Omeprazole Stadapharm 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol 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.

Always follow the instructions for taking this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• 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, even if they are side 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 stadapharm is and what it is used for
2. What you need to know before taking Omeprazol stadapharm
3. How to take Omeprazol stadapharm
4. Possible side effects
5. How to store Omeprazol stadapharm
6. Contents of the pack and other information

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

Omeprazol stadapharm 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.

Omeprazol stadapharm 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 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 to achieve symptom improvement.

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

2. What you need to know before taking Omeprazol stadapharm

Do not take Omeprazol stadapharm:

• 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).

If you have any doubts, consult your doctor or pharmacist before starting to take Omeprazol stadapharm.

Warnings and precautions

Do not take Omeprazol stadapharm for longer 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 symptoms of other conditions. Therefore, consult your doctor immediately if you experience any of the following before starting or during treatment with Omeprazol stadapharm:

• Unintentional 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.
• A history of gastric ulcer or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Experiencing indigestion or heartburn continuously for 4 weeks or more.
• Jaundice or severe liver disease.
• You are over 55 years of age and your symptoms have recently changed or are new.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazol stadapharm used to reduce stomach acid.
• You are scheduled for 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 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, kidney inflammation may occur. Signs and symptoms may include reduced 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.

Taking Omeprazol stadapharm with other medicines

Inform 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. Omeprazol stadapharm may affect how some medicines work, and some medicines may affect Omeprazol stadapharm.

Do not take Omeprazol stadapharm 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, posaconazole, 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 in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol stadapharm
• 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 treatment with Omeprazol stadapharm
• 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 in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with Omeprazol stadapharm

Taking Omeprazol stadapharm with food and drink

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

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

Driving and using machines

Omeprazol stadapharm 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 stadapharm contains sucrose

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

Omeprazol stadapharm contains sodium

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

3. How to take Omeprazol stadapharm

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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 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 breaking down due to stomach acid. It is important not to damage the granules. These granules contain omeprazol as the active substance and are enteric-coated to protect them and prevent breakdown as they pass through 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 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), or apple puree.
  • Always shake the mixture 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, fill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprazol 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 adverse effects, although not everyone will experience them.

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

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Red, blistering or peeling skin. Severe blisters and bleeding may also occur in the lips, eyes, mouth, nose, and genitals. These could be signs of “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 include:

Common 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 stomach polyps.

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 issues.
• Skin rash, hives, and itching.
• General feeling of being unwell 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 muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden 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).
• 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.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhoea).
• If you are being treated with Omeprazol stadapharm for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, 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 levels of potassium or 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, Omeprazol stadapharm may affect white blood cells 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 deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about any medication 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 side 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 Stadapharm

• 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 refers to the last day of the month indicated.
• Alu/Alu blister:

Store below 30°C.

Keep in the original packaging to protect from moisture.

• PVC-PVDC/Al blister:

Store below 30°C.

Keep in the original packaging to protect from moisture.

• Bottle:

No special storage conditions required.

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

Keep the bottle tightly closed to protect from moisture.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol stadapharm

• The active substance is omeprazole. Omeprazol stadapharm gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other components 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, triethyl citrate (E-1505). Capsule: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide and shellac). See section 2: Omeprazol stadapharm contains sucrose.

Appearance of the product and contents of the pack

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

White HDPE bottle with cap and security ring equipped with a desiccant: 7 and 14 capsules.

Alu/Alu blister: 7 and 14 capsules.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

TOWA PHARMACEUTICAL EUROPE, S.L.

C/ de Sant Martí, 75-97

08107 - Martorelles (Barcelona)

Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/