31.25 mg rectal solution
Prednisolone sodium phosphate
What Prednisolone Unimedic is and what it is used for
Prednisolone Unimedic is a cortisone preparation used for moderate or severe ulcerative proctosigmoiditis (painful inflammation of the colon), in particular the treatment of acute deterioration of the lower part of the colon or rectum.
Prednisolone sodium phosphate (a type of cortisone ) contained in Prednisolone Unimedic may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Prednisolone Unimedic
Do not use Prednisolone Unimedic
– if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
if you have a local viral, fungal, or bacterial infection (such as tuberculosis or gonorrhea ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Prednisolone Unimedic.
Contact a doctor if you experience blurred vision or other visual disturbances.
Other medicines and Prednisolone Unimedic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Prednisolone Unimedic may affect the dosage of one of the medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following:
|Medicines (active substance)||Purpose of the medicinal product|
|phenobarbital, phenytoin and carbamazepine||prevent seizures|
|rifampicin||Treat infections like tuberculosis|
|itraconazole||treat fungal infections|
|ketoconazole (other than shampoo )||used in Cushing’s syndrome (when the body produces too much cortisol )|
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is only limited experience with the use of Prednisolone Unimedic during pregnancy.
Prednisolone Unimedic passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Prednisolone Unimedic
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide which dosage is best for you.
The doctor’s dosing instructions should always be followed, but the recommended dose in adults is usually 125 ml of rectal solution in the rectum every night before bedtime.
Instructions for use.
- Prednisolone Unimedic rectal solution is taken at bedtime. Use a plastic bag as hand protection (see photos).
- Push the protective sleeve down as far as it will go all the way down to the top of the lid (NOTE! Do not turn).
- Remove the depressed protective sleeve.
- Lie on the left side, possibly with a pillow under the hip, and insert the tip of the bottle into the rectum. The insertion can be facilitated if you lubricate the tip with a little Vaseline.
- Start by squeezing out a little, so that the intestine gets used to it, and then slowly empty the contents of the bottle into the intestine for a few minutes.
- Remove the tip when the bottle is emptied, but keep the bottle still compressed to prevent re-suction.
- If you need to pause while using the rectal solution, pull out the spout with the bottle still compressed to prevent re-suction. Then continue injecting the rest of the medicine. Discard the bottle after use.
- Rollover on your stomach and stay in this position for 3-5 minutes!
- The rectal fluid should be kept in the intestine for as long as possible, preferably overnight.
Thread the plastic bag over your hand and grab the bottle. Keep the handle around the bottle after it has been emptied. Pull the bag down over the bottle, which is then thrown away.
If you use more Prednisolone Unimedic than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Prednisolone Unimedic
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Prednisolone Unimedic is given in the rectum. When prednisolone is given in the rectum, the body does not absorb as much prednisolone and therefore has few side effects. With long-term use, the levels of certain hormones that are formed in the adrenal cortex can decrease (part of the adrenal glands) (plasma cortisol lowering).
Common (may affect up to 1 in 10 people): Nausea
Rare (may affect up to 1 in 1,000 people): Lowering plasma cortisol levels
Has been reported (occurs in an unknown number of users): Blurred vision
How to store Prednisolone Unimedic
Keep this medicine out of the sight and reach of children.
Store in the outer carton to protect from light.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
- The active substance is prednisolone sodium phosphate. 125 ml rectal solution contains 31.25 mg prednisolone sodium phosphate equivalent to 23.25 mg prednisolone
- The other ingredients are purified water, sodium chloride, 96% ethanol, nicotinamide, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium citrate, disodium phosphate dihydrate, sodium hydroxide, and citric acid.
What the medicine looks like and the contents of the pack
Each package contains 6 soft plastic bottles of 125 ml with an insertion tip and protective sleeve.
Marketing Authorization Holder and Manufacturer
Unimedic Pharma AB Box 6216
102 34 Stockholm
Tel: 010-130 99 50
864 21 Matfors