Package Leaflet: Information for the User

Omeprazole Cinfa 20 mg Hard Capsules (Gastro-resistant EFG)

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

omeprazol cinfa contains the active ingredient omeprazole.It belongs to a group of medicines called“proton pump inhibitors”. These medicines act by reducing the amount of acid produced by the stomach.

omeprazol cinfais used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat with the stomach), causing pain, inflammation, and burning.
• 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 possible 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). Omeprazole can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess acid in the stomachcaused 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 disorder, stomach acid passes into the esophagus (the tube that connects the throat with the stomach), causing pain, inflammation, and burning.
  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 this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take omeprazol cinfa

• If you are allergic to omeprazol or any of the other components of this medication (listed in section 6).
• If you are allergic to medications that contain proton pump inhibitors (e.g. pantoprazol, lansoprazol, rabeprazol, esomeprazol).
• If you are taking a medication that contains nelfinavir (used for HIV infection).

Do not take omeprazol if you fall into any of the above cases. If you are unsure, consult your doctor or pharmacist before taking omeprazol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazol cinfa.

Severe skin reactions have been reported in relation to omeprazol treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular psoriasis (PEGA). Stop taking omeprazol and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

• 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 omeprazol has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a similar medication to omeprazol for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranina A).

If you take omeprazol 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.

Taking a proton pump inhibitor like omeprazol, especially for more than a year, may slightly increase the risk of fractures in the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

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

Omeprazol may cause kidney inflammation. 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.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medication to children under 1 year of age or <10>

Other medications and omeprazol cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications that can be purchased without a prescription. This is becauseomeprazol may affect the mechanism of action of some medications and some medications may affect omeprazol.

Do not take omeprazol if you are taking a medication that containsnelfinavir(used to treat HIV infection).

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

• Ketoconazol, itraconazol, posaconazolor voriconazol (used to treat fungal infections).
• Digoxina (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles, or epilepsy).
• Fenitoína (used in epilepsy). If you are taking fenitoína, your doctor will need to monitor you when starting or stopping omeprazol treatment.
• Medications used to prevent blood clot formation, such as warfarina or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazol treatment.
• Rifampicina (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimús (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 preventblood clots).
• Erlotinib (used to treat cancer).
• Metotrexato (chemotherapy medication used in high doses to treat cancer) – if you are taking a high dose of metotrexato, your doctor will need to temporarily stop omeprazol treatment.

If your doctor has prescribed you the antibiotics amoxicilina and claritromicina to treat ulcers caused byHelicobacter pyloriinfection, it is essential to inform your doctor of any other medications you are taking.

Administration of omeprazol cinfa with food and beverages

You can take your capsules with food or on an empty stomach (see section 3).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Omeprazol passes into breast milk but is unlikely to affect the baby when used in therapeutic doses.

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

Driving and operating machinery

Omeprazol is unlikely to affect your ability to drive or use tools or machines. However, you may experience side effects such as dizziness and visual disturbances (see section 4). If you experience these, you should not drive or operate machinery.

Omeprazol cinfa contains saccharose

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Omeprazol cinfa contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Use in adults

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

• If your doctor checks that you have mild damage to the esophagus, the recommended 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 recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the recommended dose is 10 mg once a day.

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

• The recommended 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 recommended 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.

Prevention of the recurrence of stomach and duodenal ulcers:

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

Prevention of stomach and duodenal ulcers during the administration of NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment ofulcers caused by the infectionbyHelicobacter pyloriand prevention of its recurrence:

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

Use in children and adolescents

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

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

Treatment ofulcers caused by the infectionbyHelicobacter pyloriand prevention of its recurrence:

• Children over 4 years old may take omeprazole. The dose for children is based on body weight, and your doctor will decide on 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.

If you take more omeprazole cinfa than you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take omeprazole cinfa

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.

If you interrupt the treatment with omeprazole cinfa

Do not stop taking omeprazole without first talking to your doctor or pharmacist. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

If you experience any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking omeprazole and consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden sibilance), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• • Generalized rash, elevated body temperature, and lymph node inflammation (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare).
  • A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema). (rare).
• Yellow skin discoloration, dark urine, and fatigue, which may be symptoms of liver problems (rare).

Other side effects are:

Frequent side effects (may affect up to 1 in 10 people)

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

Infrequent side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (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 (may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Low sodium levels in the blood. May cause weakness, vomiting, and cramps.
• Restlessness, 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.
• Hair loss (alopecia).
• Rash on the skin with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal blood count, such as agranulocytosis (lack of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking omeprazole for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very poor general condition or fever with local infection symptoms, 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.

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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Blister:Do not store at a temperature above 25°C.Store in the outer packaging to protect it from moisture.

Bottle: Keep the bottle perfectly closed to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging, bottle label, or blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of omeprazole cinfa

• The active ingredient is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other components are:
• Content of the capsule:sugar spheres (saccharose, cornstarch and purified water), magnesium hydroxide and cornstarch, sodium lauryl sulfate, disodium hydrogen phosphate, mannitol (E-421), hypromellose, macrogol 6000, talc, poloxamer 80, titanium dioxide (E-171), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion, and carboxymethylcellulose sodium type A (from potato).
• Capsule coating:

Capsule cap:titanium dioxide (E-171) and gelatin.

Capsule body:iron oxide black (E-172), titanium dioxide (E-171) and gelatin.

Appearance of the product and contents of the package

Hard gelatin capsules with blue cap and white body, containing white to cream-colored microgranules.

Aluminum/Aluminum blister pack or PVC/PE/PVDC-Aluminum (triple-layer) pack. Each pack contains 14, 28, 56 or 500 (clinical pack) capsules.

HDPE bottle with screw cap and desiccant capsule. Each pack contains 14, 28 or 56 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

or

Liconsa, S.A.

Avenida Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 - Azuqueca de Henares - Spain

Last review date of this leaflet:March 2023

For detailed information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63983/P_63983.html

QR code to:https://cima.aemps.es/cima/dochtml/p/63983/P_63983.html