Esomeprazole Normon 40 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazol Normon 40 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 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 side 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 stomach acid flows back up into the esophagus (the tube that goes from the throat to the stomach), causing pain, inflammation, and heartburn.

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

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

Adolescents from 12 years of age:

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

2. What you need to know before starting to take Esomeprazol Normon

Do not take Esomeprazol Normon:

• If you are allergic to esomeprazole or to 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 or peeling of the skin, blistering, or mouth ulcers after taking Esomeprazol Normon or other related medicines.

If any of these situations 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 a lot of weight without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

If Esomeprazol Normon has been prescribed only to treat symptoms as they occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Esomeprazol Normon, particularly 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 it may be necessary to stop treatment with Esomeprazol Normon. Remember to mention any other symptoms you may notice, such as joint pain.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Esomeprazol Normon. Stop taking Esomeprazol Normon and seek immediate medical attention if you notice any symptoms related to these serious 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 interrupt your treatment with Esomeprazol Normon.
• Tacrolimus (organ transplant).
• 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 time.

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, rare or very rare adverse effects such as dizziness or blurred vision may occur (see section 4). You should not drive or use machines 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 diagnosed you with an intolerance to certain sugars, consult 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 you should 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 mildly 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of excessive stomach acid caused by a pancreatic tumor (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 for prevention of 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 mildly 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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 prevent 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 all the medication, 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 cannot 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 the lips, tongue, throat or entire body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Red skin with blisters or peeling. There may also be severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals. This could be "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 swollen 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 disturbance (insomnia).
• Dizziness, tingling or numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, skin itching.
• Fracture of hip, wrist, or spine (if Esomeprazol Normon is used at high doses and for a long 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 cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Eye disorders such as blurred vision.
• Sudden sensation 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 yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• 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).
• Aggression.
• 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 manifest 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 potassium or calcium levels 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 worsening of 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 this case, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Esomeprazol 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 conditions regarding temperature 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 first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Normon

-The active substance is esomeprazole.

Esomeprazol Normon capsules contain 40 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

Esomeprazol Normon 40 mg are opaque pink hard capsules, size 2 (approximately 18 mm), printed (cap ES/body 40), containing spherical granules.

Esomeprazol Normon 40 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 tamper-evident polyethylene (PE) screw cap:

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

Only some 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 latest review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product 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 medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/81798/P_81798.html

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This information is intended exclusively for healthcare professionals:

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 vigorously 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 (the syringe must be kept with the tip facing upwards to prevent blockage of the tip).
7. Reposition the syringe 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 residue 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.