Macroherm Powder For Oral Solution
Out of date information, search another[Read all ofthis leaflet carefully because lit contains important information for you.
phis medicine is available without brescription. 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.
I* You must contact a doctor if your symptoms worsen or do not improve I 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.
|ln this leaflet:
j1. What Macroherm is and what it is used for
|2. Before you take Macroherm |3. How to take Macroherm |4. Possible side effects l5. How to store Macroherm |6. Further information
ll. WHAT MACROHERM IS AND WHAT jlT IS USED FOR
jMacroherm is a laxative used for the treatment of long term constipation. It is not Irecommended for children below 12 years |of age. Macrogol 3350 makes your faeces Isofter and easier to pass, giving you relief jfrom constipation. The electrolytes (salts) pelp to maintain your body's normal levels bfsodium, potassium and waterwhile you re being treated for constipation.
. BEFORE YOU TAKE MACROHERM
I
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, Crohn's disease or toxic megacolon
|lf any of these applies to you, please talk to jyour doctor or pharmacist for further advice.
jTaking other medicines
|Some medicines, e.g. anti-epileptics, may hot work as effectively during use with
Macroherm.
|Please tell your doctor or pharmacist if you jare taking, or have recently taken, any pther medicines, including medicines bbtained 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 ofthe 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. Ifyou 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 sulphurdioxide (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. Stir 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.
Ifyou take more Macroherm than you should
This can cause severe pain and swelling in yourabdomen (stomach), orvomiting (sickness) ordiarrhoea. 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.
jlf you stop taking Macroherm
|Tb get the most benefit from Macroherm, lalways finish the course of treatment according to the directions in this package leaflet. This will make sure that your jconstipation is cleared, otherwise the pymptoms you are suffering from may persist.
|you must contact a doctor if your symptoms Worsen or do not improve after 14 days.
|lf you have any further questions on the juse of this product, ask your doctor or pharmacist.
I
Like all medicines, Macroherm can cause jside effects, although not everybody gets them.
jlfyou experience any ofthe following Iside effects, stop taking Macroherm and jsee 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 body's fluid or
electrolyte levels (salt levels), such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased
thirst with headache
[The following side effects are also possible: I* abdominal (stomach) pain !• mild diarrhoea (when starting to take Macroherm, this usually stops ifyou reduce the number of sachets you take) !• nausea (feeling sick)
vomiting
!• swelling of your abdomen (feeling bloated)
I* stomach rumbling !• flatulence (wind)
soreness ofthe anus (bottom)
ilf 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.
I5. HOW TO STORE MACROHERM
I
|Keep out ofthe reach and sight ofchildren.
jDo not use Macroherm after the expiry date Iwhich is stated on the carton and sachet, jfhe expiry date refers to the last day of that month.
Do not store above 25 °C.
jDo not use Macroherm if you notice that jany of the sachets are damaged.
I
jReconstituted Macroherm solution can be povered and stored in the refrigerator (2°C jto 8°C), and should be used within 24 pours. After 24 hours, any unused solution Ishould be discarded.
to dispose of unused sachets, which you noj longer require. These measures will help to' protect the environment.
6. FURTHER INFORMATION
What Macroherm contains
The active substances are:
Each sachet contains: macrogol3350 13.125 g
sodiumhydrogencarbonate 0.1785 g potassium chloride 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, citricj acid, sulphurdioxide [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 ofthese pack sizes are marketed.
Marketing Authorisation Holder
Hermes Arzneimittel GmbH Georg-Kalb-Strasse 5-8 82049 Grosshesselohe/Munchen Germany
Manufacturer
Hermes Pharma Ges.m.b.H.
Allgau 36 9400 Wolfsberg Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Laxaherm Pulver zur
Herstellung einer Losung zum Einnehmen
Belgium: Laxaherm 13.8g poeder
voor orale oplossing Denmark: Laxaherm
Finland: MacrogolHermesjauhe
oraaliliuosta varten
Germany: Macrogol Hermes plus
Elektrolyte Pulver zur Herstellung einer Losung zum Einnehmen
Luxembourg: Macrogol Hermes
Poland: Laxaherm
Sweden: Laxaherm pulver till oral
losning
United Kingdom: Macroherm
This leaflet was last revised in January 2013
jUnused sachets of Macroherm should not be disposed ofvia wastewater or household waste. Ask your pharmacist how