ARAPRIDE 20 mg GASTRO-RESISTANT HARD CAPSULES

2. What you need to know before taking ARAPRIDE 20 mg

Do not takeArapride 20 mg.

• if you are allergic (hypersensitive) to omeprazole or any of the other components of Arapride 20 mg.
• if you are allergic to medications that contain proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medication that contains nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Arapride 20 mg.

Be especially careful withArapride 20 mg.

Arapride 20 mg may hide the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to take Arapride 20 mg or during treatment, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (stools stained with blood).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.

If you take Arapride 20 mg for a long period (more than 1 year), your doctor will likely perform regular check-ups. You should report any new or unusual symptoms and circumstances whenever you visit your doctor.

Warnings and precautions

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.

Consult your doctor before starting to take Arapride:

if you have ever had a skin reaction after treatment with a medication similar to Arapride to reduce stomach acidity.

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 Arapride. Remember to mention any other symptoms you may notice, such as joint pain.

If you are scheduled to have a specific blood test (Chromogranin A).

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Arapride 20 mg may affect the mechanism of action of some medications, and some medications may affect Arapride 20 mg.

Do not take Arapride 20 mg if you are taking a medication that contains nelfinavir(used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medications:

• 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 Arapride 20 mg
• Medications 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 Arapride 20 mg
• 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 the other medications you are taking.

Taking Arapride 20 mg with food and drinks

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

Pregnancy and breastfeeding

Before taking Arapride 20 mg, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Arapride 20 mg during that time.

Your doctor will decide if you can take Arapride 20 mg if you are breastfeeding.

Driving and using machines

It is unlikely that Arapride 20 mg will affect your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Important information about some of the components of Arapride 20 mg

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

3. How to take ARAPRIDE 20 mg

Follow the administration instructions of Arapride 20 mg indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate how many capsules you should take and for how long. This will depend on your condition and 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 esophagus, the normal 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 normal dose once the esophagus has healed is 10 mg once a day.
• If you do not have esophageal damage, the normal dose is 10 mg once a day.

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

• 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 once a day for 4 weeks.

Treatment of stomach ulcers(gastric ulcer):

• 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 once a day for 8 weeks.

Prevention of the recurrenceof 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 once a day.

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

• 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 the infection byHelicobacter pyloriandprevention of their recurrence:

• The normal dose is 20 mg of Arapride twice a day for one week.

• Your doctor will also indicate that you take two antibiotics: amoxicillin, clarithromycin, and metronidazole.

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 should take the medication.

Children:

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

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

Treatment of ulcerscausedby the infection byHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years of age can take Arapride. 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 medication

• 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 medication from breaking down due to the action of stomach acid. 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 just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
  • To ensure that all the medication is taken, fill the glass with water to the halfway point, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Arapride 20 mg than you should

If you have taken more Arapride 20 mg 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 medication and the amount ingested.

If you forget to take Arapride 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 side effects

Like all medications, Arapride 20 mg can cause side effects, although not everyone will experience them.

If you notice any of the following rare but serious side effects, stop taking Arapride 20 mg and consult your doctor immediately:

• 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 on the lips, eyes, mouth, nose, and genitals may also appear. 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.

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

Other side effects are:

Common side effects

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

Uncommon side effects

• 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 side effects

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the likelihood of contracting infections.
• Allergic reactions, sometimes very intense, which include 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 disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• An 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 sun exposure.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• 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.
• 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 men.
• Low magnesium levels in the blood.

Unknown side effect:

• Skin rash, possibly with joint pain.

In very rare cases, Arapride 20 mg 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.

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

5. Storage of ARAPRIDE 20 mg

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

• Do not use Arapride 20 mg after the expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

• Do not store at a temperature above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Arapride 20 mg

The active ingredient is omeprazole. Arapride 20 mg capsules contain 20 mg of omeprazole.

The other components (excipients) are sugar spheres (cornstarch and sucrose), sodium lauryl sulfate, anhydrous disodium hydrogen phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, and a copolymer of methacrylic acid and ethyl acrylate.

The composition of the hard capsule is gelatin, purified water, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

The Arapride 20 mg capsules have a yellow body and an opaque yellow cap.

Package sizes:

HDPE bottles with 28 capsules.

Blisters of 14 and 28 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

ARAFARMA GROUP, S.A.

c/ Fray Gabriel de San Antonio, 6-10 Pol. Ind. Del Henares (Marchamalo)

19180- Spain

Manufacturer

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10 Pol. Ind. Del Henares (Marchamalo)

19180- Spain

Date of the Last Revision of this Prospectus: December 2023

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