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MACROHERM POWDER FOR ORAL SOLUTION

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Package Leaflet Macroherm PL 17740/0008

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PACKAGE LEAFLET: INFORMATION FOR THE USER Macroherm Powder for oral solution Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Macroherm carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve after 14 days. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Macroherm is and what it is used for 2. Before you take Macroherm 3. How to take Macroherm 4. Possible side effects 5. How to store Macroherm 6. Further information

1. WHAT MACROHERM IS AND WHAT IT IS USED FOR Macroherm is a laxative used for the treatment of long time constipation. It is not recommended for children below 12 years of age. Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes (salts) help to maintain your bodys normal levels of sodium, potassium and water while you are beeing treated for constipation.

2. BEFORE YOU TAKE MACROHERM

Do not take Macroherm - if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in Macroherm - if you have a perforated gut (bowel) wall - if you have a blockage in your intestine (gut obstruction, ileus) - if you have severe inflammatory bowel disease such as ulcerative colitis, Crohns disease or toxic megacolon If any of these applies to you, please talk to your doctor or pharmacist for further advice.

PIL. 17740/0008

August 2012

Licence application

CT

Package Leaflet Macroherm PL 17740/0008

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Taking other medicines Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macroherm. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Taking Macroherm with food and drink Macroherm can be taken at any time with or without food or drink Pregnancy and breast-feeding If you are pregnant or breast-feeding talk to your doctor before taking Macroherm. Driving and using machines Macroherm has no effect on the ability to drive or use machinery. Important information about some of the ingredients of Macroherm Macroherm contains 0.63 mmol (25 mg) of potassium per sachet. This should be taken into consideration if you take more than one sachet daily and you have reduced kidney function, or if you are on a controlled potassium diet. Macroherm contains 8.1 mmol (187 mg) of sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet. The orange flavour in Macroherm contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The orange flavour and the lemon lime flavours contain sulphur dioxide (E220), which may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (a sudden shortness of breath or wheezing).

3. HOW TO TAKE MACROHERM Adults, children (aged 12 years and above) and the elderly: The usual dose for constipation is one sachet taken one to three times daily. How to mix Open the sachet and pour the contents into a glass. Add about 125 ml or a quarter pint of water to the glass. Stirr well until the powder has dissolved and then drink it. Duration of treatment This course of treatment for constipation should not normally last longer than 2 weeks.
PIL. 17740/0008 August 2012 Licence application CT

Package Leaflet Macroherm PL 17740/0008

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If you take more Macroherm than you should This can cause severe pain and swelling in your abdomen (stomach), or vomiting (sickness) or diarrhoea. If this happens, contact your doctor or pharmacist. If you forget to take Macroherm If you forget to take a dose, take it as soon as you remember and then continue on as before. Do not take a double dose to make up for a forgotten dose. If you stop taking Macroherm To get the most benefit from Macroherm, always finish the course of treatment according to the directions in this package leaflet. This will make sure that your constipation is cleared, otherwise the symptoms you are suffering from may persist. You must contact a doctor if your symptoms worsen or do not improve after 14 days. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS Like all medicines, Macroherm can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Macroherm and see your doctor immediately: - signs of an allergy, such as a rash, itching, shortness of breath or difficulty in breathing. - signs of a change in your bodys fluid or electrolyte levels (salts levels), such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache The following side effects are also possible: - abdominal (stomach) pain - mild diarrhoea (when starting to take Macroherm, this usually stops if you reduce the number of sachets you take) - nausea (feeling sick) - vomiting - swelling of your abdomen (feeling bloated) - stomach rumbling - flatulence (wind) - soreness of the anus (bottom)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

PIL. 17740/0008

August 2012

Licence application

CT

Package Leaflet Macroherm PL 17740/0008

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5. HOW TO STORE MACROHERM Keep out of the reach and sight of children. Do not use Macroherm after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month. Do not store above 25 C. Do not use Macroherm if you notice that any of the sachets is damaged. Reconstituted Macroherm solution can be covered and stored in the refrigerator (2C to 8C), and should be used within 24 hours. After 24 hours, any unused solution should be discarded. Unused sachets of Macroherm should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused sachets, which you no longer require. These measures will help to protect the environment.

6. FURTHER INFORMATION What Macroherm contains The active substances are: Each sachet contains: macrogol 3350 sodium chloride sodium hydrogen carbonate potassium chloride

13.125 g 0.3507 g 0.1785 g 0.0466 g

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (Orange flavour contains: natural flavouring substances, glucose, maltodextrin, acacia gum, alpha-tocopherol, sulphur dioxide [E220]) and lemon lime flavour (Lemon lime flavour contains: natural flavouring substances and extracts, nature identical flavouring substances, maltodextrin, acacia gum, citric acid, sulphur dioxide [E220]).

What Macroherm looks like and contents of the pack Macroherm is a white powder. Each sachet contains 13.8 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50, 60 (2x30) and 100 (2x50) sachets. Not all of these pack sizes are marketed.

PIL. 17740/0008

August 2012

Licence application

CT

Package Leaflet Macroherm PL 17740/0008

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Marketing Authorisation Holder Hermes Arzneimittel GmbH Georg-Kalb-Strasse 5-8 82049 Grosshesselohe/Mnchen Germany

Manufacturer
Klocke Pharma-Service GmbH Strassburger Strasse 77 77767 Appenweier Germany Hermes Pharma Ges.m.b.H. Allgu 36 9400 Wolfsberg Austria

This medicinal product is authorised in the Member States of the EEA und the following names: Austria Belgium: Denmark: Finland: Germany: Luxembourg: Poland: Sweden: United Kingdom: Laxaherm Pulver zur Herstellung einer Lsung zum Einnehmen Laxaherm powder for oral solution Laxaherm Macrogol Hermes Macrogol Hermes plus Elektrolyte Pulver zur Herstellung einer Lsung zum Einnehmen Macrogol Hermes Laxaherm Laxaherm Macroherm

This leaflet was last approved in 10/2010

PIL. 17740/0008

August 2012

Licence application

CT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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