ESOMEPRAZOL NORMON 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Normon 20 mg Gastro-Resistant Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Esomeprazol Normon contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazol Normon is used to treat the following conditions:

Adults:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers of the duodenum (the tube leading out of the stomach) caused by bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Stomach ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Normon can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
• Treatment of NSAID-induced peptic ulcers after intravenous esomeprazole sodium.

Adolescents from 12 years of age:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers of the duodenum (the tube leading out of the stomach) caused by bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take 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 proton pump inhibitor medicines (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV).
• If you have ever had a skin reaction such as a severe rash with blistering, peeling or bleeding of the skin after taking Esomeprazol Normon or other medicines used to reduce stomach acid.

If any of the above apply to you, do not take Esomeprazol Normon. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazol Normon.

Warnings and precautions

Tell your doctor or pharmacist before taking 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 that reduces stomach acid.
• If you are due to have an operation to check your stomach (endoscopy) or a specific blood test.

Esomeprazol Normon may hide the symptoms of other diseases. Therefore, if you notice any of the following, contact your doctor immediately:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If your doctor has prescribed Esomeprazol Normon only when you have symptoms, you should contact your doctor if your symptoms persist or change.

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

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazol Normon. Remember to also mention any other symptoms that you may have such as joint pain or fever.

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with Esomeprazol Normon. Stop taking Esomeprazol Normon and contact your doctor immediately if you get any of the symptoms described in section 4.

Taking Esomeprazol Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Esomeprazol Normon can affect the way some medicines work and some medicines can increase the chance of you getting side effects.

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

Tell your doctor if you are taking:

• Atazanavir (used to treat HIV).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungi).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Esomeprazol Normon.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Normon.
• Cilostazol (used to treat intermittent claudication – a condition where the leg does not get enough blood when walking).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your Esomeprazol Normon treatment.
• Tacrolimus (used to prevent organ rejection after transplant).
• Rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat depression).

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

Taking Esomeprazol Normon with food and drink

You can take the capsules with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazol Normon during this time.

It is not known if Esomeprazol Normon passes into breast milk. Therefore, you should not take Esomeprazol Normon if you are breast-feeding.

Driving and using machines

Esomeprazol Normon is unlikely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol Normon contains sucrose

Esomeprazol Normon contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Esomeprazol Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you are taking it for more than a year).

• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

How much to take

• Your doctor will tell you how many capsules to take and when to take them. This will depend on your condition, age and kidney function.
• The recommended doses are given below.

Adults aged 18 years and over

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Esomeprazol Normon 40 mg capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once your oesophagus has healed, the recommended dose is one Esomeprazol Normon 20 mg capsule once a day.
• If your oesophagus is not damaged, the recommended dose is one Esomeprazol Normon 20 mg capsule once a day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazol Normon 20 mg capsule per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pylori infection and to stop them coming back:

• The recommended dose is one Esomeprazol Normon 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one Esomeprazol Normon 20 mg capsule once a day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

For the treatment of too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one Esomeprazol Normon 40 mg capsule twice a day. Your doctor will adjust the dose depending on your needs and also decide how long you will need to take the medicine for. The maximum dose is two Esomeprazol Normon 80 mg capsules per day.

Treatment of NSAID-induced peptic ulcers after intravenous esomeprazole sodium:

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

Use in adolescents aged 12 years and over

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one Esomeprazol Normon 40 mg gastro-resistant capsule once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• Once your oesophagus has healed, the recommended dose is one Esomeprazol Normon 20 mg gastro-resistant capsule once a day.
• If your oesophagus is not damaged, the recommended dose is one Esomeprazol Normon 20 mg gastro-resistant capsule once a day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pylori infection and to stop them coming back:

• The recommended dose is one Esomeprazol Normon 20 mg gastro-resistant capsule twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

Taking this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the capsules:

• Open the capsule and swallow the contents with half a glass of non-fizzy water. Do not use other liquids.
• Stir the mixture and drink it immediately or within 30 minutes. Always stir well before drinking.
• To make sure that you have taken all the medicine, rinse the glass with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush them.
• If you cannot swallow at all, the contents of the capsule can be mixed with a little water and put into a syringe. It can then be given through a nasogastric tube.

Children under 12 years of age

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

Elderly

No dose adjustment is necessary for the elderly.

If you take more Esomeprazol Normon than you should

If you have taken more Esomeprazol Normon than you should, talk to your doctor or pharmacist straight away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the national toll free poison help line at 91 562 04 20, indicating the medicine and the amount taken.

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, skip the missed dose.

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

If you have any further questions on 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 all people suffer from them.

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

• A sudden difficulty breathing, swelling of lips, tongue, and throat or body in general, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. This could be a "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems.
• Widespread rash, high body temperature, and enlargement of 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:

Frequent(may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: 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.
• Disruption of sleep (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Fracture of the 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 a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that can cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

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

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that can lead to liver failure or brain inflammation.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms can be accompanied by high fever and pain in the joints. (Erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.

Frequency Not Known(frequency cannot be estimated from available data)

• If you are treated with Esomeprazol Normon for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium or calcium levels. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Inflammation of the intestine (can lead to diarrhea).
• Skin rash, possibly with pain in the joints.

In very rare cases, Esomeprazol Normon can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of your general condition or fever with symptoms of a local infection such as pain in the neck, throat, mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the 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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

-Blister:No special temperature storage conditions are required. Keep in the original packaging to protect it from moisture.

-Bottle:Do not store at a temperature above 30°C. Keep the container perfectly closed to protect it from moisture. The product must be used within 200 days after the first opening of the bottle.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Normon

-The active ingredient is esomeprazole.

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

The other ingredients are:

Contents of the capsule:

Sugar spheres (carboxymethylcellulose sodium (from corn) 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, red iron oxide (E-172), titanium dioxide (E171), hypromellose, and printing ink (containing shellac, potassium hydroxide, and black iron oxide E-172).

Appearance of the Product and Package Contents

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

Esomeprazol Normon 20 mg is available in:

Aluminum/Aluminum blister packs:

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

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

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

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). 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 only for healthcare professionals:

Administration through a nasogastric or gastric tube

1. Add the contents of a capsule to approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml of water is required to avoid clogging the tube). Shake.
2. Empty the suspension into a syringe and add approximately 5 ml of air.
3. Shake the syringe immediately for approximately 2 minutes to disperse the pellets.
4. Hold the syringe with the tip up and check that the tip is not clogged.
5. Connect the syringe to the tube while maintaining the previous position.
6. Shake the syringe and place it with the tip down. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to avoid clogging the tip).
7. Put the syringe back with the tip down and inject immediately 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 sediment remaining in the syringe. For some tubes, 50 ml of water are required.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.