80 mg / 12.5 mg, 160 mg / 12.5 mg, 160 mg / 25 mg, 320 mg / 12.5 mg, 320 mg / 25 mg film-coated tablets 
Valsartan / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Diovan Comp is and what it is used for 
2. What you need to know before you take Diovan Comp 
3. How to take Diovan Comp 
4. Possible side effects 
5. How to store Diovan Comp 
6. Contents of the packaging and other information 

1. What Diovan Comp is and what it is used for

Diovan Comp film-coated tablets contain two active substances, valsartan and hydrochlorothiazide. Both substances help control high blood pressure.

  • Valsartan belongs to a group of medicines called ‘angiotensin II receptor blockers and is used to lower high blood pressure. Angiotensin II is a substance found in the body that constricts blood vessels, which increases blood pressure  Valsartan works by inhibiting the effects of angiotensin II. This causes the blood vessels to dilate and the blood pressure to drop.
  • Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also called diuretics). Hydrochlorothiazide increases urine production, which also lowers blood pressure 

Diovan Comp is used to treat high blood pressure that can not be lowered enough with just one of the substances.

High blood pressure increases the load on the heart and blood vessels. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and lead to stroke ( stroke ), heart failure, or kidney failure. High blood pressure increases the risk of a heart attack. Lowering blood pressure to a normal level reduces the risk of these diseases.

2. What you need to know before taking Diovan Comp

Do not take Diovan Comp

  • if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide ), or to any of the other ingredients of this medicine (listed in section 6).
  • Pregnant women should not use Diovan Comp during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Diovan 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 the buildup of bile in the liver (cholestasis).
  • if you have severe kidney disease.
  • if you can not produce urine ( anuria ).
  • if you are treated with an artificial kidney.
  • if your blood potassium or sodium level is lower than normal or if your blood calcium level is higher than normal despite treatment.
  • if you have gout.
  • if you have diabetes or kidney problems and you are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, talk to your doctor and do not take Diovan Comp.

Warnings and cautions

Talk to your doctor

  • if you are taking potassium-sparing medicines, potassium supplements, salt substitutes that contain potassium, or other medicines that increase the amount of potassium in the blood, such as heparin. Your doctor may need to check the amount of potassium in your blood regularly.
  • if you have low potassium in your blood.
  • if you have diarrhea or severe vomiting.
  • if you take high dose s of water 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 et alaldosterone. If this applies to you, Diovan 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 you are taking Diovan Comp, stop taking Diovan Comp 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, or high triglyceride levels in your blood.
  • if you have had an allergic reaction when using other antihypertensive agents belonging to this group of medicines ( angiotensin II receptor blockers) or if you have allergies or asthma.
  • if you experience visual impairment or eye pain. These may be symptoms of fluid retention in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks of taking Diovan 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.
  • 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.
    • aliskiren
  • if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with 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 Diovan Comp.

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 Diovan Comp”.

Diovan Comp can increase the skin’s sensitivity to the sun.

The use of Diovan Comp in children and adolescents (under 18 years of age) is not recommended.

Contact your doctor if you think you may be pregnant or become pregnant during treatment. Diovan 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 Diovan Comp

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines, or might take any other medicines.

The treatment effect may be affected if Diovan Comp is taken with certain other medicines. It may be necessary to change the dose, take other precautions, or in some cases discontinue treatment with one of the drugs. This is especially true for the following medicines:

  • lithium, a drug used to treat certain types of mental illness
  • drugs or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing drugs, and heparin
  • drugs that can reduce the amount of potassium in the blood, e.g. diuretics (liquid tablets), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
  • certain antibiotics (rifamycin), a drug used to protect against transplant rejection (cyclosporine), or antiretroviral drugs against HIV – / AIDS infection (ritonavir). These medicines may increase the effect of Diovan Comp
  • drugs that can cause “torsades de pointes” (irregular heartbeat), e.g. antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics
  • drugs that can reduce the amount of sodium in the blood, e.g. antidepressants, antipsychotics, antiepileptics
  • drugs for gout, e.g. allopurinol, probenecid, sulfinpyrazone
  • therapeutic vitamin Ds and calcium supplements
  • diabetes drugs (oral drugs, such as metformin or insulin )
  • other blood pressure-lowering medicines including methyldopa, ACE inhibitors(such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Diovan Comp” and “Warnings and precautions”).
  • drugs to increase blood pressure, e.g. noradrenaline or adrenaline
  • digoxin or other digitalis glycosides (medicines used to treat heart problems)
  • drugs that increase blood sugar, e.g. diazoxide or beta-blockers
  • cytotoxic drugs (used to treat cancer), e.g. methotrexate or cyclophosphamide
  • analgesics such as non-steroidal anti-inflammatory drugs ( NSAIDs ), including selective cyclooxygenase 2 inhibitors (COX 2 inhibitors) and acetylsalicylic acid more than 3 grams
  • muscle relaxants, e.g. tubokurarin
  • anticholinergic drugs (agents for the treatment of a variety of disorders, such as gastrointestinal cramps, bladder spasm, 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 commonly used for high levels of lipids(fats) in the blood)
  • cyclosporine, a drug used in organ transplantation to prevent rejection
  • alcohol, sleeping pills, and anesthetics (drugs with anesthetic or analgesic effect used, for example, in surgery)
  • iodine contrast agents (agents used in imaging studies).

Diovan Comp with food, drink, and alcohol

Avoid drinking alcohol until you have talked to your doctor. Alcohol can lower blood pressure further and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If you think you may be pregnant or become pregnant during treatment, consult your doctor.

Your doctor will usually suggest that you stop taking Diovan Comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Diovan 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 planning to start breast-feeding.

Diovan Comp is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.

Driving and using machines

Before driving, using tools or machines, or performing activities that require concentration, make sure you know how Diovan Comp affects you. Like many other medicines for high blood pressure, Diovan Comp can in rare cases cause dizziness and affect your 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Diovan Comp

Always take this medicine exactly as your doctor has told you. It will give 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 feel any symptoms of this. Many feel as usual. It is therefore important that you go to your doctor’s visits as planned even if you feel good.

Your doctor will tell you how many Diovan Comp tablets to take. Depending on the treatment outcome, your doctor may increase or decrease the dose.

  • The recommended dose of Diovan Comp is one tablet per day.
  • Do not change the dose of one or stop treatment without consulting your doctor.
  • The drug should be taken at the same time each day, usually in the morning.
  • You can take Diovan Comp regardless of the meal.
  • Swallow Diovan Comp with a glass of water.

If you take more Diovan Comp then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you experience severe dizziness and/or fainting, lie down and contact a doctor immediately.

If you forget to take Diovan Comp

If you forget to take a dose, take it as soon as you remember. If it is soon time for your next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Diovan Comp

If you stop taking Diovan 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 on the use of this product, ask your doctor or pharmacist.

4. 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
  • A severe skin condition that causes rash, redness, blisters on the lips, eyes, or mouth, skin rash, fever ( toxic epidermal necrolysis )
  • Visual impairment or pain in your eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma )
  • Fever, sore throat, more frequent infection is ( agranulocytosis )

These side effects are very rare or with no known frequency (frequency can not be calculated from the available data).

If you get any of these symptoms, stop taking Diovan Comp and contact your doctor immediately (see section 2 “Warnings and precautions”).

The side effects are:

Uncommon (may affect up to 1 in 100 people):

  • cough
  • low blood pressure
  • dizzy
  • dehydration (with symptoms such as thirst, dryness in the mouth and tongue, rarely having to empty the bladder, dark-colored urine, dry skin)
  • pain in the muscles
  • fatigue
  • tingling and numbness
  • dimsyn
  • roaring and buzzing in the ears

Very rare (may affect up to 1 in 10,000 people):

  • dizziness
  • diarrhea
  • joint pain

Has been reported (occurs in an unknown number of users):

  • difficulty breathing
  • significantly reduced urine output
  • low sodium levels in the blood (which can trigger fatigue, confusion, muscle twitching, and/or cramps in severe cases)
  • low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, abnormal heart rhythm)
  • the low value of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat, or cold sores due to infection, weakness)
  • elevated bilirubin levels in the blood (which in severe cases can cause yellow skin and yellow eyes)
  • elevated levels of urea nitrogen and creatinine in the blood (which may indicate impaired renal function)
  • elevated uric acid levels in the blood (which in severe cases can trigger gout )
  • syncope (fainting)

The following side effects have been reported with products containing valsartan or hydrochlorothiazide:

Valsartan

Uncommon (may affect up to 1 in 100 people):

  • feeling of spinning
  • abdominal pain

Has been reported (occurs in an unknown number of users):

  • blistering of the skin (signs of dermatitis, 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, reddish-purple-red spots, fever, itching (symptoms of inflammation of the blood vessels)
  • low platelet count (sometimes with unusual bleeding or bruising)
  • high potassium levels 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 mainly in the face and throat, rash, itching
  • elevated liver function values
  • decreased hemoglobin value and decreased percentage of red blood cells in the blood (both can in severe cases lead to anemia ( anemia ))
  • kidney failure
  • low levels of sodium in the blood (which can trigger fatigue, confusion, muscle twitching, and/or cramps in severe cases)

Hydrochlorothiazide

Very common (may affect more than 1 user in 10):

  • low level of potassium in the blood
  • elevated lipid levels in the blood

Common (may affect up to 1 in 10 people):

  • low level of sodium in the blood
  • low level of magnesium in the blood
  • high level of uric acid in the blood
  • itchy rash and other types of rash
  • decreased appetite
  • mild nausea and vomiting
  • dizziness, fainting when you get up
  • inability to get or maintain an erection

Rare (may affect up to 1 in 1,000 people):

  • swelling and blisters on the skin (due to increased sensitivity to the sun)
  • high level of calcium in the blood
  • high blood sugar level
  • sugar in the urine
  • worsening of metabolic diabetes
  • constipation, diarrhea, stomach,h and intestinal discomfort, liver disorders that can occur with yellow skin and yellow eyes
  • irregular heartbeats
  • headache
  • sleep disorders
  • 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 people):

  • inflammation of the blood vessels with symptoms such as rash, reddish-purple-red spots, fever ( vasculitis )
  • rash, itching, hives, difficulty breathing or swallowing, dizziness ( hypersensitivity reactions )
  • rash on the face, joint pain, muscle disease, fever ( cutaneous lupus erythematosus)
  • severe pain in the upper abdomen ( pancreatitis )
  • difficulty breathing with fever, cough, wheezing, shortness of breath (shortness of breath including pneumonitis and pulmonary edema )
  • pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia )
  • fever, sore throat or sore mouth due to infection is ( leukopenia )
  • confusion, fatigue, muscle twitching and spasms, rapid breathing (hypochloremic alkalosis )

Has been reported (occurs in an unknown number of users):

  • weakness, bruising and frequent infections ( aplastic anemia )
  • sharply reduced urine production (possible signs of kidney disease or kidney failure )
  • skin rash, redness, blisters on the lips, eyes, or mouth, flaking of the skin, fever (possible signs of erythema multiforme)
  • muscle cramps
  • fever ( pyrexia )
  • weakness ( asthenia )
  • skin and lip cancer (non-melanoma skin cancer)

5. How to store Diovan Comp

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. respectively “EXP”. The expiration date is the last day of the specified month.
  • Do not store above 30 ° C. Store in the original package. Moisture sensitive.
  • Do not use this medicine if you notice that the package is damaged or shows signs of having opened earlier.
  • The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is valsartan and hydrochlorothiazide . Each tablet contains 80 mg, 160 mg and 320 mg valsartan and 12.5 mg and 25 mg hydrochlorothiazide,respectively .
  • The core of the tablet contains microcrystalline cellulose, colloidal, anhydrous silica, crospovidone, magnesium stearate.
  • The film cover of the tablet contains hypromellose, macrogol 8000 (80 mg / 12.5 mg and 160 mg / 12.5 mg only), macrogol 4000 (160 mg / 25 mg, 320 mg / 12.5 mg and 320 mg / 25 mg only) , talc, red iron oxide (E 172, not 320 mg / 25 mg), yellow iron oxide (E 172, 80 mg / 12.5 mg only, 160 mg / 25 mg and 320 mg / 25 mg), black iron oxide (E 172 , only 160 mg / 25 mg and 320 mg / 12.5 mg), titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Diovan Comp 80 mg / 12.5 mg film-coated tablets are bright orange, oval tablets, marked with “HGH” on one side and “CG” on the other side.

Diovan Comp 160 mg / 12.5 mg film-coated tablets are dark red, oval tablets, marked with “HHH” on one side and “CG” on the other side.

Diovan Comp 160 mg / 25 mg film-coated tablets are brown, oval tablets, marked with “HXH” on one side and “NVR” on the other side.

Diovan Comp 320 mg / 12.5 mg film-coated tablets are pink, oval tablets with beveled edges, marked with “NVR” on one side and “HIL” on the other side.

Diovan Comp 320 mg / 25 mg film-coated tablets are yellow, oval tablets with beveled edges, marked with “NVR” on one side and “CTI” on the other side.

The tablets are supplied in blister packs of 7 pcs (Diovan Comp 320 mg / 12.5 mg and 320 mg / 25 mg only), 14 pcs, 28 pcs as a calendar pack , 30 pcs (Diovan Comp 80 mg / 12.5 mg only), 56 pcs, 98 pcs as calendar packaging or 280 pcs tablets.

Perforated unit dose blister pack of 56×1, 98×1, or 280×1 tablets is also available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Novartis Sverige AB,

Box 1218

164 28 Kista

Phone: 08-732 32 00

Muhammad Nadeem

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