OMEPRAZOL TARBIS 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet:information for the user

Omeprazol Tarbis 20mg 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 and other information:

1. What is Omeprazol Tarbis and what is it used for
2. What you need to know before you take Omeprazol Tarbis
3. How to take Omeprazol Tarbis
4. Possible side effects
   1. Storage of Omeprazol Tarbis

1. Contents of the pack and other information

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

Omeprazol Tarbis 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 Tarbis is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the esophagus (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 infected 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 NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Tarbis can 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 esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include return of stomach contents to the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers infected 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 Tarbis

Do not take Omeprazol 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 proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Omeprazol Tarbis.

Warnings and precautionsTalk to your doctor or pharmacist before taking Omeprazol Tarbis.

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.

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

• Loses a lot of weight without apparent reason and has difficulty swallowing.
• Has stomach pain or indigestion.
• Starts vomiting food or vomiting blood.
• Has black stools (stools stained with blood).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Has severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol Tarbis to reduce stomach acidity.
• 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 Omeprazol Tarbis. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A)

If you take Omeprazol Tarbis for a long time (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.

Using Omeprazol Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Omeprazol Tarbis may affect the action of some medicines and some medicines may affect Omeprazol Tarbis.

Do not take Omeprazol 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, 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 Tarbis
• 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 Tarbis
• 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))

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 Tarbis with food and drinks

You can take your capsules with food or on an empty stomach.

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.

Your doctor will decide whether you can take Omeprazol Tarbis if you are breastfeeding.

Driving and using machines

Omeprazol 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.

Omeprazol Tarbis 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.

3. How to take Omeprazol Tarbis

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 usual doses are as follows.

Adults:

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

• If your doctor confirms that you have mild esophageal damage, the usual 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 usual dose once the esophagus has healed is 10 mg once a day.
• If you do not have esophageal damage, the usual dose is 10 mg once a day.

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

• The usual 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 usual 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 usual 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 ulcerscaused by NSAIDs(non-steroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring NSAID therapy:

• The usual dose is 20 mg once a day

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of recurrence:

• The usual dose is 20 mg of Omeprazol Tarbis twice a day for one week.

• Your doctor will also tell you to take two antibiotics: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomachcaused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual 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

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 Omeprazol Tarbis. The dose for children is based on body weight and the doctor will decide the correct dose.

Treatment of ulcerscausedby Helicobacter pyloriinfectionand prevention of recurrence:

• Children over 4 years of age can take Omeprazol Tarbis. 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 problems swallowing the capsules

• If you or your child have problems 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 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 to about half, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazol Tarbis than you should

If you have taken more Omeprazol Tarbis than prescribed by your doctor, talk to your doctor or pharmacist immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazol Tarbis

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 Tarbis

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 but serious adverse effects, stop taking Omeprazol Tarbis 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).
• 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".
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Adverse effects can occur with certain frequencies, which are defined as follows:

Other adverse effects are:

Common Adverse Effects

• 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

• 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.
• General feeling of discomfort and lack of energy.

Rare Adverse Effects

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
• 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.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects

• Blood count changes, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance of an intense rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Increased breast size in males.

Adverse Effects of Unknown Frequency

• If you are taking proton pump inhibitors like Omeprazol Tarbis, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking Omeprazol Tarbis for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may recommend periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol 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.

Do not worry about this list of possible adverse effects. You may not experience any of them. If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Omeprazol Tarbis

• Keep this medicine out of the 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.

• Do not store at a temperature above 30°C.

• Keep this blister pack in the original packaging to protect it from moisture.

• Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 Tarbis

• The active ingredient is omeprazol. Omeprazol Tarbis capsules contain 20 mg of omeprazol.

The other components are neutral microgranules (cornstarch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, methacrylic acid copolymer, and ethyl acrylate. The gelatin capsule is composed of: gelatin, water, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Omeprazol Tarbis 20 mg capsules are formed by a yellow opaque body and a yellow opaque cap.

Package sizes:

Aluminum/aluminum blisters with 14, 28, and 56 capsules; clinical package of 500 capsules.

Bottles with 14, 28, and 56 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:

LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

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/