OMEPRAZOL CINFAMED 40 mg HARD GASTRORESISTENT CAPSULES

2. What you need to know before starting to take omeprazole Cinfamed

Do not take omeprazole Cinfamed

• If you are allergic to omeprazole 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., pantoprazole, lansoprazole, rabeprazol, esomeprazol).
• If you are taking a medication that contains nelfinavir (used to treat HIV infection).

Do not take omeprazole if you are in any of the above cases. If you are unsure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole Cinfamed.

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

Omeprazole may mask 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 apparent reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained).
• 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 ever had a skin reaction after treatment with a medication similar to omeprazole to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A).

If you take omeprazole for a long period (more than 1 year), your doctor will likely 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 a year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or 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 output 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 administer this medication to children under 1 year of age or weighing less than 10 kg.

Other medications and omeprazole Cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes medications that can be purchased without a prescription. This is because 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 to treat HIV infection).

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

• 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 omeprazole.
• Medications 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 omeprazole.
• 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 medication 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 omeprazole.

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

Taking omeprazole Cinfamed with food and drinks

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

Pregnancy and lactation

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

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 omeprazole if you are breastfeeding.

Driving and using machines

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

Omeprazole Cinfamed contains sucrose

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

Omeprazole Cinfamed contains sodium

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

3. How to take omeprazole Cinfamed

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly. If you have any doubts, 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 as heartburn and acid regurgitation:

• If your doctor confirms that you have mild esophageal damage, 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 esophageal damage, the recommended dose is 10 mg once a day.

Treatment of ulcers in the upper part of the 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 of stomach 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.

Preventionof 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(non-steroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring the administration of NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• The recommended dose is 20 mg of omeprazole twice a day 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 medication.

Use in children and adolescents

Treatment of symptoms of GERD, 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 ulcerscausedby Helicobacter pyloriinfectionand prevention of their 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 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 due to the action of stomach acid. It is essential not to damage the granules.

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

If you or your child have difficulty 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 still water, acidic 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 you have taken all the medication, fill the glass with water to the halfway point, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more omeprazole Cinfamed 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take omeprazole Cinfamed

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 the missed doses.

If you interrupt treatment with omeprazole Cinfamed

Do not interrupt treatment with 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.

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 adverse 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 on the lips, eyes, mouth, nose, and genitals may also appear. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome 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 adverse effects are:

Common Adverse 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 Adverse 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 test results.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare Adverse 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 infection.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• 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 Adverse Effects (may affect up to 1 in 10,000 people)

• Abnormal blood count, 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.
• Increased breast size in males.

Frequency Not Known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).
• If you are being treated with omeprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, 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 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 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 Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Omeprazole Cinfamed

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Aluminum/Aluminum blister: Do not store above 25°C. Store in the original packaging to protect from moisture.

PVC/PE/PVDC-Aluminum blister: Do not store above 30°C. Store in the original packaging to protect from moisture.

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

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

6. Package Contents and Additional Information

Composition of Omeprazole Cinfamed

• The active ingredient is omeprazole. Each hard capsule contains 40 mg of omeprazole.
• The other ingredients are:

Capsule content: sugar spheres (cornstarch, sucrose, and purified water), magnesium hydroxide, cornstarch, sodium lauryl sulfate, disodium hydrogen phosphate, mannitol (E-421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion at 30%, and sodium carboxymethylcellulose type A (from 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 white cap and gray body, containing white to cream-colored microgranules.

Aluminum/Aluminum or PVC/PE/PVDC-Aluminum (triplex) blister packs. Each package contains 14, 28, or 56 capsules.

HPDE bottles with a polypropylene cap and a safety ring, and a desiccant capsule of polyethylene inside. Each package contains 14, 28, or 56 capsules.

Only certain package 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

LABORATORIOS LICONSA

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara) Spain

Date of 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/65570/P_65570.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65570/P_65570.html