Esomeprazole Cipla Europe: detailed information

Package leaflet: Information for the user

Esomeprazolo Cipla Europe 10 mg gastro-resistant granules for oral suspension in sachet
esomeprazole
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Esomeprazolo Cipla Europe is and what it is used for
What you need to know before taking Esomeprazolo Cipla Europe
How to take Esomeprazolo Cipla Europe
Possible side effects
How to store Esomeprazolo Cipla Europe
Contents of the pack and other information

1. What Esomeprazolo Cipla Europe is and what it is used for

Esomeprazolo Cipla Europe contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Esomeprazolo Cipla Europe is used to treat the following conditions:

Adults

'Gastro-oesophageal reflux disease' (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
Stomach or upper intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". For these conditions, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole may also be used to prevent the development of stomach ulcers during treatment with NSAIDs.
Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment to prevent re-bleeding of ulcers, following intravenous esomeprazole for initial prevention.

Adolescents from 12 years of age

'Gastro-oesophageal reflux disease' (GORD). This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
Stomach or upper intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". For these conditions, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Children aged 1 to 11 years
Esomeprazolo Cipla Europe is used to treat a condition called 'gastro-oesophageal reflux disease' (GORD).

This occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and acid regurgitation. Acid regurgitation is a burning sensation rising from the stomach or lower chest up towards the neck.
In children, symptoms of this condition may include return of stomach contents into the mouth (regurgitation), feeling unwell (vomiting), and poor weight gain.

Children over 4 years of age

Ulcers associated with infection by bacteria called "Helicobacter pylori". If your child has 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 taking Esomeprazole Cipla Europe:

Do not take Esomeprazole Cipla Europe

if you are allergic to esomeprazole or to other similar proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole), or to any of the other ingredients of this medicine (listed in section 6);
if you are taking a medicine containing nelfinavir (used to treat HIV);
if you have ever had a severe skin rash or skin peeling, or a skin rash with blisters and/or mouth ulcers after taking esomeprazole or other related medicines.

Do not take Esomeprazole Cipla Europe if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Esomeprazole Cipla Europe.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole Cipla Europe:

if you have severe liver problems;
if you have severe kidney problems;
if you have ever had a skin reaction after treatment with a medicine similar to Esomeprazole Cipla Europe that reduces stomach acid;
if you are scheduled to undergo a specific blood test (chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if any of the following occur while you are
taking Esomeprazole Cipla Europe, inform your doctor immediately:

you lose weight significantly without reason;
you experience stomach pain or indigestion;
you start vomiting repeatedly;
you have difficulty swallowing;
you vomit blood or your stools are black (blood-stained stools).

If Esomeprazole Cipla Europe has been prescribed for "on-demand" use, contact your doctor if symptoms persist or change in nature. "On-demand" treatment has not been studied in children and is therefore not recommended in this patient group.
Taking a proton pump inhibitor such as esomeprazole, especially for more than one year, may cause a slight increase in the risk of fractures of the hip, wrist, or spine. Consult your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
Skin rash and skin-related symptoms
If you notice a skin rash, particularly in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazole Cipla Europe. Remember to also report any other side effects such as joint pain.
Serious skin reactions have been reported in association with esomeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using Esomeprazole Cipla Europe and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Severe skin rashes have occurred in patients taking esomeprazole (see also section 4).
The skin rash may involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, and muscle pain. The rash may cover large areas of the body, with blistering and skin peeling.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
Other medicines and Esomeprazole Cipla Europe
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription. This is because esomeprazole may affect how certain medicines work, and certain medicines may affect esomeprazole.
Do not take Esomeprazole Cipla Europe if you are taking a medicine containing nelfinavir (used to treat HIV).
Inform your doctor or pharmacist if you are taking any of the following medicines:

Atazanavir (used to treat HIV).
Clopidogrel (used to prevent blood clots).
Ketoconazole, itraconazolo, or voriconazole (used to treat fungal infections).
Erlotinib (used to treat cancer).
Diazepam (used to treat anxiety or for muscle relaxation).
Citalopram, imipramine, or clomipramine (used to treat depression).
Phenytoin (used in epilepsy).
Warfarin or coumarin (anticoagulant medicines used to thin the blood).
Cilostazol (used to treat intermittent claudication – leg pain when walking caused by inadequate blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Esomeprazole Cipla Europe.
Tacrolimus (used in organ transplants).
Rifampicin (used to treat tuberculosis).
St. John’s Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed antibiotics such as amoxicillin and clarithromycin together with esomeprazole for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.
Esomeprazole Cipla Europe with food and drink
The tablets can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Esomeprazole Cipla Europe during this time.
It is not known whether esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Cipla Europe if you are breastfeeding.
Driving and using machines
It is unlikely that esomeprazole will affect your ability to drive or use tools or machines.
However, side effects such as dizziness and visual disturbances may occur uncommonly or rarely (see section 4). If these occur, you should not drive or use machinery.
Esomeprazole Cipla Europe contains sucrose and glucose
Esomeprazole Cipla Europe contains sucrose and glucose, which are types of sugar. Good oral hygiene and regular tooth brushing are therefore important. If your doctor has diagnosed you with an intolerance to certain sugars, inform them before taking Esomeprazole Cipla Europe.

3. How to take Esomeprazole Cipla Europe

Take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or
pharmacist.
Your medicine comes as granules contained in individual sachets. Each sachet contains 10 mg of
esomeprazole. Your doctor will tell you how many sachets to take each day and for how long.

Empty the contents of the sachet or sachets into a glass of water. Do not use carbonated water. The amount of water needed depends on the number of sachets your doctor has instructed you to take at one time.
Use 15 millilitres (ml) of water (3 teaspoons) for each sachet. This means you will need 15 ml for one sachet and 30 ml for two sachets.
Mix the granules in the water.
Allow the mixture to thicken for a few minutes.
Stir again and drink the mixture immediately. The granules must not be chewed or crushed, as this may damage the gastro-resistant coating. Do not leave the mixture for more than 30 minutes before drinking.
If any residue remains in the glass after taking the dose, add a small amount of additional water, stir, and drink immediately.

Esomeprazole Cipla Europe granules may be taken with or without food.
If you are fed via a tube (gastric feeding), your doctor or nurse will administer Esomeprazole Cipla Europe
through the tube. Information for doctors or nurses is provided at the end of this leaflet.

Recommended doses are as follows:
Adults from 18 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has observed mild damage to your oesophagus, the recommended dose is 4 sachets of 10 mg granules for oral suspension once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if healing has not occurred.
After healing of the oesophagus, the recommended dose is 2 sachets of 10 mg granules for oral suspension once daily.
If your oesophagus is not damaged, the recommended dose is 2 sachets of 10 mg granules for oral suspension once daily. When symptoms are under control, your doctor may advise you to take the medicine only as needed, up to a maximum of 2 sachets of 10 mg granules for oral suspension once daily.
If you have severe liver problems, your doctor may prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

The recommended dose is 2 sachets of 10 mg granules for oral suspension twice daily for one week.
Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is 2 sachets of 10 mg granules for oral suspension once daily for 4–8 weeks.

Prevention of gastric ulcers during NSAID (Non-Steroidal Anti-Inflammatory Drugs) treatment:

The recommended dose is 2 sachets of 10 mg granules for oral suspension once daily.

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

The recommended dose of esomeprazole is 40 mg twice daily.
Your doctor will adjust the dose according to your needs and will determine how long you should take the medicine. The maximum dose is 80 mg twice daily.

Long-term treatment following intravenous esomeprazole to prevent re-bleeding from ulcers:

The recommended dose is 4 sachets of 10 mg granules for oral suspension once daily for 4 weeks.

Adolescents from 12 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has observed mild damage to your oesophagus, the recommended dose is 4 sachets of 10 mg granules for oral suspension once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for an additional 4 weeks if healing has not occurred.
After healing of the oesophagus, the recommended dose is 2 sachets of 10 mg granules for oral suspension once daily.
If your oesophagus is not damaged, the recommended dose is 2 sachets of 10 mg granules for oral suspension once daily.
If you have severe liver problems, your doctor may prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

The recommended dose is 2 sachets of 10 mg granules for oral suspension once daily for one week.
Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

Children aged 1 to 11 years

Esomeprazole Cipla Europe is not recommended for children under 1 year of age.

Treatment of gastroesophageal reflux disease (GERD):

The recommended dose is one sachet (10 mg) or two sachets (20 mg) once daily. The dose for children is based on body weight. Your doctor will determine the correct dose.

Children from 4 years of age
Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

The recommended dose is based on the child's body weight. Your doctor will determine the correct dose and will prescribe two antibiotics for the child.

Use in adults and adolescents
Esomeprazole oral suspension can also be used in patients who have difficulty swallowing crushed
gastro-resistant esomeprazole tablets.

Elderly
No dose adjustment is necessary for elderly patients.

Patients with liver problems

For patients with severe liver problems, the maximum daily dose of esomeprazole is 2 sachets (20 mg). For children aged 1 to 11 years with severe liver problems, the maximum dose should not exceed 10 mg.

Patients with kidney problems

There are no specific dosage restrictions for patients with kidney problems. However, if you have severe kidney problems, your doctor may decide to perform regular monitoring tests.

If you take more Esomeprazole Cipla Europe than you should
If you have taken more Esomeprazole Cipla Europe than prescribed by your doctor, consult your doctor.

If you forget to take Esomeprazole Cipla Europe
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 to make up for the forgotten dose.
If you have any doubts about how to use 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 you notice any of the following serious side effects, stop taking Esomeprazole Cipla Europe and contact your doctor immediately:

Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems. These effects are rare (may affect up to 1 in 1,000 people).
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.
Sudden wheezing, swelling of the lips, tongue, throat or body, rash, feeling faint, or difficulty swallowing (severe allergic reaction). These effects are rare (may affect up to 1 in 1,000 people).
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. These skin rashes may progress to cause serious, widespread damage to the skin (peeling of the epidermis and superficial mucous membranes), with potentially life-threatening consequences. These symptoms may be related to “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. These effects are very rare (may affect up to 1 in 10,000 people).

Other side effects include:
Common (may affect up to 1 in 10 people)

Headache.
Stomach or intestinal problems: diarrhoea, stomach pain, constipation, gas (flatulence).
Feeling unwell (nausea) or being unwell (vomiting).
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling sensations like “pins and needles”, drowsiness.
Feeling dizzy (vertigo).
Dry mouth.
Changes in blood tests assessing liver function.
Rash, hives, and itching.
Fracture of the hip, wrist, or spine (if esomeprazole is used at high doses and for prolonged periods).

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

Blood problems, such as a 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, feeling unwell (vomiting), and cramps.
Feeling restless, confused, or depressed.
Altered taste.
Vision problems, such as blurred vision.
Sudden wheezing or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “candidiasis” that may affect the intestine and is caused by a fungus.
Liver problems, including jaundice which may cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash after exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of being unwell and lack of energy.
Increased sweating.

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

Changes in the number of blood cells, including agranulocytosis (lack of white blood cells in the blood).
Aggression.
Seeing, feeling, or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of a severe skin rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

If you have been taking Esomeprazole Cipla Europe for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If any of these symptoms occur, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to monitor your blood magnesium levels periodically.
Inflammation of the intestine (which may lead to diarrhoea).
Erythema, possibly associated with joint pain.

Esomeprazole may, very rarely, affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in your general health, or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, you should contact your doctor as soon as possible so that a lack of white blood cells in the blood (agranulocytosis) can be ruled out by a blood test. It is important for you to provide information about the medicines you are taking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Esomeprazole Cipla Europe

Keep in the original packaging to protect the medicine from light and moisture.
Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after Exp. The expiry date refers to the last day of that month.
The reconstituted suspension must be taken within 30 minutes.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo Cipla Europe granules for oral suspension contains

The active substance is esomeprazole. Each sachet contains esomeprazole magnesium dihydrate equivalent to 10 mg of esomeprazole.
The excipients are:

o Esomeprazole granules: Glycerol monostearate, Hypromellose, Magnesium stearate, Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, Polysorbate 80, Sugar spheres (sucrose and maize starch), Talc, Triethyl citrate.
o Excipient granules: Anhydrous citric acid, Glucose, Crospovidone, Yellow iron oxide, Hydroxypropylcellulose, Xanthan gum.

Description of the appearance of Esomeprazolo Cipla Europe and the contents of the pack
Each sachet of Esomeprazolo Cipla Europe contains fine yellow powder consisting of white to light brownish esomeprazole granules and pale yellow inactive granules.
The oral suspension is an opaque, viscous liquid, pale yellow in colour with suspended particles.
Each carton contains 28 sachets. Each sachet contains 3.2 grams.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium

Manufacturer responsible for batch release
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Esomeprazol Cipla 10 mg, maagsapresistent granulaat voor suspensie voor oraal gebruik in sachet
France Esomeprazole Cipla 10 mg, granulés gastro-résistants pour suspension buvable en sachet
Norway Esomeprazol Cipla
Italy Esomeprazolo Cipla Europe
Sweden Esomeprazol Cipla

The following information is intended exclusively for medical and healthcare professionals:

Administration instructions for patients with nasogastric or gastric tubes:

For a 10 mg dose, add the contents of one 10 mg sachet to 15 ml of water.
For a 20 mg dose, add the contents of two 10 mg sachets to 30 ml of water.
Mix.
After reconstitution, the oral suspension is a viscous, opaque, pale yellow liquid containing suspended particles.
Allow to thicken for a few minutes.
Mix again.
Draw up the suspension into a syringe.
Inject through a tube with a diameter of 6 French or larger into the stomach within 30 minutes after reconstitution.
Refill the syringe with 15 ml of water for the 10 mg dose or with 30 ml of water for the 20 mg dose.
Shake and inject the remaining contents into the nasogastric or gastric tube into the stomach.

Any unused suspension must be discarded.