TEVALER 20 mg. 30 tablets

WHAT TEVALER 20 mg tablets IS AND WHAT IT IS USED
TevaLer belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives).
TevaLer used to treat high blood pressure, known as hypertension in adults aged over 18 years (not recommended for children under the age of 18).

2. BEFORE YOU TAKE TEVALER 20 mg tablets
Do not take TevaLer:
If you are allergic (hypersensitive) to lercanidipine or to any of the ingredients of TevaLer;
If you have experienced allergic reactions to medicines that are similar to TevaLer (as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine);
If you have any heart disease:
untreated heart failure;
narrowing the outlet of the heart;
unstable angina (get fit at rest or with increasing intensity);
within one month after a heart attack (infarction);
If you have severe liver or kidney disease;
If you are taking drugs that are inhibitors of isoenzyme CYP3A4: antifungals (such as ketoconazole or itraconazole);
If you are taking another drug called cyclosporine (a drug used after organ transplantation);
With grapefruit or grapefruit juice;
If you are pregnant or planning to become pregnant, or you are a woman of childbearing age, not using contraception;
If you are breastfeeding.
Take special care with TevaLer
You should consult with your doctor before taking TevaLer tablets:
If you have certain heart diseases with impaired left ventricular function or irregular heartbeat syndrome sick sinus and your pacemaker;
If you have angina, lercanidipine can in rare cases lead to more frequent or prolonged seizures or they become severe. In isolated cases have been reported myocardial infarction;
If you have mild or moderate problems with their liver or kidneys.
Taking other medicines
Please tell your doctor if:
You are taking or have recently taken any other medicines, including those obtained without a prescription;
If you are taking beta-blockers, eg. metoprolol, diuretics (water pills) or ACE inhibitors (medications for high blood pressure);
If you are taking cimetidine (more than 800 mg daily medicine for ulcers, indigestion or heartburn);
If you are taking digoxin (a medicine to treat heart problems);
If you are taking midazolam (a medicine that helps to sleep);
If you are taking rifampicin (medicine to treat tuberculosis);
If you are taking astemizole, terfenadine or (medicines for allergies);
If you are taking amiodarone or quinidine (medicines for the treatment of accelerated heartbeat);
If you are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want to monitor your blood pressure more often than usual;
If you are taking simvastatin (a medicine that lowers high cholesterol). TevaLer should be taken in the morning and simvastatin in the evening;
If you are taking antifungal medicines (such as ketoconazole or itraconazole). The effect of TevaLer can be enhanced and these drugs should not be administered simultaneously (see section "Do not take TevaLer");
If you are taking cyclosporine (a medicine used after organ transplants). TevaLer and effects of cyclosporine can be increased so that these drugs should not be co-administered (see section "Do not take TevaLer").
Taking TevaLer with food and drink
You should not drink alcohol, eat grapefruit or drink grapefruit juice as it may enhance the effect of TevaLer.

Pregnancy and lactation
TevaLer Do not take if you are pregnant or nursing, or want to become pregnant are not using contraception. If you take TevaLer and think you may be pregnant, talk to your doctor.
Consult your doctor before taking any medicine.

Driving and using machines
TevaLer has a negligible effect on your ability to drive or operate machinery. However, due to the possibility of dizziness, weakness and fatigue, caution is needed. Do not drive or operate machinery until you know
how you act TevaLer.

Important information about some of the ingredients of TevaLer
TevaLer contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
TevaLer tatrazine contain aluminum lake (E102) and may cause allergic reactions.

3. HOW TO TAKE TEVALER 20 mg tablets
Always take TevaLer just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The usual dose is one tablet TevaLer 10 mg daily at the same time each day, preferably in the morning, at least 15 minutes before breakfast, as a high-fat meal significantly increases the level of this medicine in the blood.
If necessary, your doctor may increase the dose to one tablet TevaLer of 20 mg daily.
The tablets should be swallowed whole with half a glass of water.

Elderly patients: although no adjustment is required daily dose when initiating treatment with lercanidipine in elderly patients, caution is needed.

Patients with mild to moderate kidney or liver problems, such patients need special attention at the beginning of treatment and increase the daily dose to 20 mg should be cautious.

TevaLer not recommended for use in children and adolescents under 18 years of age.

If you take more dose TevaLer
Do not exceed your recommended dose.
If you take a higher dose than prescribed, or overdose, seek medical advice immediately and if possible take the tablets and / or the container with you.
Exceeding the correct dose can lead to very low blood pressure and rapid or irregular heart beat. Furthermore, it may be the cause of vomiting or unconsciousness.

If you forget to take TevaLer
If you forgot to take your tablet, just skip it and proceed as usual. Do not take a double dose to make up for forgotten tablet.

If you stop taking TevaLer
If you stop taking TevaLer your blood pressure may increase again. Please consult your doctor before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, TevaLer can cause side effects, although not everybody gets them.
Some side effects can be serious: if you experience any of these side effects, call your doctor immediately.
Rare (affects 1 to 10 users in 10,000):
Angina (chest pain due to insufficient blood in the heart).
Very rare (affects less than 1 user in 10 000):
Chest pain, decrease in blood pressure, seizures and allergic reactions (symptoms include itching, rash, hives).
If you have pre-existing angina medications of the group to which it belongs lercanidipine can lead to increased frequency, duration or severity of these attacks. They may be isolated cases of myocardial infarction (heart attack).

Other possible side effects:
Uncommon side effects (affects 1 to 10 users in 1000):
Headache, dizziness;
Rapid heart beat, palpitations, swelling around the ankles;
Sudden reddening of the face, neck or upper chest.
Rare side effects (affects 1 to 10 users in 10,000):
Drowsiness;
Angina (chest pain);
Heartburn, nausea, diarrhea, stomach pain, vomiting;
Skin rash;
Muscle pain;
Passing large amounts of urine;
Tiredness.
Very rare side effects (affects less than 1 user in 10 000):
Swelling of the gums;
More frequent urination than usual;
Changes in liver function (identified by blood tests).
Other side effects with unknown frequency (frequency assessment can not be made from the available data):
Disorders combining rigidity, tremor and / or impaired movement.
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 TEVALER 20 mg tablets
Keep out of reach of children.
Do not use TevaLer 10 mg tablets after the expiry date stated on the label, carton or bottle after "EXP" The expiry date refers to the last day of that month.

Blisters
Store in the original container to protect from light.

Bottles
Store in the original container to protect from light.

Bottles (after first opening)
Store in the original container to protect from light. Discard 30 days after opening.

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

6. ADDITIONAL INFORMATION
What TevaLer 20 mg tablets
The active substance is lerkanidipinov hydrochloride.
One film-coated tablet contains 20 mg lerkanidipinov hydrochloride equivalent to 9,4 mg lercanidipine.
The other ingredients are lactose monohydrate, sodium starch glycolate (potatoes), microcrystalline cellulose, povidone and magnesium stearate in the tablet core and film coating:
Opadry 03F32418 yellow, containing hypromellose (E464), titanium dioxide (E171), tartrazine aluminum lake (E102), macrogol 6000, talc and yellow iron oxide (E172).

Looks TevaLer 20 mg film-coated tablets and contents of the pack
Yellow to dark yellow, round, convex tablet with a debossed "10" on one side and scored on the other. The tablet can be divided into two equal halves.
TevaLer 10 mg film-coated tablets in blister packs containing 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 tablets Hospital pack: 50x1 tablets and calendar packs of 28 tablets.
Not all pack sizes may be marketed.