Esomeprazole Normon 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Esomeprazol Normon 20 mg gastro-resistant hard capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What Esomeprazol Normon is and what it is used for

Esomeprazol Normon contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazol Normon is used to treat the following conditions:

Adults:

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Gastric ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol Normon may also be used to prevent ulcers from developing if you are taking NSAIDs.

• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

• Continuation treatment to prevent rebleeding from peptic ulcer after initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol Normon

Do not take Esomeprazol Normon:

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking Esomeprazol Normon or other related medicines.

If any of these apply to you, do not take Esomeprazol Normon. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Normon.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Esomeprazol Normon:

• if you have severe liver problems.
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Normon used to reduce stomach acid.
• if you are scheduled to have a specific blood test (chromogranin A).

Esomeprazol Normon may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking Esomeprazol Normon, contact your doctor immediately:

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (stained with blood).

If Esomeprazol Normon has been prescribed only for use when symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Esomeprazol Normon, especially for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Esomeprazol Normon may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), in association with treatment with Esomeprazol Normon. Stop taking Esomeprazol Normon and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Taking Esomeprazol Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because Esomeprazol Normon may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Normon.

Do not take Esomeprazol Normon if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform your doctor if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol Normon.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Normon.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Normon.
• Tacrolimus (used in organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St. John’s wort (Hypericum perforatum) (used for depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazol Normon to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol Normon with food and drink

You may take the capsules with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can take Esomeprazol Normon during this period.

It is not known whether Esomeprazol Normon passes into breast milk. Therefore, Esomeprazol Normon should not be taken during breastfeeding.

Driving and using machines

Esomeprazol Normon is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

Esomeprazol Normon contains saccharose

Esomeprazol Normon contains sugar spheres that contain saccharose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Esomeprazol Normon

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).

• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many capsules to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are indicated below.

Adults from 18 years of age

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one 40 mg Esomeprazol Normon capsule daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one 20 mg Esomeprazol Normon capsule once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg Esomeprazol Normon capsule once daily. Once your condition is under control, your doctor may instruct you to take the medicine only when symptoms occur, up to a maximum of one 20 mg Esomeprazol Normon capsule per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg Esomeprazol Normon capsule twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg Esomeprazol Normon capsule once daily for 4 to 8 weeks.

To prevent gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg Esomeprazol Normon capsule once daily.

For the treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg Esomeprazol Normon capsule twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment to prevent rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg Esomeprazol Normon capsule once daily for 4 weeks.

Use in adolescents from 12 years of age

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one gastro-resistant 40 mg Esomeprazol Normon capsule daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one gastro-resistant 20 mg Esomeprazol Normon capsule once daily.
• If your esophagus is not affected, the recommended dose is one gastro-resistant 20 mg Esomeprazol Normon capsule once daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one gastro-resistant 20 mg Esomeprazol Normon capsule twice daily for one week. Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

How to take this medicine

• You may take the capsules at any time of day.
• You may take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain granules that protect the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the capsules:

• Open the capsule and empty the granules into half a glass of still (non-carbonated) water. Do not use other liquids.

• Stir the mixture and drink it immediately or within 30 minutes. Always stir just before drinking.

• To ensure you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

  • If you are unable to swallow at all, the granules can be mixed with a small amount of water and drawn into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

Children under 12 years of age

Esomeprazol Normon is not recommended for children under 12 years of age.

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Normon than you should

If you take more Esomeprazol Normon than your doctor has prescribed, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol Normon

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.

• Do not take a double dose (two doses at the same time) to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop taking Esomeprazol Normon and contact a doctor immediately:

• Sudden difficulty breathing, swelling of lips, tongue and throat, or swelling of the whole body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Red skin with blisters or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. These could be signs of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These effects are rare and may affect up to 1 in 1,000 people.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling or numbness, drowsiness.
• Dizziness or vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, itching.
• Fracture of the hip, wrist, or spine (if Esomeprazol Normon is used at high doses and for a prolonged period).

Rare (may affect up to 1 in 1,000 patients)

• Blood disorders such as decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in blood. This may cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden feeling of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the esophagus.
• Liver problems including jaundice, which may cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 patients)

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. These symptoms may be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Breast enlargement in men.

Frequency not known (frequency cannot be estimated from available data)

• If you are being treated with Esomeprazol Normon for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (which may lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Normon may affect white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in such cases, you inform your doctor about the medication you are taking.

Reporting of adverse effects

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

5. Storage of Esomeprazole Normon

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

• 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.

• Blister packs: No special storage temperature conditions are required. Store in the original packaging to protect from moisture.

• Bottle: Do not store above 30°C. Keep the container tightly closed to protect from moisture. The product should be used within 200 days of the first opening of the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Esomeprazole Normon

• The active substance is esomeprazole.

Esomeprazole Normon capsules contain 20 mg of esomeprazole (as sodium salt).

The other components are:

Contents of the capsule:

Sugar spheres (sodium carboxymethylstarch (from maize) and sucrose), methylcellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid copolymer and triethyl citrate.

Capsule shell:

Carrageenan, potassium chloride, iron oxide red (E-172), titanium dioxide (E171), hypromellose and printing ink (containing shellac, potassium hydroxide and black iron oxide E-172).

Appearance of the product and contents of the pack

Esomeprazole Normon 20 mg are opaque light pink hard capsules, size 4 (approximately 14 mm), printed (head "ES", body "20"), containing spherical granules.

Esomeprazole Normon 20 mg is available in:

Aluminum/Aluminum blisters:

7, 14, 15, 28, 30, 56, 60, 90 (2x45), and 100 (2x50) capsules

White opaque polyethylene (PE) bottles, containing silica gel as desiccant, with an inseparable polyethylene (PE) screw cap:

7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100 and 500 capsules

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Manufacturer:

TOWA Pharmaceutical Europe S.L.

C/ de Sant Martí, 75-97

Martorelles, 08107 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2025

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/81797/P_81797.html

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This information is intended for healthcare professionals only:

Administration via nasogastric or gastric tube

1. Add the contents of one capsule into approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml of water is required to avoid pellet blockage of the tube). Shake.
2. Empty the suspension into a syringe and add approximately 5 ml of air.
3. Immediately shake the syringe for about 2 minutes to disperse the pellets.
4. Hold the syringe with the tip facing upwards and check that the tip is not blocked.
5. Connect the syringe to the tube while maintaining the previous position.
6. Shake the syringe and position it with the tip facing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip facing upwards to prevent blockage of the tip).
7. Turn the syringe back with the tip facing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
8. Fill the syringe with 25 ml of water and 5 ml of air, and repeat step 6 if necessary to flush any remaining sediment from the syringe. For some tubes, 50 ml of water may be required.

Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.