80mg/12.5mg; 160 mg/12.5 mg , 160 mg/25 mg film-coated tablets
valsartan/hydrochlorothiazide
What Valsartan/Hydrochlorothiazide Rivopharm is and what it is used for
Valsartan/Hydrochlorothiazide Rivopharm 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.
Valsartan/Hydrochlorothiazide Rivopharm 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 you use Valsartan/Hydrochlorothiazide Rivopharm
Do not take Valsartan/Hydrochlorothiazide Rivopharm
- if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide ), soya oil, peanut oil, or any of the other ingredients of this medicine (listed in section 6).
- if you have been pregnant for more than three months: Pregnant women should not use Valsartan/Hydrochlorothiazide Rivopharm during the last 6 months of pregnancy (even earlier in pregnancy it is better to avoid Valsartan/Hydrochlorothiazide Rivopharm – see 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 empty your bladder.
- 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 applies to you, you should not take this medicine. Talk to your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Valsartan/Hydrochlorothiazide Rivopharm, especially:
- 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 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 Rivopharm is not recommended.
- 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 Rivopharm, stop taking Valsartan/Hydrochlorothiazide Rivopharm immediately and never take it again. See also section 4.
- 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 Rivopharm. 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 Valsartan/Hydrochlorothiazide Rivopharm.
- 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 Rivopharm”.
Children and young people
Use of Valsartan/Hydrochlorothiazide Rivopharm in children and adolescents (younger than 18 years) is not recommended.
Other medicines and Valsartan/Hydrochlorothiazide Rivopharm
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 Rivopharm 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 drug 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 lower the amount of potassium in the blood ( hypokalemia ), e.g. diuretics (water tablets), corticosteroids (eg prednisone), some laxatives (eg castor oil), ACTH (a hormone ), carbenoxolone (used to treat mouth ulcers), amphotericin (an antifungal medicine), penicillin G (an antibiotic ), salicylic acid and closely related substances.
- 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 Rivopharm
- 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 medicines including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartan/Hydrochlorothiazide Rivopharm” and “Warnings and precautions”
- medicines to increase blood pressure et, e.g. norepinephrine or adrenaline
- digoxin or other digitalis glycosides (medicines used to treat heart problems)
- medicines that can 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 ) e.g. atropine or bike ride
- amantadine (an agent used to prevent influenza and to treat Parkinson’s disease )
- cholestyramine and colestipol (medicines used for high levels of blood fats)
- 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).
Valsartan/Hydrochlorothiazide Rivopharm with food and alcohol
You can take Valsartan/Hydrochlorothiazide Rivopharm 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 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.
- Tell your doctor if you think you are pregnant or become pregnant during treatment. Your doctor will usually suggest that you stop taking Valsartan/Hydrochlorothiazide Rivopharm before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Valsartan/Hydrochlorothiazide Rivopharm is not recommended in early pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects.
- Tell your doctor if you are breastfeeding or intend to start breastfeeding.Valsartan/Hydrochlorothiazide Rivopharm is not recommended for mothers who are 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, use tools or machines, or perform activities that require concentration, make sure you know how Valsartan/Hydrochlorothiazide Rivopharm affects you. Like many other medicines for the treatment of high blood pressure, Valsartan/Hydrochlorothiazide Rivopharm 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. Description of these effects and side effects are 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 Rivopharm contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Valsartan/Hydrochlorothiazide Rivopharm contains soybean oil
Valsartan/Hydrochlorothiazide Rivopharm contains soybean oil. If you are allergic to peanuts or soya, you should not take this medicine.
Valsartan/Hydrochlorothiazide Rivopharm contains sodium
Valsartan/Hydrochlorothiazide Rivopharm contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. almost “sodium-free”.
Valsartan/Hydrochlorothiazide Rivopharm contains paraorange (E110)
This can cause allergic reactions.
How to use Valsartan/Hydrochlorothiazide Rivopharm
Always take Valsartan/Hydrochlorothiazide Rivopharm as directed by your doctor. 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 Rivopharm tablets to take. Depending on the treatment result, the doctor can raise or lower the dose.
- The recommended dose of Valsartan/Hydrochlorothiazide Rivopharm is one tablet per day.
- Do not change the dose or stop the treatment without consulting the doctor first.
- The medicine should be taken at the same time every day, normally in the morning.
- You can take Valsartan/Hydrochlorothiazide Rivopharm with or without food.
- Swallow Valsartan/Hydrochlorothiazide Rivopharm with a glass of water.
If you have taken too much Valsartan/Hydrochlorothiazide Rivopharm
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 Rivopharm
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 Valsartan/Hydrochlorothiazide Rivopharm
If you stop your treatment with Valsartan/Hydrochlorothiazide Rivopharm, 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, pharmacist, or nurse.
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.
If you get any of these symptoms, stop taking Valsartan/Hydrochlorothiazide Rivopharm and contact your doctor immediately (see section 2)
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, and dry skin)
- pain in the muscles
- fatigue
- tingling and numbness
- blurred vision
- noises (such as buzzing 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 level of sodium in the blood (which can trigger nausea, tiredness, confusion, feeling unwell, and cramps)
- 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 other products containing only 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) :
- 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
- dullness, fainting when standing up
- impotence
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, stomach, and intestinal discomfort, liver disorders (yellow skin or 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 )
- severe skin disease causing skin rash, redness, blisters on the lips, eyes, or mouth, peeling, fever ( toxic epidermal necrolysis )
- rash on the face associated with pain in the joints, muscle disease, fever ( cutaneous lupus erythematosus)
- severe pain in the upper part of the stomach ( pancreatitis ); lack of or low values of various blood cells
- difficulty breathing
- with fever, cough, wheezing, lung infection, and shortness of breath (shortness of breath including pneumonitis and pulmonary edema)
- fever, sore throat, more frequent infections ( agranulocytosis )
- 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 )
- reduced vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and the sclera) or acute narrow-angle glaucoma )
- skin rash, redness, blisters on the lips, eyes, or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
- skin and lip cancer (non-melanoma skin cancer)
- muscle cramp
- fever ( pyrexia )
- weakness ( asthenia )
How to store Valsartan/Hydrochlorothiazide Rivopharm
Store out of sight and reach of children.
Blister packs:
Store at a maximum of 30ºC.
Cans:
No special storage instructions. After the first opening: use within 100 days.
Use before the expiry date which is stated on the carton, blister, and cans after EXP or EXP. The expiration date is the last day of the specified month.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with 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 substance is valsartan and hydrochlorothiazide.
One film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide
One film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide
One film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide
Other ingredients are:
tablet core :
– microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K29/32, talc, magnesium stearate, colloidal anhydrous silica
Film coating :
80/12.5 mg tablets: poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol 3350, lecithin (contains soybean oil) (E322), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
160/12.5 mg tablets: poly(vinyl alcohol), talc, macrogol 3350, titanium dioxide (E171), red iron oxide (E172), para-orange (E110), lecithin (contains soybean oil) (E322).
160/25 mg tablets: poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol 3350, yellow iron oxide (E172), lecithin (contains soybean oil) (E322), red iron oxide (E172), black iron oxide (E172).
Appearance and package sizes of the medicine
Valsartan/Hydrochlorothiazide Rivopharm 80 mg/12.5: Pink, oval, biconvex film-coated tablets, diameter 11×5.8 mm, marked “V” on one side and “H” on the other side.
Valsartan/Hydrochlorothiazide Rivopharm 160 mg/12.5 mg: Red, oval, biconvex film-coated tablets, diameter 15 x 6 mm, marked “V” on one side and “H” on the other side.
Valsartan/Hydrochlorothiazide Rivopharm 160 mg/25 mg: Orange, oval, biconvex film-coated tablets, diameter 15 x 6 mm, marked “V” on one side and “H” on the other side.
Package sizes:
Blisters:
7, 14, 28, 30, 56, 98 and 280 tablets.
Cans:
7, 14, 28, 30, 56, 98, 100 and 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer:
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN3000
Malta
Balkanpharma Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Agent:
SanoSwiss UAB
Lviv 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com