Prospect: information for the user

Nuclosina 20 mg hard-gastroresistent capsules

Omeprazole

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to 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 prospect. See section 4.

1.What is Nuclosina and for what it is used

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

3.How to take Nuclosina

4.Possible adverse effects

5.Storage of Nuclosina

6.Contents of the package and additional information

Nuclosina contains the active ingredient omeprazole. It belongs to a group of medications known as “proton pump inhibitors”. These medications act by reducing the amount of acid produced by the stomach.

Nuclosina is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and burning.
• 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 medications called NSAIDs (nonsteroidal anti-inflammatory drugs). Nuclosina may 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 ≥ 10 kg

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and burning. 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 Nuclosina:

• if you are allergic to omeprazole or any of the other components of this medication (listed in section 6).
• if you are allergic to medications that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazol, esomeprazol).
• if you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking Nuclosina.

Warnings and precautions

Before taking this medication, consult your doctor.

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

• You lose weight significantly without apparent reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (stained with blood).
• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have had a skin reaction after treatment with a similar medication to Nuclosina for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranina A).

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

When taking omeprazole, it may cause kidney inflammation. Signs and symptoms may include decreased urine volume or the presence of 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 Nuclosina for a long period (more than 1 year), your doctor will likely perform regular check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

Use of Nuclosina with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Nuclosina may affect the mechanism of action of some medications, and some medications may affect Nuclosina.

Do not take Nuclosina if you are taking a medication that contains nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam, triazolam, or fluracepam (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 Nuclosina 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 Nuclosina 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)
• Vitamin B12 (cobalamin) (to treat vitamin B12 deficiency)
• Ciclosporin (to suppress the immune system and reduce inflammation)
• Disulfiram (to treat alcoholism)
• Enzalutamide (used to treat prostate cancer)
• Citalopram or escitalopram (used to treat depression and anxiety disorders)
• Metotrexate (chemotherapy medication used in high doses to treat cancer) - if you are taking a high dose of metotrexate, your doctor will need to temporarily stop Nuclosina treatment.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor of any other medications you are taking.

Taking Nuclosina with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Your doctor will decide if you can take Nuclosina during this time.

Your doctor will decide if you can take Nuclosina if you are breastfeeding.

Driving and operating machinery:

Nuclosina 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, you should not drive or operate machinery.

Nuclosina contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor 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:

Adults:

Treatment of symptoms of GERD, such as heartburnand acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, 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 damage to the esophagus, the normal dose is 10 mg once a day.

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

• 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 ofstomach ulcers(gastric ulcer):

• 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 reappearance ofstomach 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 byNSAIDs (nonsteroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring NSAID administration:

• The normal dose is 20 mg once a day

Treatment ofulcers causedbyHelicobacter pyloriinfection and prevention of their reappearance:

• The normal dose is 20 mg of omeprazole (1 Nuclosina capsule) twice a day for a week.
• Your doctor will also tell you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by atumor 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 will also decide for how long you should take the medication.

Children:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

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

Treatment ofulcers causedbyHelicobacter pyloriinfection and prevention of their reappearance:

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

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 contain coated granules that prevent the medication from breaking down in the stomach acid. It is essential not to damage the granules.

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 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 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 Nuclosina than you should

If you have taken more Nuclosina 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 ingested.

If you forget to take Nuclosina

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.

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

If you experience any of the following rare but serious side effects, stop taking Nuclosina and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden sibilance), swelling of the lips, tongue, and throat or body, skin rash, dizziness, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

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

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disorders (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

• Blood disorders, 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 very intense, including swelling of the lips, tongue, and throat, fever, and sibilance.
• Low sodium levels in the blood. This can cause weakness, vomiting, and 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.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• 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

• Blood count abnormalities, 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 inflammation of the brain.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. 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 men.

In very rare cases, Nuclosina may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very poor general condition 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 that at that time you provide information about the medication you are taking.

Withunknown frequencyit has been described that:

-If you are taking Nuclosina for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium and calcium levels.

-Skin rash, possibly with joint pain.

Uncommon:

-If you are taking proton pump inhibitors such as Nuclosina, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

Do not worry about this list of possible side effects. You may not experience any of them.

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 the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Do not store at a temperature above 25°C. Store in its original packaging to protect it from humidity.

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 after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nuclosina

-The active ingredient is omeprazole. Nuclosina 20 mg capsules contain 20 mg of omeprazole.

-The other components are:laurilsulfate sodium, disodium phosphate anhydrous, mannitol, hypromellose, macrogol 6000, talc, polisorbate 80, titanium dioxide, copolymer of methacrylic acid and ethyl acrylate, sugar spheres, magnesium hydroxide, purified water, starch sodium glycolate.The gelatin capsule is composed of: gelatin, titanium dioxide (E171)and indigotin-FD & C Blue 2 (E132).

Appearance of the product and content of the packaging

Nuclosina capsules are hard gelatin, white and blue.

Packaging sizes:

Blister with 14, 28, 56or 500 (clinical packaging) capsules.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Liconsa, S.A.

C/Dulcinea S/N

28805 Alcalá de Henares, Madrid

Spain

Responsible manufacturer

Labiana Pharmaceuticals S.L.

Casanova 27-31

08757- Corbera de Llobregat (Barcelona)

Spain

Or

Laboratorios Liconsa, S.A.

Avenida de Miralcampo, 7

19200 - Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:March 2021

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