Emanera 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Emanera 20 mg gastro-resistant hard capsules EFG

esomeprazole

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Contents of this leaflet:

1. What Emanera is and what it is used for

2. What you need to know before taking Emanera

3. How to take Emanera

4. Possible side effects

5. How to store Emanera

6. Contents of the pack and other information

1. What Emanera is and what it is used for

Emanera contains a medicine called esomeprazole magnesium dihydrate, which belongs to a group of medicines known as "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).

Reflux occurs when stomach acid rises up into the oesophagus (the tube that connects the throat to the stomach), which may become inflamed and painful. This can cause symptoms such as a burning discomfort in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience relief from acid reflux and heartburn symptoms after the first day of taking this medicine, but this does not mean immediate relief will occur. You may need to take the capsules for 2–3 days consecutively before you start to feel better. You should consult a doctor if your symptoms worsen or do 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 in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking Emanera or other related medicines.

If any of these apply to you, do not take Emanera. If you are unsure, consult your doctor or pharmacist before taking Emanera.

Warnings and precautions

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

• You have had a stomach ulcer or stomach surgery in the past.
• You have been receiving continuous treatment for reflux or heartburn for 4 weeks or longer.
• You have jaundice (yellowing of the skin or eyes) or serious liver problems.
• You have serious kidney problems.
• You are over 55 years old and have new or recently changed reflux symptoms, or need to take over-the-counter 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 with Emanera treatment. Stop taking Emanera and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
• You are scheduled to have a specific blood test (Chromogranin A).

Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be signs of a more serious condition:

• You lose a lot of weight without reason.
• You have difficulty or pain when swallowing.
• 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-ground-like particles in your vomit.
• You have black stools (blood-stained faeces).
• You have severe or persistent diarrhoea; esomeprazole has been associated with a small increased risk of infectious diarrhoea.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop 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, lightheadedness, or shoulder pain with difficulty breathing. These could be signs of a serious heart condition.

Inform your doctor before taking this medicine if:

• You are scheduled for an endoscopy or a urea breath test.
• You need to have a specific blood test (Chromogranin A).

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

Children and adolescents

This medicine must not be used in 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 need to take any other medicines. This includes medicines obtained without a prescription. This is because Emanera may affect how some medicines work, and some medicines may influence the effect of Emanera.

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

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

Do not take this medicine with other medicines that reduce stomach acid production, such as proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazol, or omeprazole) or an H2 antagonist (e.g., ranitidine or famotidine).

You may take this medicine with antacids (e.g., magaldrate, alginate acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations of these) if needed.

Inform your doctor if you are taking any of the following medicines:

• Ketoconazole and itraconazole (for fungal infections)
• Voriconazole (for fungal infections) and clarithromycin (for treating infections). Your doctor may adjust your dose of Emanera if you also have serious liver problems and are receiving long-term treatment.
• 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 treatment of depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy).
• Medicines used to make the blood less likely to clot, 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 poor blood flow).
• Cisapride (used for indigestion and heartburn).
• Rifampicin (to treat tuberculosis).
• Tacrolimus (in organ transplantation).
• St John’s wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, you should preferably avoid taking Emanera during pregnancy. Emanera must not be taken during breast-feeding.

Driving and using machines

Emanera is unlikely to affect your ability to drive or use machines. However, adverse effects such as dizziness and visual disturbances (see section 4) may rarely occur. If you are affected, you must 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 certain sugars, consult him 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 provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

• The recommended dose is one capsule per day.
• Do not take more than one capsule per day (20 mg), even if you do not experience 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 treatment duration is up to 14 days.
• Once your reflux symptoms have completely resolved, you should stop taking this medicine.
• If your reflux symptoms worsen or do not improve after taking this medicine for 14 consecutive days, you must consult a doctor.

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

How to take this medicine

• You may take your capsule at any time of day, with or without food.
• Swallow the capsule whole 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 medicine. It is important not to damage the pellets.

Alternative method for taking this medicine

• Open the capsule and empty the granules into half a glass of still (non-carbonated) water. Do not use any other liquids.
• Then drink the mixture immediately or within 30 minutes. Always stir well just before drinking.
• To ensure you have taken all the medication, rinse the glass thoroughly with half a glass of water and drink it. 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 Toxicology Information Service. Telephone 91 5620420, stating 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 missed dose.

If you have any further 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 everyone will experience them.

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

• Sudden difficulty breathing, swelling of lips, tongue and throat or the whole body, skin rash, fainting or difficulty swallowing (severe allergic reaction, seen rarely).
• Reddening of the skin with blistering or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose and genitals may also occur. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis", seen rarely.
• Yellowing of the skin, dark urine and tiredness, which may be symptoms of liver problems, seen rarely.
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

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

In very rare cases, this medicine may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a very poor general condition, or fever with symptoms of a local infection such as neck, throat or mouth pain, or difficulty urinating, you must consult your doctor as soon as possible so that 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 adverse effects include:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia), feeling drowsy.
• Dizziness, tingling and numbness sensations.
• Vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, itchy skin.

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

• Blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising or increased risk of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
• Agitation, confusion or depression.
• Disturbance in taste.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" which may affect the oesophagus.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

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

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

• Low levels of magnesium in the blood. Low magnesium levels may cause feeling unwell (vomiting), cramps, tremor and changes in heart rhythm (arrhythmias). Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood.
• Inflammation of the intestine (may lead to diarrhoea).
• Skin rash, possibly with joint pain.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Emanera Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Blister pack consisting of an OPA/Al/PE + DES/aluminium foil sheet

This medicine does not require any special storage temperature.

Store in the original packaging to protect from moisture.

Blister pack consisting of an OPA/Al/PVC sheet and an aluminium foil sheet

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emanera

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other components are sugar spheres (sucrose and maize 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 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”.

Appearance of the product and contents of the pack

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

Capsules are available in cartons containing 7 or 14 capsules in blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the latest review of this leaflet: June 2025

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

ADDITIONAL INFORMATION

What are the symptoms of acid reflux?

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

Why do these symptoms occur?

Heartburn may result from eating large amounts of food, consuming high-fat foods, eating too quickly, or drinking large amounts of alcohol. You may notice that symptoms worsen when lying down. The likelihood of experiencing heartburn increases if you are overweight or smoke.

What can I do to help relieve my symptoms?

• Eat a healthier diet and try to avoid spicy foods, fatty foods, and large meals shortly before going to bed.
• Avoid carbonated drinks, coffee, chocolate, and alcohol.
• Eat slowly and in smaller portions.
• Try to lose weight.
• Stop smoking.

When should I seek advice or help?

• Seek urgent medical attention if you experience chest pain accompanied by dizziness, sweating, lightheadedness, shoulder pain, or difficulty breathing.
• If you experience any of the symptoms listed in section 2 of this leaflet and are advised to speak with your doctor or pharmacist.
• If you experience any of the adverse effects listed in section 4 that require medical attention.