Omeprazole Aurovitas Pharma 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

OmeprazolAurovitas Pharma 20 mg gastro-resistant hard capsules EFG

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated 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 you get worse or do not improve after 14 days.

Contents of the leaflet

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

1. What Omeprazol Aurovitas Pharma 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.

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

Reflux is the backflow of acid from the stomach into the oesophagus, which may become inflamed and painful. 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.

Consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazol Aurovitas Pharma

Do not take Omeprazol Aurovitas Pharma:

• 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 other proton pump inhibitors (such as 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, speak with your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take omeprazole.

Do not take omeprazole for longer than 14 days without consulting your doctor. If you do not experience relief, or if 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 symptoms before starting or during treatment with omeprazole:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• New onset of vomiting food or vomiting blood.
• Black stools (indicating blood in the stool).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• A history of gastric ulcer or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Experiencing persistent indigestion or heartburn for 4 weeks or more.
• Jaundice or severe liver disease.
• You are over 55 years old and your symptoms have recently changed or are new.
• You have ever had a skin reaction after treatment with a medicine similar to omeprazole used to reduce stomach acid.
• You 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 stop treatment with omeprazole. 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 should report these signs to your treating doctor.

Patients should not take omeprazole as preventive medication.

Taking Omeprazol Aurovitas Pharma with other medicines

Tell 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).

You should specifically inform your doctor if you are taking clopidogrel (used to prevent blood clots (thrombi)).

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, muscle relaxation, or 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 clot formation, 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).
• 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 omeprazole treatment.

Taking Omeprazol Aurovitas Pharma with food and drinks

You may take your capsules with food or on an empty stomach. Do not chew or crush the capsules. Swallow the capsules whole with a glass of water.

Pregnancy and breastfeeding

Before taking omeprazole, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide whether you can take omeprazole during this time.

Your doctor will decide whether you can take omeprazole if you are breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools or machinery.

However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or operate machinery.

Omeprazol Aurovitas Pharma contains Sucrose

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

Omeprazol Aurovitas Pharma contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule; essentially "sodium-free".

3. How to take Omeprazol Aurovitas Pharma

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

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 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 have an enteric coating that protects them and prevents them from dissolving in the stomach. The granules release the active substance in the intestine, where it is absorbed into the body to produce its effect.

What to do if you have difficulty swallowing the capsules

• If you have trouble 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 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 halfway with water, swirl it well, and drink it. Do not use milk or carbonated water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Aurovitas Pharma than you should

If you have taken more omeprazol than recommended, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprazol Aurovitas Pharma

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 everyone experiences them.

If you notice any of the following rare but serious adverse effects, stop taking omeprazole and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. 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 effects: 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.
• Sensation of spinning (vertigo).
• Abnormal blood test results indicating liver function problems.
• Skin rash, hives, and itching.
• General malaise 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, 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.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• 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).
• Severe 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.
• Enlargement of the breasts in males.

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

• Inflammation in the intestine (causing diarrhea).
• Hypomagnesemia.
• If you are taking omeprazole for more than three months, magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and 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 very poor general condition, or fever with signs of localized 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 taking.

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, consult 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Aurovitas Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer and inner packaging following EXP.: The expiry date refers to the last day of the month indicated.
• Do not store above 25 °C.
• Store this medicine in its original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Aurovitas Pharma

• The active substance is omeprazole. The gastro-resistant capsules contain 20 mg of omeprazole.
• The other components are:

Capsule contents: sugar spheres (sucrose and maize starch), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, and 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1).

Capsule coating: gelatin, quinoline yellow, and titanium dioxide.

Appearance of the product and contents of the pack

Omeprazol Aurovitas Pharma 20 mg gastro-resistant capsules are opaque yellow in colour and contain spherical microgranules of whitish to cream-white colour.

Aluminum blister: 14 capsules.

HDPE bottles with silica gel desiccant in the polypropylene cap: 14 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A

Av. Miralcampo no. 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the most recent review of this leaflet: November 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/