OMEPRAZOL ALMUS 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole Almus 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 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 and other information:

1. What is Omeprazole Almus and what is it used for
2. What you need to know before you take Omeprazole Almus
3. How to take Omeprazole Almus
4. Possible side effects
5. Storing Omeprazole Almus
6. Contents of the pack and other information

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

Omeprazole Almus 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 is used to treat the following conditions:

In adults:

• “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 non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Almus may be used in addition 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 ≥ 10 kg

• “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, the symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• 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 Omeprazole Almus

Do not take Omeprazole Almus

• 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 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).

Warnings and precautions

Consult your doctor or pharmacist before taking Omeprazole Almus.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in relation to the use of Omeprazole Almus. Stop taking Omeprazole Almus and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

Omeprazole may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to take Omeprazole 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 have ever had a skin reaction after treatment with a medicine similar to Omeprazole Almus to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

When taking omeprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output 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.

If you take Omeprazol 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.

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

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

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 Almus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Omeprazole may affect the action of some medicines and some medicines may affect Omeprazole.

Do not take Omeprazole 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:

• 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 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 (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 Almus

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 your doctor of any other medicines you are taking.

Taking Omeprazole Almus with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

Omeprazole 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 this happens, do not drive or use machines.

Omeprazole Almus contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is essentially “sodium-free”.

3. How to take Omeprazole Almus

Follow the instructions for administration of Omeprazole indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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:

• 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:

• 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:

• 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.

Preventionof the recurrence of 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 caused byHelicobacter pyloriinfectionand prevention of their recurrence:

• The normal dose is 20 mg of Omeprazole 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):

• 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.

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 body weight, and the doctor will decide the correct dose.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of their recurrence:

• Children over 4 years of age can take Omeprazole. 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

• 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

• 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 mix the contents with a small amount of yogurt, 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 medicine is taken, fill the glass with water to the half, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Almus than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Almus

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.

If you stop taking Omeprazole Almus

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

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 Almus and 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)

Efectos adversos frecuentes (pueden afectar hasta 1 de cada 10 personas)becomes Frequent Adverse Effects (may affect up to 1 in 10 people)

Frequent 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.

Efectos adversos poco frecuentes (pueden afectar hasta 1 de cada 100 personas)becomes Infrequent Adverse Effects (may affect up to 1 in 100 people)

Infrequent 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).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Efectos adversos raros (pueden afectar hasta 1 de cada 1.000 personas)becomes Rare Adverse Effects (may affect up to 1 in 1,000 people)

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 likelihood of infections.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside 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 (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Efectos adversos muy raros (pueden afectar hasta 1 de cada 10.000 personas)becomes Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

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

• Blood count alterations, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• 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 males.

Efectos adversos con frecuencia no conocida (no puede estimarse a partir de los datos disponibles)becomes Adverse Effects with Unknown Frequency (cannot be estimated from available data)

Adverse Effects with Unknown Frequency (cannot be estimated from available data)

• Inflammation in the intestine (which causes diarrhea).
• If you are taking Omeprazol Almus for more than three months, it is possible that magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol can affect the white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very 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 an adverse effect that does not appear in this prospectus. You can also report them directly through 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 medicine.

5. Conservation of Omeprazol Almus

• Keep out of sight and reach of children.

• Do not use Omeprazol after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. HDPE bottle: use before 3 months have passed since its opening.
• Store below 25 ºC.

• Keep this blister in its original packaging or keep the bottle perfectly closed to protect it from moisture. Replace the cap firmly after use.
• Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Almus

• The active ingredient is omeprazol. Omeprazol Almus capsules contain 40 mg of omeprazol.

• The other components are:
• • Capsule content: sugar spheres (formed by cornstarch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethyl acrylate copolymer (1:1).
  • Capsule coating: gelatin, indigo carmine (E 132), and titanium dioxide (E 171).

Product Appearance and Package Contents

Opaque blue and white capsule containing white or almost white spherical microgranules.

Package sizes:

Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, or 140 capsules; hospital packaging of 280 or 500 capsules.

HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90, or 100 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

LABORATORIOS LICONSA, S.A.

Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this prospectus:March 2023

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