Patient Information for  Grünwalder MACROLAX^®

Package leaflet: Information for the user Grünwalder Macrolax® effervescent tablets 

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. If you are unsure or have any further questions ask your doctor or pharmacist. 

Grünwalder Macrolax® effervescent tablets is a medicine for the symptomatic treatment of obstipation and for the softening of hard stools with obstipation.  

Keep this leaflet. You may need to read it again. 

What is in this leaflet

1. What Grünwalder Macrolax® is and what it is used for

2. What you need to know before you take Grünwalder Macrolax®

3. How to take Grünwalder Macrolax®

4. Possible side effects

5. How to store Grünwalder Macrolax®

6. Other information

 

1. What Grünwalder Macrolax® is and what it is used for 

Macrolax® are effervescent tablets for the preparation of a solution that contain Macrogol 4000 as main ingredient, an osmotically acting laxative for the treatment of obstipation, which promotes regular and comfortable evacuation of the bowels.  

Grünwalder Macrolax® effervescent tablets are used:

 

2. What you need to know before you take Grünwalder Macrolax® effervescent tablets  

Grünwalder Macrolax® effervescent tablets: 

• if you are oversensitive (allergic) towards the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe inflammatory intestinal diseases (such as Colitis ulcerosa, Morbus Crohn) or toxic mega colon
• intestinal perforation or existing risk for an intestinal perforation
• Ileus or suspected intestinal obstruction or symptomatic stenosis
• painful abdominal syndrome of unclear cause 

Do not take Grünwalder Macrolax® effervescent tablets if any of the above-mentioned criteria apply for you. If you are unsure ask your doctor or pharmacist before you start taking Grünwalder Macrolax® effervescent tablets.

Individuals with a tendency towards disorders in the water and electrolyte metabolism (e.g. with heart, liver or kidney failure, intake of diuretics) should only take Grünwalder Macrolax® effervescent tablets under specific medical recommendation. 

Special caution is necessary 

As with all laxatives, an organic disease must be excluded before starting the treatment.  Grünwalder Macrolax^® should not be used every day over a longer period of time without prior clarification of the cause for the constipation. Consult with your doctor if you have persistent abdominal pain. 

Patients that have taken products containing Macrogol have reported allergic reactions (such as anaphylactic shock, anaphylactic reactions, angioedema, urticaria,skin rash and oversensitivity).

 

Do not continue taking Grünwalder Macrolax® effervescent tablets and immediately consult a doctor if you experience any of the signs and symptoms described above.

 

Pregnancy and breast-feeding

Grünwalder Macrolax® effervescent tablets can be taken during pregnancy or breast-feeding as the resorption of Macrogol 4000 is negligible, and for this reason no effects are to be anticipated. If you are pregnant or are breastfeeding you should however ask your doctor for advice before you start using Grünwalder Macrolax® effervescent tablets.

Use with children

This product should not be used with children under 12 years of age. 

Application with patients with Diabetes mellitus

Grünwalder Macrolax® is suitable for people suffering from diabetes. The solution does not contain any sugar. 

Intake of Grünwalder Macrolax® effervescent tablets together with other products

Macrogol 4000 increases the osmotic pressure in the intestines and can therefore change the resorption of other simultaneously administered products from the intestines. 

 

3. How to take Grünwalder Macrolax® effervescent tablets  

Always use Grünwalder Macrolax® effervescent tablets exactly as described in this package leaflet. Check with your doctor or pharmacist if you are not sure.

Adults and children over 12 years of age:

The following dosage recommendations apply if not prescribed differently by your doctor:

With constipation dissolve one effervescent tablet in a glass of water (200 ml) 2 - 3 times daily and drink immediately. By dissolving the tablets in water it is ensured that the liquid quantity is taken that is necessary for unfolding the desired effect.

Depending on the severity of the obstipation an intake duration of 2 – 3 days or an increase of the dosage to up to 5 effervescent tablets daily may be necessary to cause the desired effect. With the intake of two Grünwalder Macrolax® effervescent tablets the quantity of water in which the effervescent tablets are dissolved must be explicitly doubled.

With repeated application the dosage can be adapted, e.g. to 1 -2 effervescent tablets daily.

In case of constipation the duration of the treatment should normally not exceed 2 weeks. Should the constipation continue to persist the cause of the constipation must be clarified.

Grünwalder Macrolax® effervescent tablets can however be used repeatedly if required. 

Please note:

The effect of Grünwalder Macrolax® normally only sets in after 24 – 72 hours. Clinical studies show that with regular application the frequency of the bowel evacuation tendentially balances itself to once daily.  

If take more Grünwalder Macrolax® than intended

Overdoses of Grünwalder Macrolax® effervescent tablets can cause diarrhoea, stomach pain, and feelings of tension in the abdomen and vomiting, which subside again after discontinuation of the treatment or reduction of the dosage.

Severe loss of fluids through diarrhoea or vomiting can make it necessary to correct electrolyte derailments. Under these circumstances see a doctor for advice. 

If you forget to take Grünwalder Macrolax®

Do not take double the amount of Grünwalder Macrolax® effervescent tablets if you have forgotten to take the previous dose.  

 

4. Possible side effects 

Side-effects have usually proven to be slight and temporary. 

Also with the use as intended diarrhoea, stomach pain, feelings of tension in the abdomen, nausea, vomiting, stool incontinence and flatulence may occur.

In rare cases anaphylactic shock, anaphylactic reactions, angioedema, urticaria,skin rash and oversensitivity can occur. 

If one of the mentioned side effects severely impairs you, or you notice side effects that are not mentioned in the information leaflet, then please inform your doctor or pharmacist.

 

5. How to store Grünwalder Macrolax® effervescent tablets  

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

Do not use Grünwalder Macrolax® effervescent tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Always store Grünwalder Macrolax® effervescent tablets in a dry place and not above 25°C.

Please make sure that the tube is firmly closed again after use.

 

6. Further information 

After dissolving an effervescent tablet in 200 ml water the drinking solution contains the following electrolyte concentrations:

 

Grünwalder Macrolax® is marketed in a package with 10 effervescent tablets.

 

 

0044

  

Marketing in Benelux through: OCEBIO 

Date of revision of the text: October 2013