Moviprep Sachets Original - 4 Sachets

If you are in poor health or have a serious medical condition, you should be particularly aware of the possible side effects listed in section 4. Contact your doctor or pharmacist if you are concerned. Talk to your doctor or pharmacist before taking Moviprep if you have any of the following:

• a tendency to regurgitate swallowed drink, food or acid from the stomach, or if have problems with swallowing (see also Moviprep with food and drink).

• kidney disease.

• heart failure or heart disease including high blood pressure, irregular heartbeats or palpitations.

• thyroid disease

• acute flare of inflammatory bowel disease (Crohn’s disease or ulcerative colitis).

Moviprep should not be given to patients with impaired consciousness without medical supervision. If you experience sudden abdominal pain or rectal bleeding when taking Moviprep for bowel preparation, contact your doctor or seek medical advice immediately.

Possible side effects

Like all medicines Moviprep can cause side effects, although not everybody gets them. It is normal to get diarrhoea when you take Moviprep. Stop your intake and tell your doctor immediately if you have any of the following side effects:

• rash or itching
• swelling of your face, ankles or other part of your body
• palpitations
• extreme fatigue
• shortness of breath

These are symptoms of a severe allergic reaction. If you do not have a bowel movement within 6 hours of taking Moviprep, stop the intake and contact your doctor immediately. Other side effects include: Very common side effects (may affect more than 1 in 10 people): Abdominal pain, abdominal distension, tiredness, feeling generally unwell, soreness of the anus, nausea and fever. Common side effects (may affect up to 1 in 10 people): Hunger, problems sleeping, dizziness, headache, vomiting, indigestion, thirst and chills. Uncommon side effects (may affect up to 1 in 100 people): Discomfort, difficulties swallowing, and changes to tests of liver function. The following side effects have sometimes been seen but it is not known how often they occur because the frequency cannot be estimated from the available data: flatulence (wind), temporary increase in blood pressure, irregular heart rhythm or palpitations, dehydration, retching (straining to vomit), very low blood sodium levels that can cause convulsions (fits) and changes to the levels of salts in the blood such as decreased bicarbonate, increased or decreased calcium; increased or decreased chloride and decreased phosphate. Blood potassium and sodium levels could also decrease. These reactions usually only occur for the duration of the treatment. Should they persist, consult your doctor. Allergic reactions may cause a skin rash, itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches, palpitations and shortness of breath.

Ingredients

Sachet A contains these active substances:

• Macrogol (also known as polyethylene glycol) 3350 - 100 g
• Sodium sulfate anhydrous - 7.500 g
• Sodium chloride - 2.691 g
• Potassium chloride - 1.015 g

Sachet B contains these active substances:

• Ascorbic acid - 4.700 g
• Sodium ascorbate - 5.900 g

The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows:

• Sodium 181.6 mmol/L (of which not more than 56.2 mmol is absorbable)
• Chloride 59.8 mmol/L
• Sulfate 52.8 mmol/L
• Potassium 14.2 mmol/L
• Ascorbate 56.5 mmol/L

The other ingredients are: Lemon flavouring (containing maltodextrin, citral, lemon oil, lime oil, xanthan gum, vitamin E), aspartame (E951) and acesulfame potassium (E950) as sweeteners.