Suvacid Heartburn Relief.pdf by xiaoshuogu


									Suvacid Heartburn Relief

Consumer Medicine Information

What is in this leaflet                 Frequent heartburn is when you have       • the active ingredient pantoprazole
                                        heartburn for two or more days a          • any of the other ingredients listed
This leaflet answers some common        week. Heartburn that occurs                 at the end of this leaflet under
questions about Suvacid Heartburn       frequently is a typical symptom of          Product Description.
Relief. It does not contain all the     gastro-oesophageal reflux disease         • any other similar medicines.
available information. It does not      (GORD).
                                                                                  Some of the symptoms of an allergic
take the place of talking to your       Suvacid Heartburn Relief is               reaction may include:
doctor or pharmacist.                   recommended for adults 18 years of
                                                                                  • shortness of breath
All medicines have risks and            age and over, suffering from
                                                                                  • wheezing or difficulty breathing
benefits. Your doctor or pharmacist     heartburn at least 2 times a week.
has weighed the risks of you taking                                               • swelling of the face, lips, tongue
                                        It is not the right medicine for you if     or other parts of the body
this medicine against the benefits      you suffer from heartburn only
they expect it will have for you.                                                 • rash, itching or hives on the skin.
                                        occasionally (one episode of
Take this medicine as directed and      heartburn a week or less), or if you      Do not take Suvacid Heartburn
follow the advice given in this         want immediate relief of heartburn.       Relief in combination with
                                                                                  atazanavir (an anti-viral
If you have any concerns about          How Suvacid Heartburn Relief
                                        works                                     Do not take this medicine if you
taking this medicine, ask your
                                                                                  have cirrhosis or severe liver
doctor or pharmacist.
                                        Pantoprazole belongs to a group of        disease.
Keep this leaflet with the medicine.    medicines called proton pump
                                                                                  This medicine should not be given
You may need to read it again.          inhibitors (PPIs). It works by
                                                                                  to children and adolescents under
                                        decreasing the amount of acid the         the age of 18 years.
                                        stomach makes, to give relief from        Safety and effectiveness in children
                                        the symptoms.                             and adolescents has not been
What Suvacid                            It will start to suppress acid within a   established.
Heartburn Relief is used                few hours, however it will not give       Do not take this medicine after the
for                                     instant symptom relief. You may           expiry date printed on the pack has
                                        need to take this medicine for a few      passed
Suvacid Heartburn Relief contains       days before experiencing the full         If you take this medicine after the
the active ingredient pantoprazole.     effect.                                   expiry date it may not work as well.
It is used for lasting symptomatic      This medicine is not addictive.           Do not take this medicine if the
relief of frequent heartburn and                                                  packaging is torn or shows signs of
stomach acid complaints due to                                                    tampering.
gastro-oesophageal reflux.                                                        If it is damaged, return it to your
This can be caused by washing back      Before you take                           pharmacist for disposal. If you are
(reflux) of food and acid from the      Suvacid Heartburn                         not sure whether you should start
stomach into the food pipe, also        Relief                                    taking this medicine, talk to your
known as the oesophagus.                                                          doctor or pharmacist.

Reflux can cause a burning sensation
                                        When you must not take it                 Before you start to take it
in the chest rising up to the throat,
also known as heartburn.                Do not take this medicine if you          Tell your doctor or pharmacist if :
                                        have an allergy to:
                                                                                  1. you have allergies to:

Suvacid Heartburn Relief                                           Published by MIMS/myDr October 2010               1
• pantoprazole                           • atazanavir (an anti-viral               If you forget to take it
• any of the ingredients listed at the     medication)
                                                                                   If it is almost time for your next
  end of this leaflet                    • medicines used to prevent blood
                                                                                   dose, skip the dose you missed and
• any other medicines, foods,              clots (anticoagulants)
                                                                                   take your next dose when you are
  preservatives or dyes.                 • medicines whose activity depends        meant to. Otherwise take it as soon as
2. you are pregnant or plan to             on the acidity of the stomach such      you remember, and continue to take
   become pregnant or are                  as ketoconazole.                        it as you would normally.
   breastfeeding                         These medicines may be affected by
                                                                                   Do not take a double dose to make
3. you have or have had any              Suvacid Heartburn Relief or may
                                                                                   up for the dose that you missed.
   other medical conditions              affect how well it works.
                                                                                   This may increase the chance of you
If you have not told your doctor or      Speak with your doctor or pharmacist      getting an unwanted side effect.
pharmacist about any of the above,       if you have any concerns about
                                                                                   If you have trouble remembering to
tell them before you start taking        taking Suvacid Heartburn Relief with
Suvacid Heartburn Relief.                                                          take your medicine, ask your
                                         other medications. They have more
                                                                                   pharmacist for some hints.
Talk to your doctor first before         information on medicines to be
taking this medicine if:                 careful with or avoid while taking
                                         this medicine.                            If you take too much
• you have previously taken                                                        (overdose)
  heartburn / indigestion
  medications continuously for 4 or                                                Immediately telephone your doctor
  more weeks to control your                                                       or the Poisons Information Centre
  heartburn                              How to take Suvacid                       (telephone Australia 13 11 26,
• you have jaundice, liver               Heartburn Relief                          New Zealand 0800 764 766) for
                                                                                   advice, or go to Accident and
  problems, anaemia, previous
                                                                                   Emergency at the nearest hospital,
  gastric ulcer or gastrointestinal
                                         How much to take                          if you think that you or anyone else
  surgery                                                                          may have taken too much Suvacid
• you have new or recently changed       Take one tablet once a day (every 24      Heartburn Relief. Do this even if
  symptoms including persistent          hours).                                   there are no signs of discomfort or
  vomiting or vomiting of blood,                                                   poisoning.
  blood in the stools or unexplained     How to take it                            You may need urgent medical
  weight loss.                                                                     attention.
                                         Swallow the tablets whole with a full
If you have experienced any of the
                                         glass of water, with or without food.
above you should see your doctor
immediately.                             Do not crush or chew the tablets.
If you have suffered from frequent       The tablets have a special coating to     While you are taking
heartburn/indigestion symptoms for       protect them from the acidic contents     Suvacid Heartburn
some time you should see your            of your stomach. For the tablets to       Relief
doctor.                                  work effectively, this coating must
                                         not be broken.
You should also speak to your doctor                                               Things you must do
before taking this medicine if you are
                                         When to take it                           Take this medicine exactly as your
due to have an endoscopy (a special
test ordered by your doctor).                                                      doctor or pharmacist has advised.
                                         Take your medicine at about the
                                         same time each day.                       Tell your doctor if you become
Taking other medicines                   Taking it at the same time each day       pregnant while taking Suvacid
                                         will have the best effect. It will also   Heartburn Relief.
Tell your doctor or pharmacist if        help you remember when to take it.
you are taking any other                                                           Tell all doctors, dentists, and
medicines, including any that you                                                  pharmacists who treat you that
buy without a prescription from          How long to take it                       you are taking this medicine.
your pharmacy, supermarket or            Take one tablet daily for at least 7      Tell your doctor or pharmacist if
health food shop.                                                                  you do not feel better while taking
                                         days, and up to 14 days. You should
Some medicines may interfere with        not take it for more than 14 days         this medicine.
Suvacid Heartburn Relief. These          unless directed by a doctor.

Suvacid Heartburn Relief                                            Published by MIMS/myDr October 2010              2
If symptoms persist or recur            Side effects                            • chest pain
within 2 weeks of completing the                                                • shortness of breath
course, consult a doctor.
                                        Tell your doctor or pharmacist as       • swelling of the legs
Further examination may be              soon as possible if you do not feel
recommended.                                                                    • bleeding or bruising more easily
                                        well while you are taking Suvacid
                                                                                  than normal
                                        Heartburn Relief.
                                                                                • depression, confusion or anxiety.
Things you must not do                  Suvacid Heartburn Relief helps most
                                                                                The above list includes serious side
Do not give your medicine to            people with reflux disease but it may
                                                                                effects that may require urgent
anyone else, even if they have the      have unwanted side effects in a few
                                                                                medical attention. These side effects
same symptoms as you.                   people.
                                                                                are rare.
Do not take Suvacid Heartburn           All medicines can have side effects.
                                                                                Tell your doctor or pharmacist if
Relief to treat any other               Sometimes they are serious, most of
                                                                                you notice anything else that is
complaints unless your doctor tells     the time they are not. You may need
                                                                                making you feel unwell.
you to.                                 medical attention if you get some of
                                                                                Other side effects not listed above
                                        the side effects.
                                                                                may also occur in some people.
Things that may help your               Ask your doctor or pharmacist to        Do not be alarmed by the lists of
condition                               answer any questions you may
                                                                                possible side effects. You may not
                                        have. Tell your doctor or
Some self help measures suggested                                               experience any of them.
                                        pharmacist if you notice any of the
below may help your condition.          following and they worry you:
Talk to your doctor or pharmacist
about these measures and for more       • headache, dizziness
information.                            • nausea or vomiting
                                                                                After taking Suvacid
• Alcohol your doctor may advise        • diarrhoea, stomach pain,
                                                                                Heartburn Relief
  you to limit your alcohol intake.       excessive gas in the
• Aspirin and many other                • stomach or bowel, constipation,
  medicines used to treat                 indigestion                           Storage
  arthritis/period pain/headaches       • dry mouth
                                                                                Keep your medicine in the original
  these medicines may irritate the      • metallic taste                        container.
  stomach and may make your             • weakness or tiredness                 If you take it out of its original
  condition worse. Your doctor or       • increased sweating                    container it may not keep well.
  pharmacist may suggest other
                                        • blurred vision                        Keep your medicine in a cool dry
  medicines you can take.
                                        • skin problems such as itchiness       place where the temperature stays
• Caffeine your doctor may advise
                                          and rash.                             below 25°C.
  you to limit the number of drinks
  which contain caffeine, such as       The above list includes the more        Do not store Suvacid Heartburn
  coffee, tea, cocoa and cola drinks,   common side effects of your             Relief or any other medicine in the
  because they contain ingredients      medicine.                               bathroom or near a sink. Do not
  that may irritate your stomach.                                               leave it on a window sill or in the
                                        Tell your doctor immediately if
• Eating habits eat smaller, more       you notice any of the following:
                                                                                Heat and dampness can destroy some
  frequent meals. Eat slowly and        • unusual tiredness or weakness         medicines.
  chew your food carefully. Try not
                                        • nausea or vomiting in
  to rush at meal times.                                                        Keep it where children cannot
                                          combination with loss of appetite,
• Smoking your doctor may advise                                                reach it.
                                          feeling generally unwell, fever,
  you to stop smoking or at least                                               A locked cupboard at least one-and-
                                          itching, yellowing of the skin and
  cut down.                                                                     a-half metres above the ground is a
                                          eyes, and dark coloured urine
                                                                                good place to store medicines.
• Weight your doctor may suggest          skin problems such as swelling,
  losing some weight to help your         blistering or peeling of the skin
  condition.                            • swelling of the face, lips, mouth,
                                          tongue or throat which may cause      If you stop taking this medicine or
                                          difficulty in swallowing or           the expiry date has passed, ask your
                                          breathing                             pharmacist what to do with any
                                        • frequent infections such as fever,    medicine that is left over.
                                          severe chills, sore throat or mouth

Suvacid Heartburn Relief                                          Published by MIMS/myDr October 2010             3
Product description

What it looks like
Yellow and oval shaped enteric (
acid-resistant ) coated tablets, coded
"20" in black ink on one side.
Available in blister packs of 7 and 14
enteric-coated tablets.

Suvacid Heartburn Relief contains 20
mg of pantopazole (as pantoprazole
sodium sesquihydrate) as the active
It also contains:
• sodium carbonate anhydrous
• microcrystalline cellulose
• crospovidone
• hydroxypropylcellulose
• colloidal anhydrous silica
• calcium stearate
• Opadry complete film coating
  system 03B22011
• Eudragit L30D-55
• triethyl citrate
• 2212 Fine Black Ink.
This medicine does not contain
gluten, lactose, sucrose, or tartrazine.

Suvacid Heartburn Relief is supplied
in Australia by:
Novartis Consumer Health
Australasia Pty Ltd
ABN 46 004 535 513
329-333 Police Road
Mulgrave Vic 3170
NZ Office: Auckland, New Zealand
Toll-free phone
Australia: 1800 069 643
New Zealand: 0800 700 222
This leaflet was prepared in August
Australian Register Number AUST R

Suvacid Heartburn Relief                   Published by MIMS/myDr October 2010   4

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