Omeprazol stadapharm 20 mg capsulas duras gastrorresistentes

Package Leaflet: Information for the User

Omeprazole stadapharm 20 mg Hard Capsules

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

Follow exactly the administration instructions for 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 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 you worsen or do not improve after 14 days.

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

2.What you need to know before you start taking Omeprazole stadapharm

3.How to take Omeprazole stadapharm

4.Possible side effects

5.Storage of Omeprazole stadapharm

6.Contents of the pack and additional information

Omeprazol stadapharmcontains the active ingredient omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These medicines act by reducing the amount of acid produced by the stomach.

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

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

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

Do not take Omeprazol stadapharm:

• 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 to treat HIV infection).

If you are unsure, consult your doctor or pharmacist before starting to take Omeprazol stadapharm.

Warnings and precautions

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

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

• you lose weight significantly without apparent reason and have trouble swallowing.
• you have stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (hematochezia).
• if you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcer or gastrointestinal surgery.
• you are receiving ongoing treatment to treat indigestion or stomach burning for 4 weeks or more.
• you continuously experience indigestion or stomach burning 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 similar medicine to Omeprazol stadapharm to reduce stomach acidity.
• if you are scheduled to have a specific blood test (Cromogranina A).

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Omeprazol stadapharm. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

When taking omeprazole, it may cause inflammation in the kidneys. 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 inform your doctor of these signs.

Administration of Omeprazol stadapharm with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. Omeprazol stadapharm may affect the mechanism of action of some medicines and some medicines may affect Omeprazol stadapharm.

Do not take Omeprazol stadapharm if you are taking a medicine that containsnelfinavir(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, relax muscles, or epilepsy)
• Fenitoin (used in epilepsy). If you are taking fenitoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol stadapharm
• 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 treatment with Omeprazol stadapharm
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplant)
• 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)
• Metotrexate (chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of metotrexate, your doctor will need to temporarily stop treatment with Omeprazol stadapharm

Administration of Omeprazol stadapharmwith food and drinks

You can 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 Omeprazol stadapharm, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Omeprazol stadapharm during that time.

Your doctor will decide if you can take Omeprazol stadapharm if you are breastfeeding.

Driving and operating machinery

Omeprazol stadapharm 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.

Omeprazol stadapharm contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Omeprazol stadapharm contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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 better symptom relief.

How to take this medication

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

What to do if you have trouble swallowing the capsules

• If you have trouble 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 water without gas, a sour 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 all the medication has been taken, fill the glass with water up to the middle, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

What to do if you take more Omeprazol stadapharm than you should

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

What to do if you forget to take Omeprazol stadapharm

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Sudden hissing sounds while breathing (sudden onset of bronchospasm), 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 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 side effects are:

Frequent side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Less frequent side 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 that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

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

• Blood disorders, 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 intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" that can affect the intestines and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and inflammation of the brain.
• Sudden onset of intense rash, blistering, or peeling of the skin. 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 men.

Unknown frequency (cannot be estimated from available data)

• Inflammation of the intestines (causing diarrhea).
• If you are taking Omeprazol stadapharm for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest 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 can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In rare cases, Omeprazol stadapharm may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very poor general condition or fever with local infection symptoms, such as neck pain, throat pain, 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 to provide information about the medication you are taking at that time.

Do not worry about this list of possible side effects. You may not experience any of them. If you consider any of the side effects you experience to be severe or if you experience any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Alu/Alu blister:

Store below 30°C.

Store in the original packaging to protect it from moisture.

• PVC-PVDC/Al blister:

Store below 30°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 disposed of through the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Omeprazol stadapharm

• The active ingredient is omeprazole. Omeprazol stadapharm hard-gastrorresistant capsules contain 20 mg of omeprazole.
• The other components are sugar spheres (saccharose and cornstarch), hypromellose (E-464),talc (E-553b), titanium dioxide (E-171), anhydrous disodium hydrogen phosphate (E-339 ii), sodium lauryl sulfate, polisorbate 80,copolymer of methacrylic acid and ethyl acrylate, triethyl citrate (E-1505).Capsule:gelatin, titanium dioxide (E-171), printing ink (iron oxide black (E-172), potassium hydroxide, and shellac). See section 2 Omeprazol stadapharmcontains Saccharose.

Appearance of the product and contents of the packaging

Omeprazol stadapharmcapsules are hard gelatin capsules of white opaque color marked with “OM 20” that contain spherical granules.

HDPE white bottle with cap and safety ring equipped with a desiccant agent: 7 and 14 capsules.

Alu/Alu blister: 7 and 14 capsules.

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

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible manufacturer

TOWA PHARMACEUTICAL EUROPE, S.L.

C/ de Sant Martí, 75-97

08107 - Martorelles (Barcelona)

Spain

Last review date of this leaflet: February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/