AULCER 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USERAULCER 20 mg hard gastro-resistant capsules

(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 side effects listed in this leaflet, or if you notice any other side effects not listed, please tell your doctor or pharmacist.

Contents of the pack:

1. What AULCER is and what it is used for.
2. Before you take AULCER.
3. How to take AULCER.
4. Possible side effects.
5. Storing AULCER.
6. Further information.

1. What AULCER is and what it is used for

AULCER contains the active ingredient 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.

AULCER is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, stomach acid passes into the oesophagus (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 non-steroidal anti-inflammatory drugs (NSAIDs). AULCER may also be used to prevent ulcers if you are taking NSAIDs.
• Excess 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

• “Gastroesophageal reflux disease” (GORD). In this condition, stomach acid passes into the oesophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease may include reflux of stomach contents into 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. BEFORE YOU TAKE AULCER

Do not take AULCER

• if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of AULCER.
• 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 AULCER.

Warnings and precautions

Before you take this medicine, tell your doctor if:

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

• 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 stools).
• 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 AULCER to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A).

If you get 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 AULCER. 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 output 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 AULCER 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.

Using other medicines

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

Do not take AULCER 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 AULCER
• 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 AULCER
• 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 AULCER with food and drinks

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

Pregnancy and Breast-feeding

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

Your doctor will decide if you can take AULCER if you are breast-feeding.

Driving and using machines

AULCER 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 this happens, do not drive or use machines.

Important information about some of the ingredients of AULCER 20 mg

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

3. HOW TO TAKE AULCER

Follow the instructions for administration of AULCER exactly as prescribed by your doctor. Ask 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 damage to the oesophagus, the normal dose is 20 mg once a day for 4-8 weeks. Your doctor may prescribe a dose of 40 mg (2 capsules of 20mg) for another 8 weeks if the oesophagus has not yet healed.

• The normal dose once the oesophagus has healed is 10 mg once a day.
• If you do not have damage to the oesophagus, the normal dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The normal 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 (2 capsules of 20mg) once a day for 4 weeks.

Treatment of gastric ulcers:

• The normal 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 (2 capsules of 20mg) once a day for 8 weeks.

Preventionof the recurrence of stomach and duodenal ulcers:

• The normal dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg (2 capsules of 20mg) once a day.

Treatment of stomach and duodenal ulcers caused by NSAIDs:

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

Prevention of stomach and duodenal ulcersduring the administration of NSAIDs:

• The normal dose is 20 mg once a day

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• The normal dose is 20 mg of AULCER 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 tumour in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg (3 capsules of 20mg) per day.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Children:

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 AULCER. The dose for children is based on body weight, and the doctor will decide the correct dose.

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• Children over 4 years of age can take AULCER. 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 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 to about half, rinse it well and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more AULCER than you should

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

If you forget to take AULCER 20 mg

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

If you notice any of the following rare but serious adverse effects, stop taking AULCER 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 may 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).
• Nausea or vomiting.
• Benign polyps in the stomach.

Infrequent Adverse Effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• General feeling of 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 cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• 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

• Blood count disorders, 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.
• 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.
• Low magnesium levels in the blood.

Unknown Frequency:

• Skin rash, possibly with joint pain

In very rare cases, AULCER may 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 AULCER for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like AULCER, 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).

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

5. Conservation of AULCER 20 mg Hard Gastric-Resistant Capsules

Keep in the original packaging.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use AULCER after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Keep this blister pack in the original packaging or keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of AULCER

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• Other components (excipients) are:

• Pellet: sucrose/cornstarch, sodium lauryl sulfate, disodium phosphate, mannitol, hydroxypropyl methylcellulose (hypromellose), purified water cs. Coating agents: polyethylene glycol 6000 (Macrogol 6000), talc, polysorbate 80, titanium dioxide, Eudragit L30D, and purified water.
• Capsule components: indigo carmine, quinoline yellow, titanium dioxide, and gelatin (cap) and titanium dioxide and gelatin (body).

Appearance of the Product and Packaging Content

AULCER 20 mg is presented in the form of hard capsules, which contain spherical gastric-resistant omeprazole microgranules, in packages of 14 and 28 gastric-resistant capsules.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

Sagitario 14

03006 Alicante

Spain

Manufacturer

Especialidades Farmacéuticas Centrum SA (Laboratorios Centrum SA)

C/Sagitario 14

03006 Alicante

Date of the Last Revision of this Prospectus:March 2023.