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Assessed against
the UK PIL dated
December 2016



Cyclophosphamide 50 mg Tablets

By Caroline McDermott at

This product is available as the above name but will be referred to as Cyclophosphamide throughout the
following leaflet.
Read all of this leaflet carefully before you start taking this medicine because 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 has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes possible side effects not
listed in this leaflet. See section 4.

Important things to know about Cyclophosphamide
Your doctor has prescribed Cyclophosphamide because you have cancer that can be treated.
Cyclophosphamide is a medicine that kills cancer cells but, as a result, also attacks normal cells. It can
therefore have a number of side effects. Your doctor will not give you Cyclophosphamide unless he or she
thinks that your cancer is more of a risk to you than any possible side effects. Your doctor will check you
regularly and treat any side effects where possible.
• will reduce your blood cell count, which may make you feel tired and be more likely to get infections.
• can affect your kidneys and bladder. You may be given another medicine called Mesna to help prevent
any damage. If you notice blood in your urine, tell your doctor immediately.
• like most anti-cancer or chemotherapy medicines, you may lose your hair (anything from thinning to
total loss), although it should start to grow back once your treatment has finished. It may also make you
feel sick or be sick. Your doctor can give you advice or medicines to help.
• Men or women should not have a child during treatment with Cyclophosphamide or for at least 6
months after treatment. You should use an effective contraceptive. Ask your doctor for advice.
Now read the rest of this leaflet. It includes other important information on the use of
Cyclophosphamide that might be especially important for you.

In this leaflet:
1. What Cyclophosphamide is and what it is used for
2. What you need to know before you take Cyclophosphamide
3. How to take Cyclophosphamide
4. Possible side effects
5. How to store Cyclophosphamide
6. Contents of the pack and other information

1 What Cyclophosphamide is and what it is used for
Cyclophosphamide is a cytotoxic drug or anti-cancer drug. It works by killing cancer cells, this is sometimes
called ‘chemotherapy’. It is used to treat lots of different cancers. Cyclophosphamide is often used together
with other anti-cancer drugs or radiotherapy.
Occasionally, some doctors may prescribe Cyclophosphamide for other conditions not related to cancer, your
doctor will tell you if this applies to you.

2 What you need to know before you take Cyclophosphamide
Do not take Cyclophosphamide if:
• you have ever had an allergic reaction to the active ingredient or any of the other ingredients (listed in

Section 6). An allergic reaction can include shortness of breath, wheezing, rash, itching or swelling of the
face and lips
your bone marrow is not working properly (especially if you have previously had chemotherapy or
radiotherapy). You will have blood tests to check how well your bone marrow is working
you have a urinary tract infection, which can be recognised as pain when passing urine (cystitis)
you currently have any infections
you have ever had kidney or bladder problems as a result of previous chemotherapy or radiotherapy.
you have a condition which decreases your ability to urinate (Urinary outflow obstruction).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cyclophosphamide if:
• you are already having, or have recently had, radiotherapy or chemotherapy
• you have diabetes
• you have liver or kidney problems. Your doctor will check how well your liver and kidneys are working by
doing a blood test
• you have had your adrenal glands removed
• you have heart problems or have had radiotherapy in the area of your heart
• you have poor general health or are frail
• you are elderly.

Take special care with Cyclophosphamide
• Cyclophosphamide can have effects on your blood and immune system
• Blood cells are made in your bone marrow. Three different types of blood cell are made:

– red blood cells, which carry oxygen around your body
– white blood cells, which fight infection, and
– platelets, which help your blood to clot.
After taking Cyclophosphamide, your blood count of the three types of cells will drop. This is an
unavoidable side effect of Cyclophosphamide. Your blood count will reach its lowest level about 5 to 10
days after you start taking Cyclophosphamide and will stay low until a few days after you finish the course.
Most people recover to a normal blood count within 21 to 28 days. If you have had a lot of chemotherapy in
the past, it may take a little longer to return to normal.
You may be more likely to get infections when your blood count drops. Try to avoid close contact with
people who have coughs, colds and other infections. Your doctor will treat you with appropriate medicine if
they think you have, or are at risk, of an infection.
Your doctor will check that the number of red blood cells, white blood cells and platelets is high enough
before and during your treatment with Cyclophosphamide. They may need to reduce the amount you are
given or delay your next dose.
Cyclophosphamide can affect wound healing. Keep any cuts clean and dry, and check they are healing
It is important to keep your gums healthy, as mouth ulcers and infections can occur. Ask your doctor about
this if you are unsure.
Cyclophosphamide can damage the lining of your bladder, causing bleeding into your urine and pain on
urination. Your doctor knows this can happen and, if necessary, he or she will give you a medicine called
Mesna which will protect your bladder.
Mesna can either be given to you as a short injection, or mixed into the drip solution with your
Cyclophosphamide, or as tablets.
More information on Mesna can be found in the Patient Information Leaflet for Mesna Injection and Mesna
Most people having Cyclophosphamide with Mesna do not develop any problems with their bladder, but
your doctor may want to test your urine for the presence of blood using a ‘dipstick’ or microscope.
If you notice that you have blood in the urine, you must tell your doctor straight away as they may need to
stop giving you Cyclophosphamide.
Cancer medicines and radiation therapy can increase the risk of you developing other cancers; this can be
a number of years after your treatment has stopped. Cyclophosphamide has an increased risk of causing
cancer in the area of your bladder.
Cyclophosphamide can cause damage to your heart or affect the rhythm of it beating. This increases with
higher doses of Cyclophosphamide, if you are being treated with radiation or other chemotherapy
medicines or if you are elderly. Your doctor will monitor your heart closely during treatment.
Cyclophosphamide can cause inflammation or scarring in your lungs. This can occur more than six months
after your treatment. If you start having difficulty breathing tell your doctor straight away.
Cyclophosphamide can have life threatening effects on your liver. If you have sudden weight gain, liver
pain and jaundice tell your doctor straight away.
Hair thinning or baldness can occur. Your hair should grow back normally though it may be different in
texture or colour.

• Cyclophosphamide can make you feel sick or be sick. This can last for about 24 hours after taking

Cyclophosphamide. You may need to be given medicines to stop feeling or being sick. Ask your doctor
about this.

Using other medicines and treatments
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines
you have bought yourself. In particular, tell them about the following medicines or treatments as they may not
work well with Cyclophosphamide:
The following medicines can reduce how effective Cyclophosphamide is:
• aprepitant (used to prevent being sick)
• bupropion (an anti-depressant)
• busulfan, thiotepa (used to treat cancer)
• ciprofloxacin, chloramphenicol (used to treat bacterial infections)
• fluconazole, itraconazole (used to treat fungal infections)
• Prasugrel (used to thin the blood)
• Sulfonamides, such as sulfadiazine, sulfasalazine, sulfamethoxazole (used to treat bacterial infections)
The following medicines can increase the toxicity of Cyclophosphamide:
• allopurinol (used to treat gout)
• azathioprine (used to reduce the activity of the immune system)
• chloral hydrate (used to treat insomnia)
• cimetidine (used to reduce stomach acid)
• disulfiram (used to treat alcoholism)
• glyceraldehyde (used to treat warts)
• protease inhibitors (used to treat viruses)
• ondansetron (used to prevent being sick)
• medicines that increase liver enzymes such as:
– rifampicin (used to treat bacterial infections)
– carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
– St. John’s wort (a herbal remedy for mild depression)
– Corticosteroids (used to treat inflammation)
• medicines that can increase the toxic effects on your blood cells and immunity
– ACE inhibitors (used to treat high blood pressure)
– natalizumab (used to treat multiple sclerosis)
– paclitaxel (used to treat cancer)
– thiazide diuretics such as hydrochlorothiazide or chlortalidone (used to treat high blood pressure or
water retention)
– zidovudine (used to treat viruses)
– Clozapine (used to treat symptoms of some psychiatric disorders)
• medicines that can increase the toxic effects on your heart
– anthracyclines such as bleomycin, doxorubicin, epirubicin, mitomycin (used to treat cancer)
– cytarabine , pentostatin, trastuzumab (used to treat cancer)
– radiation in the area of your heart
• medicines that can increase the toxic effects on your lungs
– amiodarone (used to treat irregular heart beat)
– G-CSF, GM-CSF hormones (used to increase white blood cell numbers after chemotherapy)
• medicines that can increase the toxic effects on your kidneys
– amphotericin B (used to treat fungal infections)
– Indomethacin (used to treat pain and inflammation)
Other medicines that can affect or be affected by Cyclophosphamide include:
• etanercept (used to treat rheumatoid arthritis)
• metronidazole (used to treat bacterial or protozoal infections)
• tamoxifen (used to treat breast cancer)
• bupropion (used to help stop smoking)
• coumarins such as warfarin (used to thin the blood)
• cyclosporine (used to reduce the activity of the immune system)
• succinylcholine (used to relax muscles during medical procedures)
• digoxin, β-acetyldigoxin (used to treat heart conditions)
• vaccines
• verapamil (used to treat high blood pressure, angina or irregular heart beat)

Cyclophosphamide with food and drink
Drinking alcohol can increase the nausea and vomiting caused by Cyclophosphamide.

Pregnancy, breast-feeding and fertility
Do not become pregnant while taking Cyclophosphamide. This is because it can cause miscarriage or
damage your unborn baby. Tell your doctor if you are pregnant, think you might be pregnant or are trying to
become pregnant.
• Men or women should not try to have a child during or for at least 6 to 12 months after treatment. You
should use an effective contraceptive. Ask your doctor for advice.
• Cyclophosphamide can affect your ability to have children in the future. Talk to your doctor about freezing
sperm samples or eggs before your treatment starts.
Do not breast-feed while being treated with Cyclophosphamide. Ask your doctor for advice.

Driving or using machines
Some of the side effects of treatment with Cyclophosphamide might affect your ability to drive and use
machines safely. Your doctor will decide if it is safe for you to do so.

What to do if you see a different doctor, or have to go to hospital
If you see any other doctor or have to go to hospital for any reason, tell them what medicines you are taking.
Do not take any other medicines unless your doctor knows you are taking Cyclophosphamide.

3 How to take Cyclophosphamide
Taking this medicine
• Cyclophosphamide Tablets are to be taken by mouth. Do not chew them.
• If you are also having Mesna, your doctor will tell you how much you need to drink. You should take your

tablets with enough liquid to make them easy to swallow.
• Cyclophosphamide is often given with other anti-cancer drugs or radiotherapy.

The usual dose
• Your doctor will decide how much of the medicine you need and when you should take it.
• The amount of Cyclophosphamide you will need to take depends on:

– the type of illness you have
– how big you are (a combination of your height and weight)
– your general health
– whether you are being given other anti-cancer drugs or having radiotherapy.
• The usual dose is between 100 mg (2 tablets) and 300 mg (6 tablets) per day. You can take all of one
day's tablets together, but you should try to take them about the same time each day, preferably in the
morning. If you are not sure how to take your tablets, ask your doctor or pharmacist.
Cyclophosphamide is usually taken for several days in a row as a course, and then there is a break (a period
when no tablets are taken) before the next course. Sometimes you may need to take different numbers of
tablets on alternate days, for instance, 3 tablets one day and 4 the next.
Your doctor may need to change the amount of medicine you are given and monitor you more closely if you:
• have problems with your liver or kidneys
• you are elderly.

If you forget to take Cyclophosphamide
If you forget to take your Cyclophosphamide:
• you should take them as soon as you remember, if it is on the same day. If you have forgotten to take a
whole day's tablets, then you should talk to your doctor.
• Never take more tablets in one day than you were meant to
– so never take two days worth of tablets on the same day in order to ‘catch up’.

If you take too much Cyclophosphamide
In the event of an overdose, or if a child swallows any of your tablets, talk to your doctor or local hospital
emergency department immediately. Hospital admission for special treatment may be needed.

4 Possible side effects
Like all medicines, Cyclophosphamide can cause side effects, although not everybody gets them. Side effects
can sometimes occur after ending the treatment. The following side effects may happen with this medicine.

Tell your doctor straight away, and go to hospital immediately if you notice any of
the following serious side effects:
• allergic reactions, signs of this would be shortness of breath, wheezing, rash, itching or swelling of the face

and lips (hypersensitivity). Severe allergic reactions could lead to difficulty in breathing or shock, with a
possible fatal outcome (anaphylactic shock, anaphylactic/ anaphylactoid reaction)
getting bruises without knocking yourself, or bleeding from your gums. This may be a sign that the platelet
levels in your blood are getting too low
a lowering of your white blood cell count - your doctor will check this during your treatment. It will not cause
any signs, but you will be more likely to get infections. If you think you have an infection (a high
temperature, feeling cold and shivery, or hot and sweaty, or any signs of infection such as a cough, or
stinging on passing water) you may need antibiotics to fight infections because your blood count is lower
than usual
blood in your urine, pain while passing urine, or less urine being passed (hemorrhagic cystitis, haematuria)
inflammation of your intestines or bowel which may resulting in bleeding (hemorrhagic enterocolitis)
fits (convulsions)
life threatening conditions which cause rash, ulcers, sore throat, fever, conjunctivitis, separation of skin
layers (toxic epidermal necrolysis, Stevens-Johnson syndrome). Swelling, numbness, red lumps and
peeling of skin on the hands and feet (Palmar-plantar erythrodysesthesia syndrome)
life threatening decrease in the abilities of your kidney to adequately remove toxins and waste products
from the blood (kidney failure). These changes to the tissues within your kidney can prevent them from
working correctly, and induce kidney failure (renal tubular necrosis, renal tubular disorder)
pneumonia. Signs of this could be chest pain when you breathe or cough, confusion, coughing, fever,
sweating and chills, fatigue, shortness of breath, nausea, vomiting or diarrhoea
severe infection spreading through the blood which may lead to a dangerous drop in blood pressure with a
possible fatal outcome (sepsis, shock)
effects on the brain (encephalopathy), signs of this can be problems in thinking or concentrating, reduced
alertness, changes in personality, tiredness, fits, muscle twitching, and shaking
a syndrome called reversible posterior leukoencephalopathy syndrome, which can cause swelling of the
brain, headache, confusion, fits and loss of sight
heart attack (myocardial infarction)
decrease in your hearts ability to pump enough blood around your body which may be life threatening
(cardiogenic shock, heart failure or cardiac arrest)
life-threatening decrease of your lungs ability to transfer oxygen in to your blood (respiratory failure)
a build-up of toxins in the body due to liver failure (hepatotoxicity). This may affect the brain causing
confusion, reduced consciousness or coma (hepatic encephalopathy)

Tell your doctor straight away, if you notice any of the following serious side effects:
• haemolytic uremic syndrome - a condition causing abnormal break down of the red blood cells, decreased

numbers of platelets in the blood and kidney failure
• cancer of your blood (leukaemia)
• cancer of the bone marrow (myelodysplastic syndrome)
• swelling of the brain due to too much water in your blood (water intoxication). Signs of this can be

headache, changes in personality or behaviour, confusion, drowsiness
• formation of small blood clots in your blood vessels disrupting the normal blood flow around your body

(disseminated intravascular coagulation)
• blood clot in the lungs which causes chest pain and breathlessness (pulmonary embolism)
• blood clot, usually in a leg, which causes pain swelling or redness (venous thrombosis)
• low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma

• tummy discomfort or severe tummy and back pain, this may be caused by inflammation of the pancreas

(acute pancreatitis)
• high blood sugar levels which can cause thirst, tiredness and irritability (hyperglycaemia)
• low blood sugar levels which can cause confusion and sweating (hypoglycaemia)
• effects on the spinal cord (Myelopathy), which can cause numbness, weakness and tingling in the hands,

loss of motor skills
• disease of the heart muscle (cardiomyopathy); inflammation of the tissues in or around your heart

(myocarditis, pericarditis); build up of fluid in the sac around your heart (pericardial effusion). Increased
pressure from this fluid can stop the heart filling properly (cardiac tamponade); abnormal ECG heart tracing
(Electrocardiogram QT prolonged) – These could be considered causes of arrythmia
changes in your heart rhythm (arrhythmia) which may be noticeable (palpitations):
o irregular heart beat (fibrillation)
o faster heart beat (tachycardia), which may be life threatening (ventricular tachycardia)
o slower heart beat (bradycardia)
blood clot in the lungs which causes chest pain and breathlessness (pulmonary veno-occlusive disease)
scarring of the lungs which causes shortness of breath (pulmonary fibrosis)
conditions causing inflammation of the lungs which can cause breathlessness, cough and raised
temperature or scarring of the lungs (pneumonitis, acute respiratory distress syndrome, obliterative
bronchiolitis, organizing pneumonia, alveolitis allergic)
fluid in or around the lungs (pulmonary oedema, pleural effusion)
increased blood pressure in the lungs which can cause shortness of breath, fatigue, cough, angina,
fainting, peripheral oedema (pulmonary hypertension)
abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)

Other possible side effects, listed by frequency, may be:
Very common: may affect more than 1 in 10 people
• reduction in the effectiveness of your immune system (immunosuppression)
• hair loss (alopecia)
• pain and difficultly passing urine (cystitis)
• very pale, lethargic and tired. This may be a sign of low red blood cells (anaemia). Usually, no treatment is
required, your body will eventually replace the red blood cells. If you are very anaemic, you may need a
blood transfusion
Common: may affect up to 1 in 10 people
• increased risk and severity of bacterial, fungal, viral, protozoal or parasitic infections due to the effect of
cyclophosphamide on your immune system
• reactivation of infections you have had before (latent infections)
• increased levels of certain proteins produced by your liver called enzymes. Your doctor will do blood tests
to test for these
• inflammation of the bladder lining which causes pain, bleeding, blood in the urine, reduced urine flow
(haemorrhagic cystitis)
• inflammation of the linings of your body cavities (mucosal inflammation)

Unknown: frequency cannot be estimated from the available data
• changes to your metabolism caused by the breakdown of the dying cancer cells (Tumour lysis syndrome)
• inflammation of your intestines or bowel which may resulting in bleeding (enteritis, cecitis)
• bleeding in your stomach or intestines (gastrointestinal haemorrhage)
• inflammation which causes abdominal pain or diarrhoea (colitis)
• swelling of the glands in your neck (parotid gland inflammation).
• a disorder of the nerves which can cause weakness, tingling or numbness (peripheral neuropathy). This
could be in more than one set of nerves (polyneuropathy)
• pain from your nerves, which can also feel like an aching or burning sensation (neuralgia)
• tingling or numbness, often in the hands or feet (paresthesia)
• shaking (tremor)
• changes in your sense of touch (dysesthesia) or loss of sensation (hypoesthesia)
• changes in your sense of taste (dysgeusia) or loss of taste (hypogeusia)
• changes in your sense of smell (parosmia)
• increased tear formation (lacrimation)
• deafness or hearing impairment
• ringing in the ears (tinnitus)
• inflammation of the blood vessels (vasculitis)
• reduced blood supply to your hands and feet (peripheral ischemia). This may cause pain, weakness,
numbness, ulcers, changes in skin colour or temperature
• difficulty in breathing or wheezing (bronchospasm)
• shortness of breath (dyspnea)
• decrease levels of oxygen in your body (hypoxia)
• cough
• blocked or runny nose
• pain at the back of your throat
• increased liver size (hepatomegaly)
• yellowing of the skin or whites of the eyes (jaundice)
• blockage of the small veins in your liver (veno-occlusive liver disease) which can cause weight gain,
increased liver size, pain and jaundice
• conditions causing inflammation of the liver which can cause jaundice, weight loss and malaise (hepatitis)
• disruption of the formation of bile by the liver which can cause itchiness, jaundice, pale coloured stools,
dark urine (cholestasis)
• a build-up of fluid in the abdomen causing swelling of the tummy and shortness of breath (ascites)
• dark red raised itchy rash (urticaria)
• redness and blistering of the skin appearing months or years after treatment (radiation recall dermatitis)
• itchy, red rash which can develop in to sores (erythema multiforme)
• excessive sweating (hyperhidrosis)
• swelling of the face
• itching (pruritus)
• serious illness which causes thickening of the skin and the connective tissue in your internal organs
• muscle spasms
• muscle pain (myalgia) or joint pain (arthralgia)
• damage to the kidneys by toxins in the blood (toxic nephropathy)
• glucose in the urine (nephrogenic diabetes insipidus)
• inflammation of the urethra which causes pain and bleeding (haemorrhagic ureteritis)
• death of the cells and tissues (necrosis)
• decrease in the size of the bladder (bladder contracture)
• changes to the cells in the lining of your bladder
• increase in the levels of creatinine or urea nitrogen in your blood. Your doctor will do blood tests to test for
• premature labour
• infertility. Sperm production in men and egg production in women may be reduced or stop. In some cases
this can be permanent
• reduced frequency of menstrual periods (oligomenorrhea)
• decrease in testicle size (testicular atrophy)
• decrease in the hormone oestrogen in the blood
• increase in the hormone gonadotrophin in the blood
• use in young patients may result in some impairments of future fertility
• reduction in growth, deformity or death of a foetus while in the womb
• toxic effects on the foetus such as myelosuppression and gastroenteritis
• life threatening failure of multiple organs such as heart, lungs, kidney, liver (see symptoms throughout
section 4)
• general physical deterioration
• flu-like symptoms such as headache, fever, chills, joint and muscle pain, weakness, tiredness
• swelling
• injection site reaction.

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
Yellow Card Scheme

5 How to store Cyclophosphamide
• Keep out of the sight and reach of children.
• Do not use Cyclophosphamide after the expiry date which is stated on the label after EXP. The expiry date

refers to the last day of that month.
• Do not store above 25ºC. Store in the original package.
• Medicines should not be disposed of via wastewater or household waste. If you have any medicine left

over, take it back to your pharmacist.
• If your medicine becomes discoloured, or shows any signs of deterioration, consult your pharmacist who

will tell you what to do.

6 Contents of the pack and other information
What Cyclophosphamide contains
Each tablet contains cyclophosphamide monohydrate equivalent to 50 mg cyclophosphamide.
Other ingredients are: maize starch, lactose monohydrate, calcium hydrogen phosphate dihydrate, talc,
magnesium stearate, gelatine, glycerol (85%), sucrose, titanium dioxide (E171), calcium carbonate, macrogol
35000, colloidal anhydrous silica, povidone, carmellose sodium, polysorbate 20, montan glycol wax.

Uncommon: may affect up to 1 in 100 people
• loss of appetite (anorexia)
• reddening of the skin (flushing) which may be accompanied by feeling hot or sweating (hot flushing)

What Cyclophosphamide looks like and contents of the pack

Rare: may affect up to 1 in 1,000 people
secondary tumours in various parts of the body, often in the area of the bladder
blurring, reduction or loss of sight
changes in colour of your fingernails and skin.
inflammation of this skin which may cause rash, blisters, itching, sores, oozing and scarring (dermatitis)
absence of menstrual periods (amenorrhea)
chest pain

PL: 15814/1305

Very rare: may affect up to 1 in 10,000 people
• increase in the release of antidiuretic hormone from the pituitary gland. This affects the kidneys causing
the low levels of sodium in your blood (hypernatremia) and water retention
• accumulation of fluid in the body (water retention), which may been seen as fluid beneath the skin or
swelling in you limbs
• feeling sick and being sick (nausea, vomiting)
• constipation or diarrhoea
• ulcers in the lining of your digestive system (mucosal ulceration)
• inflammation of the lining of your mouth including ulcers (stomatitis)
• confusion
• ulceration or scaring (fibrosis) of the bladder
• inflammation of the eye (conjunctivitis)
• eye oedema (swelling)

Cyclophosphamide are white, round, coated tablets with a white core and available in blister packs containing
100 tablets.

Manufactured by Baxter Oncology GmbH, Kantstrasse 2, 33790 Halle-Kunsebeck, Germany. Procured from
within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 08.02.2017.

To request a copy of this in Braille, large print or
audio please call 01923 332 796.

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