NORMOGASTROL 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before taking Normogastrol

Do not take Normogastrol

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Normogastrol 20 mg (listed in section 6 "Composition of Normogastrol").
• If you are taking any medicine that contains atazanavir (for the treatment of HIV infection).
• If you are under 18 years old.
• If you are pregnant or breastfeeding.

Warnings and Precautions

Consult your doctor first:

• If you have received treatment for heartburn or dyspepsia continuously for 4 or more weeks.
• If you are over 55 years old and take a daily treatment for dyspepsia without a prescription.
• If you are over 55 years old and have new or recently changed symptoms.
• If you have previously had a gastric ulcer or stomach surgery.
• If you have liver problems or jaundice (yellowing of the skin or eyes).
• If you regularly visit your doctor for severe discomfort or illness.
• If you are going to have an endoscopy or a test called a urea breath test.
• If you have ever had a skin reaction after treatment with a medicine similar to Normogastrol 20 mg to reduce stomach acid.
• If you suffer a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Normogastrol 20 mg. Remember to mention any other symptoms you may notice, such as joint pain.

If you take Normogastrol 20 mg for longer periods, there may be additional risks such as: decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in the blood. You should consult your doctor if you have been taking this medicine for more than 4 weeks. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelybefore or after taking this medicine, if you notice any of the following symptoms, which could be signs of a more serious illness:

• Involuntary weight loss (not related to any diet or exercise).
• Vomiting, especially if it is repeated.
• Blood in the vomit, which may appear as dark coffee grounds in the vomit.
• You notice blood in your stools, which may appear black or like tar.
• Difficulty swallowing or pain when swallowing.
• You are pale or feel weak (anemia).
• Chest pain.
• Stomach pain.
• Severe and/or persistent diarrhea, as Normogastrol 20 mg has been associated with a slight increase in the occurrence of infectious diarrhea.

Your doctor may decide that it is necessary to perform some tests.

If you are going to have a blood test, inform your doctor that you are taking this medicine.

You may notice relief from acid reflux symptoms and heartburn after one day of treatment with Normogastrol 20 mg, but this does not mean that the medicine will provide immediate relief. You should not take it as a preventive measure.

If you have suffered from dyspepsia or heartburn symptoms repeatedly for some time, remember to visit your doctor periodically.

Before taking this medicine, tell your doctor if:

• You are scheduled to have a specific blood test (Chromogranin A).

Using Normogastrol with other medicines

Normogastrol 20 mg may prevent other medicines from working properly.

Tell your doctor if you are using any medicine that contains any of the following active substances:

• Ketoconazole (used to treat fungal infections)
• Warfarin or phenprocoumon (used to make blood more liquid and prevent clot formation). You may have additional blood tests.
• Atazanavir (used to treat HIV infection). You should not use Normogastrol 20 mg if you are taking atazanavir.

Do not take Normogastrol 20 mg with other medicines that limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazol, lansoprazol, or rabeprazol) or an H2 antagonist (e.g., ranitidine, famotidine).

However, if necessary, you can take Normogastrol 20 mg with antacids (e.g., magaldrate, alginate acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations).

Tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription. This also includes herbal or homeopathic treatments.

Using Normogastrol with food and drinks

The tablets should be swallowed whole, with some liquid before a meal.

Pregnancy and breastfeeding

Do not take Normogastrol 20 mg if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Normogastrol contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Normogastrol

Follow the instructions for taking Normogastrol 20 mg described in this leaflet or as indicated by your doctor or pharmacist. If you are in doubt, ask your doctor or pharmacist.

Take one tablet per day. Do not exceed the recommended dose of 20 mg of pantoprazole per day.

You should take this medicine for at least two or three consecutive days. Stop taking Normogastrol 20 mg when you are completely free of symptoms. You may notice relief from acid reflux symptoms and heartburn after one day of treatment with Normogastrol 20 mg, but this does not mean that the medicine will provide immediate relief.

If you do not notice relief from symptoms after taking this medicine for 2 consecutive weeks, consult your doctor.

Do not take Normogastrol 20 mg tablets for more than 4 weeks without consulting your doctor.

Take the tablet before one of the main meals, at the same time every day. You should swallow the tablet whole with a little water. Do not chew or break the tablet.

Use in children and adolescents

Normogastrol 20 mg should not be used in children or adolescents under 18 years old.

If you take more Normogastrol than you should

Inform your doctor or pharmacist immediately. If possible, take your medicine and this leaflet with you.

No symptoms of overdose are known.

If you forget to take Normogastrol

Do not take a double dose to make up for forgotten doses. Take the normal dose the next day, at the usual time.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normogastrol 20 mg can cause side effects, although not everyone gets them.

Tell your doctor immediatelyor contact the emergency department of the nearest hospital if you notice any of the following side effects. Stop taking this medicine immediately, but take this leaflet and/or the tablets with you.

• Severe allergic reactions (rare): hypersensitivity reactions, also called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue, and/or throat, which can cause difficulty swallowing or breathing, hives (urticaria), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown): skin rash with swelling, blistering, or peeling of the skin, skin loss, and bleeding around the eyes, nose, mouth, or genitals, and rapid deterioration of your general health, or skin rash after sun exposure.
• Other serious side effects (frequency unknown): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain when urinating and pain in the lower back with fever.
  • Feeling of tingling, prickling, paresthesia (tingling), burning, or numbness (frequency unknown)

Side effects may occur with a certain frequency, and are described as follows:

• Very common: affects more than 1 in 10 patients.
• Common: affects 1 to 10 patients in 100.
• Uncommon: affects 1 to 10 patients in 1,000.
• Rare: affects 1 to 10 patients in 10,000.
• Very rare: affects less than 1 patient in 10,000.
• Frequency unknown: cannot be estimated from available data.

• Common side effects:

Benign polyps in the stomach.

• Uncommon side effects:

Headache; dizziness; diarrhea; nausea, vomiting; swelling and flatulence (gas); constipation; dry mouth; stomach discomfort and pain; hives or skin rash; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; increased liver enzymes in blood tests.

• Rare side effects:

Distortion or complete loss of taste; vision disorders such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs; allergic reactions; depression; increased bilirubin and fat levels in the blood (detected in blood tests), increased breast size in men; high fever and sudden drop in circulating granulocytes (observed in blood tests).

• Very rare side effects

Disorientation, decreased platelet count in the blood, which can lead to more frequent bleeding or bruising than usual; decreased white blood cell count, which can lead to more frequent infections; coexistence of an abnormal reduction in the number of red blood cells, white blood cells, and platelets (observed in blood tests).

• Frequency unknown

Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood.

If you are taking Normogastrol 20 mg for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Normogastrol 20 mg, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Inflammation of the large intestine that causes persistent watery diarrhea.

If you experience any side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you think any of the side effects you are suffering from are serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Normogastrol

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original package.

Expiration Date

Do not use this medicine after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Normogastrol

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (sodium sesquihydrate).
• The other ingredients are:

Sodium carbonate, mannitol, sodium carmellose, sodium starch glycolate (from gluten-free potato), magnesium stearate, colloidal silica, propylene glycol, yellow iron oxide (E-172), titanium dioxide (E-171), hypromellose, triethyl citrate, and methacrylic acid - ethyl acrylate copolymer (1:1).

Appearance of the Product and Package Contents

Normogastrol 20 mg is presented in the form of orange, oval, and biconvex gastro-resistant tablets, which are available in packages of 7 and 14 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was last revised in July 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)http://www.aemps.es/