ESTOPAXO SUSPENSION

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