Package Leaflet: Information for the User

OMAPREN 20 mg Hard Capsules

Omeprazole

Read the package leaflet carefully beforestarting to take the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

1. What Omapren is and what it is used for

2. Before taking Omapren

3. How to take Omapren

4. Possible side effects

5. Storage of Omapren

6. Additional Information

Omapren contains theactive ingredient omeprazole. It belongs toagroup of medications known as “proton pump inhibitors”. These medications act by reducing the amountof acidproduced by thestomach.

Omapren isusedto treat the following diseases:

Inadults:

• “Gastroesophageal reflux disease” (GERD). In this condition, stomach acid flows into the esophagus (the tube that connects the throat to 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 is possiblethatyour doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medications known as NSAIDs (nonsteroidal anti-inflammatory drugs). Omapren can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid 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 flows into the esophagus (the tube that connects the throat to the stomach),causing pain, inflammation, and heartburn.
  In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, 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 this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not takeOmapren

• if you are allergic (hypersensitive) to omeprazole or any of the other components of Omapren.
• 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, consult your doctor or pharmacist before taking Omapren.

Be especially careful with Omapren

Omapren may mask the symptoms of other diseases.Therefore, if you experience any of the following symptoms before starting to take Omapren 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 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.
• You have had a skin reaction after treatment with a similar medication to omeprazole for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranina A)

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

When taking omeprazole, inflammation in the kidneys may occur. Signs and 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 signs.

If you take Omapren for a long period (more than 1 year), your doctor will likely perform regular check-ups. 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.Omapren may affect the mechanism of action of some medications, and some medications may affect Omapren.

Do not take Omapren if you are taking a medication that contains nelfinavir (used to treat 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)
• Fenitoin (used in epilepsy). If you are taking fenitoin, your doctor will need to monitor you when starting or stopping treatment with Omapren
• Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with Omapren
• 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 you the antibiotics amoxicillin and clarithromycin, in addition to Omapren, to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor of any other medications you are taking.

Taking Omapren with food and drinks

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

Pregnancy and breastfeeding

Before taking Omapren, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Omapren during this time.

Your doctor will decide if you can take Omapren if you are breastfeeding.

Driving and operating machinery

Omapren 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 operate machinery.

Important information about some components of Omapren

Omapren 20 mg capsules contain saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Your doctor will tell you how manycapsulesyou should take and for how long. This will depend on your condition and age.

The usual doses are indicated below.

Adults:

Treatment of symptoms ofGERD, such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the usual dose is20mgonce a day for 4‑8 weeks. Your doctor may prescribe a dose of 40mg for another 8 weeks if the esophagus has not yet healed.

• The usual dose once the esophagus has healed is 10mgonce a day.
• Ifyou do not have damage to the esophagus, the usual dose is 10mg once a day.

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

• The usual dose is 20mg 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 fully heal, the dose may be increased to40mg once a day for 4 weeks.

Treatment ofstomach ulcers(gastric ulcer):

• The usual dose is 20mg 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 fully heal, the dose may be increased to 40mg 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 40mg 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 pyloriand prevention of their recurrence:

• The usual dose is 20 mg of Omapren twice a day for a week.

• Your doctor will also tell you to 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 per 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 may take Omapren. The dose for children is based on their body weight, and your doctor will decide the correct dose.

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years old may takeOmapren. The dose for children is based on their 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 yourcapsuleswith 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 containcoated granulesthat prevent the medication from breaking down in the stomach acid. It is essential not to damage thegranules.

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 capsulesandswallowthe contentsdirectly with half a glass of waterorpour the contentsinto a glass of water without gas, a sour fruit juice (e.g., apple, orangeorpineapple) or apple sauce.
  • Always shake the mixture justbeforedrinking it (the mixture will not be transparent). Then, drink the mixture immediately or within the next30 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.

If you take more Omapren than you should

If you have taken more Omapren than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call theToxicological Information Service, phone91 562 04 20,indicating themedicationand the amount ingested.

If you forgot to take Omapren

If you forgot to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

Like all medications,Omaprencan cause side effects, although not everyone will experience them.

If you experience any ofthe following rare but serious side effects, stop taking Omapren and consult your doctor immediately:

• Sudden wheezing while breathing (sudden onset of wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with the formation of blisters or peeling. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

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), benign polyps in the stomach.
• Nausea or vomiting.

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, 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.
• Fracture of the hip, wrist, and spine.

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 intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
• 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 difficulty 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 count 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 a severe 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.

Unknown frequency

• Low magnesium levels in the blood (hypomagnesemia).
• Skin rash, possibly with joint pain.

In very rare cases, Omapren may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a general state of deterioration or fever with symptoms of local infection, such as neck pain, throat pain, or mouth 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 to provide information about the medication you are taking at that time.

If you take Omapren for more than three months, it is possible that magnesium levels in the blood may decrease. 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.

If you are taking proton pump inhibitors such as Omapren, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, or spine 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 ofside effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep out of the sight and reach of children.

• Do not use Omapren after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 86°F (30°C).

• Store this blister pack in the original packaging to protect it from moisture.

• Medicines should not be disposed of through drains or in the trash.Deposit unused packaging and medicines at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Omapren

• The active ingredient is omeprazole. Omapren capsules contain 20 mg of omeprazole.
• The other components are: sugar spheres (cornstarch and sucrose), sodium lauryl sulfate, anhydrous disodium hydrogen phosphate, mannitol, hypromellose, macrogol 6000, talc, poloxamer 80, titanium dioxide (E-171), and copolymer of methacrylic acid and ethyl acrylate.
• The gelatin capsule is composed of: gelatin, water, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the product and content of the container

Omapren 20 mg capsules are formed by a yellow opaque body and cap , in containers of 14, 28, 56, or 500 capsules .

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This leaflet was approved in March 2023

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