Omeprazole Stada 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol STADA 20 mg gastro-resistant hard capsules EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• 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.

Contents of the leaflet:

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

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

Omeprazol STADA 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 in the stomach.

Omeprazol STADA is used to treat the following conditions:

In adults:

• Gastroesophageal reflux disease (GERD). In this disorder, stomach acid passes into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol STADA may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• Gastroesophageal reflux disease (GERD). In this disorder, stomach acid passes into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include return of stomach contents into the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Omeprazol STADA

Do not take Omeprazol STADA

• 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 are unsure, talk to your doctor or pharmacist before taking Omeprazol STADA.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Omeprazol STADA.

Omeprazol STADA may mask symptoms of other conditions. Therefore, if you experience any of the following conditions before starting or during treatment with Omeprazol STADA, consult your doctor immediately:

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your bowel movements are black (blood-stained stools).
• You have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• You have severe liver problems.
• You have previously had a skin reaction after treatment with a medicine similar to Omeprazol STADA used to reduce stomach acid.
• You are scheduled to have a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol STADA. Remember to mention any other symptoms you may notice, such as joint pain.

If you take Omeprazol STADA for a long period (more than 1 year), your doctor will likely arrange periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit to your doctor.

If you are taking proton pump inhibitors such as Omeprazol STADA, especially for more than one year, there may be a slight increase in the risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Omeprazole may interfere with certain tests (chromogranin A). To avoid this interference, omeprazole treatment should be temporarily discontinued at least 5 days before the test.

Kidney inflammation may occur while taking omeprazole. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your treating doctor.

Taking Omeprazol STADA with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription. Omeprazol STADA may affect how some medicines work, and some medicines may affect Omeprazol STADA.

Do not take Omeprazol STADA 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, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, to 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 STADA
• 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 STADA
• Rifampicin (used to treat tuberculosis), atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• 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 may need to temporarily stop treatment with Omeprazol
• 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))

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin, in addition to omeprazole, to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about any other medicines you are taking.

Taking Omeprazol STADA with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take Omeprazol STADA while breastfeeding.

Driving and using machines

Omeprazol STADA is unlikely to affect your ability to drive or operate 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 use machinery.

Omeprazol STADA contains sucrose

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

Omeprazol STADA contains sodium

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

3. How to take Omeprazol STADA

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

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and your age.

The usual doses are given below.

Adults:

Treatment of symptoms of GERD (gastroesophageal reflux disease), such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild damage to the esophagus, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The recommended dose once the esophagus has healed is 10 mg once daily.
• If you do not have esophageal damage, the usual dose is 10 mg once daily.

Treatment of upper intestinal ulcers (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of stomach and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily for 4–8 weeks.

Prevention of stomach and duodenal ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The usual dose is 20 mg of Omeprazol STADA twice daily for one week.
• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine.

Use in children and adolescents

Treatment of symptoms of GERD, such as heartburn and acid regurgitation:

• Children over one year of age weighing more than 10 kg may take Omeprazol STADA. The dose for children is based on body weight, and the doctor will determine the correct dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• Children over 4 years of age may take Omeprazol STADA. The dose for children is based on body weight, and the doctor will determine the correct dose.
• Your doctor will also prescribe two antibiotics for your child: amoxicillin and clarithromycin.

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 that prevent the medicine from being broken down by stomach acid. It is important not to damage the granules.

What to do if you or your child have difficulty swallowing the capsules

• If you or your child 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 well before drinking (the mixture will not be transparent). Then drink the mixture immediately or within 30 minutes.

• To ensure that all the medicine is taken, refill the glass halfway with water, swirl well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol STADA than you should

If you have taken more Omeprazol STADA than prescribed by your doctor, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone: (91) 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazol STADA

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 missed one. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you stop taking Omeprazol STADA

Do not stop treatment with Omeprazol STADA without first talking to your doctor or pharmacist.

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 STADA 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 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 tiredness, 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: diarrhea, 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 used to monitor liver function.
• 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.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision 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 tiredness.
• 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 appearance of a 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 in the intestine (causing diarrhea).

• If you are being treated with omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present 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 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 STADA may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a severely deteriorated 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 that you provide information about the medicines you are taking at that time.

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

5. Storage of Omeprazole STADA

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.

Blister packs:

Store below 30°C.

Keep the blister in the original container to protect it from moisture.

HDPE bottles:

Store below 30°C.

Keep the bottle tightly closed to protect it from moisture.

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

6. Contents of the container and additional information

Composition of Omeprazol STADA

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components are: corn starch and sucrose; sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, methacrylic acid and ethyl acrylate copolymer. Capsule components: water, gelatin, quinoline yellow (E-104), titanium dioxide (E-171).

Appearance of the product and contents of the container

Omeprazol STADA is presented as opaque yellow hard gelatin capsules containing spherical microgranules of whitish to cream color.

The capsules are supplied in Al/Al blisters or in HDPE bottles containing 14, 28, or 56 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

Liconsa, S.A.

Avda. Miralcampo, 7.

P.I. Miralcampo

19200 Azuqueca de Henares

Guadalajara - Spain

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

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