Package Leaflet: Information for the User

ARAPRIDE 40 mg Hard Capsules (Gastro-resistant)

Omeprazole

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What ARAPRIDE 40 mg is and what it is used for

2. What you need to know before you start taking ARAPRIDE 40 mg

3. How to take ARAPRIDE 40 mg

4. Possible side effects

5. Storage of ARAPRIDE 40 mg

6. Contents of the pack and additional information

ARAPRIDE 40 mg 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.

ARAPRIDE 40 mg is used to treat the following conditions:

In adults:

1. •Gastroesophageal reflux disease (GERD). In this disorder, stomach acid flows up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.

•Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).

•Ulcers infected by a bacteria called "Helicobacter pylori". If you have this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

•Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). ARAPRIDE 40 mg can also be used to prevent the formation of 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 weighing = 10 kg

1. •Gastroesophageal reflux disease (GERD). In this disorder, stomach acid flows up into the esophagus (the tube that connects 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

1. •Ulcers infected by a bacteria called "Helicobacter pylori". If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not takeArapride40 mg

1. •if you are allergic (hypersensitive) to omeprazole or to any of the other components of Arapride 40 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 for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking Arapride 40 mg.

Be especially careful with ARAPRIDE®40 mg

Arapride 40 mg may mask the symptoms of other diseases. Therefore, if you experience any of the following complaints before starting to take Arapride 40 mg or during treatment, consult your doctor immediately:

1. •you lose weight significantly without apparent reason and have trouble swallowing.

•you have stomach pain or indigestion.

•you start vomiting food or vomiting blood.

•your stools are black (stained with blood).

•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 take Arapride 40 mg for a long period (more than 1 year), your doctor will probably perform regular check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

Warnings and precautions

When taking omeprazole, it may cause inflammation in the kidneys. 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 inform your doctor of these signs.

Consult your doctor before starting to take Arapride:

• if you have ever had a skin reaction after treatment with a similar medication to Arapride for reducing stomach acid.

If you have a skin rash, especially in sun-exposed areas, 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 (Cromogranina A).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Arapride 40 mg may affect the mechanism of action of some medications and some medications may affect Arapride 40 mg.

Do not take Arapride 40 mg if you are taking a medication that containsnelfinavir(used to treat HIV infection).

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

1. •ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)

•digoxin (used to treat heart problems)

•diazepam (used to treat anxiety, relax muscles, or epilepsy)

•phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will have to monitor you when you start or stop treatment with Arapride 40 mg

•medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will have to monitor you when you start or stop treatment with Arapride 40 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)

1. •cilostazol (used to treat intermittent claudication)

•saquinavir (used to treat HIV infection)

•clopidogrel (used to prevent blood clots)

If your doctor, in addition to Arapride 40 mg, has prescribed the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is very important that you inform your doctor of any other medications you are taking.

Taking Arapride 40 mg with food and drinks

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

Pregnancy and breastfeeding

Before taking Arapride 40 mg, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Arapride 40 mg during this time.

Your doctor will decide if you can take Arapride 40 mg if you are breastfeeding.

Driving and operating machinery

Arapride 40 mg 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.

Important information about some of the components of Arapride 40 mg.

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

Follow exactly the administration instructions for Arapride 40 mg 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 listed below.

Adults:

Treatment of symptoms of ERGE, such asheartburn and acid regurgitation:

1. •If your doctor checks that you have mild damage to the esophagus, 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 damage to the esophagus, the usual dose is 10 mg once a day.

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

1. •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 ofstomach ulcers(gastric ulcer):

1. •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.

Prevention of the recurrence of stomach and duodenal ulcers:

1. •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 ulcers caused by NSAIDs(nonsteroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

1. •The usual dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their recurrence:

1. •The usual dose is 20 mg of Arapride twice a day for a week.

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

Treatment ofexcess acid in the stomach caused by atumor in the pancreas (Zollinger-Ellison syndrome):

1. •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 should take the medication.

Children:

Treatment of symptoms of ERGE, such asheartburn and acid regurgitation

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

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

1. •Children over 4 years old may take Arapride. The dose for children is based on body weight, and your doctor will decide on the correct dose.

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

How to take this medication

1. •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 in the stomach acid. It is essential not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

1. •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 water without gas, a sour fruit juice (e.g., apple, orange, or pineapple), or a cooked apple puree.

-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 has been taken, fill the glass with water up to the middle, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Arapride 40 mg than you should

If you have taken more Arapride 40 mg than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Arapride 40 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 compensate for the missed doses.

Like all medicines, Arapride 40 mg may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop taking Arapride 40 mg and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden sibilance), 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 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.

Side effects may occur at certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

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

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare side effects

• Blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, and sibilance.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" that can affect the intestines 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.
• Muscle or joint pain (arthralgias or myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Blood count alterations, such as agranulocytosis (lack of white blood cells).
• Aggression.
• To see, feel, or hear 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 may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.
• Low magnesium levels in the blood.

Unknown side effect:

• Skin rash, possibly with joint pain.

In very rare cases, Arapride 40 mg may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as high fever and a severely deteriorated general condition or fever with symptoms of local infection, such as neck pain, throat pain, 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 to 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 consider any of the side effects you are experiencing to be severe or if you experience any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

• Do not use Arapride 40 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Arapride 40 mg

The active ingredient is omeprazole. Arapride 40 mg capsules contain 40 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, poloxamer 80, titanium dioxide, and 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 content of the packaging

Arapride 40 mg capsules are formed by a white opaque body and a blue opaque cap.

Package sizes:

Blister packs of 14 and 28 capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

ARAFARMA GROUP, S.A.

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

19180- Spain

Responsible manufacturer

ARAFARMA GROUP, S.A.

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

19180- Spain

Last review date of this leaflet:

December 2023

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