Omeprazole Tarbis Farma 40 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazol Tarbis Farma 40 mg gastro-resistant hard capsules

Read the entire leaflet carefully before you start taking this medicine because 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 side effects, talk to your doctor or pharmacist, even if they are side 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:

• “Gastro-oesophageal reflux disease” (GORD). In this disorder, stomach acid passes into the oesophagus (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 medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Tarbis Farma may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and = 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this disorder, stomach acid passes into the oesophagus (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, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking 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. pantoprazol, lansoprazol, rabeprazol, esomeprazol).
• 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 these signs to your treating physician.

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

Omeprazol Tarbis Farma may mask 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 using, have recently used, or might need to use any other medicines. Omeprazol Tarbis Farma may affect the action of some medicines, 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, 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 you the antibiotics amoxicillin and clarithromycin along with Omeprazol Tarbis Farma to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about 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 may take Omeprazol Tarbis Farma if you are breastfeeding.

Driving and using machines

Omeprazol Tarbis Farma is unlikely to affect your ability to drive or use 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 Tarbis Farma contains sucrose

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

3. How to take Omeprazol Tarbis Farma

Follow exactly the instructions for using this medicine 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 damage to the esophagus, 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.

• Once the esophagus has healed, the usual dose is 10 mg once daily.

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

Treatment of upper intestinal ulcers (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 heal completely, 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 heal completely, 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 of the following antibiotics: 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 for how long you should 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.
• The 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 breaking down in the 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 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 the water. 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, contact 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 your 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 may produce adverse effects, although not everyone will experience 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, throat, or body, 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, and genitals may also occur. 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.

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 concentration in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult 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 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 of unknown frequency

• If you are taking proton pump inhibitors such as Omeprazol Tarbis Farma, especially for 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 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, consult 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 accompanied by 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 inform your doctor about any medication you are currently 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 effects 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 40 mg of omeprazole.

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

The gelatin capsule shell consists 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).

Appearance of the product and contents of the pack

OMEPRAZOL TARBIS FARMA 40 mg is presented as blue-capped and orange-bodied hard gastro-resistant capsules, printed in white ink with an "O" on the cap and "40" on the body, containing white-beige omeprazole microgranules.

Pack sizes:

Blister packs containing 14 and 28 gastro-resistant capsules.

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

Only some 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

Ferrer Internacional, S.A.
Joan Buscallá, 1-9
08173 - Sant Cugat del Vallès (Barcelona)
or

Teva Pharma, S.L.U.
Malpica Industrial Estate, Street C, 4
50016 Zaragoza, Spain

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 Medical Devices (AEMPS): http://www.aemps.gob.es/