Omeprazole Mabo 40 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol Mabo 40 mg gastro-resistant hard capsules

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 you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Omeprazol Mabo contains the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Omeprazol Mabo is used to treat the following conditions:

In adults:

• "Gastroesophageal reflux disease" (GERD). In this disorder, 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 associated 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). Omeprazole may also be used to prevent ulcers from developing 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 disorder, 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 regurgitation of stomach contents into the mouth, vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers associated 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 Mabo

Do not take Omeprazol Mabo:

• 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).

Do not take omeprazole if you fall into any of the above categories. If you are unsure, speak with your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole.

Serious skin adverse reactions have been reported with omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking omeprazole and contact your doctor immediately if you experience any symptoms related to these serious skin reactions described in section 4.

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

• Unintentional weight loss and difficulty swallowing.

• Stomach pain or indigestion.

• New onset of vomiting food or vomiting blood.

• Black stools (blood-stained faeces).

• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.

• Severe liver problems.

• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol Mabo used to reduce stomach acid.

• If you are scheduled to have a specific blood test (chromogranin A).

Kidney inflammation may occur while taking omeprazole. 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 should report these signs to your treating doctor.

If you take omeprazole for a long period (more than 1 year), your doctor may schedule periodic check-ups. You should report any new or unusual symptoms or circumstances during visits to your doctor.

Taking a proton pump inhibitor such as omeprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine.

Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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 omeprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling sensations
• Tongue pain or red, sore tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

Children

Some children with chronic conditions may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or weighing <10 kg.

Taking Omeprazol Mabo with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Omeprazole may affect how some medicines work, and some medicines may affect omeprazole.

Do not take omeprazole 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, posaconazole, 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 omeprazole treatment.
• 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 omeprazole treatment.
• 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)).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy drug used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may need to temporarily stop omeprazole treatment.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics along with omeprazole 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 Mabo with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Omeprazole passes into breast milk but is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take omeprazole while breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

Omeprazol Mabo contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Omeprazol Mabo

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The recommended doses are:

Use in adults

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

• If your doctor confirms that 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.

• 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 part of the 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 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 gastric 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 gastric and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

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

Prevention of gastric and duodenal ulcers during NSAID therapy:

• The recommended dose is 20 mg once daily.

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

• The recommended dose is 20 mg of omeprazole 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 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 will decide how long you should continue taking the medicine.

Use in children and adolescents

Treatment of symptoms of GERD, such as heartburn 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 the doctor will determine the correct dose.

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

• Children over 4 years of age may take omeprazole. 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 the 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 due to 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 juice), 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 that 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 Mabo than you should

If you have taken more omeprazole than prescribed by your doctor, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprazol Mabo

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 taking Omeprazol Mabo

Do not stop treatment with omeprazole without first talking to your doctor or pharmacist.

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 (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Omeprazol Mabo and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Skin redness with blistering or peeling. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems. (rare)

Other adverse effects include:

Common adverse effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling of spinning (vertigo).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood disorders, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden feeling of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• 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 (may affect up to 1 in 10,000 people)

• 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.
• Muscle weakness.
• Enlargement of the breasts in males.

Adverse effects with unknown frequency (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhoea).
• If you are taking omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severely deteriorated 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 to provide information about the medicines you are taking at that time.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Mabo

Keep this medicine out of sight and reach of children.

PVC-PVDC/Al blister:

Store below 25 °C.

Keep in the original packaging to protect from moisture.

HDPE bottles:

No special storage conditions required. Keep the bottle tightly closed to protect from moisture.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Mabo

• The active substance is omeprazole. Each gastro-resistant hard capsule contains 40 mg of omeprazole.
• The other components are: sugar spheres (containing sucrose and maize starch), hypromellose (E-464), sodium hydrogen phosphate dihydrate (E-339ii), talc (E-553b), titanium dioxide (E-171), methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, and triethyl citrate (E-1505).
• Capsule components: gelatin, titanium dioxide (E-171), and purified water. Printing ink (containing shellac, ethyl alcohol, isopropyl alcohol, propylene glycol (E-1520), n-butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water, and black iron oxide (E-172)).

Appearance of the product and contents of the pack

Omeprazol Mabo 40 mg capsules consist of a white body marked with "40" and a white cap marked with "OM".

Pack sizes:

PVC-PVDC/Al blister: containing 28 and 56 capsules

White HDPE bottle with closure and security ring equipped with a desiccant agent: 28 and 56 capsules.

Some pack sizes may not be marketed.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain

Manufacturer

Towa Pharmaceutical Europe S.L.

C/ Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the most recent review of this leaflet: April 2023

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