Lercan

Package Leaflet: Information for the Patient

Lercan, 10 mg, Film-Coated Tablets

Lercan, 20 mg, Film-Coated Tablets

Lercanidipine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication May Harm Another Person, Even if Their Symptoms are the Same.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Lercan and What is it Used For
• 2. Important Information Before Taking Lercan
• 3. How to Take Lercan
• 4. Possible Side Effects
• 5. How to Store Lercan
• 6. Package Contents and Other Information

1. What is Lercan and What is it Used For

Lercan Contains the Active Substance Lercanidipine Hydrochloride, Which Belongs to a Group of Medications Called Calcium Antagonists (Dihydropyridine Derivatives), Which Lower Blood Pressure. Lercan is Used to Treat Mild to Moderate Hypertension (High Blood Pressure) in Adults Over 18 Years Old (the Medication is Not Recommended for Use in Children Under 18 Years Old).

2. Important Information Before Taking Lercan

When Not to Take Lercan:

• If You are Allergic to Lercanidipine Hydrochloride or Any of the Other Ingredients of this Medication (Listed in Section 6)
• If You Have Certain Heart Diseases:
• Narrowing of the Blood Vessel Leaving the Heart
• Untreated Heart Failure
• Unstable Angina (Chest Pain at Rest or Increasing in Severity)
• Myocardial Infarction Within the Last Month
• If You Have Severe Liver Disease
• If You Have Severe Kidney Disease or are Undergoing Dialysis
• If You are Taking Medications that Inhibit Liver Metabolism, Such as:
• Antifungal Medications (Such as Ketoconazole or Itraconazole)
• Macrolide Antibiotics (Such as Erythromycin, Troleandomycin or Clarithromycin)
• Antiviral Medications (Such as Ritonavir)
• If You are Taking Another Medication Called Cyclosporine (Used After Organ Transplantation to Prevent Rejection)
• If You Consume Grapefruit or Drink Grapefruit Juice

Warnings and Precautions

Before Starting to Take Lercan, Discuss it with Your Doctor or Pharmacist:

• If You Have Heart Disease
• If You Have Liver or Kidney Disease

Tell Your Doctor About Pregnancy, Suspected Pregnancy, or Planning Pregnancy, as Well as Breastfeeding (See "Pregnancy, Breastfeeding, and Fertility").

Children and Adolescents

The Safety and Efficacy of Lercan in Children Under 18 Years Old Have Not Been Established.

Lercan and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Medications You Plan to Take. This is Because if Lercan is Used with Other Medications, its Effect or the Effect of Other Medications May Change, and Certain Side Effects May Occur More Frequently (See Also Section 2, Subsection "When Not to Take Lercan"). In Particular, Inform Your Doctor or Pharmacist if You are Taking Any of the Following Medications:

• Phenytoin, Phenobarbital, or Carbamazepine (Medications Used to Treat Epilepsy)
• Rifampicin (a Medication Used to Treat Tuberculosis)
• Astemizole or Terfenadine (Antihistamines)
• Amiodarone, Quinidine, or Sotalol (Medications Used to Treat Fast Heart Rate)
• Midazolam (a Sedative)
• Digoxin (a Medication Used to Treat Heart Conditions)
• Beta-Adrenergic Blockers, Such as Metoprolol (a Medication Used to Treat High Blood Pressure, Heart Failure, and Heart Rhythm Disorders)
• Cimetidine (in Doses Greater than 800 mg per Day; a Medication Used to Treat Ulcers, Indigestion, or Heartburn)
• Simvastatin (a Medication that Lowers Cholesterol Levels in the Blood)
• Medications Used to Treat High Blood Pressure

Lercan with Food, Drink, and Alcohol

• A High-Fat Meal Significantly Increases the Concentration of the Medication in the Blood (See Section 3)
• Alcohol May Enhance the Effect of Lercan. Do Not Consume Alcohol During Treatment with Lercan
• Do Not Take Lercan with Grapefruit or Grapefruit Juice (May Enhance the Blood Pressure-Lowering Effect). See Section 2, Subsection "When Not to Take Lercan"

Pregnancy, Breastfeeding, and Fertility

Lercan is Not Recommended if You are Pregnant. Do Not Use it During Breastfeeding. There is No Data on the Use of Lercan in Pregnant or Breastfeeding Women. If You are Pregnant or Breastfeeding, if You are Not Using Any Contraceptive Method, if You Suspect You May be Pregnant, or if You Plan to Have a Child, Consult Your Doctor or Pharmacist Before Using this Medication

Driving and Operating Machinery

If You Experience Dizziness or Drowsiness While Taking this Medication, Do Not Drive or Operate Machinery

Lercan Contains Lactose

If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication

Sodium

This Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Considered "Sodium-Free"

3. How to Take Lercan

Always Take this Medication Exactly as Your Doctor has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist. Adults:

• The Recommended Dose is 10 mg, Taken Once a Day at the Same Time, Preferably in the Morning, at Least 15 Minutes Before Breakfast
• If Necessary, Your Doctor May Increase the Dose to One 20 mg Tablet of Lercan per Day (See Section 2, Subsection "Lercan with Food, Drink, and Alcohol")
• The Score Line on the 10 mg Tablet of Lercan is Only to Facilitate Breaking the Tablet to Make it Easier to Swallow, and Not to Divide it into Equal Doses
• The 20 mg Tablet can be Divided into Equal Doses
• Swallow the Tablets Whole with a Small Amount of Water

Use in Children and Adolescents

• Do Not Use Lercan in Children and Adolescents Under 18 Years Old

Elderly:

• No Dose Adjustment is Necessary, However, Particular Caution Should be Exercised at the Beginning of Treatment

Patients with Impaired Liver or Kidney Function:

• Particular Caution Should be Exercised at the Beginning of Treatment and When Increasing the Daily Dose to 20 mg

Taking More Lercan than Prescribed

Do Not Take More than the Prescribed Dose. If You Have Taken More than the Prescribed Dose, Contact Your Doctor or Go to the Emergency Department of the Nearest Hospital Immediately. Take the Medication Packaging with You. Taking More than the Prescribed Dose of Lercan May Cause Excessive Lowering of Blood Pressure and Irregular or Rapid Heartbeat

Missing a Dose of Lercan

If You Forget to Take a Dose of Lercan, Skip the Missed Dose and Take the Next Dose the Next Day as Scheduled. Do Not Take a Double Dose to Make Up for the Missed Dose

Stopping Lercan Treatment

If You Stop Taking Lercan, Your Blood Pressure May Increase Again. Before Stopping Treatment, Consult Your Doctor. If You Have Any Further Questions About the Use of this Medication, Ask Your Doctor or Pharmacist

4. Possible Side Effects

Like All Medications, Lercan Can Cause Side Effects, Although Not Everybody Gets Them. The Following Side Effects May Occur When Taking this Medication:

Some Side Effects Can be Serious

If You Experience Any of the Following Side Effects, Tell Your Doctor Immediately:

Rarely (May Occur in Less than 1 in 1000 People): Angina Pectoris (e.g., Chest Pain Caused by Insufficient Blood Flow to the Heart), Allergic Reactions (Symptoms Include Itching, Rash, Urticaria), Fainting. In Patients with Pre-Existing Angina Pectoris, the Frequency, Duration, or Severity of Angina Attacks May Increase During Treatment with Medications from the Same Group as Lercan. In Rare Cases, Myocardial Infarction May Occur

Other Possible Side Effects:

Common (May Occur in Less than 1 in 10 People): Headache, Rapid Heartbeat, Feeling of Rapid or Irregular Heartbeat (Palpitations), Sudden Redness of the Face, Neck, or Upper Part of the Chest (Flushes), Swelling of the Ankle Area. Uncommon (May Occur in Less than 1 in 100 People): Dizziness, Low Blood Pressure, Heartburn, Nausea, Stomach Pain, Skin Rash, Itching, Muscle Pain, Increased Urination, Weakness, Fatigue. Rarely (May Occur in Less than 1 in 1000 People): Drowsiness, Vomiting, Diarrhea, Urticaria, Increased Urination, Chest Pain. Frequency Not Known (Frequency Cannot be Estimated from the Available Data): Gum Swelling, Liver Function Disorders (Detected in Blood Tests), Clouding of the Fluid (During Dialysis with a Catheter in the Abdominal Cavity), Swelling of the Face, Lips, Tongue, or Throat, Which May Cause Difficulty Breathing or Swallowing. Reporting Suspected Side Effects If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side Effects Can Also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication

5. How to Store Lercan

Keep the Medication Out of Sight and Reach of Children. Do Not Use this Medication After the Expiration Date Stated on the Carton and Blister Pack After "EXP". The Expiration Date Refers to the Last Day of the Month

Lercan 10 mg:

Store in the Original Packaging

Lercan 20 mg:

Store at a Temperature Below 25°C. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications that are No Longer Needed. This Will Help Protect the Environment

6. Package Contents and Other Information

What Lercan Contains

Lercan, 10 mg

• The Active Substance is Lercanidipine Hydrochloride. One Film-Coated Tablet of Lercan Contains 10 mg of Lercanidipine Hydrochloride, Which Corresponds to 9.4 mg of Lercanidipine
• The Other Ingredients are: Tablet Core: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Carboxymethylcellulose (Type A), Povidone K30, Magnesium Stearate. Coating: Hypromellose, Talc, Titanium Dioxide (E 171), Macrogol 6000, Yellow Iron Oxide (E 172)

Lercan, 20 mg

• The Active Substance is Lercanidipine Hydrochloride. One Film-Coated Tablet of Lercan Contains 20 mg of Lercanidipine Hydrochloride, Which Corresponds to 18.8 mg of Lercanidipine
• The Other Ingredients are: Tablet Core: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Carboxymethylcellulose (Type A), Povidone K30, Magnesium Stearate. Coating: Hypromellose, Talc, Titanium Dioxide (E 171), Macrogol 6000, Red Iron Oxide (E 172)

What Lercan Looks Like and Contents of the Package

Lercan, 10 mg are Yellow, Round, Biconvex Film-Coated Tablets with a Diameter of 6.5 mm and a Score Line on One Side. Lercan, 10 mg is Available in Packs Containing 14, 28, 35, 50, 56, 98, or 100 Tablets in Aluminum/PVC Blister Packs in a Carton. Not All Pack Sizes May be Available. Lercan, 20 mg are Pink, Round, Biconvex Film-Coated Tablets with a Diameter of 8.5 mm and a Score Line on One Side. Lercan, 20 mg is Available in Packs Containing 7, 14, 28, 35, 42, 50, 56, 98, or 100 Tablets in Aluminum/PVC Blister Packs in a Carton. Not All Pack Sizes May be Available

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Ireland

Manufacturer

RECORDATI Industria Chimica e Farmaceutica S.p.A. Via Civitali, 1 20148 Milan Italy

Date of Last Revision of the Package Leaflet:

Other Sources of Information

Detailed Information on this Medication is Available on the Website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl/