Normogastrol 20 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normogastrol 20 mg gastro-resistant tablets

Pantoprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• You should not use Normogastrol 20 mg gastro-resistant tablets for more than 4 weeks without consulting a doctor.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult a doctor if your condition worsens or if you do not improve after 14 days.

Leaflet contents

1. What Normogastrol is and what it is used for
2. What you need to know before taking Normogastrol
3. How to take Normogastrol
4. Possible side effects
5. How to store Normogastrol
6. Contents of the pack and other information

1. What Normogastrol is and what it is used for

Normogastrol 20 mg contains the active substance pantoprazole, which blocks the acid-producing "pump" in the stomach. Therefore, this medicine reduces the amount of acid in the stomach.

Normogastrol 20 mg is used for the short-term treatment of reflux symptoms (for example: heartburn and acid regurgitation) in adults.

Reflux is the backward flow of acid from the stomach into the throat (esophagus), which can cause inflammation and pain. This may cause symptoms such as a painful burning sensation in the chest, which may extend up to the throat (heartburn), and a sour taste in the mouth (acid regurgitation).

You may notice relief from acid reflux and heartburn symptoms after one day of treatment with Normogastrol 20 mg, but this does not mean the medicine provides immediate relief. It may be necessary to take the tablets for 2–3 consecutive days before symptom relief occurs.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before starting to take Normogastrol

? Do not take Normogastrol

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of Normogastrol 20 mg (listed in section 6 “Composition of Normogastrol”).
• If you are taking any medication containing atazanavir (used to treat HIV infection).
• If you are under 18 years of age.
• 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 daily treatment for dyspepsia without a prescription.
• If you are over 55 years old and experience new symptoms or symptoms that have recently changed.
• 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 due to severe discomfort or illness.
• If you are scheduled to undergo 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 used to reduce stomach acid.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue 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 prolonged periods, additional risks may occur, such as: decreased levels of magnesium in the blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate). In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. You should consult your doctor if you have been taking this medication for more than 4 weeks. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of a more serious condition:

• Unintentional weight loss (not related to diet or exercise).
• Vomiting, especially if repeated.
• Blood in the vomit, which may appear as dark coffee-ground-like material.
• Blood in your stools, which may appear black or tarry.
• Difficulty swallowing or pain when swallowing.
• You look 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 risk of infectious diarrhea.

Your doctor may decide that further tests are necessary.

If you are scheduled for a blood test, inform your doctor that you are taking this medicine.

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

If you have experienced symptoms of dyspepsia or heartburn repeatedly over time, remember to visit your doctor periodically.

Before taking this medicine, inform your doctor if:

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

? Use of Normogastrol with other medicines

Normogastrol 20 mg may prevent other medicines from working properly.

Inform your doctor if you are taking any medicine containing any of the following active substances:

• ketoconazole (used to treat fungal infections)
• warfarin or phenprocoumon (used to thin the blood and prevent clot formation). You may require additional blood tests.
• atazanavir (used to treat HIV infection). You must not take Normogastrol 20 mg if you are taking atazanavir.

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

However, if necessary, Normogastrol 20 mg may be taken together with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations).

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

? Use of 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 operate machinery if you experience adverse effects such as dizziness or blurred vision.

Normogastrol contains sodium

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

3. How to take Normogastrol

Follow exactly the instructions for use of Normogastrol 20 mg described in this leaflet or those provided by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Take one tablet daily. 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 symptom-free. You may notice relief from acid reflux symptoms and heartburn after one day of treatment with Normogastrol 20 mg, but this does not mean the medicine provides immediate relief.

If you do not experience symptom relief 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 some water. Do not chew or break the tablet.

Use in children and adolescents

Normogastrol 20 mg must not be used in children or in individuals under 18 years of age.

? If you take more Normogastrol than you should

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

Symptoms of overdose are not known.

? If you forget to take Normogastrol

Do not take a double dose to make up for missed doses. Take the next dose at the usual time on the following day.

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

4. Possible adverse effects

Like all medicines, Normogastrol 20 mg can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately or go to the nearest hospital emergency department if you notice any of the following adverse effects. Stop taking this medicine immediately, but bring this leaflet and/or the tablets with you.

• Severe allergic reactions (rare): hypersensitivity reactions, also known as anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue, and/or throat, which may cause difficulty swallowing or breathing; hives (urticaria); severe dizziness with very 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, rapid deterioration in your general health, or skin rash after exposure to sunlight.
• Other serious adverse effects (frequency unknown): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain when urinating, lower back pain with fever.
  • Tingling, prickling, paresthesia (tingling), burning or numbness (frequency not known)

Adverse effects may occur with varying frequency, described as follows:

• very common: affects more than 1 in 10 people.

• common: affects 1 to 10 in 100 people.

• uncommon: affects 1 to 10 in 1,000 people.

• rare: affects 1 to 10 in 10,000 people.

• very rare: affects fewer than 1 in 10,000 people.

• frequency not known: cannot be estimated from available data.

• Common adverse effects:

Benign gastric polyps.

• Uncommon adverse effects:

Headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence; 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 adverse effects:

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

• Very rare adverse effects:

Disorientation; decreased platelet count in the blood, which may lead to increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; concurrent abnormal reduction in red blood cells, white blood cells, and platelets (observed in blood tests).

• Frequency not known:

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, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Normogastrol 20 mg, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Inflammation of the large intestine causing persistent watery diarrhoea.

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

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this leaflet, inform 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 packaging.

Expiry

Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Normogastrol

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

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

Appearance of the product and contents of the pack

Normogastrol 20 mg is presented as orange-colored, oval, biconvex gastro-resistant tablets, available in packs 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 reviewed in July 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/