ARAPRIDE 40 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

ARAPRIDE 40 mg Gastro-Resistant Hard Capsules

Omeprazole

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What ARAPRIDE 40 mg is and what it is used for
2. What you need to know before you take 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 other information

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

Arapride 40 mg contains the active substance 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” (GORD). In this condition, acid from the stomach passes into the esophagus (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 NSAIDs (non-steroidal anti-inflammatory drugs). Arapride 40 mg can also be used to prevent 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 = 10 kg

1. • “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease can include reflux of stomach contents into the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

1. • 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. What you need to know before you take ARAPRIDE 40 mg

Do not takeArapride 40 mg

1. • if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Arapride 40 mg.

• 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 Arapride 40 mg.

Be cautious with ARAPRIDE®40 mg

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

1. • 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 40 mg 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.

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 such signs to your doctor.

Talk to your doctor before starting to take Arapride:

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

If you get a skin rash, especially in areas of the skin exposed to the sun, talk to 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 medicines

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

Do not take Arapride 40 mg 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:

1. • 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 40 mg
• 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 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 (thrombi))

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to take with Arapride 40 mg to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell them about any other medicines 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, tell 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 using machines

Arapride 40 mg is unlikely to 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 ingredients of Arapride 40 mg

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

3. How to take ARAPRIDE 40 mg

Follow the instructions for administration of Arapride 40 mg exactly as indicated by your doctor. Talk to 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:

1. • If your doctor confirms that you have mild esophageal damage, 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 duodenal ulcers:

1. • 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 gastric ulcers:

1. • 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 recurrence of stomach and duodenal ulcers:

1. • 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:

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

Prevention of stomach and duodenal ulcersduring the administration of NSAIDs:

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

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

1. • The normal dose is 20 mg of Arapride 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 tumor 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 decide how long you need to take the medicine.

Children:

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

1. • 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 ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

1. • 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 medicine

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 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

1. • 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 clear). Then, drink the mixture immediately or within 30 minutes.
• To make sure you have taken all the medicine, fill the glass with water, rinse it well, and drink the water. The solid parts contain the medicine; 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, talk to your doctor or pharmacist immediately. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 make up for the missed doses.

4. Possible side effects

Like all medicines, Arapride 40 mg can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Arapride 40 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. It could also be accompanied by blistering and bleeding of the lips, eyes, mouth, nose, and genitals. It could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and tiredness, 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).
• Abnormal liver blood tests.
• Skin rash, hives, and itching.
• General feeling of 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 risk of infection.
• Allergic reactions, sometimes severe, which include swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. It 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.
• 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 tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Blood disorders, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. It can 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 the white blood cells 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 sore throat, 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 important that you provide information about the medicine you are taking at that time.

Do not worry about this list of possible side effects. You may not get 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 leaflet, tell your doctor or pharmacist.

5. Storage of ARAPRIDE 40 mg

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

• Do not use Arapride 40 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 SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Packaging contents and additional information

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, 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 packaging contents

The Arapride 40 mg capsules have a white opaque body and an opaque blue cap.

Package sizes:

Blisters of 14 and 28 capsules.

Not all 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 leaflet:

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/