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Iberogast Oral liquid


IBEROGAST®

Oral liquid


Consumer Medicine Information

What is in this leaflet ?

This leaflet answers some common questions about IBEROGAST®.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet You may need to read it again.

What IBEROGAST® is used for

IBEROGAST® is a herbal medicine indicated for the treatment of gastric and abdominal discomfort associated with functional and motility-conditioned gastrointestinal disturbances such as functional dyspepsia and irritable bowel syndrome.

Advice before using IBEROGAST®

When you must not take it

Do not take/use IBEROGAST® after the expiry date printed on the pack has passed. If you take this medicine after the expiry date it may have no effect at all, or an unexpected effect.

Do not take IBEROGAST® if the packaging shows signs of having been tampered with.

Before you take IBEROGAST®

Tell your pharmacist if you are allergic to any of the active ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; rash, itching (pruritus) or hives on the skin.

Patients with pre-existing liver disease should consult their doctor prior to commencing treatment with IBEROGAST®

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.

Taking other medicines

There are no known interactions of IBEROGAST® with any other types of medication.

How to use IBEROGAST® properly

Shake the bottle before use.

IBEROGAST® contains a built-in central dropper in the mouth of the bottle. To dispense the accurate number of drops required remove the white screw cap, turn the bottle upside down, hold it at a 45°angle and give a slight shake you will notice that the drops will begin to be dispensed

When to use it

Unless otherwise prescribed, IBEROGAST® is to be taken before or with meals mixed in about a quarter of a glass (60 mL) of liquid.

How much to take

  • Adults and children over 12 years
    – Take 20 drops 3 times a day (1.0 mL)
  • Children 6 to 12 years
    – Give 15 drops 3 times a day (0.75 mL)
  • Children 3 to 6 years
    – Give 10 drops 3 times a day (0.5 mL)
  • Children 3 months to 3 years
    – Give 8 drops 3 times a day (0.4 mL)
  • Children under 3 months
    – Give 6 drops 3 times a day (0.3 mL)

If you forget to take it

Skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If symptoms persist consult your doctor or pharmacist.

Unwanted effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using IBEROGAST®.

Note: If patients experience side effects that are not mentioned in this package insert they should report them to a physician or pharmacist.

Tell your doctor or pharmacist immediately if you experience any of the formerly described allergic side effects, particularly if they worry you.

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell when you are taking, or soon after you have finished taking, IBEROGAST®.

Do not be alarmed by the above mentioned side effects. You may not experience any of them.

In case of overdose

If you take too much (overdose)

If you take more than you are meant to, you are unlikely to experience overdose.

There have been no cases of acute overdose reported to date.

Storage conditions

Keep IBEROGAST® in a cool place where the temperature stays below 25°C.

IBEROGAST® must not be used after the expiry date indicated on the label and the packaging.

Keep IBEROGAST® where young children cannot reach it.

Product description

What it looks like

IBEROGAST® is a dark brown, clear to lightly cloudy liquid supplied in brown glass bottles with a built-in central dropper, and a white screw cap.

Ingredients

IBEROGAST® oral liquid contains extracts equivalent to:

  • Iberis amara (bitter candytuft) fresh whole plant
    – 75.00mg/mL
  • Angelica archangelica (angelica root) dried root
    – 33.33mg/mL
  • Matricaria recutita (chamomile) dried flower head
    – 66.67mg/mL
  • Carum carvi (caraway) dried fruit
    – 33.33mg/mL
  • Silybum marianum (milk thistle) dried fruit
    – 33.33mg/mL
  • Melissa officinalis (balm leaf) dried leaf
    – 33.33mg/mL
  • Mentha x piperitae (peppermint) dried leaf
    – 16.67 mg/mL
  • Chelidonium majus (celandine) dried herb
    – 33.33mg/mL
  • Glycyrrhiza glabra (liquorice) dried root
    – 33.33mg/mL

IBEROGAST® also contains ethanol and purified water.

IBEROGAST® is available in the following pack sizes:

50 mL bottle – AUST R 168967

Manufacturer/Sponsor/Distributor

Manufacturer
IBEROGAST® is made by:
Steigerwald Arzneimittelwerk GmbH
Havelstraße 5
64295 Darmstadt
Germany

Australian Sponsor and Distributor
Flordis
Level 5, 156 Pacific Highway
St. Leonards
NSW 2065
Australia

Date of Preparation
This leaflet was prepared in February 2010

Published by MIMS July 2010