LODOTRA 1 MG MODIFIED-RELEASE TABLETS

Active substance: PREDNISONE

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Prednisone
Read all of this leaflet carefully before you
start taking this medicine.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lodotra is and what it is used for
2. Before you take Lodotra
3. How to take Lodotra
4. Possible side effects
5. How to store Lodotra
6. Further information

1. What Lodotra is and what it is used for
Lodotra is a tablet with a delayed release
behaviour of the active compound prednisone,
which is a corticosteroid. Corticosteroids
have an anti-inflammatory action. Antiinflammatory medicines reduce pain, swelling,
stiffness, redness and heat in affected joints.
These tablets are used to treat:
• moderate to severe, active rheumatoid
arthritis in adults, particularly when
accompanied by morning stiffness
These tablets are modified-release tablets.
This means that they are designed to release
prednisone approximately 4 hours after
swallowing. This allows you to take Lodotra at
bedtime and feel an improvement in your early
morning symptoms such as stiffness.

Do NOT take Lodotra
• if you are allergic (hypersensitive) to
prednisone or any of the other ingredients of
these tablets (see section 6 of this leaflet).
Take special care with Lodotra
You must tell your doctor if you have (at the
moment) or have had (in the past) any of the
following conditions or treatments:
• too high a level of sugar (glucose) in your
blood (diabetes). Your doctor may increase
your diabetes medication and closely
monitor your treatment.
• weakened bones (osteoporosis).
• softened bones (osteomalacia).
• ulcers of the stomach and bowel.
• severe ulcerative colitis (inflammation of the
colon) with high risk of a perforation (hole)
in the colon.
• inflammation of the bowel (diverticulitis).
• immediately after surgery to connect two
parts of your bowel (entero-anastomosis).
• hepatitis B (a liver disease caused by a
virus).
• tuberculosis (TB) which is a bacterial
infection usually affecting the lungs or if
you have swelling and inflammation of
the lymph nodes after BCG vaccination (a
vaccination against TB).
• polio (an infectious disease caused by a
virus affecting the nervous system).
• acute viral infection (e.g. chickenpox, lip or
eye herpes, measles or shingles).
• acute bacterial infection (e.g. bacterial
tonsillitis) or chronic bacterial infections
(e.g. TB).

• acute fungal infection (e.g. thrush).
• parasitic infection (e.g. roundworms).
• high blood pressure. You may need more
frequent blood pressure checks.
• eye diseases (glaucoma). You may need
closer monitoring of your conditions.
• injuries or ulcers on the cornea (the
transparent front of the eye that covers the
iris and pupil).
• heart problems. You may need closer
monitoring of your condition.
• mental illness.
• sleep disorder occurs during the treatment
and does not improve. In these situations
your doctor may prescribe a different
medicine.
Also tell your doctor if you have recently
had (within the last 2 weeks) or plan to have
(within the next 8 weeks) a vaccination.
These tablets cannot achieve the desired
blood concentration of prednisone if taken
under fasting conditions. Therefore, these
tablets should always be taken with or after
the evening meal in order to ensure they
work properly. In addition, low plasma
concentrations may occur in 6%–7% of doses
when taken according to the recommendations.
This should be considered if these tablets are
not sufficiently effective. In these situations
your doctor may prescribe a different
medicine.
Lodotra is a tablet with a delayed release
behaviour of the active compound prednisone.
Therefore it should only be used to treat
the conditions described in section 1 ‘What
Lodotra is and what it is used for’.

In one of the treatments or conditions above
a different type of medicine may be more
suitable for you. See also ‘Other things you
should know about Lodotra’.
Your doctor will advise you on what to do.
Other things you should know about
Lodotra
These tablets can affect your immune system.
This affects your body’s ability to fight
disease. If your immune system is affected:
• vaccination with an inactivated vaccine
(e.g. flu or cholera vaccines) may not be as
effective if you are taking, or start taking
these tablets.
• certain viral diseases (chicken pox and
measles) may be more severe. You are
at particular risk if you have not been
vaccinated against these diseases.
• you may be at a greater risk of other severe
infections.
Your treatment with these tablets may make
you more likely to develop an infection. If you
are developing an infection, it may be more
difficult to be detected while you are taking
these tablets.
You may need a smaller dose of these tablets
if you have:
• hypothyroidism (an underactive thyroid
gland);
• cirrhosis of the liver (liver disease caused by
alcoholism or hepatitis).
You may need a higher dose of these tablets
during stressful events such as:
• a surgical procedure;
• during infection.

If you take these tablets for several months or
more, your doctor will carry out regular checkups including:
• eye examination;
• blood test;
• blood pressure check.
Treatment with these tablets may have
a negative effect on the way calcium is
metabolised in your bones. Therefore, you
should clarify with your doctor the risk
of osteoporosis (bone loss and fractures),
particularly if you have family members who
have a history of bone fractures, you do not
take exercise regularly, you are a woman
during or after menopause or if you are elderly.
When stopping these tablets there is a risk of:
• the symptoms of your rheumatoid arthritis
returning;
• adrenal failure. This is when your adrenal
gland does not produce enough cortisol
(a hormone). This is especially likely in
stressful situations such as:
–– during infections;
–– after accidents;
–– when you are under increased physical
strain;
• cortisone withdrawal syndrome (a serious
illness caused by your body not producing
cortisol).
Your doctor will advise you what to do.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

The effects of the following medicines may be
increased by these tablets:
• heart medication such as cardiac glycosides
(e.g. digoxin);
• laxatives or salt depleting drugs such as
some diuretics (water tablets);
• ciclosporin, a drug used after transplant
surgery or occasionally in severe rheumatoid
arthritis;
• muscle relaxants, such as suxamethonium,
used in hospitals;
• cyclophosphamide, a treatment for various
types of cancer.
The effects of the following medicines may be
decreased by these tablets:
• somatropin, a growth hormone;
• praziquantel, a treatment for parasitic
infections;
• diabetes medicines, e.g. insulin, metformin,
glibenclamide.
The following medicines may reduce the effect
of these tablets on your rheumatoid arthritis
symptoms:
• treatments for epilepsy such as barbiturates,
phenytoin and primidone;
• rifampicin, a treatment for infection;
• bupropion, a treatment to help you stop
smoking or for depression;
• aluminium and magnesium antacids.
The following medicines may increase the
effect of these tablets on your rheumatoid
arthritis symptoms:
• oestrogen containing medicines, for example
oral contraceptives, Hormone Replacement
Therapy (HRT);

• liquorice (used as an expectorant in
cough medicines and also present in
confectionery).
Other effects of medicines:
• non-steroidal anti-inflammatory drugs
(NSAIDs) such as acetylsalicylic acid,
diclofenac and ibuprofen increase the risk of
gastrointestinal bleeding;
• warfarin may have reduced or increased
blood thinning effects depending upon the
individual;
• treatment with ACE inhibitors (e.g. captopril
or enalapril) for high blood pressure or heart
failure may increase the risk of changes in
the numbers of blood cells;
• anticholinergic medicines (e.g. atropine)
may increase the risk of raised pressure in
the eye (glaucoma);
• medications to treat or prevent malaria
(e.g. chloroquine, hydroxychloroquine,
mefloquine) may increase the risk of muscle
weakness, including heart muscle weakness;
• amphotericine B, an antifungal drug, may
increase the risk of hypokalaemia;
• some diagnostic tests may be affected, for
example:
–– skin tests for allergies;
–– a blood test to measure your levels of a
hormone produced by the thyroid gland
Your doctor will advise you on what to do.

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Lodotra® 1 mg, 2 mg and 5 mg
modified-release tablets

: 2. Before you take Lodotra

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Package leaflet : Information for the user

Driving and using machines
These tablets are unlikely to affect your ability
to drive or using machines. However, if you
develop eye pain or a blurred vision during the
treatment, you should avoid these activities.
Important information about some of the
ingredients of your Lodotra modified-release
tablets
The medicinal product contains a sugar called
lactose. If you have been told that you have
an intolerance to some sugars, contact your
doctor before taking these tablets.

Method of administration:
• How to open and close the bottle
especially designed for rheumatoid
arthritis patients: see ‘Directions for
opening and closing the container’.
• Take the number of tablets that your
doctor has told you.
• Do not break the tablet as the coating
is important for these tablets to work
properly.
• Swallow the tablets whole: Do not break,
divide or chew the tablets.
• Take the tablets in the evening (usually at
about 10 pm) with a glass of water.
• You should take these tablets with or after
the evening meal. If more than 2–3 hours.
have passed since eating, take the tablet
with a light meal or snack.

Directions for opening and closing
the container:
Please follow the instructions below:
ope
n

op

If you forget to take Lodotra
You should contact your doctor on
how to proceed.

en

To Open
Place pen or similar object between the
raised sections of the lid and turn in
the direction shown (anticlockwise).

To Close
Place pen or similar object between the
raised sections of the lid and turn in
the direction shown (clockwise).

If you stop taking Lodotra
Do not suddenly stop taking your
tablets.
If you stop taking these tablets your
rheumatoid arthritis symptoms may
return.
It is important that your dose is
reduced slowly. Your doctor will
advise you how to reduce your dose
gradually.
Lodotra should not be substituted by
prednisone immediate-release tablets
without first talking to your doctor.
If you have any further questions on
the use of this product, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines Lodotra can cause side
effects although not everybody gets them.
The frequency and severity of the
undesirable effects listed below depend on
dosage and duration of treatment.
Common side effects (less than 1 in 10
people but more than 1 in 100 people taking
these tablets):
• A hormone imbalance causing Cushing’s
syndrome (typical symptoms: a round face
often called a ‘moon face’, upper body
weight gain and rash on the face) as well
as a reduced production of glucocorticoids
in the body.
• Disturbances of the balance of sugars, fats
and salts in the body possibly resulting in:
–– increased appetite and weight gain;
–– diabetes;
–– high cholesterol;
–– heart rhythm disturbances (because of
increased potassium excretion);
–– accumulation of water (oedema,
because of reduced sodium excretion).
• Reduced ability to fight infections,
infections may be more severe or the
symptoms may be masked.
• Clouding of the lens (cataract) and
increased pressure in the eye (glaucoma)
with or without eye pain.
• Stretch marks, bruising or red marks on
the skin or in the mouth, wasting of the
skin.
• An increase or decrease in the number of
blood cells.
• Muscle wasting and weakness.
• Bone wasting resulting in an increased
risk of bone fractures (osteoporosis).

• Difficulty in sleeping.
• Headache.
Uncommon side effects (less than 1
in 100 people but more than 1 in 1000
people taking these tablets):
• High blood pressure.
• Thickening or inflammation of the
lining of the blood vessels and blood
clots.
• Stomach ulcers and bleeding in the
bowel.
• Increased hair growth, spots and
other skin blemishes, delayed healing
of skin wounds, acne.
Rare side effects (less than 1 in 1000
people but more than 1 in 10000 people
taking these tablets):
• Allergic reactions including blistering
on the skin.
• Inflammation of the pancreas causing
severe abdominal pain.
• Disturbances in sex hormone
secretion, possibly resulting in
absence of monthly periods in women
or impotence in men.
• Disturbance of the thyroid function.
• Depression (feeling sad), irritability,
feelings of happiness that are
not justified by reality, increased
impulse, loss of contact with reality
(psychosis).
• Increased pressure in the head
resulting in headache, vomiting and
double vision.
• Development or worsening of
epileptic fits.
• Worsening of existing eye ulcers or
infections.
• Loss of bone (osteonecrosis).

If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
:
5. How to store Lodotra
• Keep out of the reach and sight of
children.
• Do not take these tablets after the
expiry date which is stated on the
bottle and the carton.
• The expiry date refers to the last day
of that month.
• Do not store above 25°C.
• Medicines should not be disposed of
in wastewater or household waste.
Ask your pharmacist how to dispose
of medicines that are no longer
required. These measures will help to
protect the environment.
:
6. Further information
What Lodotra contains
The active substance is prednisone.
Each modified-release tablet contains
1 mg, 2 mg or 5 mg of prednisone.
The other ingredients are:
• Colloidal anhydrous silica
• Croscarmellose sodium
• Lactose monohydrate
• Magnesium stearate
• Povidone K 29/32
• Red ferric oxide E 172
• Calcium hydrogen phosphate
dihydrate
• Glycerol dibehenate
• Yellow ferric oxide E 172.

What Lodotra looks like and contents
of the pack
The 1 mg modified-release tablets are
pale yellowish-white, circular with ‘NP1’
embossed on one side.
The 2 mg modified-release tablets are
yellowish-white, circular with ‘NP2’
embossed on one side.
The 5 mg modified-release tablets
are light yellow, circular with ‘NP5’
embossed on one side.
In each bottle there are 30 or 100 tablets.

Marketing authorisation holder and
manufacturer
Marketing authorisation holder
Napp Pharmaceuticals Ltd,
Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW,
United Kingdom.
Manufacturer
Horizon Pharma GmbH,
Joseph-Meyer-Str. 13-15, 68167
Mannheim,
Germany.

This leaflet is also available in large print,
Braille or as an audio CD.
To request a copy, please call the
RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name
and reference number. These are as follows:
Product name: Lodotra
Reference number: 16950/0173
This leaflet was last revised in May 2011.
® Lodotra is a registered trade mark of Horizon Pharma AG, and is used under licence.
NAPP and the ‘NAPP’ device (logo) are registered trade marks of the Napp
Pharmaceutical Group.
© 2010 - 2011 Napp Pharmaceuticals Limited.

UK00BZT04

If you take more Lodotra than you
should
Acute intoxications with these tablets
are not known. In case of overdosing,
you are likely to experience an
increase in undesirable effects
including:
• disturbances in hormone function;
• effects on your metabolism;
• effects on your electrolyte (salt)
balance, leading to increased risk of
abnormal heartbeats.
Contact your doctor if you are
concerned or experience an increase
in side effects.

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Always take the tablets exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
The dose your doctor will prescribe will
depend on the severity of your disease.
This should not usually be more than 10 mg
prednisone per day.
Your starting dose may be reduced on
your doctor’s advice in steps to a lower
maintenance dose depending on:
• your rheumatoid arthritis symptoms;
• your response to Lodotra.
If you are changing over from taking
standard corticosteroid tablets in the
morning to taking Lodotra in the evening,
your dose should contain the same amount
of active substance (prednisone).

• Always take the tablets after dinner
or a light snack (see section 2 ‘Take
special care…’).
These modified-release tablets are
usually taken for several months or
longer. Your doctor will talk to you
about how long you need to take your
tablets.

c lo s e

Pregnancy and breastfeeding
Ask your doctor for advice before taking any
medicine.
Pregnancy
You must tell your doctor if you think you
may be pregnant or you are planning to have
a baby. Your doctor will advise you if you can
take these tablets.
Breastfeeding
The active substance of these tablets passes
into breast milk. Your doctor will advise you if
you can take these tablets while breastfeeding.

3. How to take Lodotra

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Taking Lodotra with food and drink
Take your tablets in the evening usually
around 10 pm. Ideally, you should take your
tablets with or after your evening meal.
You should swallow the tablets whole, with
sufficient liquid, e.g. glass of water.
You should not break, divide or chew the
tablets.
If more than 2–3 hours have passed since
eating, you should take your tablets with a
light meal or snack.

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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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