General Information
What NEXIUM Hp7 is taken for
Most people who have a peptic (gastric or duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach. Nexium Hp7 is a combination pack, which contains three different medicines. When taken together in the right doses, they will:
heal a duodenal ulcer associated with Helicobacter pylori
kill Helicobacter pylori in patients with an active or healed peptic (gastric or duodenal) ulcer.
Nexium is the brand name of esomeprazole (E), and it is given with Amoxil (amoxycillin (A)) and Klacid (clarithromycin ©), which are both types of antibiotic. How NEXIUM Hp7 worksNexium is a type of medicine called a proton-pump inhibitor.Nexium works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.Amoxycillin and clarithromycin are both antibiotics which help kill Helicobacter pylori. Nexium also helps kill the bacteria. When all three are taken together they are more effective than taken one or two at a time. It is possible that the antibiotics may not always kill Helicobacter pylori. Your doctor will have explained why you are being treated with Nexium Hp7 and told you what dose to take.Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
There is no evidence that Nexium Hp7 is addictive.
Before you take NEXIUM Hp7
When you must not take it
Do not take Nexium Hp7 if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved. We do not know if it is safe for you to take it while you are pregnant. It may affect your baby.
Your baby can take in all the medicines in Nexium Hp7 from breast milk if you are breastfeeding. Your doctor may monitor your baby if you decide to breast feed while taking Nexium Hp7.
Nexium Hp7 is not approved for use in children.
There is no specific information about use in children, so Nexium Hp7 is not recommended in children.
Do not take Nexium Hp7 if you are allergic to esomeprazole, other proton pump inhibitors or any of the other ingredients in Nexium.
Do not take Nexium Hp7 if you are allergic to penicillins, cephalosporins or macrolide antibiotics.
Do not take Nexium Hp7 if you are taking cisapride, pimozide, ergotamine or dihydroergotamine.
Do not use after the use by (expiry) date printed on the pack. If you take this medicine after their expiry date has passed, it may not work (as well).
Do not use Nexium Hp7 if the packaging is torn or shows signs of tampering.
Do not use it to treat any other complaints unless your doctor tells you.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Before you start to use it
You must tell your doctor if:
1. you have any allergies to:
Nexium Hp7 or any ingredients listed at the end of this leaflet.
penicillin, cephalosporins or other macrolide antibiotics
other proton pump inhibitors or any other medicine
any other substances, such as food, preservatives or dyes.
If you have an allergic reaction you may get a skin rash, hayfever, asthma or feel faint.
2. you have any of these medical conditions
problems with your blood
problems with your liver or kidneys.
It may not be safe for you to take Nexium Hp7 if you have any of these conditions. Taking other medicines
Tell your doctor if you are taking any other medicines, including:
cisapride (see When you must not take it)
pimozide (see When you must not take it)
some medicines for migraine headaches such as ergotamine, dihydroergotamine (see When you must not take it)
diazepam
ketoconazole, itraconazole or fluconazole
warfarin
allopurinol, probenecid or colchicine
phenytoin
lovastatin or simvastatin
theophylline
carbamazepine
medicines used to treat HIV eg. zidovudine, atazanavir
repaglinide
heart medicines such as digoxin, quinidine, disopyramide
antidepressants such citalopram, fluoxetine, clomipramine, imipramine
other antibiotics such as rifabutin, rifampicin
oral contraceptives or birth control pills. Talk to your doctor about the need for an additional method of contraception while on Nexium Hp7
medicines used to prevent organ transplant rejection or to treat certain problems with the immune system eg. tacrolimus, cyclosporin
any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
These medicines may affect the way Nexium Hp7 works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. If you have not told your doctor about any of these things, tell them before you take any Nexium Hp7.
Taking NEXIUM Hp7
How to take it
There are three different medicines in Nexium Hp7. It is very important that you take Nexium Hp7 exactly as follows:
Nexium (esomeprazole)=E
Take one 20 mg tablet in the morning and one at night.
Amoxil (amoxycillin)=A
Take two 500 mg capsules in the morning and at night.
Klacid (clarithromycin)=C
Take one 500 mg tablet in the morning and at night.
Morning
1 E, 2 A, 1 C
Night
1 E, 2 A, 1 C
Swallow Nexium whole with a glass of water. For patients with swallowing difficulties, the tablet can be placed in half a glass of non-carbonated water (mineral water is not suitable). The tablet may be gently mixed and care should be taken not to crush the tablet. Rinse the glass with half a glass of fluid and drink.
Nexium tablets may also be administered, dispersed in non-carbonated water, through a gastric tube.
If the tablets are chewed or crushed they won't work properly.
Take the Amoxil capsules and Nexium/Klacid tablets during or after meals.
Continue taking the capsules and tablets until you finish the course or until your doctor tells you to stop. If you do not complete the full course prescribed by your doctor, the Helicobacter pylori may not clear completely and your symptoms may return.
Tell your doctor if your symptoms return. It is possible that the antibiotics may not kill Helicobacter pylori. You may need treatment with more antibiotics.
If you forget to take it
If you forget to take any of the medicines in Nexium Hp7 take it as soon as you remember, as long as it is more than four hours before the next dose of that medicine is due.
Do not take a double dose to make up for any dose that you miss.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Taking too much (overdose)
Telephone your doctor, the Poisons Information Centre (13 11 26) or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much Nexium Hp7 even if there are no signs of discomfort or poisoning. If you take too much Nexium Hp7 you may vomit and have severe stomach problems.
While you are taking it
Things you must do
You must take all the medicine in the Nexium Hp7 pack even if you feel better before you finish them. If you do not, your ulcer may come back and be harder to treat next time.
Use Nexium Hp7 exactly as your doctor has prescribed.
Tell your doctor if you become pregnant while you are taking Nexium Hp7.
If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Nexium Hp7 has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
If you get a sore, white mouth or tongue while taking, or soon after stopping, Nexium Hp7, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal/yeast infection called thrush.
Sometimes the use of Nexium Hp7 allows fungi/yeast to grow and the above symptoms to occur. Nexium Hp7 does not work against fungi/yeast.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Nexium Hp7.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Nexium Hp7.
Things you must not do
Do not stop taking Nexium Hp7, or change any of the doses, unless you have discussed it with your doctor. You need to take all the capsules and tablets in the pack for it to work properly.
Do not give Nexium Hp7 to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how Nexium affects you. Nexium Hp7 may cause dizziness in some people. Make sure you know how you react.
Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Nexium Hp7. Nexium Hp7 helps most people with peptic ulcer and Helicobacter pylori infection, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
diarrhoea, nausea and vomiting
headache, dizziness
constipation
loss of appetite
hair loss
muscle pain or weakness
confusion or mood changes
depression
dryness of the mouth and other body cavities
changes in sleep patterns
"pins and needles"
metallic taste or other change in taste or smell.
These are all mild side effects of Nexium Hp7. Tell your doctor immediately or go to casualty at your nearest hospital if you notice the following:
severe diarrhoea, even several weeks after finishing Nexium Hp7
increase in breast size (males)
fever
change in sexual function
blurred vision
yellowing of the skin or eyes.
These may be serious side effects. You may need urgent medical attention Serious side effects are rare.
If any of the following happen, stop taking Nexium Hp7 and tell your doctor immediately or go to casualty at your nearest hospital:
skin rash
swollen face, lips or neck
increased bruising
difficultly breathing.
These are very serious side effects. If you have them, you may have had a serious (allergic) reaction to one of the medicines in Nexium Hp7. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.
Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while taking Nexium Hp7.
In rare cases blood disorders may occur.
In very rare cases, severe skin disorders or inflammation of the liver has been reported.
After taking it
Storage
Keep the three medicines in Nexium Hp7 in their separate blisters until it is time to take them.
Keep it in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.
Product description
What NEXIUM Hp7 looks like
Nexium Tablets 20mg are a light pink, oblong shaped, marked with 20mg on one side and A/EH on the other side. Amoxil capsules 500 mg are brown and yellow, marked with AMOXIL 500. Klacid tablets 500 mg are pale yellow, oval film coated. Ingredients
Each Nexium tablet contains esomeprazole 20 mg as the active ingredient; plus,Glyceryl monostearate (E471)
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate (E572)
Methylacrylic acid copolymer
Microcrystalline cellulose (E460)
Paraffin hard
Macrogol 6000
Polysorbate 80 (E433)
Crospovidone
Sodium stearyl fumarate
Purified talc (E553(b))
Titanium dioxide (E171)
Triethyl citrate
Sugar spheres
in a blister wallet of 14 tablets
The tablets are coloured with iron oxide red CI77491 and iron oxide yellow CI77492.
Each Amoxil capsule contains amoxycillin trihydrate 500 mg;
plus,
Magnesium stearate (E 572)
- in blisters of 28 capsules.
The hard gelatin (E 441) capsule is coloured with titanium dioxide (E 171), iron oxide yellow (E 172), red iron oxide (E 172) and Opacode White S-1-7085.Each Klacid tablet contains clarithromycin 500 mg as the active ingredient, plus; Croscarmellose sodium
Cellulose (E 460)
Povidone
Silicon dioxide
Hydroxypropylcellulose
Sorbitan mono-oleate
Stearic acid (E 570)
Magnesium stearate (E 572)
Propylene glycol (E 1520)
Sorbic acid
Vanillin flavour
Titanium dioxide (E 171)
Quinoline yellow (E 104)
- in blisters of 14 tablets.
Nexium Hp7 does not contain added gluten, tartrazine or any other azo dyes.Manufacturer
AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
North Ryde NSW 2113
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia, Victoria 3155
Abbott Australasia Pty Ltd
Lord Street
Botany NSW 2019