SOMAC Heartburn Relief Tablets

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					SOMAC® Heartburn Relief Tablets
Pantoprazole


Consumer Medicine Information

                                        Reflux can cause a burning
What is in this leaflet                 sensation in the chest rising up to
                                        the throat, also known as
This leaflet answers some common        heartburn.
                                                                               Before you start to take
questions about SOMAC Heartburn         Frequent heartburn is when you         SOMAC Heartburn
Relief. It does not contain all the     have heartburn for two or more
available information.                                                         Relief
                                        days a week. Heartburn that occurs
                                        frequently is a typical symptom of
It does not take the place of talking   gastro-oseophageal reflux disease      When you must not take it
to your doctor or pharmacist.           (GORD).
                                                                               Do not take SOMAC Heartburn
All medicines have risks and            Who should use SOMAC                   Relief if you have an allergy to:
benefits. Your doctor or pharmacist
has weighed the risks of you taking
                                        Heartburn Relief                           •   pantoprazole or
SOMAC Heartburn Relief against                                                     •   any of the ingredients listed
                                        SOMAC Heartburn Relief is                      at the end of this leaflet.
the benefits this medicine is
                                        recommended for adults over 18
expected to have for you.
                                        years of age suffering from            Some symptoms of an allergic
                                        heartburn at least 2 times a week.     reaction include skin rash, itching,
Use SOMAC Heartburn Relief as
directed and follow the advice given                                           shortness of breath or swelling of
                                        SOMAC Heartburn Relief is not the      the face, lips or tongue, which may
in the leaflet.
                                        right medicine for you if you suffer   cause difficulty in swallowing or
                                        heartburn only occasionally (one       breathing.
If you have any concerns about
                                        episode of heartburn a week or
taking this medicine, ask your
                                        less), or if you want immediate
doctor or pharmacist.                                                          Do not take SOMAC Heartburn
                                        relief of heartburn.
                                                                               Relief if you have severe liver
Keep this leaflet with the                                                     disease or cirrhosis.
                                        How SOMAC Heartburn Relief
medicine.
You may need to read it again.          works
                                                                               Do not take SOMAC Heartburn
                                        SOMAC Heartburn Relief belongs         Relief if the packaging is torn or
                                        to a group of medicines called         shows signs of tampering.
What SOMAC                              proton pump inhibitors (PPIs).
                                                                               Do not take SOMAC Heartburn
Heartburn Relief is                                                            Relief after the expiry date (EXP)
                                        SOMAC Heartburn Relief works by
used for                                decreasing the amount of acid the      printed on the pack has passed.
                                        stomach makes to give relief from
The name of your medicine is            the symptoms .                         Do not take SOMAC Heartburn
SOMAC Heartburn Relief. It                                                     Relief in combination with
contains the active ingredient          SOMAC Heartburn Relief will start      atazanavir (an anti-viral
pantoprazole.                           to suppress acid within a few          medication).
                                        hours, however it will not give
SOMAC Heartburn Relief is used          instant symptom relief. You may        SOMAC Heartburn Relief should
for lasting symptomatic relief of       need to take SOMAC Heartburn           not be given to children and
frequent heartburn and stomach          Relief for a few days before           adolescents under 18 years of
acid complaints due to gastro-          experiencing the full effect.          age. Safety and effectiveness of
oseophageal reflux.                                                            SOMAC Heartburn Relief in
This can be caused by “washing          There is no evidence that SOMAC        children has not been established.
back” (reflux) of food and acid from    Heartburn Relief is addictive.
the stomach into the food pipe, also                                           If you are not sure whether you
known as the oesophagus.                This medicine is available only from   should start taking SOMAC
                                        your pharmacist or your doctor.        Heartburn Relief alone or SOMAC
Heartburn Relief in combination       You should also speak to your
with any other medications talk to    doctor before taking SOMAC              If you forget to take it
your doctor or pharmacist.            Heartburn Relief if you are due to
                                      have an endoscopy (a special test       If it is almost time for your next
Before you start to take it           ordered by your doctor).                dose, skip the dose you missed
                                                                              and take your next dose when you
You must tell your doctor or          Taking other medicines                  are meant to. Otherwise, take it as
pharmacist if:                                                                soon as you remember, and then
                                      Tell your doctor or pharmacist if       go back to taking it as you would
1. you have any allergies to:         you are taking any other                normally.
   • pantoprazole                     medicines, including medicines
                                      that you buy without a                  Do not take a double dose to
   • any of the ingredients listed                                            make up for the dose that you
                                      prescription from your
     at the end of this leaflet                                               missed. This may increase the
                                      pharmacy, supermarket or health
   • any other medicines, or any      food shop.                              chance of you getting an unwanted
     other substances, such as                                                side effect.
     foods, preservatives or dyes.    Some medicines may be affected
                                      by SOMAC Heartburn Relief, or           If you have trouble remembering to
2. you are pregnant, intend to        may affect how well it works.           take your medicine, ask your
   become pregnant, are breast-       These may include medicines used        pharmacist for some hints.
   feeding or intend to breast-       to prevent blood clots
   feed.                              (anticoagulants), atazanavir (an        If you take too much
                                      antiviral medication) and medicines     (overdose)
3. you have or have had any           whose activity depend on the            Immediately telephone your
   other medical conditions.          acidity of the stomach e.g.             doctor or Poisons Information
                                      ketoconazole.                           Centre for advice – the telephone
If you have not told your doctor                                              number in Australia is 13 11 26
or pharmacist about any of the        Speak with your pharmacist or           and in New Zealand is 0800
above, tell them before you take      doctor if you have any concerns         POISON or 0800 764 766 – or go
SOMAC Heartburn Relief.               about taking SOMAC Heartburn            to Accident and Emergency
                                      Relief with other medications.          (Casualty) at your nearest
Talk to your doctor first before                                              hospital, if you think that you or
taking SOMAC Heartburn Relief if:                                             anyone else may have taken too
                                      How to take SOMAC                       much SOMAC Heartburn Relief.
• you have previously taken                                                   Do this even if there are no signs
  heartburn / indigestion             Heartburn Relief                        of discomfort or poisoning. You
  medications continuously for 4                                              may need urgent medical
  or more weeks to control your       How much to take                        attention. Keep telephone
  heartburn                                                                   numbers for these places handy.
• you have jaundice, liver            Take one SOMAC Heartburn Relief
  problems, anaemia, previous         tablet once a day (every 24 hours)
  gastric ulcer or gastrointestinal
  surgery.                            How and when to take it
                                                                              While you are taking
• you have new or recently                                                    SOMAC Heartburn
  changed symptoms including          Swallow your tablets whole with a
  persistent vomiting or vomiting
                                                                              Relief
                                      little water with or without food.
  of blood, blood in the stools or
  unexplained weight loss.            Do not crush or chew the tablets.       Things you must do
                                      SOMAC Heartburn Relief tablets
If you have experienced any of the    have a special coating to protect       Use SOMAC Heartburn Relief
above you should see your doctor      them from the acidic contents of        exactly as your doctor or
immediately.                          your stomach. For SOMAC                 pharmacist has advised.
                                      Heartburn Relief to work effectively,
If you have suffered from frequent    this coating must not be broken.        Tell all doctors, dentists and
heartburn / indigestion symptoms                                              pharmacists who are treating
for some time you should see your     How long to take it                     you that you are taking SOMAC
doctor.                                                                       Heartburn Relief.
                                      Take one tablet daily for up to 14
                                      days. You should not take it for        Tell your doctor or pharmacist if
                                      more than 14 days unless directed       you do not feel better while
                                      by a doctor.                            taking SOMAC Heartburn Relief
If symptoms persist or recur           connected with the medicine or          • shortness of breath
within 2 weeks of completing the       they are not listed in this leaflet.    • high blood pressure
course, consult a doctor.
                                       Like other medicines, SOMAC             • swelling of the legs
Further examination may be             Heartburn Relief can cause some         • bleeding or bruising more easily
recommended.                           side effects. If they occur, most are     than normal
                                       likely to be minor and temporary.       • depression, confusion or anxiety
                                       However, some may be serious
Things that may help your              and need medical attention.             These may be serious side effects
condition                                                                      and you may need urgent medical
                                       Ask your doctor or pharmacist           attention. Serious side effects are
Some self help measures                any questions you may have.             rare.
suggested below may help your
condition. Talk to your doctor or      Tell your doctor or pharmacist if       Other side effects not listed above
pharmacist about these measures        you notice any of the following         may occur in some people. Tell
and for more information.              and they worry you:                     your doctor or pharmacist if you
                                       • headache                              notice anything that is making
• Alcohol – you may be advised                                                 you feel unwell when you are
                                       • dizziness
  to limit your alcohol intake.                                                taking, or soon after you have
                                       • diarrhoea                             finished taking, SOMAC
• Aspirin and many other               • nausea or vomiting                    Heartburn Relief.
  medicines used to treat              • stomach pain
  arthritis, period pain,                                                      Ask your doctor or pharmacist if
  headaches - these medicines          • excessive gas in the stomach or
                                                                               you do not understand some of
  may irritate the stomach and           bowel
                                                                               the information in this list.
  may make your condition worse.       • indigestion
  Your doctor or pharmacist may        • constipation                          Do not be alarmed by this list of
  suggest other medicines you                                                  possible side effects. You may not
  can take.                            • dry mouth
                                                                               experience any of them.
                                       • metallic taste
• Caffeine - you may be advised        • weakness or tiredness
  to limit the number of drinks
  which contain caffeine, such as
                                       • increased sweating                    After taking SOMAC
  coffee, tea, cocoa and cola          • blurred vision                        Heartburn Relief
  drinks, because they contain         • skin problems such as itchiness
  ingredients that may irritate your     and rash                              Storage
  stomach.
                                       These are the more common side          Keep your tablets in their blister
• Eating habits - eat smaller,         effects of SOMAC Heartburn Relief.      pack until it is time to take them.
  more frequent meals. Eat
  slowly and chew your food            See your doctor immediately if          If you take the tablets out of the
  carefully. Try not to rush at        you notice any of the following:        blister pack they may not keep well.
  meal times.
                                       • unusual tiredness or weakness
                                                                               Keep SOMAC Heartburn Relief
• Smoking - it is advisable for you    • nausea, vomiting, loss of             tablets in a cool dry place where
  to stop smoking or at least cut        appetite, feeling generally
                                                                               the temperature stays below 30°C.
  down.                                  unwell, fever, itching, yellowing
                                         of the skin and eyes, and dark
                                                                               Do not store SOMAC Heartburn
• Weight - you may be advised            coloured urine.
                                                                               Relief or any other medicines in
  that losing some weight will help    • skin problems such as itchiness       a bathroom or near a sink. Do
  your condition.                        and rash, or swelling, blistering     not leave it in the car or on
                                         or peeling of the skin.               window sills.
                                       • swelling of the face, lips, mouth,
Side effects                             tongue or throat which may            Heat and dampness can destroy
                                         cause difficulty in swallowing or     some medicines.
Tell your doctor or pharmacist as        breathing.
                                       • frequent infections such as           Keep SOMAC Heartburn Relief
soon as possible if you have any
                                         fever, severe chills, sore throat     where children cannot reach it.
problems while taking SOMAC
Heartburn Relief, even if you do         or mouth ulcers
                                                                               A locked cupboard at least one-
not think the problems are             • chest pain                            and-a-half metres above the
ground, is a good place to store         Germany and are supplied in
medicines.                               Australia by:

                                         Nycomed Pty Ltd
Disposal                                 2-4 Lyonpark Road
                                         North Ryde
If you stop taking SOMAC                 NSW 2113
Heartburn Relief or the tablets have     Australia
passed their expiry date, ask your
pharmacist what to do with any           For medical enquiries, call
tablets that are left over.              (AUST) 1800 675 957



Product description                      Australian Registration
                                         Numbers
What it looks like
                                         SOMAC Heartburn Relief
SOMAC Heartburn Relief is                AUST R xxxxxx
available as a 20 mg tablet. The
tablets have an acid-resistant           ® Registered trademark of
coating called an enteric coating.       Nycomed GmbH
The tablets are yellow and oval          This leaflet was prepared in
shaped, marked with ‘P20’ on one         May 2008
side.

SOMAC Heartburn Relief tablets
are available in blister packs
containing 2, 7 and 14 tablets.

Ingredients

The active ingredient in SOMAC
Heartburn Relief tablets is
pantoprazole. Each SOMAC
Heartburn Relief tablet contains the
equivalent of 20 mg pantoprazole.

SOMAC Heartburn Relief tablets
also contain sodium carbonate
anhydrous, mannitol, crospovidone,
povidone, calcium stearate,
hypromellose, titanium dioxide, iron
oxide yellow (CI 77492), propylene
glycol, methacrylic acid copolymer,
polysorbate 80, sodium lauryl
sulfate, triethyl citrate and printing
ink.

SOMAC Heartburn Relief tablets do
not contain gluten, lactose,
sucrose, tartrazine or other azo
dyes.


Manufacturer and Supplier

SOMAC Heartburn Relief tablets
are made by Nycomed GmbH,

				
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Description: SOMAC Heartburn Relief Tablets