omeprazole capsules, amoxycillin trihydrate capsules and clarithromycin tablets
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Probitor Hp7.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT PROBITOR HP7 IS USED FOR
This medicine is used to treat an infection in your stomach caused by a bacterium called Helicobacter pylori and allows your peptic ulcer to heal.
Probitor Hp7 is a composite pack which contains three different medicines:
Probitor contains the active ingredient omeprazole. Omeprazole belongs to a group of medicines called proton pump inhibitors. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. Probitor also helps kill the bacteria.
Amoxycillin Sandoz contains the active ingredient amoxycillin trihydrate.
Clarihexal contains the active ingredient clarithromycin.
Amoxycillin trihydrate and clarithromycin belong to a group of medicines called antibiotics. They help kill Helicobacter pylori.
When all three medicines 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is only available with a doctor's prescription.
BEFORE YOU TAKE PROBITOR HP7
When you must not take it
Do not take this medicine if you have an allergy to:
clarithromycin, amoxycillin trihydrate or omeprazole, the active ingredients, or to any of the other ingredients listed at the end of this leaflet under Product Description.
any other similar medicines, such as proton pump inhibitors, penicillins, macrolides or other antibiotics.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take Probitor Hp7 at the same time as the following other medicines:
cisapride, a medicine used to treat gastro-oesophageal reflux
pimozide, a medicine used to treat certain mental and emotional conditions
terfenadine, astemizole, medicines used to treat allergic conditions
ergotamine, dihydroergotamine, medicines used to treat migraine
cilostazol, a medicine used to treat the symptom of intermittent claudication due to a blockage in the blood vessels to the legs.
Do not give this medicine to children and adolescents under the age of 18 years. Safety and effectiveness in children and adolescents younger than 18 years have not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have any of the following medical conditions:
problem with your blood
problem with your liver or kidneys
myasthenia gravis, a condition in which the muscles become weak and tire easily.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking Probitor Hp7.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Probitor Hp7 may interfere with each other. These include:
warfarin, a medicine used to prevent blood clotting
ketoconazole, fluconazole, itraconazole, voriconazole, medicines used to treat fungal infections
colchicine, allopurinol or probenecid, medicines used to treat gout
phenytoin , carbamazepine, sodium valproate, medicines used for epilepsy
protease inhibitors, medicines used to treat HIV, such as indinavir, saquinavir, zidovudine, ritonavir, atazanavir, efavirenz, nevirapine
rifampicin, rifabutin, medicines used to treat certain infections
tacrolimus, a medicine used in patients who have received organ transplants
methylprednisolone, a corticosteroid
vinblastine, a medicine used to treat cancer
digoxin, a medicine used to treat heart failure
sildenafil, tadalafil, vardenafil, medicines used to treat erectile dysfunction in adult males
antiarrythmics, such as quinidine, disopyramide, medicines used to treat irregular heart beats
theophylline, a medicine used to treat asthma
triazolam, midazolam, medicines used to treat sleeplessness
alprazolam, diazepam, medicines used to treat anxiety
repaglinide, a medicine used to treat diabetes
simvastatin, a medicine used to treat high levels of cholesterol in the blood
tolterodine, a medicine used to treat bladder dysfunction
cilostazol, a medicine used to treat the symptom of intermittent claudication due to a blockage in the blood vessels to the legs.
These medicines may be affected by Probitor Hp7 or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
HOW TO TAKE PROBITOR HP7
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
There are three different medicines in Probitor Hp7. It is very important that you take it exactly as follows:
Probitor = P
Take one 20mg capsule in the morning and at night. You may be told to take two capsules together in the morning. Swallow Probitor capsules whole with a glass of water. If the granules in the capsules are chewed or crushed they won't work properly.
Amoxycillin Sandoz = A
Take two 500mg capsules in the morning and at night.
Clarihexal = C
Take one 500mg tablet in the morning and at night.
Morning 1 P + 2 A + 1 C
Night 1 P + 2 A + 1 C
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Probitor Hp7 may not work as well and your problem may not improve.
How to take it
Swallow the tablets/capsules whole with a full glass of water.
When to take Probitor Hp7
Take the capsules and tablets during or immediately after a meal, at about the same time each day.
How long to take Probitor Hp7
Continue taking your medicine for as long as your doctor tells you.
If you do not complete the full course prescribed by your doctor, the H. 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 H. pylori You may need treatment with more antibiotics.
If you forget to take it
Take your dose as soon as you remember, as long as it is more than four hours before the next dose is due, and continue to take it as you would normally.
Do not take a double dose to make up for the dose you have missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Probitor Hp7. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include vomiting and severe stomach problems.
WHILE YOU ARE TAKING PROBITOR HP7
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Probitor Hp7.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Things you must not do
Do not take Probitor Hp7 to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine without checking with your doctor. You must take all the medicine in the Probitor 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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Probitor Hp7. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
diarrhoea, nausea and vomiting
loss of appetite, taste disturbances
muscle pain or weakness
confusion or mood changes
changes in sleep patterns
dryness of the mouth and other body cavities
"pins and needles".
Tell your doctor as soon as possible if you notice the following:
severe diarrhoea, even several weeks after finishing Probitor Hp7
increase in breast size (males)
sleepiness or drowsiness
depression, agitation, confusion, mood changes or hallucinations
change in sexual function
signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite.
The above list includes side effects that may require medical attention. These side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
watery and severe diarrhoea, which may also be bloody
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
blood in urine
swelling of feet, hands and ankles
bruising or bleeding more easily than normal, frequent infections such as fever, severe chills, sore throat or mouth ulcers.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.
AFTER TAKING PROBITOR HP7
Keep your medicines in the original containers.
If you take them out of their original containers they may not keep well.
Keep your medicines in a cool dry place where the temperature stays below 25°C.
Do not store Probitor Hp7 or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Probitor Hp7 is composed of three different medicines:
Probitor 20mg - opaque yellow cap and body capsules containing off-white to cream-white spherical pellets.
Available in blister packs of 14 capsules.
Amoxycillin Sandoz 500mg - opaque yellow hard gelatin capsules.
Available in blister packs of 28 capsules.
Clarihexal 500mg - white, oblong, convex, coated tablets scored on both faces.
Available in blister packs of 14 tablets.
Probitor 20mg - 20mg omeprazole
Amoxycillin Sandoz 500mg - 500mg amoxycillin (as trihydrate)
Clarihexal 500mg – 500mg clarithromycin.
sodium lauryl sulfate
dibasic anhydrous sodium phosphate
quinoline yellow CI47005.
Amoxycillin Sandoz 500mg:
iron oxide yellow C177492
colloidal anhydrous silica
This medicine does not contain gluten, tartrazine or other azo dyes.
Probitor Hp7 is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
This leaflet was prepared in May 2010.
Australian Register Number(s)
Probitor Hp7: AUST R 158334 (composite pack)
Published by MIMS/myDr September 2010
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