MACROGOL

MACROGOL AbZ Powder for Oral Solution

Important notes (mandatory information)

Macrogol AbZ 13.8 g powder for oral solution. Areas of application: for the treatment of acute and chronic constipation in adults and adolescents aged 12 and over.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Macrogol AbZ 13.8 g powder for oral solution for use in adults and adolescents aged 12 and over


Read all of this leaflet carefully because it contains important information for you. This medical device is available without a prescription. However, to achieve the best possible treatment results, Macrogol AbZ must be taken as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen, you must see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

1. HOW DOES MACROGOL ABZ WORK AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING MACROGOL ABZ?
3. HOW SHOULD MACROGOL ABZ BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MACROGOL ABZ BE STORED?
6. FURTHER INFORMATION

1. HOW DOES MACROGOL ABZ WORK AND WHAT IS IT USED FOR?

Macrogol AbZ contains macrogol 3350 and electrolytes as active ingredients. Due to the high water-binding capacity of macrogol 3350 - comparable to a sponge - the ingested amount of water is retained and transported into the large intestine without the body being deprived of fluid. This softens hard stools and increases stool volume. This leads to the triggering of natural bowel movements and ultimately to bowel movements. Macrogol 3350 is excreted in the process. Therefore, it does not burden the organism. The addition of electrolytes (potassium and sodium salts) results in an isoosmotic, isotonic drinking solution. This prevents a loss of the body's own electrolytes or water or a fluid overload of the body. It is a product from the group of laxatives for the treatment of acute and chronic constipation in adults and adolescents aged 12 and over.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING MACROGOL ABZ?

You must not take Macrogol AbZ:

• if you are hypersensitive to any of the ingredients of Macrogol AbZ.
• if you have a narrowing of the intestine or an intestinal obstruction.
• if there is a risk of a bowel perforation.
• in severe inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis, toxic megacolon).
• in abdominal pain of unknown cause.

Special care should be taken when taking Macrogol AbZ if you experience symptoms that indicate a shift in fluid and electrolyte balance, such as accumulation of tissue fluid (edema), shortness of breath, increasing fatigue, dehydration or heart failure. In this case, stop taking Macrogol AbZ immediately and contact your doctor. He will perform electrolyte measurements and take the necessary measures.

Children

There is insufficient experience with the use of Macrogol AbZ in children. Therefore, use in children under 12 years of age is not recommended.

Pregnancy and breastfeeding

Macrogol AbZ can be taken during pregnancy and breastfeeding. Ask your doctor or pharmacist for advice before taking Macrogol AbZ.

When taking Macrogol AbZ with other products

The effectiveness of some medicines, such as antiepileptics, may be reduced while taking Macrogol AbZ. Please inform your doctor or pharmacist if you are taking or have recently taken any medicines, even if they are not prescription products.

3. HOW SHOULD MACROGOL ABZ BE TAKEN?

You can take the product at any time and regardless of food and drink intake. Always take Macrogol AbZ exactly as directed in this leaflet. This product must not be taken undiluted.

Unless otherwise prescribed by your doctor, the usual dose for constipation in adults and adolescents aged 12 and over is: One dose of Macrogol AbZ corresponds to the contents of one sachet. Depending on the severity of the constipation, take one sachet 1 to 3 times a day.

Patients with impaired renal function

No dose adjustment is required.

Preparing the solution

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

Notes

The drinking solution should be freshly prepared before taking. The drinking solution must not be mixed with other solutions, drinks or additives so that the electrolyte concentration is not altered. You can choose the time of intake (morning, noon, evening, or before, during or after meals) freely.

Duration of use for constipation

You should normally not take Macrogol AbZ for longer than 2 weeks. However, Macrogol AbZ can be used repeatedly if necessary. Long-term use may be necessary for severe chronic or persistent constipation. In this case, please talk to your doctor. This can also occur in diseases such as multiple sclerosis or Parkinson's disease or be caused by taking constipating medications such as strong painkillers (opioids) or medicines for Parkinson's disease (anticholinergics). The usual effective dose for long-term treatment is 1 or 2 sachets per day.

If you have taken more Macrogol AbZ than you should

You may get diarrhea, which can lead to dehydration. If this occurs, stop taking Macrogol AbZ and drink plenty of fluids. If you experience severe pain, bloating or severe diarrhea, please contact your doctor.

If you forget to take Macrogol AbZ

Do not take a double dose. Continue taking the intended dosage.

If you have any further questions about the use of Macrogol AbZ, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Macrogol AbZ can have side effects, but not everyone gets them. Stop taking Macrogol AbZ and tell your doctor immediately if you get a serious allergic reaction that makes it difficult to breathe or causes swelling of your face, lips, tongue, or throat.

Other possible side effects

In individual cases, hypersensitivity reactions/allergic reactions (skin rash, itching, redness of the skin, hives), swollen hands, feet or ankles, headache and increased and decreased potassium concentration in the blood may occur. Diarrhea may occur, especially at the beginning of therapy or at too high a dosage. Sometimes you may experience indigestion, abdominal pain or increased bowel sounds. You may also feel bloated, suffer from flatulence, nausea or vomiting, irritation of the anus and mild diarrhea at the start of taking Macrogol AbZ. These side effects generally improve once the dose of Macrogol AbZ is reduced.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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 about the safety of this medicine.

5. HOW SHOULD MACROGOL ABZ BE STORED?

Keep out of reach of children! Do not use Macrogol AbZ after the expiry date (see sachet or folding box). The expiry date refers to the last day of the month. Opened or damaged sachets should not be used. Do not store above 25°C.

6. FURTHER INFORMATION

What does Macrogol AbZ contain?:
1 sachet contains as active ingredients: Macrogol 3350 13.121 g, sodium chloride 0.350 g, sodium hydrogen carbonate 0.179 g, potassium chloride 0.046 g. The other ingredients are: Saccharin sodium, flavoring (orange-lemon-lime).

Dosage form and contents of the pack

Powder for oral solution Packs of 10, 20, 50 and 100 sachets.

Pharmaceutical entrepreneur

AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 11/2020
Areas of application: for the treatment of acute and chronic constipation in adults and adolescents aged 12 and over.