Esomeprazol Tova

Package Leaflet: Information for the Patient

Esomeprazol Towa, 20 mg, Gastro-Resistant Capsules

Esomeprazol Towa, 40 mg, Gastro-Resistant Capsules

Esomeprazolum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Esomeprazol Towa and what is it used for
• 2. Important information before taking Esomeprazol Towa
• 3. How to take Esomeprazol Towa
• 4. Possible side effects
• 5. How to store Esomeprazol Towa
• 6. Contents of the pack and other information

1. What is Esomeprazol Towa and what is it used for

Esomeprazol Towa 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.

Esomeprazol Towa is used for the following conditions:

Adults

• Gastroesophageal reflux disease, which is a condition where acid from the stomach flows back into the esophagus (the tube that connects the mouth to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers or ulcers in the upper part of the intestine caused by the bacterium Helicobacter pylori. If you have these symptoms, 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). Esomeprazol Towa can also be used to prevent stomach ulcers when taking NSAIDs.
• Excessive acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment after prevention of rebleeding from ulcers with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease, which is a condition where acid from the stomach flows back into the esophagus (the tube that connects the mouth to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers or ulcers in the upper part of the intestine caused by the bacterium Helicobacter pylori. If you have these symptoms, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. Important information before taking Esomeprazol Towa

Do not take Esomeprazol Towa

• 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)

Do not take Esomeprazol Towa if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Towa.

Warnings and precautions

Before taking Esomeprazol Towa, inform your doctor or pharmacist:

• If you have severe liver disease
• If you have severe kidney disease
• If you have a vitamin B12 deficiency
• If you have ever had a skin reaction with a medicine that reduces stomach acid
• If you are due to have a specific blood test (chromogranin A)

Esomeprazol Towa may mask the symptoms of other diseases. Therefore, you should immediately
tell your doctor about the following symptoms that occur before or during treatment with Esomeprazol Towa:

• Unintentional weight loss and difficulty swallowing.
• Abdominal pain or indigestion.
• Vomiting blood or black tarry stools.
• Black stools (with blood).

If you are taking Esomeprazol Towa on demand, you should see your doctor if your symptoms do not improve or change.
When taking proton pump inhibitors, such as Esomeprazol Towa, especially for a period longer than one year, there may be a slightly increased risk of hip, wrist, or spine fractures.
You should inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
If you experience a skin rash, especially in areas exposed to sunlight, you should immediately tell your doctor, as it may be necessary to stop taking Esomeprazol Towa.
You should also inform your doctor about any other side effects, such as joint pain.

Other medicines and Esomeprazol Towa

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.
Esomeprazol Towa may interact with some other medicines and some other medicines may affect the action of Esomeprazol Towa.
Do not take Esomeprazol Towa if you are taking nelfinavir (used to treat HIV infection).
Inform your doctor if you are taking:

• Atazanavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Erlotinib (used to treat cancer)
• Citalopram, imipramine, or clomipramine (used to treat depression)
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy)
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, you should be monitored by your doctor when starting or stopping Esomeprazol Towa.
• Blood-thinning medicines, such as warfarin - you may need to be monitored by your doctor when starting or stopping Esomeprazol Towa.
• Cilostazol (used to treat intermittent claudication - a condition where you experience pain in your legs when you walk)
• Cisapride (used to treat indigestion and heartburn)
• Digoxin (used to treat heart conditions)
• Methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may advise you to temporarily stop taking Esomeprazol Towa.
• Tacrolimus (used after organ transplantation)
• Rifampicin (used to treat tuberculosis)
• St John's Wort (Hypericum perforatum) (used to treat depression)

If you are taking amoxicillin and clarithromycin with Esomeprazol Towa to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor about any other medicines you are taking.

Esomeprazol Towa with food and drink

The capsules can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, 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 Esomeprazol Towa.
There is not enough information about the safety of Esomeprazol Towa during pregnancy.
Do not take Esomeprazol Towa if you are breastfeeding, as it is not known whether this medicine passes into breast milk.

Driving and using machines

Esomeprazol Towa is unlikely to affect your ability to drive or use machines. However, occasionally or rarely, side effects such as dizziness and blurred vision (see section 4) may occur. If this happens to you, do not drive or use machines.

Esomeprazol Towa contains sugar

Esomeprazol Towa contains sugar spheres, which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Esomeprazol Towa contains sodium

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

3. How to take Esomeprazol Towa

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

• If you are taking this medicine for a long time (especially longer than one year), you may need to have regular check-ups with your doctor.
• If your doctor has prescribed this medicine to be taken on demand, you should inform your doctor about any changes in your symptoms.

Dosage

• Your doctor will decide the correct dose for you and how long you need to take the medicine. The dose depends on your condition, age, and liver function.
• The recommended doses are given below.

Adults aged 18 years and older

Treatment of gastroesophageal reflux disease:

• For patients with mild esophageal lesions, the recommended dose is 40 mg of Esomeprazol Towa once daily for 4 weeks. If the esophagus has not healed, your doctor may prescribe the same dose for another 4 weeks.
• The recommended dose after healing of the esophagus is 20 mg of Esomeprazol Towa once daily.
• If the esophagus has not been damaged, the recommended dose of Esomeprazol Towa is 20 mg once daily. After the symptoms have been controlled, your doctor may prescribe the medicine to be taken on demand in a dose of up to 20 mg once daily.
• In patients with severe liver disease, your doctor may prescribe a lower dose.

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

• The recommended dose is 20 mg of Esomeprazol Towa twice daily for one week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Treatment of stomach ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg of Esomeprazol Towa once daily for 4 to 8 weeks.

Prevention of stomach ulcers during treatment with non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg of Esomeprazol Towa once daily.

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

• The recommended dose is 40 mg of Esomeprazol Towa twice daily.
• Your doctor will adjust the dose according to your needs and decide on the duration of treatment. The maximum dose of Esomeprazol Towa is 80 mg twice daily.

Prolonged treatment after prevention of rebleeding from ulcers with intravenous esomeprazole:

• The recommended dose is 40 mg of Esomeprazol Towa once daily for 4 weeks.

Adolescents aged 12 years and older

Treatment of gastroesophageal reflux disease:

• For patients with mild esophageal lesions, the recommended dose is 40 mg of Esomeprazol Towa once daily for 4 weeks. If the esophagus has not healed, your doctor may prescribe the same dose for another 4 weeks.
• The recommended dose after healing of the esophagus is 20 mg of Esomeprazol Towa once daily.
• If the esophagus has not been damaged, the recommended dose of Esomeprazol Towa is 20 mg once daily.
• In patients with severe liver disease, your doctor may prescribe a lower dose.

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

• The recommended dose is 20 mg of Esomeprazol Towa twice daily for one week. Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

How to take Esomeprazol Towa

• 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 water. Do not chew or crush the capsules, as they contain pellets with a coating that protects them from the acid in the stomach. It is very important not to damage the pellets.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules:
• 1. Carefully open the capsule and pour the pellets into a glass containing half a glass of non-carbonated water. Do not use any other liquids.
• 2. Stir. Then drink the mixture immediately, or within 30 minutes. Always stir before drinking.
• 3. To make sure you take all the medicine, refill the glass with water, up to half a glass, and drink it. The undissolved solid residue contains the medicine - do not chew or crush it.
• If you cannot swallow, the contents of the capsule can be mixed with water and drawn up into a syringe, and then given through a nasogastric tube into the stomach.

Children and adolescents under 12 years

Esomeprazol Towa should not be used in children under 12 years.

Elderly patients

No dose adjustment is necessary in elderly patients.

What to do if you take more Esomeprazol Towa than you should

If you take more Esomeprazol Towa than you should, contact your doctor or pharmacist immediately.

What to do if you forget to take Esomeprazol Towa

• 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.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Esomeprazol Towa and contact your doctor immediately:

• Wheezing, swelling of the face, lips, tongue, or throat, or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling, or mouth sores (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Yellow skin, dark urine, and tiredness, which can be signs of liver problems.

These side effects are rare (may affect up to 1 in 1,000 people).
Other side effects:
Common (may affect up to 1 in 10 people)

• Headache
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, bloating (with gas).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, or drowsiness.
• Vertigo (feeling of spinning).
• Dry mouth.
• Changes in blood tests that show how the liver is working.
• Skin rash, hives, or itching.
• Fractures of the hip, wrist, or spine (if Esomeprazol Towa is taken in high doses and for a long time).

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

• Blood disorders, such as a decrease in the 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 weakness, vomiting, and cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Changes in vision, such as blurred vision.
• Sudden difficulty breathing, or rapid heartbeat (bronchospasm).
• Oral thrush (infection of the mouth or throat by a fungus).
• Fungal infections (e.g. thrush).
• Liver problems, including jaundice, which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash, especially after exposure to sunlight.
• Joint pain or muscle pain.
• General feeling of being unwell or lack of energy.
• Excessive sweating.

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

• Blood disorders, such as agranulocytosis (a decrease in the number of white blood cells).
• Aggression.
• Hallucinations (seeing, hearing, or feeling things that are not there).
• Severe liver problems, leading to liver failure and encephalopathy (a condition that affects the brain and nervous system).
• Sudden onset of a severe rash or blisters, or peeling of the skin. These can be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men (gynaecomastia).

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

• If you have taken Esomeprazol Towa for more than three months, it is possible that the level of magnesium in your blood may be low. Low levels of magnesium can cause fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, and a rapid heartbeat. If you experience any of these symptoms, you should contact your doctor immediately. 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 level of magnesium.
• Colitis (inflammation of the colon, which can cause diarrhea).
• Skin rash that may be associated with joint pain.

In very rare cases, Esomeprazol Towa may affect the white blood cells, leading to a deficiency in the immune system. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, contact your doctor immediately. It is essential to inform your doctor that you are taking Esomeprazol Towa.

Reporting of side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported to the national reporting system listed below.

5. How to store Esomeprazol Towa

• 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, blister, or bottle after 'EXP'. The expiry date refers to the last day of that month.
• Blister: Store in a temperature not exceeding 30°C. Store in the original package to protect from moisture.
• Bottle: Store in a temperature not exceeding 30°C. Store the bottle tightly closed to protect from moisture.
• Bottle: Shelf life after first opening: 200 days.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Esomeprazol Towa contains

• The active substance is esomeprazole. Esomeprazol Towa is available in two strengths, containing 20 mg or 40 mg of esomeprazole (as esomeprazole sodium).
• The other ingredients are: Capsule content: Sucrose, pellets (containing maize starch and sucrose), methylcellulose, talc, titanium dioxide (E 171), glyceryl monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid - ethyl acrylate copolymer, triethyl citrate.

Cap shell:

Carageenan, potassium chloride, iron oxide, red (E 172), titanium dioxide (E 171), hypromellose, purified water, ink (containing shellac, potassium hydroxide, and iron oxide, black (E 172)).

What Esomeprazol Towa looks like and contents of the pack

• Esomeprazol Towa 20 mg gastro-resistant capsules: capsules with a non-transparent light pink cap and body, size 4 (length approximately 14 mm), with the imprint: on the cap ES/ on the body 20, containing spherical pellets.
• Esomeprazol Towa 40 mg gastro-resistant capsules: capsules with a non-transparent pink cap and body, size 2 (length approximately 18 mm), with the imprint: on the cap ES/ on the body 40, containing spherical pellets.

Esomeprazol Towa 20 mg gastro-resistant capsules are available in the following packs:

Blister OPA/Aluminum/PE with a desiccant/Aluminum:

7, 14, 28, 56 capsules, in a cardboard box.

White non-transparent polyethylene (PE) bottle with a polyethylene cap with a tamper-evident ring, containing a desiccant:

14, 28, 56 capsules, in a cardboard box.

Esomeprazol Towa 40 mg gastro-resistant capsules are available in the following packs:

Blister OPA/Aluminum/PE with a desiccant/Aluminum:

7, 14, 28, 56 capsules, in a cardboard box.

White non-transparent polyethylene (PE) bottle with a polyethylene cap with a tamper-evident ring, containing a desiccant:

14, 28, 56 capsules, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/de Sant Marti 75-97, Martorelles,

08107 Barcelona,

Spain

Date of last revision of the package leaflet

Information intended for healthcare professionals only:

Administration via a nasogastric tube

• 1. Add the contents of the capsule to approximately 25 ml or 50 ml of water. (For some types of nasogastric tubes, it is necessary to mix the pellets with 50 ml of water to avoid clogging the tube). Stir.
• 2. Draw up the mixture into a syringe and add approximately 5 ml of air.
• 3. Shake the syringe vigorously for approximately 2 minutes to mix the pellets.
• 4. Turn the syringe upside down and check that the tip is not clogged.
• 5. Connect the syringe to the nasogastric tube and hold it with the tip up.
• 6. Shake the syringe and position it with the tip down. Immediately inject 5-10 ml into the nasogastric tube. After injection, turn the syringe upside down and shake (the syringe must be turned upside down to avoid clogging).
• 7. Turn the syringe with the tip down and immediately inject another 5-10 ml into the nasogastric tube. Repeat this process until the syringe is empty.
• 8. Fill the syringe with 25 ml of water and 5 ml of air, and if necessary, repeat step 6 to rinse the syringe and nasogastric tube. For some types of nasogastric tubes, it may be necessary to add 50 ml of water.

Any unused product or waste material should be disposed of in accordance with local requirements.