Noacid

Package Leaflet: Information for the Patient

Noacid, 40 mg, Gastro-Resistant Tablets

Pantoprazole

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, Pharmacist, or Nurse.
• This Medication has been Prescribed Specifically for You. Do not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same as Yours.
• If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Noacid 40 mg and what is it used for
• 2. Important Information Before Taking Noacid 40 mg
• 3. How to Take Noacid 40 mg
• 4. Possible Undesirable Effects
• 5. How to Store Noacid 40 mg
• 6. Package Contents and Other Information

1. What is Noacid 40 mg and what is it used for

Noacid 40 mg Gastro-Resistant Tablets Contain the Active Substance Pantoprazole. Pantoprazole is a Selective
“Proton Pump Inhibitor,” a Medication that Reduces Stomach Acid Secretion. It is Used to Treat Stomach and Intestinal Diseases Associated with Excessive Acid Secretion.

Noacid 40 mg is Used to Treat:

Adults and Adolescents Aged 12 Years and Older:

• Gastroesophageal Reflux Disease. Treatment of Esophagitis (Inflammation of the Esophagus) with Accompanying Acid Reflux.

Adults:

• Infection with the Bacterium Helicobacter pyloriin Patients with Gastric and Duodenal Ulcer Disease in Combination with Two Antibiotics (Eradication Therapy) to Eliminate the Bacteria and Prevent Ulcer Recurrence.
• Gastric and Duodenal Ulcer Disease.
• Zollinger-Ellison Syndrome and Other Conditions Associated with Excessive Acid Secretion.

2. Important Information Before Taking Noacid 40 mg

When Not to Take Noacid 40 mg Tablets

• If the Patient is Allergic to Pantoprazole, Soybeans, or Soybean Oil, or any of the Other Ingredients of this Medication (Listed in Section 6).
• If the Patient is Allergic to Medications Containing Other Proton Pump Inhibitors.

Warnings and Precautions

Before Starting Noacid 40 mg, Discuss with a Doctor or Pharmacist.

• If the Patient is Scheduled for a Specific Blood Test (Chromogranin A Levels).
• If the Patient has Severe Liver Impairment. Inform the Doctor if the Patient has Ever had Liver Impairment, Especially if the Patient has been Taking Noacid 40 mg for a Long Time. If Liver Enzyme Levels Increase, the Medication should be Discontinued.
• If the Patient has a Vitamin B12 Deficiency or Risk Factors for Reduced Vitamin B12 Levels, and is Being Treated Long-Term with Pantoprazole. Like all Medications that Reduce Gastric Acid Secretion, Pantoprazole may Lead to Reduced Vitamin B12 Absorption.
• If the Patient is Taking HIV Protease Inhibitors such as Atazanavir (Used to Treat HIV Infection), the Patient should Consult a Doctor for Detailed Advice.
• Taking a Proton Pump Inhibitor like Noacid 40 mg, Especially for a Period Longer than One Year, may Slightly Increase the Risk of Hip, Wrist, or Spine Fracture. Inform the Doctor if the Patient has Osteoporosis (Reduced Bone Density) or if the Doctor has Informed the Patient that the Patient is at Risk of Osteoporosis (e.g., if the Patient is Taking Steroid Medications).
• If the Patient has been Taking Noacid 40 mg for More than 3 Months, Low Blood Magnesium Levels may Occur. Low Magnesium Levels may Cause Fatigue, Muscle Cramps, Seizures, Dizziness, and Rapid Heart Rate. If these Symptoms Occur, Inform a Doctor Immediately. Low Magnesium Levels may also Lead to Low Potassium or Calcium Levels in the Blood. The Doctor may Decide to Perform Regular Blood Tests to Monitor Magnesium Levels.
• If the Patient has Ever Experienced a Skin Reaction After Taking a Medication that Reduces Stomach Acid.
• If the Patient Develops a Skin Rash, Especially in Areas Exposed to the Sun, Inform a Doctor Immediately, as it may be Necessary to Discontinue Noacid 40 mg. Also, Inform the Doctor about any Other Undesirable Effects, such as Joint Pain.

Inform a Doctor Immediately if the Following Symptoms Occur, which may be Signs of More Serious Diseases:

• - Unintentional Weight Loss;
• Vomiting, Especially Recurring;
• Bloody Vomiting, which may Appear as Dark Coffee Grounds;
• Blood in Stool, Black or Tarry Stool;
• Difficulty Swallowing or Pain when Swallowing;
• Pallor and Weakness (Anemia);
• Chest Pain;
• Abdominal Pain;
• Severe and/or Persistent Diarrhea, as Noacid 40 mg may be Associated with a Small Increased Risk of Infectious Diarrhea.

The Treating Doctor may Decide to Perform Tests to Rule out a Malignant Disease, as Pantoprazole Treatment may Mask the Symptoms of a Malignant Disease and Delay its Diagnosis. If Symptoms Persist Despite Treatment, Further Tests should be Considered.
In Case of Long-Term Use of Noacid 40 mg (More than 1 Year), the Patient will Probably be Under Regular Medical Supervision. In this Case, Inform the Doctor about any New or Unexpected Symptoms and their Onset during Each Visit.

Children and Adolescents

Noacid 40 mg is not Recommended for Use in Children Under 12 Years of Age Due to Limited Safety and Efficacy Data in this Age Group.

Noacid 40 mg and Other Medications

Inform a Doctor about all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take, as Noacid 40 mg may Affect the Efficacy of Other Medications. Therefore, Inform a Doctor if the Patient is Taking:

• Medications such as Ketoconazole, Itraconazole, or Posaconazole (Used to Treat Fungal Infections) or Erlotinib (Used to Treat Certain Types of Cancer), as Noacid 40 mg may Inhibit the Proper Function of these and Other Medications,
• Warfarin and Phenprocoumon (Medications Used to Prevent Blood Clots), as there may be a Need for Further Tests,
• HIV Treatments such as Atazanavir,
• Methotrexate (Used to Treat Rheumatoid Arthritis, Psoriasis, and Cancer) - if the Patient is Taking Methotrexate, the Doctor may Temporarily Discontinue Noacid Treatment, as Pantoprazole may Increase Methotrexate Levels in the Blood,
• Fluvoxamine (Used to Treat Depression and Other Mental Health Conditions) - if the Patient is Taking Fluvoxamine, the Doctor may Reduce the Dose,
• Rifampicin (Used to Treat Infections),
• St. John's Wort (Hypericum perforatum) Used to Treat Mild Depression.

Pregnancy, Breastfeeding, and Fertility

There are no Adequate Data on the Use of Pantoprazole in Pregnant Women. The Active Substance of the Medication has been Shown to Pass into Breast Milk.
If the Patient is Pregnant or Breastfeeding, or Thinks they may be Pregnant, or is Planning to have a Child, they should Consult a Doctor or Pharmacist Before Taking this Medication.
The Medication should only be Used if the Doctor Considers that the Benefits to the Patient Outweigh the Potential Risk to the Unborn Child or Infant.

Driving and Using Machines

Pantoprazole has no or Negligible Influence on the Ability to Drive and Use Machines.
Do not Drive or Operate Machinery if the Patient Experiences Undesirable Effects such as Dizziness or Visual Disturbances.

Noacid 40 mg Contains Soybean Lecithin, Maltitol, and Sodium

Do not Take this Medication if the Patient is Hypersensitive to Peanuts or Soybeans.
If the Doctor has Informed the Patient of Intolerance to some Sugars, Consult a Doctor Before Taking this Medication.
The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, i.e., it is Considered “Sodium-Free”.

3. How to Take Noacid 40 mg

Always Take this Medication Exactly as the Doctor or Pharmacist has Told the Patient. If the Patient is Uncertain, they should Consult a Doctor or Pharmacist.

When and How to Take Noacid 40 mg

Take the Medication 1 Hour Before a Meal, Without Chewing or Breaking the Tablet. Swallow Whole, with Water.
If the Doctor has not Prescribed a Different Dosage, the Recommended Dose is:
Adults and Adolescents Aged 12 Years and Older:

In the Treatment of Gastroesophageal Reflux Disease:

The Recommended Dose is One Tablet per Day. The Doctor may Increase the Dose to 2 Tablets per Day. The Treatment Period for Gastroesophageal Reflux Disease is Usually 4 to 8 Weeks. The Doctor will Decide How Long the Patient should Take the Medication.
Adults:
In the Treatment of Infection with the Bacterium Helicobacter pyloriin Patients with Duodenal and Gastric Ulcer Disease in Combination with Two Antibiotics (Eradication Therapy):
One Tablet Twice a Day plus Two Antibiotic Tablets: Amoxicillin, Clarithromycin, or Metronidazole (or Tinidazole) Taken Twice a Day with a Pantoprazole Tablet. The First Pantoprazole Tablet should be Taken 1 Hour Before Breakfast, and the Second Pantoprazole Tablet 1 Hour Before Dinner. Follow the Doctor's Instructions and Read the Patient Information Leaflets in the Antibiotic Packages. The Treatment is Usually Taken for 1 to 2 Weeks.

In the Treatment of Gastric and Duodenal Ulcers:

The Recommended Dose is One Tablet per Day. After Consulting a Doctor, the Dose may be Doubled. The Doctor will Decide How Long the Patient should Take the Medication. The Treatment Period for Gastric Ulcers is Usually 4 to 8 Weeks. The Treatment Period for Duodenal Ulcers is Usually 2 to 4 Weeks.

In Long-Term Treatment of Zollinger-Ellison Syndrome and Other Conditions Associated with Excessive Acid Secretion:

The Recommended Initial Dose is Usually Two Tablets per Day.
Both Tablets should be Taken 1 Hour Before a Meal. Later, the Dosage may be Adjusted by the Doctor, Depending on the Amount of Acid Secreted in the Stomach. If More than Two Tablets per Day are Prescribed, they should be Taken Twice a Day.
If the Doctor Prescribes a Daily Dose Higher than Four Tablets per Day, they will Inform the Patient When to Stop Taking the Medication.

Special Patient Groups:

Patients with Renal Impairment

• If the Patient has Kidney Disease, they should not Take Noacid 40 mg for Helicobacter pyloriEradication.

Patients with Hepatic Impairment

• If the Patient has Moderate or Severe Liver Disease, they should not Take Noacid 40 mg for Helicobacter pyloriEradication.
• If the Patient has Severe Liver Disease, they should not Take More than One 20 mg Pantoprazole Tablet per Day (20 mg Tablets are Available for this Purpose).

Use in Children and Adolescents

Noacid 40 mg is not Recommended for Use in Children Under 12 Years of Age.

Taking More than the Recommended Dose of Noacid 40 mg

Consult a Doctor or Pharmacist. The Symptoms of Overdose are not Known.

Missing a Dose of Noacid 40 mg

Do not Take a Double Dose to Make up for a Missed Dose. Take the Next Dose at the Usual Time.

Stopping Noacid 40 mg Treatment

Do not Stop Taking the Tablets Without Consulting a Doctor or Pharmacist.
If the Patient has any Further Questions on the Use of this Medication, they should Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

If the Patient Experiences any of the Following Undesirable Effects, they should Immediately Inform a Doctor or Contact the Nearest Emergency Department:

• - Severe Allergic Reactions (Rare - May Affect up to 1 in 1,000 Patients):Swelling of the Tongue and/or Throat, Difficulty Swallowing, Hives, Difficulty Breathing, Allergic Swelling of the Face (Quincke's Edema/Anaphylactic Edema), Severe Dizziness with Rapid Heart Rate and Excessive Sweating.
• - Severe Skin Reactions (Frequency Unknown - Frequency Cannot be Estimated from the Available Data):the Patient may Notice One or More of the Following Symptoms - Blistering of the Skin and Rapid Deterioration of General Condition, Ulcers in the Eyes, Nose, Mouth, and/or Genital Area, or a Rash, Especially on Sun-Exposed Skin Areas. Joint Pain or Flu-Like Symptoms, Fever, Swollen Lymph Nodes (e.g., in the Armpits), and Changes in Blood Test Results may also Occur (Stevens-Johnson Syndrome, Lyell's Syndrome, Erythema Multiforme, Subacute Cutaneous Lupus Erythematosus, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Hypersensitivity to Light).
• - Other Severe Reactions (Frequency Unknown):Yellowing of the Skin and Eyes (Severe Liver Damage, Jaundice) or Fever, Rash, and Kidney Problems Manifested by Enlargement of the Kidneys, Sometimes with Pain when Urinating and Pain in the Lower Back (Severe Kidney Inflammation, which may Lead to Kidney Failure).

Other Undesirable Effects:

• - Common(May Affect up to 1 in 10 Patients) Mild Gastric Polyps.
• - Uncommon(May Affect up to 1 in 100 Patients) Headache, Dizziness, Diarrhea, Nausea, Vomiting, Feeling of Fullness in the Abdomen and Flatulence, Constipation, Dry Mouth, Abdominal Pain and Discomfort, Skin Rash, Redness, Skin Inflammation (Caused by Infection), Itching, Weakness, Fatigue, or General Feeling of Illness, Sleep Disturbances, Hip, Wrist, or Spine Fracture.
• - Rare(May Affect up to 1 in 1,000 Patients) Taste Disturbances or Complete Loss of Taste, Visual Disturbances such as Blurred Vision, Hives, Joint Pain, Muscle Pain, Weight Changes, Elevated Body Temperature, Peripheral Edema (Swelling of the Extremities), Allergic Reactions, Depression, Breast Enlargement in Men.
• - Very Rare(May Affect up to 1 in 10,000 Patients)

Disorientation.

• - Frequency Unknown(Frequency Cannot be Estimated from the Available Data) Hallucinations, Confusion (Especially in Patients who have Experienced these Symptoms Before), Tingling, Numbness, or Burning Sensation, Skin Rash Sometimes with Joint Pain. Colitis (Inflammation of the Colon) that Causes Persistent Watery Diarrhea.

Undesirable Effects Identified by Blood Tests:

• - Uncommon(May Affect up to 1 in 100 Patients) Elevated Liver Enzyme Activity.
• - Rare(May Affect up to 1 in 1,000 Patients) Elevated Bilirubin Levels, Elevated Blood Lipid Levels, Sudden Decrease in White Blood Cell Count with High Fever.
• - Very Rare(May Affect up to 1 in 10,000 Patients) Decreased Platelet Count, which may Cause Frequent Bleeding and Bruising, Decreased White Blood Cell Count, which may Increase the Risk of Infections, Concurrent Abnormal Decrease in Red and White Blood Cell and Platelet Counts.
• - Frequency Unknown(Frequency Cannot be Estimated from the Available Data) Decreased Sodium, Magnesium, Calcium, or Potassium Levels in the Blood (See Section 2).

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, they should Inform a Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 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 this Medication.

5. How to Store Noacid 40 mg

Keep the Medication out of Sight and Reach of Children.
The Medication does not Require Special Storage Conditions.
Tablets Packaged in Plastic Bottles: Noacid 40 mg can be Used for 3 Months After Opening the Package.
Do not Use this Medication After the Expiration Date (Month and Year) Stated on the Blister Pack and Carton After “Expiration Date (EXP)”. The Expiration Date Refers to the Last Day of the Specified Month.
Do not Use this Medication if Visible Signs of Deterioration are Observed.
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 Noacid 40 mg Contains

The Active Substance of the Medication is Pantoprazole. Each Gastro-Resistant Tablet Contains 40 mg of Pantoprazole (as Pantoprazole Sodium Sesquihydrate).
The Other Ingredients are:
Tablet Core:
Maltitol (E 965), Crospovidone Type B, Sodium Carboxymethylcellulose, Anhydrous Sodium Carbonate (E 500), Calcium Stearate.
Tablet Coating:
Polyvinyl Alcohol, Talc (E 553b), Titanium Dioxide (E 171), Macrogol 3350, Soybean Lecithin (E 322), Yellow Iron Oxide (E 172), Anhydrous Sodium Carbonate (E 500), Methacrylic Acid and Ethyl Acrylate Copolymer (1:1), Triethyl Citrate (E 1505).

What Noacid 40 mg Looks Like and Package Contents

Noacid 40 mg Tablets are Yellow, Oval, Gastro-Resistant Tablets with a Length of 10.3 mm and a Diameter of 5.5 mm.
Noacid 40 mg is Available in Packages Containing 7, 14, 28 Tablets in Blisters and in Packages Containing 7, 14, 28 Tablets in Bottles.
Not all Package Sizes may be Marketed.

Marketing Authorization Holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Hungary (RMS): Noacid 40 mg gyomornedv-ellenálló tabletta
Bulgaria:
Ноацид 40 mg стомашно-устойчиви таблетки
Noacid 40 mg gastro-resistant tablets
Poland:
Noacid
Romania:
Noacid 40 mg comprimate gastro-rezistente

Date of Last Revision of the Package Leaflet: 18.11.2021