Arapride 40 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ARAPRIDE 40 mg Hard gastro-resistant capsules

Omeprazole

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What ARAPRIDE 40 mg is and what it is used for
2. What you need to know before taking ARAPRIDE 40 mg
3. How to take ARAPRIDE 40 mg
4. Possible side effects
5. How to store 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 known as "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 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). Arapride 40 mg may also be used to prevent the formation of ulcers 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

1. • 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

1. • Ulcers infected with a bacterium called Helicobacter pylori. If your child has this condition, their doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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

Do not take Arapride 40 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 medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazol, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infection).

If you are unsure, talk to your doctor or pharmacist before taking Arapride 40 mg.

Take special care with ARAPRIDE® 40 mg

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

1. • Unintentional weight loss and difficulty swallowing.

• Stomach pain or indigestion.
• New onset of vomiting food or vomiting blood.
• Black stools (blood-stained faeces).
• If you develop severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• If you have severe liver problems.

If you take Arapride 40 mg 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.

Warnings and precautions

Kidney inflammation may occur when taking omeprazole. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your treating doctor if you notice any of these signs.

Consult your doctor before starting Arapride:

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

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 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 with other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription. Arapride 40 mg may affect the way some medicines work, and some medicines may affect Arapride 40 mg.

Do not take Arapride 40 mg 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:

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 starting or stopping 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 starting or stopping treatment with Arapride 40 mg

• 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)

  1. • Cilostazol (used to treat intermittent claudication)

• Saquinavir (used to treat HIV infection)

• Clopidogrel (used to prevent blood clots (thrombi))

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin along with Arapride 40 mg to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about any other medicines you are taking.

Taking Arapride 40 mg with food and drink

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

Pregnancy and breast-feeding

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

Your doctor will decide whether you may take Arapride 40 mg if you are breast-feeding.

Driving and using machines

It is unlikely that Arapride 40 mg affects your ability to drive or operate tools or machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machinery.

Important information about some of the ingredients of Arapride 40 mg

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take ARAPRIDE 40 mg

Follow exactly the instructions for administering Arapride 40 mg as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many capsules you should take and for how long. This will depend on your condition and your age.

The usual doses are indicated below.

Adults:

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

1. • If your doctor confirms that you have mild damage to the esophagus, the usual dose is 20 mg once daily 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 after healing of the esophagus is 10 mg once daily.
• If you do not have damage to the esophagus, the usual dose is 10 mg once daily.

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

1. • The usual dose is 20 mg once daily for 2 weeks. Your doctor may prescribe this 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 daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

1. • The usual dose is 20 mg once daily for 4 weeks. Your doctor may prescribe this 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 daily for 8 weeks.

Prevention of recurrence of gastric and duodenal ulcers:

1. • The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

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

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

Prevention of gastric and duodenal ulcers during treatment with NSAIDs:

1. • The usual dose is 20 mg once daily.

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

1. • The usual dose is 20 mg of Arapride twice daily for one week.

• Your doctor will also instruct you to take two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

1. • The usual dose is 60 mg daily.

• 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 GERD symptoms, such as heartburn 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 the doctor will determine the correct dose.

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

1. • Children over 4 years of age may take Arapride. 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

1. • 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

1. • 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 (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To ensure you have taken the entire dose, fill the glass halfway with water, swirl well, and drink the water. The solid particles 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, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

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

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

• Sudden wheezing, swelling of the lips, tongue, throat, or 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, and 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 at certain frequencies, defined as follows:

Other adverse effects are:

Frequent adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation and gas (flatulence).
• Nausea or vomiting.
• Frequent stomach polyps.

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results used to monitor liver function.
• Skin rash, hives and itching.
• General feeling of malaise and lack of energy.

Rare adverse effects

• Blood problems, such as a decrease in 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 concentration in the blood. This may cause weakness, vomiting and cramps.
• Agitation, confusion or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called "candidiasis" which may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash occurring 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 skin peeling. 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 concentration in the blood.

Adverse effect not known:

• Skin rash, possibly with joint pain.

In very rare cases, Arapride 40 mg may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severely deteriorated 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 inform your doctor about any medication you are taking at that time.

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 mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of ARAPRIDE 40 mg

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

• Do not use Arapride 40 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

• Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Arapride 40 mg

The active substance is omeprazole. Arapride 40 mg capsules contain 40 mg of omeprazole.

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

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

Appearance of the product and contents of the container

Arapride 40 mg capsules consist of an opaque white body and an opaque blue cap.

Container sizes:

Blister packs of 14 and 28 capsules.

Only certain pack 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 most recent review of this summary:

December 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/