OMEPRAZOL FARMA TARBIS 40 mg HARD GASTRORESISTENT CAPSULES

2. What you need to know before you take Omeprazole Farma Tarbis

Do not take Omeprazole Farma Tarbis

• 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 other 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 Omeprazole Farma Tarbis if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Farma Tarbis.

Warnings and precautions

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 inform your doctor of these signs.

Omeprazole Farma Tarbis may mask the symptoms of other diseases. Therefore, if any of the following occur before or while you are taking Omeprazole Farma Tarbis, talk to your doctor or pharmacist:

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• You have black stools (stools with blood).
• You experience severe or persistent diarrhea, as omeprazole has been associated with a small 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 Farma Tarbis to reduce stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A).

If you get 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 Farma Tarbis. Remember to mention any other symptoms you may notice, such as joint pain.

Taking a proton pump inhibitor like Omeprazole Farma Tarbis, especially for 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 can increase the risk of osteoporosis).

If you take Omeprazole Farma Tarbis for a long period of time (more than 1 year), your doctor will probably keep you under regular surveillance. You should inform your doctor of any new or exceptional circumstances or symptoms.

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 Omeprazole Farma Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because Omeprazole Farma Tarbis may affect the way other medicines work and some medicines may have an effect on Omeprazole Farma Tarbis.

Do not take Omeprazole Farma Tarbis 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, as a muscle relaxant, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole Farma Tarbis.
• Medicines used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeprazole Farma Tarbis.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infections).
• Tacrolimus (in cases of organ transplants).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (to treat HIV infections).
• Clopidogrel (used to prevent blood clots (thrombi).
• Erlotinib (used to treat different types of 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 Omeprazole.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Omeprazole Farma Tarbis to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.

Omeprazole Farma Tarbis with food and drinks

See section 3 “How to take Omeprazole Farma Tarbis”.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole is excreted in breast milk but it is unlikely to affect the baby at therapeutic doses. Your doctor will decide whether you can take Omeprazole Farma Tarbis during breastfeeding.

Driving and using machines

Omeprazole Farma Tarbis 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.

Omeprazole Farma Tarbis contains sucrose

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

3. How to take Omeprazole Farma Tarbis

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Adults:

Treatment of symptoms associated with gastroesophageal reflux disease (GORD) such as heartburn and acid regurgitation:

• If your doctor has found that your gullet (esophagus) is slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for an additional period of 8 weeks if your esophagus has not healed.
• The recommended dose once your esophagus has healed is 10 mg once a day.
• If your esophagus has not been damaged, the recommended dose is 10 mg once a day.

For the 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 tell you to take the same dose for another 2 weeks if the ulcer has not healed.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once a day for 4 weeks.

For the treatment of ulcers in the stomach(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the ulcer has not healed.
• If the ulcer has not healed completely, the dose may be increased to 40 mg once a day for 8 weeks.

For the prevention of relapse of duodenal and stomach 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.

For the treatment of duodenal and stomach ulcers caused by NSAIDs(non-steroidal anti-inflammatory drugs):

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

For the prevention of duodenal and stomach ulcersif you are taking NSAIDs:

• The recommended dose is 20 mg once a day.

For the treatment of ulcers caused by Helicobacter pylori infectionand to prevent relapse:

• The recommended dose is 20 mg twice a day for 1 week.
• Your doctor will also prescribe two antibiotics to treat the infection, among amoxicillin, clarithromycin, and metronidazole.

For the treatment of excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

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

Use in children

Treatment of symptoms associated with gastroesophageal reflux disease (GORD) such as heartburn and acid regurgitation:

• Children over 1 year of age and weighing more than 10 kg can take Omeprazole Farma Tarbis. In children, the recommended dose is based on the child's weight, and the doctor will decide the correct dose.

For the treatment of ulcers caused by Helicobacter pylori infectionand to prevent relapse:

• Children over 4 years of age can take Omeprazole Farma Tarbis. The recommended dose in children is based on the child's weight, and the doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics to treat the infection, called amoxicillin and clarithromycin, for your child.

Taking the medicine:

• It is recommended that you take the capsules in the morning.
• You can take the 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 the capsules contain coated particles that prevent the medicine from being broken down by stomach acid. It is important not to damage the particles.

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

If you or your child has trouble swallowing the capsules:

• Open the capsules and swallow the contents directly with half a glass of water or put the contents in a glass of water (still), or any acidic fruit juice (e.g. apple, orange, or pineapple) or apple sauce.
• Always stir the mixture just before taking it (the mixture will not be clear). Then, drink the mixture immediately or within 30 minutes. To ensure that you have taken all the medicine, fill the glass with water to about half, rinse it well, and drink the water. The solid pieces contain the medicine – do not chew or crush them.

If you take more Omeprazole Farma Tarbis than you should

If you think you have been given too much Omeprazole Farma Tarbis, talk to your doctor 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), or go to the nearest hospital.

If you forget to take Omeprazole Farma Tarbis

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

If you stop taking Omeprazole Farma Tarbis

Do not stop taking omeprazole without talking to your doctor or pharmacist first.

If you have any further questions on the use of this medicine, 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 experience any of the following rare but serious adverse effects, stop taking Omeprazol Farma Tarbis and contact your doctor immediately:

• Whistling, swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Other adverse effects include:

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache
• Effects on the stomach or intestine: diarrhea, stomach pain, constipation, flatulence.
• Feeling dizzy (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 disturbances (insomnia).
• Dizziness, tingling sensation like "pins and needles", feeling of sleepiness.
• Feeling that everything is spinning (vertigo).
• ·
• Abnormalities in blood tests that check liver function.

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• Skin rash, rash with hives (urticaria) and itching of the skin.
• Generally, feeling unwell and lacking energy.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

• Blood problems, such as a reduced number of white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infections.
• Allergic reactions, sometimes severe, which include swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Feeling agitated, confused, or depressed.
• Abnormalities in taste.
• Vision problems, such as blurred vision.
• Suddenly feeling difficulty breathing or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis", which can affect the intestine and is caused by a fungus. · Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash due to sun exposure.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

• Changes in blood cell count, including 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.
• Sudden appearance of severe rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

Frequency Not Known (cannot be estimated from the available data):

• Inflammation of the intestine (which causes diarrhea).
• If you take Omeprazol Farma Tarbis for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can be detected by 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 consider performing periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol Farma Tarbis can affect the white blood cells in the blood 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. 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. Conservation of Omeprazol Farma Tarbis

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Farma Tarbis

The active ingredient is omeprazol. Each hard gastro-resistant capsule contains 40 mg of omeprazol.

The other components are:

Granules: sugar spheres (sucrose, cornstarch), hypromellose 2910 5CPS, talc, cornstarch, sodium hydroxide, methacrylic acid copolymer and ethyl acrylate (1:1) dispersion 30% (methacrylic acid and ethyl acrylate (1:1) dispersion at 30%. macrogol 400, titanium dioxide (E 171).

Capsules: gelatin, red iron oxide (E172), titanium dioxide (E 171).

Printing inkshellac (E904), black iron oxide (E172).

Appearance of Omeprazol Farma Tarbis and Package Contents

Description:

Omeprazol Farma Tarbis 40 mg hard gastro-resistant capsules: cap and body of reddish-brown color, number 1, filled with white to almost white pellets and marked with "H" and "O3" on the body of the capsule

Package Sizes:

The capsules are available in blisters in cardboard boxes, which contain: 7, 7x1, 10, 14, 14x1, 15, 28, 28x1, 30, 50, 50x1, 60, 56, 56x1, 60, 98, 100, and 500 hard gastro-resistant capsules. It is also available in bottles with 14, 30, and 100 hard gastro-resistant capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028, Barcelona,

Spain

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola, PLA 3000;

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Omeprazol Amarox 40 mg magensaftresistente Hartkapsel

Denmark Omeprazol Amarox

Spain Omeprazol Farma Tarbis 40 mg hard gastro-resistant capsules EFG

Netherlands Omeprazol Amarox 40 mg, maagsapresistente capsules, hard

Sweden Omeprazol Amarox 40 mg, enterokapsel, hård

Date of the Last Revision of this Prospectus: March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/