Pancrex V Capsules
PANCREATIN CAPSULES
Each capsule contains not less than the following activity: Free protease 430 B.P Units
Lipase 8000 B.P. Units
Amylase 9000 B.P. Units
DOSE: Infants: The contents of 1-2 capsules mixed thoroughly with feeds.
Older Children and Adults: 2-6 capsules 4 times daily swallowed whole with meals.
If mixed with liquids use within one hour.
Store at a temperature not exceeding 15°C.
KEEP ALL MEDICINES OUT OF CHILDREN'S REACH
PL 41094/0006 EP00072 E2078
Essential Pharmaceuticals Ltd Egham, Surrey, TW20 8RB, UK.
Signs of an allergy to something include rash, wheezing, breathlessness, swollen eyelids, face or lips, and in extreme cases collapse. In the unlikely event that you should get any of these symptoms soon after taking Pancrex V Capsules, don’t take any more. Tell a doctor straight away and take the packaging and this leaflet with you.
Rarely, high levels of uric acid in the blood and urine have been reported when extremely high doses of pancreatin have been taken.
Narrowing of parts of the bowel, and inflammation of the colon, have been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements.
Some irritation of the skin of the mouth may occur if the capsules are chewed or the contents kept in the mouth. Irritation of the anus may also occur, which may be prevented by use of a barrier cream.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PANCREX V CAPSULES
Store at, or below, 15°C. This is best achieved by storing the container in the fridge.
Keep out of the reach and sight of children.
Do not use Pancrex V Capsules after the expiry date which is stated on the pack after Expiry Date. The expiry date refers to the last day of that 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.
6. FURTHER INFORMATION What Pancrex V Capsules contain
The active substance is Pancreatin BP. BP is a British standard measure of potency (expected biological effect) of a pharmaceutical product.
Each capsule contains at least:
- 430 BP units of free protease, an enzyme that digests protein
- 8000 BP units of lipase, an enzyme that digests fat
- 9000 BP units of amylase, an enzyme that digests starch and sugars
Each capsule also contains aluminium oxide, magnesium stearate, microcrystalline cellulose, gelatin, titanium dioxide, yellow iron oxide (E172), quinoline yellow (E104).The capsule is made of gelatin, which is of bovine origin.
What Pancrex V Capsules look like and contents of the pack
Pancrex V Capsules consist of white or buff-coloured powder in an ivory-coloured hard gelatin shell imprinted with 'Pancrex V' and a company logo. Each plastic container holds 300 capsules.
Internet sites for patients with your condition
There are a number of websites available on your condition and its treatment, which may provide you with further useful information. Contact the Pancreatic Society of Great Britain and Ireland for assistance.
Marketing authorisation holder and manufacturer
The Marketing Authorisation for Pancrex V Capsules is held by Essential Pharmaceuticals Ltd, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK.
The capsules are manufactured by Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK.
EP00072 E2078
PANCREATIN CAPSULES
Each capsule contains not less than the following activity: Free protease 430 B.P Units
Lipase 8000 B.P. Units
Amylase 9000 B.P. Units
flbS]Xjnts: The content^ 1-2cjjsul|jJ ^ mixed thoroughly with feeds.
• Olde^ldren andtdults: 2-6 capsules 4 times L dailyswaEwejVholewith meals.
If mixed with liquids use within one hour.
Store at a temperature not exceeding 15°C.
KEEP ALL MEDICINES OUT OF CHILDREN'S REACH
PL 41094/0006 EP00072 E2078
0
Essential Pharmaceuticals Ltd Egham, Surrey, TW20 8RB, UK.
Patient Information Leaflet Pancrex V Capsules
Pancreatin
Read all of this leaflet carefully before you start taking this medicine. It contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine is available without prescription. However, you still need to take Pancrex carefully to get the best results from it. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pancrex V Capsules are and what they are used for
2. Before you take Pancrex V Capsules
3. How to take Pancrex V Capsules
4. Possible side effects
5. How to store Pancrex V Capsules
6. Further information
1. WHAT PANCREX V CAPSULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in Pancrex V Capsules is pancreatin.
Pancreatin is a combination of enzymes normally produced by the pancreas which help to digest protein, fat, starch and sugars in the food that you eat.
Pancreatin is given to people who do not produce enough enzymes to digest their food properly, in conditions such as cystic fibrosis, persistent inflammation of the pancreas, and when the pancreas has been removed. Pancrex V Capsules may also be used when the stomach has been removed, as an aid to digestion.
These capsules may be used when small amounts of Pancrex are required, such as in younger children. The capsules may also be used in patients who cannot easily dissolve the special coating of other pancreatin preparations.
The pancreatin in Pancrex V Capsules is derived from pancreases of pigs.
2. BEFORE YOU TAKE PANCREX V CAPSULES Do not take Pancrex V Capsules if you
- are allergic (hypersensitive) to pancreatin or any of the other ingredients of
Pancrex V Capsules (see list in section 6 ‘Further Information’)
There are no known diseases that may prevent you from taking Pancrex V Capsules.
Taking other medicines
Pancrex V Capsules are not known to interfere with any other medicines that you may be taking. However if you are prescribed another medicine, inform the doctor you are taking Pancrex V Capsules.
Pregnancy and breast-feeding
If you are pregnant, thinking of becoming pregnant or breast-feeding, discuss this with your doctor before taking your medicine as dose adjustments may be necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pancrex V Capsules do not interfere with your ability to drive or operate machinery.
3. HOW TO TAKE PANCREX V CAPSULES Dosage
Your doctor or pharmacist will advise you on the amount of Pancrex V Capsules to take before each meal, although you may find with experience that you need to adjust the dose according to the size and type of meal that you eat. If loose pale stools (faeces) occur you may need to increase the dose. Always check with your pharmacist if you are not sure.
The following should provide a good starting point for adjustment of the dose:
• For infants, the contents of 1-2 capsules mixed with feeds.
• For older children and adults, 2-6 capsules (or their contents) with each meal or snack.
If the capsule contents are mixed with liquids or feeds, use within one hour.
If you take more Pancrex V Capsules than you should
There are no special precautions to take, although the use of a barrier cream may help prevent possible irritation of the anus.
If you forget to take Pancrex V Capsules
Simply skip that dose and take the next dose with your next meal or snack.
If you have any further questions on the use of this product, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pancrex V Capsules can cause side effects, although not everybody gets them.
It is possible that some people may be allergic (hypersensitive) to Pancrex V Capsules. Allergic/asthmatic reactions have occasionally occurred on handling the capsule contents.