LODOTRA 1 MG MODIFIED-RELEASE TABLETS

Active substance: PREDNISONE

View full screen / Print PDF » Download PDF ⇩

Transcript
P0930-A
1487
Lodotra Tablets leaflet
N/A
UK
P0930-A
PharmaCode - N/A
N/A
N/A
Temmler
530x150mm (LSN-CON-15) (L) V1
CON-PMS-TBA

Drawing No(s).:
Prefixes:
Dimensions:
Folded Dimensions:
Pattern Repeat (mm):
Unwind No.:
Page Count:
Application Used:
Created By:
Version:
Date Created:

LSN-CON-15
N/A
530x150mm
265x150mm
N/A
N/A
N/A
Adobe InDesign CS5
Rebecca Philpott
2
02-04-13

Colour(s):
PMS 280 U
PMS 280 U @ 20%

Non-Printing Colours
PINK
BLUE
PURPLE
BUFF
Font(s):

XXXXXX-YYMM

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

POR No.:
Item Description:
Pack Size:
Country:
Item Number:
Security Code Type and No.:
Edge Code No(s):
Bar Code Type:
Bard F&P Line/Contractor:
Keyline Template No.:
PMS No.:

Times New Roman
Helvetica

V5-2009

Lodotra Tablets PIL UK P0930-A V2.indd 1

03/04/2013 09:02

Lodotra® 1 mg modified-release tablets
Lodotra® 2 mg modified-release tablets
Lodotra® 5 mg modified-release tablets
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.
See section 4.
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.
: 2. Before you take Lodotra
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).

Lodotra Tablets PIL UK P0930-A V2.indd 2

• 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.
Lodotra with food and drink
Take your Lodotra 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.

P0930-A

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).

XXXXXX-YYMM

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

Package leaflet : Information for the user

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 Lodotra while breastfeeding.
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.

03/04/2013 09:02

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.

Lodotra Tablets PIL UK P0930-A V2.indd 3

Directions for opening and closing the container:
Please follow the instructions below:
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).

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

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 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 (may affect up to 1 in
10 people):
• 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 (may affect up to 1
in 100 people):
• 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 and delayed healing of skin
wounds, acne.
Rare side effects (may affect up to 1 in
1,000 people):
• 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 of Lodotra where the
frequency is not known (frequency cannot
be estimated from the available data):
• Reversible fat overgrowth in the spine,
heart or chest (lipomatosis).
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 use this medicine 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. Further information
What Lodotra contains
The active substance is prednisone.
One Lodotra 1 mg modified-release tablet
contains 1 mg of prednisone.
One Lodotra 2 mg modified-release tablet
contains 2 mg of prednisone.
One Lodotra 5 mg modified-release tablet
contains 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.

In each bottle there are 30 or 100 tablets.

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.

Marketing authorisation holder
Napp Pharmaceuticals Ltd,
Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW,
United Kingdom.

Marketing authorisation holder and
manufacturer

Manufacturer
Horizon Pharma GmbH,
Joseph-Meyer-Str. 13-15, 68167 Mannheim,
Germany.

P0930-A

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.

XXXXXX-YYMM

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 can 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).

c lo s e

3. How to take Lodotra

• 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.

close

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

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.

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 - 2013 Napp Pharmaceuticals Limited.

03/04/2013 09:02

Expand view ⇕

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.

Hide
(web3)