Esomeprazole towa

Package leaflet: information for the patient

Esomeprazol Towa, 20 mg, hard enteric-coated capsules
Esomeprazol Towa, 40 mg, hard enteric-coated capsules
Esomeprazolum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Esomeprazol Towa is and what it is 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 Esomeprazol Towa is and what it is 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 in the stomach.
Esomeprazol Towa is used in the following cases:
Adults

• Gastroesophageal reflux disease (GERD), which involves the backflow of acidic stomach contents into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Peptic ulcer of the stomach or upper part of the intestine associated with infection by the bacterium Helicobacter pylori. If you have such symptoms, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Peptic ulcer of the stomach caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Towa may also be used to prevent stomach ulcers during NSAID treatment.
• Excessive stomach acid production caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment following prevention of recurrent bleeding from ulcers with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD), which involves the backflow of acidic stomach contents into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Peptic ulcer of the stomach or upper part of the intestine associated with infection by the bacterium Helicobacter pylori. If you have such symptoms, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. Important information before using Esomeprazol Towa

Do not use Esomeprazol Towa

• If the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other medicines in the proton pump inhibitor class (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If the patient is taking a medicine containing nelfinavir (used to treat HIV infections).

Do not use Esomeprazol Towa if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Esomeprazol Towa.

Warnings and precautions

Before using Esomeprazol Towa, consult a doctor or pharmacist:

• If the patient has severe liver disease
• If the patient has severe kidney disease
• If the patient has vitamin B deficiency
• If the patient has ever had a skin reaction after taking a medicine similar to Esomeprazol Towa that reduces gastric acid secretion
• If the patient is due to have a specific blood test (chromogranin A level).

Esomeprazol Towa may mask symptoms of other diseases. Therefore, it is important to inform the doctor immediately about the following symptoms occurring before or during treatment with Esomeprazol Towa:

• Significant unintentional weight loss and difficulty swallowing.
• Abdominal pain or indigestion.
• Vomiting food or blood.
• Black stools (containing blood).

If Esomeprazol Towa is used on an as-needed basis, consult a doctor if symptoms do not improve or change in nature.

Taking proton pump inhibitors such as Esomeprazol Towa, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has been diagnosed with osteoporosis or is taking corticosteroid medicines (which may increase the risk of osteoporosis).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as it may be necessary to discontinue Esomeprazol Towa.

Also remember to inform the doctor about any other adverse reactions, such as joint pain.

Other medicines and Esomeprazol Towa

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Esomeprazol Towa may interact with certain other medicines, and some medicines may affect the action of Esomeprazol Towa.

Do not take Esomeprazol Towa if the patient is also taking nelfinavir (used to treat HIV infections).

Inform the doctor if the patient is taking any of the following medicines:

• Atazanavir (used to treat HIV infections).
• 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 for anxiety, as a muscle relaxant, or in epilepsy).
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, medical supervision is required when starting or stopping Esomeprazol Towa.
• Medicines used to thin the blood, such as warfarin – the patient may require monitoring by a doctor when starting or stopping Esomeprazol Towa.
• Cilostazol (used to treat intermittent claudication – leg pain during walking due to poor blood circulation).
• Cisapride (used to treat indigestion and heartburn).
• Digoxin (used to treat heart disorders).
• Methotrexate (a chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the doctor may temporarily advise discontinuing Esomeprazol Towa.
• Tacrolimus (used after organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If amoxicillin and clarithromycin are taken together with Esomeprazol Towa for the treatment of ulcers caused by Helicobacter pylori infection, it is extremely important to inform the doctor about all other medicines being taken.

Esomeprazol Towa with food and drink

Capsules may be taken with food or on an empty stomach.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Esomeprazol Towa should be used.

There is no data on whether Esomeprazol Towa passes into breast milk; therefore, Esomeprazol Towa should not be taken during breastfeeding.

Driving and operating machinery

It is unlikely that Esomeprazol Towa will affect the ability to drive or operate tools or machines. However, dizziness and blurred vision may occur occasionally or rarely (see section 4). If these occur, do not drive or operate machinery.

Esomeprazol Towa contains sucrose

Esomeprazol Towa contains sugar-coated pellets which contain sucrose, a type of sugar. If the patient has been diagnosed with an intolerance to certain sugars, he or she should consult a doctor before using this medicine.

Esomeprazol Towa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, this medicine is considered "sodium-free".

3. How to use Esomeprazol Towa

This medicine should always be taken exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• If you are taking this medicine for a long time (especially for longer than one year), medical monitoring may be necessary.
• If your doctor has prescribed this medicine for occasional use, you should inform your doctor about any changes in your symptoms.

Dosage

• Your doctor will decide the dose and duration of treatment. The dose depends on your condition, age, and liver function.
• The usual recommended doses are given below.

Adults aged 18 years and older
Treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• In patients with mild oesophageal damage, the usual dose is 40 mg of Esomeprazol Towa once daily for 4 weeks. If healing has not occurred, your doctor may recommend continuing the same dose for another 4 weeks.
• The usual dose after healing of the oesophagus is 20 mg of Esomeprazol Towa once daily.
• If there was no oesophageal damage, the usual dose of Esomeprazol Towa is 20 mg daily. After symptom relief, your doctor may recommend occasional use at a dose of up to 20 mg per day.
• In case of severe liver disease, your doctor may prescribe a lower dose.

Treatment of peptic ulcer caused by Helicobacter pylori infection and prevention of recurrence:

• The usual 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 gastric ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy:

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

Prevention of gastric ulcers during non-steroidal anti-inflammatory drug (NSAID) therapy:

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

Treatment of excess stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome):

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

Continuation of treatment after prevention of recurrent bleeding from ulcers with intravenous esomeprazole:

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

Adolescents aged 12 years and older
Treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• In patients with mild oesophageal damage, the usual dose is 40 mg of Esomeprazol Towa once daily for 4 weeks. If healing has not occurred, your doctor may recommend continuing the same dose for another 4 weeks.
• The usual dose after healing of the oesophagus is 20 mg of Esomeprazol Towa once daily.
• If there was no oesophageal damage, the usual dose of Esomeprazol Towa is 20 mg daily.
• In case of severe liver disease, your doctor may prescribe a lower dose.

Treatment of peptic ulcer caused by Helicobacter pylori infection and prevention of recurrence:

• The usual 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 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 coated with an acid-protective layer. 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 empty the pellets into a glass half-filled with still (non-carbonated) water. Do not use any other liquid.
  2. Stir the mixture and drink it immediately or within 30 minutes. Always stir before drinking.
  3. To ensure the entire dose is taken, refill the glass with half water again and drink it. The undissolved solid residue contains the medicine – do not chew or crush it.
• If you are unable to swallow on your own, the capsule contents should be mixed with water, drawn into a syringe, and administered directly into the stomach via a feeding tube.

Children and adolescents under 12 years of age
Esomeprazol Towa is not recommended for use in children under 12 years of age.
Elderly patients
No dose adjustment is necessary for elderly patients.
Taking more Esomeprazol Towa than prescribed
If you take more Esomeprazol Towa than prescribed, contact your doctor or pharmacist immediately.
Missed dose of Esomeprazol Towa

• If you miss a dose, take it as soon as possible. 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 missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If any of the following side effects occur, stop taking the medicine
Esomeprazol Towa and contact your doctor immediately:

• Wheezing, swelling of the mouth, tongue or throat, or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling of the skin. Blisters and bleeding of the lips, eyes, mouth, nose and genitals may also occur. These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and tiredness, which may be symptoms of liver disease.

The above side effects are rare and affect fewer than 1 in 1,000 patients.
Other side effects:
Common (may occur in up to 1 in 10 people)

• Headache
• Effects on stomach or intestines: diarrhoea, abdominal pain, constipation, bloating (with passing wind).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon (may occur in up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Dizziness (spinning sensation).
• Dryness of the mouth.
• Changes in blood test results indicating liver function.
• Skin rash, raised itchy rash (urticaria), itching of the skin.
• Fractures of the hip, wrist or spine (if Esomeprazol Towa is taken in high doses and for a long time).

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

• Blood disorders, such as a decrease in white blood cells or platelets. This may cause weakness, easy bruising and increased susceptibility to infections.
• Low sodium levels in the blood. This may cause weakness, vomiting and cramps.
• Feeling of restlessness, disorientation or depression.
• Taste disturbances.
• Vision disorders, such as blurred vision.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Inflammation of the mouth.
• Fungal infection called candidiasis, which may affect the intestines.
• Liver diseases, including jaundice, which causes yellowing of the skin, dark urine and tiredness.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint or muscle pain.
• Malaise and lack of energy.
• Excessive sweating.

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

• Disorders of blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Hallucinations (seeing, hearing or sensing things that are not there).
• Severe liver diseases leading to liver failure and encephalopathy.
• Sudden appearance of severe rash or blisters or peeling of the skin. These symptoms may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney diseases.
• Breast enlargement in men.

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

• If Esomeprazol Towa has been taken for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms are observed, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Inflammation of the intestine (leading to diarrhoea).
• Rash which may be accompanied by joint pain.

In very rare cases, Esomeprazol Towa may adversely affect white blood cells,
leading to immunodeficiency. If infections occur, with symptoms such as fever with
very poor general condition or fever with signs of local infection, such as neck pain,
throat or mouth pain, or difficulty urinating, contact your doctor immediately for
blood tests to rule out agranulocytosis (lack of white blood cells). It is very important to inform your doctor about taking this medicine.
Reporting of side effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor or pharmacist. Side effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

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 stated on the carton, container, or blister pack. The expiry date refers to the last day of the stated month.
• Blister: Store at a temperature not exceeding 30°C. Keep in the original packaging to protect from moisture.
• Container: Store at a temperature not exceeding 30°C. Keep the container tightly closed to protect from moisture.
• Container: Shelf life after first opening: 200 days.
• Medicines must 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 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).
• Other ingredients are:
  Capsule contents: Sucrose, pellets (containing maize starch and sucrose), methylcellulose, talc, titanium dioxide (E 171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid and ethyl acrylate copolymer, triethyl citrate.

Capsule shell:
Carrageenan, 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 hard capsules: hard capsules with an opaque light pink cap and body, size 4 (approximately 14 mm in length), printed with: ES on the cap and 20 on the body, containing spherical pellets.
• Esomeprazol Towa 40 mg gastro-resistant hard capsules: hard capsules with an opaque pink cap and body, size 2 (approximately 18 mm in length), printed with: ES on the cap and 40 on the body, containing spherical pellets.

Esomeprazol Towa 20 mg gastro-resistant hard capsules are available in the following
packs:
OPA/Aluminium/PE blister with desiccant/Aluminium:
7, 14, 28, 56 capsules in a cardboard box.
White opaque polyethylene (PE) container with a polyethylene screw cap with tamper-evident ring, containing a capsule with desiccant:
14, 28, 56 capsules in a cardboard box.

Esomeprazol Towa 40 mg gastro-resistant hard capsules are available in the following
packs:
OPA/Aluminium/PE blister with desiccant/Aluminium:
7, 14, 28, 56 capsules in a cardboard box.
White opaque polyethylene (PE) container with a polyethylene screw cap with tamper-evident ring, containing a capsule with desiccant:
14, 28, 56 capsules in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation 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 Martí 75-97, Martorelles,
08107 Barcelona,
Spain

Information intended for healthcare professionals only:
Administration via gastric tube

1. Empty the contents of the capsule into approximately 25 ml or 50 ml of water. (In case of using certain types of gastric tubes, mix the pellets with 50 ml of water to avoid tube blockage.) Mix well.
2. Draw the suspension into a syringe and add about 5 ml of air.
3. Immediately shake the syringe vigorously for about 2 minutes to disperse the pellets.
4. Turn the syringe with the tip upwards and check whether it is blocked.
5. Attach the syringe to the gastric tube, keeping it in this position.
6. Shake the syringe and orient it so that the tip is pointing downwards. Immediately inject 5–10 ml into the gastric tube. After injection, turn the syringe upside down and shake it (the syringe must be inverted with the tip upwards to avoid blockage).
7. Turn the syringe with the tip downwards and immediately inject another 5–10 ml into the gastric tube. Repeat this procedure until the syringe is completely emptied.
8. Fill the syringe with 25 ml of water and 5 ml of air and, if necessary, repeat step 6 to flush any residue remaining in the syringe. For certain types of gastric tubes, 50 ml of water may be required.

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