10 mg enterogranulate for oral suspension , sachet
esomeprazole
What Nexium is and what it is used for
Nexium contains a substance called esomeprazole. This belongs to a group of medicines called proton pump inhibitors or acid inhibitors. These work by inhibiting the stomach acid produced in the stomach.
Nexium is used to treat the following conditions:
Children from 1 year of age
Nexium is used to treat a condition called gastroesophageal reflux disease ( GERD ).
- Leakage of acidic gastric juice up to the esophagus causing pain, inflammation and heartburn. Heartburn manifests itself as a burning sensation from the abdomen or lower part of the chest to the mouth
- In children, the symptom picture may include acid regurgitation, vomiting and poor weight gain
Children from 4 years of age
- Wounds that are infected with bacteria called “Helicobacter pylori “. If your child has this condition, your doctor may also prescribe antibiotics to treat an infection and get a stomach ulcer healed.
What you need to know before you take Nexium
Do not take Nexium
- If you are allergic to esomeprazole or other similar antacids (so-called proton pump inhibitors such as pantoprazole, lansoprazole, rabeprazole, omeprazole) or any of the other ingredients of this medicine (listed in section 6)
- If you are taking a medicine that contains nelfinavir (medicine for HIV infection )
You should not take Nexium if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before taking Nexium:
- 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 like Nexium that reduces stomach acid.
- if you are going to have a specific blood test (chromogranin A).
Nexium treatment can mask the symptoms of other diseases. Therefore, you should contact your doctor as soon as possible at:
- Unintentional sharp weight loss
- Stomach pain or indigestion
- Repeated vomiting
- Difficult to swallow
- Blood in vomit or feces
If you have been told to take Nexium “when needed”, contact your doctor if your symptoms persist or change in nature. On-demand dosing in children has not been studied and is therefore not recommended for this patient group.
Using proton pump inhibitors such as Nexium and especially if you use Nexium for more than a year, may increase the risk of having a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
Skin rash and skin symptoms
If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Nexium. Also remember to mention any other side effects, such as joint pain.
Severe rash has occurred in patients taking esomeprazole (see also section 4). The rash may consist of sores in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes often come after flu-like symptoms such as fever, headache, body aches. The rash can cover large parts of the body with blisters and skin detachment.
If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
Other medicines and Nexium
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Some medicines may affect or be affected by treatment with Nexium.
Do not take Nexium if you are also taking medicines containing nelfinavir (used to treat HIV infection ).
Tell your doctor or pharmacist if you are taking the following medicines:
- Atazanavir (medicine used to treat HIV infection ).
- Clopidogrel (used to prevent blood clots)
- Ketoconazole , itraconazole and voriconazole (medicines used to treat fungal infections)
- Erlotinib (used to treat cancer)
- Diazepam (sedative and antispasmodic)
- Citalopram , imipramine, clomipramine (antidepressants)
- Phenytoin ( antiepileptic medicine )
- Warfarin or coumarin (blood thinners)
- Cilostazol (used to treat window disease – pain in the legs when walking due to insufficient blood supply to the legs)
- Cisapride (medicine for stomach upset and heartburn)
- Digoxin (used for heart problems)
- Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Nexium
- Tacrolimus (organ transplant)
- Rifampicin (used to treat tuberculosis )
- St. John’s wort – Hypericum perforatum (used to treat depression)
If your doctor has prescribed both the antibiotics amoxicillin and clarithromycin and Nexium for the treatment of wounds caused by Helicobacter pylori infection, it is very important that you tell your doctor if you are taking any other medicines.
Nexium enterogranulate with food and drink
Nexium enterogranulate can be taken with or without food.
Pregnancy, breastfeeding and fertility
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 if you can take Nexium or not.
It is not known if Nexium passes into breast milk. Therefore, you should not take Nexium if you are breastfeeding.
Driving and using machines
Nexium is unlikely to affect your ability to drive or handle tools or machines. However, side effects such as dizziness and visual disturbances may occur in less common cases (see section 4). If you are affected, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nexium contains sucrose and glucose
Nexium contains sucrose and glucose, both of which are sugars. Careful oral hygiene and regular toothbrushing are therefore important.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before starting Nexium treatment.
How to take Nexium
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your medicine is in the form of small granules, packed in single sachets. Each sachet contains 10 mg of esomeprazole. Your doctor will tell you how many sachets to take each day.
Your doctor will also tell you how long the treatment should last.
- Pour the contents of one or more sachets into a glass of water. Do not use carbonated water. The amount of water in the glass depends on how many sachets you should take at one time.
- Use 15 ml of water (3 teaspoons) for each sachet . That is, 15 ml of water for 1 sachet, 30 ml of water for 2 sachets
- Stir granules into water
- Let the mixture stand for a few minutes until it has thickened
- Stir again and drink up. The granules must not be chewed or crushed. Do not let mixture stand for more than 30 minutes
- If anything remains in the glass, pour in some water, stir and drink at once
It does not matter if you take Nexium with food or not.
If you have a ventricular tube, healthcare professionals can administer Nexium via the ventricular tube. Further instructions for healthcare professionals can be found at the end of the package leaflet.
The recommended doses are given below:
Use for children from 1 to 11 years
- Nexium is not recommended for children under 1 year of age
For the treatment of gastroesophageal reflux disease.
- The recommended dose is 1-2 sachets (10-20 mg) once a day, based on the baby’s body weight. Your doctor will determine the exact dose
Use in children aged 4 years and older
For the treatment of wounds caused by Helicobacter pylori infection and to prevent their recurrence.
- Dose one for children is based on the weight of the child and the doctor will determine the correct dose . Your doctor will also prescribe two antibiotics for your child
Use for adults and adolescents
Nexium oral suspension can also be used by patients who have difficulty swallowing dissolved Nexium enteric tablets. Dosage information for patients from the age of 12 years can be found in the Nexium enteric-tablet product information (ask your doctor and pharmacist for further information).
Older
Dose adjustment is not necessary for elderly patients.
In case of impaired liver function
- If you have severe hepatic impairment, the maximum daily dose is 2 sachets (20 mg). For children 1-11 years with severe hepatic impairment, the maximum dose is 10 mg
In case of impaired renal function
- There are no dose restrictions in renal impairment. However, in case of severe renal impairment, your doctor may want to take some extra samples
If you take more Nexium than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Nexium
If you forget to take your dose at one time, take it as soon as you remember or wait until the next time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Nexium and contact your doctor immediately, if you notice any of the following serious side effects:
- Yellowed skin, dark urine and fatigue, which can be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.
- Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction ). These side effects are rare and may affect up to 1 in 1,000 people.
- Sudden, severe rash or redness of the skin with blistering or flaking may occur even after several weeks of treatment. Severe blistering and bleeding on the lips, eyes, mouth, nose and genitals may also occur. The skin rash can develop into severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes) with life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or “drug reaction with eosinophilia and systemic symptoms”. These side effects are very rare and may affect up to 1 in 10,000 people.
Other side effects:
Common (may affect less than 1 in 10 people taking Nexium):
- Headache
- Symptoms of gastrointestinal upset: diarrhea, flatulence, abdominal pain, constipation
- Nausea, vomiting
- Benign polyps are in the stomach
Uncommon (may affect less than 1 in 100 people taking Nexium):
- Ankle and foot swelling
- Insomnia
- Dizziness, sensations such as tingling and ant crawling ( paresthesias ), drowsiness
- Feeling dizzy
- Dry mouth
- Elevation of liver enzymes
- Skin rash, hives , itching
- Hip, wrist or vertebral fractures (if Nexium is used in high doses and for a long time)
Rare (may affect less than 1 in 1,000 people taking Nexium):
- Changes in the blood picture such as decreased number of white blood cells or platelets . This may cause weakness, bruising or susceptibility to infection.
- Decreased level of sodium in the body ( hyponatremia ). This can cause weakness, vomiting and cramps.
- Confusion, restlessness, depression
- Taste changes
- Vision problems such as blurred vision
- Sudden wheezing or shortness of breath ( bronchospasm )
- Inflammation of the oral mucosa
- An infection called ‘cod’ that can affect the gut and is caused by fungi
- Liver problems including jaundice, which can cause yellowing of the skin, dark urine and fatigue.
- Hair loss (alopecia)
- Photosensitivity ( photosensitivity )
- Muscle pain ( myalgia ), joint pain ( arthralgia )
- General malaise and lack of energy
- Increased sweating
Very rare (may affect less than 1 in 10,000 people taking Nexium):
- Changes in blood count including agranulocytosis (lack of white blood cells )
- Aggression
- Hallucinations
- Serious liver problems leading to liver failure and encephalitis
- Sudden rash, blisters or scaly skin that may occur with high fever and joint pain ( Stevens-Johnson syndrome , erythema multiforme, toxic epidermal necrolysis ), drug reaction with eosinophilia and systemic symptoms)
- Muscle weakness
- Severe kidney effects (kidney inflammation)
- Enlargement of the mammary glands in men
No known frequency (can not be calculated from the available data)
- If you use Nexium for more than three months, your magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
- Inflammation of the intestine (causes diarrhea)
- Skin rash, possibly with joint pain.
Nexium can in very rare cases affect the white blood cells so that the immune system deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
How to store Nexium
No special storage instructions.
- Keep this medicine out of the sight and reach of children
- Use before the expiry date which is stated on the outer carton and on the bag after Ex. dat. The expiration date is the last day of the specified month
- The reconstituted suspension should be used within 30 minutes
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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is esomeprazole. Each sachet contains 10 mg of esomeprazole as magnesium trihydrate.
Other ingredients are:
Esomeprazole granules
Glycerol monostearate 40-55
Hydroxypropylcellulose
Hypromellose
Magnesium stearate
Methacrylic acid-ethyl acrylate copolymer (1: 1) dispersion 30%
Polysorbate 80
Sugar spheres (sucrose and corn starch)
Talc
Triethyl citrate
Other granules
Citric acid anhydrous (for pH adjustment)
Krospovidon
Glucose
Hydroxypropylcellulose
Yellow iron oxide (E 172)
Xanthan gum
What the medicine looks like and contents of the pack
Each sachet contains pale yellow small granules. Brownish granules may occur.
The oral suspension is a thick yellow liquid consisting of slurried granules.
Each pack contains 28 or 30 sachets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany
Manufacturer:
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany