Package Insert: Information for the User

Losec 20mg Hard Gastroresistant Capsules

Omeprazol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Losec and for what it is used

2.What you need to know before starting to take Losec

3.How to take Losec

4.Possible adverse effects

1. Storage of Losec

6.Contents of the package and additional information

Losec 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.

Losec is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows 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). Losec 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

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid flows 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 the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• 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 take Losec:

• If you are allergic to omeprazole or any of the other ingredients of this medication (listed in section6).
• 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).

Do not take Losec if you fall into any of the above categories. If you are unsure, consult your doctor or pharmacist before taking Losec.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losec.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute pustular psoriasis (PEGA), have been reported in association with Losec treatment. Stop taking Losec and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Food or blood vomiting.
• Black stools (blood-stained feces).
• 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 similar medication to Losec for reducing stomach acid.
• You aredue to have a specific blood test (Cromogranina A).

If you take Losec for a long period (more than 1year), your doctor will likely perform regular check-ups. Inform your doctor of any new or unusual symptoms whenever you visit.

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

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue Losec treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Omeprazole may cause kidney inflammation. 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. Inform your doctor of these signs.

This medication may affect the way 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 may indicate low vitamin B12levels:

• Extreme fatigue or lack of energy.
• Tickling.
• Pain or redness in the tongue or mouth, mouth ulcers.
• Muscle weakness.
• Visual disturbances.
• Memory problems, confusion, depression.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medication to children under 1 year of age or <10>

Other medications and Losec

Taking Losec with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications that can be purchased without a prescription. This is because Losec may affect the mechanism of action of some medications, and some medications may affect Losec.

Do not take Losec 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:

• Ketoconazole, itraconazole, posaconazole, 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 need to monitor you when starting or stopping Losec treatment.
• Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping Losec treatment.
• 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).
• Erlotinib (used to treat cancer).
• Methotrexate (chemotherapy medication used in high doses to treat cancer) -if you are taking a high dose of methotrexate, your doctor will need to temporarily stop Losec treatment.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is essential to inform your doctor of any other medications you are taking.

Taking Losec with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Losec 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, patients should not drive or operate machinery.

Losec capsules contain lactose and sodium

Losec capsules contain lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Losec capsules contain less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 recommended dose is described below:

Use in adults

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

• If your doctor checks that you have mild damage to the esophagus, the recommended dose is 20mg once a day for 4 to 8 weeks. Your doctor may prescribe a dose of 40mg for another 8 weeks if the esophagus has not yet healed.

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

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

• The recommended dose is 20mg once a day for 2weeks. Your doctor may prescribe the same dose for another 2weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40mg once a day for 4weeks.

Treatment ofstomach ulcers(gastric ulcer):

• The recommended dose is 20mg once a day for 4weeks. Your doctor may prescribe the same dose for another 4weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40mg once a day for 8weeks.

Preventionof the reappearanceofstomach and duodenal ulcers:

• The recommended dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg once a day.

Treatment of stomach and duodenal ulcers caused by NSAIDs(nonsteroidal anti-inflammatory drugs):

• The recommended dose is 20mg once a day for 4 to 8 weeks.

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The recommended dose is 20mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their reappearance:

• The recommended dose is 20mg of Losec twice a day for a week.

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

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

• The recommended dose is 60mg per day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medication.

Use in children and adolescents

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

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

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of their reappearance:

• Children over 4 years old may take Losec. The dose for children is based on 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 medication

• 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 containgranulescoated that prevent the medication from breaking down by the action of stomach acid. It is essential not to damage thegranules.

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

• 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 of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Losec than you should

If you have taken more Losec 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 taken.

If you forget to take Losec

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Losec

Do not interrupt the treatment with Losec without first talking to your doctor or pharmacist.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience 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 side effects, stop taking Losec and consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden sibilance), 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. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Generalized rash, high body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare)
• A red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema). (rare)
• Yellow skin discoloration, dark urine, and fatigue, which may be symptoms of liver problems. (rare)

Other side effects are:

Frequent side effects (may affect up to 1 in 10 people)

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

Infrequent side effects (may affect up to 1 in 100 people)

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

Rare side 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 infections.
• 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.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal blood count, 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.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).

• If you are taking Losec for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease 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, Losec can affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very deteriorated general state 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.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging or in the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store this medication in the original packaging (blister) to protect it from moisture.

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

Composition of Losec

• The active ingredient is omeprazole. Each capsule (gastro-resistant capsule) contains 20mg of omeprazole.

• The other components are sodium dihydrogen phosphate, low-substitution hydroxypropylcellulose, hypromellose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion of 30%, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E172, titanium dioxide E171, gelatin, printing ink (containing shellac, ammonia, potassium hydroxide, and iron oxide black E172), anhydrous colloidal silica, and liquid paraffin. See section 2 “losec contains lactose”.

Appearance of the product and contents of the package

• Losec 20mg capsules are formed by a pink body marked with 20 and a brown-red cap marked with A/OM.

Package sizes:

• 20mg: Blister packs of 14 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local Representative:

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany

This medicine is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:August 2023

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