OMEPRAZOL TARBIS FARMA 40 mg HARD GASTRORESISTENT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole Tarbis Farma 40 mg hard gastro-resistant capsules

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

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

Omeprazole Tarbis Farma 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.

Omeprazole Tarbis Farma is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers caused by a bacteria 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 non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Tarbis Farma may also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing >= 10 kg

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn.
• In children, the symptoms of the disease can include the return of stomach contents into the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

Ulcers caused by a bacteria 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 Omeprazole Tarbis Farma

Do not take Omeprazole Tarbis Farma:

• 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 containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

Warnings and precautions

Kidney inflammation may occur when taking omeprazole. 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 inform your doctor of such signs.

Talk to your doctor or pharmacist before starting to take Omeprazole Tarbis Farma.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained faeces).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight 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 Tarbis Farma to reduce stomach acid.
• 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 Tarbis Farma. Also, 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 Omeprazole Tarbis Farma for a long period (more than 1 year) your doctor will probably keep you under regular surveillance. You should inform your doctor of any new or unusual symptoms or circumstances whenever you visit your doctor.

Taking Omeprazole Tarbis Farma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Omeprazole Tarbis Farma may affect the way some medicines work and some medicines may affect the way Omeprazole Tarbis Farma works.

Do not take Omeprazole Tarbis Farma if you are taking a medicine containing 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 taking Omeprazole Tarbis Farma
• 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 taking Omeprazole Tarbis Farma
• 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 take with Omeprazole Tarbis Farma to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you tell your doctor about any other medicines you are taking.

Taking Omeprazole Tarbis Farma with food and drink

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Omeprazole Tarbis Farma if you are breast-feeding.

Driving and using machines

Omeprazole Tarbis Farma is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If affected, you should not drive or operate machinery.

Omeprazole Tarbis Farma 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 Tarbis Farma

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.

The recommended dose is:

Adults:

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

• If your doctor finds that you have mild oesophageal damage, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for another 8 weeks if the oesophagus has not yet healed.

• The usual dose once the oesophagus has healed is 10 mg once a day.
• If you do not have oesophageal damage, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The usual 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 yet healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The usual 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 yet healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and stomach 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 ulcers caused by NSAIDs:

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

Prevention of ulcers caused by NSAIDs:

• The usual dose is 20 mg once a day

Treatment of ulcers caused by Helicobacter pyloriinfectionand prevention of their return:

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

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

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

• The usual dose is 60 mg a day.
• Your doctor will adjust the dose depending on 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 and weighing >= 10 kg can take Omeprazole Tarbis Farma. The dose for children is based on their body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pyloriinfectionand prevention of their return:

• Children over 4 years of age can take Omeprazole Tarbis Farma. The dose for children is based on their body weight and your doctor will decide the correct dose.
• Your 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 trouble swallowing the capsules

• If you or your child have trouble 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 stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
  • To make sure you have taken all the medicine, fill the glass with water, rinse it well and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Tarbis Farma than you should

If you have taken more Omeprazole Tarbis Farma than your doctor prescribed, talk to your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Omeprazole Tarbis Farma

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 forgotten dose.

If you stop taking Omeprazole Tarbis Farma

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 Farma 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).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general 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 infections.
• 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 alterations, 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 Farma, especially for more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking Omeprazol Tarbis Farma for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may recommend periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol Tarbis Farma 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 suffering from 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 Medicines Monitoring System for Human Use: 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 Farma

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.

Store below 30°C.

Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown away through drains 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 Farma

• The active ingredient is omeprazol. Each capsule contains 40 mg of omeprazol.

• The other components are sugar spheres (sucrose and cornstarch), sodium starch glycolate, lauryl sulfate, povidone, disodium phosphate dodecahydrate, hypromellose dispersion 30% copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E-171), talc, and sodium hydroxide.

The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), indigo carmine (E-132), erythrosine (E-127), and water.

Printing ink:Shellac, polyvinylpyrrolidone, propylene glycol, sodium hydroxide, and titanium dioxide (E-171).

Product Appearance and Package Contents

OMEPRAZOL TARBIS FARMA 40 mg is presented in the form of hard gastro-resistant capsules with a blue cap and orange body, marked with white ink with a "O" on the cap and a "40" on the body, containing white-beige omeprazol microgranules.

Package sizes:

Blister packs of 14 and 28 gastro-resistant capsules.

HDPE bottles of 14, 28, and 56 gastro-resistant capsules.

Only some 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

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés (Barcelona)

or

Teva Pharma, S.L.U.

Polígono Malpica C/C, 4

50016 Zaragoza 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/