SOMAC® Heartburn Relief Tablets

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					SOMAC® Heartburn Relief Tablets

Consumer Medicine Information

What is in this leaflet                    Reflux can cause a burning sensation    This medicine is available only from
                                           in the chest rising up to the throat,   your pharmacist or your doctor.
This leaflet answers some common           also known as heartburn.
questions about SOMAC Heartburn            Frequent heartburn is when you have
Relief. It does not contain all the        heartburn for two or more days a
available information.                     week. Heartburn that occurs             Before you start to take
It does not take the place of talking to   frequently is a typical symptom of      SOMAC Heartburn
your doctor or pharmacist.                 gastro-oseophageal reflux disease       Relief
All medicines have risks and
benefits. Your doctor or pharmacist                                                When you must not take it
has weighed the risks of you taking        Who should use SOMAC
SOMAC Heartburn Relief against the         Heartburn Relief                        Do not take SOMAC Heartburn
benefits this medicine is expected to                                              Relief if you have an allergy to:
                                           SOMAC Heartburn Relief is
have for you.
                                           recommended for adults over 18          • pantoprazole or
Use SOMAC Heartburn Relief as              years of age suffering from heartburn   • any of the ingredients listed at
directed and follow the advice given       at least 2 times a week.                  the end of this leaflet.
in the leaflet.                                                                    Some symptoms of an allergic
                                           SOMAC Heartburn Relief is not the
If you have any concerns about             right medicine for you if you suffer    reaction include skin rash, itching,
taking this medicine, ask your             heartburn only occasionally (one        shortness of breath or swelling of the
doctor or pharmacist.                      episode of heartburn a week or less),   face, lips or tongue, which may cause
                                           or if you want immediate relief of      difficulty in swallowing or breathing.
Keep this leaflet with the medicine.
You may need to read it again.             heartburn.                              Do not take SOMAC Heartburn
                                                                                   Relief if you have severe liver
                                           How SOMAC Heartburn Relief              disease or cirrhosis.
                                           works                                   Do not take SOMAC Heartburn
What SOMAC                                 SOMAC Heartburn Relief belongs to
                                                                                   Relief if the packaging is torn or
Heartburn Relief is used                   a group of medicines called proton
                                                                                   shows signs of tampering.
for                                        pump inhibitors (PPIs).                 Do not take SOMAC Heartburn
                                                                                   Relief after the expiry date (EXP)
The name of your medicine is               SOMAC Heartburn Relief works by
                                                                                   printed on the pack has passed.
                                           decreasing the amount of acid the
SOMAC Heartburn Relief. It
                                           stomach makes to give relief from       Do not take SOMAC Heartburn
contains the active ingredient
                                           the symptoms .                          Relief in combination with
pantoprazole.                                                                      atazanavir (an anti-viral
SOMAC Heartburn Relief is used for         SOMAC Heartburn Relief will start       medication).
                                           to suppress acid within a few hours,
lasting symptomatic relief of frequent                                             SOMAC Heartburn Relief should not
                                           however it will not give instant
heartburn and stomach acid                                                         be given to children and adolescents
complaints due to gastro-oseophageal       symptom relief. You may need to
                                           take SOMAC Heartburn Relief for a       under 18 years of age. Safety and
reflux.                                                                            effectiveness of SOMAC Heartburn
                                           few days before experiencing the full
This can be caused by "washing             effect.                                 Relief in children has not been
back" (reflux) of food and acid from                                               established.
                                           There is no evidence that SOMAC
the stomach into the food pipe, also
                                           Heartburn Relief is addictive.
known as the oesophagus.

SOMAC® Heartburn Relief Tablets                                         Published by MIMS/myDr June 2009             1
If you are not sure whether you        You should also speak to your doctor     How long to take it
should start taking SOMAC              before taking SOMAC Heartburn
                                                                                SOMAC Heartburn Relief tablets
Heartburn Relief alone or SOMAC        Relief if you are due to have an
                                                                                should be taken for at least seven
Heartburn Relief in combination with   endoscopy (a special test ordered by
any other medications talk to your     your doctor).                            days, and up to 14 days. You should
doctor or pharmacist.                                                           not take it for more than 14 days
                                                                                unless directed by a doctor.
                                       Taking other medicines
Before you start to take it
                                       Tell your doctor or pharmacist if        If you forget to take it
You must tell your doctor or           you are taking any other
                                       medicines, including medicines           If it is almost time for your next
pharmacist if:
                                       that you buy without a                   dose, skip the dose you missed and
1. you have any allergies to:                                                   take your next dose when you are
                                       prescription from your pharmacy,
• pantoprazole                         supermarket or health food shop.         meant to. Otherwise, take it as soon
• any of the ingredients listed at                                              as you remember, and then go back
                                       Some medicines may be affected by
  the end of this leaflet                                                       to taking it as you would normally.
                                       SOMAC Heartburn Relief, or may
• any other medicines, or any          affect how well it works. These may      Do not take a double dose to make
  other substances, such as foods,     include medicines used to prevent        up for the dose that you missed.
  preservatives or dyes.               blood clots (anticoagulants),            This may increase the chance of
2. you are pregnant, intend to         atazanavir (an antiviral medication)     you getting an unwanted side
   become pregnant, are breast-        and medicines whose activity depend      effect.
   feeding or intend to breast-        on the acidity of the stomach e.g.       If you have trouble remembering to
   feed.                               ketoconazole.                            take your medicine, ask your
3. you have or have had any other                                               pharmacist for some hints.
                                       Speak with your pharmacist or doctor
   medical conditions.
                                       if you have any concerns about
If you have not told your doctor or    taking SOMAC Heartburn Relief            If you take too much
pharmacist about any of the above,     with other medications.                  (overdose)
tell them before you take SOMAC
Heartburn Relief.                                                               Immediately telephone your doctor
                                                                                or Poisons Information Centre for
Talk to your doctor first before
                                                                                advice - the telephone number in
taking SOMAC Heartburn Relief if:      How to take SOMAC                        Australia is 13 11 26 and in New
• you have previously taken            Heartburn Relief                         Zealand is 0800 POISON or 0800
  heartburn / indigestion                                                       764 766 - or go to Accident and
  medications continuously for 4                                                Emergency (Casualty) at your
  or more weeks to control your        How much to take                         nearest hospital, if you think that
  heartburn                                                                     you or anyone else may have taken
                                       Take one SOMAC Heartburn Relief          too much SOMAC Heartburn
• you have jaundice, liver             tablet once a day (every 24 hours)       Relief. Do this even if there are no
  problems, anaemia, previous                                                   signs of discomfort or poisoning.
  gastric ulcer or gastrointestinal                                             You may need urgent medical
                                       How and when to take it
  surgery.                                                                      attention. Keep telephone numbers
• you have new or recently             Swallow your tablets whole with a        for these places handy.
  changed symptoms including           little water with or without food.
  persistent vomiting or vomiting      Do not crush or chew the tablets.
  of blood, blood in the stools or     SOMAC Heartburn Relief tablets
  unexplained weight loss.             have a special coating to protect them   While you are taking
If you have experienced any of the     from the acidic contents of your         SOMAC Heartburn
above you should see your doctor       stomach. For SOMAC Heartburn             Relief
immediately.                           Relief to work effectively, this
If you have suffered from frequent     coating must not be broken.
                                                                                Things you must do
heartburn / indigestion symptoms for
some time you should see your                                                   Use SOMAC Heartburn Relief
doctor.                                                                         exactly as your doctor or
                                                                                pharmacist has advised.

SOMAC® Heartburn Relief Tablets                                     Published by MIMS/myDr June 2009              2
Tell all doctors, dentists and          Side effects                              • frequent infections such as
pharmacists who are treating you                                                    fever, severe chills, sore throat
that you are taking SOMAC                                                           or mouth ulcers
                                        Tell your doctor or pharmacist as
Heartburn Relief.
                                        soon as possible if you have any          • chest pain
Tell your doctor or pharmacist if you   problems while taking SOMAC               • shortness of breath
do not feel better while taking         Heartburn Relief, even if you do
                                                                                  • high blood pressure
SOMAC Heartburn Relief                  not think the problems are
                                        connected with the medicine or            • swelling of the legs
If symptoms persist or recur            they are not listed in this leaflet.      • bleeding or bruising more
within 2 weeks of completing the        Like other medicines, SOMAC                 easily than normal
course, consult a doctor.               Heartburn Relief can cause some side      • depression, confusion or
Further examination may be              effects. If they occur, most are likely     anxiety
recommended.                            to be minor and temporary. However,
                                                                                  These may be serious side effects and
                                        some may be serious and need
                                                                                  you may need urgent medical
Things that may help your               medical attention.
                                                                                  attention. Serious side effects are
condition                                                                         rare.
                                        Ask your doctor or pharmacist any
Some self help measures suggested       questions you may have.
                                                                                  Other side effects not listed above
below may help your condition. Talk     Tell your doctor or pharmacist if         may occur in some people. Tell your
to your doctor or pharmacist about      you notice any of the following and       doctor or pharmacist if you notice
these measures and for more             they worry you:                           anything that is making you feel
                                        • headache                                unwell when you are taking, or soon
• Alcohol - you may be advised to       • dizziness                               after you have finished taking,
  limit your alcohol intake.                                                      SOMAC Heartburn Relief.
                                        • diarrhoea
• Aspirin and many other                                                          Ask your doctor or pharmacist if you
                                        • nausea or vomiting
  medicines used to treat                                                         do not understand some of the
                                        • stomach pain
  arthritis, period pain,                                                         information in this list.
  headaches - these medicines may       • excessive gas in the stomach or
                                          bowel                                   Do not be alarmed by this list of
  irritate the stomach and may
                                        • indigestion                             possible side effects. You may not
  make your condition worse. Your
                                                                                  experience any of them.
  doctor or pharmacist may suggest      • constipation
  other medicines you can take.         • dry mouth
• Caffeine - you may be advised to      • metallic taste
  limit the number of drinks which      • weakness or tiredness
  contain caffeine, such as coffee,                                               After taking SOMAC
                                        • increased sweating                      Heartburn Relief
  tea, cocoa and cola drinks,
  because they contain ingredients      • blurred vision
  that may irritate your stomach.       • skin problems such as itchiness
                                          and rash                                Storage
• Eating habits - eat smaller, more
  frequent meals. Eat slowly and        These are the more common side            Keep your tablets in their blister
  chew your food carefully. Try not     effects of SOMAC Heartburn Relief.        pack until it is time to take them.
  to rush at meal times.                See your doctor immediately if you        If you take the tablets out of the
• Smoking - it is advisable for you     notice any of the following:              blister pack they may not keep well.
  to stop smoking or at least cut
                                        • unusual tiredness or weakness           Keep SOMAC Heartburn Relief
  down.                                                                           tablets in a cool dry place where the
                                        • nausea, vomiting, loss of
• Weight - you may be advised that                                                temperature stays below 30°C.
                                          appetite, feeling generally
  losing some weight will help your
                                          unwell, fever, itching, yellowing       Do not store SOMAC Heartburn
                                          of the skin and eyes, and dark          Relief or any other medicines in a
                                          coloured urine.                         bathroom or near a sink. Do not
                                        • skin problems such as itchiness         leave it in the car or on window
                                          and rash, or swelling, blistering       sills.
                                          or peeling of the skin.                 Heat and dampness can destroy some
                                        • swelling of the face, lips, mouth,
                                          tongue or throat which may
                                          cause difficulty in swallowing
                                          or breathing.

SOMAC® Heartburn Relief Tablets                                       Published by MIMS/myDr June 2009               3
Keep SOMAC Heartburn Relief              Manufacturer and Supplier
where children cannot reach it.
A locked cupboard at least one-and-      SOMAC Heartburn Relief tablets are
a-half metres above the ground, is a     made by Nycomed GmbH, Germany
good place to store medicines.           and are supplied in Australia by:
                                         Nycomed Pty Ltd
                                         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       For medical enquiries, call
pharmacist what to do with any           (AUST) 1800 675 957
tablets that are left over.

                                         Australian Registration
Product description                      SOMAC Heartburn Relief
                                         AUST R 154252
                                         ® Registered trademark of Nycomed
What it looks like
SOMAC Heartburn Relief is                This leaflet was prepared in July
available as a 20 mg tablet. The         2008
tablets have an acid-resistant coating
called an enteric coating.
The tablets are yellow and oval
shaped, marked with 'P20' on one
SOMAC Heartburn Relief tablets are
available in blister packs containing
2, 7 and 14 tablets.

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.

SOMAC® Heartburn Relief Tablets                                        Published by MIMS/myDr June 2009   4

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