LERCANIDIPINE 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lercanidipine Medreg, 10 mg, Film-Coated Tablets
3. Lercanidipine Medreg, 20 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents:
4. What is Lercanidipine Medreg and What is it Used for
5. Important Information Before Taking Lercanidipine Medreg
   1. When Not to Take Lercanidipine Medreg
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Lercanidipine Medreg and Other Medications
   5. Lercanidipine Medreg with Food, Drink, and Alcohol
   6. Pregnancy, Breastfeeding, and Fertility
   7. Driving and Operating Machinery
   8. Lercanidipine Medreg Contains Sodium
6. How to Take Lercanidipine Medreg
   1. Adults
   2. Elderly Patients
   3. Use in Children and Adolescents
   4. Patients with Liver or Kidney Impairment
   5. Taking More than the Recommended Dose of Lercanidipine Medreg
   6. Missing a Dose of Lercanidipine Medreg
   7. Stopping Treatment with Lercanidipine Medreg
7. Possible Undesirable Effects
   1. Some Undesirable Effects can be Serious. If any of the Following Symptoms Occur, Contact a Doctor Immediately:
   2. Reporting Undesirable Effects
8. How to Store Lercanidipine Medreg
9. Package Contents and Other Information
   1. What Lercanidipine Medreg Contains
   2. Lercanidipine Medreg, 10 mg, Film-Coated Tablets
   3. Lercanidipine Medreg, 20 mg, Film-Coated Tablets
   4. What Lercanidipine Medreg Looks Like and Contents of the Pack
   5. Marketing Authorization Holder and Manufacturer/Importer
   6. Marketing Authorization Holder:
   7. Manufacturer/Importer:
   8. This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:
   9. Date of Last Revision of the Package Leaflet: 09/2024

Package Leaflet: Information for the Patient

Lercanidipine Medreg, 10 mg, Film-Coated Tablets

Lercanidipine Medreg, 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 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 the Patient Experiences any Undesirable Effects, Including those not Mentioned in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

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

1. What is Lercanidipine Medreg and What is it Used for

Lercanidipine Medreg Belongs to a Group of Medications Known as Calcium Channel Antagonists.
Calcium Channel Antagonists Block the Entry of Calcium into the Cells of the Heart Muscle and Blood Vessels that Carry Blood from the Heart (Arteries). The Entry of Calcium into these Cells Causes the Heart to Contract and the Arteries to Constrict. By Blocking the Entry of Calcium, Calcium Channel Antagonists Reduce the Contraction of the Heart and Dilate the Arteries, thus Lowering Blood Pressure.
Lercanidipine Medreg has been Prescribed to Treat High Blood Pressure, which is Medically Known as Hypertension.
Lercanidipine Medreg is Intended for Adults.

2. Important Information Before Taking Lercanidipine Medreg

When Not to Take Lercanidipine Medreg

• If the Patient is Allergic to Lercanidipine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6)
• If the Patient has Certain Heart Diseases:
• Impaired Blood Flow from the Heart
• Untreated Heart Failure
• Unstable Angina (Chest Pain at Rest or with Increasing Severity)
• Within a Month of a Heart Attack
• If the Patient has Severe Liver Disease
• If the Patient has Severe Kidney Impairment or is Undergoing Dialysis
• If the Patient is Taking Certain Medications that are Inhibitors of Liver Metabolism:
• Antifungal Medications (Such as Ketoconazole or Itraconazole)
• Macrolide Antibiotics (Such as Erythromycin or Troleandomycin or Clarithromycin)
• Antiviral Medications (Such as Ritonavir)
• If the Patient is Taking a Medication Called Cyclosporine (Used After Organ Transplantation to Prevent Rejection)
• If the Patient Consumes Grapefruit or Grapefruit Juice.

Warnings and Precautions

Before Starting Lercanidipine Medreg, the Patient Should Discuss the Following with their Doctor:

• If the Patient has Heart Disease
• If the Patient has Liver or Kidney Impairment, they Should Inform their Doctor of any Suspected (or Planned) Pregnancy or Breastfeeding (See Section on Pregnancy, Breastfeeding, and Fertility).

Children and Adolescents

The Safety and Efficacy of Lercanidipine Medreg in Children Under 18 Years of Age have not been Established.
This Medication is not Recommended for Children and Adolescents Under 18 Years of Age.

Lercanidipine Medreg and Other Medications

The Patient Should Tell their Doctor or Pharmacist About all Medications they are Currently Taking or Have Recently Taken, as well as any Medications they Plan to Take.
Taking Lercanidipine Medreg with Certain Other Medications (See Below) may Change the Effects of those Medications or Lercanidipine Medreg, and Certain Undesirable Effects may Occur More Frequently.
It is Especially Important to Inform the Doctor About 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 (Medications for Allergies)
• Amiodarone, Quinidine, or Sotalol (Medications Used to Treat Rapid Heartbeat)
• Midazolam (a Medication that Facilitates Sleep)
• Beta-Adrenergic Blockers, such as Metoprolol (a Medication Used to Treat High Blood Pressure, Heart Failure, and Heart Rhythm Disorders)
• Digoxin (a Medication Used to Treat Heart Conditions)
• Cimetidine in Doses Greater than 800 mg (a Medication Used for Stomach Ulcers, Indigestion, or Heartburn)
• Simvastatin (a Medication that Lowers Blood Cholesterol Levels)
• Other Medications Used to Treat High Blood Pressure.

Lercanidipine Medreg with Food, Drink, and Alcohol

A High-Fat Meal Significantly Increases the Concentration of this Medication in the Blood (See Section 3).
Lercanidipine Medreg Should not be Taken with Grapefruit or Grapefruit Juice (as they may Enhance the Hypotensive Effect). See Section 2 "Lercanidipine Medreg with Food, Drink, and Alcohol".
Alcohol may Enhance the Effect of Lercanidipine Medreg. Do not Consume Alcohol During Treatment with Lercanidipine Medreg.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult their Doctor or Pharmacist Before Taking this Medication.
Lercanidipine Medreg is not Recommended During Pregnancy and Should not be Used During Breastfeeding. There are no Data on the Use of Lercanidipine in Pregnant or Breastfeeding Women.

Driving and Operating Machinery

If the Patient Experiences Dizziness, Weakness, or Drowsiness While Taking this Medication, they Should not Drive or Operate Machinery.

Lercanidipine Medreg Contains 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 Lercanidipine Medreg

This Medication Should Always be Taken as Directed by the Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.

Adults

The Recommended Dose is 1 Tablet of Lercanidipine Medreg 10 mg Once a Day. The Tablet Should be Taken Daily at the Same Time, Preferably in the Morning, at Least 15 Minutes Before Breakfast, as a High-Fat Meal Significantly Increases the Concentration of this Medication in the Blood. If Necessary, the Doctor may Decide to Increase the Dose to 20 mg Once a Day.
The Tablets Should be Swallowed Whole with Water. The Medication Should not be Taken with Grapefruit Juice (See Section 2 "Lercanidipine Medreg with Food, Drink, and Alcohol").
The Score Line is Only to Facilitate Breaking the Tablet to Make it Easier to Swallow, and not to Divide it into Equal Doses.

Elderly Patients

There is no Need to Adjust the Daily Dose. However, Particular Caution Should be Exercised at the Beginning of Treatment.

Use in Children and Adolescents

Lercanidipine Medreg is not Recommended for Children and Adolescents Under 18 Years of Age.

Patients with Liver or Kidney Impairment

Particular Caution Should be Exercised When Starting Treatment in these Patients, and Caution Should be Exercised When Increasing the Daily Dose to 20 mg.
Lercanidipine Medreg Should not be Given to Patients with Severe Liver Impairment or Severe Kidney Impairment, Including those Undergoing Dialysis (See Section 2 "When Not to Take Lercanidipine Medreg").

Taking More than the Recommended Dose of Lercanidipine Medreg

Do not Take a Higher Dose than Prescribed. In Case of Overdose, Contact a Doctor or Go to the Emergency Department of the Nearest Hospital Immediately. Take the Medication Packaging with You. Taking Too Much of this Medication may Cause Excessive Lowering of Blood Pressure and Abnormal or Rapid Heartbeat.

Missing a Dose of Lercanidipine Medreg

If a Dose is Missed, Skip the Missed Dose and Take the Next Dose at the Usual Time.
Do not Take a Double Dose to Make Up for a Missed Dose.

Stopping Treatment with Lercanidipine Medreg

If Treatment with Lercanidipine Medreg is Stopped, High Blood Pressure may Return. Before Stopping Treatment, Consult a Doctor.
In Case of Further Doubts About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Lercanidipine Medreg can Cause Undesirable Effects, although not Everybody Gets them.

Some Undesirable Effects can be Serious. If any of the Following Symptoms Occur, Contact a Doctor Immediately:

Rare(May Affect up to 1 in 1000 Patients):

• Chest Pain (e.g., Tightness in the Chest Due to Lack of Blood to the Heart) Patients with Pre-Existing Chest Pain may Experience Increased Frequency, Duration, or Severity of these Episodes when Taking Medications from the Same Group as Lercanidipine Medreg. Isolated Cases of Heart Attack may be Observed.
• Allergic Reactions (Such as Itching, Rash, Hives)
• Fainting.

Other Possible Undesirable Effects:
Common(May Affect up to 1 in 10 Patients):

• Headache
• Fast Heartbeat, Feeling of Fast or Irregular Heartbeat (Palpitations)
• Sudden Redness of the Face, Neck, or Upper Part of the Chest (Flush)
• Swelling of the Ankles.

Uncommon(May Affect up to 1 in 100 Patients):

• Dizziness
• Low Blood Pressure
• Heartburn, Nausea, Stomach Pain
• Skin Rash, Itching
• Muscle Pain
• Frequent Urination
• Feeling of Weakness or Fatigue.

Rare(May Affect up to 1 in 1000 Patients):

• Drowsiness
• Vomiting, Diarrhea
• Hives
• More Frequent than Usual Urination
• Chest Pain.

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

• Gum Swelling, Clouding of the Fluid (During Dialysis with a Catheter Placed in the Abdominal Cavity)
• Liver Function Disorders (Detected in Blood Tests)
• Swelling of the Face, Lips, Tongue, or Throat, which may Cause Difficulty Breathing or Swallowing.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those not Mentioned in this Package Leaflet, the Patient Should Inform their Doctor or Nurse. Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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
Reporting Undesirable Effects will Help to Gather More Information on the Safety of this Medication.
Undesirable Effects can also be Reported to the Marketing Authorization Holder.

5. How to Store Lercanidipine Medreg

Keep the Medication out of Sight and Reach of Children.
Do not Store Above 25°C.
Store in the Original Packaging to Protect from Light.
Do not Use this Medication After the Expiry Date Stated on the Blister or Carton After: EXP. The Expiry Date Refers to the Last Day of the Month Stated.
Medications Should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Lercanidipine Medreg Contains

Lercanidipine Medreg, 10 mg, Film-Coated Tablets

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

Lercanidipine Medreg, 20 mg, Film-Coated Tablets

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

What Lercanidipine Medreg Looks Like and Contents of the Pack

Lercanidipine Medreg, 10 mg, Film-Coated Tablets: Yellow, Round, Biconvex Film-Coated Tablets (Approximately 6.5 ± 0.2 mm in Diameter) with a Score Line on one Side and a Smooth Surface on the Other. The Score Line on the Tablet is Only to Facilitate Breaking it to Make it Easier to Swallow, and not to Divide it into Equal Doses.
Lercanidipine Medreg, 20 mg, Film-Coated Tablets: Pink, Round, Biconvex Film-Coated Tablets (Approximately 8.5 ± 0.2 mm in Diameter) with a Score Line on one Side and a Smooth Surface on the Other. The Score Line on the Tablet is Only to Facilitate Breaking it to Make it Easier to Swallow, and not to Divide it into Equal Doses.
The Film-Coated Tablets are Supplied in Non-Transparent Blister Packs of PVC/PVDC/Aluminum, in a Cardboard Box.
Package Sizes: 7, 14, 28, 30, 35, 42, 50, 56, 60, 90, 98, or 100 Film-Coated Tablets.
Not all Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer/Importer

Marketing Authorization Holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Czech Republic:
Lercanidipine Medreg
Poland:
Lercanidipine Medreg

Date of Last Revision of the Package Leaflet: 09/2024