Nexive®

Patient Information

Nexive^®contains a medicine called esomeprazole. This belongs to a group of medicines

called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

What Nexive^® is used for:

Adults and young people aged 12 years and above:

• ‘Gastro-oesophageal reflux disease’ (GORD).
• Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called

‘Helicobacter pylori’.

Adults:

• Stomach ulcers caused by medicines called NSAIDs
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison

syndrome).

• Prolonged treatment after prevention of re-bleeding of ulcers with intravenous esomeprazole.

Tell your doctor or pharmacist before using Nexive^® if:

• 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

that reduces stomach acid.

• If you are due to have a specific blood test (Chromogranin A).
• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

Who should not take Nexive^®:

• If you are allergic to esomeprazole or any of the other ingredients of this medicine.
• If you are allergic to the group of medicines called ‘benzimidazoles’, which includes other

proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole) as

well as other different types of medicine.

• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

How to take your Nexive^®:

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Esomeprazole is not recommended for children less than 12 years old.
• If you are taking this medicine for a long time, your doctor will want to monitor you
• (particularly if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.
• You can take your capsules at any time of the day.
• You can take your capsules with food or on an empty stomach.
• Swallow your capsules whole with a drink of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you forget to take a dose:

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time

for your next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

While taking your medicine:

• If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole during this time.
• It is not known if esomeprazole passes into breast milk. Therefore, you should not take
• Esomeprazole if you are breast-feeding.
• Esomeprazole can cause side effects such as dizziness and blurred vision. If you are affected by these you should not drive, use tools or operate machinery.

Call your doctor right away if you have:

• Fracture of the hip, wrist or spine.
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulty swallowing or breathing (severe allergic reaction).
• Yellow skin, dark urine, pale stools with fever, feeling or being sick and tiredness, which can be signs of liver problems.

Low numbers of white blood cells, which may lead to a severely reduced general condition or fever with signs of a local infection such as pain in the neck, throat or mouth or difficulty urinating.

• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, with joint pain and high fever. This could be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, ‘drug reaction with eosinophilia and systemic symptoms’ or ‘toxic epidermal necrolysis’.
• Passing less urine than usual or being unable to pass urine, blood or mucous in the urine, pain in the lower back possibly with rash, fever, feeling or being sick. These may be signs of kidney problems.

What to do if you take too much capsules:

If you take more Nexive^® than your doctor has told you to, talk to your doctor or pharmacist straight away.

Side effects:

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

• Common: headache, diarrhoea, stomach pain, constipation, wind (flatulence), feeling sick (nausea) or being sick (vomiting), benign polyps in the stomach.
• Uncommon: swelling of the feet and ankles, disturbed sleep (insomnia), dizziness, tingling feelings such as “pins and needles”, feeling sleepy, spinning feeling (vertigo), dry mouth, changes in blood tests that check how the liver is working, skin rash, lumpy rash (hives) and itchy skin.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed here.

You can also report side effects directly via the Yellow Card Scheme at: www.dorsapharma.com/ (ADR form)

By reporting side effects, you can help provide more information on the safety of this medicine.