Lernidum

Package Leaflet: Information for the Patient

Lernidum, 10 mg, Film-Coated Tablets

Lernidum, 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.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed to You by a Doctor and Should not be Given to Others. It May Harm Them, Even if their Symptoms are the Same as Yours.
• If You Experience any Undesirable Effects, Including those not Mentioned in this Package Leaflet, Inform Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Lernidum and What is it Used for

Lernidum Contains the Active Substance Lercanidipine Hydrochloride, which Belongs to a Group of so-called Calcium Antagonists (Dihydropyridine Derivatives) - Medications that Lower Blood Pressure. This Medication is Used to Treat High Blood Pressure (Hypertension) in Adults.

Indications for Use of Lernidum

Treatment of Mild to Moderate Essential Hypertension in Adults.

2. Important Information Before Taking Lernidum

When Not to Take Lernidum

• If You are Allergic to Lercanidipine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6);
• If You have Experienced Allergic Reactions to Similar Medications in the Past (Such as: Amlodipine, Nicardipine, Felodipine, Isradipine, Nifedipine or Lacidipine);
• If You have Uncontrolled Heart Failure, Narrowing of the Left Ventricular Outflow Tract, Unstable Angina Pectoris (Chest Pain at Rest or Increasing), or if You have had a Heart Attack in the Last Month;
• If You have Severe Liver or Kidney Impairment, or if You are Undergoing Dialysis;
• If You are Taking Medications that are Inhibitors of the CYP3A4 Enzyme: Antifungal Medications (Such as Ketokonazole or Itraconazole), Macrolide Antibiotics (Such as Erythromycin, Troleandomycin or Clarithromycin), Antiviral Medications (Such as Ritonavir);
• If You are Taking a Medication Called Cyclosporine (Used to Prevent Transplant Rejection);
• If You Consume Grapefruit or Drink Grapefruit Juice.

This Medication Must not be Used During Pregnancy or Breastfeeding (See Section: "Pregnancy, Breastfeeding and Fertility").

Warnings and Precautions

Before Taking Lernidum, Discuss with Your Doctor or Pharmacist if You:

• Have Other Heart Conditions and do not have a Pacemaker or have had Angina Pectoris in the Past;
• Have Liver or Kidney Impairment.

If You are Pregnant (or Think You May be Pregnant) or Breastfeeding, Inform Your Doctor (See Section: "Pregnancy, Breastfeeding and Fertility").

Children and Adolescents

This Medication Must not be Used in Children and Adolescents Under 18 Years of Age, as the Safety and Efficacy of Lercanidipine have not been Established.

Lernidum and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take, Especially if You are Taking:

• Beta-Adrenergic Blocking Agents (Such as Metoprolol);
• Cimetidine in Doses Greater than 800 mg (Medication Used to Treat Ulcer Disease, Indigestion or Heartburn);
• Digoxin (Medication Used to Treat Heart Conditions);
• Midazolam (Medication that Facilitates Sleep);
• Rifampicin (Medication Used to Treat Tuberculosis);
• Astemizole or Terfenadine (Antihistamine Medications);
• Amiodarone, Quinidine or Sotalol (Medications that Slow Heart Rate);
• Phenytoin, Phenobarbital or Carbamazepine (Medications Used to Treat Epilepsy) - Your Doctor will Recommend More Frequent Blood Pressure Checks;
• Simvastatin (Medication that Lowers Cholesterol Levels) - Take Lernidum in the Morning and Simvastatin in the Evening;
• Ketoconazole or Itraconazole (Antifungal Medications) - See Section "When Not to Take Lernidum";
• Erythromycin, Troleandomycin or Clarithromycin (Macrolide Antibiotics) - See Section "When Not to Take Lernidum";
• Ritonavir (Antiviral Medication) - See Section "When Not to Take Lernidum";
• Cyclosporine (Medication Used to Prevent Transplant Rejection) - See Section "When Not to Take Lernidum";
• Other Medications Used to Treat High Blood Pressure.

If any of the Above Applies to You, Tell Your Doctor Before Taking the Medication.

Tell Your DoctorBefore Taking the Medication.

Lernidum with Food, Drink and Alcohol

During Treatment, Do not:

• Drink Alcohol,
• Eat Grapefruits or Drink Grapefruit Juice,
• Consume Meals with High Fat Content, as this May Enhance the Effect of the Medication.

Pregnancy, Breastfeeding and Fertility

If You are Pregnant or Breastfeeding, Think You May be Pregnant or Plan to Have a Child, Do not Take Lernidum.
Women of Childbearing Age Should Use Effective Contraception While Taking Lernidum. If You Become Pregnant During Treatment, Inform Your Doctor Immediately, who will Decide on Further Treatment.

Driving and Operating Machines

Lernidum Does not Have a Significant Effect on the Ability to Drive or Operate Machines, but Undesirable Effects Such as Dizziness, Weakness, Fatigue and Rarely - Drowsiness May Occur. Be Cautious and Do not Drive or Operate Machines Until You Know Your Individual Reaction to the Medication.

Lernidum Contains Sodium

Lernidum, 10 mg Contains 0.928 mg of Sodium in Each Tablet.
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, i.e. it is Considered "Sodium-Free".
Lernidum, 20 mg Contains 1.437 mg of Sodium in Each Tablet.
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, i.e. it is Considered "Sodium-Free".

3. How to Take Lernidum

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

Adults

The Recommended Dose is 10 mg (1 Tablet) Once a Day, Taken at the Same Time Every Day, Preferably in the Morning, at Least 15 Minutes Before Breakfast.
If Necessary, Your Doctor May Increase the Dose to 20 mg (1 Tablet) Once a Day.
Swallow the Tablets Whole with Water.
The Score Line on the Lernidum, 10 mg Tablet is Only to Facilitate Breaking the Tablet to Make it Easier to Swallow, and not to Divide it into Equal Doses.
The Lernidum, 20 mg Tablet can be Divided into Equal Doses.

Elderly

No Dose Adjustment is Necessary, but Caution Should be Exercised at the Beginning of Treatment.

Patients with Liver or Kidney Impairment

Caution Should be Exercised at the Beginning of Treatment and When Increasing the Dose to 20 mg Once a Day.

Use in Children and Adolescents

This Medication Must not be Used in Children and Adolescents Under 18 Years of Age.

Taking a Higher Dose of Lernidum than Recommended

Do not Take a Higher Dose than Recommended.
In Case of Overdose or if You have Taken More than the Recommended Dose, Seek Medical Attention Immediately and, if Possible, Bring the Remaining Tablets and/or the Medication Packaging with You.
Taking a Higher Dose than Recommended May Cause Excessive Lowering of Blood Pressure and Irregular or Rapid Heartbeat, which can also Lead to Loss of Consciousness.

Missing a Dose of Lernidum

If You Miss a Dose, Skip the Missed Dose and Take the Next Tablet at the Usual Time the Next Day. Do not Take a Double Dose to Make up for the Missed Dose.

Stopping Treatment with Lernidum

If You Stop Taking the Medication, Your Blood Pressure May Increase Again. Before Stopping the Medication, Consult Your Doctor.
If You have any Further Questions on the Use of this Medication, Consult Your Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Lernidum can Cause Undesirable Effects, although not Everybody gets them.
You Should ImmediatelyStop Taking this Medication and Consult Your Doctor or Go to the Emergency Department of the Nearest Hospital if You Experience:

• Angina Pectoris (Chest Pain Due to Reduced Blood Flow to the Heart), Allergic Reactions (Such as Itching, Rash, Hives), Fainting - Rare (May Occur in Less than 1 in 1000 People),
• Swelling of the Face, Lips, Tongue or Throat, which May Cause Difficulty Breathing or Swallowing - Frequency Not Known.

In Patients with Angina Pectoris, the Use of Medications from the Same Group as Lernidum may Increase the Frequency, Duration or Severity of Pain Attacks. Isolated Cases of Heart Attack have been Observed.

Other Possible Undesirable Effects

Common (May Occur in Less than 1 in 10 People):

• Headache,
• Increased Heart Rate, Palpitations (Strong or Rapid Heartbeat),
• Sudden Redness of the Face, Neck or Upper Part of the Body, Swelling of the Ankles.

Uncommon (May Occur in Less than 1 in 100 People):

• Dizziness,
• Low Blood Pressure,
• Nausea, Indigestion, Stomach Pain,
• Rash, Itching,
• Muscle Pain,
• Increased Urination,
• Weakness, Fatigue.

Rare (May Occur in Less than 1 in 1000 People):

• Drowsiness,
• Vomiting, Diarrhea,
• Hives,
• Increased Urination,
• Chest Pain.

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Gingival Swelling,
• Liver Function Disorders (Detected in Blood Tests),
• Clouding of the Fluid (During Dialysis with a Catheter in the Abdominal Cavity).

Reporting Undesirable Effects

If You Experience any Undesirable Effects, Including those not Mentioned in this Package Leaflet, Inform Your Doctor, Pharmacist or Nurse. Undesirable Effects can be Reported Directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301;
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Lernidum

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.
Lernidum, 10 mg
Store in the Original Packaging to Protect from Light.
Lernidum, 20 mg
Store at a Temperature Below 30°C.
Store in the Original Packaging to Protect from Light.
Lot - Means Batch Number.
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 Lernidum Contains

Lernidum, 10 mg
The Active Substance is Lercanidipine Hydrochloride.
Each Film-Coated Tablet Contains 10 mg of Lercanidipine Hydrochloride, which Corresponds to 9.4 mg of Lercanidipine.
Other Ingredients are:
Tablet Core: Corn Starch, Sodium Carboxymethylcellulose (Type A), Colloidal Silica, Microcrystalline Cellulose, Poloxamer 188, Sodium Stearyl Fumarate, Macrogol 6000.
Tablet Coating: Hypromellose 6cps, Macrogol 6000, Yellow Iron Oxide (E 172), Titanium Dioxide (E 171).
Lernidum, 20 mg
The Active Substance is Lercanidipine Hydrochloride.
Each Film-Coated Tablet Contains 20 mg of Lercanidipine Hydrochloride, which Corresponds to 18.8 mg of Lercanidipine.
Other Ingredients are:
Tablet Core: Microcrystalline Cellulose, Corn Starch, Sodium Carboxymethylcellulose (Type A), Colloidal Silica, Povidone K-30, Sodium Stearyl Fumarate.
Tablet Coating: Hypromellose 6cps, Macrogol 6000, Red Iron Oxide (E 172), Titanium Dioxide (E 171).

What Lernidum Looks Like and Contents of the Package

Lernidum, 10 mg is a Yellow, Round, Biconvex Film-Coated Tablet with a Score Line on One Side, Smooth on the Other Side, with Dimensions of Approximately 6.5 mm x 3.3 mm.
Lernidum, 10 mg is Packaged in Blisters. One Package Contains: 10, 14, 28 or 56 Film-Coated Tablets in a Carton.
Lernidum, 20 mg is a Pink, Round, Biconvex Film-Coated Tablet with a Score Line on One Side, Smooth on the Other Side, with Dimensions of Approximately 8.5 mm x 4.0 mm.
Lernidum, 20 mg is Packaged in Blisters. One Package Contains: 10, 14, 28 or 56 Film-Coated Tablets in a Carton.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka Street 133/151,
95-200 Pabianice
Phone: (42) 22-53-100

Importer

Aflofarm Farmacja Polska Sp. z o.o.
Szkolna Street 31,
95-054 Ksawerów
Poland

Date of Last Revision of the Package Leaflet: