OMEPRAZOL MABO 40 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Mabo 40 mg gastro-resistant hard 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 is Omeprazole Mabo and what is it used for
2. What you need to know before you take Omeprazole Mabo
3. How to take Omeprazole Mabo
4. Possible side effects
5. Storing Omeprazole Mabo
6. Contents of the pack and other information

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

Omeprazole Mabo 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 Mabo is used to treat the following conditions:

In adults:

• “Gastro-oesophageal 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 ulcer) or stomach (gastric ulcer).
• Ulcers which are infected with 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 Mabo may also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach 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 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 infection with 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 Mabo

Do not take Omeprazole Mabo:

• 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).

Do not take omeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking omeprazole.

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment. Stop taking omeprazole and contact your doctor immediately if you experience any of these symptoms and they are severe.

Omeprazole may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking omeprazole, consult your doctor immediately:

• Losing a lot of weight without reason and having problems swallowing.
• HAVING stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (faeces) due to bleeding.
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Having severe liver problems.

• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol Mabo to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

When taking omeprazol, kidney inflammation may occur. 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.

If you take omeprazol 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, whenever you see your doctor.

Taking a proton pump inhibitor like omeprazole, especially over a period of more than one year, may slightly increase the risk of hip, wrist or spine fractures.

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

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with omeprazol. Also remember to mention any other symptoms that you may notice, such as joint pain.

This medicine may affect the way your body absorbs vitamin B12. If you have to take omeprazol for a long time, talk to your doctor, as you may need to have your vitamin B12 levels checked. Contact your doctor if you experience any of the following symptoms, which could be signs of low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Pain in the tongue or mouth, mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression

Children

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

Taking Omeprazole Mabo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Omeprazole may affect the way some medicines work and some medicines may affect the way omeprazole works.

Do not take omeprazole 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, posaconazole, itraconazole or voriconazole (used to treat fungal infections).
• Digoxin (used for 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.
• 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.
• 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)).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with omeprazole.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell them about any other medicines you are taking.

Taking Omeprazole Mabo with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

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.

Omeprazole passes into breast milk but it is unlikely to affect the baby at doses used to treat acid-related diseases. Your doctor will decide whether you can take omeprazole if you are breast-feeding.

Driving and using machines

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

Omeprazole Mabo contains Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1mmol sodium (23mg) per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Omeprazole Mabo

Always take this medicine exactly as your doctor 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.

The recommended dose is:

Use in adults

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

• If your doctor finds that you have mild inflammation of the oesophagus (oesophagitis), 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 a further 8 weeks if the oesophagus has not healed.

• The usual dose is 10 mg once a day. Your doctor may tell you to take a dose of 20 mg once a day if your gullet has not healed.
• If your gullet has not been damaged, 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 a further 2 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully 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 a further 4 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose may be increased to 40 mg once a day for 8 weeks.

Prevention of 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 duodenal and stomach ulcers caused by NSAIDs:

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

Prevention of duodenal and stomach ulcers caused by NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand to prevent them from coming back:

• The recommended dose is 20 mg of omeprazole twice a day for one week. Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

Treatment of Zollinger-Ellison syndrome:

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose depending on your needs and also decide how long you need to take the medicine for.

Use in children and adolescents

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

• Children over 1 year of age and ≥ 10 kg can take omeprazole. The dose for children is based on the child’s weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand to prevent them from coming back:

• Children over 4 years of age can take omeprazole. The dose for children is based on the child’s 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 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 which stop 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 put the contents into a glass of water (non-carbonated), 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). Drink the mixture straight away or within 30 minutes.
• To make sure that you have taken all the medicine, rinse the glass with half a glass of water, swirl and drink.

If you take more Omeprazole Mabo than you should

If you have taken more omeprazole than prescribed by your doctor, contact your doctor or pharmacist immediately, or call the national poison centre on 91 562 04 20, stating the name of the medicine and the amount you have ingested.

If you forget to take Omeprazole 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 forgotten dose.

If you stop taking Omeprazole Mabo

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

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 adverse effects(may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious, stop taking Omeprazol Mabo 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). (rare)
• 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". (very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other adverse effects are:

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

• 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 (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormalities in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

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

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Low sodium levels in the blood. It 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.
• 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 (may affect up to 1 in 10,000 people)

• Abnormalities in the blood count, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Muscle weakness.
• Increased breast size in males.

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

• Inflammation of the intestine (causing diarrhea).
• If you are taking omeprazol for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazol 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.

Reporting of Adverse Effects

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

5. Storage of Omeprazol 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 it from moisture.

HDPE bottles:

No special storage conditions are required. Keep the bottle perfectly closed to protect it from moisture.

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.

Medicines should not be thrown away through wastewater or household waste. 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 ofOmeprazol Mabo

• The active ingredient is omeprazol. Each gastro-resistant capsule contains 40 mg of omeprazol.
• The other ingredients are: sugar spheres (containing sucrose and cornstarch), hypromellose (E-464), sodium dihydrogen phosphate dihydrate (E-339ii), talc (E-553b), titanium dioxide (E-171), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% and triethyl citrate (E-1505).
• Capsule ingredients: gelatin and 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 Package Contents

Omeprazol Mabo 40 mg capsules are formed by a white body marked with "40" and a white cap marked with "OM".

Package sizes:

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

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

Some package sizes may not be marketed.

Marketing Authorization Holder

MABO-FARMA, S.A.

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 Last Revision of this Prospectus: April 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/.