EMANERA 20 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Emanera 20 mg Gastro-Resistant Hard Capsules EFG

esomeprazole

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.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or if it does not improve after 14 days.

Contents of the Package Leaflet:

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

1. Contents of the pack and further information

1. What is Emanera and what is it used for

Emanera contains a medicine called esomeprazole magnesium dihydrate, which belongs to a group of medicines 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 reflux (e.g., heartburn and acid regurgitation)

Reflux occurs when stomach acid rises up into 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 medicine, 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 it worsens or if it does not improve after 14 days.

2. What you need to know before taking Emanera

Do not take Emanera

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines of the proton pump inhibitor group (e.g., pantoprazole, lansoprazole, rabeprazole, or omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash, blistering, or peeling of the skin after taking Emanera or other related medicines.

If you are in any of these situations, do not take Emanera. If you are not sure, 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 heartburn 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 a non-prescription treatment for indigestion or heartburn every day.
• You have ever had a skin reaction after treatment with a medicine similar to Emanera that reduces stomach acid. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with Emanera. Stop taking Emanera and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.
• You are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be a sign of a more serious illness.

• You lose a lot of weight without reason.
• You have difficulty or pain swallowing.
• You have stomach pain or signs of indigestion such as nausea, bloating, swelling, especially after eating.
• You start vomiting food or blood, which may appear as dark brown coffee grounds in your vomit.
• You have black stools (stool stained with blood).
• You have severe or persistent diarrhea; esomeprazole has been associated with a small increased risk of infectious diarrhea.
• 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 Emanera. Remember to mention any other symptoms you may notice, such as joint pain.

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

Tell your doctor before taking this medicine if:

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

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

Children and adolescents

This medicine should not be used by children and adolescents under 18 years of age.

Other medicines and Emanera

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because Emanera can affect how some medicines work and some medicines may affect the effect of Emanera.

Do not take Emanera capsules if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

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

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

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

Tell your doctor if you are using any of the following medicines:

• Ketoconazole and itraconazole (for fungal infections)
• Voriconazole (for fungal infections) and clarithromycin (to treat infections). Your doctor may adjust your dose of Emanera if you also have severe liver problems and are receiving treatment for a prolonged period.
• Erlotinib (used in the treatment of cancer).
• Methotrexate (for the treatment of cancer and rheumatic disease).
• Digoxin (used to treat heart problems)
• Atazanavir, saquinavir (used to treat HIV infection).
• Citalopram, imipramine, clomipramine (for the treatment of depression).
• Diazepam (used for the treatment of anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy).
• Medicines used to make blood more fluid, such as warfarin. Your doctor may need to monitor when you start or stop taking Emanera.
• Cilostazol (used to treat intermittent claudication – leg pain and difficulty walking caused by insufficient blood pumping).
• Cisapride (used for indigestion and heartburn).
• Rifampicin (to treat tuberculosis).
• Tacrolimus (in the case of organ transplantation).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breastfeeding

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

As a precautionary measure, you should avoid taking Emanera during pregnancy. You should not take Emanera during breastfeeding.

Driving and using machines

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

Emanera contains sucrose and sodium

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

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

3. How to take Emanera

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 reflux symptoms improve (e.g., heartburn and acid regurgitation).
• The duration of treatment is up to 14 days.
• When your reflux symptoms have completely disappeared, you should stop taking this medicine.
• If your reflux symptoms worsen or do not improve after taking this medicine 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 medicine, you should consult your doctor.

How to take this medicine

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

Alternative method for taking this medicine

• Open the capsule and empty the pellets into half a glass of still water (without bubbles). Do not use other liquids.
• Then drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To ensure that 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 pellets.

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, consult the Toxicology Information Service. Telephone 91 5620420, indicating the medicine and the amount ingested.

If you forget 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 make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• A sudden difficulty breathing, swelling of the lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction, seen rarely).
• Redness of the skin with blisters or peeling. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. This could be a “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”, seen rarely.
• Yellow skin, dark urine, and tiredness, which can be symptoms of liver problems, seen rarely.
• Widespread rash, high body temperature, and increased lymph node size (DRESS or drug hypersensitivity syndrome), which is observed very rarely.

Tell your doctor as soon as possible if you experience any of the following signs of infection

In very rare cases, this medicine may affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a greatly reduced general state or fever with symptoms of a local infection such as pain in the neck, throat, or mouth, or difficulty urinating, you should consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you provide information about your medication at this time.

Other side effects include:

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Swelling of the feet and ankles.
• Sleep disturbance (insomnia), feeling drowsy.
• Dizziness, tingling sensation, and numbness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.

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

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

• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as “candidiasis” that can affect the esophagus and is caused by a fungus.
• Hair loss (alopecia).
• Phototoxic dermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 patients)

• Low number of red blood cells, white blood cells, and platelets (a condition called pancytopenia).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that can lead to liver failure or brain inflammation.
• Muscle weakness.
• Severe kidney disorders.
• Increased breast size in men.

Frequency not known (frequency cannot be estimated from the available data)

• Low magnesium levels in the blood. Low magnesium levels can cause a feeling of sickness (vomiting), cramps, tremors, and changes in heart rhythm (arrhythmias). Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood.
• Inflammation of the intestine (which can lead to diarrhea).
• Skin rash, possibly with joint pain.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emanera

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

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Blister pack consisting of a OPA/Al/PE + DES/Al sheet

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Blister pack consisting of a OPA/Al/PVC sheet and an Al sheet

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Emanera Composition

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

Product Appearance and Container Content

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

The capsules are available in boxes of 7 and 14 capsules in blisters.

Only some pack 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 under the following names:

Date of the Last Revision of this Leaflet:June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es

ADDITIONAL INFORMATION

What are the symptoms of acidity?

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

Why do these symptoms occur?

Acidity can occur as a result of eating too much, eating foods with high fat content, eating too quickly, and drinking large amounts of alcohol. You may notice that when you lie down, the acidity worsens. If you are overweight or smoke, the likelihood of suffering from acidity increases.

What can I do to help alleviate my symptoms?

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

When should I seek advice or help?

• Seek urgent medical attention if you experience chest pain with dizziness, sweating, fainting, or shoulder pain with difficulty breathing.
• If you experience any of the symptoms detailed in section 2 of this leaflet, and it is advised that you speak with your doctor or pharmacist.
• If you suffer from any of the adverse effects detailed in section 4 that require medical attention.