OMEPRAZOL STADA 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Omeprazole Stada 40 mg Hard Gastro-Resistant Capsules

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Omeprazole 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 by the stomach.

Omeprazole is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects 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 caused by a bacteria 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 medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole may be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects 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 insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by a bacteria called “Helicobacter pylori”. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Omeprazole Stada

Do not take Omeprazole Stada

• 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 that contains nelfinavir (used to treat HIV infection).

Do not take this medicine if you are among these cases. If you are not sure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take omeprazole.

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in relation to omeprazole treatment. Stop taking omeprazole and contact your doctor immediately if you experience any of these symptoms related to serious skin reactions described in section 4.

Omeprazole may hide the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to take omeprazole or during treatment, contact your doctor immediately if:

• You lose a lot of weight without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained faeces).
• 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 ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A).

This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

• Extreme tiredness or lack of energy
• Numbness
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression

When taking omeprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should report such signs to your treating doctor.

If you take omeprazole for a long period (more than 1 year), your doctor will probably perform regular check-ups. You should report any new or unusual symptoms or circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like omeprazole, especially for a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Omeprazole Stada

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. Omeprazole may affect the action of some medicines and some medicines may affect omeprazole.

Do not take omeprazole 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, itraconazole, posaconazole 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 you start or stop treatment with omeprazole
• 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 (thrombi))
• 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 omeprazole.

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

Taking Omeprazole Stada with food and drinks

See section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 in therapeutic doses. Your doctor will decide whether you can take omeprazole if you are breast-feeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools or machines.

However, side effects such as dizziness and blurred vision (see section 4) may occur. If this happens, do not drive or use machines.

Omeprazole Stada contains sucrose

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

Omeprazole Stada contains sodium

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

3. How to take Omeprazole Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

The recommended dose is:

Adults:

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

• If your doctor finds that you have mild damage to the oesophagus, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If you do not have damage to the oesophagus, the recommended dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once a day 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 a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once a day 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 a day for 8 weeks.

Preventionof stomach and duodenal ulcers:

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

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

• The recommended dose is 20 mg once a day for 4-8 weeks.

Prevention of stomach and duodenal ulcersduring NSAID therapy:

• The recommended dose is 20 mg once a day

Treatment of ulcers causedby Helicobacter pyloriinfection and prevention of their recurrence.

• The recommended dose is 20 mg of omeprazole twice a day for one week.
• Your doctor will also tell you to take two antibiotics, amoxicillin and clarithromycin.

Treatment of excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

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

Use in children and adolescents:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation

• Children over 1 year of age who weigh more than 10 kg can take omeprazole. The dose for children is based on body weight and your doctor will decide the correct dose.

Treatment of ulcers causedby Helicobacter pyloriinfection and prevention of their recurrence:

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

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.

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

• If you or your child have problems 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, acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
• Always shake the mixture well before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To make sure you have taken all the medicine, fill the glass 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 Stada than you should

If you have taken more omeprazole than prescribed by your doctor, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist or the Toxicology Information Service, telephone: (91) 562 04 20, indicating the medicine and the amount administered.

If you forget to take Omeprazole 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 forgotten doses.

If you stop taking Omeprazole Stada

Do not stop taking omeprazole without talking to your doctor or pharmacist first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious adverse effects, stop taking omeprazole and consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (Rare)
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (Very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (Rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (Rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (Rare)

Other adverse effects are:

Frequent adverse 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.

Infrequent adverse 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).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Rare adverse 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.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alterations.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• 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 adverse effects (may affect up to 1 in 10,000 people)

• Blood count alterations, 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 brain inflammation.
• ERYthema multiforme,
• Muscle weakness.
• Increased breast size 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 magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, 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 periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole can affect the white blood cells in the blood 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 neck, throat, 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 that you provide information about the medication you are taking at that time.

Reporting adverse effects:

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

5. Storage of Omeprazol Stada

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

OPA-Al-PVC/Al blister packs: store in the original packaging to protect it from moisture.

HDPE plastic container: keep the container perfectly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Stada

• The active ingredient is omeprazole. Each Omeprazol Stada 40 mg capsule contains 40 mg of omeprazole.

• Other components are:
  • Capsule content: sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), and methacrylic acid-ethyl acrylate copolymer (1:1).
  • Capsule: gelatin, indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Blue and white opaque capsule containing white to off-white spherical microgranules.

The capsules are supplied in OPA-Al-PVC/Al blister packs of 14 and 28 capsules; and in HDPE plastic containers of 14, 28, and 56 capsules.

Only some package 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

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7. P.I. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus:May 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/