Zolextra-Jr Sachet

1. What Zolextra-Jr is and what it is used for

Zolextra-Jr contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors (PPIs). It works by reducing the amount of acid produced in the stomach.

Zolextra-Jr is used in children from 1 year of age and weighing 10 kg or more for:

treatment of gastro-oesophageal reflux disease (GERD), including treatment of endoscopically proven erosive reflux oesophagitis and symptomatic GERD;
treatment of duodenal ulcer caused by Helicobacter pylori, in children over 4 years of age, together with appropriate antibiotics.

The prescribing information supplied with this product also lists use for risk reduction of NSAID-associated gastric ulcer and pathological hypersecretory conditions, including Zollinger-Ellison syndrome. The dose and suitability for these uses must be determined by the treating doctor.

How Zolextra-Jr works
Esomeprazole is the S-isomer of omeprazole. It specifically inhibits the gastric acid pump in the stomach's acid-producing cells, thereby reducing gastric acid secretion.

2. What you need to know before your child takes Zolextra-Jr

Do not give Zolextra-Jr if:

your child is allergic to esomeprazole, substituted benzimidazoles or any of the other ingredients of this medicine;
your child is taking nelfinavir.

Talk to your child's doctor or pharmacist before giving Zolextra-Jr if:

your child has significant unexplained weight loss, repeated vomiting, difficulty swallowing, vomiting blood or black stools. These symptoms need medical assessment before treatment because a serious stomach condition should be excluded.
your child has severe liver problems or severe kidney problems.
your child has risk factors for low vitamin B12 levels or is expected to receive long-term treatment.
your child is expected to receive prolonged treatment or is taking medicines such as digoxin or diuretics that may cause low magnesium levels.
your child has osteoporosis or other risk factors for fractures.
your child develops a skin rash, especially on sun-exposed areas, particularly if it is accompanied by joint pain.
your child has previously had a serious skin reaction after treatment with a proton pump inhibitor.
your child is going to have a Chromogranin A (CgA) test for investigation of a neuroendocrine tumour; esomeprazole can interfere with this test.

Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections such as Salmonella and Campylobacter.

Serious skin reactions
Very rarely, serious skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Stop treatment and seek medical attention immediately if your child develops signs of a severe skin reaction, such as extensive rash, blistering, peeling skin or symptoms involving the mouth, eyes or other mucous membranes.

Other medicines and Zolextra-Jr
Tell the doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Atazanavir – concomitant use with esomeprazole is not recommended.
Nelfinavir – must not be used with esomeprazole.
Clopidogrel – concomitant use should be discouraged as a precaution.
Methotrexate – high-dose methotrexate may require temporary withdrawal of esomeprazole.
Tacrolimus – blood levels and kidney function may need monitoring.
Warfarin or other coumarin derivatives – monitoring may be required.
Phenytoin – blood levels may need monitoring when esomeprazole is started or stopped.
Diazepam and other medicines metabolised through CYP2C19 – their concentrations may be affected.
Medicines such as ketoconazole, itraconazole, erlotinib and digoxin may be affected because esomeprazole changes stomach acidity.
Rifampicin or St John's wort may reduce esomeprazole levels.
Clarithromycin and other medicines affecting CYP2C19/CYP3A4 may increase esomeprazole exposure.

Interaction studies have only been performed in adults. The doctor will decide which medicines can be used together in a child.

Pregnancy, breast-feeding and fertility
If the patient is pregnant, thinks she may be pregnant or is planning to have a baby, ask the doctor for advice before taking this medicine. Available clinical data do not indicate a malformative or foeto/neonatal toxic effect, but caution should be exercised during pregnancy.

Esomeprazole should not be used during breast-feeding because it is not known whether it passes into human breast milk and there is insufficient information on effects in newborns/infants.

Animal data with omeprazole do not indicate an effect on fertility.

Driving and using machines
Esomeprazole has a minor influence on the ability to drive and use machines. Dizziness and blurred vision have been reported. If your child is affected, they should not drive or use machines.

3. How to give Zolextra-Jr

Always give this medicine exactly as your child's doctor has told you. Check with the doctor or pharmacist if you are not sure.

Recommended doses in children

Children 1–11 years of age weighing 10 kg or more:

Erosive reflux oesophagitis: 10 mg once daily for 8 weeks in children weighing ≥10 to <20 kg; 10 mg or 20 mg once daily for 8 weeks in children weighing ≥20 kg.
Symptomatic GERD: 10 mg once daily for up to 8 weeks.
Doses above 1 mg/kg/day have not been studied.

Children over 4 years of age – Helicobacter pylori-associated duodenal ulcer:

Less than 30 kg: Zolextra-Jr 10 mg with amoxicillin 25 mg/kg and clarithromycin 7.5 mg/kg, all twice daily for one week.
30–40 kg: Zolextra-Jr 20 mg with amoxicillin 750 mg and clarithromycin 7.5 mg/kg, all twice daily for one week.
More than 40 kg: Zolextra-Jr 20 mg with amoxicillin 1 g and clarithromycin 500 mg, all twice daily for one week.

Helicobacter pylori treatment should be supervised by a specialist, and the choice of antibiotics should follow applicable local and national guidance on resistance and treatment duration.

Children below 1 year of age
Treatment with esomeprazole is not recommended in children below 1 year of age because experience in this age group is limited.

How to prepare Zolextra-Jr

For a 10 mg dose, empty the contents of one 10 mg sachet into a glass containing 15 mL of water.
Do not use carbonated water.
Stir until the granules are dispersed and leave for a few minutes to thicken.
Stir again and drink the suspension within 30 minutes.
Do not chew or crush the granules.
Rinse the glass with 15 mL of water and drink it to make sure all granules are taken.

For a 20 mg dose, use two 10 mg sachets in 30 mL of water and follow the same preparation instructions.

The medicine may be taken with or without food.

If you give more Zolextra-Jr than you should
If your child receives more Zolextra-Jr than prescribed, contact a doctor or pharmacist for advice. Experience with deliberate overdose is very limited. Reported symptoms after 280 mg included gastrointestinal symptoms and weakness. Treatment of overdose is generally supportive because there is no specific antidote.

If you forget to give Zolextra-Jr
Give the missed dose as soon as you remember unless it is nearly time for the next dose. Do not give a double dose to make up for a forgotten dose. If you are unsure, ask your child's doctor or pharmacist.

If you stop giving Zolextra-Jr
Do not stop treatment early unless the doctor tells you to do so, particularly when Zolextra-Jr is being used as part of Helicobacter pylori eradication treatment.

4. Possible side effects

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

Common side effects

headache
abdominal pain
constipation
diarrhoea
flatulence
nausea or vomiting
benign fundic gland polyps

Uncommon side effects

swelling of the limbs (peripheral oedema)
insomnia
dizziness, tingling or sleepiness
vertigo
dry mouth
increased liver enzymes
dermatitis, itching, rash or hives
fracture of the hip, wrist or spine

Rare or very rare side effects

low white blood cell or platelet counts, and very rarely agranulocytosis or pancytopenia
severe allergic reactions, including angioedema and anaphylaxis
low sodium or low magnesium levels
confusion, depression, agitation, aggression or hallucinations
taste disturbance or blurred vision
bronchospasm
stomatitis or gastrointestinal candidiasis
hepatitis, sometimes with jaundice, and very rarely liver failure
hair loss or photosensitivity
serious skin reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS
joint or muscle pain and, very rarely, muscle weakness
interstitial nephritis and, in some cases, kidney failure
gynaecomastia
malaise or increased sweating

Other side effects
The frequency is not known for some effects, including microscopic colitis, hypomagnesaemia with possible associated low calcium or potassium, and subacute cutaneous lupus erythematosus.

Get medical help immediately if your child develops:

swelling of the face, lips, tongue or throat, difficulty breathing or other signs of a severe allergic reaction;
a severe skin rash with blistering, peeling or sores involving the mouth, eyes or other mucous membranes;
vomiting blood or passing black stools;
severe or persistent symptoms that concern you.

Reporting side effects
If your child gets any side effects, talk to the doctor or pharmacist. You can also report suspected adverse reactions to the pharmacovigilance contact provided for this product: medico@zorvia.com.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolextra-Jr

Keep this medicine out of sight and reach of children.
Store below 30°C.
Protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Contents of the pack and other information

What Zolextra-Jr contains

The active substance is esomeprazole. Each sachet contains esomeprazole magnesium trihydrate equivalent to esomeprazole 10 mg, as enteric-coated granules.
Other ingredients: excipients q.s.; colour: Sunset Yellow FCF; in a flavoured base.