Leaflet: information for the user

Belmazol 40 mg hard gastro-resistant capsules

Omeprazole

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

1. What Belmazol 40 mg is and what it is used for

2. What you need to know before you start taking Belmazol 40 mg

3. How to take Belmazol 40 mg

4. Possible side effects

5. Storage of Belmazol 40 mg

6. Contents of the pack and additional information

Belmazol contains the active ingredient 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.

Belmazol is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Belmazol can also be used to prevent the formation of 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” (GERD). In this disorder, stomach acid flows up 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 the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Belmazol

• if you are allergic to omeprazole or any of the components of this medication (listed in section 6).
• if you are allergic to medications containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, consult your doctor or pharmacist before taking Belmazol 40 mg hard-gastrorresistent capsules.

Warnings and precautions

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

• You lose weight significantly without apparent reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools 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.
• You have had a skin reaction after treatment with a similar medication to Belmazol for reducing stomach acid.
• You have a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt Belmazol treatment. Remember to mention any other symptoms you may notice, such as joint pain.
• You are scheduled to have a specific blood test (Cromogranina A)

When taking omeprazole, it may cause inflammation in the kidneys. 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. Inform your doctor of these signs.

If you take Belmazol for a long period (more than 1 year), your doctor will likely perform regular check-ups. Inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

If you are taking proton pump inhibitors such as omeprazole, especially for more than a year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Omeprazole may interfere with some diagnostic tests (cromogranina A). To avoid these interferences, omeprazole treatment should be suspended at least five days before the measurement.

Taking Belmazol with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Belmazol may affect the mechanism of action of some medications and some medications may affect Belmazol.

Do not take Belmazol if you are taking a medication that containsnelfinavir(used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles, or epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment.
• Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment.
• 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)
• Erlotinib (used to treat cancer)
• Methotrexate (chemotherapy medication used in high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor will need to temporarily stop omeprazole treatment.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor of any other medications you are taking.

Taking Belmazol with food and drinks

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

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take Belmazol during this time.

Omeprazole passes into breast milk but is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide if you can take Belmazol while breastfeeding.

Driving and operating machinery

Belmazol 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 they do, you should not drive or operate machinery.

Belmazol contains saccharose and sodium

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Belmazol contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 age.

The usual doses are indicated below.

Adults:

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, 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 damage to the esophagus, the usual dose is 10 mg once a day.

Treatment ofulcers 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 ofstomach 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 ofstomach 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 ulcers caused bynonsteroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The usual dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of its recurrence:

• The usual dose is 20 mg of omeprazole twice a day for a week.
• Your doctor will also tell you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

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

• The usual dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and will also decide for how long you should take the medication.

Use in children:

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation

• Children over one year of age who weigh more than 10 kg may take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of its recurrence:

• Children over 4 years old may take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics for your child, amoxicillin, and clarithromycin.

How to take this medication

• 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 medication from breaking down in the stomach acid. It is essential 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 water without gas, a sour fruit juice (e.g., apple, orange, or pineapple), or a cooked apple sauce.
  • Always shake the mixture just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
  • To ensure that all the medication has been taken, fill the glass of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Belmazol than you should

If you have taken more Belmazol than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Belmazol

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, contact your doctor or go to the hospital immediately:

• Sudden hissing sounds when breathing (sudden sibilance), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blister formation or peeling. Intense blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellow skin discoloration, dark urine, and fatigue, which may be symptoms of liver problems.

Other side effects are:

Frequent side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Rare side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.
• Fracture of the wrist, hip, or spine.

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

• Blood disorders, such as agranulocytosis (low white blood cell count).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance of intense rash, blister formation, 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 men.

In rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very poor general condition or fever with local infection symptoms, such as neck pain, throat pain, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a white blood cell deficiency (agranulocytosis). It is essential to provide information about the medication you are taking at that time.

Unknown frequency (cannot be estimated from available data)

• If you are taking omeprazole for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

• Skin rash, possibly with joint pain.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication 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.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Belmazol 40 mg hard-gastrorresistant capsules

• The other components (excipients) are: sugar spheres (sucrose and cornstarch), carboxymethylcellulose sodium type A (from potato), sodium lauryl sulfate, povidone, trisodium dodecyl phosphate dodecahydrate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.

The capsule is composed of: erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), gelatin, quinoline yellow (E104).

Printing ink:Shellac, propylene glycol, sodium hydroxide, polyvinylpyrrolidone, titanium dioxide (E171).

Appearance of the product and content of the container

Belmazol 40 mg capsules are formed by a orange-colored body marked with a "40" and a blue-colored cap marked with "O", containing white-beige-colored omeprazole microgranules.

Container sizes:

HDPE bottles with 14 and 28 capsules.

Blister packs of 14 and 28 capsules.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

TEVA PHARMA, S.L.U.

C/ Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Spain

Responsible manufacturer

TEVA PHARMA, S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza.

Spain

Last review date of this leaflet:March 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/