clarithromycin, amoxycillin trihydrate and omeprazole
Consumer Medicine Information
PLEASE READ THIS INFORMATION CAREFULLY
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What KLACID HP7 is for?
Klacid Hp7 is a combination pack which contains three different medicines. When taken together in the right doses, they will kill a bacteria in your stomach called Helicobacter pylori and let your peptic ulcer heal.
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.
Helicobacter pylori
Most people who have a peptic ulcer also have Helicobacter pylori in their stomach. If the bacteria is killed it is very unlikely that your ulcer will come back.
Probitor® is the brand name of omeprazole (P). It is given with amoxycillin (A), brand name Amoxycillin Sandoz and clarithromycin (K), brand name Klacid® which are both types of antibiotic.
Your doctor will have explained why you are being treated with Klacid 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.
Klacid Hp7 is not addictive.
How KLACID HP7 works
Probitor is a type of medicine called a proton-pump inhibitor.
Probitor 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 Sandoz and Klacid are both antibiotics which help kill Helicobacter pylori. Probitor 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.
Before you use KLACID Hp7
When you must not use it
Do not take Klacid 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.
Your baby can take in all the medicines in Klacid Hp7 from breast milk if you are breastfeeding.
Do not give Klacid Hp7 to children. There have been no studies of this combination of medicines in children.
Do not use after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take any of the medicines after their expiry date.
Do not use Klacid 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 to.
Do not give this medicine to anyone else.
Taking other medicines
Do not take Klacid Hp7 if you are taking
cisapride
pimozide
terfenadine
astemizole
repaglinide
ergotamine or dihydroergotamine
Please check with your doctor or pharmacist if you are not sure if you are taking any of these drugs. These medicines will be affected by the Klacid in Klacid Hp7 and it is more likely that you will get side effects.
Tell your doctor of pharmacist if you are taking any other medicines, including
digoxin, quinidine, disopyramide
warfarin
phenytoin, carbamazepine, hexobarbital, sodium valproate
theophylline
triazolam, midazolam, alprazolam
cilostazol
simvastatin, lovastatin
methylprednisolone
vinblastine
sildenafil, tadalafil, vardenafil
cyclosporine, tacrolimus
ketoconazole, itraconazole or fluconazole
allopurinol or probenecid
protease inhibitors used to treat HIV
zidovudine, ritonavir, indinavir, saquinavir, atazanavir, efavirenz, nevirapine, rifampicin, rifabutin
colchicine
repaglinide
verapamil
voriconazole
clopidogrel
diazepam
tolterodine
any other medicine that you have bought from a chemist, supermarket or health food shop.
These medicines may affect the way Klacid Hp7 works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Before you start to use it
You must tell your doctor if:
1. you have any allergies to
other proton pump inhibitors
penicillin or other antibiotic
any ingredients listed at the end of this leaflet.
any other substances
Symptoms of an allergic reaction may include skin rash, swollen face or tongue, difficulty breathing.
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 Klacid Hp7 if you have any of these conditions.
If you have not told your doctor about any of these things, tell them before you take any Klacid Hp7.
Using KLACID HP7
How to take it
There are three different medicines in Klacid Hp7. It is very important that you take it exactly as follows:
Probitor = P
Take one 20 mg capsule in the morning and at night. You may be told to take two capsules together in the morning.
Amoxycillin Sandoz = A
Take two 500 mg capsules in the morning and at night.
Klacid = K
Take one 500 mg tablet in the morning and at night.
Morning
1 P, 2 A, 1 K
Night
1 P, 2 A, 1 K
Swallow Probitor capsules whole with a glass of water.
If the granules in the capsules are chewed or crushed they won't work properly.
Take the capsules and 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 H. pylori may not clear completely or your symptoms may return.
Tell your doctor if your symptoms return.
It is possible that the antibiotics may not kill H. pylori. You may need treatment with more antibiotics.
If you forget to take it
If you forget to take any of the medicines in Klacid 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.
If you take 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 Klacid Hp7 even if there are no signs of discomfort or poisoning.
If you take too much Klacid Hp7 you may vomit and have severe stomach problems.
While you are using it
Things you must do
You must take all the medicine in the Klacid 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 Klacid Hp7 exactly as your doctor has prescribed.
Tell your doctor if you become pregnant while you are taking Klacid Hp7.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Klacid Hp7.
Things you must not do
Do not stop taking Klacid Hp7, or change any of the doses, unless you have discussed it with your doctor.
Do not give Klacid Hp7 to anyone else, even if they have the same condition as you. You need to take all the capsules and tablets in the pack for it to work properly.
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 Klacid Hp7.
Klacid Hp7 helps most people with peptic ulcer and H. 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, metallic taste
muscle pain or weakness
confusion or mood changes
dryness of the mouth and other body cavities
changes in sleep patterns
"pins and needles"
These are all mild side effects of Klacid 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 Klacid Hp7
increase in breast size (males)
fever
change in sexual function
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 Klacid Hp7 and tell your doctor immediately or go to casualty at your nearest hospital
skin rash
swollen face, lips or neck
increased bruising
These are very serious side effects. If you have them, you may have had a serious reaction to one of the medicines in Klacid 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 Klacid Hp7.
After using it
Storage
Keep the three medicines in Klacid Hp7 in their separate bottles 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.
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.
Do not leave it in the car on hot days.
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 Klacid Hp7 looks like
Probitor are opaque yellow hard gelatin capsules.
Amoxycillin Sandoz are opaque yellow hard gelatin capsules.
Klacid tablets are pale yellow, oval film coated, and imprinted on one side.
Ingredients
Each Probitor capsule contains omeprazole 20 mg as the active ingredient in enteric-coated, off white to cream-white spherical pellets. It also contains the following inactive ingredients; sodium lauryl sulfate, sodium phosphate-dibasic anhydrous, hypromellose, mannitol, macrogol 6000, talc-purified, polysorbate 80, titanium dioxide, Eudagrit L30-D-55 (ARTG 3700), starch-maize, sucrose, gelatin and quinoline yellow CI47005.
Blister pack of 14 capsules.
Each Amoxycillin Sandoz capsule contains amoxycillin 500 mg as the trihydrate as an active ingredient. It also contains the following inactive ingredients; cellulose-microcrystalline, magnesium stearate, gelatin, iron oxide yellow CI77492 and titanium dioxide.
Blister pack of 28 capsules.
Each Klacid tablet contains clarithromycin 500 mg as the active ingredient. It also contains the following inactive ingredients; croscarmellose sodium, cellulose, povidone, silicon dioxide, hydroxypropylcellulose, sorbitan mono-oleate, stearic acid, magnesium stearate, propylene glycol, sorbic acid, vanillin flavour, titanium dioxide (E 171), and quinoline yellow (E 104).
Bottle of 14 tablets.
Klacid Hp7 does not contain gluten.
Sponsor
Abbott Australasia Pty Ltd
32-34 Lord St
Botany NSW 2019
Australia
Distributed in Australia by:
Sandoz Pty Ltd
54 Waterloo Road
North Ryde, NSW 2113
Australia
This leaflet was prepared on 29 May 2009
Version 08
Australian Registration Number: AUST R 91895
