EKSFORDZH HCT table . 10 mg. 160 mg. 25 mg

EKSFORDZH HCT table . 10 mg.  160 mg.  25 mg
€ 39.00
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Exforge HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All three of these substances help to control high blood pressure.
  Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine stops calcium from moving into the blood vessel wall, which prevents the contraction of blood vessels.



 EKSFORDZH HCT  table . 10 mg. / 160 mg. / 25 mg
 

EXFORGE HCT WHAT IS AND WHAT IT IS USED

Exforge HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All three of these substances help to control high blood pressure.
Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine stops calcium from moving into the blood vessel wall, which prevents the contraction of blood vessels.
Valsartan belongs to a group of substances known as angiotensin-II receptor blockers. Angiotensin II is produced by the body and causes constriction of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
 Hydrochlorothiazide belongs to a group of substances called "thiazide diuretics". Hydrochlorothiazide increases urine output, which also lowers blood pressure.
As a result of the action of three mechanisms, the blood vessels relax and blood pressure is lowered.
Exforge HCT is used to treat high blood pressure in adult patients already taking amlodipine, valsartan and hydrochlorothiazide and who would be beneficial to take one tablet containing all three substances.

 BEFORE YOU TAKE EXFORGE HCT

Do not take Exforge HCT
 If you are pregnant after 3 months. (Better to avoid use of Exforge HCT in early pregnancy - see section "Pregnancy").
 If you are allergic (hypersensitive) to amlodipine, valsartan, hydrochlorothiazide, sulfonamide derivatives (medicines used to treat chest or urinary infections) or any of the other ingredients of Exforge HCT (see section 6, "What Exforge HCT" ).
If you think you may be allergic, do not take Exforge HCT and talk to your doctor.
If you have liver disease, destruction of small bile ducts in the liver (biliary cirrhosis), resulting in accumulation of bile in the liver (cholestasis).
  If you have severe kidney problems or if you are on dialysis.
 If you can not separate urine (anuria).
 If you have very low levels of potassium or sodium in the blood despite treatment.
 If you have very high levels of calcium in the blood despite treatment.
 If you have gout (uric acid crystals in the joints).
If any of the above apply to you, do not take Exforge HCT and talk to your doctor.
Take special care with Exforge HCT
 If you have low levels of potassium or magnesium in the blood (with or without symptoms such as muscle weakness, muscle spasms, irregular heartbeat);
 If you have low sodium levels in the blood (with or without symptoms such as fatigue, confusion, muscle twitching, convulsions);
  If you have high levels of calcium in the blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and fibrillation);
 If you are taking medicines or substances that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
 
You may need potassium levels in your blood to be regularly checked;
 If you have kidney problems, have undergone a kidney transplant or are you saying that you have a narrowing of the renal arteries;
 If you have liver problems;
If you have or have had heart failure or coronary artery disease, especially if you are taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg);
 If your doctor has told you that you have a narrowing of the valves of the heart (called "aortic or mitral stenosis") or that the thickness of the heart muscle is abnormally increased (called "obstructive hypertrophic cardiomyopathy");
  If you hyperaldosteronism. This is a condition in which the adrenal glands produce too much of the hormone aldosterone. If this applies to you, do not recommend the use of Exforge HCT;
 If you have a disease called systemic lupus erythematosus (also called "Chavka" or "SLE");
 If you have diabetes (high blood sugar);
 If you have high cholesterol or triglycerides in the blood;
 If you have skin reactions such as rash after sun exposure;
 If you have had allergic reactions to other medications to treat high blood pressure or diuretics (a type of medicine known as "water pills"), especially if you have asthma or allergies;
 If you are sick (vomiting or diarrhea);
 If you have dizziness and / or you faint during treatment with Exforge HCT, tell your doctor immediately;
 If you have loss of vision or eye pain. These may be symptoms of raised pressure in the eye, and can occur within hours to weeks after starting taking Exforge HCT. This can lead to permanent visual impairment if not treated.
If any of the above applies to you, consult your doctor.
You should tell your doctor if you are (or think you might become) pregnant. Exforge HCT is not recommended in early pregnancy, and must not be taken if you are pregnant after 3 months, as it may cause serious harm to your baby if used at that stage (see section "Pregnancy and lactation" ).
Not recommended the use of Exforge HCT in children and adolescents under 18 years.
Exforge HCT and the elderly (aged 65 years and over)
Exforge HCT may be used in patients aged 65 years and over in the same dose as for other adults in the same way as received until three substances called amlodipine, valsartan and hydrochlorothiazide. Elderly patients, particularly those taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg), should monitor their blood pressure regularly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may need your doctor to change your dose or take other precautions. In some cases you may need to stop taking one of the medications. This is especially important if you are taking any of the medicines listed below:
Do not take together with:
 lithium (a medicine used to treat some types of depression);
 drugs and substances that increase the level of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Take caution with:
 alcohol, sleeping pills and anesthetics (medicines that allow patients to undergo surgery and other procedures);
 amantadine (a medicine to treat Parkinson's disease, and to treat and prevent certain diseases caused by viruses);
 anticholinergics (drugs used to treat a number of diseases such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and some of the drugs in anesthesia);
 anticonvulsants, mood stabilizers, drugs used to treat epilepsy and bipolar disorder (eg, carbamazepine, phenytoin, fosphenytoin, primidone);
 cholestyramine, colestipol, or other resins (substances used mainly to treat high levels of lipids in the blood);
 simvastatin (a drug used to control high cholesterol);
 ciclosporin (a medicine used in transplantation to prevent rejection of a transplanted organ or other conditions, eg. Rheumatoid arthritis or atopic dermatitis);
 cytotoxic drugs (used to treat cancer), such as methotrexate or cyclophosphamide;
 digoxin or other digitalis glycosides (medicines used to treat heart problems);
 verapamil, diltiazem (heart medicines);
 iodinated contrast agents (agents that are used in imaging studies);
  medicines for diabetes (oral agents such as metformin or insulin);
 medicines used to treat gout and allopurinol;
 Medicines that may increase blood sugar levels (beta blockers, diazoxide);
 drugs that may induce "torsades de pointes" (irregular heart rhythm), and antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
 drugs that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, anticonvulsants;
 drugs that can reduce the amount of potassium in the blood, such as diuretics (water pills), corticosteroids, laxatives, amphotericin or penicillin G;
 drugs
 high blood pressure, adrenaline and noradrenaline; • medicines used for HIV / AIDS (eg ritonavir, indinavir, nelfinavir);
 medicines used to treat fungal infections (eg ketoconazole, itraconazole);
 medicines to treat ulcers and inflammation of the esophagus (karbenolokson);
  medicines used to relieve pain and inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase 2 inhibitors (COX-2);
 muscle relaxants (drugs used to relax the muscles that are used during operations);
  nitroglycerin and other nitrates, or other substances called "vasodilators";
 other medicines to treat high blood pressure, including methyldopa;
 rifampicin (used for example for treating tuberculosis);
 St. John's wort;
 Dantrolene (infusion in severe abnormalities in body temperature);
 Vitamin D and calcium salts.
Consult with your doctor before you drink alcohol. Alcohol can lower your blood pressure, excessive and / or increase the ability to feel dizzy or faint you.
Taking Exforge HCT with food and drink
You can take Exforge HCT with or without food. People taking Exforge HCT, should not consume grapefruit or grapefruit juice. The reason for this is that grapefruit and grapefruit juice may result in increased plasma levels of the active substance amlodipine, which in turn can lead to unpredictable enhance the antihypertensive effect of Exforge HCT.
 
Pregnancy and lactation
Pregnancy
You should tell your doctor if you think you are pregnant or may become pregnant. In Your doctor will advise you to stop taking Exforge HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge HCT. Exforge HCT is not recommended in early pregnancy, and must not be taken if you are pregnant after 3 months, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Treatment with Exforge HCT is not recommended for mothers who are breastfeeding, your doctor may prescribe other treatments if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Ask your doctor or pharmacist before taking any medicine.
Driving and operating machinery
Like many other medicines used to treat high blood pressure, this drug may make you dizzy. If you experience this symptom, do not drive or operate machinery.

 HOW TO TAKE EXFORGE HCT

Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor. This will help you achieve the best results and lower the risk of side effects.
The usual dose of Exforge HCT is one tablet daily.
 It's best to take the tablets at the same time each day, preferably in the morning.
 Swallow the tablet whole with a glass of water.
 You can take Exforge HCT with or without food. Do not take Exforge HCT with grapefruit or grapefruit juice.
Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
If you take an overdose of Exforge HCT
If you accidentally take too many tablets of Exforge HCT, immediately contact your doctor. You may need medical attention.
If you forget to take Exforge HCT
If you forget to take a dose, take it as soon as you remember and then take your next dose at the regular time. If it is almost time for your next dose, just take your next tablet at the usual time. Do not take a double dose (two tablets at a time) to make up the missed dose.
If you stop taking Exforge HCT
Cessation of therapy with Exforge HCT may worsen your condition. Do not stop taking your medicine unless your doctor tells you to do so.
Always take the medicine even if you feel better
People who have high blood pressure often do not notice any signs of the problem. Many feel normal. It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appointments with your doctor even if you feel well.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

 POSSIBLE SIDE EFFECTS

Like all medicines, Exforge HCT can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10;
common: affects 1 to 10 users in 100;
uncommon: affects 1 to 10 users in 1000;
rare: affects 1 to 10 users in 10,000;
very rare: affects less than 1 user in 10,000;
Not known from the available data can not be estimated frequency.
Some side effects can be serious and need immediate medical attention:
Go immediately to your doctor if you have any of these symptoms:
Common
· Dizziness
· Low blood pressure (feeling of faintness, fainting, sudden loss of consciousness)
Uncommon
· Greatly reduced urine output (decreased renal function)
Rare
· Spontaneous bleeding
· An irregular heartbeat
· Liver disorder
Very rare
· An allergic reaction with symptoms such as rash, itching
· Angioedema: swelling of the face or lips or tongue, difficulty breathing
· Pinch / firming chest pain that increases or does not go away
· Weakness, bruising, fever and frequent infections
· Stiffness
Other possible side effects of Exforge HCT:
Common
· Stomach discomfort after eating
· Fatigue
· Swelling
· Low levels of potassium in the blood
· Headache
· Frequent urination
Uncommon
· Palpitations
· Vertigo
· Visual disturbances
· Upset stomach
· Pain in chest
ncrease in urea, creatinine and uric acid
· High levels of calcium, fat and sodium in the blood
· Low blood potassium levels
· Bad Breath
· Diarrhea
· Dry mouth
· Nausea
· Vomiting
· Abdominal pain
· Weight gain
· Loss of appetite
· Taste disturbances
· Back pain
· Swelling of the joints
· Muscle cramps / weakness / pain
· Pain in extremity
· Irregularities in standing or walking
· Weakness
· Coordination disorders
· Dizziness when standing or after exercise
· Lack of energy
· Sleep disorders
· Tingling or numbness
· Neuropathy
· Drowsiness
· Sudden, brief loss of consciousness
· Low blood pressure when standing
· Impotence
· Cough
· Shortness of breath
· Sore Throat
· Excessive sweating
· Itching
· Swelling, redness and pain along a vein
· Flushing
· Tremor
Not known
 Changes in blood tests to assess kidney function, increased potassium levels in the blood, reducing the number of red blood cells.
Adverse reactions that were reported in self-administration of amlodipine or valsartan or hydrochlorothiazide alone, but not observed in Exforge HCT or observed with a higher frequency:
Amlodipine
Common
· Palpitations
· Abdominal pain
· Nausea
· Drowsiness
· Hot flashes
Uncommon
· Tinnitus
· Changes in motility
· Pain
 Drop weight
 Joint pain
Tremor
 Changes in mood
 Interfere with urination
 Nighttime urination
 Breast enlargement in men
Fever
 Hair Loss
 Skin eruptions
 Purple spots on the skin
 Rash
 A change in skin color
Very rare
·Reduce the number of white blood cells and platelets
 An irregular heartbeat
Heart attack
 Inflammation of the gastric mucosa or pancreas; expansion of the gums, abnormal assessment of liver function
·Liver disorder which can occur together with yellow skin and eyes, or dark urine
 Allergic reactions including swelling of the skin in depth and difficulty breathing
  High levels of blood sugar
 Increased muscle stiffness
·Skin reactions with redness and peeling of the skin, blistering of the lips, eyes or mouth
Itchy rash
 Inflammation of blood vessels
Not known
 Numbness of limbs and trembling hands
 
Valsartan
Not known
 Abnormal results in the study of red blood cells
 Reduction in the number of certain types of white blood cells and platelets
 Increase potassium levels
 Increased blood creatinine
 Abnormal assessment of liver function
 Allergic reactions including swelling of the skin in depth and difficulty breathing
 Muscle pain
 Greatly reduce the amount of urine
 Itching
 Rash
 Inflammation of blood vessels
Hydrochlorothiazide
Very common
 Low levels of potassium in the blood
 Increased blood lipids
Common
 High levels of uric acid in the blood
 Low levels of magnesium in the blood
 Low levels of sodium in the blood
 Dizziness, fainting upon standing
 Decreased appetite
 Nausea and vomiting
 Itchy rash and other types of rash
 Inability to achieve or maintain an erection
Rare
 Low levels of platelets (sometimes with bleeding or bruising of the skin)
 Glucose in urine
 High levels of blood sugar
 Worsening of diabetes
 Low mood (depression)
 An irregular heartbeat
 Upset stomach
 Constipation
 Liver disorder which can occur together with yellow skin and eyes, or dark urine (hemolytic anemia)
 Increased sensitivity of skin to sun
Purple spots on the skin
 Renal disorders
Very rare
 Fever, sore throat or mouth sores, frequent infections (no or very low levels of white blood cells)
 Pale skin, fatigue, shortness of breath, urine (hemolytic anemia, abnormal breakdown of red blood cells in the blood vessels or elsewhere in the body)
  Confusion, fatigue, muscle twitching and cramping, tachypnea (hypochloremic alkalosis)
 Severe pain in the upper stomach (inflammation of the pancreas)
 Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity)
 Difficulty breathing fever, coughing, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
 Facial rash, joint pain, muscle disorders, fever (systemic lupus erythematosus)
 Inflammation of the blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
 Severe skin disease that causes a rash, redness, blistering of lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
Not known
 Weakness, bruising and severe infections (aplastic anemia)
 Reduction in vision or eye pain due to increased pressure (possible symptoms of acute angle closure glaucoma)
 Shortness of breath
 Greatly reduce the amount of urine (possible signs of renal dysfunction or renal failure)
 Severe skin disease that causes rash, skin redness, blistering getting mouth, skin peeling, fever (erythema multiforme)
 Muscle cramps
 Fever (pyrexia)
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE EXFORGE HCT

Keep out of reach of children.
Do not use Exforge HCT after the expiry date stated on the carton and blister after (EXP :/ EXP). The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Store in the original package to protect from moisture.
Do not use containers of Exforge HCT, which is damaged or signs of tampering.

 ADDITIONAL INFORMATION

What Exforge HCT
 The active substances of Exforge HCT are: amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
 Exforge HCT 10/160/25mg tablets: Each tablet contain 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide. The other ingredients are cellulose microcrystalline, crospovidone, silica colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171).
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