Wednesday, October 19, 2016

Scheriproct Suppositories





INTENDIS




Scheriproct
Ointment


(1.9 mg prednisolone hexanoate / 5.0 mg cinchocaine hydrochloride per 1 g)



Scheriproct
Suppositories


(1.3 mg prednisolone hexanoate / 1.0 mg cinchocaine hydrochloride per suppository)



Read all of this leaflet carefully before you start using 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.

  • If you experience any side effect and this becomes serious, tell your doctor or pharmacist.



In this leaflet:



  • 1. What Scheriproct is and what it is used for


  • 2. Before you use Scheriproct


  • 3. How to use Scheriproct


  • 4. Possible side effects


  • 5. How to store Scheriproct


  • 6. Further information




What Scheriproct is and what it is used for


Scheriproct contains a substance which reduces inflammation (predinisolone) and a local anaesthetic (cinchocaine) which
relieves pain.


This medicine is used for the relief of the inflammation, swelling, itching and soreness of piles (haemorrhoids) and to relieve itching of the anus (back passage). It is used short-term usually for 5 to 7 days.




Before you use Scheriproct



Do not use Scheriproct if you:


  • are allergic (hypersensitive) to prednisolone hexanoate, cinchocaine hydrochloride, other local anaesthetics or any of the other ingredients of Scheriproct.

  • have a viral infection (e.g. herpes, shingles, chicken-pox)

  • have any bacterial or fungal infections of the skin or elsewhere for which you are not receiving treatment.



Take special care with Scheriproct


  • Long-term continuous treatment should be avoided because it increases the possibility of side effects. This is
    particularly important for infants and small children because continuous treatment with Scheriproct for long periods may reduce the activity of the adrenal glands and so lower resistance to disease. Also, long-term treatment can cause the skin to thin and deteriorate in the affected area (see section 4, “Possible Side Effects”) and some of the medicine may be absorbed into the blood stream.

  • If the area treated with Scheriproct is also infected your doctor should prescribe another medicine, to use with
    Scheriproct, to treat the infection.

  • Do not use a waterproof dressing to cover areas where you have applied the cream.



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.




Pregnancy and breast-feeding


Contact your doctor for advice before using this medicine if you are pregnant or intending to become pregnant or are breast-feeding. There may be a very small risk to the development of a baby in pregnant women treated with Scheriproct. As with most medicines, this risk is likely to be greatest during the first 3 months of pregnancy.




Driving and using machines


Scheriproct has no influence on the ability to drive and use machines.





How to use Scheriproct


Always use Scheriproct exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not use Scheriproct for more than 7 days.


Always wash your hands before and after applying Scheriproct.



How to use Scheriproct Ointment:


  • 1. Before you use the ointment, gently but thoroughly wash and dry the anus (back passage) and the skin around it.

  • 2. If the ointment is to be used for the area around the anus:

  • Squeeze a small quantity (about the size of a pea) on to the top of your finger.

  • Spread it gently over the skin and just inside the anus.

  • Do not rub it in.

  • 3. If the ointment is to be used inside the anus:

  • Put the separate nozzle (applicator) onto the tube.

  • Squeeze the tube until the nozzle is full of ointment. The amount of ointment in the nozzle is one dose.

  • Insert the nozzle very carefully into the anus until the whole length of the nozzle is inside.

  • Then, while squeezing the tube gently, withdraw the nozzle.

  • Wash the nozzle carefully in hot soapy water and rinse thoroughly.

Generally, the ointment should be applied twice a day, but it may be applied three or four times on the first day, to obtain quick relief.




How to use Scheriproct Suppositories:


  • 1. Before you insert a suppository find the small tear in the foil packet and remove the covering foil, by tearing it in half.

  • 2. If the suppositories have become softened, owing to warm temperature, they can be hardened by putting them into cold water before you remove the covering foil.

  • 3. Insert the whole suppository into the anus.

  • 4. To make insertion easier, either stand with one foot raised on a chair or squat down.

The usual treatment is one suppository a day, to be inserted preferably after a bowel movement. However, if your discomfort is severe, you should insert one suppository two or three times a day at the start of treatment.




If you use more Scheriproct than you should or if you accidentally swallow some Scheriproct


If you use too much Scheriproct or accidentally swallow Scheriproct it is unlikely to be dangerous but contact your doctor or pharmacist if you are worried.




If you forget to use Scheriproct


Do not use a double dose to make up for a forgotten dose. When you remember, use the next prescribed dose and continue with the treatment. See your doctor or pharmacist, if you are worried.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Scheriproct Suppositories Side Effects


Like all medicines, Scheriproct can cause side effects, although not everybody gets them.


Some thinning of the skin may occur if too much Scheriproct is applied for long periods of time (much longer than 5 to 7 days).


Allergic skin reactions may occur in rare cases. Castor oil, one of the ingredients of Scheriproct Ointment may cause a skin reaction.


If you experience any of these side effects and this becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How to store Scheriproct



  • Store Scheriproct out of the reach and sight of children.

  • There are no special storage precautions for Scheriproct Ointment.

  • Do not store Scheriproct Suppositories above 25ÂșC.

  • Do not use Scheriproct after the expiry date which is stated on the pack.

  • Medicines must 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.



Further information



What Scheriproct Ointment contains


  • The active substances are prednisolone hexanoate and cinchocaine hydrochloride. 1 g of Scheriproct Ointment contains 1.9 mg prednisolone hexanoate and 5.0 mg cinchocaine hydrochloride

  • The other ingredients are polyethylene glycol 400 monoricinoleate, hydrogenated castor oil, castor oil, 2
    octyldodecanol, chypre perfume oil.



What Scheriproct Suppositories contain


  • The active substances are prednisolone hexanoate and cinchocaine hydrochloride. Each suppository contains 1.3 mg
    prednisolone hexanoate and 1.0 mg cinchocaine hydrochloride

  • The other ingredient is hard fat.



What Scheriproct looks like and contents of the pack



  • Scheriproct Ointment is a colourless to slightly yellowish ointment supplied in tubes of 30g.


  • Scheriproct Suppositories are yellowish-white and are supplied in packs of 12 suppositories.



Marketing Authorisation Holder



Intendis GmbH

Max-Dohrn-Strasse 10

D-10589

Berlin

Germany




Manufacturer


The ointment is manufactured by:



Intendis Manufacturing, S.p.A

Milan

Italy


The suppositories are manufactured by:



Istituto de Angeli S.r.l.

Reggello

Italy


or



Intendis Manufacturing, S.p.A

Milan

Italy




Distributor in the UK



Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop Stortford

CM22 6PU

UK




This leaflet was last approved in July 2009



Scheriproct is a registered trademark of Intendis GmbH.




438850/GB/4



64013336





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