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Areta ACE 20 mg. / 10 mg. 30 tablets

Brand: STADA
Product Code: Areta ACE 20 mg. / 10 mg. 30 tablets
Availability: In Stock
Product viewed: 1209

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What is Areta ACE and what it is used for

Arjeta ACE is a fixed combination of an ACE - inhibitor (enalaprilic maleate) and a calcium antagonist (lerkanidipinov hydrochloride), two drugs that lower blood pressure.

Areta ACE 10 mg / 10 mg film-coated tablets
Areta ACE is used to treat high blood pressure (hypertension) in patients whose blood pressure can not be optimally controlled by taking lercanidipine 10 mg as monotherapy.

Areta ACE 20 mg / 10 mg film-coated tablets
Areta ACE is used to treat high blood pressure (hypertension) in patients whose blood pressure can not be optimally controlled by taking enalapril 20 mg as a monotherapy.

Areta ACE should not be used for the initial treatment of hypertension.

2. What you need to know before you take Areta ACE

Do not take Areta ACE

if you are allergic to enalapril or lercanidipine or any of the other ingredients of this medicine (listed in section 6);
if you have ever had an allergic reaction to medication, like those in Aretha ACE (amlodipine, felodipine, nifedipine, captopril, fosinoprkl, lisinopril, ramipril);
if you are pregnant after 3 months (additionally, you should avoid AREA ACE, pregnancy - see "Pregnancy");
if you suffer from some heart disease:
untreated heart failure;
obstruction of blood flow from the left ventricle of the heart, including narrowing of the aorta (stenosis of the aorta);
unstable angina (chest discomfort occurring during rest or worsening or emerging more often);
within one month after myocardial infarction.
if you have severe liver or kidney problems or if you are undergoing dialysis.
if you are taking medicines such as:
antifungal agents (e.g., ketoconazole, itraconazole);
macrolide antibiotics (eg erythromycin, trolandomycin);
antiviral agents (eg ritonavir).
if you are taking another medicine called ciclosporin (used after transplantation)
prevention of rejection of organs);
with grapefruit or grapefruit juice;
if you have had angioedema (swelling of the face, lips, mouth, tongue and / or throat, arms, legs), which caused difficulty in swallowing or breathing after taking a drug called an ACE inhibitor;
if you have a hereditary susceptibility to the formation of edema (inflammation) of the tissues, or you get inflammation with an unclear cause (hereditary or idiopathic angioedema);
if you have diabetes or kidney problems and you are taking a medicine containing aliskiren to lower your blood pressure.
If you think any of the above applies to you or are unsure, do not take this medicine. First talk to your doctor and follow his advice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Areta ACE.

if you have recently felt bad (vomiting) or have had diarrhea or are dehydrated;
if you have problems with your heart, including a disturbed blood flow (ischaemia);
if you have heart problems;
if you have a disturbed blood flow to the brain (cerebrovascular disease);
if you have kidney problems;
if hepatic enzymes are elevated or if you suffer from jaundice;
If you have a problem with the blood, such as low or lack of white blood cells (leukopenia, agranulocytosis), which may make you - prone to infection and severe general symptoms;
if you have connective tissue disease affecting both blood vessels - collagen vascular disease;
if you are taking allopurinol (a medicine to treat gout), procainimide (a medicine used to treat irregular rhythm) or lithium (a medicine used to treat certain types of depression);
If a hypersensitivity reaction with swelling of the face, lips, throat (angioedema), difficulty swallowing or breathing during treatment or otherwise;
if you have diabetes;
if you develop persistent dry cough;
if there is a risk of elevated potassium in the blood;
if your blood pressure does not decrease adequately during treatment for ethnic reasons (in black patients);
if you think you are (or may be) pregnant. Areta ACE is not recommended in early pregnancy and should not be taken if you are pregnant after 3 months as it may harm your baby (see section on pregnancy);
if you are taking a medicine of the following classes used to treat high blood pressure:
angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan and especially if you have diabetes-related kidney problems;
Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood.

See also the information titled "Do not take Areta ACE"

If you are not sure if any of these apply to you, please consult your doctor or pharmacist before taking Areta ACE.
Other medicines and Areta ACE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

When Areta ACE is taken with some other medicines, the effect of Areta ACE or the other medicine may change or some side effects may occur more often.

- ciclosporin, tacrolimus (medicines to suppress the immune system);
- oral antifungal medicines such as ketoconazole and itraconazole;
- antiviral agents such as ritonavir;
- macrolide antibiotics such as erythromycin and trolandomycin;
- a remedy for ulcers and heartburn, called cimetidine, at daily doses above 800 mg;
- diuretics - hydrochlorothiazide, chlorthalidone, furosemide, triamterene, amiloride, indapamide, spironolactone or other blood pressure lowering drugs;
- some vasodilating medicines - glycerin trinitrate and organic nitrates (isosorbide) or anesthetic medicines;
- some antidepressants or antipsychotic medicines;
- baclofen;
- some painkillers (eg paracetamol, ibuprofen, naproxen, indomethacin or aspirin, unless the latter is used in low doses);
- medicines that affect blood vessels (for example, noradrenaline, isoprenaline, dopamine, salbutamol);
- anticonvulsants such as phenytoin and carbamazepine;
- rifampicin, a medicine used in tuberculosis;
- heparin - a medicine for blood thinning;
- trimethoprim (a medicine to treat infections);
- corticosteroids - medicines that reduce inflammation and can be used in certain skin conditions and tetrazocide - used primarily for the diagnosis and treatment of adrenal cortex disorders.

If you are taking digoxin (a medicine that regulates heart rhythm disturbances), ask your doctor for any side effects that you should monitor with extreme caution.

Blood potassium levels may increase if you are taking potassium-sparing diuretics (eg spironolactone) or potassium supplements.

Concurrent administration of Areta ACE and lithium carbonate may lead to an increase in serum lithium and toxicity.

If you are taking medicines called immunosuppressants or medicines to treat gout, in very rare cases it may make you more prone to severe infections.

If you are diabetic, keep in mind that concomitant use of Areta ACE with insulin or with oral antidiabetic agents such as sulphonylureas or biguanides may lead to hypoglycaemia (a sharp fall in blood sugar) during the first month of treatment.

Please tell your doctor if you are taking concomitant antihistamines such as terfenadine or astemizole, medicines used to treat heart rhythm such as amiodarone and quinidine, and if you are taking estramustine, amifostine or gold-containing medicines as drug interactions are possible between them and Aretha ACE .

Your doctor may need to change your dose and / or take other precautions
- If you are taking angiotensin II receptor blocker (ARB) or aliskiren (see also the information titled "Do not take Areta ACE" and "Warnings and Precautions").

Areta ACE with food, beverages and alcohol
Areta ACE should be taken at least 15 minutes before a meal.
Alcohol may increase the effect of Aretta ACE and lead to the occurrence of side effects. Therefore, it is recommended not to consume alcohol or strictly limit alcohol intake.
Areta ACE should not be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

You should tell your doctor if you think you are pregnant (or plan to become pregnant). Your doctor will usually advise you to stop taking Aceta ACE before you become pregnant or as soon as you know you are pregnant and take another medicine instead of Aretha ACE.

Areta ACE is not recommended during pregnancy and should not be taken if the pregnancy is after the 3rd month, as this may cause serious harm to your baby after the third month of pregnancy.

Tell your doctor if you are breast-feeding or intend to breast-feed. Breastfeeding of newborn babies (the first few weeks after birth) and especially premature babies is not recommended while taking Areta ACE. Your doctor should advise on the benefits and risks of taking Areta ACE while nursing compared to others therapies.

Driving and using machines
If you develop dizziness, weakness, fatigue or drowsiness during treatment with this medicine, you should not drive or operate machinery.

Areta ACE contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Areta ACE

Always take this medicine exactly
In addition, excessive blood pressure lowering may lead to reduced blood flow to important organs and cause cardiovascular or renal failure.
If you forget to take Areta ACE

If you forget to take a tablet, take it as soon as you remember, unless it is time to take the next dose. Then continue with the usual reception. Do not take a double dose to make up for the missed dose.
If you stop taking Areta ACE

If you stop taking Areta ACE, your blood pressure may rise again. Talk to your doctor before stopping Aresta ACE.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Areta ACE 10 mg / 10 mg film-coated tablets
The most commonly observed side effects (with a frequency of 1 to 10%) in Areta ACE 10 mg / 10 mg film-coated tablets are cough, dizziness and drowsiness. All adverse reactions observed with Areta ACE 10 mg / 10 mg and lercanidipine and enalapril administered alone are listed below.

Areta ACE 20 mg / 10 mg film-coated tablets
The most commonly observed side effects (with a frequency of 1 to 10%) in Areta ACE 20 mg / 10 mg film-coated tablets are cough, headache, dizziness, peripheral edema and rash. All adverse reactions observed with Areta 20 mg / 10 mg and with lercanidipine and enalapril administered alone are listed below.

If you experience any of the following side effects, stop taking this medicine immediately and contact your doctor:
- severe lowering of blood pressure, including lowering of blood pressure when standing up;
- short-term memory loss (seizure);
- a heart attack or stroke
- chest pain
- swelling of the face, lips, tongue or throat
- fever, chills, fatigue, loss of appetite, stomach pain, fainting, yellowing of the skin or eyes (jaundice). This may be a sign of liver problems such as hepatitis (inflammation of the liver) or hepatic impairment.

Other Adverse Reactions
The other side effects listed below are mostly mild and their onset does not require you to stop your treatment.

Very common (affects more than 1 user in 10)
Blurred vision, cough, fatigue.

Common (affects 1 to 10 people)
Headache, depression, chest tightness, palpitations, shortness of breath, abdominal discomfort, reddening of the face, redness and feeling of warming of the skin, skin rashes, swelling of the hands, sudden flushing of the face, blood potassium, levels of creatinine in the blood.

Uncommon (affects 1 to 100 people)
Anemia, very low blood sugar levels, confusion, insomnia, nervousness, abnormal feeling (tingling in the skin), swelling of the ankles, runny nose, circulatory collapse (severe decrease in blood pressure which may lead to loss of consciousness) , hoarseness, wheezing, asthma, abdominal pain, nausea, slow movement of food through the gut, inflammation of the pancreas, vomiting, indigestion, constipation, loss of appetite, irritable stomach, dry mouth, ulcer, inflammation of the tongue, a feeling of heat on the skin increased sweating, itching, hives, joint pain, increased number of urine at night, hair loss, kidney problems, impotence, fatigue, low blood platelet counts (hypertriglyceridemia), muscle spasms, ears, malaise, fever, facial flushing, elevated levels of urea in the blood, decreased levels of sodium in the blood.

Rare (may affect up to 1 in 1,000 people)
Reducing the number of certain types of blood cells, lowering the values ​​of some laboratory tests (hemoglobin and hematocrit), bone marrow suppression, swollen lymph nodes, autoimmune diseases, strange dreams or sleep problems, drowsiness, very cold hands and feet, pulmonary infiltrates, inflammation of the lungs, diarrhea, inflammation and ulceration of the lining of the oral cavity, severe skin reactions, muscle pain, decreased urine output, increased urine output, cation of the mammary glands in males, higher levels of laboratory values ​​(measured by a blood test - liver enzymes serum bilirubin).

Very rare (affects 1 to 10,000 people)
Disease of the gums, swelling of the gut

There have been reports of a complex of symptoms that may include some or all of the following side effects: fever, inflammation of the mucous membranes, inflammation of the blood vessels, pain in the muscles and joints / inflammation of the muscles or joints, and changes in laboratory tests. Rash, photosensitivity and other skin manifestations may occur.
How to Store Areta ACE
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store below 250 ° C.

Store in the original package for protection from light and moisture.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What contains Areta ASB
Each film-coated tablet contains: 10 mg enalapril maleate and 10 mg lercanidipine hydrochloride.

Each film-coated tablet contains: 20 mg of enalapril maleate and 10 mg of lercanidipine hydrochloride

The excipients are:
Core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, sodium hydrogen carbonate.

Film coverage:
Areta ACE 10 mg / 10 mg film-coated tablets
Opadry II white 85F18422, composed of: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b)

Areta ACE 20 mg / 10 mg film-coated tablets
Opadry II yellow 85F32645, composed of: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide (E172).

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