CYCLOPHOSPHAMIDE 50 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CYCLOPHOSPHAMIDE 50 MG TABLETS

Patient Information Leaflet

Read all of this leaflet carefully before you starttaking this medicine because it contains importantinformation 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.

Throughout this leaflet, Cyclophosphamide 50 mg Tablets w ill be called Cyclophosphamide.

Important things to know about Cyclophosphamide

Your doctor has prescribed Cyclophosphamide because you have cancerthat can betreated.

Cyclophosphamide is a medicine that kills cancer cells but, as a result, also attacks normal cells. It can theref ore have a number of side effects. Your doctor w ill 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 w ill check you regularly and treat any side effects w here possible.

Cyclophosphamide:

w ill reduce your blood cell count, w hich 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 w omen should not have a child during treatment w ith 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 w hat 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 w orks 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 anticancer drugs or radiotherapy.

Occasionally, some doctors may prescribe Cyclophosphamide for other conditions not related to cancer, your doctor w ill 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, w heezing, rash, itching or sw elling of the face and lips
your bone marrow is not w orking properly (especially if you have previously had chemotherapy or radiotherapy). You will have blood tests to check how w ell your bone marrow is w orking
you have a urinary tract infection, w hich can be recognised as pain w hen 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 w hich 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 w ill check how w ell your liver and kidneys are w orking 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.
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, w hich carry oxygen around your body
– w hite blood cells, w hich fight infection, and – platelets, w hich help your blood to clot.

After taking Cyclophosphamide, your blood count of the three types of cells w ill drop. This is an unavoidable side effect of Cyclophosphamide. Your blood count w ill reach its low est level about 5 to 10 days after you start taking Cyclophosphamide and w ill stay low until a few days after you finish the course. Most people recover to a normal blood count w ithin 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 w hen your blood count drops. Try to avoid close contact w ith people w ho have coughs, colds and other inf ections. Your doctor w ill treat you w ith appropriate medicine if they think you have, or are at risk, of an infection.
Your doctor w ill check that the number of red blood cells, w hite blood cells and platelets is high enough bef ore and during your treatment w ith 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 normally. thy, as mouth ulcers and inf ections It is important to keep your gums heal

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 know s this can happen and, if necessary, he or she w ill give you a medicine called Mesna w hich w ill protect your bladder.
Mesna can either be given to you as a short injection, or mixed into the drip solution w ith your Cyclophosphamide, or as tablets.
More inf ormation on Mesna can be found in the Patient Inf ormation Leaflet for Mesna Injection and Mesna tablets.
Most people having Cyclophosphamide w ith Mesna do not develop any problems w ith their bladder, but your doctor may w ant 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 aw ay 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 w ith higher doses of Cyclophosphamide, if you are being treated w ith radiation or other chemotherapy medicines or if you are elderly. Your doctor w ill 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 aw ay.
Cyclophosphamide can have life threatening effects on your liver. If you have sudden w eight gain, liver pain and jaundice tell your doctor straight aw ay.
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 follow ing medicines or treatments as they may not w ork w ell with Cyclophosphamide:

The follow ing 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 follow ing medicines can increase the toxicity of Cyclophosphamide:

allopurinol (used to treatgout)
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 w arts)
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 w ort (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 w ater 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 w arfarin (used to thin the blood)
cyclosporine (used to reduce the activity of the immune system)
succinylcholine (used to relax muscles during medical procedures)
digoxin, li-acetyldigoxin (used to treat heart conditions)
vaccines
verapamil (used to treat high blood pressure, angina or irregular heart beat)

Cyclophosphamide w ith food and drink

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

Pregnancy, breast-feeding and fertility

Do not become pregnant w hile 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 w omen 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 spermsamples or eggs before your treatment starts.

Do not breast-feed w hile being treated w ith Cyclophosphamide. Ask your doctor for advice.

Driving or using m achines

Some of the side effects of treatment w ith Cyclophosphamide might affect your ability to drive and use machines saf ely. Your doctor w ill 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 w hat medicines you are taking. Do not take any other medicines unless your doctor know s you are taking Cyclophosphamide.

3) how to take cyclophosphamide

the usual dose is betw een 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, pref erably 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 w hen no tablets are taken) bef ore 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 w ith 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 w hole day's tablets, then you should talk to your doctor.
Never take more tablets in one day than you w ere meant to
– so never take tw o 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 sw allow s 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 follow ing side effects may happen w ith this medicine.

Tell your doctor straight aw ay, and go to hospital immediately if you notice any of the follow ing serious side effects:

allergic reactions, signs of this w ould be shortness of breath, w heezing, rash, itching or sw elling of the face and lips (hypersensitivity). Severe allergic reactions could lead to difficulty in breathing or shock, w ith a possible fatal outcome (anaphylactic shock, anaphylactic/ anaphylactoid reaction)
getting bruises w ithout knocking yourself, or bleeding from your gums. This may be a sign that the platelet levels in your blood are getting too low
a low ering of your w hite blood cell count – your doctor w ill check this during your treatment. It w ill not cause any signs, but you w ill be more likely to get inf ections. If you think you have an inf ection (a high temperature, feeling cold and shivery, or hot and sw eaty, or any signs of inf ection such as a cough, or stinging on passing w ater) you may need antibiotics to fight infections because your blood count is low er than usual
blood in your urine, pain w hile passing urine, or less urine being passed (hemorrhagic cystitis, haematuria)
inflammation of your intestines or bow el w hich may resulting in bleeding (hemorrhagic enterocolitis)
fits (convulsions)
life threatening conditions w hich cause rash, ulcers, sore throat, fever, conjunctivitis, separation of skin layers (toxic epidermal necrolysis, Stevens-Johnson syndrome). Sw elling, 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 w aste products from the blood (kidney failure). These changes to the tissues w ithin your kidney can prevent them from w orking correctly, and induce kidney failure (renal tubular necrosis, renal tubular disorder)
pneumonia. Signs of this could be chest pain w hen you breathe or cough, conf usion, coughing, fever, sweating and chills, fatigue, shortness of breath, nausea, vomiting or diarrhoea
severe inf ection spreading through the blood w hich may lead to a dangerous drop in blood pressure w ith 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 tw itching, and shaking
a syndrome called reversible posterior leukoencephalopathy syndrome, w hich can cause sw elling of the brain, headache, conf usion, fits and loss of sight
heart attack (myocardialinfarction)
decrease in your hearts ability to pump enough blood around your body w hich 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 conf usion, 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 dow n 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)
sw elling of the brain due to too much w ater in your blood (w ater intoxication). Signs of this can be headache, changes in personality or behaviour, confusion, drow siness
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 w hich causes chest pain and breathlessness (pulmonary embolism)
blood clot, usually in a leg, w hich causes pain sw elling or redness (venous thrombosis)
low blood levels of sodium w hich can cause tiredness and conf usion, muscle twitching, fits and coma (hyponatremia) n, this may be caused by tummy discomfort or severe tummy and back pai inflammation of the pancreas (acute pancreatitis)
high blood sugar levels w hich can cause thirst, tiredness and irritability (hyperglycaemia)
low blood sugar levels w hich can cause conf usion and sw eating (hypoglycaemia)
effects on the spinal cord (Myelopathy), w hich can cause numbness, w eakness 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) w hich may be noticeable (palpitations):

o irregular heart beat (fibrillation)

o faster heart beat (tachycardia), w hich may be life threatening (ventricular tachycardia)

o slow er heart beat (bradycardia)

blood clot in the lungs w hich causes chest pain and breathlessness (pulmonary veno-occlusive disease)
scarring of thelungs w hich causes shortness of breath (pulmonary fibrosis)
conditions causing inflammation of the lungs w hich 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 w hich can cause shortness of breath, fatigue, cough, angina, fainting, peripheral oedema (pulmonary hypertension)
abnormal muscle breakdow n w hich 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

reductionin the effectivenessof yourimmune 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 w ill 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

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)
increasedlevels of certain proteins produced by your liver called enzymes. Your doctor w ill do blood tests to test for these
inflammation of the bladder lining w hich causes pain, bleeding, blood in the urine, reduced urine flow (haemorrhagic cystitis)
inflammation of the linings of your body cavities (mucosal inflammation)

Uncommon: may effect up to 1 in 100 people

loss of appetite (anorexia)
reddening of the skin (flushing) w hich may be accompanied by feeling hot or sw eating (hot flushing)

Rare: may effect up to 1 in 1,000 people

secondary tumours in various parts of the body, often in the area of the bladder
dehydration
dizziness
blurring, reduction or loss of sight
changes in colour of your fingernails and skin.
inflammation of this skin w hich may cause rash, blisters, itching, sores, oozing and scarring (dermatitis)
absence of menstrual periods (amenorrhea)
chest pain

Very rare: may effect 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 (w ater retention), which may been seen as fluid beneath the skin or sw elling in you limbs
feeling sick and being sick (nausea, vomiting)
constipationor diarrhoea
ulcers in the lining of your digestive system (mucosal ulceration)
inflammation of the lining of your mouth including ulcers (stomatitis)
conf usion
ulceration or scaring (fibrosis) of the bladder
inflammation of the eye (conjunctivitis)
eye oedema (sw elling)

Unknow n: frequency cannot be estimated from the available data

changes to your metabolism caused by the breakdow n of the dying cancer cells (Tumour lysissyndrome)
inflammation of your intestines or bow el w hich may resulting in bleeding (enteritis, cecitis)
bleeding in your stomach or intestines (gastrointestinal haemorrhage)
inflammation w hich causes abdominal pain or diarrhoea (colitis)
sw elling of the glands in your neck (parotid gland inflammation).
a disorder of the nerves w hich can cause w eakness, tingling or numbness (peripheral neuropathy). This could be in more than one set of nerves (polyneuropathy)
pain from your nerves, w hich 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, w eakness, numbness, ulcers, changes in skin colour or temperature
difficulty in breathing or w heezing (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)
yellow ing of the skin or w hites of the eyes (jaundice)
blockage of the small veins in your liver (veno-occlusive liver disease) which can cause w eight gain, increased liver size, pain and jaundice
conditions causing inflammation of the liver w hich can cause jaundice, w eight loss and malaise (hepatitis)
disruption of the formation of bile by the liver w hich can cause itchiness, jaundice, pale coloured stools, dark urine (cholestasis)
a build-up of fluid in the abdomen causing sw elling 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 w hich can develop in to sores (erythema multiforme)
excessive sw eating (hyperhidrosis)
sw elling of theface
itching(pruritus)
serious illness w hich causes thickening of the skin and the connective tissue in your internal organs (scleroderma)
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 w hich 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 w ill do blood tests to test for these
premature labour
infertility. Sperm production in men and egg production in w omen 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 grow th, deformity or death of a foetus w hile in the w omb
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
sw elling
injection sitereaction.

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 at: r search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5) how to store cyclophosphamide

Keep all medicines out of the sight and reach of children.
Do not use after the expiry date printed on the carton, label or blister strip.
Do not store above 25°C. Store in the original container.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.
Medicines should not be disposed of via w astew ater or household w aste. Ask your pharmacist how to dispose of medicines no longer required. These measures w ill help to protect the environment.

6) contents of the pack and other information

What Cyclophosphamide contains:

Each tablet contains cyclophosphamide monohydrate equivalent to 50mg cyclophosphamide.

Other ingredients are: maize starch, lactose monohydrate, calcium hydrogen phosphate anhydrous, talc, magnesium stearate, gelatin, glycerol, sucrose, titanium dioxide (E171), calcium carbonate, macrogol, colloidal anhydrous silica, povidone, carmellose sodium, polysorbate 80, montan glycol w ax.

What Cyclophosphamide looks like and contents of the pack

Cyclophosphamide Tablets are w hite round, biconvex sugar coated tablets w ith a w hite core.

Cyclophosphamide Tablets are available as blister packs of 20 Tablets.

PL 46420/0400 Cyclophosphamide 50mgTablets |POM |

Who makes and repackages your medicine?

Your medicine is manuf actured by Baxter Oncology GmbH Kantstrasse 2, 33790 Halle/Westfalen Germany. Procured from within the EU and repackaged by the Product Licence holder: Suerte Pharma Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 26.02.2020

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