Omeprazole Mabo 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Omeprazol Mabo 20 mg 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.
  1. If you have any questions, ask your doctor or pharmacist.
  2. 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 may 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 adverse effects

   1. Storage of Omeprazol Mabo

5. 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 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 Mabo can 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 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, your 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 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 any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Talk to 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 Omeprazol and contact your doctor immediately if you experience any of these symptoms related to serious skin reactions described in section 4.

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

• Unexplained weight loss and difficulty swallowing.

• Stomach pain or indigestion.

• 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 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. Inform your treating doctor if you notice any of these signs.

If you take omeprazole for a long period (more than 1 year), your doctor will likely perform periodic check-ups. Always report any new or unusual symptoms or circumstances during your visits.

Taking a proton pump inhibitor such as Omeprazol, 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 treatment with Omeprazol may need to be discontinued. 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
• Vision changes
• 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 less than 10 kg.

Taking Omeprazol Mabo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because omeprazole can affect how some medicines work, and some medicines can 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, 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 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 medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with omeprazole.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin in addition to 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 drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 diagnosed you with 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; essentially "sodium-free".

3. How to take Omeprazol Mabo

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, 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 dose is described below:

Use in adults

Treatment of symptoms of GERD (gastroesophageal reflux disease), 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 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 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.

Prevention of stomach and duodenal ulcers during treatment with NSAIDs (non-steroidal anti-inflammatory drugs):

• 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 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 also decide for how long you need to take the medicine.

Use in children and adolescents

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

• Children over one year of age weighing 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 Helicobacter pylori infection 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.
• 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 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), or apple puree.
• Always shake the mixture 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, refill the glass with water up to halfway, swirl 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, 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 taken.

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 forgotten doses.

If you stop treatment with 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 will experience 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)
• Reddening of the skin with blistering or peeling. Blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. 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 effects: 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
• Sensation of spinning (vertigo)
• Abnormal blood test results used to check liver function
• Skin rash, hives, and itching
• General feeling of being unwell 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 may cause weakness or bruising and increase the likelihood of developing infections.
• 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
• A 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)
• Serious liver problems leading to liver failure and brain inflammation
• Erythema multiforme
• Muscle weakness
• Enlargement of the breasts in males

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

• Inflammation of the intestine (causing diarrhoea)
• If you are being treated with omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, 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 carry out periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain

In very rare cases, omeprazole may affect the 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 inform your doctor about any medication you are currently taking. If you are taking proton pump inhibitors such as omeprazole, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of 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 the 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 required. Keep the bottle tightly closed to protect it 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 your pharmacy. If you have any doubts, 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 20 mg of omeprazole.
• The other components are: sugar spheres (containing sucrose and maize starch), hypromellose (E-464), disodium 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 20 mg capsules consist of a white body marked with “20” and a white cap marked with “OM”.

Pack sizes:

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

White HDPE bottle with cap 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/.