Package Insert: Information for the User

Omeprazol Farma Tarbis 40 mg Hard Gastrorresistant Capsules

Omeprazol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isOmeprazol Farma Tarbisand for what it is used

2. What you need to know before starting to takeOmeprazol Farma Tarbis

3. How to takeOmeprazol Farma Tarbis

4. Possible adverse effects

5. Storage ofOmeprazol Farma Tarbis

6. Contents of the package and additional information

Omeprazol Farma Tarbis contains the active ingredient omeprazole. It belongs to a group of medicines called "proton pump inhibitors". They work by reducing the amount of acid produced by the stomach.

Omeprazol Farma Tarbis is used to treat the following diseases:

Adults:

· Gastroesophageal reflux disease (GERD). This occurs when stomach acid escapes 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) · To prevent recurrence of ulcers in the upper part of the small intestine (duodenal ulcer) and the stomach (gastric ulcer).

· Infected ulcers caused by a bacteria called Helicobacter pylori. If this is the case, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

· Ulcers caused by certain medications called NSAIDs (nonsteroidal anti-inflammatory drugs). Omeprazol Farma Tarbis may 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).

Children:

Children over 1 year and ≥ 10 Kg

· Gastroesophageal reflux disease (GERD). This occurs when stomach acid escapes into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation, and heartburn.

In children, symptoms may include the return of stomach contents to the mouth (regurgitation), nausea (vomiting), and inadequate weight gain.

Children over 4 years and adolescents

· Infected ulcers caused by a bacteria called Helicobacter pylori. If this is the case for your child, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Omeprazol Farma Tarbis

· If you are allergic to omeprazole or any of the other ingredients of this medication (listed in section 6).

· If you are allergic to medications that contain other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).

· If you are taking a medication that contains nelfinavir (used to treat HIV infection).

Do not take Omeprazol Farma Tarbisif you fall into any of the above cases. If you are unsure, consult your doctor or pharmacist before taking Omeprazol Farma Tarbis.

Warnings and precautions

When taking omeprazole, kidney inflammation 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.

Omeprazol Farma Tarbis may mask symptoms of other diseases. Therefore, if any of the following occur before taking Omeprazol Farma Tarbis or while taking it, consult your doctor or pharmacist:

· You lose a lot of weight without reason and have trouble swallowing.

· You experience 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 similar medication to Omeprazol Farma Tarbis for reducing stomach acid.

· You are scheduled to have a specific blood test (Cromogranina A).

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 treatment with Omeprazol Farma Tarbis. Remember to mention any other symptoms you may notice, such as joint pain.

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

If you take Omeprazol Farma Tarbis for a long period of time (more than 1 year), your doctor will likely 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 administer this medication to children under 1 year of age or <10

Other medications and Omeprazol Farma Tarbis

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications, even those purchased without a prescription. This is because Omeprazol Farma Tarbis may affect the way other medications work, and some medications may affect Omeprazol Farma Tarbis.

Do not take Omeprazol Farma Tarbis 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:

· 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).

· Phenobarbital (used in epilepsy).If you are taking phenobarbital, your doctor will need to monitor you when you start or stop taking Omeprazol Farma Tarbis.

· Medications used to thin your blood, such as warfarin or other vitamin K antagonists. Your doctor may need to monitor you when you start or stop taking Omeprazol Farma Tarbis.

· Rifampicin (used to treat tuberculosis).

· Atazanavir (used to treat HIV infection).

· Tacrolimus (in cases of organ transplants).

· 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).

· Erlotinib (used to treat various types of 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 discontinue treatment with Omeprazol.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Omeprazol Farma Tarbis to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor if you are taking other medications.

Omeprazol Farma Tarbis with food and drinks

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

Omeprazol 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 they do, you should not drive or operate machinery.

Omeprazol Farma Tarbis 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.

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

Your doctor will tell you how many capsules to take and for how long, depending on your conditions and age.

Adults:

Treatment of symptoms associated with gastroesophageal reflux disease (GERD) such asheartburn and acid regurgitation:

· If your doctor has determined that the esophagus has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may indicate that you take a dose of 40 mg for an additional 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 treatingulcers in the upper part of the intestine(duodenal ulcer):

· The recommended dose is 20 mg once a day for 2 weeks. Your doctor may indicate that you take the same dose for another 2 weeks if the ulcer has not healed.

· If the ulcer does not fully heal, the dose may be increased to 40 mg once a day for 4 weeks.

For treatingulcers in the stomach(gastric ulcer):

· The recommended dose is 20 mg once a day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if the ulcer has not healed.

· If the ulcer does not fully heal, the dose may be increased to 40 mg once a day for 8 weeks.

For preventingrecurrences of duodenal and gastric 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 treatingulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs)(AINEs):

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

Forpreventing duodenal and gastric ulcersif taking AINEs:

· The recommended dose is 20 mg once a day.

For treatingulcers caused by Helicobacter pylori infectionand preventing their recurrences:

· The recommended dose is 20 mg twice a day for 1 week.

· Your doctor will also prescribe two antibiotics to treat the infection, amoxicillin, clarithromycin, and metronidazole.

For treatinggastric hyperacidity 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 depending on your needs and also decide for how long you should take the medication.

Use in children

Treatment of symptoms associated with gastroesophageal reflux disease (GERD) such asheartburn and acid regurgitation:

· Children over 1 year of age and with a body weight of over 10 kg may take Omeprazol Farma Tarbis. In children, the recommended dose is based on the child's weight, and your doctor will decide the correct dose.

For treatingulcers caused by Helicobacter pylori infectionand preventing their recurrences:

· Children over 4 years may take Omeprazol Farma Tarbis. The recommended dose in children is based on the child's weight, and your doctor will decide the correct dose.

· Your doctor will also prescribe two antibiotics to treat the infection, amoxicillin, and clarithromycin, for your child.

Medication intake:

- 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 they contain coated particles that prevent the medication from breaking down in the stomach. It is essential 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 (without gas), or any acidic fruit juice (such as apple, orange, or pineapple) or apple sauce.

· Always remove 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 medication,fill the glass with water up to the middle, rinse it well, and drink the water.. The solid pieces contain the medication – do not chew or crush them.

If you take more Omeprazol Farma Tarbis than you should:

If you think you have been given too much Omeprazol 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 medication and the amount ingested), or go to the nearest hospital.

If you forget to take Omeprazol Farma Tarbis:

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 treatment with Omeprazol Farma Tarbis:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

If you experience any of the following rare but serious side effects, stop taking Omeprazol Farma Tarbis and contact your doctor immediately:

· Tinnitus, swelling of the lips, tongue, and throat, or skin rash, dizziness, or difficulty swallowing (severe allergic reaction).

· Skin redness 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 may be symptoms of liver problems.

Other side effects include:

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

· Headache

· Gastrointestinal effects: diarrhea, stomach pain, constipation, flatulence.

· Feeling dizzy (nausea) or vomiting.

· Benign stomach polyps.

Less frequent side effects (may affect up to 1 in 100 people):

· Swelling of the feet and ankles.

· Sleep disturbances (insomnia).

· Dizziness, pins and needles sensation, drowsiness.

· Feeling that everything is 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 disorders, 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, 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.

· Feeling agitated, confused, or depressed.

· Taste disturbances.

· Vision problems, such as blurred vision.

· Sudden difficulty breathing or shortness of breath (bronchospasm).

· Dry mouth.

· Inflammation of the inside of the mouth.

· Infection called "candidiasis," which can affect the intestines and is caused by a fungus. · Liver problems, including jaundice that can cause yellowing of the skin, dark urine, and fatigue.

· Hair loss (alopecia).

· Skin rash caused by exposure to sunlight.

· Joint pain (arthritis) or muscle pain (myalgia).

· Severe kidney problems (interstitial nephritis).

· Increased sweating.

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

· Changes in blood cell counts, 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 skin 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.

· Breast enlargement in men.

Unknown frequency (cannot be estimated from available data):

· Inflammation of the intestines (causing diarrhea).

· If you take Omeprazol Farma Tarbis for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can be detected by 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 reduction in potassium or calcium levels in the blood. Your doctor may consider performing regular blood tests to monitor your magnesium levels.

· Skin rash, possibly with joint pain.

In rare cases, Omeprazol Farma Tarbis 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, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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

This medication does not require special conservation conditions.

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

Composition of Omeprazol Farma Tarbis

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

The other components are:

Granules: sugar spheres (saccharose, cornstarch), hypromellose 2910 5CPS, talc, cornstarch, sodium hydroxide, copolymer of methacrylic acid 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, iron oxide red (E172), titanium dioxide (E 171).

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

Appearance of Omeprazol Farma Tarbis and contents of the package

Description:

Omeprazol Farma Tarbis 40 mg gastro-resistant capsules: brownish-red cap and body, size 1, filled with white to almost white pellets and marked with “H” and “O3” on the capsule body

Packaging sizes:

The capsules are available in blisters in carton packaging, which contain: 7, 7x1, 10, 14, 14x1, 15, 28, 28x1, 30, 50, 50x1, 60, 56, 56x1, 60, 98, 100 and 500 gastro-resistant capsules. They are also available in bottles with 14, 30 and 100 gastro-resistant capsules.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028, Barcelona,

Spain

Responsible for manufacturing

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 with the following names:

GermanyOmeprazol Amarox 40 mg gastro-resistant hard capsule

DenmarkOmeprazol Amarox

SpainOmeprazol Farma Tarbis 40 mg gastro-resistant hard capsules EFG

NetherlandsOmeprazol Amarox 40 mg, gastric-resistant capsules, hard

SwedenOmeprazol Amarox 40 mg, enteric capsule, hard

Last review date of this leaflet: March 2023

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