Lodotra

modified release tablets

Prednisone
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Lodotra. It does not contain all the information that is known about Lodotra. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What LODOTRA® modified release tablets are taken for

LODOTRA® modified release tablets contain a medicine called prednisone, and act through a delayed release mechanism. Prednisone belongs to a group of medicines called corticosteroids.
LODOTRA® modified release tablets are used to treat moderate to severe, active rheumatoid arthritis, particularly when accompanied by stiffness of the joints in the morning.
Corticosteroids have an anti-inflammatory action, and are used to reduce the pain, swelling, redness and heat in the affected joints.
LODOTRA® modified release tablets are designed to release prednisone approximately four hours after being swallowed. When taken at bedtime, they produce an improvement in the joint stiffness and other symptoms usually experienced upon wakening.
Your doctor, however, may prescribe LODOTRA® modified release tablets for another purpose.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is only available with a doctor's prescription.

Before you take it

When you must not take it

Do not take LODOTRA® modified release tablets if you are:
allergic (hypersensitive) to prednisone, prednisolone or to any of the ingredients listed at the end of this leaflet.
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take it after the expiry date has passed, it may not work very well.
Do not take LODOTRA® modified release tablets if you have a current serious uncontrolled infection.
Do not take it if the packaging is torn or shows signs of tampering.
Do not give this medicine to a child or adolescent.
Safety and effectiveness in children and adolescents have not been established.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
an acute viral infection, such as chickenpox, herpes, measles, shingles
an acute bacterial infection, such as bacterial tonsillitis
an acute fungal infection, such as thrush
a parasitic infection, such as roundworms
tuberculosis (TB), or other chronic bacterial infection
swelling and inflammation of lymph nodes following a tuberculosis vaccination
polio infection
high blood sugar levels (diabetes)
weak or softened bones or osteoporosis
stomach or bowel ulcers
inflammation of the bowel or colon
immediately after surgery to connect two parts of the bowel (entero-anastomosis)
eye problems, such as glaucoma, corneal injuries or ulcers
high blood pressure
kidney, heart or liver problems, including liver disease caused by alcoholism or hepatitis
mental illness
epilepsy
underactive thyroid gland
intolerant to lactose/galactose.
Tell your doctor if you are planning to have a vaccination with a live vaccine, or have recently had a live vaccination.
Tell your doctor if you think you may be pregnant or intend to become pregnant.
Your doctor will advise if you can take LODOTRA® modified release tablets.
Tell your doctor if you are breast-feeding or intend to breast-feed while taking LODOTRA® modified release tablets.
The active substance in LODOTRA® modified release tablets passes into breast milk. Your doctor will advise if you can take LODOTRA® modified release tablets while breast-feeding.
If you have not told your doctor about any of the above, tell them before you take any LODOTRA® modified release tablets.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and LODOTRA® modified release tablets may interfere with each other.
LODOTRA® modified release tablets may increase the effects of the following medicines:
medicines for the heart, e.g. digoxin
laxatives, water tablets (diuretics) and salt-depleting medicines
cyclosporin, a medicine used after transplant surgery and in severe rheumatoid arthritis
suxamethonium, a muscle relaxing medicine used in surgery
cyclophosphamide, a medicine used in cancer.
LODOTRA® modified release tablets may decrease the effects of the following medicines:
somatropin, a growth hormone medicine
praziquantel, a medicine for parasitic infections
medicines for diabetes, e.g. insulin, metformin and glibenclamide.
The effect of LODOTRA® modified release tablets on rheumatoid arthritis may be reduced by the following medicines:
medicines for epilepsy, e.g. barbiturates, phenytoin and primidone
rifampicin, a medicine for infection
bupropion, a medicine for smoking cessation
antacid medicines containing aluminium and magnesium.
The effect of LODOTRA® modified release tablets on rheumatoid arthritis may be increased by the following medicines:
oral contraceptives and hormone replacement therapy medicines
liquorice, used in cough medicines and in confectionery.
When LODOTRA® modified release tablets are taken with some medicines, alcohol or some types of food, other effects may occur that you should discuss with your doctor:
aspirin, ibuprofen, diclofenac and other non-steroidal anti-inflammatory drugs (gastrointestinal bleeding risk)
coumarin, warfarin and other anti-coagulants (blood thinning changes)
captopril, enalapril and other blood pressure and heart failure medicines (blood cell changes)
atropine and other anticholinergic medicines (raised eye pressure and glaucoma risk)
chloroquine, mefloquine, hydroxychloroquine and other anti-malaria medicines (muscle weakness risk, including heart)
amphotericin B and other anti-fungal medicines (low levels of potassium in blood risk)
alcohol
sodium-containing medicines or foods.
You may need to take different amounts of your medicines, or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking this medicine.
LODOTRA® modified release tablets can affect the results of some diagnostic tests, as follows:
skin tests for allergies
blood tests for thyroid hormones
tests for infections.

How to take LODOTRA® modified release tablets

How much to take

Your doctor will tell you exactly how much LODOTRA® modified release tablets to take. The dose of LODOTRA® modified release tablets that you are prescribed will depend on the severity of your disease.
Follow the instructions given to you by your doctor or pharmacist exactly.
If you are changing over from taking an immediate- release prednisone medicine in the morning to taking LODOTRA® modified release tablets in the evening, your dose should contain the same amount of prednisone.
Your doctor may advise you to reduce your starting dose gradually to a lower maintenance dose, depending on your symptoms and how well you respond to LODOTRA® modified release tablets.
LODOTRA® modified release tablets are usually taken for several months or longer. Your doctor will advise you how long to take them.

How to take it

Take LODOTRA® modified release tablets at bedtime (about 10:00 pm). Swallow LODOTRA® modified release tablets whole with a glass of water with or after the evening meal. If more than 2-3 hours have passed since your evening meal, take LODOTRA® modified release tablets with a light meal or snack. LODOTRA® modified release tablets should not be taken on an empty stomach.
Taking LODOTRA® modified release tablets on an empty stomach can result in lower levels of prednisone in the body. Thus, LODOTRA® modified release tablets must be taken with food to ensure the tablets work properly.
You must only take LODOTRA® modified release tablets by mouth.
Do not chew, break or divide the tablets. LODOTRA® modified release tablets are designed to work properly only if they are swallowed whole.
If you have trouble swallowing your tablets whole, talk to your doctor.

When to take it

Take LODOTRA® at bedtime (around 10:00 pm).
If you are changing over to LODOTRA® modified release tablets from a standard treatment regime where your dose is taken in the morning, you should take the same dose of LODOTRA® modified release tablets, but instead take it at bedtime (about 10:00 pm).
Continue taking your medicine for as long as your doctor tells you. Do not stop taking LODOTRA® modified release tablets suddenly.
If you do stop taking your medicine suddenly, you may experience the return of your rheumatoid arthritis symptoms or experience side effects resulting from your body not producing enough cortisol.
If you need to stop taking LODOTRA® modified release tablets, it is important that the dose is reduced slowly. Your doctor will advise you how to reduce the dose gradually.
Do not change to any other types of prednisone tablets unless you first discuss it with your doctor.

Directions for opening and closing the container

To Open:
Place pen or similar between the raised sections of the lid and turn in anticlockwise direction.
To Close
Place pen or similar between the raised sections of the lid and turn in clockwise direction.

If you forget to take it

Contact your doctor or pharmacist on how to proceed if you forget to take LODOTRA® modified release tablets.
It is important that you take your tablets at the same time every day, around 10:00 pm.
Do not try to make up for missed doses by taking more than one dose at a time.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: telephone 13 11 26, New Zealand: telephone 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too many LODOTRA® modified release tablets, even if there are no signs of discomfort.
Keep telephone numbers for these places handy.
You may need urgent medical attention.
If you have taken too many LODOTRA® modified release tablets, you may experience an increase in side effects, particularly side effects associated with changes in hormone levels, metabolic disorders e.g. increases in blood glucose levels, and electrolyte and fluid imbalance.
When seeking medical attention, take this leaflet and any remaining tablets with you to show the doctor. Also report any other medicines or alcohol which have been taken.

While you are taking it

Things you must do

Take LODOTRA® modified release tablets exactly as your doctor has prescribed.
LODOTRA® modified release tablets should always be taken with or after an evening meal for it to work properly.
If you are about to start any new medicine, remind your doctor and pharmacist that you are taking LODOTRA® modified release tablets.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
Your doctor may need to increase the dose of LODOTRA® modified release tablets during stressful events such as surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
If you take LODOTRA® modified release tablets for several months, your doctor will do regular checks on your eyes, your blood pressure and take blood tests.
Tell your doctor if your symptoms of rheumatoid arthritis worsen or you feel that the tablets are not working properly.
Tell your doctor straight away if you are a diabetic and you notice a change in the results of your blood or urine sugar levels.
This medicine may affect your blood sugar levels.
Tell your doctor if you are having any problems or difficulties while you are being treated with LODOTRA® modified release tablets.
Keep enough LODOTRA® modified release tablets with you to last over weekends and holidays.

Things you must not do

Do not take LODOTRA® modified release tablets to treat any other complaint unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
LODOTRA® modified release tablets should not be stopped suddenly. It is important that you follow your doctor's instructions and reduce your dose slowly. You must also follow your doctor's instructions when you are switching to another medicine.
If you stop taking LODOTRA® modified release tablets suddenly, there is a risk that:
your rheumatoid arthritis symptoms will return.
your adrenal gland does not produce enough cortisol hormone or fails, especially if you are under stress such as with serious infections, increased physical strain and after major accidents.
you may experience cortisone withdrawal syndrome caused by your body not producing cortisol.
Do not stop taking your medicine or change the dosage without checking with your doctor.
If you need to stop taking this medicine, your doctor will gradually reduce the amount you take each day, if possible, before stopping the medicine completely.

Things to be aware of

Taking LODOTRA® modified release tablets may affect your body's ability to fight disease and affect your immune system. If so:
you may be more likely to develop an infection, including severe infections, and it may be harder to detect them.
some viral diseases, such as chicken pox and measles, may be more severe if you catch them, especially if you have not been vaccinated against them. Avoid close contact with anyone who has a contagious disease.
vaccination with an inactivated vaccine may not be as effective, such as those for influenza or cholera.
See your doctor for medical advice for any but the most minor infections.
Tell your doctor straight away if you think you have been exposed to contagious diseases such as chickenpox or measles.
Talk to your doctor before you have any immunisations while you are being treated with LODOTRA® modified release tablets.
LODOTRA® modified release tablets can affect your bones and calcium metabolism.
You should ask your doctor about your risk of osteoporosis, bone loss and fractures, especially if you are elderly, your family members have osteoporosis, you do not exercise much, and you are menopausal or post-menopausal.
Do not drive or operate machinery until you know how LODOTRA® modified release tablets affect you.
If you develop blurred vision or eye pain, you should avoid these activities. Ask your doctor about any impact that LODOTRA® modified release tablets may have on your ability to drive or operate machinery.
Check with your doctor first before drinking alcohol while you are taking LODOTRA® modified release tablets.

Side effects

All medicines may have some unwanted side effects. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
You may not experience any of them. The risk of side effects depends on the dose and length of time LODOTRA® modified release tablets are taken.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LODOTRA® modified release tablets.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
bloating and rounding of the face ('moon face')
increased appetite, weight gain
fluid retention, leading to swollen legs and feet
headaches
bruising or red marks on skin or in mouth, stretch marks, skin blemishes
muscle weakness
sleeping difficulties
reduced ability to fight infections, infections may be more severe, delayed wound healing.
Tell your doctor as soon as possible if you notice any of the following and they worry you:
abnormal heart rhythm
pain in stomach possibly caused by ulcers
changes in eyes such as decreased or blurred vision, cataracts, worsening of existing eye ulcers or infections
increased blood sugar levels, particularly if you have diabetes
depression, irritability, feelings of happiness which are not justified by reality, increased impulse or loss of contact with reality
irregular or loss of periods
impotence.
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
you have an allergic reaction: shortness of breath, wheezing, shallow or difficulty breathing; swelling of the face, lips, tongue, throat; rash, itching or blistering on the skin
significant bleeding from the bowel or black bowel motions possibly due to a bleeding stomach ulcer
severe abdominal pain caused by inflammation of the pancreas
double vision, vomiting and headache caused by increased pressure in the head
severe eye pain with or without vision impairment
development or worsening of seizures, fits or convulsions.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Some side effects can only be detected by your doctor, so it is important to visit your doctor for regular check-ups while being treated with LODOTRA®.
Such side effects can include:
changes in bone such as brittleness or softening of the bone, which can result in an increased chance of fractures
changes in hormone levels
higher cholesterol levels
changes to your white blood cells
increased blood pressure
increased pressure in the skull or eye (glaucoma).
Other side effects not listed above may also occur in some people.

After taking it

Storage

Keep your tablets in the bottle until it is time to use them.
If you take the tablets out of the bottle they may not keep as well.
Keep your tablets in a cool, dry place where the temperature stays below 25°C.
Keep the bottle tightly closed to protect your tablets from moisture.
Do not store it or any other medicine in the bathroom, near a sink or on a window sill.
Do not leave it in the car.
Heat and damp can destroy some medicines.
Keep it where children cannot reach it or see it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets or the tablets have passed their expiry date, return any unused medicine to your pharmacist.

Product description

What it looks like

LODOTRA® modified release tablets are round tablets. Each strength is embossed on one side as follows:
2 mg - yellowish white, embossed with "NP" over "2" on one side
5 mg - light yellow, embossed with "NP" over "5" on one side.
LODOTRA® modified release tablets come in white plastic bottles of 30 tablets.
A white capsule (desiccant) is fitted into the inside of each bottle cap. Do not eat this capsule.

Ingredients

Active ingredient:
Each strength contains the following quantity of active ingredient:
The 2 mg tablet strength contains 2 mg prednisone
The 5 mg tablet strength contains 5 mg prednisone.
Inactive ingredients:
lactose
silica - colloidal anhydrous
magnesium stearate
croscarmellose sodium
povidone
calcium hydrogen phosphate
glyceryl behenate.
In addition, the tablets also contain the colourants listed below:
iron oxide red CI77491
iron oxide yellow CI77492.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer / Sponsor

LODOTRA® modified release tablets are made in France and Germany and supplied in Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
50 Bridge Street
Sydney NSW 2000
Phone: 1800 188 009
LODOTRA® modified release tablets are made in France and Germany and supplied in New Zealand by:
Mundipharma New Zealand Limited
C/- Pharmaco (NZ) Ltd
PO Box 4079
Auckland 1140
Toll Free (Medical Enquiries): 0800 773 310
®: LODOTRA is a Registered Trademark.
This leaflet was prepared in September 2012.
Australian Registration Numbers for LODOTRA® modified release tablets are:
2 mg - AUST R 183794
5 mg - AUST R 183795
Orbis RA-0025 (Oct 2012)