Normax Suspension
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Patient Information Leaflet : Normax Suspension Sodium Docusate and Danthron
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Normax Suspension is for
2. Before you take Normax Suspension
3. How to take Normax Suspension
4. Possible side effects
5. How to store Normax Suspension
6. Further information.
1. What Normax Suspension is for
Normax Suspension is used to treat constipation in terminally ill patients.
It contains two active ingredients, danthron and docusate sodium. Danthron is a laxative which stimulates the lower bowel and encourages normal bowel movement. Docusate sodium helps to produce soft stools which are easier to pass. Together they encourage normal bowel movement.
2. Before you take Normax Suspension
Do not take Normax Suspension if:
• You are allergic to danthron or docusate sodium
• You are allergic to any of the other ingredients in Normax suspension (listed in section 6)
• You have stomach pain which the doctor has been unable to diagnose
• Your doctor suspects you have an obstruction in your intestines
• You are pregnant or breastfeeding.
If any of the above applies to you talk to your doctor or pharmacist.
Check with your doctor before taking Normax Suspension if:
• You are incontinent
• You are on a low-sodium diet
• You are intolerant to Sorbitol.
Taking other medicines Tell your doctor if you are taking any other medicine, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Do not take Normax suspension if you are pregnant, trying to become pregnant or breast-feeding.
Warnings about some of the ingredients
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine because it contains sorbitol
The suspension contains the preservatives methyl and propyl parahydroxybenzoate. These can sometimes cause allergic reactions (possibly delayed).
The suspension contains 13.28 mg of sodium in 5 ml. This may be harmful to people on a low sodium diet.
If any of the above applies to you, talk to your doctor
3. How to take Normax Suspension
Always take Normax Suspension exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Remember to shake the bottle before taking this medicine.
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Adults
• Take one to three 5 ml spoonfuls at bedtime. Children
• Take one 5 ml spoonful at bedtime.
Normax Suspension normally works 8 hours after a dose is taken.
Do not take more than your doctor has recommended. If you are still constipated after a few days, tell the doctor. Long term use of laxatives is not recommended.
If you take more Normax Suspension than you should
If you accidentally take too much, drink plenty of water and tell your doctor.
If you forget to take a dose
If you forget to take a dose one night, take it the next night. Never double-up on the next dose to make-up for the one missed.
If you have any other questions about taking this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Normax suspension can cause side effects, although not everybody gets them.
• A few people will find that they get an orange colour in their urine. This is due to the danthron in Normax and is not a cause for concern.
• If you are incontinent you might find that the skin around your bottom gets red.
• At higher doses the sorbitol in the medicine may cause stomach upset and diarrhoea.
• Danthron may cause growths in the bowel and liver. This may make you bleed from the back passage, have stomach pains or diarrhoea. There is a possible, but very small, risk of this happening.
• With prolonged use or high doses of this medicine you may have a discolouration of the lining of your bowel.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Normax Suspension
Keep out of the reach and sight of children.
Do not use Normax Suspension after the expiry date on the pack. The expiry date refers to the last day of that month.
Store below 25°C. Keep the suspension in its original pack to protect it from light. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6. Further information
What Normax Suspension contains
The suspension contains two active substances. Each 5 ml contains 50 mg of danthron and 60 mg of docusate sodium.
The other ingredients are methylcellulose, xanthan gum, glycerol, methyl and propyl parahydroxy benzoates, sorbitol, saccharin sodium, disodium hydrogen orthophosphate, sodium dihydrogen orthophosphate, peppermint oil and purified water.
What Normax Suspension looks like
Normax Suspension is an orange yellow colour with a smell of peppermint. It comes in either a 30 ml or a 200ml bottle. Not all pack sizes may be marketed.
Marketing Authorisation Holder
RPH Pharmaceuticals AB, Lagervagen 7,
136 50 Haninge, Sweden.
Manufacturer
Pinewood Healthcare, Ballymacarbry, Clonmel, Co. Tipperary, Ireland. Distributed by Focus Pharmaceuticals Ltd. The leaflet was last revised 05/2013.
If this leaflet is difficult to see or read or
you would like it in a different format, please contact
RPH Pharmaceuticals AB, Lagervagen 7,
136 50 Haninge, FOCUS
Sweden. 23LF00849PW
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