Omeprazol normon 20 mg capsulas duras gastrorresistentes efg

PATIENT INFORMATION LEAFLET

Omeprazole NORMON 20 mg Hard Capsules EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same.
• If you think you have suffered a side effect, you can help us by reporting it at the following website www.mhra.gov.uk/yellowcard.

OmeprazolNormoncontains the active ingredient omeprazole. It belongs to a group of medicinesknown as “proton pump inhibitors”. These medicines work by reducing the amount of acid produced by the stomach.

Omeprazol is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this condition, stomach acid flows

into the esophagus (the tube that connects the throat with the stomach), causing pain, inflammation, and heartburn.

• Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, it ispossible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs).

Omeprazol can also be used to prevent the formation of ulcers if you are takingNSAIDs.

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

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastroesophageal reflux disease” (GERD). In this condition, stomach acid flowsinto the esophagus (the tube that connects the throat withthe stomach), causing pain, inflammation, and heartburn.In children, the symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has thisdisease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Omeprazol Normon

• If you are allergic (hypersensitive) to omeprazole or any of the other components of omeprazole.
• If you are allergic to medications that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazol, esomeprazole).
• If you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking omeprazole.

Be especially careful with Omeprazol Normon

Omeprazole may mask the symptoms of other diseases. Therefore, if you experience any of the following symptoms before starting to take this medication or during treatment, consult your doctor immediately:

• You lose weight significantly without apparent reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained stools).
• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• If you have ever had a skin reaction after treatment with a similar medication to omeprazole for reducing stomach acidity.

• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with this medication. Remember to mention any other symptoms you may notice, such as joint pain.

If you take omeprazole for a long period (more than 1 year), your doctor will likely perform regular check-ups. You must inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Omeprazole may affect the mechanism of action of some medications, and some medications may affect omeprazole.

Do not take omeprazole if you are taking a medication that contains nelfinavir (used for HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles, or epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment.
• Medications used to prevent blood clot formation, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of organ transplantation).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor of any other medications you are taking.

Warnings and precautions

Before taking this medication, inform your doctor if:

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

Omeprazole may cause inflammation in the kidneys. Symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these symptoms.

Taking omeprazol normon with food and drinks

You can take your capsules with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medication. Your doctor will decide if you can take omeprazole during this time.

.

Driving and operating machinery

Omeprazole is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Important information about some components of Omeprazol Normon

This medication contains lactose and sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking the medication.

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

Follow exactly the administration instructions for omeprazole indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The usual doses are indicated below.

Adults:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The usual dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the usual dose is 10 mg once a day.

Treatment ofulcers in the upper part of the small intestine (duodenal ulcer):

• The usual dose is 20 mg once a day for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment ofstomach ulcers (gastric ulcer):

• The usual dose is 20 mg once a day for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof the recurrence ofstomach and duodenal ulcers:

• The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of stomach and duodenal ulcers caused by NSAIDs (nonsteroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The usual dose is 20 mg once a day.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of theirrecurrence:

• The usual dose is 20 mg of omeprazole twice a day for a week.
• Your doctor will also indicate that you take two antibiotics, amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by atumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medication.

Children:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

• Children over one year of age who weigh more than 10 kg can take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of theirrecurrence:

• Children over 4 years old can take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin, and clarithromycin, for your child.

How to take this medication

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules that prevent the medication from breaking down in the stomach acid.It is essential not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

• If you or your child have trouble swallowing the capsules:
• • Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water without gas, a sour fruit juice (e.g., apple, orange, or pineapple) or apple sauce.
  • Always shake the mixture just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
  • To ensure that all the medication has been taken, fill the glass of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

What to do if you take more OmeprazolNormonthan you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

What to do if you forget to take OmeprazolNormon

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

Like all medications, omeprazole may cause side effects, although not everyone will experience them.Not everyone will experience them.

If you notice any of the following rare but serious side effects, stop taking omeprazole and consult your doctor immediately:

grave).

This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare side effects

• Blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections. Allergic reactions, sometimes very severe, including swelling of the lips, tongue, andthroat, fever, and sibilant breathing.

• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" that can affect the intestines and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and

fatigue.

• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Blood abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and inflammation of the brain.
• Sudden appearance of intense skin rash, blistering, or peeling of the skin.

This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Muscle weakness.
• Enlargement of the breasts in men.

In rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a generalverydeteriorated state or fever with symptoms of local infection, such as neck pain, throat pain, orbuccal pain or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential that at that moment you provide information about the medication you are taking.

Side effects of unknown frequency

If you are taking omeprazole 20 mg hard-gastrorresistant capsules 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 have any of these symptoms, go to 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.

Skin rash, possibly with joint pain.

If you are taking proton pump inhibitors such as omeprazole 20 mg hard-gastrorresistant capsules, especially for a period of more than a year, you may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they can increase the risk of osteoporosis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment

Omeprazol Normon Composition

• The active ingredient is omeprazole. Omeprazol Normon capsules contain 20 mg of omeprazole.

• The other components (excipients) are sucrose, cornstarch, lactose, hypromellose, hydroxypropylmethylcellulose, sodium lauryl sulfate, dodecahydrate disodium phosphate, phthalate, and diethyl phthalate. The gelatin capsule is composed of: gelatin, erythrosine (E-127), indigo carmine (E-132), and titanium dioxide (E-171).

Product Appearance and Packaging Contents

Omeprazol Normon 20 mg capsules are red/white in color.

Blister packs containing 14, 28, 56, or 500 capsules.

Omeprazol Normon is presented in the form of hard gelatin capsules containing gastro-resistant microgranules of omeprazole, in packs containing 14, 28, 56, or 500 capsules.

Marketing Authorization Holder and Responsible Manufacturer

LABORATORIOS NORMON, S.A.

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

Last Review Date of this Leaflet: June 2023

Further detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/