OMEKASTE 20 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Omekaste 20 mg Hard Gastro-Resistant Capsules

Omeprazole

Read all of this 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 as 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet

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

1. What is Omekaste and what is it used for

Omekaste 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.

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

Reflux is the rise of acid from the stomach to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that rises 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 to achieve an improvement in symptoms.

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

2. What you need to know before taking Omekaste

Do not take Omekaste

• 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 that contain proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used for HIV infection).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omekaste.

Do not take Omekaste for more than 14 days without consulting your doctor. If you do not experience relief, or if your symptoms worsen, consult your doctor.

Omekaste may mask the symptoms of other diseases. Therefore, consult your doctor immediately if you experience any of the following conditions before starting to take Omekaste or during treatment:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (bloody stools).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have a history of stomach ulcers or gastrointestinal surgery.
• You are receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• You have persistent indigestion or heartburn for 4 weeks or more.
• You have jaundice or severe liver disease.
• You are over 55 years old and your symptoms have changed recently or are new.
• If you have ever had a skin reaction after treatment with a medicine similar to Omekaste to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A).

If you suffer from a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Omekaste. Remember to mention any other symptoms you may notice, such as joint pain.

Patient should not take omeprazole as a preventive medication.

When taking omeprazole, kidney inflammation may occur. The 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 such signs to your doctor.

Children and Adolescents

Children and adolescents under 18 years should not take this medicine.

Other Medicines and Omekaste

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because Omekaste may affect the mechanism of action of some medicines and some medicines may affect Omekaste.

Do not take Omekaste if you are taking a medicine that contains 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 treatment with Omekaste.
• 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 treatment with 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).
• Erlotinib (used to treat cancer).
• Methotrexate (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 Omekaste.

Taking Omekaste with Food and Drinks

See section 3.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 when used at therapeutic doses. Your doctor will decide whether you can take Omekaste if you are breastfeeding.

Driving and Using Machines

Omekaste is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Omekaste Contains Sucrose

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

Omekaste Contains Sodium

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

3. How to Take Omekaste

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is one 20 mg capsule once a day for 14 days. Contact your doctor if symptoms do not disappear after this time.

You may need to take the capsules for 2-3 consecutive days to achieve an improvement in symptoms.

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 broken down by the acid in the stomach. It is important not to damage the granules. These granules contain omeprazole as the active substance and have an enteric coating that protects them and prevents them from breaking when passing through the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to obtain an effect.

What to Do if You Have Difficulty Swallowing the Capsules

• If you have difficulty 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 non-carbonated water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.
• Always shake the mixture just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
• To ensure that you have taken all the medicine, fill the glass with water to the half, rinse it well, and drink the water. Do not usemilk or carbonated water. The solid parts contain the medicine; do not chew or crush them.

Use in Children and Adolescents

Children and adolescents under 18 years should not take this medicine.

If You Take More Omekaste than You Should

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

If You Forget to Take Omekaste

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Also, blisters and bleeding in the lips, eyes, mouth, nose, and genitals may appear. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and tiredness, which can be symptoms of liver problems.

Other side effects are:

Common Side 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 Side 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).
• Changes in blood tests that check liver function.
• Rash, itching, and hives.
• General feeling of discomfort and lack of energy.

Rare Side 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.
• Allergic reactions, sometimes very severe, which include swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Rash on the skin with sun exposure.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Side Effects (may affect up to 1 in 10,000 people)

• Changes in 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 can cause liver failure and brain inflammation.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

Frequency Not Known (cannot be estimated from the available data)

• Inflammation of the intestine (which can cause diarrhea).
• Hypomagnesemia.
• Skin rash, possibly with joint pain.

In very rare cases, Omekaste may affect the white blood cells 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 sore throat, neck, or mouth, 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 important that you provide information about the medicine you are taking at that time.

Do not worry about this list of possible side effects. You may not get any of them. If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omekaste

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Al/Al blister: Store below 30°C. Store in the original package to protect from moisture.

PVC-PVDC/Al blister: Store below 25°C. Store in the original package to protect from moisture.

Bottle: This medicine does not require special storage conditions. Keep the bottle tightly closed to protect from moisture.

Shelf life after first opening of the bottle: 100 days.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Omekaste

• The active substance is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other ingredients are: sugar spheres (sucrose and corn starch), hypromellose, talc, titanium dioxide (E-171), sodium hydrogen phosphate dihydrate, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid and ethyl acrylate), triethyl citrate. Hard gelatin capsule: Body and cap: gelatin and titanium dioxide (E-171). Printing ink: black ink (shellac, propylene glycol, potassium hydroxide, and iron oxide black (E-172)).

Appearance of the Product and Contents of the Pack

Hard gelatin capsules, white, opaque, (size #3) marked with "OM" on the cap and with the number "20" on the body, containing spherical pellets.

It is presented in HDPE white bottles with a cap and a security ring equipped with a desiccant. Each pack contains 7 or 14 capsules.

It is presented in Alu/Alu blisters. Each pack contains 7 or 14 capsules.

It is presented in PVC-PVDC/Alu blisters. Each pack contains 7 or 14 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

TOWA PHARMACEUTICAL EUROPE S.L.

C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

Date of Last Revision of this Leaflet:March 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/.