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


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


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03/02/2017 10:53

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
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.


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
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
• 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.

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
• 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
• 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.

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
• 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 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:
• Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
• Some medicines may increase the effects of
Lodotra and your doctor may wish to monitor
you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir,
• 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
• 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 tablets.
If more than 2–3 hours have passed since eating, you
should take your tablets with a light meal or snack.

7 0 7 7 8 3 3

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.

If you take these tablets for several months or 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 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 strain;
• cortisone withdrawal syndrome (a serious
illness caused by your body not producing
Your doctor will advise you on what to do.


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

• 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.
• 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
Your doctor will advise you on what to do.


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

Package leaflet : Information for the user

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
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.

03/02/2017 10:53

c lo s e

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

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.

3. How to take Lodotra
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
• 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:



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


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;
• 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
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
• 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
• 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
• 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

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 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
• 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
• 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 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 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,

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 January 2017.
® 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.

03/02/2017 10:53

+ Expand Transcript

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.