Nexes Otc gastric – resistant Tablets

Esomeprazole belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Esomeprazole is used to treat the following conditions: NEXES OTC is indicated for the temporary, short-term relief of heartburn and hyperacidity subject to:

• a) a maximum daily dose of 20 milligrams
• b) a maximum treatment period of 14 days.

Do not take NEXES OTC:

• If you are allergic to esomeprazole or any of the other ingredients of NEXES OTC.
• If you are allergic to other “proton pump inhibitors”.
• If you are taking medication for HIV treatment (atazanavir or nelfinavir).

Warnings and precautions

Tell your doctor or health care provider before taking NEXES OTC:

• if you have been experiencing indigestion
• if you develop kidney problems
• if you have been on continuous medication for longer than a year
• if you have been taking a medication that contains clopidogrel (used in the treatment of blood clots)
• if you are due to have a specific blood test (Chromogranin A)
• If you have had previous intestinal conditions
• If you develop severe diarrhoea that has watery stools, abdominal pain and fever
• If you are taking NEXES OTC when necessary and your symptoms change
• If you have vitamin B12 deficiency
• If you develop tiredness dizziness, tremor and muscle problems (hypomagnesaemia)
• If you have been diagnosed with osteoporosis (brittle bones) or are at risk of breaking your bones
• If you develop ‘butterfly rash’ with sensitivity to sunlight (subacute cutaneous lupus erythematosus)

If any of these applies to you, tell your doctor or nurse before you are given NEXES OTC.

Children and adolescents

NEXES OTC should not be used in children younger than 1 year.

Other medicines and NEXES OTC

Always tell your health care provider if you are taking any other medicine. It is particularly important that you mention the following:

• Itraconazole, ketoconazole voriconazole used in the treatment of fungal infections
• Diazepam used in the treatment of anxiety
• Medicines used to prevent fitting (phenytoin)
• Medicines used to prevent blood clotting (warfarin or clopidogrel)
• Medicine used to help the symptoms of intermittent claudication (cilostazol)
• Medicines used to speed up stomach emptying (cisapride)
• Digoxin used in the treatment of heart problems
• Rifampicin used for the treatment of Tuberculosis
• St. John’s Wort - used to treat depression, or certain type of antimalignancy medicines (such as erlotinib or another antimalignancy medicine from the same class.
• NEXES OTC should not be taken at the same time as some medicines for HIV, such as atazanavir and nelfinavir, as NEXES OTC may reduce the blood levels of your antiretroviral medicine.
• Tipranavir used to treat HIV
• Clarithromycin, an antibiotic
• If you are taking a high dose of methotrexate (a chemotherapy medicine in which high dose is used to treat cancer), NEXES OTC may need to be temporarily withdrawn.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine. You should not take NEXES OTC if you are pregnant or breastfeeding your baby.

Driving and using machines

NEXES OTC may cause dizziness and blurred vision, thereby affecting the ability to drive or use machinery.

NEXES OTC contains sugar in the form of sucrose and lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Do not share medicines prescribed for you with any other person. Always take NEXES OTC exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose is one capsule a day.
• Do not take more than this recommended dose of one capsule (20 mg) a day, even if you don’t feel an improvement immediately.
• You may need to take the capsules for 2 or 3 days in a row before your reflux symptoms (for example, heartburn and acid regurgitation) get better.
• The treatment length is up to 14 days.
• When your reflux symptoms have completely gone you should stop taking this medicine.
• If your reflux symptoms get worse or do not improve after taking this medicine for 14 days in a row, you should consult a doctor.

If you take more NEXES OTC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take NEXES OTC

Do not take a double dose to make up for forgotten individual doses. If it is almost time for your next dose, do not take the missed dose, and just take the next dose on time.

NEXES OTC can have side effects. Not all side effects reported for NEXES OTC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NEXES OTC, please consult your health care provider for advice.

If any of the following happens, stop taking NEXES OTC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
• Rash or itching in the form of reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens - Johnson syndrome’ or ‘toxic epidermal necrolysis’.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

These are all very serious side effects. If you have them, you may have had a serious reaction to NEXES OTC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Tightening of chest accompanied with severe coughing (bronchospasm)
• Loss or decreased vision
• Abdominal swelling (may be an indication of liver failure)
• Excessive sweating
• Blood in the urine (Nephritis)
• Significant reduction in the amount of urine with shortness of breath (This could be a sign of kidney failure)

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Stomach pain
• Diarrhoea
• Nausea/Vomiting
• Constipation
• Headache

Less Frequent side effects:

• Muscle weakness/pain
• Fever
• Development of breast tissue in males
• Joint pain
• Hair loss
• Dry mouth
• Inflammation of the mouth and lips
• Dizziness
• Blurred vision
• Tingling sensation
• Loss of balance
• Taste disturbance
• Sleepiness
• Inability to sleep
• Confusion
• Depression
• Agitation
• Hallucination
• Low white blood cell count

Side effects of which is frequency is unknown:

• Decreased levels of calcium
• Decreased levels of magnesium
• “Butterfly rash” that lasts hours – days

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store all medicines out of reach of children.
• Protect from light / moisture.
• Do not use after the expiry date stated on the label.
• Do not store above 30 ⁰C.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).