Aulcer 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

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

(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 only and must not be given to other people, even if they have the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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. How to store AULCER.
6. Further information.

1. What AULCER is and what it is used for

AULCER 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.

AULCER is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows back 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). AULCER may also be used to prevent ulcers from forming 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 flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, 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, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. BEFORE TAKING AULCER

Do not take AULCER

• if you are allergic (hypersensitive) to omeprazole or to any of the other components of AULCER.
• if you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazol, rabeprazol, esomeprazol).
• if you are taking a medicine containing nelfinavir (used for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking AULCER.

Warnings and precautions

Before taking this medicine, tell your doctor if:

AULCER may mask symptoms of other diseases. Therefore, if you experience any of the following conditions before starting AULCER or during treatment, 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 diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to AULCER used to reduce stomach acidity.
• 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 AULCER. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, inflammation of the kidney may occur. 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 must report these signs to your treating doctor.

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

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any 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 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 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 starting or stopping treatment with AULCER
• 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, in addition to AULCER, the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them of any other medicines you are taking.

Taking AULCER with food and drinks

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

Pregnancy and breastfeeding

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

Your doctor will decide whether you can take AULCER while breastfeeding.

Driving and using machines

It is unlikely that AULCER will affect your ability to drive or operate tools or machines. However, adverse effects such as dizziness and visual disturbances (see section 4) may occur. If they do occur, you should not drive or operate machinery.

Important information about some of the components of AULCER 20 mg

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

3. HOW TO TAKE AULCER

Follow exactly the administration instructions for AULCER given 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 your age.

The usual doses are indicated below.

Adults:

Treatment of symptoms of GERD, 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 daily for 4–8 weeks. Your doctor may prescribe a dose of 40 mg (2 capsules of 20 mg) for another 8 weeks if the oesophagus has not yet healed.

• The normal dose after healing of the oesophagus is 10 mg once daily.

• If you do not have oesophageal damage, the normal dose is 10 mg once daily.

Treatment of ulcers in the upper part of the intestine (duodenal ulcer):

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

Treatment of stomach ulcers (gastric ulcer):

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

Prevention of recurrence of gastric and duodenal ulcers:

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

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

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

Prevention of gastric and duodenal ulcers during NSAID therapy:

• The normal dose is 20 mg once daily.

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

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

• The usual dose is 60 mg (3 capsules of 20 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.

Children:

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

• Children over one year of age weighing more than 10 kg may take AULCER. 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 AULCER. The dose for children is based on body weight, and the doctor will determine the correct dose.
• The 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 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 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 puree.
  • Always shake the mixture just before drinking it (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 it well, and drink the water. The solid particles 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 may also call the Toxicology Information Service at telephone number 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 your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

4. Possible adverse effects

If you experience any of the following rare but serious adverse effects, stop taking AULCER 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).
• Skin redness with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, or genitals may also occur. These could be signs of "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 effects: diarrhoea, stomach pain, constipation and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests used to assess liver function.
• Skin rash, hives and itching.
• General malaise and lack of energy.

Rare adverse effects

• Blood problems, such as decreased 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 difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection known as “candidiasis” which 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

• 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 onset of severe rash, blistering or peeling of the skin. 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.
• Low magnesium levels in the blood.

Frequency “not known”:

• Skin rash, possibly with joint pain

In very rare cases, AULCER may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a very poor general condition, or fever with signs of local 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 medication you are taking at that time.

Unknown frequency

If you are taking AULCER for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see 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 your magnesium levels.

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

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 effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of AULCER 20 mg gastro-resistant hard capsules

Keep in the original packaging.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use AULCER after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store this blister in the original packaging or keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of AULCER

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.

• The other components (excipients) are:

• Pellets: sucrose/corn starch, sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose (hydroxypropylmethylcellulose), purified water q.s. 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 medicinal product and contents of the pack

AULCER 20 mg is presented as hard capsules containing spherical gastro-resistant microgranules of omeprazole, in packs of 14 and 28 gastro-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 most recent revision of this leaflet: March 2023.