Prospect: information for the patient

Emanera 20 mg hard-gastrorresistant EFG capsules

esomeprazole

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

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor or pharmacist.

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

-If you need advice or more information, consult your pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist or nurse, even if they do not appear in this prospect. See section 4.

• You must consult a doctor if it worsens or does not improveafter 14 days.

Contents of the package and additional information

Emanera contains a medication called esomeprazole magnesium dihydrate that belongs to a group of medications called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Emanera is used for the short-term treatment of symptoms of acid reflux (for example heartburn and acid regurgitation)

Acid reflux occurs when stomach acid rises up the esophagus (the tube that goes from the throat to the stomach) which can become inflamed and painful. This can cause symptoms such as a painful sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience relief from acid reflux symptoms and heartburn after the first day of taking this medication, but it does not mean you will feel immediate relief. You may need to take the capsules for 2-3 consecutive days before feeling better. You should consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Emanera

• If you are allergic to esomeprazole or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).

If you find yourself in any of these situations, do not take Emanera. If you are unsure, consult your doctor or pharmacist before taking Emanera.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Emanera if:

• You have had stomach ulcers or stomach surgery in the past.
• You have been receiving continuous treatment for reflux or acidity for 4 weeks or more.
• You have jaundice (yellowing of the skin or eyes) or severe liver problems.
• You have severe kidney problems.
• You are over 55 years old and have new or recently changed reflux symptoms or need to take an over-the-counter medication for indigestion or acidity every day.
• You have ever had a skin reaction after treatment with a similar medication to Emanera that reduces stomach acid.
• You are scheduled to have a specific blood test (Cromogranin A).

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

Inform your doctor immediately before or after taking this medication if you notice any of the following symptoms, which may be a sign of a more serious underlying disease.

• You lose a lot of weight without reason.
• You have swallowing problems or pain.
• You have stomach pain or signs of indigestion such as nausea, fullness, bloating, especially after eating.
• You start vomiting food or blood, which may appear as dark coffee grounds in your vomit.
• You have black stools (stools stained with blood).
• You have severe or persistent diarrhea; esomeprazole has been associated with a small increase in the risk of infectious diarrhea.

Seek emergency medical attention if you experience chest pain with dizziness, sweating, dizziness, or shoulder pain with difficulty breathing. This could be a sign of a serious heart disease.

Inform your doctor before taking this medication if:

• You are scheduled to have an endoscopy or a breath test with urea.
• You are scheduled to have a specific blood test (Cromogranin A).

If you find yourself in any of the above situations (or are unsure), consult your doctor immediately.

Children and adolescents

This medication should not be used by children and adolescents under 18 years old.

Other medications and Emanera

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription. This is because Emanera may affect the way some medications work and some medications may influence the effect of Emanera.

Do not take Emanera capsules if you are taking a medication that contains nelfinavir (used for HIV treatment).

You must inform your doctor or pharmacist specifically if you are taking clopidogrel (used to prevent blood clotting).

Do not take this medication with other medications that limit the amount of acid produced in your stomach, such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole) or an H2 antagonist (e.g. ranitidine or famotidine).

You can take this medication with antacids (e.g. magaldrate, aluminum hydroxide, sodium bicarbonate, magnesium carbonate, or combinations of these) if necessary.

Inform your doctor if you are using any of the following medications:

• Ketoconazole and itraconazole (for fungal infections)
• Voriconazole (for fungal infections) and clarithromycin (for infections). Your doctor may adjust your Emanera dose if you also have severe liver problems and receive treatment for a prolonged period.
• Erlotinib (used in cancer treatment)
• Methotrexate (for cancer and rheumatic disease treatment)
• Digoxin (used to treat heart problems)
• Atazanavir, saquinavir (used to treat HIV infection)
• Citalopram, imipramine, clomipramine (for depression treatment)
• Diazepam (used for anxiety, muscle relaxation, or epilepsy treatment)
• Phenytoin (for epilepsy)
• Medications used to make blood thinner, such as warfarin. Your doctor may need to control when you start or stop taking Emanera.
• Cilostazol (used to treat intermittent claudication – pain in the legs and difficulty walking caused by poor blood circulation)
• Cisapride (used for indigestion and heartburn)
• Rifampicin (for tuberculosis treatment)
• Tacrolimus (in organ transplant cases)
• St. John's Wort (Hypericum perforatum) (used to treat depression)

Pregnancy and breastfeeding

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

As a precaution, you should avoid taking Emanera during pregnancy. Emanera should not be taken during breastfeeding.

Driving and operating machines

Emanera has a low probability of affecting your ability to drive or operate machines. However, with low frequency, it may cause side effects such as dizziness and visual disturbances (see section 4). If you are affected, you should not drive or operate machines.

Emanera contains saccharose and sodium

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

This medication contains less than 23 mg (1 mmol) of sodium per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions contained in this leaflet or indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

How much to take

• The recommended dose is one capsule per day.
• Do not take more than one capsule per day (20 mg), even if you do not feel immediate improvement.
• You may need to take the capsules for 2 or 3 consecutive days before your symptoms of reflux (such as stomach burning and acid regurgitation) improve.
• The treatment duration is up to 14 days.
• When your symptoms of reflux have completely disappeared, you should stop taking this medication.
• If your symptoms of reflux worsen or do not improve after taking this medication for 14 consecutive days, you should consult a doctor.

If you have persistent or long-lasting symptoms that recur frequently even after treatment with this medication, you should contact your doctor.

How to take this medication

• You can take your capsule at any time of the day with food or on an empty stomach.
• Swallow the entire capsule with a glass of water. Do not chew or crush the capsule. This is because the capsule contains coated granules that prevent stomach acid from breaking down the medication. It is essential not to damage the pellets.

Alternative method for taking this medication

• Open the capsule and empty the granules into half a glass of water without gas (without bubbles). Do not use other liquids.
• Then drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To ensure you have taken all the medication, rinse the glass well with half a glass of water and drink. The solid particles contain the medication – do not chew or crush the granules.

If you take more Emanera than you should

If you take more Emanera than recommended, consult your doctor or pharmacist immediately.

You may experience symptoms such as diarrhea, stomach pain, constipation, nausea, or vomiting and weakness.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91 5620420, indicating the medication and the amount ingested.

If you forgot to take Emanera

If you forget to take a dose, take it as soon as you remember, on the same day. Do not take a double dose to compensate for the missed dose.

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

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

If you notice any of the following serious side effects, stop taking Emanera and contact a doctor immediately:

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction, rarely seen).
• Redness of the skin with blisters or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also appear. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis," rarely seen.
• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems, rarely seen.

Talk to your doctor as soon as possible if you experience any of the following signs of infection:

In rare cases, this medicine may affect white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a very reduced general state or fever with symptoms of a local infection such as neck pain, throat pain, or mouth pain or difficulty urinating, you must consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) through a blood test. It is essential to provide information about your medication at this time.

Other side effects include:

Frequent (may affect up to1 in 10 patients)

• Headache.
• Gastrointestinal effects: diarrhea, stomach pain, constipation, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach

Occasional(may affect up to1 in 100 patients)

• Swelling of the feet and ankles.
• Insomnia, feeling drowsy.
• Dizziness, tingling, and numbness.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.

Rare(may affect up to1 in 1,000 patients)

• Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or increase the likelihood of infections.

• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A known infection called "candidiasis" that may affect the esophagus and is caused by a fungus.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare(may affect up to1 in 10,000 patients)

• Low number of red blood cells, white blood cells, and platelets (a condition called pancitopenia).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that may lead to liver insufficiency or brain inflammation.
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.

Frequency unknown(the frequency cannot be estimated from the available data)

• Low levels of magnesium in the blood. Low magnesium levels may cause nausea, cramps, tremors, and changes in heart rhythm (arrhythmias). Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

Reporting of 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso HumanoWebsite: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 after CAD. The expiration date is the last day of the month indicated.

Blister packaging consisting of an OPA/Al/PE + DES/aluminum foil laminate

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Blister packaging consisting of an OPA/Al/PVC and aluminum foil laminate

Do not store at a temperature above30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medications.By doing so, you will help protect the environment.

Composition of Emanera

• The active ingredient is esomeprazole. Each gastro-resistant hard capsule contains 20 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other components are sugar spheres (sucrose and cornstarch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol 6000, macrogol 3000, talc (E553b), heavy magnesium carbonate, poloxamer 80 (E433) and copolymer of methacrylic acid - ethyl acrylate (1:1) dispersion at 30% in the capsule core, and gelatin, titanium dioxide (E171) and iron oxide red (E172) in the capsule cap. See section 2 “Emanera contains sucrose and sodium”

Appearance of the product and contents of the package

The body and cap of the 20 mg gastro-resistant hard capsules are light pink in color. The capsules contain white or almost white granules. Capsule size: No. 3.

The capsules are available in boxes of7 and 14capsules in blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: November 2020

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

ADDITIONAL INFORMATION

What are the symptoms of acid reflux?

The normal symptoms of reflux are a burning sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Why do these symptoms occur?

Acid reflux can occur as a result of eating too much, eating fatty foods, eating too quickly, and drinking a large amount of alcohol. You may notice that when you lie down, the acid reflux worsens. If you are overweight or smoke, the likelihood of experiencing acid reflux increases.

What can I do to help alleviate my symptoms?

• Eat a healthier diet and try to avoid spicy and fatty foods and large meals close to bedtime.
• Avoid carbonated drinks, coffee, chocolate, and alcohol.
• Eat slowly and in small portions.
• Try to lose weight.
• Stop smoking.

When should I seek advice or help?

• Seek immediate medical attention if you experience chest pain with dizziness, sweating, dizziness, or difficulty breathing.
• If you experience any of the symptoms listed in section 2 of this leaflet, consult your doctor or pharmacist.

If you experience any of the adverse effects listed in section 4 that require medical attention.