Omeprazole Tarbis Farma 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Omeprazol Tarbis Farma 20mg gastro-resistant hard capsules EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Omeprazol 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.

Omeprazol Tarbis Farma is used to treat the following conditions:

In adults:

• Gastroesophageal reflux disease (GERD). In this condition, 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).
• Ulcers infected with 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 a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Tarbis Farma can also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥10 kg

• Gastroesophageal reflux disease (GERD). In this condition, stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include return of stomach contents into the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, their 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 Tarbis Farma

Do not take Omeprazol Tarbis Farma:

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

If you are unsure, speak with your doctor or pharmacist before taking Omeprazol Tarbis Farma.

Warnings and precautions

When taking omeprazole, kidney inflammation may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report such signs to your treating physician.

Consult your doctor or pharmacist before starting to take Omeprazol Tarbis Farma.

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

• You lose weight significantly without apparent reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You begin vomiting food or vomiting blood.
• Your bowel movements are black (blood-stained stools).
• 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 Omeprazol Tarbis Farma used to reduce stomach acidity.
• 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 Tarbis Farma. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (Chromogranin A)

If you take Omeprazol Tarbis Farma for a long period (more than 1 year), your doctor will likely perform periodic check-ups. You must report any new or unusual symptoms or circumstances during every visit to your doctor.

Use of Omeprazol Tarbis Farma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Omeprazol Tarbis Farma may affect the way some medicines work, and some medicines may affect Omeprazol Tarbis Farma.

Do not take Omeprazol Tarbis Farma 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, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, to relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol Tarbis Farma
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with Omeprazol Tarbis Farma
• 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))

If your doctor has prescribed Omeprazol Tarbis Farma along with the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them of any other medicines you are taking.

Taking Omeprazol Tarbis Farma with food and drinks

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

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.

Your doctor will decide whether you can take Omeprazol Tarbis Farma while breastfeeding.

Driving and using machines

Omeprazol Tarbis Farma 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 operate machinery.

Omeprazol Tarbis Farma contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Omeprazol Tarbis Farma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

Adults:

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

• If your doctor confirms you have mild esophageal damage, the usual dose is 20 mg once daily 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 after healing of the esophagus is 10 mg once daily.

• If you do not have esophageal damage, the usual dose is 10 mg once daily.

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

• The usual dose is 20 mg once daily 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 fully heal, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual dose is 20 mg once daily 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 fully heal, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

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

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

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

Prevention of stomach and duodenal ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The usual dose is 20 mg of Omeprazol Tarbis Farma twice daily for one week.

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

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

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will also decide how long you need to take the medicine.

Use in children

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

• Children over one year of age weighing more than 10 kg may take Omeprazol Tarbis Farma. The dose for children is based on body weight, and the doctor will determine the correct dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may 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 stomach acid. It is important not to damage the granules.

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

• If you or your child have difficulty swallowing the capsules:
  • Open the capsule 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 puree.
  • Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
  • To ensure you have taken all the medicine, fill the glass halfway with water, swirl it well, and drink it. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Tarbis Farma than you should

If you have taken more Omeprazol Tarbis Farma than prescribed by your doctor, consult your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Omeprazol Tarbis Farma

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 a missed dose.

If you stop treatment with Omeprazol Tarbis Farma

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 experiences them.

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

• Sudden wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Red skin rash with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, or genital area may also occur. These could be signs of "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Adverse effects may occur with certain frequencies, defined as follows:

Other adverse effects are:

Frequent adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, 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.
• Sensation of spinning (vertigo).
• Abnormal blood test results used to check liver function.
• Skin rash, hives, and itching.
• General feeling of malaise and lack of energy.

Rare adverse effects

• Blood problems, such as a decrease in white blood cells or platelets. This may cause weakness, bruising, and increase the likelihood of developing infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection known as "candidiasis" that may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe skin rash, blistering, or skin peeling. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in males.

Adverse effects with unknown frequency

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

In very rare cases, Omeprazol Tarbis Farma may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very deteriorated general condition or fever with signs of localized 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 medication you are taking at that time.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Tarbis Farma

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.

Store below 30°C.

Keep the bottle tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please 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 Tarbis Farma

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.

• The other components are sugar spheres (sucrose and corn starch), sodium carboxymethyl starch from potato (potato starch), sodium lauryl sulfate, povidone, dodecahydrate trisodium phosphate, hypromellose, 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), 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).

Nature of the product and pack contents

OMEPRAZOLE TARBIS FARMA 20 mg is presented as gastro-resistant hard capsules with a blue cap and orange body, printed in white ink with an "O" on the cap and "20" on the body, containing white-beige omeprazole microgranules.

Pack sizes:

Blister packs of 14, 28 and 56 gastro-resistant capsules.

HDPE bottles containing 14, 28 or 56 gastro-resistant capsules.

Only some pack 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 Vallès (Barcelona)

or

Teva Pharma, S.L.U.

Polígono Malpica C/C, 4

50016 Zaragoza

Date of latest review of this leaflet: March 2023

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