Skip to Content

COSMOCOL ORANGE FLAVOUR POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

*VZTV*VS6YHUNL-SH]V\Y
Powder for oral solution
9LHKHSSVM[OPZSLHÅL[JHYLM\SS`ILMVYL`V\Z[HY[[HRPUN[OPZTLKPJPUL
ILJH\ZLP[JVU[HPUZPTWVY[HU[PUMVYTH[PVUMVY`V\
This medicine is available without prescription. However, you still need to take
CosmoCol Orange Flavour carefully to get the best results from it.
 2LLW[OPZSLHÅL[@V\TH`ULLK[VYLHKP[HNHPU
- Ask your pharmacist if you need more information or advice.
 @V\T\Z[JVU[HJ[HKVJ[VYPM`V\YZ`TW[VTZ^VYZLUVYKVUV[PTWYV]LHM[LY
14 days.
 0M`V\NL[HU`ZPKLLɈLJ[Z[HSR[V`V\YKVJ[VYVYWOHYTHJPZ[;OPZPUJS\KLZ
HU`WVZZPISLZPKLLɈLJ[ZUV[SPZ[LKPU[OPZSLHÅL[
>OH[PZPU[OPZSLHÅL[!
1. What CosmoCol Orange Flavour is and what it is used for
2. What you need to know before you take CosmoCol Orange Flavour
3. How to take CosmoCol Orange Flavour
7VZZPISLZPKLLɈLJ[Z
5. How to store CosmoCol Orange Flavour
6. Contents of the pack and other information
>OH[*VZTV*VS6YHUNL-SH]V\YPZHUK^OH[P[PZ\ZLKMVY
CosmoCol Orange Flavour is a laxative used for the treatment of long term
(chronic) constipation and faecal impaction (persistent constipation, where
a large volume of stools cause a blockage of the rectum and / or colon). It is
not recommended for children below 12 years of age. Macrogol 3350 makes
your faeces softer and easier to pass, giving you relief from constipation.
The electrolytes (salts) help to maintain your body’s normal levels of sodium,
potassium and water while you are being treated for constipation.
>OH[`V\ULLK[VRUV^ILMVYL`V\[HRL*VZTV*VS6YHUNL-SH]V\Y
+VUV[[HRL*VZTV*VS6YHUNL-SH]V\Y
- if you are allergic (hypersensitive) to macrogol 3350, sodium chloride,
sodium hydrogen carbonate, potassium chloride, or any of the other
ingredients in CosmoCol Orange Flavour
- if you have a perforated gut (bowel) wall
- if you have a blockage in your intestine (gut obstruction, ileus)
 PM`V\OH]LZL]LYLPUÅHTTH[VY`IV^LSKPZLHZLZ\JOHZ\SJLYH[P]LJVSP[PZ 
Crohn’s disease or toxic megacolon
If any of these applies to you, please talk to your doctor or pharmacist for
further advice.
6[OLYTLKPJPULZHUK*VZTV*VS6YHUNL-SH]V\Y
:VTLTLKPJPULZLNHU[PLWPSLW[PJZTH`UV[^VYRHZLɈLJ[P]LS`K\YPUN\ZL
with CosmoCol Orange Flavour.
Please tell your doctor or pharmacist if you are taking, or have recently taken,
any other medicines, including medicines obtained without a prescription.
*VZTV*VS6YHUNL-SH]V\Y^P[OMVVKHUKKYPUR
CosmoCol Orange Flavour can be taken at any time with or without food or
drink
7YLNUHUJ`HUKIYLHZ[MLLKPUN
If you are pregnant or breast-feeding talk to your doctor before taking
CosmoCol Orange Flavour.
+YP]PUNHUK\ZPUNTHJOPULZ
*VZTV*VS6YHUNL-SH]V\YOHZUVLɈLJ[VU[OLHIPSP[`[VKYP]LVY\ZL
machinery.
0TWVY[HU[PUMVYTH[PVUHIV\[ZVTLVM[OLPUNYLKPLU[ZVM*VZTV*VS
6YHUNL-SH]V\Y
CosmoCol Orange Flavour contains 0.63 mmol (25 mg) of potassium per
sachet. This should be taken into consideration if you take more than
one sachet daily and you have reduced kidney function, or if you are on a
controlled potassium diet.
CosmoCol Orange Flavour contains 8.1 mmol (187 mg) of sodium per sachet.
This should be taken into consideration if you are on a controlled sodium diet.
/V^[V[HRL*VZTV*VS6YHUNL-SH]V\Y
;YLH[TLU[VMJOYVUPJJVUZ[PWH[PVUPUHK\S[ZJOPSKYLUHNLK`LHYZHUK
HIV]LHUK[OLLSKLYS`!
The recommended dose for constipation is one sachet taken one to three
times daily.
Duration of treatment
This course of treatment for constipation should not normally last longer than
2 weeks.
;YLH[TLU[VMMHLJHSPTWHJ[PVUPUHK\S[ZJOPSKYLUHNLK`LHYZHUK
HIV]LHUK[OLLSKLYS`!
Before you take CosmoCol Orange Flavour for faecal impaction, your doctor
T\Z[JOLJR[VJVUÄYT[OH[`V\OH]L[OPZJVUKP[PVU;OLYLJVTTLUKLKKVZLPZ
8 sachets daily, all of which should be consumed within 6 hours.
To prevent further problems from faecal impaction, your doctor may advise
[OH[`V\JVU[PU\L[HRPUN[OPZTLKPJPUL@V\ZOV\SK\ZL[OLKVZLMVY[YLH[PUN
chronic constipation.
Duration of treatment
The course of treatment for faecal impaction should be stopped when a large
volume of stools is passed and does not normally last longer than 3 days.
How to mix
Open the sachet and pour the contents into a glass. Add about 125 ml or a
quarter pint of water to the glass. Stir well until the powder has dissolved and
then drink it.
0M`V\[HRLTVYL*VZTV*VS6YHUNL-SH]V\Y[OHU`V\ZOV\SK
This can cause severe pain and swelling in your abdomen (stomach), or
vomiting (sickness) or diarrhoea. If this happens, contact your doctor or
pharmacist.
0M`V\MVYNL[[V[HRL*VZTV*VS6YHUNL-SH]V\Y
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.
0M`V\Z[VW[HRPUN*VZTV*VS6YHUNL-SH]V\Y
;VNL[[OLTVZ[ILULÄ[MYVT*VZTV*VS6YHUNL-SH]V\YHS^H`ZÄUPZO[OL
JV\YZLVM[YLH[TLU[HJJVYKPUN[V[OLKPYLJ[PVUZPU[OPZWHJRHNLSLHÅL[;OPZ^PSS
make sure that your constipation is cleared, otherwise the symptoms you are
Z\ɈLYPUNMYVTTH`WLYZPZ[

@V\T\Z[JVU[HJ[HKVJ[VYPM`V\YZ`TW[VTZ^VYZLUVYKVUV[PTWYV]LHM[LY
14 days.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
7VZZPISLZPKLLɈLJ[Z
3PRLHSSTLKPJPULZ*VZTV*VS6YHUNL-SH]V\YJHUJH\ZLZPKLLɈLJ[Z
although not everybody gets them.
0M`V\L_WLYPLUJLHU`VM[OLMVSSV^PUNZPKLLɈLJ[ZZ[VW[HRPUN*VZTV*VS
6YHUNL-SH]V\YHUKZLL`V\YKVJ[VYPTTLKPH[LS`!
 ZPNUZVMHUHSSLYN`Z\JOHZHYHZOP[JOPUNZOVY[ULZZVMIYLH[OVYKPɉJ\S[`
in breathing.
 ZPNUZVMHJOHUNLPU`V\YIVK`»ZÅ\PKVYLSLJ[YVS`[LSL]LSZZHS[ZSL]LSZ

such as swelling (mainly in the ankles), feeling weak, increasingly tired or
increased thirst with headache
;OLMVSSV^PUNZPKLLɈLJ[ZHYLHSZVWVZZPISL!
- abdominal (stomach) pain
- mild diarrhoea (when starting to take CosmoCol Orange Flavour, this usually
stops if you reduce the number of sachets you take)
- nausea (feeling sick)
- vomiting
- swelling of your abdomen (feeling bloated)
- stomach rumbling
 ÅH[\SLUJL^PUK
- soreness of the anus (bottom)
0M`V\NL[HU`ZPKLLɈLJ[Z[HSR[V`V\YKVJ[VYVYWOHYTHJPZ[;OPZPUJS\KLZHU`
WVZZPISLZPKLLɈLJ[ZUV[SPZ[LKPU[OPZSLHÅL[
9LWVY[PUNVMZPKLLɈLJ[Z
0M`V\NL[HU`ZPKLLɈLJ[Z[HSR[V`V\YKVJ[VYWOHYTHJPZ[VYU\YZL;OPZ
PUJS\KLZHU`WVZZPISLZPKLLɈLJ[ZUV[SPZ[LKPU[OPZSLHÅL[@V\JHUHSZVYLWVY[
ZPKLLɈLJ[ZKPYLJ[S`]PH[OL@LSSV^*HYK:JOLTLH[!
www.mhra.gov.uk/yellowcard
)`YLWVY[PUNZPKLLɈLJ[Z`V\JHUOLSWWYV]PKLTVYLPUMVYTH[PVUVU[OLZHML[`
of this medicine.
/V^[VZ[VYL*VZTV*VS6YHUNL-SH]V\Y
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 store above 25 °C.
Do not use this medicine if you notice that any of the sachets is damaged.
Reconstituted CosmoCol Orange Flavour 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.
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.
*VU[LU[ZVM[OLWHJRHUKV[OLYPUMVYTH[PVU
;OLHJ[P]LZ\IZ[HUJLZHYL!
,HJOZHJOL[JVU[HPUZ!
macrogol 3350
sodium chloride
sodium hydrogen carbonate
potassium chloride

13.125 g
0.3507 g
0.1785 g
0.0466 g

The other ingredients are colloidal anhydrous silica, saccharin sodium and
VYHUNLÅH]V\Y6YHUNLÅH]V\YJVU[HPUZ!ÅH]V\YPUNZ\IZ[HUJLZHUKÅH]V\YPUN
preparations, maltodextrin, acacia gum, alpha-tocopherol).
>OH[*VZTV*VS6YHUNL-SH]V\YSVVRZSPRLHUKJVU[LU[ZVM[OLWHJR
CosmoCol Orange Flavour is a white powder.
Each sachet contains 13.8 g of powder and is packed in cartons containing
20, 30, 50, 60 (2x30) and 100 (2x50) sachets.
Not all of these pack sizes are marketed.
4HYRL[PUN(\[OVYPZH[PVU/VSKLY
Stirling Anglian Pharmaceuticals Ltd
Hillington Park Innovation Centre
1 Ainslie Road
Hillington Park
Glasgow
G52 4RU
United Kingdom

4HU\MHJ[\YLY
Klocke Pharma-Service GmbH
Strassburger Strasse 77
77767 Appenweier
Germany
Hermes Pharma Ges.m.b.H.
Allgäu 36
9400 Wolfsberg
Austria

;OPZSLHÅL[^HZSHZ[YL]PZLKPU

73441 B

60007804

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide