Patient leaflet - Mycophenolate Mofetil Ascend 1 g /5 ml powder for oral suspension
1. What Mycophenolate mofetil is and what it is used for
Mycophenolate mofetil contains the active substance mycophenolate mofetil, it belongs to a group of medicines called “immuno-suppressants”.
Mycophenolate mofetil is used to prevent the body rejecting a transplanted organ in adults and children:
- A kidney, heart or liver.
Mycophenolate mofetil should be used together with other medicines: · ciclosporin and corticosteroids.
2. What you need to know before you take Mycophenolate mofetil
WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not take Mycophenolate mofetil:
If you are allergic to Mycophenolate mofetil, mycophenolic acid or any of the other
ingredients in this medicine (listed in section 6)
If you are a woman who could be pregnant and you have not provided a negative
pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
If you are pregnant or planning to become pregnant or think you may be pregnant · If you are not using effective contraception (see Pregnancy, contraception and breast-
feeding).
- If you are breast-feeding.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Mycophenolate mofetil.
Warnings and precautions
Talk to your doctor straight away before starting treatment with Mycophenolate mofetil: · If you are older than 65 years as you may have an increased risk of developing
adverse events such as certain viral infections, gastrointestinal bleeding and pulmonary oedema when compared to younger patients
- If you have a sign of infection such as a fever or sore throat.
- If you have any unexpected bruising or bleeding.
If you have ever had a problem with your digestive system such as a stomach ulcer. · If you have a rare problem with your metabolism called “phenylketonuria” which
runs in families.
If you are planning to become pregnant or if you get pregnant while you or your
partner are taking Mycophenolate mofetil.
If you have a hereditary enzyme deficiency such as Lesch-Nyhan and Kelley-
Seegmiller syndrome
If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with Mycophenolate mofetil.
The effect of sunlight
Mycophenolate mofetil reduces your body's defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by: · wearing protective clothing that covers your head, neck, arms and legs · using a sunscreen with a high protection factor.
Children
Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.
Do not give this medicine to children younger than 1 year because based on the limited safety and efficacy data for this age group no dose recommendations can be made. If you are not sure about anything for your child's treatment, talk to your doctor or pharmacist before use.
Other medicines and Mycophenolate mofetil:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. This is because Mycophenolate mofetil can affect the way some other medicines work. Also, other medicines can affect the way Mycophenolate mofetil works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start Mycophenolate Mofetil:
azathioprine or other medicines that suppress your immune system - given after a
transplant operation
- cholestyramine - used to treat high cholesterol
rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis
(TB)
antacids or proton pump inhibitors - used for acid problems in your stomach such as
indigestion
phosphate binders - used by people with chronic kidney failure to reduce how much
phosphate gets absorbed into their blood.
- antibiotics – used to treat bacterial infections
- isavuconazole – used to treat fungal infections
- telmisartan – used to treat high blood pressure
Vaccines
If you need to have a vaccination (a live vaccine) while taking Mycophenolate mofetil, talk to your doctor or pharmacist first. Your doctor will have to advise you on which vaccines you can have.
You must not donate blood during treatment with Mycophenolate mofetil and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with Mycophenolate Mofetil and for at least 90 days after stopping treatment.
Mycophenolate mofetil with food and drink
Taking food and drink has no effect on your treatment with Mycophenolate Mofetil.
Contraception in women taking Mycophenolate Mofetil
If you are a woman who could become pregnant, you must use an effective method of contraception with Mycophenolate mofetil. This includes:
- Before you start taking Mycophenolate Mofetil.
- During your entire treatment with Mycophenolate Mofetil.
- For 6 weeks after you stop taking Mycophenolate Mofetil.
Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
You cannot become pregnant if any of the following conditions applies to you: · You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant)
- Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-oophorectomy)
- Your womb (uterus) has been removed by surgery (hysterectomy) · Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
- You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis · You are a child or teenager who has not started having periods.
Contraception in men taking Mycophenolate mofetil
The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution, you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking Mycophenolate Mofetil.
If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.
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 or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
- You plan to become pregnant.
- You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
- You have sex without using effective method of contraception.
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking Mycophenolate mofetil until you see him or her.
Pregnancy
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed). Your baby may be affected by one or more of these.
If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Breast-feeding
Do not take Mycophenolate mofetil if you are breast-feeding. This is because small amounts of the medicine can pass into the mother's milk.
Driving and using machines
Mycophenolate mofetil has a moderate influence on your ability to drive or use any tools or machines. If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
Important information about some of the ingredients of Mycophenolate mofetil
- This medicine contains 1 mg aspartame in each 1 mL, which is equivalent to 5 mg/5 mL of suspension. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains 402.98 mg sorbitol in each1 mL, which is equivalent to
2014.9 mg/5 mL of suspension. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
This medicine contains methyl parahydroxybenzoate. It may cause allergic reactions
(possibly delayed).
Mycophenolate mofetil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
3. How to take Mycophenolate mofetil
Always take Mycophenolate mofetil exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.
How much to take
The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent rejection of your transplant organ.
Kidney transplant
Adults
- The first dose is given within 3 days of the transplant operation.
- The daily dose is 10 ml suspension (2 g of the medicine) taken as 2 separate doses. · Take 5 ml suspension in the morning and then 5 ml suspension in the evening Children (aged 1 to 18 years)
- The dose given will vary depending on the size of the child.
Your doctor will decide the most appropriate dose based on your child's height and weight (body surface area – measured as square metres or “m²”). The recommended initial dose is 600 mg/m² taken twice a day. The recommended maintenance dose
2
remains at 600 mg/m twice a day (maximum total daily dose of 2 g or 10 ml of the oral suspension). The dose should be individualised based on the doctor's clinical assessment.
Heart transplant
Adults
- The first dose is given within 5 days of the transplant operation.
- The daily dose is 15 ml suspension (3 g of the medicine) taken as 2 separate doses. · Take 7.5 ml suspension in the morning and then 7.5 ml suspension in the evening.
Children (aged 1 to 18 years)
- The dose given will vary depending on the size of the child.
Your child's doctor will decide the most appropriate dose based on your child's height
2 and weight (body surface area – measured as square metres or “m ”). The recommended initial dose is 600 mg/m² taken twice a day. The dose should be individualised based on the doctor's clinical assessment. If well tolerated, the dose
2 can be increased to 900 mg/m twice daily if required (maximum total daily dose of 3 g, or 15 ml of the oral suspension).
Liver transplant
Adults
- The first dose of oral Mycophenolate mofetil will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications. · The daily dose is 15 ml suspension (3 g of the medicine) taken as 2 separate doses. · Take 7.5 ml suspension in the morning and then 7.5 ml suspension in the evening.
Children (aged 1 to 18 years)
- The dose given will vary depending on the size of the child.
Your child's doctor will decide the most appropriate dose based on your child's height
2 and weight (body surface area – measured as square metres or “m ”). The recommended initial dose is 600 mg/m² taken twice a day. The dose should be individualised based on the doctor's clinical assessment. If well tolerated, the dose
2 can be increased to 900 mg/m twice daily if required (maximum total daily dose of 3 g, or 15 ml of the oral suspension).
PT 9131-03 Back
Child
Safety
Bottle
Cap
Making up the medicine
The medicine comes as a powder. This needs mixing with purified water before using. Your pharmacist will normally make up the medicine for you. If you need to do it yourself, see section 7 “Making up the medicine”
Taking the medicine
You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose. Try not to inhale the dry powder. Also, try not to get it on your skin, inside your mouth or nose.
Take care not to let the made-up medicine get into your eyes.
- If this happens, rinse your eyes with plain water.
Take care not to let the made-up medicine get onto your skin.
- If this happens, wash the area thoroughly with soap and water.
- Shake the closed bottle well for about 5 seconds before each use.
- Take off the child safety bottle cap.
Take the dispenser and push the plunger completely down toward the tip of the
dispenser.
- Then put the tip of the dispenser firmly into the opening of the bottle adapter.
- Turn the whole thing upside down (bottle and dispenser – see picture below).
- Pull the plunger out slowly.
- Keep pulling it out until the desired amount of medicine is in the dispenser.
- Turn the whole thing back round the right way.
Holding onto the body of the dispenser, carefully pull the dispenser out of the bottle
adapter.
The bottle adapter should stay in the bottle.
Put the end of the dispenser directly into your mouth and swallow the medicine. · Do not mix the medicine with any other liquid when you swallow it. Close the bottle
with the child safety bottle cap after each use.
Immediately after use – take the dispenser to pieces and rinse it under running tap
water. Allow it to dry in the air before using it again.
Do not use solvent-containing wipes for cleaning. Do not use cloths or wipes for
drying.
Contact your doctor, pharmacist or nurse if both dispensers are lost or damaged, and they will advise you on how to continue to take your medication.
If you take more Mycophenolate mofetil than you should
If you take more Mycophenolate mofetil than you should, talk to a doctor or go to a hospital straight away. Also do this if someone else accidentally takes your medicine. Take the medicine pack with you.
If you forget to take Mycophenolate mofetil
If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take it at the usual times. Do not take a double dose to make up for a missed dose.
If you stop taking Mycophenolate mofetil
Do not stop taking Mycophenolate mofetil unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Mycophenolate mofetil can cause side effects, although not everybody gets them.
Talk to a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- you have a sign of infection such as a fever or sore throat
- you have any unexpected bruising or bleeding
rash, itching, hives, breathlessness or difficult breathing, wheezing or coughing,
lightheadedness, dizziness, changes in level of consciousness, hypotension, with or without mild generalized itching, skin reddening and facial/throat swelling (symptoms of severe allergic reaction).
Usual problems
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
- the number of your blood cells or signs of infections.
Fighting infections
Mycophenolate mofetil reduces your body's defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Lymph and skin cancer
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of patients on Mycophenolate mofetil have developed cancer of the lymphoid tissues and skin.
General unwanted effects
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.
Other unwanted effects may include:
Skin problems such as:
- acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Urinary problems such as:
- blood in the urine.
Digestive system and mouth problems such as:
- swelling of the gums and mouth ulcers,
- inflammation of the pancreas, colon or stomach,
- gastrointestinal disorders including bleeding,
- liver disorders,
diarrhoea, constipation, feeling sick (nausea), indigestion, loss of appetite,
flatulence.
Nervous system problems such as:
- feeling dizzy, drowsy or numb,
- tremor, muscle spasms, convulsions,
- feeling anxious or depressed, changes in your mood or thoughts.
Heart and blood vessel problems such as:
- change in blood pressure, accelerated heartbeat, widening of blood vessels.
Lung problems such as:
- pneumonia, bronchitis,
- shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor if you develop a persistent cough or breathlessness · fluid on the lungs or inside the chest,
- sinus problems.
Other problems such as:
- weight loss, gout, high blood sugar, bleeding, bruising.
Additional side effects in children and adolescents
Children, especially those under 6 years old, may be more likely than adults to have some side effects, including diarrhoea, vomiting, infections, fewer red cells and fewer white cells in the blood, and possibly lymph or skin cancer.
Reporting of side effects
If you get any side effects, talk to your doctor 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. Website: www.mhra.gov.uk/yellowcard or 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 Mycophenolate mofetil
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
- The shelf-life of the reconstituted suspension is two months. Do not use the suspension past this expiry date.
- Powder for oral suspension: Do not stored above 25 °C.
- Reconstituted suspension: Do not stored above 25 °C.
- 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 protect the environment.
6. Contents of the pack and other information
What Mycophenolate mofetil contains
- The active substance is mycophenolate mofetil.
- The other ingredients are sorbitol (E420), anhydrous citric acid, sodium citrate dihydrate, soya bean lecithin, N&A gum fruit, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218) and colloidal anhydrous silica. * contains phenylalanine equivalent to 2.5 mg/5 ml of suspension.
What Mycophenolate mofetil looks like and contents of the pack
- Each bottle of 110 g powder for oral suspension contains 35 g mycophenolate mofetil. When reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 – 165 ml.
5 ml of the reconstituted suspension contains 1 g of mycophenolate mofetil. · A bottle adapter and 2 oral dispensers are also provided.
- 7. Making up the medicine
Your pharmacist will normally make up the medicine for you. If you need to do it yourself, follow the steps below:
Try not to inhale the dry powder. Also try not to get it on your skin, inside your mouth or nose.
Take care not to let the made-up medicine get into your eyes.
If this happens, rinse your eyes with plain water.
Take care not to let the made-up medicine get on your skin.
- If this happens, wash the area thoroughly with soap and water.
- Tap the bottom of the closed bottle several times to loosen the powder.
- Measure 94 ml of purified water in a measuring cylinder.
- Add about half of the total amount of purified water to the bottle. · Then shake the closed bottle well for about 1 minute.
- Add the rest of the water.
- Then shake the closed bottle well for about another minute.
- Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle.
- Then, tightly close the bottle with the child safety bottle cap.
- This will make sure that the bottle adapter and child safety bottle cap are in the right position.
- Write the expiry date of the made-up medicine on the bottle label. · The made-up medicine can be used for 2 months.
Marketing Authorisation Holder
Ascend Laboratories (UK) Limited
Elsley Court,
20-22 Great Titchfield Street
London, W1W 8BE
United Kingdom
Tel: 0800 047 0073
Manufacturer
Ascend Laboratories (UK) Limited
th4 floor, Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA85 AW
United Kingdom