Nextell Otc, Gastro – 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 for the temporary short-term relief of heartburn and acid reflux conditions in adults.

Do not take NEXTELL OTC

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

Warnings and precautions

Special care should be taken with NEXTELL OTC:

• if you have been experiencing indigestion or heartburn for 4 or more weeks
• if you develop kidney problems called interstitial nephritis (blood or pus in the urine, cloudy urine, frequent urination, pain in the kidney area or burning sensation while urinating
• if you have had previous stomach ulcer or surgery on stomach
• if you have jaundice or severe liver disease
• If you are aged over 55 years with new or recently changed symptoms
• 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 NEXTELL OTC when necessary and your symptoms change
• if you have vitamin B12 deficiency
• If you develop ‘butterfly rash’ with sensitivity to sun light (subacute cutaneous lupus erythematosus)

If any of these applies to you, tell your doctor or nurse before you are given NEXTELL OTC. Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.

Other medicines and NEXTELL 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.
• NEXTELL OTC should not be taken at the same time as some medicines for HIV, such as atazanavir and nelfinavir, as NEXTELL 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), NEXTELL OTC may need to be temporarily withdrawn.

Pregnancy and breastfeeding

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 NEXTELL OTC if you are pregnant or breastfeeding your baby.

Driving and using machines

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

NEXTELL OTC contains sugar in the form of sucrose. 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 NEXTELL OTC exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2 – 3 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should consult a doctor.

Method of administration

The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.

If you take more NEXTELL OTC, 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 use NEXTELL OTC

Do not take / receive 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.

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

If any of the following happens, stop taking / using NEXTELL 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, seen rarely).
• 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’ seen very rarely.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems, seen rarely. These are all very serious side effects. If you have them, you may have had a serious reaction to NEXTELL 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)
• Cloudy, dark or discoloured urine, reduced frequency of urination, difficulty passing urine, pain over the bladder or kidneys and swelling of the feet, legs or hands. This may be due to kidney problems (interstitial nephritis) which may lead to kidney failure.
• Significant reduction in the amount of urine with shortness of breath (This could be a sign of kidney failure)

This medicine may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

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:

• Headache
• Stomach pain
• Diarrhoea
• Nausea/Vomiting
• Constipation
• Wind (flatulence)
• Benign growths (polyps) in the stomach

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
• Sleepiness
• Inability to sleep
• Confusion
• Depression
• Low white blood cell count
• Skin rash, lumpy rash (hives) and itchy skin
• Swelling of the feet and ankles.

Side effects of which is frequency is unknown:

• Decreased levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and changes in heart rhythm (arrhythmias). If you have very low levels of magnesium, you may also have low levels of calcium and/or potassium in your blood.
• “Butterfly rash” that lasts hours – days
• Taste disturbance
• Agitation
• Hallucination
• Low numbers of red blood cells, white blood cells, and platelets (a condition called pancytopenia)
• Inflammation of the gut (leading to diarrhoea).
• Severe liver problems leading to liver failure and inflammation of the brain.

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

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of NEXTELL OTC. Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected].

Store all medicines out of reach of children. Do not store above 30 °C. Store in original packaging to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).