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Active substance(s): PREDNISONE

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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
• 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
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.


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
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
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
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
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
• 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

• 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
• cortisone withdrawal syndrome (a serious
illness caused by your body not producing
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
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
• 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
• Diabetes medicines, e.g. insulin, metformin,

The following medicines may reduce the effect
of these tablets on your rheumatoid arthritis
• 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
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
• 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
• 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
–– 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
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
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.


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

• 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
• 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.


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Package leaflet : Information for the user

05/12/2014 10:13




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
• 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
• 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
• 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,
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
• Loss of bone (osteonecrosis).
Side effects where the frequency is not
known (cannot be estimated from the available
• 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
• Nausea.
• Diarrhoea.
• Vomiting.
• Extra hair growth in women (hirsutism).
• Muscle wasting of the upper arms and legs,
tendon rupture, vertebral and long bone
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
By reporting side effects you can help
provide more information on the safety of this
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
• The expiry date refers to the last day of that
• 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
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
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

In each bottle there are 30 or 100 tablets.
Marketing authorisation holder and
Marketing authorisation holder
Napp Pharmaceuticals Ltd,
Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW,
United Kingdom.
Horizon Pharma GmbH,
Joseph-Meyer-Str. 13-15, 68167 Mannheim,


• effects on your metabolism;
• effects on your electrolyte (salt) balance,
leading to increased risk of abnormal
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
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.



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
Method of administration:
• How to open and close the bottle especially
designed for rheumatoid arthritis patients:
see ‘Directions for opening and closing the
• 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
Please follow the instructions below:


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
© 2010 - 2014 Napp Pharmaceuticals Limited.

05/12/2014 10:13

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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.