MACROGOL

MACROGOL-ratiopharm Balance Plv.zHeLzEinn.

Important notes (mandatory information)

Macrogol-ratiopharm Balance Powder. Areas of application: for the treatment of chronic constipation in adolescents, adults and elderly patients.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Macrogol-ratiopharm Balance Powder for preparing a solution for oral use

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS MACROGOL–RATIOPHARM BALANCE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MACROGOL–RATIOPHARM BALANCE?
3. HOW TO TAKE MACROGOL–RATIOPHARM BALANCE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MACROGOL–RATIOPHARM BALANCE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MACROGOL-RATIOPHARM BALANCE AND WHAT IS IT USED FOR?

The name of this medicine is Macrogol-ratiopharm Balance. Macrogol-ratiopharm Balance is a medicine from the group of laxatives for the treatment of chronic constipation in adolescents, adults and elderly patients. It is not recommended for use in children under 12 years of age. Macrogol-ratiopharm Balance helps you to have comfortable bowel movements, even if you have been suffering from constipation for a long time. If you do not feel better or if you feel worse, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MACROGOL-RATIOPHARM BALANCE?

Macrogol-ratiopharm Balance must not be taken:

• 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.
• in case of perforated intestinal wall.
• if you have a bowel obstruction (intestinal obstruction, ileus).
• in severe inflammatory bowel diseases such as ulcerative colitis, Crohn's disease or toxic megacolon.

Warnings and precautions

While taking Macrogol-ratiopharm Balance, you should continue to drink enough fluids. The fluid content of Macrogol-ratiopharm Balance does not replace your regular fluid intake.

Taking Macrogol-ratiopharm Balance with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. The effectiveness of some medicines, such as antiepileptics, may be reduced while taking Macrogol-ratiopharm Balance.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Macrogol-ratiopharm Balance can be taken during pregnancy and breast-feeding.

Driving and using machines

Macrogol-ratiopharm Balance does not affect your ability to drive or operate machines.

Macrogol-ratiopharm Balance contains potassium, sodium and sorbitol

Macrogol-ratiopharm Balance contains 0.63 mmol (25 mg) potassium per sachet. This should be taken into account if you are taking more than one sachet per day and have impaired renal function, or if you need to follow a controlled diet (low potassium diet). This medicine contains 187 mg sodium (main component of cooking salt/table salt) per sachet. This corresponds to 9.4% of the maximum daily recommended sodium intake for an adult with food. Talk to your doctor or pharmacist if you need 3 sachets daily for a longer period of time, especially if you are advised to follow a low-salt (low-sodium) diet. This medicine contains 0.75 mg sorbitol per sachet.

3. HOW TO TAKE MACROGOL-RATIOPHARM BALANCE?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. This medicine can be taken at any time and independently of a meal.

Adults, children (from 12 years) and elderly patients

The recommended dose for constipation is 1 to 3 sachets daily, depending on your individual needs.

Use in children (under 12 years)

Macrogol-ratiopharm Balance is not recommended for use in children under 12 years of age. Other products are available for this age group.

Method of administration

Open the sachet and pour the contents into a glass. Add approximately 125 ml of water. Stir until the powder has completely dissolved and the solution is clear or slightly cloudy. You can now drink the solution.

Duration of use

The duration of use for constipation should normally not exceed 2 weeks. On the advice of your doctor, you may need to take Macrogol-ratiopharm Balance for longer than 2 weeks if you have persistent constipation or a condition that causes constipation (such as Parkinson's disease or multiple sclerosis), or if you regularly take other constipating medications. In these cases, your doctor may advise you to reduce the dose to 1 or 2 sachets once a day.

If you have taken more Macrogol-ratiopharm Balance than you should

You may experience very severe diarrhoea, which can lead to dehydration. If this occurs, stop taking Macrogol-ratiopharm Balance and drink plenty of fluids. If you are not sure, ask your doctor or pharmacist.

If you forget to take Macrogol-ratiopharm Balance

If you forget to take a dose, take it as soon as you remember. Continue taking the medicine as prescribed. Do not take a double dose to make up for a forgotten dose.

If you stop taking Macrogol-ratiopharm Balance

To get the most benefit from Macrogol-ratiopharm Balance, always take the medicine as directed in the package leaflet or exactly as agreed with your doctor or pharmacist. This will ensure that your constipation is relieved, otherwise the symptoms you are suffering from may persist. If your symptoms worsen or do not improve, you must see a doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

If you are affected by any of the following side effects, do not take Macrogol-ratiopharm Balance any further and see your doctor immediately:

• Signs of an allergic reaction, such as shortness of breath or difficulty breathing, swelling of the face, lips, tongue or throat, hives, itching, rash or skin redness.
• Signs of fluid or electrolyte imbalances in the body such as swelling (mainly in the ankles), feeling weak, feeling tired, increased thirst with headache.

Other side effects include:

• Abdominal pain
• Bowel sounds
• Diarrhoea. At the beginning of taking Macrogol–ratiopharm Balance, you may have mild diarrhoea, which generally improves as soon as the dose of Macrogol–ratiopharm Balance is reduced.
• Vomiting
• Nausea
• Discomfort in the anal area (unpleasant feeling in the anus)
• Flatulence
• Flatulence
• Swollen hands, feet or ankles
• Headache
• Indigestion
• Decreased or increased potassium levels in the blood

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MACROGOL-RATIOPHARM BALANCE?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and sachets. The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not use this medicine if you notice that a sachet is damaged. If the prepared ready-to-use solution cannot be taken immediately in its entirety, it should be covered and stored in the refrigerator (2°C to 8°C) and used within 24 hours. After 24 hours, any unused solution should be discarded. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Macrogol-ratiopharm Balance contains

The active ingredients 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. The other ingredients are Colloidal silicon dioxide, saccharin sodium, orange flavour (orange flavour contains: flavour preparations, flavourings, natural flavourings, maltodextrin, gum arabic, alpha-tocopherol) and lemon-lime flavour (lemon-lime flavour contains: natural lemon oil, natural lemon flavour powder, lime flavour powder, maltodextrin, mannitol, gluconolactone, sorbitol [E 420], gum arabic, colloidal silicon dioxide).

What Macrogol-ratiopharm Balance looks like and contents of the pack

Macrogol-ratiopharm Balance is a white powder. Each sachet contains 13.8 g of powder and is packed in packs of 10, 30, 50 and 100 sachets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This package leaflet was last revised in January 2019.

Source: Package leaflet information
Status: 07/2020
Areas of application: for the treatment of chronic constipation in adolescents, adults and elderly patients.