Lacrofarm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lacrofarm, powder for oral solution, sachet
Text to be used nationally where Lacrofarm is available without prescription:
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, pharmacist or nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4
• You must talk to a doctor if your symptoms worsen or do not improve after 14 days for constipation.
Text to be used nationally where Lacrofarm is subject to medical prescription:
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4
In is in this leaflet:
1. What Lacrofarm is and what it is used for
2. What you need to know before you take Lacrofarm
3. How to take Lacrofarm
4. Possible side effects
5. How to store Lacrofarm
6. Contents of the pack and other information
1. What Lacrofarm is and what it is used for
The name of this medicine is Lacrofarm
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It is a laxative for the treatment of chronic constipation in adults, children (aged 12 years and above) and the elderly.
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It helps you to have a comfortable bowel movement even if you have been constipated for a long time. It also works in very bad constipation called faecal impaction (complete severe constipation).
2. What you need to know before you take Lacrofarm
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if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients listed in section 6.
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if you have a perforated gut wall.
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if you have a blockage in your intestine (gut obstruction, ileus) for example by paralysis of the intestine.
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if you have severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon.
If any of these apply to you, please talk to your doctor or pharmacist for further advice.
Warnings and precautions
If you develop symptoms such as swelling, shortness of breath, feeling tired, dehydration (symptoms include increasing thirst, dry mouth and weakness) or heart problems you should stop taking Lacrofarm and contact your doctor immediately.
Do not take Lacrofarm for longer periods of time unless you have been instructed to do so by your doctor; for example if you take drugs that can cause constipation or if you have a disease which cause constipation for example Parkinson’s disease or multiple sclerosis (MS).
Other medicines and Lacrofarm
Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines.
Pregnancy and breast-feeding
Lacrofarm can be used during pregnancy or while breast-feeding.
If you are pregnant or breast-feeding, think 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
Lacrofarm has no effect on the ability to drive or use machines.
Lacrofarm contains sodium
This medicinal product contains 8.125 mmol (or 187 mg) sodium per sachet. To be taken into consideration by patients on a controlled sodium diet.
3. How to take Lacrofarm
For medicines available without prescription:
Always take Lacrofarm 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.
For medicines available on prescription only:
Always take Lacrofarm exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Chronic Constipation(constipation for a long time)
Dosage – adults and children above 12 years
1 sachet one to three times daily. The normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed. The dose depends on the severity of your constipation. The dose can be adjusted down to the lowest effective dose after a couple of days. The time of the treatment is normally 2 weeks. If the symptoms persist after 2 weeks of treatment contact your doctor.
Children (below 12 years of age)
Not recommended.
Patients with renal insufficiency
No dosage change is necessary for treatment of chronic constipation.
Patients with a heart condition
Do not take more than 2 sachets in one hour.
Faecal Impaction (complete severe constipation)
Before you take this medicine for faecal impaction, it should be confirmed by a doctor that you have this condition.
Dosage – adults and children above 12 years
The usual dose for faecal impaction (complete severe constipation) is 8 sachets daily. The 8 sachets should be taken within a 6 hour periodeach day for up to 3 days if required.
Children (below 12 years of age)
Not recommended.
Patients with renal insufficiency
No dosage change is necessary for treatment of faecal impaction
Patients with a heart condition
Do not take more than 2 sachets in one hour.
How to use Lacrofarm
This medicine can be taken at any time with or without food or drink.
Dissolve the contents of 1 sachet in a glass of water (125ml or ¼ pint), stir well and drink. If you are being treated for faecal impaction it may be easier to dissolve all 8 sachets in 1 litre of water.
If you take more Lacrofarm than you should
You may develop diarrhoea. Stop taking Lacrofarm until it clears, then start again at a lower dose. If you are worried contact your doctor or pharmacist.
If you forget to take Lacrofarm
Take the dose as soon as you remember and then continue on as before. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Lacrofarm can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Lacrofarm and see your doctor immediately:
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a serious allergic reaction which causes difficulty in breathing or dizziness, or swelling of the face, lips, tongue or throat.
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signs of an allergy, such as a rash, itching or shortness of breath.
The following side effects have also been reported:
Common (may affect up to 1 in 10 people):
Stomach rumbling, swollen stomach or stomach pain, suffering from wind, vomiting, feeling sick, indigestion or a sore anus (bottom). If you experience mild diarrhoea when you start to take Lacrofarm your condition will generally get better if you reduce the amount of Lacrofarm you take.
Very rare (may affect up to 1 in 10,000 people):
Hives, reddening of the skin or a nettle rash, swelling of the hands, feet or ankles.
Other side effects include:
Headaches, high and low levels of potassium in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: [To be completed nationally]. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Lacrofarm
Keep out of the sight and reach of children.
Do not use Lacrofarmafter the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.
Unopened sachet: No special storage conditions.
Once you have made up Lacrofarmin water, if you cannot drink it straight away keep it covered and store in a refrigerator (2°C – 8°C). Throw away any solution not used within a 24 hour period.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Lacrofarm contains
The active substances are macrogol 3350 (13.125g), sodium chloride (350.7mg), sodium hydrogen carbonate (178.5mg) and potassium chloride (46.6mg).
The other ingredients are lemon flavour and acesulfame potassium (E950) as a sweetener. The lemon flavour contains the following ingredients: acacia gum (E414) and flavouring.
What Lacrofarm looks like and contents of the pack
Lacrofarm is a white powder packed in sachets.
It is available in boxes of 2, 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.
Not all pack sizes may be marketed.
OTC packages: [To be completed nationally]
Marketing Authorisation Holder and Manufacturer
<[to be completed nationally]>.
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last approved in 2014-11-04
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