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LODOTRA 1 MG MODIFIED-RELEASE TABLETS

Active substance(s): PREDNISONE

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Transcript
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information 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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Lodotra is and what it is used for
2. What you need to know before you take
Lodotra
3. How to take Lodotra
4. Possible side effects
5. How to store Lodotra
6. Contents of the pack and other 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.

LODOTRA TABLETS PIL UK P0930-A V6.indd 2

These tablets are used to treat:
• moderate to severe, active rheumatoid
arthritis, particularly when accompanied by
morning stiffness, in adults.
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.
2. What you need to know before you
take Lodotra
Do NOT take Lodotra
• if you are allergic (hypersensitive) to
prednisone or any of the other ingredients of
these tablets (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
these tablets.
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).

• 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 osteoporsis (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 on what to do.
Other medicines and Lodotra
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines.
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.
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.
Pregnancy and breastfeeding
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.
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.
Lodotra tablets contains lactose
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.

P0930-A

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

• 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).
In patients with known or suspected
threadworm (Strongvloides) infestation.
These tablets may lead to massive
Strongvloides infection and widespread
larval migration.
• 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.
• Recent heart attack.
• Kidney disease.
• Mental illness.

XXXXXX-YYMM

530x150mm (LSN-CON-15) (L) V1

Package leaflet : Information for the user

05/12/2014 10:13

LODOTRA TABLETS PIL UK P0930-A V6.indd 3

op

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 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;

4. Possible side effects
Like all medicines these tablets 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.
• Increased susceptibility to and severity of
infections.
• 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).
Side effects where the frequency is not
known (cannot be estimated from the available
data):
• Reversible fat overgrowth in the spine, heart
or chest (lipomatosis).
• Accelerated heart beat
• Acid-base imbalance in the blood due to low
potassium levels (hypokalaemic alkalosis).
• Leakage of fluid under the retina resulting
in visual distortion (central serous
chorioretinopathy).
• Nausea.
• Diarrhoea.
• Vomiting.
• Extra hair growth in women (hirsutism).
• Muscle wasting of the upper arms and legs,
tendon rupture, vertebral and long bone
fractures.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the national

reporting system in the United Kingdom:
Yellow Card Scheme
Tel: Freephone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of this
medicine.
5. How to store Lodotra
• Keep this medicine out of the sight and
reach 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.
• After first opening the container, the
tablets can be stored in the bottle for up to
14 weeks. After that time, dispose of the
remaining tablets.
• Do not store 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
to protect the environment.
6. Contents of the pack and other
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.

P0930-A

• 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.
If you forget to take Lodotra
You should contact your doctor on how to
proceed.
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 medicine, ask your doctor or pharmacist.

XXXXXX-YYMM

ope
n

c lo s e

Always take the tablets exactly as your doctor
or pharmacist has told you. 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).
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.
• 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.
Directions for opening and closing the
container:
Please follow the instructions below:

close

530x150mm (LSN-CON-15) (L) V1

3. How to take Lodotra

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 December 2014.
® 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 - 2014 Napp Pharmaceuticals Limited.

05/12/2014 10:13

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 antiinflammatory action. Anti-inflammatory medicines
reduce pain, swelling, stiffness, redness and heat in
affected joints.
These tablets are used to treat:
• moderate to severe, active rheumatoid
arthritis, particularly when accompanied by
morning stiffness, in adults.
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.

LODOTRA TABS PIL UK UK00BZP01 V3.indd 2

2. What you need to know before you
take Lodotra

Do NOT take Lodotra
• if you are allergic (hypersensitive) to
prednisone or any of the other ingredients of
these tablets (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking these
tablets.
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). In
patients with known or suspected threadworm
(Strongvloides) infestation, these tablets may
lead to massive Strongvloides infection and
widespread larval migration.
• 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).

• 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.
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.
Pregnancy and breastfeeding
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.
Driving and using machines
These tablets are unlikely to affect your ability to
drive or use machines. However, if you develop
eye pain or blurred vision during the treatment, you
should avoid these activities.
Lodotra tablets contains lactose
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.

7 0 6 9 6 6 7

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information 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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Lodotra is and what it is used for
2. What you need to know before you take
Lodotra
3. How to take Lodotra
4. Possible side effects
5. How to store Lodotra
6. Contents of the pack and other information

more, your doctor will carry out regular check-ups
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 on what to do.
Other medicines and Lodotra
Tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines.
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.

7069667

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

• Heart problems. You may need closer
monitoring of your condition.
• Recent heart attack.
• Kidney disease.
• 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

UK00BZP01

330x225mm (LSN-CON-47) (L) V2

Package leaflet : Information for the user

02/09/2015 15:44

330x225mm (LSN-CON-47) (L) V2

UK00BZP01

7069667

ope
n

op

en

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

LODOTRA TABS PIL UK UK00BZP01 V3.indd 3

close

Always take the tablets exactly as your doctor or
pharmacist has told you. 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).
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.
• 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.
Directions for opening and closing the
container:
Please follow the instructions below:

c lo s e

3. How to take Lodotra

To Close
Place pen or similar object between the raised
sections of the lid and turn in the direction shown
(clockwise).
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.
If you forget to take Lodotra
You should contact your doctor on how to proceed.
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
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines these tablets 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.
• Increased susceptibility to and severity of
infections.
• 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).
Side effects where the frequency is not known
(cannot be estimated from the available data):
• Reversible fat overgrowth in the spine, heart
or chest (lipomatosis).
• Accelerated heart beat
• Acid-base imbalance in the blood due to low
potassium levels (hypokalaemic alkalosis).
• Leakage of fluid under the retina resulting
in visual distortion (central serous
chorioretinopathy).

• Nausea.
• Diarrhoea.
• Vomiting.
• Extra hair growth in women (hirsutism).
• Muscle wasting of the upper arms and legs,
tendon rupture, vertebral and long bone
fractures.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the
safety of this medicine.

5. How to store Lodotra
• Keep this medicine out of the sight and reach
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.
• After first opening the container, the tablets
can be stored in the bottle for up to 14 weeks.
After that time, dispose of the remaining
tablets.
• Do not store 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 to
protect the environment.

6. Contents of the pack and other
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 dehydrate
• Glycerol dibehenate
• Yellow ferric oxide E 172
What Lodotra looks like and contents of the pack
The 1 mg modified-release tablets are pale yellowishwhite, circular with ‘NP1’ embossed on one side.
The 2 mg modified-release tablets are yellowishwhite, 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
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 August 2015.
® Lodotra is a registered trade mark of Horizon Pharma AG, and is used under licence.
NAPP and the NAPP logo are registered trade marks.
© 2010 - 2015 Napp Pharmaceuticals Limited.

02/09/2015 15:44

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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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