OMEPRAZOL ABDRUG 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole ABDrug 20 mg Hard Gastro-Resistant Capsules EFG

Omeprazole

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.
• 1. If you have any further questions, ask your doctor or pharmacist.
  2. 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 experience 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 ABDrug and what is it used for
2. What you need to know before you take Omeprazole ABDrug
3. How to take Omeprazole ABDrug
4. Possible side effects
   1. Storing Omeprazole ABDrug

1. Contents of the pack and further information

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

Omeprazole ABDrug 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 ABDrug 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 caused by a 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 ABDrug may also be used to prevent ulcers if you are taking NSAIDs.

• Excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

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 return of stomach contents into the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by a 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 ABDrug

Do not takeOmeprazole ABDrug:

• 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 ABDrug if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole ABDrug.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazole ABDrug.

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 the use of omeprazole. Stop taking Omeprazole ABDrug and contact your doctor immediately if you experience any of these symptoms.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (faeces stained with blood).
• If you have 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 ABDrug to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A)

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 ABDrug. Remember to also mention any other symptoms you might notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms can include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

If you take Omeprazol ABDrug for a long period of time (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 visit your doctor.

Taking a proton pump inhibitor like Omeprazol ABDrug, especially over a period of more than one year, may slightly increase the risk of hip, wrist or spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

This medicine may affect the way your body absorbs vitamin B12. If you have to take this medicine over a long period, contact your doctor if you get any of the following symptoms which could be a sign of a vitamin B12 deficiency:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Sore, red tongue or mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

Children

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

Taking Omeprazole ABDrug 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. Omeprazol ABDrug may affect the action of other medicines and other medicines may affect Omeprazol ABDrug.

Do not take Omeprazol ABDrug 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 Omeprazol ABDrug
• 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 Omeprazol ABDrug
• 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 Omeprazol ABDrug.

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

Taking Omeprazole ABDrug 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 is excreted in breast milk but is unlikely to affect the child when used in therapeutic doses. Your doctor will decide whether you can take Omeprazol ABDrug if you are breast-feeding.

Driving and using machines

Omeprazol ABDrug is unlikely to affect your ability to drive or use 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.

Omeprazol ABDrug contains Sucrose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Omeprazol ABDrug contains Sodium

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

3. How to take Omeprazole ABDrug

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. This will depend on your condition and age.

The recommended dose is described below:

Use in adults

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

• If your doctor finds that you have mild oesophageal damage, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for another 8 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If you do not have oesophageal damage, the recommended dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of ulcers caused by NSAIDs:

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

Prevention of ulcers caused by NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

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

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

• The recommended dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Use in children

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

• Children over 1 year of age and weighing more than 10 kg can take Omeprazol ABDrug. The dose for children is based on their body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

• Children over 4 years of age can take Omeprazol ABDrug. The dose for children is based on their body weight and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

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 that prevent the medicine from being destroyed by the acid in the stomach. It is important not to damage the granules.

What to do if you or your child have problems swallowing the capsules

• If you or your child have problems 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 still water, a glass of acidic fruit juice (e.g. apple, orange or grapefruit) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
  • To make sure you have taken all the medicine, fill the glass with water, rinse it well and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazol ABDrug than you should

If you have taken more Omeprazol ABDrug than your doctor told you to, contact your doctor or pharmacist immediately. You can also contact the national poison centre, phone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Omeprazol ABDrug

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.

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 adverse effects (may affect up to 1 in 10,000 people)but serious, stop taking Omeprazol ABDrug 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).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding on the lips, eyes, mouth, nose, and genitals may also appear. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• 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:

Frequent 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.

Infrequent 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 infections.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• 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 when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Abnormalities in blood counts, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.

• Erythema multiforme

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

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhea).
• If you are being treated with Omeprazol ABDrug for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, muscle contractions, disorientation, convulsions, dizziness, or 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.

In very rare cases, Omeprazol ABDrug may 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed 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 ABDrug

• Keep this medicine out of sight and reach of children.

• 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.

• Al/Al blister:

Store below 30°C.

Store in the original packaging to protect it from moisture.

• PVC-PVDC/Al blister:

Store below 25°C.

Store in the original packaging to protect it from moisture.

• Bottle:

No special storage conditions are required.

Validity period after the first opening of the bottle: 100 days.

Keep the bottle perfectly closed to protect it from moisture.

• Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of 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 of Omeprazol ABDrug

• The active ingredient is omeprazole. Omeprazol ABDrug gastro-resistant hard capsules contain 20 mg of omeprazole.

The other components are sugar spheres (sucrose and cornstarch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), anhydrous disodium hydrogen phosphate (E-339 i), sodium lauryl sulfate, polysorbate 80, methacrylic acid and ethyl acrylate copolymer, triethyl citrate (E-1505). Capsule:gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172),

• potassium hydroxide, and shellac).. See section 2 Omeprazol ABDrug contains sucrose.

Appearance of the product and package contents

Omeprazol ABDrug capsules are hard gelatin capsules, white opaque, marked with OM20, containing spherical granules.

HDPE white bottle with cap and safety ring equipped with a desiccant: 14 and 28 capsules.

Alu/Alu blister: 14 and 28 capsules.

PVC-PVDC/Al blister: 14 and 28 capsules.

Only some package sizes may 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/San Marti, 75-97

Martorelles, 08107, Barcelona

This medicine is authorized in the member states of the European Economic Area under the following names:

Belgium: Prenome 10, 20, 40 mg gastro-resistant capsule, hard

Spain: Omeprazol ABDrug 20, 40 mg hard gastro-resistant capsule

Netherlands: Prenome 10, 20, 40 mg maagsapresistente capsule, hard

Poland: Prenome 10, 20, 40 mg kapsulka dojelitowa, twarda

United Kingdom: Prenome 10, 20, 40 mg gastro-resistant capsule, hard

Romania: Prenome 10, 20, 40 mg capsule gastrorezistente

Date of the last revision of this prospectus: March 2023

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.