OMEPRAZOL CINFA 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

omeprazol cinfa 20 mg hard gastro-resistant 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 pack

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

1. What is omeprazol cinfa and what is it used for

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

omeprazol cinfa is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers caused by a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole may also be used to prevent ulcers if you are taking NSAIDs.
• 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” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include reflux of stomach contents into the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

Ulcers caused by a bacterium called Helicobacter pylori. If your child has 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 omeprazol cinfa

Do not take omeprazol cinfa

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Do not take omeprazol if you are among any of the above cases. If you are not sure, talk to your doctor or pharmacist before taking omeprazol.

Warnings and precautions

Talk to your doctor or pharmacist before taking omeprazol cinfa.

Serious skin reactions have been reported with omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Stop taking omeprazol and contact your doctor immediately if you experience any of these symptoms related to serious skin reactions described in section 4.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained feces).
• If 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 medicine similar to omeprazole to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A).

If you take omeprazol for a long period (more than 1 year), your doctor will probably perform regular check-ups. You should report any new or unusual symptoms and circumstances whenever you visit your doctor.

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

If you experience a skin rash, especially in areas of the skin exposed to the sun, 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, kidney inflammation may occur. The 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. You should report these signs to your doctor.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and omeprazol cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because omeprazole may affect the way some medicines work and some medicines may affect omeprazole.

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

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with omeprazol.
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment with omeprazol.
• 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 (thrombi)).
• Erlotinib (used to treat cancer).
• Methotrexate (chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with omeprazol.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform them of any other medicines you are taking.

Taking omeprazol cinfa with food and drinks

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

Pregnancy and breast-feeding

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.

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

Your doctor will decide whether you can take omeprazol if you are breast-feeding.

Driving and using machines

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 this happens, do not drive or use machines.

omeprazol cinfa contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

omeprazol cinfa contains sodium

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

3. How to take omeprazol cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 GORD, such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild esophageal damage, the recommended dose is 20 mg once daily 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 daily.
• If you do not have esophageal damage, the recommended dose is 10 mg once daily.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily 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 daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily 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 daily for 8 weeks.

Preventionof the recurrence of gastric and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of gastric and duodenal ulcers caused by NSAIDs:

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

Prevention of gastric and duodenal ulcersduring NSAID therapy:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of recurrence:

• The recommended dose is 20 mg of omeprazole twice daily for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

Treatment of excess acid in the stomach caused by a tumor 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 decide how long you need to take the medicine.

Use in children and adolescents

Treatment of symptoms of GORD, such as heartburn and acid regurgitation

• Children over 1 year of age who weigh more than 10 kg can take omeprazole. The dose for children is based on body weight and the doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of recurrence:

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

How to take this medicine

• 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 medicine from being broken down by the acid in the stomach. It is important 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 non-carbonated water, acidic fruit juice (e.g. apple, orange, or pineapple), or apple sauce.
• Always shake the mixture well before drinking it (the mixture will not be transparent). Then drink the mixture immediately or within 30 minutes.
• To make sure you have taken all the medicine, fill the glass with water, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more omeprazol cinfa than you should

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

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

If you forget to take omeprazol cinfa

If you forget 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 forgotten doses.

If you stop taking omeprazol cinfa

Do not stop taking omeprazol without talking to your doctor or pharmacist first. If you have any further questions on the use of this product, 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 notice 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 whistling when breathing (sudden wheezing), 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. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• • Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS or drug hypersensitivity syndrome). (rare).
  • A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems (rare).

Other side effects are:

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

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

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Rare side effects (may affect up to 1 in 1,000 people)

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash when exposed 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 counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).
• If you are treated with omeprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction 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 can affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as neck, throat, 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 that you provide information about the medication you are taking at that time.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Cinfa

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

Blister pack: Do not store above 25°C. Store in the outer packaging to protect from moisture.

Bottle: Keep the bottle tightly closed to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging, label, or blister pack after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazole Cinfa

• The active ingredient is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other ingredients are:
• Capsule content: sugar spheres (sucrose, corn starch, and purified water), magnesium hydroxide, and corn starch, sodium lauryl sulfate, disodium hydrogen phosphate, mannitol (E-421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion at 30%, and sodium carboxymethyl starch type A (potato).
• Capsule shell:

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

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

Appearance of the Product and Package Contents

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

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Liconsa, S.A.

Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo

19200 - Azuqueca de Henares - Spain

Date of the last revision of this leaflet: March 2023

Detailed information about 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 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