Omeprazole Farma Tarbis 40 mg gastro-resistant hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Omeprazol Farma Tarbis 40 mg gastro-resistant hard capsules

Omeprazole

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Omeprazol Farma Tarbis is and what it is used for
2. What you need to know before taking Omeprazol Farma Tarbis
3. How to take Omeprazol Farma Tarbis
4. Possible side effects
5. How to store Omeprazol Farma Tarbis
6. Contents of the pack and other information

1. What Omeprazol Farma Tarbis is and what it is used for

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

Omeprazol Farma Tarbis is used to treat the following conditions:

Adults:

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back into the esophagus, the tube connecting 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).
• Prevention of recurrence of ulcers in the upper part of the intestine (duodenal ulcer) and in the stomach (gastric ulcer).
• Ulcers associated with a bacterial infection caused by Helicobacter pylori. If this applies to you, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Farma Tarbis may also be used to prevent the development 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 of age and ≥ 10 kg

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

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

Children over 4 years of age and adolescents

• Ulcers associated with a bacterial infection caused by Helicobacter pylori. If this applies to your child, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before starting to take Omeprazol Farma Tarbis

Do not take Omeprazol Farma Tarbis

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

Do not take Omeprazol Farma Tarbis if you are in any of the above situations. If you are unsure, speak with 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. You should report these signs to your treating physician.

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

• You lose a lot of weight without reason and have difficulty swallowing.
• You experience stomach pain or indigestion.
• You begin vomiting food or blood.
• You have black stools (blood-stained stools).
• You experience severe or persistent diarrhea, as omeprazole has been associated with a small increased risk of infectious diarrhea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazol Farma Tarbis used to reduce stomach acid.
• You are scheduled to have a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, 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 such as Omeprazol Farma Tarbis, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. 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 (more than 1 year), your doctor will likely monitor you regularly. You must inform your doctor of any new or unusual symptoms.

Children

Some children with chronic conditions may require long-term treatment, although this is not recommended. Do not administer this medicine to children under 1 year of age or weighing <10 kg.

Other medicines and Omeprazol Farma Tarbis

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription. This is because Omeprazol Farma Tarbis may affect how other medicines work, and some medicines may affect Omeprazol Farma Tarbis.

Do not take Omeprazol Farma Tarbis if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform 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 starting or stopping Omeprazol Farma Tarbis.
• Medicines used to thin your blood, such as warfarin or other vitamin K antagonists. Your doctor may need to monitor you when starting or stopping Omeprazol Farma Tarbis.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in 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 various types of cancer).
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily discontinue treatment with Omeprazol Farma Tarbis.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Omeprazol 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.

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, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

Omeprazol Farma Tarbis contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Omeprazol Farma Tarbis

Follow exactly the instructions for use of this medicine as given 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 condition and age.

Adults:

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

• If your doctor has determined that the esophagus has been slightly damaged, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may instruct you to 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 daily.
• If your esophagus has not been damaged, the recommended dose is 10 mg once daily.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may instruct you to take the same dose for another 2 weeks if the ulcer has not healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

To treat stomach ulcers (gastric ulcer):

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

To prevent relapses of duodenal and gastric ulcers:

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

To treat duodenal and gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

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

To prevent duodenal and gastric ulcers if you are taking NSAIDs:

• The recommended dose is 20 mg once daily.

To treat ulcers caused by Helicobacter pylori infection and prevent their recurrence:

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

To treat excessive stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

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

Use in children

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

• Children over 1 year of age and weighing more than 10 kg may take Omeprazol Farma Tarbis. In children, the recommended dose is based on body weight; your doctor will determine the correct dose.

To treat ulcers caused by Helicobacter pylori infection and prevent their recurrence:

• Children over 4 years of age may take Omeprazol Farma Tarbis. The recommended dose in children is based on body weight, and your doctor will determine the correct dose.
• Your doctor will also prescribe two antibiotics for your child—amoxicillin and clarithromycin—to treat the infection.

How to take the medicine:

• It is recommended that you take the capsules in the morning.
• You may 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 enteric-coated granules that prevent the medicine from breaking down in stomach acid. It is important not to damage the granules.

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

? If you or your child has difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly with half a glass of water, or mix the contents in a glass of water (non-carbonated), or any acidic fruit juice (e.g., apple, orange, or pineapple), or apple puree.
• 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 you have taken all the medicine, refill the glass with water up to half, rinse it well, and drink the water.
• The solid particles contain the medicine—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, speak to your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and 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 it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

If you stop taking Omeprazol Farma Tarbis:

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

If you have any further questions about 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 everyone will experience them.

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

• Ringing in the ears, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Red skin with blistering or peeling. There may also be severe blistering 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 tiredness, which may be symptoms of liver problems.

Other adverse effects include:

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

• Headache
• Stomach or intestinal effects: diarrhoea, stomach pain, constipation, flatulence.
• Feeling sick (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", drowsiness.
• Feeling of spinning (vertigo).
  • ·
  • Abnormalities in blood tests used to check liver function.

.

• Skin rash, rash with lumps (urticaria) and itching of the skin.
• General feeling of malaise and lack of energy.

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

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

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Serious liver problems that may lead to liver failure and brain inflammation.
• Sudden onset of severe rash, blistering or skin peeling. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

Frequency not known (cannot be estimated from available data):

• Inflammation of the intestine (causing diarrhoea).
• If you take Omeprazol Farma Tarbis for more than three months, your blood magnesium levels may decrease. Low magnesium levels may be indicated 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 may also lead to reduced levels of potassium or calcium 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 may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very poor general condition or fever with signs of local infection, such as neck, throat or mouth pain or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking at that time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Farma Tarbis

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Farma Tarbis

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

The other components are:

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

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

Printing ink: shellac (E904), black iron oxide (E172).

Appearance of Omeprazol Farma Tarbis and contents of the pack

Description:

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

Pack sizes:

The capsules are available in blister packs in cardboard containers containing: 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 containing 14, 30 and 100 gastro-resistant capsules.

Only certain pack sizes may be commercially available.

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

The Netherlands

This medicinal product 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 cápsulas duras gastrorresistentes EFG

The Netherlands Omeprazol Amarox 40 mg, maagsapresistente capsules, hard

Sweden Omeprazol Amarox 40 mg, enterokapsel, hård

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/