ESOGASEC 20 mg Capsules

Contents of the leaflet

1. Patient Information Leaflet: Patient Information
2. Esogasec 20 mg, gastro-resistant hard capsules
3. Esogasec 40 mg, gastro-resistant hard capsules
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack
4. What Esogasec is and what it is used for
5. What you need to know before you take Esogasec
   1. Do not take Esogasec
   2. Warnings and precautions
   3. Children under 12 years old
   4. Esogasec with other medicines
   5. Esogasec with food and drink
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Esogasec contains sodium
6. How to take Esogasec
   1. Dose
   2. How to take the capsules
   3. What to do if you have difficulty swallowing the capsules
   4. If you take more Esogasec than you should
   5. If you forget to take Esogasec
7. Possible side effects
   1. Stop taking Esogasec and see a doctor immediately if you notice any of the following serious side effects:
   2. Reporting of side effects
8. How to store Esogasec
9. Contents of the pack and other information
   1. What Esogasec contains
   2. What Esogasec looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Marketing Authorisation Holder
   5. Manufacturer
   6. This medicinal product is authorised in the Member States of the EEA under the following names:

Patient Information Leaflet: Patient Information

Esogasec 20 mg, gastro-resistant hard capsules

Esogasec 40 mg, gastro-resistant hard capsules

Esomeprazole

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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

• 1. What Esogasec is and what it is used for
• 2. What you need to know before you take Esogasec
• 3. How to take Esogasec
• 4. Possible side effects
• 5. How to store Esogasec
• 6. Contents of the pack and other information

1. What Esogasec is and what it is used for

Esogasec contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid produced by the stomach.

Esogasec is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD): This is where stomach acid flows back into the gullet (the tube that connects the mouth to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers or ulcers of the duodenum (the first part of the intestine) caused by Helicobacter pylori bacteria. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esogasec may also be used to prevent stomach ulcers from forming when taking NSAIDs.
• Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Prevention of bleeding from stomach ulcers after treatment with esomeprazole given by injection.

Adolescents from 12 years old

• Gastroesophageal reflux disease (GERD): This is where stomach acid flows back into the gullet (the tube that connects the mouth to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers or ulcers of the duodenum (the first part of the intestine) caused by Helicobacter pylori bacteria. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Esogasec

Do not take Esogasec

• 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 proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

If any of the above apply to you, do not take Esogasec. If you are not sure, talk to your doctor or pharmacist before taking Esogasec.

Warnings and precautions

Before taking Esogasec, tell your doctor or pharmacist if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to Esogasec that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

Taking Esogasec may hide the symptoms of other diseases. Therefore, if you are taking Esogasec and you notice any of the following, contact your doctor immediately:

• Sudden onset of severe diarrhea.
• Abdominal pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe rash, blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

If you are taking Esogasec on an as-needed basis, contact your doctor if your symptoms persist or worsen.

If you have been taking Esogasec for more than three months, it is possible that the levels of magnesium in your blood may be low. Low levels of magnesium can cause tiredness, muscle cramps, disorientation, seizures, dizziness, or a rapid heartbeat. If you get any of these symptoms, you should contact your doctor as soon as possible. Low levels of magnesium can also lead to a reduction in the level of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor the levels of magnesium.

Taking a proton pump inhibitor like Esogasec, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fracture. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash and skin effects

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with esomeprazole. Also, remember to mention any other side effects like joint pain.

Children under 12 years old

Esogasec is not recommended for children under 12 years old.

Esogasec with 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. This is because Esogasec may affect how these medicines work, or these medicines may affect how Esogasec works.

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

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir or saquinavir (used to treat HIV infection).
• Clopidogrel (a medicine used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (medicines used to treat depression).
• Diazepam (a medicine used to treat anxiety, insomnia, or to relax muscles).
• Phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, your doctor may need to monitor you when you start or stop taking Esogasec.
• Warfarin (a medicine used to prevent blood clots). Your doctor may need to monitor you when you start or stop taking Esogasec.
• Cilostazol (used to treat intermittent claudication - a condition where the legs do not get enough blood).
• Cisapride (a medicine used to treat indigestion and heartburn).
• Digoxin (a medicine used to treat heart conditions).
• Methotrexate (a medicine used to treat cancer and autoimmune diseases). If you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with esomeprazole.
• Tacrolimus (a medicine used to prevent the rejection of transplanted organs).
• Rifampicin (a medicine used to treat tuberculosis).
• St. John’s Wort (Hypericum perforatum) (a medicine used to treat depression).

If your doctor has prescribed antibiotics (amoxicillin and clarithromycin) with Esogasec to treat ulcers caused by Helicobacter pylori bacteria, it is very important that you tell your doctor about any other medicines you are taking.

Esogasec with food and drink

The capsules can be taken with or without food.

Pregnancy and breast-feeding

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 Esogasec during this time.

It is not known if Esogasec passes into breast milk. Therefore, you should not take Esogasec during breast-feeding.

Driving and using machines

Esogasec is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision may occur (see section 4). If affected, you should not drive or use machines.

Esogasec contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially sodium-free.

3. How to take Esogasec

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 this medicine for a long time (particularly over one year), your doctor may need to perform some additional tests.
• If your doctor has told you to take this medicine as and when you need it, and your symptoms change, you should talk to your doctor.

Dose

• Your doctor will tell you how many capsules to take and for how long.
• The dose depends on the condition being treated.

Adults aged 18 years and over

Treatment of gastroesophageal reflux disease (GERD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule once a day for 4 weeks. If your gullet has not healed after this time, your doctor may tell you to take the same dose for another 4 weeks.
• If your gullet has healed, the recommended dose is one 20 mg capsule once a day.
• If your gullet has not been damaged, the recommended dose is one 20 mg capsule once a day.
• For patients with severe liver problems, the doctor may prescribe a lower dose.

Treatment of duodenal ulcers caused by Helicobacter pylori bacteria and prevention of recurrence:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics to treat the infection.

Treatment of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one 20 mg capsule once a day for 4-8 weeks.

Prevention of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one 20 mg capsule once a day.

Treatment of too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg capsule twice a day.
• Your doctor may adjust the dose and duration of treatment based on your needs. The maximum dose is 80 mg twice a day.

Prevention of bleeding from stomach ulcers after treatment with esomeprazole given by injection:

• The recommended dose is one 40 mg capsule once a day for 4 weeks.

Adolescents from 12 years old

Treatment of gastroesophageal reflux disease (GERD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule once a day for 4 weeks. If your gullet has not healed after this time, your doctor may tell you to take the same dose for another 4 weeks.
• If your gullet has healed, the recommended dose is one 20 mg capsule once a day.
• If your gullet has not been damaged, the recommended dose is one 20 mg capsule once a day.
• For patients with severe liver problems, the doctor may prescribe a lower dose.

Treatment of duodenal ulcers caused by Helicobacter pylori bacteria and prevention of recurrence:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics to treat the infection.

How to take the capsules

• The capsules can be taken at any time of the day.
• The capsules can be taken with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and mix the contents with half a glass of non-fizzy water.
• Stir and drink the mixture straight away or within 30 minutes. Always stir the mixture before drinking it. The mixture will not be clear.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

Children under 12 years old

Esogasec is not recommended for children under 12 years old.

Elderly

No dose adjustment is necessary in patients over 65 years old.

If you take more Esogasec than you should

If you have taken more Esogasec than you should, talk to a doctor or pharmacist immediately.

If you forget to take Esogasec

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you are not sure what to do, talk to your doctor or pharmacist.

4. Possible side effects

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

Stop taking Esogasec and see a doctor immediately if you notice any of the following serious side effects:

• Jaundice (yellowing of the skin or eyes), dark urine, and tiredness, which can be signs of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of severe rash, blistering, or peeling of the skin, and possibly blisters in the mouth, throat, eyes, and genitals. This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of severe skin rash, blistering, or peeling of the skin, and possibly blisters in the mouth, throat, eyes, and genitals. This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis. These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Common:may affect up to 1 in 10 people

• Headache.
• Diarrhea, stomach pain, constipation, wind, and swelling (bloating).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon:may affect up to 1 in 100 people

• Swelling of the feet and ankles.
• Sleep disturbances.
• Dizziness, tingling, numbness, and somnolence.
• Vertigo.
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Rash, itchy skin, and hives.
• Fracture of the hip, wrist, or spine (if Esogasec is used in high doses or over a long period of time).

Rare:may affect up to 1 in 1,000 people

• Blood disorders, such as a reduced number of white blood cells or platelets. This can cause weakness, bruising, or make you more likely to get infections.
• Low levels of sodium in the blood. This can cause tiredness, confusion, muscle cramps, and fits.
• Feeling agitated, confused, or depressed.
• Taste disturbances.
• Eye problems, such as blurred vision.
• Sudden onset of wheezing, swelling of the lips, tongue, and throat, or difficulty in swallowing (angioedema). Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.
• Severe liver problems, including liver failure and inflammation of the liver.
• Hair loss (alopecia).
• Photosensitivity reaction (a skin reaction caused by sunlight).
• Joint pain or muscle pain.
• General feeling of being unwell and lack of energy.
• Increased sweating.

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

• Changes in blood count, including agranulocytosis (a potentially life-threatening decrease in white blood cells).
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).
• Severe liver problems, including liver failure and inflammation of the liver.
• Sudden onset of severe skin rash, blistering, or peeling of the skin, and possibly blisters in the mouth, throat, eyes, and genitals. This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men (gynaecomastia).

Frequency not known:cannot be estimated from the available data

• Inflammation of the intestine (which can cause diarrhea).
• Rash that may be itchy, with joint pain.
• Low levels of magnesium in the blood (hypomagnesaemia) (see section 2).

Very rarely, Esogasec may affect the white blood cells, leading to immune system problems. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as sore throat, mouth, or urinary problems, you should contact 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 essential to inform your doctor about your current medications.

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 via the national reporting system listed in the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esogasec

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package (blister) or keep the bottle tightly closed to protect from moisture.
• Do not use this medicine after the expiry date which is stated on the carton and blister or bottle after EXP. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Esogasec contains

• The active substance is esomeprazole. Esogasec gastro-resistant hard capsules are available in two strengths containing 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other ingredients are:

Contents of the capsule

Enteric-coated pellets:carrageenan; microcrystalline cellulose; mannitol; sodium hydroxide; sodium carbonate

Enteric coating:methacrylic acid - ethyl acrylate copolymer (1:1); triethyl citrate; talc; titanium dioxide (E 171); colloidal anhydrous silica

Capsule shell:

Esogasec, 20 mg, gastro-resistant hard capsules:

Capsule cap:gelatin; titanium dioxide (E 171); yellow iron oxide (E 172); purified water

Capsule body:gelatin; titanium dioxide (E 171); purified water

Esogasec, 40 mg, gastro-resistant hard capsules:

Capsule cap:gelatin; red iron oxide (E 172); titanium dioxide (E 171); yellow iron oxide (E 172); purified water

Capsule body:gelatin; titanium dioxide (E 171); purified water

What Esogasec looks like and contents of the pack

Esogasec, 20 mg, gastro-resistant hard capsules:

Gastro-resistant hard capsules: (size 3) white, opaque body and light yellow, opaque cap containing white or almost white enteric-coated pellets.

Esogasec, 20 mg, gastro-resistant hard capsules may have a characteristic odor, which does not affect the quality of the product.

Esogasec, 40 mg, gastro-resistant hard capsules:

Gastro-resistant hard capsules: (size 1) white, opaque body and light orange, opaque cap containing white or almost white enteric-coated pellets.

Esogasec, 40 mg, gastro-resistant hard capsules may have a characteristic odor, which does not affect the quality of the product.

The capsules are packed in a high-density polyethylene bottle with a polypropylene screw cap containing a desiccant or in blisters of polyamide/Aluminum/PVC/Aluminum. Do not eat the desiccant.

Available pack sizes:

14, 28, and 56 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

c/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany

Esogasec 20mg/40 mg magensaftresistente Hartkapseln

Spain

Esomeprazol Aristo 20 mg/40 mg cápsulas gastrorresistentes

France

ESOMEPRAZOLE EVOLUGEN PHARMA 20 mg/40 mg gélule gastro-résistante

Poland

Esogasec

Portugal

Esomeprazol Aristo 20 mg/40 mg cápsulas duras gastro-resistentes

Sweden

Esomeprazol NET 20 mg enterokapslar hard

Date of revision of the leaflet:October 2023