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Macrogol-Ratiopharm Powder For Oral Solution

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Package leaflet: Information for the user Macrogol-ratiopharm powder for oral solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Macrogol-ratiopharm powder for oral solution is and what it is used for

2.    What you need to know before you take Macrogol-ratiopharm powder for oral solution

3.    How to take Macrogol-ratiopharm powder for oral solution

4.    Possible side effects

5.    How to store Macrogol-ratiopharm powder for oral solution

6.    Contents of the pack and other information

1. What Macrogol-ratiopharm powder for oral solution is and what it is used for


Macrogol-ratiopharm powder for oral solution 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 salts help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you take Macrogol-ratiopharm powder for oral solution


Do not take Macrogol-ratiopharm powder for oral solution

-    if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6)

-    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

If any of these applies to you, please talk to your doctor or pharmacist for further advice.

Other medicines and Macrogol-ratiopharm powder for oral solution

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macrogol-ratiopharm powder for oral solution.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Macrogol-ratiopharm powder for oral solution with food and drink

Macrogol-ratiopharm powder for oral solution can be taken at any time with or without food or drink. Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask talk to your doctor for advice before taking this medicine.

Driving and using machines

Macrogol-ratiopharm powder for oral solution has no effect on the ability to drive or use machinery.

Important information about some of the ingredients of Macrogol-ratiopharm powder for oral solution

Macrogol-ratiopharm powder for oral solution 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.

Macrogol-ratiopharm powder for oral solution 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 lemon lime flavour in Macrogol-ratiopharm powder for oral solution contains sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Macrogol-ratiopharm powder for oral solution


Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults, children (aged 12 years and above) and the elderly:

The recommended 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.

On your doctor's advice, you may need to take Macrogol-ratiopharm powder for oral solution longer than two weeks if you have ongoing constipation, or a disease that causes constipation (such as Parkinson’s disease or multiple sclerosis), or if you are taking other regular medicines that can cause constipation. In these cases, your doctor may advice you to reduce your dose to one sachet taken one or two times daily.

If you take more Macrogol-ratiopharm powder for oral solution 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 Macrogol-ratiopharm powder for oral solution

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 Macrogol-ratiopharm powder for oral solution

To get the most benefit from Macrogol-ratiopharm powder for oral solution, 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 medicine ask your doctor or pharmacist.

4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Macrogol-ratiopharm powder for oral solution and see your doctor immediately:

- signs of an allergy, such as a rash, nettle rash, itching, reddening of the skin, shortness of breath or difficulty in breathing, or swelling of the face, lips, tongue or throat..

-    signs of a change in your body’s fluid or electrolyte levels, such as swelling (mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache.

The following side effects are also possible:

-electrolyte disturbances, particularly high or low levels of potassium in the blood

-    headache

-    swelling of hands, feet or ankles

-    abdominal (stomach) pain

-    diarrhoea

-    mild diarrhoea (when starting to take Macrogol-ratiopharm powder for oral solution, this usually stops if you reduce the number of sachets you take)

-    nausea (feeling sick)

-    vomiting

-    indigestion

-    swelling of your abdomen (feeling bloated)

-    stomach rumbling

-    flatulence (wind)

-    soreness of the anus (bottom)

If you get any side effects gets , talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Macrogol-ratiopharm powder for oral solution


Keep this medicine out of the sight and reach of children.

Do not use this medicine 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 this medicine if you notice that any of the sachets is damaged.

Reconstituted Macrogol-ratiopharm powder for oral solution solution can be covered and stored in the refrigerator (2°C to 8°C), and should be used within six hours. After six hours, any unused solution should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.. These measures will help protect the environment.

6. Contents of the pack and other information


What Macrogol-ratiopharm powder for oral solution contains

The active substances are:

Each sachet contains:

macrogol 3350    13.125    g

sodium chloride    0.3507    g

sodium hydrogen carbonate    0.1785    g

potassium chloride    0.0466    g

4

The other ingredients are silica colloidal anhydrous, saccharin sodium, orange flavour (Orange flavour contains: flavouring preparations and substances, natural flavouring substances, maltodextrin, acacia gum, a-tocopherol) and lemon lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder flavour lemon, powder flavour lime, maltodextrin, mannitol, gluconolactone, sorbitol [E420], acacia gum, silica colloidal anhydrous).

What Macrogol-ratiopharm powder for oral solution looks like and contents of the pack

Macrogol-ratiopharm powder for oral solution 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 and 100 sachets.

Not all of these pack sizes are marketed.

Marketing Authorisation Holder

ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm

Manufacturer

Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren

This leaflet was last revised in October 2014