PANCREASE HL CAPSULES
Active substance: PANCREATIN
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PACKAGE LEAFLET: INFORMATION FOR THE USER
J-C 2011
GB - AW_73248
Pancrease HL
Pancreatin equivalent to pancrelipase
Pancrease is a trademark
Read all of this leaet carefully before you start using this medicine.
In this leaet
1 What Pancrease HL is and what it is used for 2 Before you use Pancrease HL 3 How to use Pancrease HL 4 Possible side eects 5 How to store Pancrease HL 6 Further information
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 get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
1 What Pancrease HL is and what it is used for
Pancrease HL is a white capsule that contains light brown coloured mini-tablets. It belongs to a group of medicines called pancreatic enzyme replacement therapy. Pancrease HL contains three medicines: Protease Amylase Lipase They are proteins (called enzymes) that help you to break down and digest food. Without them your body will not receive the nourishment it needs. It may be necessary to take Pancrease HL if you have or have had any of the following: Cystic fibrosis (a problem with your digestive system and lungs) Long-term inflammation of your pancreas (chronic pancreatitis). The pancreas is a gland behind your stomach Blockage of your pancreas or passage (duct) that releases bile. Bile is a fluid made by the liver Surgery to remove your pancreas or bypass your stomach
2 Before you use Pancrease HL
Do not use Pancrease HL if:
You are allergic to pork protein or anything in Pancrease HL (listed in section 6 below) You are under 15 years old and have cystic fibrosis Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Pancrease HL.
Pregnancy and breast-feeding
Taking other medicines
Talk to your doctor before using Pancrease HL if you are pregnant, think you may be pregnant or might become pregnant. You may still be able to use Pancrease HL if your doctor thinks you need to. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
You can take Pancrease HL if you are taking other medicines. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Driving and using machines
This medicine is unlikely to affect you being able to drive or use any tools or machines.
Using Pancrease HL with food and drink
You will need to drink plenty of water every day while taking Pancrease HL If you have difficulty swallowing the capsules, you can open them and mix the mini-tablets inside with drinks or soft foods that dont need to be chewed. It will not affect the taste of the food If you need to mix the mini-tablets with food or drink, please ask your doctor for advice on the best food or drink to use. Pancrease HL will not work as well if they are mixed with foods or drinks that are alkaline (this means they have a pH higher than 5.0)
3 How to use Pancrease HL
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The number of capsules you will need to take will depend on: Your symptoms How well the medicine works for you What you eat
How many capsules to take
Your doctor will tell you how many capsules you should take. It is usually one or two at a time, but may be more.
J-C 2011
GB - AW_73248
3 How to use Pancrease HL (continued)
How to use Pancrease HL
You will need to drink plenty of water every day while taking Pancrease HL The capsules should be taken by mouth with each meal or snack If you have difficulty swallowing the capsules, you can open them and mix the mini-tablets inside with drinks or soft foods that dont need to be chewed. It will not affect the taste of the food If you need to mix the mini-tablets with food or drink, please ask your doctor for advice on the best food or drink to use. Pancrease HL will not work as well if they are mixed with foods or drinks that are alkaline (this means they have a pH higher than 5.0)
It is important that you:
Do not chew or crush the capsules as this will damage the mini-tablets inside. This will stop the medicine working properly Do not take the capsules (or mini-tablets inside) on an empty stomach as they will not have any effect
When to stop using Pancrease HL
Keep taking Pancrease HL as long as your doctor tells you to. Do not stop taking it without talking to your doctor first.
If you take too much Pancrease HL
If you take a lot of capsules by accident you might: Feel sick (nausea), be sick (vomit) or have stomach pain Have a sore or itchy bottom If this happens, contact your doctor as soon as possible. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side eects
Like all medicines, Pancrease HL can cause side effects, although not everybody gets them. Stop using Pancrease HL and tell your doctor straight away if you notice the following. You may need medical treatment. Severe irritation or reddening of your skin or other signs of allergy during treatment. This only happens in a small number of people Contact your doctor as soon as possible if: You get unusual stomach pains or a change in existing stomach pain. Your doctor will check that no damage has been caused to your gut (intestine) Other side effects Very rare (affects less than 1 in 10,000 people) Feeling sick (nausea), being sick (vomiting), indigestion and stomach pain Blood in stools, constipation, diarrhoea, wind High levels of uric acid in the blood and urine if you take very high doses of Pancrease HL. These eects can be conrmed by medical tests Narrowing or inammation of the bowel in children with cystic brosis Decrease in weight If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Pancrease HL
Keep out of the sight and reach of children. Keep the bottle tightly closed Do not store above 25C Do not refrigerate or freeze Do not use Pancrease HL after the expiry date which is stated on the label. 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 protect the environment.
6 Further information
The active substances in Pancrease HL are: Protease (not less than 1,250 units) Amylase (not less than 22,500 units) Lipase (not less than 25,000 units) The other ingredients are: Mini-tablet: hydrogenated castor oil, silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, microcrystalline cellulose Mini-tablet coating: simethicone emulsion, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, water Capsule (body and cap): titanium dioxide, gelatine Ink: Shellac, red iron oxide (E172), dehydrated alcohol, strong ammonia solution, propylene glycol, isopropyl alcohol, Butyl alcohol OR Ink: Shellac, red iron oxide (E172), dehydrated alcohol, propylene glycol, isopropyl alcohol, butyl alcohol, strong ammonia solution, potassium hydroxide, water The product licence is held by: JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK Pancrease HL is made by: Lusomedicamenta Sociedade Tcnica Farmacutica SA, Estrada Consiglieri Pedroso, 69B, Queluz de Baixo, 2730-055 Barcarena, Portugal Or McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire, OX16 4RS, UK
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in 03/2012
What Pancrease HL looks like and contents of the pack
Pancrease HL is an opaque gelatine capsule, ringed with a red band and the letters HL in red. Each capsule contains a number of light brown mini-tablets. Pancrease HL capsules come in a polyethylene bottle containing 100 or 500 capsules. Not all pack sizes may be marketed.
J-C 2011
GB - AW_73248
Pancrease HL
Pancreatin equivalent to pancrelipase
Pancrease is a trademark
Read all of this leaet carefully before you start using this medicine.
In this leaet
1 What Pancrease HL is and what it is used for 2 Before you use Pancrease HL 3 How to use Pancrease HL 4 Possible side eects 5 How to store Pancrease HL 6 Further information
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 get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
1 What Pancrease HL is and what it is used for
Pancrease HL is a white capsule that contains light brown coloured mini-tablets. It belongs to a group of medicines called pancreatic enzyme replacement therapy. Pancrease HL contains three medicines: Protease Amylase Lipase They are proteins (called enzymes) that help you to break down and digest food. Without them your body will not receive the nourishment it needs. It may be necessary to take Pancrease HL if you have or have had any of the following: Cystic fibrosis (a problem with your digestive system and lungs) Long-term inflammation of your pancreas (chronic pancreatitis). The pancreas is a gland behind your stomach Blockage of your pancreas or passage (duct) that releases bile. Bile is a fluid made by the liver Surgery to remove your pancreas or bypass your stomach
2 Before you use Pancrease HL
Do not use Pancrease HL if:
You are allergic to pork protein or anything in Pancrease HL (listed in section 6 below) You are under 15 years old and have cystic fibrosis Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Pancrease HL.
Pregnancy and breast-feeding
Taking other medicines
Talk to your doctor before using Pancrease HL if you are pregnant, think you may be pregnant or might become pregnant. You may still be able to use Pancrease HL if your doctor thinks you need to. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
You can take Pancrease HL if you are taking other medicines. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Driving and using machines
This medicine is unlikely to affect you being able to drive or use any tools or machines.
Using Pancrease HL with food and drink
You will need to drink plenty of water every day while taking Pancrease HL If you have difficulty swallowing the capsules, you can open them and mix the mini-tablets inside with drinks or soft foods that dont need to be chewed. It will not affect the taste of the food If you need to mix the mini-tablets with food or drink, please ask your doctor for advice on the best food or drink to use. Pancrease HL will not work as well if they are mixed with foods or drinks that are alkaline (this means they have a pH higher than 5.0)
3 How to use Pancrease HL
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The number of capsules you will need to take will depend on: Your symptoms How well the medicine works for you What you eat
How many capsules to take
Your doctor will tell you how many capsules you should take. It is usually one or two at a time, but may be more.
J-C 2011
GB - AW_73248
3 How to use Pancrease HL (continued)
How to use Pancrease HL
You will need to drink plenty of water every day while taking Pancrease HL The capsules should be taken by mouth with each meal or snack If you have difficulty swallowing the capsules, you can open them and mix the mini-tablets inside with drinks or soft foods that dont need to be chewed. It will not affect the taste of the food If you need to mix the mini-tablets with food or drink, please ask your doctor for advice on the best food or drink to use. Pancrease HL will not work as well if they are mixed with foods or drinks that are alkaline (this means they have a pH higher than 5.0)
It is important that you:
Do not chew or crush the capsules as this will damage the mini-tablets inside. This will stop the medicine working properly Do not take the capsules (or mini-tablets inside) on an empty stomach as they will not have any effect
When to stop using Pancrease HL
Keep taking Pancrease HL as long as your doctor tells you to. Do not stop taking it without talking to your doctor first.
If you take too much Pancrease HL
If you take a lot of capsules by accident you might: Feel sick (nausea), be sick (vomit) or have stomach pain Have a sore or itchy bottom If this happens, contact your doctor as soon as possible. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side eects
Like all medicines, Pancrease HL can cause side effects, although not everybody gets them. Stop using Pancrease HL and tell your doctor straight away if you notice the following. You may need medical treatment. Severe irritation or reddening of your skin or other signs of allergy during treatment. This only happens in a small number of people Contact your doctor as soon as possible if: You get unusual stomach pains or a change in existing stomach pain. Your doctor will check that no damage has been caused to your gut (intestine) Other side effects Very rare (affects less than 1 in 10,000 people) Feeling sick (nausea), being sick (vomiting), indigestion and stomach pain Blood in stools, constipation, diarrhoea, wind High levels of uric acid in the blood and urine if you take very high doses of Pancrease HL. These eects can be conrmed by medical tests Narrowing or inammation of the bowel in children with cystic brosis Decrease in weight If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Pancrease HL
Keep out of the sight and reach of children. Keep the bottle tightly closed Do not store above 25C Do not refrigerate or freeze Do not use Pancrease HL after the expiry date which is stated on the label. 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 protect the environment.
6 Further information
The active substances in Pancrease HL are: Protease (not less than 1,250 units) Amylase (not less than 22,500 units) Lipase (not less than 25,000 units) The other ingredients are: Mini-tablet: hydrogenated castor oil, silica colloidal anhydrous, magnesium stearate, croscarmellose sodium, microcrystalline cellulose Mini-tablet coating: simethicone emulsion, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, water Capsule (body and cap): titanium dioxide, gelatine Ink: Shellac, red iron oxide (E172), dehydrated alcohol, strong ammonia solution, propylene glycol, isopropyl alcohol, Butyl alcohol OR Ink: Shellac, red iron oxide (E172), dehydrated alcohol, propylene glycol, isopropyl alcohol, butyl alcohol, strong ammonia solution, potassium hydroxide, water The product licence is held by: JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK Pancrease HL is made by: Lusomedicamenta Sociedade Tcnica Farmacutica SA, Estrada Consiglieri Pedroso, 69B, Queluz de Baixo, 2730-055 Barcarena, Portugal Or McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire, OX16 4RS, UK
For information in large print, tape, CD or Braille, telephone 0800 7318450.
This leaflet was last approved in 03/2012
What Pancrease HL looks like and contents of the pack
Pancrease HL is an opaque gelatine capsule, ringed with a red band and the letters HL in red. Each capsule contains a number of light brown mini-tablets. Pancrease HL capsules come in a polyethylene bottle containing 100 or 500 capsules. Not all pack sizes may be marketed.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
