OMEPRAZOL ARISTO 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Aristo 40 mg Hard Gastro-Resistant Capsules

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Omeprazole Aristo is and what it is used for
2. What you need to know before you take Omeprazole Aristo
3. How to take Omeprazole Aristo
4. Possible side effects
   1. Storage of Omeprazole Aristo

1. Contents of the pack and further information

1. What Omeprazole Aristo is and what it is used for

Omeprazole Aristo 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.

Omeprazole Aristo is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers caused by a bacteria 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 non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Aristo may be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and = 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease may include the return of stomach contents into the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by a bacteria 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 Omeprazole Aristo

Do not take Omeprazole Aristo

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

Do not take Omeprazole Aristo if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Aristo.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazole Aristo.

There have been reports of severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) with omeprazole (see section 4). Stop taking Omeprazole Aristo and contact your doctor immediately if you experience any of these symptoms.

Omeprazole Aristo may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking Omeprazole Aristo, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (faeces) due to bleeding.
• If you have severe or persistent diarrhea, as omeprazol has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Aristo to reduce stomach acid.
• If you are due to have a specific blood test (Chromogranin A)

If you take omeprazole for a long period (more than 1 year), your doctor will probably keep you under regular surveillance. You should report any new and unusual symptoms to your doctor whenever you visit them.

Taking a proton pump inhibitor like Omeprazole Aristo, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as it may be necessary to stop treatment with Omeprazole Aristo. Remember to also mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should inform your doctor of these signs.

This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

• Extreme tiredness or lack of energy
• Numbness
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Using Omeprazole Aristo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Omeprazole Aristo may affect the way some medicines work and some medicines may affect the way Omeprazole Aristo works.

Do not take Omeprazole Aristo if you are taking a medicine containing nelfinavir(used to treat HIV infection).

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

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used for 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 omeprazole
• 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 omeprazole
• 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))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with Omeprazole Aristo.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to take with Omeprazole Aristo to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you tell your doctor about any other medicines you are taking.

Taking Omeprazole Aristo with food and drink

See section 3.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole passes into breast milk but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide whether you can take Omeprazole Aristo if you are breast-feeding.

Driving and using machines

Omeprazole Aristo is unlikely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If affected, you should not drive or operate machinery.

Omeprazole Aristo contains lactose, sucrose, and sodium

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

This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Omeprazole Aristo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended doses are as follows.

Use in adults

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

• If your doctor confirms that you have mild oesophageal damage, 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 oesophagus has not yet healed.

• The usual dose once the oesophagus has healed is 10 mg once a day.
• If you do not have oesophageal damage, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• 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, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• 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, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and gastric ulcers:

• 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 ulcers caused by NSAIDs:

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

Prevention of ulcers caused by NSAIDs:

• The usual dose is 20 mg once a day

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

• The usual dose is 20 mg omeprazole twice a day for one week.

• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Use in children and adolescents

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

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

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

• Children over 4 years of age can take omeprazole. The dose for children is based on their body weight and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

How to take this medicine

• 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 destroyed 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

• 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, a glass of acidic fruit juice (e.g. apple, orange, or pineapple) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
  • To make sure you have taken all the medicine, refill 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 Omeprazole Aristo than you should

If you have taken more Omeprazole Aristo than prescribed by your doctor, contact your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Aristo

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 forgotten dose.

If you stop taking Omeprazole Aristo

Do not stop taking Omeprazole Aristo without talking to your doctor or pharmacist first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious adverse effects, stop taking Omeprazol Aristoand consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread red, scaly, and generalized rash with bumps under the skin and blisters that is
• accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other adverse effects are:

Common Adverse Effects(may affect up to 1 in 10 people)

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

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormalities in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• 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 feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Abnormalities in blood counts, 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.
• Erythema multiforme.
• Muscle weakness.
• Increased breast size in men.

Frequency Not Known (cannot be estimated from the available data)

• Inflammation in the intestine (causing diarrhea).
• If you are being treated with Omeprazol Aristo for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Rash, possibly with joint pain.

In very rare cases, Omeprazol Aristo can 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the notification system included in the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Omeprazol Aristo

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

• Do not use this medicine 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 25°C

• Keep the blister pack in the original packaging to protect it from moisture.

• Medicines should not be thrown down the drain or into the trash. Deposit the packaging and any unused medicines in the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Aristo

• The active ingredient is omeprazole. Omeprazol Aristo capsules contain 40 mg of omeprazole.

The other components (excipients) are sugar spheres (sucrose and cornstarch), anhydrous lactose, hypromellose (E-464), sodium lauryl sulfate (E-487), hydroxypropylcellulose (E-463), disodium phosphate dihydrate (E-339), Eudragit L30 D (methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent), triethyl citrate (E-1505), and talc. See section 2 Omeprazol Aristo capsules contain lactose, sucroseand sodium.

The capsule is composed of gelatin, water (14.5%), titanium dioxide (E-171)

Appearance of the Product and Package Contents

Omeprazol Aristo 40 mg capsules

are hard gelatin capsules with a white body and an opaque white cap.

They are presented in aluminum blisters.

Package sizes:

Blister packs of 14, 28, or 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid - Spain

Manufacturer

Laboratorios de Medicamentos Internacionales S.A

C/Solana 26

Torrejón de Ardoz

Madrid Spain

Date of the Last Revision of this Prospectus:August 2024.

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