Hypurin Porcine Isophane – patient leaflet, side effects, dosage

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 sulfate 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 insulin-dependent 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. What you need to know before you use Hypurin

Do not use Hypurin

• if you have symptoms of hypoglycaemia (low blood

  sugar or ‘hypo’ – see the section on hypoglycaemia in section 4 ‘Possible side effects’)

• ifyouareallergictoinsulinoranyoftheotheringredients

  of this medicine (listed in section 6)

If any of the above applies to you, 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.

Skin changes at the injection site:

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Hypurin). Contactyourdoctorifyouarecurrentlyinjectingintoalumpy areabeforeyoustartinjectinginadifferentarea.Yourdoctor may tell you to check your blood sugar more closely, and to adjust your insulin or other antidiabetic medications dose. Other medicines and Hypurin

Tellyourdoctororpharmacistifyouaretaking,haverecently taken or might take any other medicines.

This includes medicines you may have bought yourself without a prescription.

Taking another medicine while you are using insulin can affect how it or the other medicine works.

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,usedtotreathighbloodpressureorlowblood

  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,usedtotreatlegulcersandproblemswith blood circulation in the legs.
  • Testosterone.

Alcohol and smoking can also affect the way insulin works. If youhaveanydoubtsaboutyourmedicinethendiscussthings more fully with your doctor, pharmacist or diabetes nurse. Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

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

Alwaysusethismedicineexactlyasyourdoctorhastoldyou. Check with your doctor or pharmacist if you are not sure. 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 of Hypurin

Patients with disease of the liver, kidneys, adrenal, pituitary orthyroidglands,orcoeliacdisease(symptomsmayinclude 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 generalarea.Changetoadifferentinjectionareaeachweek. 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.

• Check that the vial 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.

• Clean the rubber plug on the vial, but do not remove it. • If you are using Hypurin Porcine Isophane, Hypurin

  Porcine 30/70 Mix, roll the vial gently between your palms or invert it several times to mix the contents immediately before use.

• Hypurin Porcine Neutral does not need to be mixed. It

  should be a clear, colourless solution and not contain any particles.

• Before withdrawing your insulin from the vial, draw air

  intothesyringeequaltotheamountofinsulintobedrawn up. Push the needle through the rubber plug of the vial and inject the air into the vial. This will make it easier for you to withdrawn the insulin.

• Leaving the needle in the vial, turn the vial upside down

  making sure the needle tip stays below the surface of the insulin. Slowly fill the syringe with slightly more than your usual dose of insulin. Push the plunger back to your correct dose, expelling any air bubbles into the vial. Take the needle out of the vial. You are now ready to inject your insulin.

• Pinch up the skin at the injection site. Stick the needle

  in fully at right angles. Do not release the skin. Push the plunger down to empty the syringe keeping the needle in place for a count of five seconds. Release the pinched up skin and take the needle out. There is no need to massage the area.

• Once the vial is opened the insulin must only be used

  by the same patient.

Ifyourdoctorrecommendsit,HypurinPorcineNeutralcanbe mixed with Hypurin Porcine Isophane in the same syringe. If youneedtodothis,drawtheHypurinPorcineNeutralintothe syringe before the Hypurin Porcine Isophane. This should be demonstrated to you before you attempt to do it yourself. Use the injection immediately.

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.

Ifyouhaveanyfurtherquestions ontheuseofthismedicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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) • severeallergicreactionsthatcausedifficultyinbreathing

  or dizziness.

Hypoglycaemia(“hypo”orinsulinreaction)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 (symptoms 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.

  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.

  • Ifamealisnotdue,takethequick-actingglucosetablets 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 and are taking insulin so that they can recognise symptoms of a “hypo” and help if necessary.

Skin changes at the injection site:

If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. 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 YellowCardSchemewww.mhra.gov.uk/yellowcardorsearch forMHRAYellowCardintheGooglePlayorAppleAppStore. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hypurin

Keep all vials and syringes out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’ or if the insulin has been frozen. The expiry date refers to the last day of that month.
• Hypurin Porcine vials 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other 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 sulfate 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 packHypurin Porcine is available in packs of glass vials, which contain10mlofsolutionorsuspension,andglasscartridges, which contain 3ml of solution or suspension for use in pen injectors.

Other formats:

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Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

WockhardtUKLtd,AshRoadNorth,Wrexham,LL139UF,UK. Manufacturer

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

This leaflet was last revised in 06/2020