Esomeprazol Tova

Package Leaflet: Information for the Patient

Esomeprazol Towa, 20 mg, Gastro-Resistant Capsules

Esomeprazol Towa, 40 mg, Gastro-Resistant Capsules

Esomeprazolum

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

• Keep this Package Leaflet, as 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 Esomeprazol Towa and what is it Used for
• 2. Important Information Before Taking Esomeprazol Towa
• 3. How to Take Esomeprazol Towa
• 4. Possible Undesirable Effects
• 5. How to Store Esomeprazol Towa
• 6. Package Contents and Other Information

1. What is Esomeprazol Towa and what is it Used for

Esomeprazol Towa Contains the Active Substance Esomeprazole, which Belongs to a Group of Medications Called Proton Pump Inhibitors. The Action of these Medications Involves Reducing the Amount of Acid Produced by the Stomach.

Esomeprazol Towa is Used in the Following Cases:

Adults

• Gastroesophageal Reflux Disease, which Involves the Reflux of Acidic Stomach Contents into the Esophagus (the Tube Connecting the Throat to the Stomach), Causing Pain, Inflammation, and Heartburn.
• Stomach Ulcer or Duodenal Ulcer with Helicobacter pylori Infection. If the Patient has Experienced such Symptoms, the Doctor may also Prescribe Antibiotics to Treat the Infection and Allow the Ulcer to Heal.
• Stomach Ulcer Caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Esomeprazol Towa may also be Used to Prevent Stomach Ulcers During NSAID Therapy.
• Excessive Acid in the Stomach Caused by a Tumor in the Pancreas (Zollinger-Ellison Syndrome).
• Prolonged Treatment After Preventing Rebleeding from Ulcers with Intravenous Esomeprazole.

Adolescents Aged 12 and Older

• Gastroesophageal Reflux Disease, which Involves the Reflux of Acidic Stomach Contents into the Esophagus (the Tube Connecting the Throat to the Stomach), Causing Pain, Inflammation, and Heartburn.
• Stomach Ulcer or Duodenal Ulcer with Helicobacter pylori Infection. If the Patient has Experienced such Symptoms, the Doctor may also Prescribe Antibiotics to Treat the Infection and Allow the Ulcer to Heal.

2. Important Information Before Taking Esomeprazol Towa

Do not Take Esomeprazol Towa

• If the Patient is Allergic to Esomeprazole or any of the other Ingredients of this Medication (listed in Section 6).
• If the Patient is Allergic to other Proton Pump Inhibitors (e.g., Pantoprazole, Lansoprazole, Rabeprazole, Omeprazole).
• If the Patient is Taking a Medication Containing Nelfinavir (used to Treat HIV Infection)

Do not Take Esomeprazol Towa if any of the Above Situations Apply to the Patient. In Case of Doubts, Consult a Doctor or Pharmacist Before Taking Esomeprazol Towa.

Warnings and Precautions

Before Taking Esomeprazol Towa, Consult a Doctor or Pharmacist:

• If the Patient has Severe Liver Disease
• If the Patient has Severe Kidney Disease
• If the Patient has a Vitamin B12 Deficiency
• If the Patient has Ever Experienced a Skin Reaction After Taking a Medication that Reduces Stomach Acid
• If the Patient is Scheduled to Undergo a Specific Blood Test (chromogranin A)

Esomeprazol Towa may Mask the Symptoms of other Diseases. Therefore, it is Essential to Immediately
Inform the Doctor about the Following Symptoms that Occur Before or During Treatment with Esomeprazol Towa:

• Significant Unintentional Weight Loss and Difficulty Swallowing.
• Abdominal Pain or Indigestion.
• Vomiting Food or Blood.
• Black Stools (with Blood).

In Case of Taking Esomeprazol Towa on an as-Needed Basis, the Patient Should Consult a Doctor if the Symptoms do not Improve or Change.

When Taking Proton Pump Inhibitors, such as Esomeprazol Towa, Especially for a Period Longer than one Year, the Risk of Osteoporosis-Related Fractures of the Hip, Wrist, or Spine may Increase. The Patient Should Inform their Doctor if they have been Diagnosed with Osteoporosis or are Taking Corticosteroids (which may Increase the Risk of Osteoporosis).

If the Patient Experiences a Skin Rash, Especially in Areas Exposed to Sunlight, they Should Inform their Doctor as Soon as Possible, as it may be Necessary to Discontinue Esomeprazol Towa.

The Patient Should also Inform their Doctor about any other Undesirable Effects, such as Joint Pain.

Other Medications and Esomeprazol Towa

Inform the Doctor or Pharmacist about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications they Plan to Take. Esomeprazol Towa may Interact with Certain other Medications, and other Medications may Affect the Action of Esomeprazol Towa.

Do not Take Esomeprazol Towa if the Patient is also Taking Nelfinavir (used to Treat HIV Infection).

Inform the Doctor if the Patient is Taking any of the Following Medications:

• Atazanavir (used to Treat HIV Infection)
• Clopidogrel (used to Prevent Blood Clots)
• Ketoconazole, Itraconazole, or Voriconazole (used to Treat Fungal Infections)
• Erlotinib (used to Treat Cancer)
• Citalopram, Imipramine, or Clomipramine (used to Treat Depression)
• Diazepam (used to Treat Anxiety, as a Muscle Relaxant, or for Epilepsy)
• Phenytoin (used to Treat Epilepsy). If the Patient is Taking Phenytoin, they Should be Monitored by their Doctor when Starting or Stopping Esomeprazol Towa.
• Medications used to Thin the Blood, such as Warfarin - the Patient may be Monitored by their Doctor when Starting or Stopping Esomeprazol Towa.
• Cilostazol (used to Treat Intermittent Claudication - Pain in the Legs when Walking due to Poor Blood Circulation)
• Cisapride (used to Treat Indigestion and Heartburn)
• Digoxin (used to Treat Heart Conditions)
• Methotrexate (a Chemotherapy Medication used to Treat Cancer) - if the Patient is Taking High Doses of Methotrexate, their Doctor may Temporarily Discontinue Esomeprazol Towa.
• Tacrolimus (used After Organ Transplantation)
• Rifampicin (used to Treat Tuberculosis)
• St. John's Wort (Hypericum perforatum) (used to Treat Depression)

In Case of Concurrent Use of Amoxicillin and Clarithromycin with Esomeprazol Towa for the Treatment of Ulcers Caused by Helicobacter pylori Infection, it is Crucial to Inform the Doctor about all other Medications being Taken.

Esomeprazol Towa with Food and Drink

The Capsules can be Taken with or Without Food.

Pregnancy and Breastfeeding

If the Patient is Pregnant, Thinks they may be Pregnant, or is Planning to have a Baby, they Should Consult their Doctor or Pharmacist Before Taking this Medication. The Doctor will Decide whether to Prescribe Esomeprazol Towa.

There is no Data on the Passage of Esomeprazol Towa into Breast Milk, so it is not Recommended to Take Esomeprazol Towa During Breastfeeding.

Driving and Operating Machinery

It is Unlikely that Esomeprazol Towa will Affect the Ability to Drive or Operate Tools and Machinery. However, Rarely or Occasionally, Undesirable Effects such as Dizziness and Blurred Vision may Occur (see Section 4). If these Symptoms Occur, the Patient Should not Drive or Operate Machinery.

Esomeprazol Towa Contains Sugar

Esomeprazol Towa Contains Sugar Coated Pellets, which Contain Sucrose, a Type of Sugar. If the Patient has been Diagnosed with Intolerance to some Sugars, they Should Consult their Doctor Before Taking this Medication.

Esomeprazol Towa Contains Sodium

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

3. How to Take Esomeprazol Towa

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

• In Case of Long-Term Use (especially for a Period Longer than one Year), Medical Monitoring may be Necessary.
• If the Doctor has Prescribed the Medication to be Taken as Needed, the Patient Should Inform their Doctor about any Changes in Symptoms.

Dosage

• The Doctor will Decide on the Dosage and Duration of Treatment. The Dosage Depends on the Patient's Condition, Age, and Liver Function.
• Typically Recommended Dosages are Listed Below.

Adults Aged 18 and Older

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease:

• For Patients with Mild Esophageal Damage, the Typically Recommended Dosage is 40 mg of Esomeprazol Towa Once a Day for 4 Weeks. If the Esophagus has not Healed, the Doctor may Prescribe the Same Dosage for an Additional 4 Weeks.
• Typically Recommended Dosage After Esophageal Healing is 20 mg of Esomeprazol Towa Once a Day.
• If the Esophagus was not Damaged, the Typically Recommended Dosage of Esomeprazol Towa is 20 mg Once a Day. After Symptom Relief, the Doctor may Prescribe the Medication to be Taken as Needed in a Dosage of up to 20 mg Once a Day.
• In Case of Severe Liver Disease, the Doctor may Prescribe a Lower Dosage of the Medication.

Treatment of Ulcer Disease Caused by Helicobacter pylori Infection and Prevention of Disease Recurrence:

• Typically Recommended Dosage is 20 mg of Esomeprazol Towa Twice a Day for 1 Week.
• The Doctor will also Prescribe Antibiotics, such as Amoxicillin and Clarithromycin.

Treatment of Stomach Ulcers Associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• Typically Recommended Dosage is 20 mg of Esomeprazol Towa Once a Day for 4 to 8 Weeks.

Prevention of Stomach Ulcers During Non-Steroidal Anti-Inflammatory Drug (NSAID) Therapy:

• Typically Recommended Dosage is 20 mg of Esomeprazol Towa Once a Day.

Treatment of Excessive Acid in the Stomach Caused by a Tumor in the Pancreas (Zollinger-Ellison Syndrome):

• Typically Recommended Dosage is 40 mg of Esomeprazol Towa Twice a Day.
• The Doctor will Adjust the Dosage According to the Patient's Needs and Decide on the Duration of Treatment. The Maximum Dosage of the Medication is 80 mg Twice a Day.

Prolonged Treatment After Preventing Rebleeding from Ulcers with Intravenous Esomeprazole:

• Typically Recommended Dosage is 40 mg of Esomeprazol Towa Once a Day for 4 Weeks.

Adolescents Aged 12 and Older

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease:

• For Patients with Mild Esophageal Damage, the Typically Recommended Dosage is 40 mg of Esomeprazol Towa Once a Day for 4 Weeks. If the Esophagus has not Healed, the Doctor may Prescribe the Same Dosage for an Additional 4 Weeks.
• Typically Recommended Dosage After Esophageal Healing is 20 mg of Esomeprazol Towa Once a Day.
• If the Esophagus was not Damaged, the Typically Recommended Dosage of Esomeprazol Towa is 20 mg Once a Day.
• In Case of Severe Liver Disease, the Doctor may Prescribe a Lower Dosage of the Medication.

Treatment of Ulcer Disease Caused by Helicobacter pylori Infection and Prevention of Disease Recurrence:

• Typically Recommended Dosage is 20 mg of Esomeprazol Towa Twice a Day for 1 Week. The Doctor will also Prescribe Antibiotics, such as Amoxicillin and Clarithromycin.

Administration of Esomeprazol Towa

• The Capsules can be Taken at any Time of Day.
• The Capsules can be Taken with or Without Food.
• The Capsules Should be Swallowed Whole, with a Glass of Water. The Capsules Should not be Chewed or Crushed, as they Contain Pellets with a Protective Coating that Resists the Action of Stomach Acid. It is Very Important not to Damage the Pellets.

What to do if the Patient has Difficulty Swallowing the Capsules

• If the Patient has Difficulty Swallowing the Capsules:
• 1. Carefully Open the Capsule and Pour the Pellets into a Glass of Water, Filled to the Halfway Point, with Non-Carbonated Water. Do not Use any other Liquids.
• 2. Stir. Then Drink the Mixture Immediately, or Within 30 Minutes. Always Stir Before Drinking.
• 3. To Ensure that the Entire Dose is Taken, Refill the Glass with Water to the Halfway Point and Drink. The Undissolved Solid Residue Contains the Medication - do not Chew or Crush it.
• If the Patient is Unable to Swallow, the Contents of the Capsule Should be Mixed with Water and Drawn into a Syringe, then Administered Through a Nasogastric Tube.

Children and Adolescents Under 12 Years of Age

Esomeprazol Towa is not Recommended for Use in Children Under 12 Years of Age.

Elderly Patients

No Dosage Adjustment is Necessary in Elderly Patients.

Overdose of Esomeprazol Towa

In Case of Overdose, the Patient Should Immediately Consult a Doctor or Pharmacist.

Missed Dose of Esomeprazol Towa

• If a Dose is Missed, the Patient Should Take it as Soon as Possible. However, if the Next Dose is Due, the Missed Dose Should be Omitted.
• The Patient Should not Take a Double Dose (two Doses at the Same Time) to Make up for the Missed Dose.

In Case of any Further Doubts about Taking this Medication, the Patient Should Consult their Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Esomeprazol Towa can Cause Undesirable Effects, although not Everyone will Experience them.

If the Patient Experiences any of the Following Undesirable Effects, they Should Stop Taking Esomeprazol Towa and Immediately Consult their Doctor:

These Include:

• Wheezing, Swelling of the Lips, Tongue, or Throat, or Body, Rash, Fainting, or Difficulty Swallowing (Severe Allergic Reaction).
• Redness of the Skin with Blisters or Peeling, which may also be Accompanied by Blisters and Bleeding from the Lips, Eyes, Mouth, Nose, and Genital Area. These may be Symptoms of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.
• Yellowing of the Skin, Dark Urine, and Fatigue, which may be Symptoms of Liver Disease.

These Undesirable Effects are Rare and Affect Less than 1 in 1000 Patients.

Other Undesirable Effects:

Common (may Affect up to 1 in 10 People)

• Headache
• Effects on the Stomach or Intestines: Diarrhea, Abdominal Pain, Constipation, Bloating (with Gas).
• Nausea or Vomiting.
• Mild Stomach Polyps.

Uncommon (may Affect up to 1 in 100 People)

• Swelling of the Feet and Ankles.
• Sleep Disturbances (Insomnia).
• Dizziness, Tingling, Drowsiness.
• Dizziness (Feeling of Spinning).
• Dry Mouth.
• Changes in Blood Test Results Indicating Liver Function.
• Skin Rash, Urticaria (Hives), Itching.
• Fractures of the Hip, Wrist, or Spine (if Esomeprazol Towa is Taken in High Doses and for a Long Time).

Rare (may Affect up to 1 in 1000 People)

• Blood Disorders, such as a Decrease in White Blood Cells or Platelets. This may Cause Weakness, Easy Bruising, and Increased Risk of Infection.
• Low Sodium Levels in the Blood. This may Cause Weakness, Vomiting, and Muscle Cramps.
• Feeling of Excitement, Disorientation, or Depression.
• Taste Disorders.
• Vision Disorders, such as Blurred Vision.
• Sudden Shortness of Breath or Difficulty Breathing (Bronchospasm).
• Mouth Inflammation.
• Fungal Infection of the Intestines.
• Liver Disease, Including Jaundice, which may Cause Yellowing of the Skin, Dark Urine, and Fatigue.
• Hair Loss (Alopecia).
• Skin Rash that may be Associated with Sunlight Exposure.
• Joint Pain or Muscle Pain.
• General Feeling of Illness and Lack of Energy.
• Excessive Sweating.

Very Rare (may Affect up to 1 in 10,000 People)

• Blood Disorders, Including Agranulocytosis (a Decrease in White Blood Cells)
• Aggression.
• Hallucinations (Seeing, Hearing, or Feeling Things that are not There).
• Severe Liver Disease Leading to Liver Failure and Encephalopathy.
• Sudden Onset of Severe Rash or Blisters, or Peeling of the Skin. These Symptoms may be Accompanied by High Fever and Joint Pain (Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Muscle Weakness.
• Severe Kidney Disease.
• Enlarged Breasts in Men.

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

• If Esomeprazol Towa is Taken for a Period Longer than Three Months, there is a Possibility of a Decrease in Magnesium Levels in the Blood. Low Magnesium Levels may Cause Fatigue, Involuntary Muscle Contractions, Disorientation, Seizures, Dizziness, and Rapid Heart Rate. If the Patient Experiences any of these Symptoms, they Should Immediately Inform their Doctor. Low Magnesium Levels may also Lead to a Decrease in Potassium or Calcium Levels in the Blood. The Doctor may Recommend Regular Blood Tests to Monitor Magnesium Levels.
• Intestinal Inflammation (Leading to Diarrhea).
• Skin Rash that may be Associated with Joint Pain.

In Very Rare Cases, Esomeprazol Towa may Adversely Affect White Blood Cells, Leading to a Decrease in Immunity. If the Patient Experiences Infections with Symptoms such as Fever with a Very Bad Feeling, or Fever with Local Signs of Infection, they Should Immediately Consult their Doctor for Blood Tests to Rule out Agranulocytosis (a Decrease in White Blood Cells). It is Very Important to Inform the Doctor about Taking Esomeprazol Towa.

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, Including those not Mentioned in this Package Leaflet, they Should Inform their Doctor or Pharmacist. Undesirable 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. Undesirable Effects can also be Reported to the Marketing Authorization Holder.

Reporting Undesirable Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Esomeprazol Towa

• The Medication Should be Stored in a Place that is not Accessible to Children.
• Do not Use this Medication After the Expiration Date Shown on the Carton, Container, or Blister. The Expiration Date Refers to the Last Day of the Specified Month.
• Blister: Store at a Temperature not Exceeding 30°C. Store in the Original Package to Protect from Moisture.
• Container: Store at a Temperature not Exceeding 30°C. Store the Container Tightly Closed to Protect from Moisture.
• Container: Shelf Life After First Opening: 200 Days.
• Medications Should not be Disposed of via Wastewater or Household Waste. The Patient Should Ask their Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Esomeprazol Towa Contains

• The Active Substance is Esomeprazole. Esomeprazol Towa is Available in Two Strengths, Containing 20 mg or 40 mg of Esomeprazole (in the Form of Esomeprazole Sodium)
• Other Ingredients are: Capsule Contents: Sucrose, Pellets (Containing Corn Starch and Sucrose), Methylcellulose, Talc, Titanium Dioxide (E 171), Glycerol Monostearate, Polysorbate 80, Sodium Lauryl Sulfate, Methacrylic Acid-Ethyl Acrylate Copolymer, Triethyl Citrate.

Capsule Shell:

Carrageenan, Potassium Chloride, Iron Oxide, Red (E 172), Titanium Dioxide (E 171), Hypromellose, Purified Water, Ink (Containing Shellac, Potassium Hydroxide, and Iron Oxide, Black (E 172)).

What Esomeprazol Towa Looks Like and Contents of the Package

• Esomeprazol Towa, 20 mg, Gastro-Resistant Capsules: Capsules with a Non-Transparent Light Pink Cap and Body, Size 4 (Length Approximately 14 mm), with the Imprint: on the Cap ES/ on the Body 20, Containing Spherical Pellets.
• Esomeprazol Towa, 40 mg, Gastro-Resistant Capsules: Capsules with a Non-Transparent Pink Cap and Body, Size 2 (Length Approximately 18 mm), with the Imprint: on the Cap ES/ on the Body 40, Containing Spherical Pellets.

Esomeprazol Towa, 20 mg, Gastro-Resistant Capsules are Available in the Following Packages:

OPA/Aluminum/PE Blister with a Desiccant/Aluminum:

7, 14, 28, 56 Capsules, in a Cardboard Box.

White Non-Transparent Polyethylene (PE) Container with a Polyethylene Cap and a Security Ring:

14, 28, 56 Capsules, in a Cardboard Box.

Esomeprazol Towa, 40 mg, Gastro-Resistant Capsules are Available in the Following Packages:

OPA/Aluminum/PE Blister with a Desiccant/Aluminum:

7, 14, 28, 56 Capsules, in a Cardboard Box.

White Non-Transparent Polyethylene (PE) Container with a Polyethylene Cap and a Security Ring:

14, 28, 56 Capsules, in a Cardboard Box.

Not all Package Sizes may be Marketed.

Marketing Authorization Holder

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/de Sant Marti 75-97, Martorelles,

08107 Barcelona,

Spain

Date of Last Revision of the Package Leaflet

Information Intended for Healthcare Professionals Only:

Administration Through a Gastric Tube

• 1. Add the Contents of the Capsule to Approximately 25 ml or 50 ml of Water. (For Certain Types of Gastric Tubes, it is Necessary to Mix the Pellets with 50 ml of Water to Avoid Clogging the Tube). Stir.
• 2. Draw the Suspension into a Syringe and Add Approximately 5 ml of Air.
• 3. Immediately Shake the Syringe for Approximately 2 Minutes to Mix the Pellets.
• 4. Invert the Syringe and Check if it is Clogged.
• 5. Connect the Syringe to the Gastric Tube, Keeping it Upright.
• 6. Shake the Syringe and Position it so that the Tip is Pointing Downwards. Immediately Inject 5-10 ml into the Gastric Tube. After Injection, Invert the Syringe and Shake (the Syringe Must be Inverted with the Tip Pointing Upwards to Avoid Clogging).
• 7. Invert the Syringe and Position it so that the Tip is Pointing Downwards, and Immediately Inject the Next 5-10 ml into the Gastric Tube. Repeat this Procedure Until the Syringe is Completely Empty.
• 8. Fill the Syringe with 25 ml of Water and 5 ml of Air, and if Necessary, Repeat Step 6 to Rinse the Residue Remaining in the Syringe. For Certain Types of Gastric Tubes, it may be Necessary to Add 50 ml of Water.

Any Unused Product or Waste Material Should be Disposed of in Accordance with Local Regulations.