BIPHASIC ISOPHANE INSULIN INJECTION BP (PORCINE)

PACKAGE LEAFLET: INFORMATION FOR THE USER

HYPURIN® PORCINE RANGE OF INSULIN
INJECTION

Read all of this leaflet carefully before
you inject your insulin.
- Keep this leaflet. You may need to
read it again while you are receiving
your treatment.
- If you have any further questions,
please ask your doctor, pharmacist
or diabetic nurse.
- This medicine has been prescribed
for you. It must not be shared with
other patients. It may harm them
even if their symptoms are the same
as yours.

In this leaflet:
1. What Hypurin® is and what it is used for
2. Before you receive Hypurin®
3. How to use Hypurin®
4. Possible side effects
5. How to store Hypurin®
6. Further information
1. WHAT HYPURIN® IS AND WHAT IT IS USED FOR
The name of your medicine is Hypurin Porcine Insulin.
Hypurin Porcine is the brand name for a range of highly
purified porcine (pig) insulin injections.
Hypurin Porcine Neutral is a sterile, clear solution of porcine
insulin (100 international units/ml). It is short acting.
Hypurin Porcine Isophane is a sterile, white suspension of
porcine insulin (100 international units/ml) with protamine
sulphate and zinc chloride in water. It is longer acting than
Hypurin Porcine Neutral.
Hypurin Porcine 30/70 Mix is a sterile, white suspension
of porcine neutral and isophane insulins (100 international
units/ml). It is intermediate acting.
What Hypurin is used for
Hypurin contains insulin which is a natural hormone,
made by a gland called the pancreas. Insulin plays a key
role in the way the body uses carbohydrate, fat and protein.
Hypurin Porcine is used for the treatment of insulindependent diabetes mellitus. In this type of diabetes, your
pancreas does not make enough insulin to control the level
of sugar in your blood. It can be treated by controlling your
diet and taking insulin. Hypurin Porcine has been prescribed
for you as a substitute for your own insulin.
2. BEFORE YOU RECEIVE HYPURIN®
You should not inject Hypurin Porcine insulin if:
• you have symptoms of hypoglycaemia (low blood sugar
or ‘hypo’ - see the section on hypoglycaemia in section
4 Possible side effects’)
• you have ever had an allergic reaction to insulin or any
of the other ingredients in Hypurin Porcine (see ‘What
Hypurin® contains’ in section 6 ‘Further information’).
If any of the above applies to you, should not inject Hypurin.
Talk to your doctor before taking this medicine if you are
taking pioglitazone, as your risk of heart failure may be
increased.
Hypurin Porcine Insulin in cartridges is only suitable for
injecting just under the skin using a reusable pen. Speak
to your doctor if you need to inject your insulin by another
method.
Taking other medicines
Taking another medicine while you are using insulin can
affect how it or the other medicine works. Tell your doctor
or pharmacist if you are taking any other medicine before
you start taking insulin. This includes medicines you may
have bought yourself without a prescription.
Medicines that can affect the way insulin works are;
• Steroids, both corticosteroids, used to treat a range of
allergic conditions, and anabolic steroids, used to treat
various metabolic disorders.
• Levothyroxine, used for an underactive thyroid gland.
• Anti-inflammatory drugs such as aspirin and NSAIDs
such as ibuprofen.
• Cyclophosphamide, used to treat a wide range of
tumours.
• Isoniazid, used to treat tuberculosis (TB).
• Some drugs used to treat high blood pressure such as
beta blockers, ACE inhibitors, nifedipine, clonidine or
guanethidine.
• Some drugs such as adrenaline, which are used to treat
shock.
• Some drugs used to treat mental illness such as
chlorpromazine, amitriptyline, fluoxetine and MAOIs
such as phenelzine.
• Thiazide diuretics or loop diuretics, used to control
excess water.
• Oral contraceptives (birth control pills).
• Octreotide, an anti-hormone preparation.
• Antimalarial drugs, such as chloroquine or quinine.
• Diazoxide, used to treat high blood pressure or low blood
sugar.
• Disopyramide or quinidine, used to treat an irregular
heartbeat.
• Fenfluramine, used to treat obesity.
• Fibrates or gemfibrozil, used to regulate lipids.
• Mebendazole, used to treat threadworm.
• Oxytetracycline, an antibiotic.
• Pentoxifylline, used to treat leg ulcers and problems with
blood circulation in the legs.
• Testosterone.

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ensure accuracy to our client’s brief,
the final responsibility must be taken by our client.
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Alcohol and smoking can also affect the way insulin works.
If you have any doubts about your medicine then discuss
things more fully with your doctor, pharmacist or diabetes
nurse.
Pregnancy and breast-feeding
Before using this medicine you should let your doctor know
if you are pregnant or wish to become pregnant or start
breast-feeding.
Particularly careful control of your diabetes and prevention
of hypoglycaemia is important for your health and the health
of your baby.
Insulin requirements should be assessed frequently by an
experienced diabetes physician during pregnancy, after
delivery and whilst breast-feeding.
Driving and using machines
Your ability to concentrate or react may be reduced if you
have hypoglycaemia. This might put yourself and others at
risk when you are driving a car or operating machinery.
You should contact your doctor about the advisability of
driving if you have:
• frequent episodes of hypoglycaemia
• reduced or lack of warning signs of hypoglycaemia.
Important information about some of the ingredients
of Hypurin
Zinc, protamine and the preservatives m-cresol and phenol
may cause allergic reactions.
3. HOW TO USE HYPURIN®
What dose is needed?
There is no ‘standard’ dose of insulin. Each person with
diabetes has their own dose calculated according to their
needs. Your doctor will decide which dose is best for you and
which insulin to use. Always follow your doctor’s instructions
exactly and also follow any special instructions or warnings
that appear on the label that the pharmacist has put on
the package.
Dosage adjustments
Patients with disease of the liver, kidneys, adrenal, pituitary
or thyroid glands, or coeliac disease (symptoms may include
severe diarrhoea and unintentional weight loss) may need
lower doses. This dose may alter during illness (including
infection and surgery), injury, emotional stress, during
puberty, around the time of a menstrual period, and during
pregnancy and after delivery. Lactating women may also
require dosage adjustments. It may also change with your
diet and lifestyle, particularly if you are exercising more.
Patients transferred to Hypurin Porcine Insulins from other
types of insulin may require dosage adjustments.
Newly diagnosed diabetic patients may require dosage
adjustments during the first weeks, months or years of
treatment.
If you do not understand or are in any doubt ask your doctor,
pharmacist or diabetes nurse.
Advice and checks to be made when using Hypurin
Porcine Insulin
• You must keep a close watch on your blood sugar by
testing your glucose levels regularly in your blood or
urine.
• Your urine should be tested for ketones at regular
intervals.
• Be aware that insulin resistance can occur, particularly
in patients who have lipid disorders (usually this will be
diagnosed by blood tests), hypertension (high blood
pressure) or heart disease. Stress can also contribute
to insulin resistance.
• If your doctor has asked you to increase the frequency
or dose of your insulin treatment in order to improve
your sugar levels, you may at some point lose some
of the warning symptoms that usually occur when your
blood sugar is falling too low (hypoglycaemia). These
symptoms include shakiness, pounding heartbeat,
sweating and feeling anxious.
• You may also lose some of the warning symptoms of
hypoglycaemia if you have had repeated attacks of
hypoglycaemia, if control of your blood sugar is greatly
improved, if you have a long history of diabetes, or if
you are also taking certain other medicines, such as
beta blockers (used to treat high blood pressure and
angina) or clonidine (used to treat high blood pressure).
• If you are elderly, you may have more severe episodes
of hypoglycaemia and some of the warning symptoms
may change, be weaker or be missing.
• Be aware that activities such as taking a hot bath,
sunbathing, or using a sunbed or sauna can increase
the rate at which insulin is absorbed and increase the
risk of hypoglycaemia.
Injection sites
Recommended injection sites include the upper arms,
thighs, buttocks and lower abdomen. It may be preferable
to use those areas that are less visible. Each time you inject
your insulin you should use a different spot in the same
general area. Change to a different injection area each week.
Hypurin Porcine Insulin in cartridges is only suitable for
injecting just under the skin using a reusable pen. Speak
to your doctor if you need to inject your insulin by another
method.
Hypurin Porcine Isophane or Hypurin Porcine 30/70
Mix should not be injected into a vein.
Hypurin Porcine Neutral may be injected into a vein, but only
by a doctor in an emergency.
Injecting Hypurin
Your doctor or diabetes nurse will advise you on how to
inject your insulin.

Customer

Wockhardt UK Limited

Colours Used

Description

LFT HYPUR P 100U-ML 3ML CTG COMMON

Black

Item Code

101972/7

Keyline (Non-Printing)

Profile

see uploaded pdf

Size

148 x 350mm

Min. Point Size

Other

Market

UK

Language

english

Pharmacode

Standard 402

Barcode
Proof By

MPI

Date

16/01/2018

Proof No.

1

• Check that the cartridge in the carton has the same
label as on the carton and that different types of Hypurin
Porcine have not been mixed up.
• Do not use Hypurin Porcine that has been frozen or
contains lumps that do not disappear on mixing.
• Wash and dry your hands.
• If you are using a new cartridge of Hypurin Porcine
Isophane or Hypurin Porcine 30/70 Mix or one that has
been used before but now looks clear, roll the cartridge
down, with a “bell ringing” action at least ten times until
the insulin appears white and cloudy. The cartridge
contains a glass bead to help mix the suspension.
• Hypurin Porcine Neutral does not need to be mixed. It
should be a clear, colourless solution and not contain any
particles.
• Put the cartridge into the pen following the pen
manufacturer’s written instructions.
• Before using the pen to inject Hypurin Porcine Isophane
or Hypurin Porcine 30/70 Mix, the insulin must be mixed
again by turning the pen up and down at least ten times
on each occasion.
• Always check that your pen is working before each
injection by performing an ‘air shot’. Hold the pen
vertically, needle up. Dial two units, press the release
button and check for a drop of insulin at the end of the
needle (repeat until insulin is seen).
• Dial your dose to the number of units required. You are
now ready to inject your insulin.
• Pinch up the skin at the injection site. Inject the Hypurin
Porcine Insulin under the skin as you have been taught,
keeping the pen in place for a count of five seconds.
Release the pinched up skin and remove the pen.
Remove the needle from the pen. There is no need to
massage the area.
• Your doctor may prescribe more than one type of Hypurin
Porcine cartridge injection for you. A separate pen must
be used for each type of insulin.
If you think you have received too much Hypurin
If you think you have received too much Hypurin, contact
your doctor or diabetes nurse immediately. Symptoms
of an overdose include weakness, sweating, trembling,
nervousness, excitement and irritability which, if untreated,
could lead to collapse and coma.
4. POSSIBLE SIDE EFFECTS
Like all medicines, insulin may cause side effects in some
patients when treatment is first started or if there is a change
in the type of insulin used.
These include:
• hypoglycaemia (see section “Treating Hypoglycaemia”
below)
• swelling (oedema)
• redness, itching or swelling around the area of injection
• stinging, or sensations of warmth or burning at the site
of injection
• thickening or pitting of the skin in the areas used for
injection (lipodystrophy).
• rash
• pain caused by nerve damage
• shortness of breath or wheezing
• low levels of potassium, which can cause muscle
weakness, twitching or abnormal heart rhythm
(hypokalaemia)
• weight gain
• nausea.
Rarely the following side effects may occur:
• allergic reactions and generalised swelling (oedema).
• severe allergic reactions that cause difficulty in breathing
or dizziness.
Hypoglycaemia(“hypo”or insulinreaction)symptoms
Hypoglycaemia means low blood sugar. The symptoms of
a “hypo” are:
• pale face, sweating
• palpitations, rapid heartbeat, heart disease (symptoms
may include chest pain and shortness of breath)
• hunger
• cramps
• deep breathing
• weakness, drowsiness, yawning, fatigue, reduced
consciousness
• altered behaviour, aggression, confusion, irritability,
anxiety, nervousness, restlessness,
excitement,
trembling
• difficulty in finding words, difficulty in concentration
• fits
• blurred vision and/or double vision, slurred speech
• tingling or numbness of the nose, mouth, fingers or toes,
paralysis
• headache, excess fluid in the brain (symptons may
include headache, loss of co-ordination), brain
damage (symptoms may include forgetfulness, learning
difficulties).
Why might hypoglycaemia occur?
Hypoglycaemia may occur for the following reasons
(or occasionally for no apparent reason):
• missing or postponing a meal or eating less than the
correct dietary allowance
• taking more exercise than usual
• injecting the wrong dose of insulin
• Episodic heavy alcohol intake - ‘binge drinking’.
Untreated “hypos” can have serious consequences. It is
important to recognise the symptoms and treat hypoglycaemia
early.

Warning! We cannot accept responsibility for any errors in this
proof after approval. Whilst we take extreme care at all times to
ensure accuracy to our client’s brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Treating hypoglycaemia
• Always carry glucose tablets or sugar lumps with you
wherever you go.
• At the first warning sign of
hypoglycaemia, stop what
you are doing and take five
glucose tablets or three sugar
lumps, preferably with water.
You should begin to feel better
almost immediately.
• If you do not feel better in ten
minutes repeat the glucose
tablets or sugar lumps.
• If the “hypo” happens shortly
before a meal or snack, treat
the “hypo” and have your meal
as soon as you can.
• If a meal is not due, take the quick-acting glucose tablets
or sugar lumps and follow them with some longer-acting
carbohydrate food like a sandwich or biscuits.
• Because of the risk of a “hypo” you should carry an
identification card or wear an identity bracelet or
necklace carrying details of your name, address, doctor
and insulin treatment. It is also important that relatives,
friends and colleagues know that you have diabetes.
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 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 HYPURIN®
Keep all cartridges, needles and pens out of the reach
and sight of children.
• Hypurin Porcine cartridges should be stored in
a refrigerator between 2°C - 8°C. Once in use, the
cartridge can be kept at room temperature (up to 25°C)
for 28 days after which it should be discarded.
• Do not use this medicine if the expiry date on the label
has passed or if the insulin has been frozen. The expiry
date refers to the last day of the month.
• The cartridge should be changed once the plunger
has reached the coloured band at the bottom of the
cartridge. The empty cartridge should be disposed of
immediately. Do not attempt to refill it. Fit a new needle to
your pen every time you inject your insulin; do not leave
a used needle on your pen between injections as this
can cause the cartridge to leak and become non-sterile.
Do not share needles.
• 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 Hypurin Porcine Contains
Hypurin Porcine Neutral is a sterile, clear solution of porcine
insulin (100 international units/ml).
It also contains m-cresol, phenol, glycerol and sodium
phosphate.
Hypurin Porcine Isophane is a sterile, white suspension of
porcine insulin (100 international units/ml) with protamine
sulphate and zinc chloride in water. It also contains m-cresol,
phenol, glycerol and sodium phosphate.
Hypurin Porcine 30/70 Mix is a sterile, white suspension
of porcine neutral and isophane insulins (100 international
units/ml). It also contains m-cresol, phenol, glycerol and
sodium phosphate.
What Hypurin Porcine looks like and contents of the
pack
Hypurin Porcine is available in packs of five glass cartridges,
which contain 3ml of solution or suspension for use in pen
injectors and glass vials, which contain 10ml of solution or
suspension.
Other formats
To listen to or request a copy of this information in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product Name

Reference Number

Hypurin® Porcine Neutral
100iu/ml Insulin Injection

29831/0124

Hypurin® Porcine Isophane
100iu/ml Insulin Injection

29831/0122

Hypurin® Porcine 30/70 Mix
100iu/ml Insulin Injection

29831/0119

Marketing Authorisation holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
This leaflet was last revised in 01/2018

101972/7

Customer

Wockhardt UK Limited

Colours Used

Description

LFT HYPUR P 100U-ML 3ML CTG COMMON

Black

Item Code

101972/7

Keyline (Non-Printing)

Profile

see uploaded pdf

Size

148 x 350mm

Min. Point Size

Other

Market

UK

Language

english

Pharmacode

Standard 402

Barcode
Proof By

MPI

Date

16/01/2018

Proof No.

1