and Valsartore 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 Valsartore 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 include potassium supplements, 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 Valsartore Comp
- 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 and 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, ACE inhibitors (such as enalapril , lisinopril, etc.) or aliskiren
- 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 (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 examinations).
Your doctor may need to change your dose and/or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Valsartore Comp” and “Warnings and precautions”)
Valsartore Comp with food, drink and alcohol
You can take Valsartore Comp 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you think you are pregnant (or become pregnant) during treatment, contact your doctor.
Your doctor will usually suggest that you stop taking Valsartore Comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Valsartore Comp 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.
Tell your doctor if you are breast-feeding or intend to start breast-feeding.
Valsartore Comp is not recommended during breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed 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 Valsartore Comp affects you. Like many other medicines for the treatment of high blood pressure , Valsartore Comp can rarely cause dizziness and affect the ability to concentrate.
You yourself 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 . 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.
Valsartore Comp contains lactose and sodium
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to use Valsartore Comp
Always take this medicine as directed by your doctor. 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 Valsartore Comp tablets to take. Depending on the treatment result, the doctor can raise or lower the dose .
- The usual dose of Valsartore 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 Valsartore Comp regardless of a meal.
- Swallow the tablet with a glass of water.
If you have used too much Valsartore Comp
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you experience severe dizziness and/or fainting, lie down and contact a doctor immediately.
If you forget to use Valsartore 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 one.
Do not take a double dose to make up for a missed tablet.
If you stop using Valsartore Comp
If you stop your treatment with Valsartore Comp, your high blood pressure may get worse. Do not stop taking your medicine unless your doctor tells you to stop.
If you have any further questions about this medicine, ask 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 and difficulty breathing
- severe skin disease causing skin rash, redness , blisters on the lips, eyes or mouth, peeling, fever ( toxic epidermal necrolysis )
- vision loss or pain in your eyes due to high pressure (possible signs 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 the frequency is not known.
If you get any of these symptoms, stop taking Valsartore Comp and contact your doctor immediately (see section 2 “Warnings and precautions”).
Other side effects are:
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, 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 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, 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 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)
- 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):
- feeling that it is spinning
- pain in the abdomen.
Has been reported (occurring in an unknown number of users):
- blistering of the skin (sign of skin inflammation, also called 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, 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, diarrhoea, discomfort in the stomach and intestines, liver disorders which can occur together with yellow skin and yellow eyes
- irregular heartbeats
- headache
- sleep disorders
- 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 users):
- inflammation of the blood vessels with symptoms such as rash, purple-red spots, fever ( vasculitis )
- rash, itching , hives, difficulty breathing or swallowing, dizziness ( hypersensitivity reaction )
- rash on the face, joint pain, muscle disease, fever ( cutaneous lupus erythematosus)
- severe pain in the upper part of the stomach ( pancreatitis )
- difficulty breathing with fever, cough, wheezing, shortness of breath (shortness of breath including pneumonitis and pulmonary oedema )
- 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):
- 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 )
- skin and lip cancer (Non- melanoma skin cancer).
How to store Valsartore Comp
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Store at a maximum of 30°C.
Do not use a Valsartore Comp package that is damaged or shows signs of having been previously opened.
Medicines must not be thrown into the drain or among 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
- hydrochlorothiazide .
Valsartore Comp 80 mg/12.5 mg film-coated tablets
Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide .
Other ingredients in the tablet core are:
- lactose monohydrate
- cellulose powder
- hypromellose
- croscarmellose sodium
- anhydrous colloidal silica
- magnesium stearate
Other ingredients in the film coating are:
- hypromellose
- macrogol 8000
- titanium dioxide (E171)
- talc
- red iron oxide (E172)
Valsartore Comp 160 mg/12.5 mg film-coated tablets
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide .
Other ingredients in the tablet core are:
- lactose monohydrate
- cellulose powder
- hypromellose
- croscarmellose sodium
- anhydrous colloidal silica
- magnesium stearate
Other ingredients in the film coating are:
- hypromellose
- macrogol 8000
- talc
- red iron oxide (E172)
- yellow iron oxide (E172)
- black iron oxide (E172)
Valsartore Comp 160 mg/25 mg film-coated tablets
Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide .
Other ingredients in the tablet core are:
- lactose monohydrate
- cellulose powder
- hypromellose
- croscarmellose sodium
- anhydrous colloidal silica
- magnesium stearate
Other ingredients in the film coating are:
- hypromellose
- macrogol 8000
- titanium dioxide (E171)
- talc
- red iron oxide (E172)
- yellow iron oxide (E172)
- black iron oxide (E172)
Appearance and package sizes of the medicine
Valsartore Comp 80 mg/12.5 mg film-coated tablets are pink, oblong and biconvex tablets.
Valsartore Comp 160 mg/12.5 mg film-coated tablets are brown, oblong and biconvex tablets.
Valsartore Comp 160 mg/25 mg film-coated tablets are orange, oblong and biconvex tablets
The tablets are supplied in blister packs of 10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
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61118 Bad Vilbel
Germany
Other manufacturers
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC Etten Leur, The Netherlands
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co. Tipperary, Ireland
Eurogenerics NV
Heizel Esplanade Heysel b 22, B-1020 Brussels, Belgium
LAMP S. Prospero SpA
Via della Pace, 25/A, I-41030 San Prospero (Modena), Italy
PharmaCoDane ApS
Marielundvej 46A, DK-2730 Herlev, Denmark
STADA Arzneimittel GmbH
Muthgasse 36/2, A-1190 Vienna, Austria
Local representative
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Marielundvej 46 A
2730 Herlev
Denmark