Lercadip (Lercanidipine) 30 Tablets

Excipients

Tablet core: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K 30, magnesium stearate

Film coating: Hypromellose, talc, titanium dioxide (E171), macrogol 6000, ferric oxide (E172)

2. What is LERCADIP and what is it used for?

LERCADIP 10 mg film tablets; yellow, round, one-face notched, two-sided, homogenous, film-coated tablets.

The LERCADIP is presented in boxes of 30 tablets containing 10 mg of lercanidipine hydrochloride as the active ingredient.

LERCADIP is a calcium antagonist of the dihydropyridine group and stops the flow of calcium from the cell membrane into the heart muscle and smooth muscle cells. The antihypertensive effect is due to the fact that it decreases blood pressure with its direct relaxation effect on vascular smooth muscles.

LERCADIP is used to treat mild to moderate hypertension (high blood pressure).

3.How to use LERCADIP?

Instructions for proper use and dose / frequency of administration Your

doctor will decide how much and how often you use LERCADİP. The initial dose is 10 mg; The dose may be increased to 20 mg depending on the response. Maximum antihypertensive effect may take approximately 2 weeks.

The route and method of

administration are taken by mouth. The drug should be swallowed without chewing.

Since an oily meal can greatly increase the level of the drug in the blood, the LERCADIP is generally used at least once a day, preferably at the same time each day, preferably at least 15 minutes before breakfast.

Different age groups

Use in children Use in the

elderly Use in the

elderly Although

clinical experience indicates that daily dose adjustment is not necessary, special attention is required when treatment is initiated in the elderly.

Special Use Conditions

Kidney / Liver Failure:

Elderly Use In

mild to moderate hepatic impairment, LERCADIP may be used at the recommended doses. However, caution should be exercised when increasing the dose. LERCADİP should not be used if severe liver failure is present.

Talk to your doctor or pharmacist if you have an impression that the effect of LERCADİP is too strong or too weak.

If you use more LERCADIP than you should not eat more than

one tablet every day. If you swallow too much, call your doctor immediately. If you cannot reach your doctor, please contact the nearest hospital's emergency department. When going to the hospital, take your medicine and box.

Talk to a doctor or pharmacist if you have used more than just what you need to use.

forgotten LERCADIP forgotten

If you haveto takeIf you haveto take your medicine and it is not near the time to take the next tablet, remember to remember. Then, continue to use the doses in normal time.

Do not take double doses to compensate for forgotten doses.

Effects that may occur when the treatment is terminated with LERCADIP If you discontinue

your treatment without consulting your doctor, the symptoms of your disease may reappear.told to by your

What are the side effects?

Like all medicines, LERCADIP may have side effects in people who are sensitive to the substances contained in its contents.

If you have any of the following, stop using LERCADIP and tell your doctor immediately or contact the emergency department of the hospital nearest you:

• Severe allergic reactions (hands, feet, wrists, face, lips, swelling in the mouth or throat, and difficulty in swallowing or breathing) , wheezing, itching, hives

• Heart failure

• Shortness of breath

• Pain in the chest wall

• Heart attack

• Fainting

• Jaundice

These are all serious side effects.

If you have one of these, you have serious allergy to LERCADIP. You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare.

If you notice any of the following, report it to your doctor immediately or contact your nearest hospital emergency department.

• Blood pressure drop

• Dizziness

• Ankle edema

• Redness

• Gingival bulge

These are serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

If you notice any of the following, tell your doctor:

• Headache

• Fatigue, weakness

• Drowsiness

• Nausea

• Indigestion

• Diarrhea

• Abdominal pain

• Vomiting

• Muscle pain

• Skin rash

• Frequent urination

These are mild side effects of LERCADIP.

2.Considering before using

CHEAP Do NOT use LERCADIP in the following cases hypersensitive

If you are

•to any of the active substance or any of the excipients or to any other drug (amlodipine, nicardipine, felodipine, isradipine, nifedipine, lacidipine) attached to the dihydropyridine group.

•pregnant If you are breastfeeding your baby if you or,

• If you are planning to become pregnant or you are not using an effective method of birth control,

• If you think you have become pregnant while using LERCADİP consult your doctor.

• If you have one of the following heart diseases;

- Untreated heart failure,

- Blocking of blood flow from the heart,

- Unstable angina (in the event of rest and prolonged angina, heart spasm),

• If you have a heart attack in the last month,have

• If you severe kidney or liver disease ,

• If you are consuming grapefruit juice,

do not use LERCADIP.

USE LERCADIP CAREFULLY

If you have

•another heart condition or you are using a pacemaker,

• If you have liver or kidney disorders or if you are on dialysis, use LERCADIP with caution.

If these warnings are valid for you, even at any time in the past, please consult your doctor.

Use of LERCADIP with food and drink

must be taken before food.

When alcohol is taken during treatment with LERCADİP, the effect of LERCADIP may increase, therefore the consumption of alcoholic beverages should be stopped or limited. Do not use with grapefruit juice.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

Pregnancy

If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Breastfeeding

Use of

tools and machines Care must be taken when using LERCADİP to avoid dizziness, fatigue, tiredness and rarely sleepiness.

Important information about some excipients in the content of LERCADIP contains LERCADİP

, lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. LERCADIP contains 0.651 mg of sodium in each dose. This should be considered for patients on a controlled sodium diet.

In combination with other drugs

LERCADIP

• The following drugs increase the absorption of lercanidipine:

- Antifungal drugs (such as ketoconazole or itraconazole)

- Antibiotics with macrolide structure (erythromycin or troleandomycin

such as))

- Antiviral drugs (used against viruses- ritonavir etc.),

• although it may be safe for use with LERCADİP beta-blockers, diuretics and ACE inhibitors (drugs used to treat high blood pressure)

• cimetidine (an ulcer, indigestion, or 800 mg for heartburn more than is used)

• Digoxin (a drug used in the treatment of heart problems),

• Midazolam (a drug used to help sleep),

• Rifampicin (a drug used in the treatment of tuberculosis),),

• Astemizole (a drug used in allergies• Terfenadine (a drug

used in allergies),

• Amiodarone and quinidine (fast drugs used for the treatment of heart beats)

• phenytoin or carbamazepine (used for epilepsy drugs),

• cyclosporine (drugs that suppress the immune system),

together with the caution should be exercised while.

5.lercadıp storing

LERCADİP 'Iwill see children Keep out of the reach and in its package.

Store at room temperature below 25 ° C and in a dry place. Use in accordance with expiration dates.

Do not use LERCADIP after the expiration date in the packaging.

Drugs must not be disposed of by wastewater or household waste. Ask your pharmacist how to dispose of the medications you no longer need. These measures will help protect the environment.

4.2. Posology and method of administration The

recommended dosage is 10 mg orally, at least 15 minutes prior to meals; the dose may be increased to 20 mg depending on the response of the patient.

Dose titration should be gradual because it may take about 2 weeks for the maximal antihypertensive effect to be observed.

Some individuals who cannot be adequately controlled by a single antihypertensive agent may benefit from the addition of LERCADIP (R) to the treatment of a beta-adrenoceptor blocker (atenolol), diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril).

Because the dose-response curve is perpendicular, it is unlikely to increase efficacy with high doses, since it reaches a level between 20 and 30 mg; On the other hand, side effects may increase.

Method of

administration: Used once a day orally.

Additional information on specific populations: Renal / hepatic impairment

Special attention should be given to patients with mild to moderate renal or hepatic dysfunction when initiating treatment. Although the recommended dosing schedule can usually be tolerated by these subgroups, the dose should be carefully considered to be increased to 20 mg per day.

In patients with hepatic disorders, the antihypertensive effect may increase and therefore an adjustment in dosage should be considered.

The use of LERCADİP® in patients with severe hepatic impairment or severe renal impairment is not recommended.

Pediatric population: Since

there is no clinical trial in patients under 18 years of age, its use in children is not currently recommended.

Geriatric population: Although

pharmacokinetic data and clinical trials suggest no need for any daily dosing, special attention should be given to the treatment of elderly people.