Omeprazole Farmamabo 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol farmaMabo 20 mg gastro-resistant hard capsules

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult a doctor if your condition worsens or if you do not improve after 14 days.

Contents of the leaflet

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

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

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

This medicine is indicated in adults for short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).

Reflux is the backflow of acid from the stomach into the esophagus, which may become inflamed and cause pain. This can cause symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2-3 consecutive days before your symptoms improve.

You should consult your doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazol farmaMabo

Do not take Omeprazol farmaMabo:

• 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 this medicine 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

Talk to your doctor or pharmacist before starting to take this medicine.

Do not take this medicine for longer than 14 days without consulting your doctor. If you do not experience relief, or if you feel your symptoms worsen, consult your doctor.

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• New onset of vomiting food or vomiting blood.
• Black stools (bloody stools).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• History of gastric ulcer or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Experiencing ongoing indigestion or heartburn for 4 weeks or more.
• Jaundice or severe liver disease.
• Are over 55 years of age and your symptoms have recently changed or are new.
• Have ever had a skin reaction after treatment with a medicine similar to omeprazole used to reduce stomach acid.
• Are scheduled to have a specific blood test (Chromogranin A).

If you develop a skin rash, especially on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with this medicine. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation may occur. 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. You must report such signs to your treating doctor.

Patients should not take omeprazole as a preventive medication.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Taking Omeprazol farmaMabo 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 may affect the action of some medicines, 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, itraconazole, posaconazole, 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 at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with this medicine.

Taking Omeprazol farmaMabo with food and drink

See section 3.

Pregnancy and breastfeeding

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

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

Driving and using machines

This medicine is unlikely to affect your ability to drive or use tools or machines. 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 farmaMabo contains sucrose and sodium

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Omeprazol farmaMabo

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 20 mg capsule once daily for 14 days. Contact your doctor if symptoms do not resolve after this period.

You may need to take the capsules for 2-3 consecutive days before experiencing symptom improvement.

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 enteric-coated granules designed to prevent the medicine from breaking down in the acidic environment of the stomach. It is important not to damage the granules. These granules contain omeprazol as the active substance and are protected by an enteric coating that prevents them from dissolving in the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to produce its effect.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules:

• Open the capsule and take the contents directly with half a glass of water, or pour the contents into a glass of still (non-carbonated) water, acidic fruit juice (e.g., apple, orange, or pineapple juice), or apple sauce.

• Always shake the mixture well 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.

Use in children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

If you take more Omeprazol farmaMabo than you should

If you have taken more omeprazol than prescribed by your doctor, contact 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 farmaMabo

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.

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 but serious adverse effects, stop taking this medicine and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or of the body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Red, blistering or peeling skin. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

Other adverse effects are:

Frequent 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).
• Abnormal blood test results used to check liver function.
• Skin rash, hives and itching.
• General feeling of malaise and lack of energy.

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

• Blood problems, such as low white blood cells or platelets. This may cause weakness, bruising and increased risk of infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue and throat, fever and wheezing.
• 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.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine and fatigue.
• 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.
• Sudden onset of severe rash, blistering or skin peeling. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in males.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhoea).
• If you are being treated with this medicine 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 potassium or calcium levels 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, this medicine may affect the white blood cells in the blood and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very poor 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 lack of white blood cells (agranulocytosis). It is important that you inform your doctor about the medicines you are taking at that time.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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 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 farmaMabo

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

• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

• Blister pack: Do not store above 25°C. Keep in the original packaging to protect from moisture.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol farmaMabo

• The active substance is omeprazole. This medicine contains 20 mg of omeprazole.
• The other components are sugar spheres (containing sucrose and corn starch), hypromellose, talc, titanium dioxide (E-171), disodium hydrogen phosphate dihydrate, sodium lauryl sulfate, polysorbate 80, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate.

Capsule shell: gelatin, titanium dioxide (E-171).

Printing ink: black iron oxide (E-172), potassium hydroxide, and shellac.

See section 2: Omeprazol farmaMabo contains Sucrose.

Appearance of the product and contents of the pack

Omeprazol farmaMabo capsules are white opaque, hard gelatin capsules marked with “OM 20”, containing spherical granules.

PVC-PVDC/Al blister packs: 7 and 14 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MABO-FARMA S.A.
Calle Vía de los Poblados, 3,
Edificio 6, 28033 Madrid,
Spain.

Manufacturer

Towa Pharmaceutical Europe S.L.
C/Sant Marti, 75-97
08107, Martorelles (Barcelona) –
Spain

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

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