Emanera

Package Leaflet: Information for the Patient

Emanera, 20 mg, Gastro-Resistant Hard Capsules

Emanera, 40 mg, Gastro-Resistant Hard Capsules

Esomeprazole

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicine Has Been Prescribed for You. Do Not Pass It On to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack and Other Information

• 1. What Emanera Is and What It Is Used For
• 2. Before You Take 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 the Active Substance Esomeprazole, Which Belongs to a Group of Medicines Called 'Proton Pump Inhibitors'. These Medicines Work by Reducing the Amount of Acid Produced by the Stomach.

Emanera Is Used to Treat the Following Conditions:

• Gastro-Oesophageal Reflux Disease (GERD). This Is a Condition in Which Acid from the Stomach Leaks Back into the Gullet (Oesophagus), Causing Pain, Inflammation, and Heartburn. Emanera Is Used to Treat the Symptoms of This Condition, Such as Heartburn and Acid Regurgitation, and to Heal the Oesophagus.
• Ulcers of the Stomach and Duodenum (the First Part of the Intestine) Caused by a Bacterial Infection Called Helicobacter Pylori. Your Doctor May Also Prescribe Antibiotics to Treat This Infection.
• Ulcers of the Stomach Caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Emanera Is Used to Treat the Ulcer and to Prevent Its Return.
• Too Much Acid in the Stomach Caused by a Tumour in the Pancreas (Zollinger-Ellison Syndrome).

Children Over 12 Years Old

• Gastro-Oesophageal Reflux Disease (GERD). This Is a Condition in Which Acid from the Stomach Leaks Back into the Gullet (Oesophagus), Causing Pain, Inflammation, and Heartburn.
• Ulcers of the Stomach and Duodenum (the First Part of the Intestine) Caused by a Bacterial Infection Called Helicobacter Pylori. Your Doctor May Also Prescribe Antibiotics to Treat This Infection.

2. Before You Take Emanera

Do Not Take Emanera:

• If You Are Allergic (Hypersensitive) to Esomeprazole or Any of the Other Ingredients of Emanera.
• If You Are Allergic to Other Proton Pump Inhibitors (Such as Pantoprazole, Lansoprazole, Rabeprazole, or Omeprazole).
• If You Are Taking a Medicine Called Nelfinavir (Used to Treat HIV Infection).
• If You Have Ever Had a Severe Skin Reaction or Blistering of the Skin, Eyes, Mouth, or Genital Area After Taking Emanera or Other Similar Medicines.

Do Not Take Emanera If Any of the Above Applies to You. If You Are Not Sure, Talk to Your Doctor or Pharmacist Before Taking Emanera.

Warnings and Precautions

Before Taking Emanera, Tell Your Doctor or Pharmacist If:

• You Have Severe Liver Problems.
• You Have Severe Kidney Problems.
• You Have a Lack of Vitamin B12.
• You Have Ever Had a Skin Reaction After Taking a Medicine That Reduces Stomach Acid.
• You Are Due to Have a Specific Blood Test (Chromogranin A).

Skin Rash and Other Skin Reactions

If You Get a Rash, or If You Notice Any of the Following Side Effects, Tell Your Doctor Immediately: Sore Mouth (Stomatitis), Blisters in the Mouth, Inflammation of the Eyes (Conjunctivitis), Serious Skin Rashes, Including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme. These Conditions Can Be Life-Threatening and You May Need to Stop Taking Emanera.

Children and Adolescents Under 12 Years Old

Emanera Should Not Be Used in Children Under 12 Years Old.

Emanera and Other Medicines

Tell Your Doctor or Pharmacist If You Are Taking, Have Recently Taken, or Might Take Any Other Medicines. This Includes Medicines That You Buy Without a Prescription.

• Nelfinavir (Used to Treat HIV Infection). Do Not Take Emanera If You Are Taking Nelfinavir.
• Atazanavir (Used to Treat HIV Infection).
• Ketoconazole, Itraconazole, or Voriconazole (Used to Treat Fungal Infections).
• Digoxin (Used to Treat Heart Conditions).
• Erlotinib (Used to Treat Cancer).
• Citalopram, Imipramine, or Clomipramine (Used to Treat Depression).
• Diazepam (Used to Treat Anxiety, Insomnia, or Epilepsy).
• Phenytoin (Used to Treat Epilepsy). If You Are Taking Phenytoin, Your Doctor May Need to Monitor You When You Start or Stop Taking Emanera.
• Medicines Used to Thin the Blood, Such as Warfarin. Your Doctor May Need to Monitor You When You Start or Stop Taking Emanera.
• Cilostazol (Used to Treat Intermittent Claudication - a Condition Where the Legs Do Not Get Enough Blood).
• Cisapride (Used to Treat Indigestion and Heartburn).
• Methotrexate (Used to Treat Cancer and Rheumatoid Arthritis). If You Are Taking High Doses of Methotrexate, Your Doctor May Need to Temporarily Stop Your Treatment with Emanera.
• Clopidogrel (Used to Prevent Blood Clots).
• Tacrolimus (Used to Prevent Organ Rejection After Transplantation).
• Rifampicin (Used to Treat Tuberculosis).
• St John's Wort (Hypericum Perforatum) (Used to Treat Mild Depression).

If You Are Taking Emanera with Amoxicillin and Clarithromycin to Treat Ulcers Caused by Helicobacter Pylori, It Is Very Important That You Tell Your Doctor About All Other Medicines You Are Taking.

Emanera with Food and Drink

Emanera Can Be Taken with or Without Food.

Pregnancy, Breast-Feeding, and Fertility

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant, or Are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine. Your Doctor Will Decide Whether You Can Take Emanera.

Driving and Using Machines

Emanera Is Not Likely to Affect Your Ability to Drive or Use Machines. However, Rarely, Dizziness and Blurred Vision May Occur. If Affected, You Should Not Drive or Use Machines.

Emanera Contains Sugar and Sodium

If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product. This Medicinal Product Contains Less Than 1 Mmol Sodium (23 Mg) Per Capsule, Which Is Essentially 'Sodium-Free'.

3. How to Take Emanera

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You. Check with Your Doctor or Pharmacist If You Are Not Sure.

• If You Are Taking Emanera for a Long Time (More Than 1 Year), Your Doctor Will Regularly Check That You Need to Keep Taking It.
• If Your Doctor Has Prescribed Emanera 'On Demand', You Should Contact Your Doctor If Your Symptoms Change.

Dose

• Your Doctor Will Tell You How Much to Take and for How Long. The Dose Depends on the Condition Being Treated and Your Age.
• The Usual Doses Are Given Below.

Adults Over 18 Years Old

Treatment of Heartburn Caused by Gastro-Oesophageal Reflux Disease (GERD):

• If Your Doctor Has Found That Your Food Pipe (Oesophagus) Is Slightly Damaged, the Usual Dose Is 40 Mg Once a Day for 4 Weeks. If Your Oesophagus Has Not Healed After 4 Weeks, Your Doctor May Prescribe You Another 4 Weeks of Treatment.
• After the Oesophagus Has Healed, the Usual Dose Is 20 Mg Once a Day.
• If Your Oesophagus Was Not Damaged, the Usual Dose Is 20 Mg Once a Day.
• If You Have Severe Liver Problems, Your Doctor May Give You a Lower Dose.

Treatment of Ulcers Caused by Helicobacter Pylori and Prevention of Return of Ulcers:

• The Usual Dose Is 20 Mg Twice a Day for 1 Week. Your Doctor Will Also Prescribe Antibiotics to Treat the Infection.

Treatment of Ulcers in the Stomach Caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• The Usual Dose Is 20 Mg Once a Day for 4-8 Weeks.

Prevention of Ulcers in the Stomach Caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• The Usual Dose Is 20 Mg Once a Day.

Prevention of Further Bleeding from Ulcers After an Injection of Esomeprazole to Stop the Bleeding:

• The Usual Dose Is 40 Mg Once a Day for 4 Weeks.

Treatment of Too Much Acid in the Stomach Caused by a Tumour in the Pancreas (Zollinger-Ellison Syndrome):

• The Usual Dose Is 40 Mg Twice a Day.
• Your Doctor Will Adjust the Dose Depending on Your Needs and Will Also Decide How Long You Need to Take the Medicine. The Maximum Dose Is 80 Mg Twice a Day.

Children Over 12 Years Old

Treatment of Heartburn Caused by Gastro-Oesophageal Reflux Disease (GERD):

• If Your Doctor Has Found That Your Food Pipe (Oesophagus) Is Slightly Damaged, the Usual Dose Is 40 Mg Once a Day for 4 Weeks. If Your Oesophagus Has Not Healed After 4 Weeks, Your Doctor May Prescribe You Another 4 Weeks of Treatment.
• After the Oesophagus Has Healed, the Usual Dose Is 20 Mg Once a Day.
• If Your Oesophagus Was Not Damaged, the Usual Dose Is 20 Mg Once a Day.
• If You Have Severe Liver Problems, Your Doctor May Give You a Lower Dose.

Treatment of Ulcers Caused by Helicobacter Pylori and Prevention of Return of Ulcers:

• The Usual Dose Is 20 Mg Twice a Day for 1 Week. Your Doctor Will Also Prescribe Antibiotics to Treat the Infection.

Taking Emanera

• You Can Take Emanera at Any Time of the Day.
• You Can Take Emanera with or Without Food.
• Swallow the Capsules Whole with Half a Glass of Water. Do Not Chew or Crush the Capsules. This Is Because the Capsules Contain Coated Pellets Which Stop the Medicine from Being Broken Down by the Acid in Your Stomach. It Is Important Not to Damage the Pellets.

If You Have Difficulty Swallowing the Capsules

• If You Have Difficulty Swallowing the Capsules, You Can Open Them and Mix the Pellets with Half a Glass of Water (Do Not Use Other Liquids). You Can Also Use a Syringe to Give the Medicine Through a Naso-Gastric Tube.

Children and Adolescents Under 12 Years Old

Emanera Should Not Be Used in Children Under 12 Years Old.

Older People

No Dose Adjustment Is Necessary in Older People.

Overdose

If You Take More Emanera Than Prescribed by Your Doctor, Contact Your Doctor or Pharmacist Immediately.

Missed Dose

• If You Forget to Take a Dose, Take It as Soon as You Remember. If It Is Almost Time for Your Next Dose, Do Not Take the Missed Dose. Take the Next Dose at the Usual Time. Do Not Take a Double Dose to Make Up for a Forgotten Dose.

If You Have Any Further Questions on 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.

Stop Taking Emanera and Contact a Doctor Immediately If You Get Any of the Following Symptoms:

And Are Allergic to Emanera:

• Yellowing of the Skin or Eyes, Dark Urine, and Tiredness, Which Can Be Signs of Liver Problems. These Are Rare Side Effects (May Affect Up to 1 in 1,000 People).
• Sudden Onset of Severe Rash, Blistering, or Peeling of the Skin, and Possibly Swelling of the Mouth, Throat, and Tongue. These Are Rare Side Effects (May Affect Up to 1 in 1,000 People).
• Sudden Wheezing, Swelling of the Lips, Tongue, and Face, Rash, or Difficulty in Swallowing. These Are Rare Side Effects (May Affect Up to 1 in 1,000 People).
• Severe Skin Blistering, Peeling, and Rashes, Which Can Affect the Eyes, Mouth, and Genital Area. These Are Very Rare Side Effects (May Affect Less Than 1 in 10,000 People).
• Redness of the Skin with Blistering, and Peeling, Which May Be Accompanied by High Fever and Enlargement of the Lymph Nodes. These Are Very Rare Side Effects (May Affect Less Than 1 in 10,000 People).

Other Side Effects Include:

• Common Side Effects (May Affect Up to 1 in 10 People):
• Headache.
• Effects on the Stomach or Intestines: Diarrhoea, Stomach Pain, Constipation, Wind (Flatulence).
• Feeling Sick (Nausea) or Vomiting.
• Mild Mucous Membrane Inflammation in the Stomach (Gastritis).

Uncommon Side Effects (May Affect Up to 1 in 100 People):

• Swelling of the Feet and Ankles.
• Disturbances in the Way the Liver Works (Shown in Blood Tests).
• Skin Rashes, Itching, or Hives (Urticaria).
• Fractures of the Hip, Wrist, or Spine (If Emanera Is Used in High Doses and Over a Long Period of Time).

Rare Side Effects (May Affect Up to 1 in 1,000 People):

• Changes in Blood Count, Including Aggravated Anaemia, Low White Blood Cell Count (Leukopenia) or Low Platelet Count (Thrombocytopenia). This May Cause Weakness, Bruising, or Make You More Susceptible to Infections.
• Low Levels of Sodium in the Blood. This May Cause Weakness, Vomiting, and Cramps.
• Feeling Agitated, Confused, or Depressed.
• Disturbances in the Way the Nerves Work (Such as Tingling or Prickling Sensations, or Difficulty in Walking).
• Eye Problems, Such as Blurred Vision, Double Vision, or Decreased Vision.
• Difficulty in Breathing (Bronchospasm).
• Oral Inflammation (Stomatitis).
• Fungal Infections (Such as Thrush).
• Changes in the Way the Liver Works (Shown in Blood Tests), Which Can Cause Yellowing of the Skin or Eyes (Jaundice), and May Lead to Liver Failure.
• Loss of Hair (Alopecia).
• Photosensitivity (Increased Sensitivity of the Skin to the Sun).
• Pain in the Joints or Muscles.
• General Feeling of Ill Health or Weakness.
• Increased Sweating.

Very Rare Side Effects (May Affect Less Than 1 in 10,000 People):

• Changes in Blood Count, Including Low White Blood Cell Count (Agranulocytosis).
• Aggression.
• Seeing, Hearing, or Feeling Things That Are Not There (Hallucinations).
• Severe Liver Problems, Which Can Lead to Liver Failure and Encephalopathy (a Brain Disease).
• Sudden Onset of Severe Rash, Blistering, or Peeling of the Skin. This May Be Accompanied by Fever, and Enlargement of the Lymph Nodes. These Are Very Rare Side Effects (May Affect Less Than 1 in 10,000 People).
• Muscle Weakness.
• Severe Kidney Problems.
• Enlargement of the Breasts in Men (Gynaecomastia).

Not Known (Frequency Cannot Be Estimated from the Available Data):

• If You Have Been Taking Emanera for More Than 3 Months, It Is Possible That the Levels of Magnesium in Your Blood May Fall. Low Magnesium Can Cause Tiredness, Muscle Cramps, Seizures, and an Irregular Heartbeat. If You Get Any of These Symptoms, You Should Tell Your Doctor Immediately. Low Magnesium Can Also Lead to a Reduction in the Level of Potassium in the Blood. Your Doctor May Decide to Monitor Your Level of Magnesium during Treatment with Emanera.
• Inflammation of the Gut (Colitis) Which Can Cause Diarrhoea.
• Rash, Possibly with Pain in the Joints (Erythema Multiforme).

In Very Rare Cases, Emanera May Affect the White Blood Cells, Leading to a Condition Called Agranulocytosis, Which Can Increase the Risk of Infections. If You Get an Infection with Symptoms Such as Fever with a Seriously Reduced General Condition, or Fever with Symptoms of a Local Infection, Such as Pain in the Neck, Throat, or Mouth, or Difficulty in Passing Urine, You Should Contact Your Doctor as Soon as Possible to Have a Blood Test.

Reporting of Side Effects

If You Get Any Side Effects, Talk to Your Doctor or Pharmacist. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the Regulatory Agency via the Website.

5. How to Store Emanera

Keep This Medicine Out of the Sight and Reach of Children.

Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton. The Expiry Date Refers to the Last Day of That Month.

Store in the Original Package to Protect from Moisture.

Do Not Throw Away Any Medicines via Wastewater or Household Waste. Ask Your Pharmacist How to Throw Away Medicines You No Longer Use. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Emanera Contains

• The Active Substance Is Esomeprazole. Each Gastro-Resistant Hard Capsule Contains 20 Mg or 40 Mg of Esomeprazole, as Esomeprazole Magnesium Dihydrate.
• The Other Ingredients Are Sucrose, Maize Starch, Povidone K30, Sodium Lauryl Sulfate, Polyvinyl Acetate Phthalate, Titanium Dioxide (E171), Macrogol 3000, Macrogol 6000, Talc, Heavy Magnesium Carbonate, Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Dispersion 30%, and Polysorbate 80 in the Pellets in the Capsule Core, and Gelatin, Titanium Dioxide (E171), and Iron Oxide Red (E172) in the Capsule Shell. See Section 2, 'Emanera Contains Sugar and Sodium'.

What Emanera Looks Like and Contents of the Pack

20 Mg: Light Pink Gastro-Resistant Hard Capsules. The Capsule Contains White to Almost White Pellets.

40 Mg: Pink Gastro-Resistant Hard Capsules. The Capsule Contains White to Almost White Pellets.

Packs Contain 7, 14, 28, 56, 60, 84, or 90 Capsules in Blisters, in a Carton.

Marketing Authorisation Holder and Manufacturer

KRKA, D.D., Novo Mesto, Šmarješka Cesta 6, 8501 Novo Mesto, Slovenia

This Medicine Is Authorised in the Member States of the European Economic Area Under the Following Names:

For More Information on This Medicine, Contact the Local Representative of the Marketing Authorisation Holder.

KRKA-POLSKA Sp. z o.o.

Ul. Równoległa 5

02-235 Warszawa

Tel. 22 57 37 500

Date of Last Revision of the Leaflet: 06.06.2025

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Information Intended for Healthcare Professionals Only:

Administration Through a Naso-Gastric Tube (≥16 French Gauge)

• 1. Open the Capsule and Pour the Pellets into a Syringe. Add 25 Ml of Water and 5 Ml of Air to the Syringe. For Some Types of Naso-Gastric Tubes, It May Be Necessary to Add 50 Ml of Water.
• 2. Immediately Shake the Syringe to Mix the Pellets with the Water.
• 3. Hold the Syringe Upright and Check That There Are No Pellets Remaining in the Tip of the Syringe.
• 4. Connect the Syringe to the Naso-Gastric Tube and Shake the Syringe Again.
• 5. Administer the Medicine Through the Naso-Gastric Tube. Then Shake the Syringe Again and Flush the Tube with 25 Ml of Water.
• 6. Repeat Steps 4 and 5 Until the Syringe Is Empty.
• 7. If Necessary, to Rinse Out Any Remaining Pellets, Add 25 Ml of Water and 5 Ml of Air to the Syringe and Repeat Steps 4, 5, and 6.