Omeprazole Qualigen 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazol Qualigen 20mg gastro-resistant hard capsules EFG

Omeprazole

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

2. What you need to know before taking Omeprazol Qualigen

3. How to take Omeprazol Qualigen

4. Possible side effects

   1. How to store Omeprazol Qualigen

5. Contents of the pack and other information

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

Omeprazol Qualigen contains the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Omeprazol Qualigen is used to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GORD). In this disorder, stomach acid passes into the oesophagus (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 medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Qualigen can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and weighing ≥10 kg

• Gastro-oesophageal reflux disease (GORD). In this disorder, stomach acid passes into the oesophagus (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 insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with 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 taking Omeprazol Qualigen

Do not take Omeprazol Qualigen

• if you are allergic (hypersensitive) 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, speak with your doctor or pharmacist before taking Omeprazol Qualigen.

Warnings and precautions

Talk to your doctor or pharmacist before starting Omeprazol Qualigen.

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• New onset of vomiting food or vomiting blood.
• Black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole for reducing stomach acid.
• If you are scheduled to have 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 discontinue treatment with omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

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 must report these signs to your treating physician.

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

Other medicines and Omeprazol Qualigen

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

Do not take Omeprazol Qualigen 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, 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 omeprazole treatment
• 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 omeprazole treatment
• 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))

If your doctor has prescribed Omeprazol Qualigen together with the antibiotics amoxicillin and clarithromycin 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 Qualigen with food and drink

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

Pregnancy and breastfeeding

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

Your doctor will decide whether you can take Omeprazol Qualigen while breastfeeding.

Driving and using machines

Omeprazol Qualigen is unlikely to affect your ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or operate machinery.

Omeprazol Qualigen contains sucrose

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

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

3. How to take Omeprazol Qualigen

Follow exactly the instructions for administering Omeprazol Qualigen given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The usual doses are indicated below.

Adults:

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

• If your doctor confirms 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 usual dose after healing of the esophagus 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 usual 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 fully heal, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual 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 fully heal, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

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

Prevention of stomach and duodenal ulcers during NSAID treatment:

• The usual 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 omeprazole twice daily for one week.

• Your doctor will also instruct you to take two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

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

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

Use in children and adolescents:

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

• Children over one year of age weighing more than 10 kg may take omeprazole. 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 omeprazole. 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 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 enteric-coated granules that prevent the medicine from breaking down due to 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 sauce.
  • Always shake the mixture well 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 well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Omeprazol Qualigen than you should

If you have taken more Omeprazol Qualigen than prescribed by your doctor, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Omeprazol Qualigen

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 may cause adverse effects, although not everybody gets them.

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

• Sudden wheezing, swelling of the lips, tongue or throat, or swelling of the body, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the 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 fatigue, which may be symptoms of liver problems.

Adverse effects may occur with certain frequencies, defined as follows:

Other adverse effects are:

Frequent adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation and gas (flatulence), benign stomach polyps.
• Nausea or vomiting.

Uncommon adverse effects

• Swelling of feet and ankles.
• Sleep disturbances (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

• Blood problems, such as a decrease in white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing 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 shortness of breath (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 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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that do not exist (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.
• Breast enlargement in males.

In very rare cases, omeprazole 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 inform your doctor about any medication you are taking at this time.

Frequency not known

If you are taking omeprazole for more than three months, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as Omeprazol Qualigen 20 mg, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

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

• Do not use Omeprazol Qualigen after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

• Store below 30°C.

• Keep the bottle tightly closed to protect it from moisture.

• Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are in doubt, please 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 Qualigen

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

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

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

• The printing ink consists of: shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol (E-1520), N-butanol, povidone, sodium hydroxide and titanium dioxide (E-171).

Appearance of the product and contents of the container

Omeprazol Qualigen 20 mg capsules contain enteric-coated granules.

Pack sizes:

HDPE bottles containing 14, 28 or 56 capsules.

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

Only certain pack 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 most recent review of this leaflet: March 2023

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