OMEPRAZOL QUALIGEN 20 mg HARD GASTRORESISTENT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole Qualigen 20mg hard gastro-resistant capsules EFG

Omeprazole

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the following symptoms, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack and other information:

1. What Omeprazole Qualigen is and what it is used for
2. What you need to know before you take Omeprazole Qualigen
3. How to take Omeprazole Qualigen
4. Possible side effects
   1. Storage of Omeprazole Qualigen

1. Contents of the pack and further information

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

Omeprazole Qualigen 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 Qualigen is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the esophagus (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 infected by 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 medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazole Qualigen can also be used to prevent ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and=10 kg

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease can include return of stomach contents to the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacterium 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 Qualigen

Do not take Omeprazole Qualigen

• if you are allergic (hypersensitive) 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 not sure, talk to your doctor or pharmacist before taking Omeprazole Qualigen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazole Qualigen.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained feces).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A)

If you experience a skin rash, especially in areas of the skin exposed to the sun, consult 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.

When taking omeprazole, kidney inflammation may occur. The 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 report these signs to your 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 and circumstances whenever you visit your doctor.

Other medicines and Omeprazole Qualigen

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. Omeprazole Qualigen may affect the action of some medicines and some medicines may affect Omeprazole Qualigen.

Do not take Omeprazole Qualigen 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, 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))

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

Taking Omeprazole Qualigen with food and drinks

You can take your capsules with food or on an empty stomach.

Pregnancy and breastfeeding

Before taking Omeprazole Qualigen, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Omeprazole Qualigen during this time.

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

Driving and using machines

Omeprazole Qualigen 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.

Omeprazole Qualigen contains sucrose

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

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

3. How to take Omeprazole Qualigen

Follow the instructions for administration of Omeprazole Qualigen exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The usual doses are indicated below.

Adults:

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

• If your doctor confirms that you have mild esophageal damage, the usual 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 esophagus has not yet healed.

• The usual dose once the esophagus has healed is 10 mg once a day.
• If you do not have esophageal damage, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The usual 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 usual 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 the recurrence of stomach and duodenal ulcers:

• The usual 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:

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

Prevention of stomach and duodenal ulcersduring NSAID therapy:

• The usual dose is 20 mg once a day

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• The usual dose is 20 mg of omeprazole twice a day for one week.

• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

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

• The usual 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 the doctor will decide the correct dose.

Treatment of ulcerscausedby Helicobacter pyloriinfectionand prevention of their recurrence:

• Children over 4 years of age can take omeprazole. The dose for children is based on body weight and the doctor will decide the correct dose.
• The 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 trouble swallowing the capsules

• If you or your child 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 non-carbonated 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 transparent). Then, drink the mixture immediately or within 30 minutes.
  • To ensure that you have taken all the medicine, fill the glass with water to the half, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Qualigen than you should

If you have taken more Omeprazole Qualigen than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprazole Qualigen

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

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 but serious adverse effects, stop taking Omeprazol Qualigen 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).
• 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".
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Adverse effects can occur with certain frequencies, which are defined as follows:

Other adverse effects are:

Frequent Adverse Effects

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

Uncommon Adverse Effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormalities in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Rare Adverse Effects

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• 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.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• 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 fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects

• Abnormalities in blood counts, 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 an intense rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Increased breast size in males.

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.

Unknown Frequency

If you are taking omeprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Omeprazol Qualigen 20 mg, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Do not worry about this list of possible adverse effects. You may not experience any of them. If you think that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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. Conservation of Omeprazol Qualigen

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

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

• Store below 30°C.
• Keep the bottle perfectly closed to protect it from moisture.

• Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Qualigen

• The active ingredient is omeprazole. Omeprazol Qualigen capsules contain 20 mg of omeprazole.

• The other components (excipients) are sugar spheres (sucrose and cornstarch), sodium starch glycolate, sodium lauryl sulfate, povidone (E-1201), sodium hydroxide, trisodium phosphate hydrate, hydroxypropyl methylcellulose (E-464), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide, talc.

• The capsule is composed of: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), indigo carmine (E-132), erythrosine (E-127).

• The ink is composed of: shellac, anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol (E-1520), n-butanol, povidone, sodium hydroxide, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Omeprazol Qualigen 20 mg capsules contain enteric-coated granules.

Package sizes:

HDPE bottles with 14, 28, or 56 capsules.

Al/Al blisters with 14, 28, or 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Teva Pharma, S.L.U.

c/ C, nº4 Polígono Malpica

50016- Zaragoza (Spain)

Date of the Last Revision of this Prospectus: March 2023

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