Macilax 13.8 G Powder For Oral Solution
Package leaflet: nformation for the user
Macilax
13.8 g 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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.
What Macilax is and what it is used for
The name of this medicine is Macilax 13.8 g Powder for Oral Solution. It is a laxative for the treatment of chronic constipation and of very bad constipation (called faecal impaction) in adults, adolescents and elderly. It is not recommended for children below 12 years of age.
It helps you to have a comfortable bowel movement even if you have been constipated for a long time.
Macilax contains potassium, sodium and sorbitol
Macilax contains 0.63 mmol (25 mg) potassium per sachet. This should be taken into consideration if you have reduced kidney function, or if you are on a controlled potassium diet.
Macilax contains 8.1 mmol (187 mg) sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet.
The lemon lime flavour in Macilax contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
What is in this leaflet:
1. What Macilax is and what it is used for
What you need to know before you take Macilax
How to take Macilax
Possible side effects
How to store Macilax
Contents of the pack and other information
2. What you need to know before you take Macilax
Do not take Macilax
• 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.
Other medicines and Macilax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines, such as anti-epileptics, may not work as effectively during use with Macilax.
Macilax with food and drink
Macilax can be taken at any time with or without food or drink.
Pregnancy and breast-feeding
Macilax can be taken during pregnancy and whilst breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Macilax has no effect on the ability to drive or use machinery.
3. How to take Macilax
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:
Chronic constipation (constipation for a long time)
The recommended dose for constipation is one sachet taken one to three times daily according to your individual response.
Faecal impaction (complete severe constipation)
Before you take this medicine for faecal impaction, it should be confirmed that you have this condition.
The recommended dose for faecal impaction (complete severe constipation) is 8 sachets daily. The 8 sachets should be taken within a 6 hour period each day. Treatment may be continued for up to 3 days if required.
Patients with a heart condition:
Do not take more than 2 sachets in one hour.
Use in children (below 12 years of age)
Macilax is not recommended for children under 12 years old. Alternative products are available for children below 12 years of age.
Method of administration
Open the sachet and pour the contents into a glass. Add about 125 ml of water to the glass. Stir well until all the powder has dissolved and the solution is clear or slightly hazy, then drink it. If you are taking Macilax for faecal impaction it may be easier to dissolve all 8 sachets in 1 litre of water and to
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drink the solution evenly spread over a 6 hour period. Reconstituted Macilax solution should be covered and stored in the refrigerator (2°C to 8°C).
Duration of treatment Constipation:
This course of treatment for constipation should not normally last longer than 2 weeks.
On your doctor's advice, you may need to take Macilax 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 advise you to reduce your dose to one sachet taken one or two times daily.
Faecal impaction:
Treatment with Macilax can be up to 3 days.
If you take more Macilax than you should
This can cause severe pain and swelling in your abdomen (stomach), vomiting (sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.
If you forget to take Macilax
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 Macilax
To get the most benefit from Macilax, always finish the course of treatment according to the directions in this package leaflet or as your doctor or pharmacist has told you. This will make sure that your constipation is cleared, otherwise the symptoms you are suffering from may persist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
• 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.
Other side effects include:
• stomach pains
• stomach rumbles
• diarrhoea. You may have mild diarrhoea when starting to take Macilax. This usually stops if you reduce the number of sachets you take
• vomiting (being sick)
• nausea (feeling sick)
• anal discomfort (uncomfortable sensation around the bottom)
• swollen stomach
• wind
• swollen hands, feet or ankles
• headaches
• indigestion
• high or low levels of potassium in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk.yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
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.
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 Macilax and see your doctor immediately:
• signs of an allergy, such as skin rash, itching, reddening of the skin, nettle rash, shortness of breath or difficulty in breathing, or swelling of the face, lips, tongue or throat
5. How to store Macilax
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 use this medicine if you notice that any of the sachets is damaged. This medicinal product does not require any special storage conditions. Reconstituted Macilax solution can be covered and stored in the refrigerator (2°C to 8°C) and should be used within 24 hours. After 24 hours, any unused solution should be discarded.
The other ingredients are silica colloidal anhydrous, saccharin sodium, orange flavour (Orange flavour contains: flavouring preparations and substances, natural flavouring substances, maltodextrin, acacia, a-tocopherol) and lemon lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder flavour lemon, powder flavour lime, maltodextrin, mannitol, gluconolactone, sorbitol, acacia, silica colloidal anhydrous).
What Macilax looks like and contents of the pack Macilax is a white powder.
Each sachet contains 13.8 g of powder and is packed in cartons containing 20, 30 and 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Klocke Pharma-Service GmbH:
StraBburger StraBe 77 77767 Appenweier Germany
This leaflet was last revised in 01/2014.
PL 00289/1813
70040-A 297x148 248661.01-GB