AURONAL R 10 mg. 30 tablets

WHAT AURONAL AND WHAT IT IS USED
The active substance of Auronal, felodipine belongs to a group of medicines called calcium channel blockers. It works by expanding the blood vessels, lowering the blood pressure, which is also important in treating angina pectoris (chest pain caused by coronary heart disease).
Your doctor may prescribe Auronal if you suffer from high blood pressure (hypertension) and / or angina (stable and vasospastic form).

2. BEFORE YOU TAKE AURONAL
Do not take Auronal:
If you are allergic (hypersensitive) to felodipine or any of the other ingredients of Auronal listed in item 6 above.
If you are pregnant or breast-feeding;
The drug should not be given to children.
Take special care with Auronal
If you suffer from severe heart disease (dysfunction of the left ventricle) or severe hypertension Auronal may be suitable for you. If you are unsure about your condition or medicines you are taking, ask the advice of your doctor.

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.
Please note that the potential for drug interactions may relate to drug taken some time ago or that will be adopted in the future.
Cimetidine (anti-ulcer), erythromycin (for the treatment of bacterial infections), phenytoin, carbamazepine, barbiturates or may affect your treatment with Auronal. Make sure your doctor knows if you are taking any of the above medicines as you may need to reduce or increase the dose of Auronal.

Taking Auronal with food and drink
Grapefruit juice can affect the way some calcium antagonists as Auronal - this is important, so you should not drink grapefruit juice while taking your tablets.

Pregnancy and lactation
Do not take this medicine if you are pregnant or breastfeeding.
If you are pregnant or breast-feeding, ask your doctor or pharmacist before taking any medicine.

Driving and using machines
If you feel dizzy after taking this medicine, you should not drive or operate machinery.
This applies especially to the beginning of treatment or after a dose increase.

Important information about some of the ingredients of Auronal
Each prolonged-release tablet of 2,5 mg contain lactose 25,20 mg, 5 mg tablet contains 23,95 mg lactose and 10 mg tablets contain lactose 21,45 mg, respectively.
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
3. HOW TO TAKE AURONAL
Always take Auronal exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist. The dose is determined individually.
If you take Auronal to treat high blood pressure (hypertension) The usual adult dose is 5 mg, taken in the morning. Your doctor may prescribe a dose of 2,5 mg or may increase your dose to 10 mg once daily.
If you take Auronal to treat angina (chest pain), the usual dose is 5 mg, taken in the morning. Your doctor may increase the dose of 10 mg.
Swallow the tablets whole with water. Do not crush or chew the tablets.
If you take more dose Auronal or if you suspect that a child has taken these tablets immediately contact the nearest unit for medical emergencies. Take the remaining tablets and this leaflet to show the doctor.

Symptoms: strong expansion of peripheral blood vessels with marked hypotension (low blood pressure), sometimes accompanied by bradycardia (slow heartbeat). Treatment is symptomatic. If appropriate or shown can be applied charcoal induced vomiting or gastric lavage.
In severe hypotension, the patient should be placed in the supine position with legs raised. Bradycardia responded to atropine 0,5-1 mg intravenously. If these measures are not sufficient, plasma volume may be increased by infusion of glucose, saline or dextran. If it does not work, may be given sympathomimetic effective primarily on alpha-adrenergic receptors (eg metaraminol or phenylephrine).

If you forget to take Auronal
Do not take a double dose to make up the missed dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Auronal can cause side effects, although not everybody gets them.

If any of these side effects occur, stop taking Auronal and immediately contact your doctor or go to the nearest unit for emergency medical care:
swelling of the lips or throat, causing difficulty in swallowing or breathing;
fainting.
These side effects are very serious but occur rarely. If you get them, you may have a serious allergic reaction to Auronal.
You may need urgent medical attention or hospitalization.

Not all side effects develop in patients taking this medicine. Some of them may appear during the adoption of Auronal, especially at the beginning of treatment or after a dose increase:
swelling of the ankles;
feeling of warmth, tiredness, weakness, palpitations, dizziness;
heartburn, nausea, constipation;
skin rash, "tingling".
Also, some people may experience:
increased heart rate, dry mouth, upset stomach, joint pain, anxiety, itching, swollen gums (worsening of edema can be avoided with good oral hygiene) changes in serum levels of liver enzymes.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE AURONAL
Keep out of reach of children.
Do not store above 25 ° C.
Do not use Auronal after the expiry date stated on the packaging. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION
What Auronal
Active substance: Each prolonged-release tablet of 2,5 mg, 5 mg, 10 mg contains respectively 2,5 mg, 5 mg or 10 mg of felodipine.
Excipients: lactose monohydrate, microcrystalline cellulose, hypromellose, povidone, propyl gallate, anhydrous colloidal silica, magnesium stearate.

Auronal 2.5 mg: film coat contains hypromellose, iron oxide yellow E172, E171 titanium dioxide, talc, propylene glycol.
Auronal 5 mg, 10 me: film coat contains hypromellose, iron oxide red E172, iron oxide yellow E172, E171 titanium dioxide, talc, propylene glycol.

Auronal looks like and contents of the pack
Auronal 2,5 mg: yellow, round, biconvex tablets marked with "2.5" on one side.
Auronal 5 mg: pale pink, round, biconvex tablets marked with "5" on one side.
Auronal 10 mg: brownish red, round, biconvex tablets marked with "10" on one side.

Packaging: 3 x 10 prolonged-release tablets are provided in blister in a carton together with the package leaflet.