1. What Estopaxo is and what it is used for?
Estopaxo contains four different active ingredients:
-Dried aluminium hydroxide gel and magnesium hydroxide belong
to a group of medicines called Antacids
-Simethicone belongs to a group of medicines called
anti-foaming agents
-Alginic acid helps in preventing GERD
Estopaxo is used for:
-Stomach upset
-Flatulence
-Indigestion
-Heartburn
-Abdominal hyperacidity
Estopaxo works by lowering the amount of acid in your
stomach. The anti-foaming agent in Estopaxo helps to remove gas from your
stomach
2. What do you need to know before you take Estopaxo
Do not take Estopaxo if:
-You are allergic (hypersensitive) to dried aluminium
hydroxide gel, magnesium hydroxide, alginic acid, simethicone or any of the other
ingredients in Estopaxo (listed in section 6)
-You have kidney disease
- You have low levels of phosphate ('hypophosphataemia').
This is shown up in blood tests.
Do not take this medicine if any of the above applies to
you. If you are not sure, talk to your health practitioner before taking
Estopaxo.
Warnings and precautions
Talk to your doctor or pharmacists before taking Estopaxo
if:
-You are on phosphate supplements (potassium phosphate)
-You are on a low-phosphorous diet
Children
In small children, the use of magnesium hydroxide may cause
hypermagnesemia particularly if they have renal impairment or dehydration.
Other medicines and Estopaxo
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines.
This includes medicines you buy without a prescription
including herbal medicines.
Estopaxo should not be taken at the same time as other
medicines as Estopaxo can affect the way other medicines work. If Estopaxo is
taken within one hour of any other medicine, it can affect the uptake of that
medicine into the blood.
There is decreased absorption of acidic drugs such as
digoxin, phenytoin, and chlorpromazine and increased absorption of pseudoephedrine
and levodopa when taken with antacids. These effects may lead to
medication ineffectiveness or toxicity.
Some medicines may be affected by magnesium hydroxide or
they may affect how well magnesium hydroxide will work. Tell your doctor or
pharmacist if you are already taking
salicylates.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this
medicine if:
-You are pregnant, might become pregnant, or think you may
be pregnant
-You are breastfeeding or planning to breastfeed.
Taking this medicine
-Shake well before use
-Take this medicine by mouth
Adults including the elderly
-Take 10 ml to 20 ml twice daily
-Take 20 to 1 hour after meals and at bedtime
Children 2 to 12 years old
- Take 5ml to 10 ml twice daily
-Give this medicine 20 minutes to 1 hour after meals and at
bedtime
-Alternatively, give as
directed by your doctor
If the symptoms do not go
away, talk to your healthcare practitioner.
If you take more Estopaxo
than you should
Talk to your healthcare
practitioner or go to a hospital straight away. Remember to take any medicine
that is left with you so the doctor knows what you have taken.
4. Possible side effects
Like all medicines,
Estopaxo can cause side effects, although not everybody gets them.
Stop taking Estopaxo and
see a doctor or go to a hospital straight away is:
-You develop an allergic
reaction. Allergic reactions may present as red and lumpy skin rash, swollen
eyelids, face, lips, mouth or tongue, itching, and difficulty breathing or
swallowing.
Tell your healthcare
practitioner if any of the following side effects get serious or last longer
than a few days. Also, tell them if you notice any side effects not listed in
this leaflet:
Uncommon (may affect up
to 1 in 100 people)
-Constipation
-Diarrhoea
Very rare (may affect up
to 1 in 10,000 people)
-Hypermagnesemia, including observations after prolonged administration
to patients with renal impairment.
Not known (frequency
cannot be estimated from the available data)
-
Hypophosphatemia, may occur at high doses of the
product or even at normal doses, especially in patients with low phosphorus
diets
-
Hyperaluminemia is an electrolyte disturbance in which there
is an abnormally elevated level of aluminium in the body
-
Abdominal pain
Reporting side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side effects not listed here.
5. How to store Estapaxo
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Estopaxo after the expiry date which is
stated on the label. The expiry date refers to the last day of that month.
Store below 30 degrees Celsius
Estopaxo should be disposed of 6 months after opening
the bottle.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of medicines no longer
required.
6. Contents of the pack and other information
What Estopaxo contains
-Each bottle contains the following active
substances in each 15ml of suspension: 330mg of dried aluminium hydroxide gel,
250mg of magnesium hydroxide, 200mg of
alginic acid and 125mg of simethicone
-The other ingredients are sucralose, sorbitol,
sodium benzoate, colloidal silicon dioxide, carboxymethyl cellulose, xanthan
gum, aspartame, methylparaben sodium and propylparaben sodium, propylene
glycol, polysorbate 80, peppermint flavour, menthol crystal, carmoisine.
What Estopaxo looks like and the contents of the pack
Estopaxo is a pinkish suspension, homogenous after
shaking and is available in an amber-coloured bottle. Each bottle contains
200ml or 100ml with tamper-evident caps.
This does not contain all the information about your
medicine. If you have any questions or are not sure about anything, ask your
doctor or pharmacist