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CYCLOPHOSPHAMIDE TABLETS 50 MG

Active substance(s): CYCLOPHOSPHAMIDE MONOHYDRATE / CYCLOPHOSPHAMIDE MONOHYDRATE / CYCLOPHOSPHAMIDE MONOHYDRATE

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
Cyclophosphamide Tablets 50 mg

Name

Cyclophosphamide monohydrate
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
ll Keep this leaflet. You may need to read it again.
ll If you have any further questions, ask your doctor or pharmacist.
ll 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.
ll 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.
Throughout this leaflet, Cyclophosphamide Tablets 50 mg will be
called Cyclophosphamide.

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.
Cyclophosphamide:
ll will reduce your blood cell count, which may make you feel
tired and be more likely to get infections.
ll 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.
ll 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.
ll 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:
ll 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
ll 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
ll you have a urinary tract infection, which can be recognised as pain
when passing urine (cystitis)
ll you currently have any infections
ll you have ever had kidney or bladder problems as a result of
previous chemotherapy or radiotherapy.
ll 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:
ll you are already having, or have recently had, radiotherapy or
chemotherapy
ll you have diabetes
ll you have liver or kidney problems. Your doctor will check how well
your liver and kidneys are working by doing a blood test
ll you have had your adrenal glands removed
ll you have heart problems or have had radiotherapy in the area of
your heart
ll you have poor general health or are frail
ll you are elderly.

Take special care with Cyclophosphamide
ll Cyclophosphamide can have effects on your blood and immune
system
ll 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.
ll 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.
ll 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.
ll 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.
ll Cyclophosphamide can affect wound healing. Keep any cuts clean
and dry, and check they are healing normally.
ll It is important to keep your gums healthy, as mouth ulcers and
infections can occur. Ask your doctor about this if you are unsure.
ll 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.
ll Mesna can either be given to you as a short injection, or mixed into
the drip solution with your Cyclophosphamide, or as tablets.
ll More information on Mesna can be found in the Patient Information
Leaflet for Mesna Injection and Mesna tablets.
ll 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.
ll 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.
ll 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.
ll 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.
ll 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.
ll Cyclophosphamide can have life threatening effects on your liver.
If you have sudden weight gain, liver pain and jaundice tell your
doctor straight away.
ll Hair thinning or baldness can occur. Your hair should grow back
normally though it may be different in texture or colour.
ll 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.

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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:
ll aprepitant (used to prevent being sick)
ll bupropion (an anti-depressant)
ll busulfan, thiotepa (used to treat cancer)
ll ciprofloxacin, chloramphenicol (used to treat bacterial infections)
ll fluconazole, itraconazole (used to treat fungal infections)
ll Prasugrel (used to thin the blood)
ll Sulfonamides, such as sulfadiazine, sulfasalazine, sulfamethoxazole
(used to treat bacterial infections)
The following medicines can increase the toxicity of
Cyclophosphamide:
ll allopurinol (used to treat gout)
ll azathioprine (used to reduce the activity of the immune system)
ll chloral hydrate (used to treat insomnia)
ll cimetidine (used to reduce stomach acid)
ll disulfiram (used to treat alcoholism)
ll glyceraldehyde (used to treat warts)
ll protease inhibitors (used to treat viruses)
ll ondansetron (used to prevent being sick)
ll 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)
ll 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)
ll 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
ll 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)
ll 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:
ll etanercept (used to treat rheumatoid arthritis)
ll metronidazole (used to treat bacterial or protozoal infections)
ll tamoxifen (used to treat breast cancer)
ll bupropion (used to help stop smoking)
ll coumarins such as warfarin (used to thin the blood)
ll cyclosporine (used to reduce the activity of the immune system)
ll succinylcholine (used to relax muscles during medical procedures)
ll digoxin, ß-acetyldigoxin (used to treat heart conditions)
ll vaccines
ll 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.
ll 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.
ll 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
ll Cyclophosphamide Tablets are to be taken by mouth. Do not chew
them.
ll 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.
ll Cyclophosphamide is often given with other anti-cancer drugs or
radiotherapy.

The usual dose
ll Your doctor will decide how much of the medicine you need and
when you should take it.
ll 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.
ll 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:
ll have problems with your liver or kidneys
ll you are elderly.

If you forget to take Cyclophosphamide
If you forget to take your Cyclophosphamide:
ll 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.
ll 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:
ll 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)

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ll 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
ll 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
ll blood in your urine, pain while passing urine, or less urine being
passed (hemorrhagic cystitis, haematuria)
ll inflammation of your intestines or bowel which may resulting in
bleeding (hemorrhagic enterocolitis)
ll fits (convulsions)
ll 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)
ll 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)
ll 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
ll severe infection spreading through the blood which may lead to a
dangerous drop in blood pressure with a possible fatal outcome
(sepsis, shock)
ll 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
ll a syndrome called reversible posterior leukoencephalopathy
syndrome, which can cause swelling of the brain, headache,
confusion, fits and loss of sight
ll heart attack (myocardial infarction)
ll decrease in your hearts ability to pump enough blood around your
body which may be life threatening (cardiogenic shock, heart failure
or cardiac arrest)
ll life-threatening decrease of your lungs ability to transfer oxygen in
to your blood (respiratory failure)
ll 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:
ll haemolytic uremic syndrome - a condition causing abnormal break
down of the red blood cells, decreased numbers of platelets in the
blood and kidney failure
ll cancer of your blood (leukaemia)
ll cancer of the bone marrow (myelodysplastic syndrome)
ll 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
ll formation of small blood clots in your blood vessels disrupting the
normal blood flow around your body (disseminated intravascular
coagulation)
ll blood clot in the lungs which causes chest pain and breathlessness
(pulmonary embolism)
ll blood clot, usually in a leg, which causes pain swelling or redness
(venous thrombosis)
ll low blood levels of sodium which can cause tiredness and
confusion, muscle twitching, fits and coma (hyponatremia)
ll tummy discomfort or severe tummy and back pain, this may be
caused by inflammation of the pancreas (acute pancreatitis)
ll high blood sugar levels which can cause thirst, tiredness and
irritability (hyperglycaemia)
ll low blood sugar levels which can cause confusion and sweating
(hypoglycaemia)
ll effects on the spinal cord (Myelopathy), which can cause numbness,
weakness and tingling in the hands, loss of motor skills
ll 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
ll changes in your heart rhythm (arrhythmia) which may be noticeable
(palpitations):
¡¡ irregular heart beat (fibrillation)
¡¡ faster heart beat (tachycardia), which may be life threatening
(ventricular tachycardia)
¡¡ slower heart beat (bradycardia)
ll blood clot in the lungs which causes chest pain and breathlessness
(pulmonary veno-occlusive disease)
ll scarring of the lungs which causes shortness of breath (pulmonary
fibrosis)
ll 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)
ll fluid in or around the lungs (pulmonary oedema, pleural effusion)
ll increased blood pressure in the lungs which can cause shortness
of breath, fatigue, cough, angina, fainting, peripheral oedema
(pulmonary hypertension)
ll abnormal muscle breakdown which can lead to kidney problems
(rhabdomyolysis)

Other possible side effects , listed by frequency,
may be:
Very common: may effect more than 1 in 10 people
ll reduction in the effectiveness of your immune system
(immunosuppression)
ll hair loss (alopecia)
ll pain and difficultly passing urine (cystitis)
ll 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 effect up to 1 in 10 people
ll increased risk and severity of bacterial, fungal, viral, protozoal or
parasitic infections due to the effect of cyclophosphamide on your
immune system
ll reactivation of infections you have had before (latent infections)
ll increased levels of certain proteins produced by your liver called
enzymes. Your doctor will do blood tests to test for these
ll inflammation of the bladder lining which causes pain, bleeding,
blood in the urine, reduced urine flow (haemorrhagic cystitis)
ll inflammation of the linings of your body cavities (mucosal
inflammation)
Uncommon: may effect up to 1 in 100 people
ll loss of appetite (anorexia)
ll reddening of the skin (flushing) which may be accompanied by
feeling hot or sweating (hot flushing)
Rare: may effect up to 1 in 1,000 people
ll secondary tumours in various parts of the body, often in the area of
the bladder
ll dehydration
ll dizziness
ll blurring, reduction or loss of sight
ll changes in colour of your fingernails and skin.
ll inflammation of this skin which may cause rash, blisters, itching,
sores, oozing and scarring (dermatitis)
ll absence of menstrual periods (amenorrhea)

ll deafness or hearing impairment
ll ringing in the ears (tinnitus)
ll inflammation of the blood vessels (vasculitis)
ll reduced blood supply to your hands and feet (peripheral ischemia).
This may cause pain, weakness, numbness, ulcers, changes in skin
colour or temperature
ll difficulty in breathing or wheezing (bronchospasm)
ll shortness of breath (dyspnea)
ll decrease levels of oxygen in your body (hypoxia)
ll cough
ll blocked or runny nose
ll pain at the back of your throat
ll increased liver size (hepatomegaly)
ll yellowing of the skin or whites of the eyes (jaundice)
ll blockage of the small veins in your liver (veno-occlusive liver
disease) which can cause weight gain, increased liver size, pain and
jaundice
ll conditions causing inflammation of the liver which can cause
jaundice, weight loss and malaise (hepatitis)
ll disruption of the formation of bile by the liver which can cause
itchiness, jaundice, pale coloured stools, dark urine (cholestasis)
ll a build-up of fluid in the abdomen causing swelling of the tummy
and shortness of breath (ascites)
ll dark red raised itchy rash (urticaria)
ll redness and blistering of the skin appearing months or years after
treatment (radiation recall dermatitis)
ll itchy, red rash which can develop in to sores (erythema multiforme)
ll excessive sweating (hyperhidrosis)
ll swelling of the face
ll itching (pruritus)
ll serious illness which causes thickening of the skin and the
connective tissue in your internal organs (scleroderma)
ll muscle spasms
ll muscle pain (myalgia) or joint pain (arthralgia)
ll damage to the kidneys by toxins in the blood (toxic nephropathy)
ll glucose in the urine (nephrogenic diabetes insipidus)
ll inflammation of the urethra which causes pain and bleeding
(haemorrhagic ureteritis)
ll death of the cells and tissues (necrosis)
ll decrease in the size of the bladder (bladder contracture)
ll changes to the cells in the lining of your bladder
ll increase in the levels of creatinine or urea nitrogen in your blood.
Your doctor will do blood tests to test for these
ll premature labour
ll infertility. Sperm production in men and egg production in women
may be reduced or stop. In some cases this can be permanent
ll reduced frequency of menstrual periods (oligomenorrhea)
ll decrease in testicle size (testicular atrophy)
ll decrease in the hormone oestrogen in the blood
ll increase in the hormone gonadotrophin in the blood
ll use in young patients may result in some impairments of future
fertility
ll reduction in growth, deformity or death of a foetus while in the
womb
ll toxic effects on the foetus such as myelosuppression and
gastroenteritis
ll life threatening failure of multiple organs such as heart, lungs,
kidney, liver (see symptoms throughout section 4)
ll general physical deterioration
ll flu-like symptoms such as headache, fever, chills, joint and muscle
pain, weakness, tiredness
ll swelling
ll 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.
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
UK
Yellow Card Scheme
www.mhra.gov.uk/yellowcard

5 How to store Cyclophosphamide
ll Keep this medicine out of the sight and reach of children.
ll 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.
ll Do not store above 25ºC. Store in the original container.

Medicines should not be disposed of via wastewater or household
waste. If you have any medicine left over, take it back to your
pharmacist.

6 Contents of the pack and other information
What Cyclophosphamide contains
The active substance is Cyclophosphamide and each tablet contains
50 mg.
Other ingredients are: maize starch, lactose monohydrate, calcium
hydrogen phosphate, talc, magnesium stearate, gelatine, glycerol,
sucrose, titanium dioxide (E171), calcium carbonate, macrogol,
colloidal anhydrous silica, povidone, carmellose sodium, polysorbate
20, montan glycol wax.

What Cyclophosphamide looks like and contents
of the pack
Cyclophosphamide Tablets are white, round, coated tablets with a
white core. There are 10 tablets in a blister strip and 10 blister strips
in a box.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd,
Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Send all enquiries to this address.
Cyclophosphamide is manufactured by:
Baxter Oncology GmbH
Kantstrasse 2, 33790 Halle/Westfalen Germany
This leaflet was last revised in 12/2016.

For information about Cyclophosphamide or to
request this leaflet in formats such as audio
or large print please contact the Marketing
Authorisation Holder: Tel: +44 (0)1635 206345.
Baxter is a trademark of Baxter International Inc

ll chest pain

Very rare: may effect up to 1 in 10,000 people
ll 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
ll accumulation of fluid in the body (water retention), which may been
seen as fluid beneath the skin or swelling in you limbs
ll feeling sick and being sick (nausea, vomiting)
ll constipation or diarrhoea
ll ulcers in the lining of your digestive system (mucosal ulceration)
ll inflammation of the lining of your mouth including ulcers (stomatitis)
ll confusion
ll ulceration or scaring (fibrosis) of the bladder
ll inflammation of the eye (conjunctivitis)
ll eye oedema (swelling)
Unknown: frequency cannot be estimated from the available data
ll changes to your metabolism caused by the breakdown of the dying
cancer cells (Tumour lysis syndrome)
ll inflammation of your intestines or bowel which may resulting in
bleeding (enteritis, cecitis)
ll bleeding in your stomach or intestines (gastrointestinal
haemorrhage)
ll inflammation which causes abdominal pain or diarrhoea (colitis)
ll swelling of the glands in your neck (parotid gland inflammation).
ll 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)
ll pain from your nerves, which can also feel like an aching or burning
sensation (neuralgia)
ll tingling or numbness, often in the hands or feet (paresthesia)
ll shaking (tremor)
ll changes in your sense of touch (dysesthesia) or loss of sensation
(hypoesthesia)
ll changes in your sense of taste (dysgeusia) or loss of taste
(hypogeusia)
ll changes in your sense of smell (parosmia)
ll increased tear formation (lacrimation)

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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