MACROGOL

MACROGOL-1A Pharma Powder for Oral Solution

Important notes (mandatory information)

Macrogol - 1 A Pharma, powder. Areas of application: for the treatment of chronic constipation.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Macrogol - 1 A Pharma, powder for oral solution
Active ingredients: Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride

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 notice 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 after 14 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS MACROGOL - 1 A PHARMA AND WHAT IS IT USED FOR?

Macrogol - 1 A Pharma is a laxative for the treatment of chronic constipation. Use in children under 12 years of age is not recommended. Macrogol 3350 softens your stool and makes it easier to pass, thus relieving you from constipation. The electrolytes (salts) help to maintain normal levels of sodium, potassium and water in your body while your constipation is being treated. If you do not feel better or if you feel worse after 14 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MACROGOL - 1 A PHARMA?

Macrogol - 1 A Pharma 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 (narrowing of the bowel, intestinal obstruction, ileus).
• in case of severe inflammatory bowel diseases such as ulcerative colitis, Crohn's disease or toxic megacolon.

Please inform your doctor or pharmacist if this applies to you.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Macrogol - 1 A Pharma.

Children

Use in children under 12 years of age is not recommended.

Taking Macrogol - 1 A Pharma with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The effect of some medicines, such as antiepileptics, may be reduced if taken at the same time as Macrogol - 1 A Pharma.

Taking Macrogol - 1 A Pharma with food and drink

Macrogol - 1 A Pharma can be taken at any time and independently of food and drink intake.

Pregnancy and breast-feeding

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

Driving and using machines

Macrogol - 1 A Pharma has no influence on the ability to drive and use machines.

Macrogol - 1 A Pharma contains potassium, sodium and sorbitol:

• Macrogol – 1 A Pharma contains 0.6 mmol (24 mg) potassium per sachet. If you have impaired kidney function or need to follow a potassium-controlled diet (low potassium diet) and you take more than 1 sachet per day, you should take this into account.
• Macrogol – 1 A Pharma contains 188 mg (8.2 mmol) sodium (main component of cooking salt/table salt) per sachet. This corresponds to 9.4% of the recommended maximum daily intake of sodium for an adult with food. The maximum recommended daily dose of this medicine contains 564 mg sodium. This corresponds to 28.2% of the recommended maximum daily intake of sodium for an adult with food. Talk to your doctor or pharmacist if you need to take 3 sachets per day over a longer period of time, especially if you have been advised to follow a low-sodium (low-salt) diet.
• The lemon-lime flavour in Macrogol – 1 A Pharma contains 0.8 mg sorbitol per sachet. Please only take this medicine after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE MACROGOL - 1 A PHARMA?

Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Taking the prepared Macrogol -1 A Pharma solution does not replace regular fluid intake; this must still be ensured.

Adults, adolescents (from 12 years of age) and elderly patients

The usual dose for constipation is 1-3 sachets 1-3 times a day.

Use in children (under 12 years of age)

Macrogol - 1 A Pharma is not recommended for use in children under 12 years of age.

Preparing the solution

Open the sachet and pour the contents into a glass. Add 125 ml or 1/8 litre of water. Stir until the powder has dissolved and then drink the solution.

Duration of use

The duration of use for constipation should normally not exceed 2 weeks. If you need to take Macrogol - 1 A Pharma for a longer period of time, please talk to your doctor. If your constipation is caused by an illness such as Parkinson's or multiple sclerosis (MS) or if you are taking medicines that cause constipation, your doctor may recommend that you take Macrogol - 1 A Pharma for longer than 2 weeks. For long-term treatment, the dose can usually be reduced to 1 or 2 sachets per day.

If you have taken more Macrogol - 1 A Pharma than you should

This could lead to severe abdominal pain and bloating (stomach), vomiting (nausea) or diarrhoea. In this case, please contact your doctor or pharmacist.

If you forget to take Macrogol - 1 A Pharma

If you forget to take a dose, take it as soon as you remember. Continue taking the intended dosage. Do not take double the amount if you have forgotten to take a previous dose.

If you stop taking Macrogol - 1 A Pharma

To get the most benefit from Macrogol - 1 A Pharma, always take the medicine as directed in the package leaflet. This ensures that your constipation is relieved, otherwise the symptoms you are suffering from may persist.

If your symptoms worsen or do not improve after 14 days, 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 - 1 A Pharma any further and see your doctor immediately:

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

The following side effects may occur when taking Macrogol - 1 A Pharma: Side effects in the digestive tract (gastrointestinal area) are most common. Mild diarrhoea generally improves as soon as the dose of Macrogol - 1 A Pharma is reduced.

Common side effects (may affect up to 1 in 10 people):

• Itching
• Headache
• Abdominal pain
• Diarrhoea
• Vomiting
• Nausea
• Flatulence
• Oedema of the extremities

Uncommon side effects (may affect up to 1 in 100 people):

• Rash
• Indigestion
• Abdominal bloating (abdominal distension)

Not known (frequency cannot be estimated from the available data):

• allergic reactions including anaphylactic reactions, shortness of breath and skin reactions
• allergic skin reactions including tissue swelling, hives (urticaria), skin redness
• electrolyte disturbances, in particular decreased/increased potassium levels in the blood
• bowel sounds
• discomfort in the anal area

Reporting of side effects

If you notice 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 - 1 A PHARMA?

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 the sachets after "use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not use Macrogol - 1 A Pharma if you notice that a sachet is damaged. The prepared ready-to-use solution can be covered and stored in the refrigerator (2°C - 8°C) and should be 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 no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Macrogol - 1 A Pharma contains

Each sachet contains the following active ingredients: Macrogol 3350 13.125 g, sodium chloride 0.3507 g, sodium hydrogen carbonate 0.1785 g and potassium chloride 0.0466 g. The other ingredients are: highly dispersed silicon dioxide, sodium saccharin, orange flavour (orange flavour contains: flavourings, maltodextrin, gum arabic, all-rac-alpha-tocopherol) and lemon-lime flavour (lemon-lime flavour contains: flavourings, maltodextrin, mannitol [Ph.Eur.], D-glucono-1,5-lactone, sorbitol [Ph.Eur.], gum arabic, highly dispersed silicon dioxide).

What Macrogol - 1 A Pharma looks like and contents of the pack

Macrogol - 1 A Pharma is a white powder. Each sachet contains 13.8 g of powder and is packed in packs of 2, 6, 8, 10, 20, 30, 50, 60 (2 x 30) and 100 (2 x 50) sachets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Phone: (089) 6138825-0

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This package leaflet was last revised in October 2018.

Source: Information from the package leaflet
Status: 10/2019
Areas of application: for the treatment of chronic constipation.