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Areta 20 mg. 30 tablets

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Areta What is and what it is used
Areta is a selective calcium channel blocker, which refers to a group of medicines called dihydropyridines. Selective calcium channel blockers lower blood pressure. They work by relaxing and widening blood vessels.

Aretha is used for:
Treatment of mild to moderate high blood pressure (essential hypertension).

2. What you need to know before taking Aretha
Do not take Areta:
if you are allergic to lerkanidipinov hydrochloride or any of the other ingredients of this medicine (listed in section 6);
If you have had allergic reactions to medicines like Aretha (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine);
if you are pregnant or nursing or may become pregnant (see section 2. Pregnancy and lactation);
if you have a proven heart disease:
uncontrolled heart failure;
abnormal blood flow from the heart;
unstable angina (chest pain at rest or progressively increasing pain);
If you had a heart attack before less than one month;
if you have severe liver or kidney disease;
if you are taking medicines / foods that may influence the effect or side effects of Areta, for example:
antifungals (eg, ketoconazole or itraconazole);
macrolide antibiotics (eg. erythromycin or troleandomycin);
Antiviral drugs (such as ritonavir, a medicine to treat AIDS);
cyclosporine (a drug that prevents transplant rejection);
grapefruit or grapefruit juice.
Warnings and Precautions
Please tell your doctor if you have or have had any of the following conditions or illnesses:
syndrome sick sinus (heart disease in which the heart beats very fast or very slowly), unless a pacemaker;
impaired function of the left ventricle (heart disease, wherein one of the chambers of the heart can not be filled or to push normal blood);
ischemic heart disease (in which blood flow to the heart is insufficient);
if you have angina (chest pain);
mild to moderate kidney or liver problems.
Other medicines and Aretha
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

Do not take Areta with drugs that inhibit the metabolism and therefore influence the effect and / or side effect of lercanidipine. Your doctor needs to know what these drugs.
For example:
Ciclosporin (a medicine used to prevent transplant rejection);
Ketoconazole or itraconazole (medicines for the treatment of fungal infections);
Ritonavir (medicine for the treatment of AIDS);
Erythromycin or troleandomycin (antibiotics).
Some drugs that are metabolized (activated or changed) by CYP3A4 may affect concentrations of lercanidipine in the blood and strengthen its action. So consult your doctor before taking any medicine.
This effect of lercanidipine is enhanced by:
midazolam (sedative medicine);
terfenadine, astemizole (antihistamines used to treat hay fever and other allergic conditions);
amiodarone, quinidine (used to treat irregular heartbeat);
cimetidine (used to treat stomach ulcers), administered in high doses (> 800 mg per day).
The effect of lercanidipine was reduced by:
Phenytoin, carbamazepine (medicines used to treat epilepsy);
Rifampicin (antibiotic);
Beta-blockers (medicines to treat high blood pressure and heart diseases, for example metoprolol).
Lercanidipine enhances the effect of:
Digoxin (used for heart disease);
Simvastatin (a medicine for lowering cholesterol).
Areta food, beverages and alcohol
Areta Always take at least 15 minutes before eating (before breakfast).
Alcohol intake can enhance the effects and side effects from the use of Aretha.
Therefore, no need to consume alcohol during therapy.
Grapefruit juice can increase the concentrations of lercanidipine in the blood. You should not eat grapefruit or drink grapefruit juice while taking Aretha.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.

You should not take  Areta  if you are pregnant. If you wish to become pregnant or think you may be pregnant, you should consult your doctor. Your treatment should be changed.

You should not accept Areta while breast-feeding. Lercanidipine passes into breast milk. If you need to continue treatment with Aretha, you should stop breast-feeding.

Driving and using machines
Areta can cause dizziness, weakness, fatigue and drowsiness. If you has such influence should not drive or use machinery.
Areta contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product.

3. How to take Areta
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Areta tablets or their halves should be swallowed whole with a glass of water, preferably in the morning at least 15 minutes before breakfast.

Areta 20 mg tablets
The tablets can be divided into two equal halves.
Keep the other half of the tablet in place, protected from light, for example, leave half of the tablet back into the blister pack, and cover it with a blister foil and store in blister pack carton. Take half of next dose.

The recommended dose is 10 mg once daily. Your doctor may increase the dose to 20 mg per day if needed.

No dose adjustment is required in elderly patients.

Patients with impaired renal or hepatic function
For mild to moderate hepatic impairment, the starting dose is usually 10 mg once a day. Your doctor may increase the dose carefully. You should not take Aretha if you have severe kidney or liver impairment.

Use in children and adolescents
Due to lack of data on safety and efficacy, Areta not recommended for children under 18 years.
Always take Aretha just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.

If you take more than the amount Areta
If you take too many tablets, contact your doctor or go to the nearest hospital. Overdose may be manifested as a very sharp drop in blood pressure (hypotension), rapid or slow heartbeat, unconsciousness or other serious effects. Other effects listed below in paragraph 4 can be reinforced in case of overdose.

If you forget to take Areta
Do not take a double dose to make up for a missed dose, take the next dose as usual.

If you stop using Areta
Do not stop treatment with Areta without consulting your doctor first.

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.

The following side effects have been reported when taking Aretha:
Increased heart rate (tachycardia);
Peripheral edema (accumulation of fluid in the extremities, especially the legs);
Rash (redness of the skin, especially the face).
Angina pectoris (chest pain);
Some like Aretha drugs can cause atrial pain (chest pain);
Stomach ache;
Skin rash;
Muscle pain;
Very rare:
If you have proven angina pectoris symptoms may occur more often, to last longer or be more severe;
Isolated cases of heart attack (myocardial infarction);
Fainting (syncope);
Increased levels of liver enzymes (they are usually reversible when treatment stopped);
Swelling of the gums (gingival hypertrophy);
Frequent urination;
Hypotension (low blood pressure);
Chest pain.
How to store Areta
Keep out of reach of children.
Areta Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Halves of the tablets should be stored in a place protected from light.
Medicines should not be disposed of in 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 pack and other information
What Areta
The active substance is lercanidipine.
Areta 10 mg film-coated tablets:
Each tablet contains 10 mg lerkanidipinov hydrochloride in the form of the hydrochloride hemihydrate lerkanidipinov.

Areta 20 mg tablets:
One tablet contains 20 mg lerkanidipinov hydrochloride in the form of the hydrochloride hemihydrate lerkanidipinov.

Other ingredients are:
Lactose monohydrate;
Pregelatinised maize starch;
Croscarmellose sodium;
Colloidal anhydrous;
Magnesium stearate.
Macrogol 8000;
Titanium dioxide (E171);
Aretha 10 mg tablets also contain yellow iron oxide (E172).
Aretha 20 mg tablets also contain red iron oxide (E172).

Areta looks like and contents of the pack
Areta 10 mg tablets
Yellow, round, biconvex, film-coated tablets scored.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Areta 20 mg tablets
Pink, round, biconvex tablets scored.
The tablets can be divided into two equal halves.

Areta is available in packs of 10, 14, 28, 30, 35, 50, 56, 84, 98, 100, 126 or 154 tablets in white opaque Aluminium / PVC / PVdC blister packs.


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