CO-DANTHRAMER 25 MG / 200 MG PER 5ML ORAL SUSPENSION - patient leaflet, side effects, dosage

1. what co-danthramer is and what it is used for

Co-Danthramer 25 mg/200 mg per 5 ml Oral Suspension (“Co-Danthramer”)be­longstoagroupo­flaxativescalled­stimulant laxatives. It worksbyencoura­gingnormalbowel­movements between 6 and 12 hours aftertakingit.Co-Danthramerisusedfor the prevention and treatmentofcon­stipationinse­riously ill patients.

• 2. What you need to knowbeforeyoutakeCo-Danthramer Do not take Co-Danthramer If you:

• are allergic to dantron, poloxamer188 or any of the other ingredients of Co-Danthramer (see Section 6 and end of Section 2).
• are pregnant or are breast-feeding.
• suffer from intestinal obstruction-bowelblockage.
• have signs of appendicitiso­rinflamedbowel(se­vere pain in your side).

Take special care with Co-Danthramer

Before you take Co-Danthramer, tell your doctor if you:

• sufferfromincon­tinenceasprolon­gedcontactwit­htheskincan cause irritation and peeling of the skin, or staining.
• have hereditary fructose intolerance.
• suffer from liver disease, alcoholism or epilepsy.
• have ever had kidney-related problems.

Taking other medicines

You must tell yourdoctorify­ouaretakingor­haverecently taken any other medicines, includingother­laxativesandme­dicines obtained without a prescription. Co-Danthramermaymodify or increase the effects of other medicines.

Pregnancy and breast-feeding

Do not take Co-Danthramer if youare, or are likely to become pregnant, or are breast-feeding (seo ofS of Section 2).

Driving and using machines

Co-Danthramer maycauseunusu­altirednessor­weakness and, if affected, you should not drive or op erate machinery (see end of Section 2).

Important Information about some of the Ingredients of Co-Danthramer:

The product contains:

• Sorbitol (E420): this medicine contains 1300 mg of sorbitol per

5 ml whichisequiva­lentto260 mgperml.Whenta­kenaccording to the dosagerecommen­dationseachdo­sesuppliesup to 2600 mg of sorbitolperlOm­l.Sorbitolisa­sourceof fructose. If your doctor has toldyouthatyou­(oryourchild) have an intolerance to some sugarsorifyou­havebeen diagnosed with hereditary fructose intolerance(HFI),a­rare genetic disorder in which a person cannot breakdownfructose, talk to your doctor before you (or your child) takeorreceive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

• Ethanol: this medicine contains150mg of alcohol (ethanol) in each 5 ml which is equivalentto30mgper ml. The amount in 5 ml of this medicine is equivalent to 3.6 ml beer, 1.5 ml wine per dose. The amount ofalcoholinthis­medicineisnotli­kely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

If you are addictedtoalco­hol.talktoyou­rdoctororphar­macist before taking this medicine.

• Propylene glycol (E1520): this medicine contains 260 mg propylene glycol in eachSmlwhichi­sequivalent to 52 mg/ml. If your baby is less than 4 weeksold.talk to your doctor or pharmacist before giving themthis medicine, in particular if the baby is given other medicinesthat­contain propylene glycol or alcohol.
• Sodium: this medicineconta­inslessthan1 mmol sodium (23 mg) per 5 ml, that is tosayessentia­lly‘sodium-free’.
• Ethyl parahydroxyben­zoate(E214),pro­pylparahydroxy­benzoate (E216), methyl parahydroxybenzoate (E218): may cause allergic reactions, which may be delayed.

3. how to take co-danthramer

Always take Co-Danthramer exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Shake the bottle well before taking Co-Danthramer, but avoid contact with skin to prevent staining.

The effects of Co-Danthramerare­usuallyseen6to12 hours after you have taken it.

The usual dose is:

Adults and children over 12 years:	OnetotwoS ml spoonfuls at bedtime.
Children under 12 years:	Shouldbeavoided, but if recommended, a suitable dose is half to one 5 ml spoonful at bedtime.

Your doctor mayadvlseyouto­takeyourmedlclne in a different way, so you must always follow your doctor's advice about when and how to take Co-Danthramer. Check with your doctor If you are unsure.

4. possible side effects

Like all medicines, Co-Danthramer can cause side effects, although not everybody gets them.

Possible side effects are:

• abdominal cramps
• rash
• urine may be coloured red
• stomach upset
• irritation andpeelingorsta­iningoftheski­ne.g.ininconti­nence
• unusual tiredness or weakness

With prolonged use, the following may occur:

• discolouration of the lining of your stomach
• kidney stones – failure
• bowels may stop working normally – stopping salt and nutrients being absorbed into the blood

In animals, dantron can causegrowthsinthe bowel and liver. There may be a possible, but verysmallriskof­thishappening in humans.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help

5. how to store co-danthramer

Keep this medicineoutof­thesightandre­achofchildren­.Do not use Co-Danthramerafter­theexpirydatew­hichisstatedon­the label. The expiry date refers tothelastdayof­thatmonth.Donot store above 25 C, and store in the original container.

Medicines should not be disposedofvia­wastewater or household waste. Ask your pharmacist howtodispose of medicines no longer required. These measures will helpto protect the environment.

6. contents of the pack and otherlnformation what co-danthramer contains

Each 5 ml of Co-Danthramer contains:

• Active ingredients: 25 mg Dantron and 200 mg Poloxamer 188.
• Other ingredients: aluminium magnesium silicate, xanthan gum, glycerol (E422),sorbitol(E420),sac­charinsodium,pro­pylene glycol(E1520),et­hanol,methylpa­rahydroxybenzo­ate(E218), ethyl parahydroxyben­zoate(E214),pro­pylparahydroxy­benzoate(E216), citric acid monohydrate, sodium citrate, purified water and peach

Braille Translation:

CO-

DANTHRAMER

#25 MG/

#200 MG