Omeprazole stadapharm 20 mg gastro-resistant hard capsules

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

Follow the instructions for administering the medicine exactly as described 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 14 days.

Leaflet contents

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

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

3. How to take Omeprazole stadapharm

4. Possible adverse effects

5. Storage of Omeprazole stadapharm

6. Package contents and additional information

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

Omeprazole Stadapharm contains the active ingredient 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 stadapharm is indicated in adults for the short-term treatment of reflux symptoms (e.g., heartburn, acid regurgitation).

Acid reflux is the backflow of stomach acid into 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 condition worsens or does not improve after 14 days.

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

Do not take Omeprazole 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 containing proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infection).

If you have any questions, consult your doctor or pharmacist before you start taking Omeprazole stadapharm.

Warnings and precautions

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

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

• She is losing a lot of weight for no apparent reason and has trouble swallowing.
• You have a stomach ache or indigestion.
• He starts vomiting food or vomiting blood.
• His bowel movements are black (bloody stools).
• If you experience severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• He has a history of gastric ulcer or gastrointestinal surgery.
• She has been receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• She has been suffering from indigestion or heartburn for 4 weeks or more.
• He/She has jaundice or a serious liver disease.
• She is over 55 years of age and her symptoms have recently changed or are new.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole stadapharm to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

If you develop a skin rash, especially on areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with Omeprazole stadapharm. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as a preventative medication.

Taking Omeprazole Stadapharm with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Omeprazole Stadapharm can affect how some medicines work, and some medicines can affect how Omeprazole Stadapharm works.

Do not take Omeprazole stadapharm 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, posoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy)
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Omeprazole stadapharm.
• 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 stadapharm.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in organ transplant cases)
• 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 drug used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor will need to temporarily stop your treatment with Omeprazole stadapharm

Taking Omeprazole stadapharm with food and drink

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 Omeprazole Stadapharm, tell your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Omeprazole Stadapharm during this time.

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

Driving and operating machinery

Omeprazole stadapharm is not likely to affect your ability to drive or operate tools or machinery. Side effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or operate machinery.

Omeprazole stadapharm contains sucrose

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

Omeprazole Stadapharm contains sodium

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

3. How to take Omeprazole stadapharm

Follow your doctor's instructions exactly when taking this medicine. If you have any questions, 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 improve 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 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 being broken down by stomach acid. It is important 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 as they pass through the stomach. The granules release the active ingredient in the intestine, where it is absorbed by the body to produce its 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 still water, an acidic fruit juice (e.g. apple, orange or pineapple) or applesauce.
  • Always shake the mixture just before drinking it (the mixture will not be clear). Then, drink the mixture immediately or within 30 minutes.
  • To ensure you have taken all the medicine, fill the glass halfway 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 Omeprazole stadapharm than you should

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

If you forgot to take Omeprazole stadapharm

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 side effects, although not everybody gets them.

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

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin reddening with blistering or peeling. Severe blistering and bleeding may also occur on the lips, eyes, mouth, nose, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and tiredness can be symptoms of liver problems.

Other adverse effects include:

Common 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.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation that everything is spinning (vertigo).
• Abnormalities in blood tests used to check liver function.
• Skin rash, hives and itching.
• Feeling of general malaise 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 likelihood of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue and throat, fever and wheezing.
• Low blood sodium levels. Can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alterations.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• An 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).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side 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 do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. May be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Increased breast size in men.

Frequency not known (cannot be estimated from the available data)

• Inflammation in the intestine (which causes diarrhea).
• If you are being treated with Omeprazole stadapharm for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or an increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium or calcium levels. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazole Stadapharm can affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever and a severely deteriorated general condition, or fever with symptoms of a local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency of white blood cells (agranulocytosis). It is important that you inform your doctor about any medication you are currently taking.

Don't worry about this list of possible side effects. You may not experience any of them. If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of adverse effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole stadapharm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that month.
• Alu/Alu blister pack:

Store below 30ºC.

Store in the original packaging to protect from moisture.

• PVC-PVDC/Al blister pack:

Store below 30ºC.

Store in the original packaging to protect from moisture.

• Jar:

It does not require special storage conditions.

Shelf life after first opening the bottle: 100 days.

Keep the jar tightly closed to protect it from moisture.

• Medicines should not be disposed of down the drain or in the trash. Take any unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of unused medicines and their packaging. By doing so, you will help protect the environment.

6. Package contents and additional information

Composition of Omeprazole stadapharm

• The active ingredient is omeprazole. Omeprazole Stadapharm gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other ingredients are sugar spheres (sucrose and maize starch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), anhydrous disodium hydrogen phosphate (E-339 ii), sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, and triethyl citrate (E-1505). Capsule: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide, and shellac). See section 2. Omeprazole stadapharm contains sucrose.