NEORAL 100MG CAPSULES

Active substance: CYCLOSPORIN

View full screen / Print PDF » Download PDF ⇩

Transcript
This product will be called Neoral capsules or Neoral in this leaflet. Other strengths are available.
What you need to know about Neoral capsules
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet
in a safe place because you may want to read it again. If you have any other questions or if there is something you don’t
understand, please ask your doctor or pharmacist.

1. What Neoral capsules are and what they are used for
Neoral capsules are available in four different strengths containing 10, 25, 50 or 100mg of the active ingredient ciclosporin.
Ciclosporin is one of a group of drugs known as immunosuppressive agents. These drugs are used to dampen down the body’s
immune reactions.
Neoral capsules can be used to treat a number of different conditions as follows:
After an organ (e.g. kidney liver etc) or bone marrow transplant:
Although you may have had a series of tests before your organ or bone marrow transplant to ensure that the match between your
body and the transplanted organ or bone marrow is as close as possible, the donor tissue will still not be identical to your tissue. As
a result, your body’s immune system will try to reject the donor tissue. Neoral capsules help to stop this rejection response by
blocking the development of special cells which would normally attack the transplanted tissue.
If you have severe psoriasis or atopic dermatitis (eczema)
These serious skin conditions are thought to be caused by your immune system over-reacting.
Neoral capsules may help to stop this by suppressing the immune system.
If you have severe rheumatoid arthritis or nephrotic syndrome
It is thought that rheumatoid arthritis and some forms of nephrotic syndrome may be caused by inappropriate immune responses in
your body. Neoral capsules may help to stop this by suppressing your immune system.

CUSTOMER
APPROVED:

2. Things to consider before you start to take Neoral capsules
Some people MUST NOT take Neoral capsules. Talk to your doctor if:
• you think you may be allergic to ciclosporin or to any of the other ingredients of Neoral capsules. (These are listed at the
end of the leaflet).
• you are taking a drug called tacrolimus.
• you are taking a drug called rosuvastatin.
• you are breast feeding.



DATE:

People with psoriasis or atopic dermatitis MUST NOT be treated with Neoral capsules if they have kidney problems,
if they have uncontrolled high blood pressure or infections, or if they have any cancer except skin cancer.
People with rheumatoid arthritis MUST NOT be treated with Neoral capsules if they are under 18 years old, or if they
have kidney problems, uncontrolled high blood pressure, infections, or any type of cancer.



People with nephrotic syndrome MUST NOT be treated with Neoral capsules if they have uncontrolled high blood
pressure or infections, or if they have any type of cancer.

DT

24/05/12

ARTWORKER:

DATE OF PROOF:
6464/0818 0819F
CODE:

TO UK PIL DATED OCTOBER 2011

04-1957
PRE-PRESS NO.:

Neoral 50mg 100mg caps
PRODUCT:

DATE:

You should also ask yourself these questions before taking Neoral capsules. If the answer to any of these questions is
YES, discuss your treatment with your doctor or pharmacist because Neoral capsules might not be the right medicine for
you.
• Have you been told that you have high levels of potassium in your blood? Are you taking potassium supplements or is
your diet particularly rich in potassium? (Fruit and vegetables are rich sources of potassium.)
• Do you have gout or other conditions caused by high levels of uric acid in your blood?
• Are you worried about any unusual spots, moles or warts on your skin?
• Are you out in the sun a lot, or do you use a sunbed?
• Do you have any skin infections, including herpes (cold sores)?
• Are you pregnant?

CUSTOMER: Waymade

Q.A.
APPROVED:



Are you taking other medicines?
Ciclosporin interacts with a large number of other medicines and this can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
• Medicines to treat heart problems or high blood pressure such as bosentan, diltiazem, nicardipine, verapamil and aliskiren.
• Drugs containing potassium (your doctor will know which these are).
• Medicines called NSAIDs used to treat pain and inflammation. (Some of these can be bought over-the-counter).
• Medicines to treat infections including antibiotics (especially erythromycin and clarithromycin) and antifungal medicines
(especially terbinafine and voriconazole).
• Oral contraceptives.
• Medicines for epilepsy.
• Cholesterol lowering medicines (including statins).
• Sleeping tablets.
• Potassium supplements.
• Diuretics or ‘water tablets’ that affect the amount of urine you produce and might also affect the level of potassium in your
blood.
• Danazol (used to treat menstrual disorders, endometriosis or breast problems).
• St John’s Wort: The herbal remedy St John’s Wort (Hypericum perforatum) should not be taken at the same time as this
medicine. If you are already taking St John’s Wort consult your doctor before stopping the St John’s Wort preparation.
• Octreotide (known as Sandostatin®).
• Medicines to treat tuberculosis.
• Medicines to treat gout.
• Metoclopramide (used to stop sickness).
• Melphalan (used to treat lymphomas or tumours).
• Imatinib (used to treat leukaemia or tumours).
• Orlistat (used to help weight loss).
• Ticlopidine (used after a stroke).
• Corticosteroids (used to treat conditions such as asthma, allergic conditions, inflammatory conditions including
inflammatory bowel disease, adrenocortical insufficiency and rheumatic disease).
• Ursodeoxycholic acid (used to treat gallstones).
• Protease inhibitors (used to treat Human Immunodeficiency Virus (HIV)).
• Tacrolimus, sirolimus and everolimus (other immunosuppressants).
• Methotrexate (used to treat tumours, severe psoriasis and rheumatoid arthritis).
• Etoposide (used to treat cancer).
• Repaglinide (used to treat diabetes).
• Medicines to treat stomach ulcers.
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as
well as medicines on prescription from your doctor.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend to become pregnant. Experience with Neoral Capsules in pregnancy is limited. In
general, Neoral Capsules should not be taken during pregnancy. If it is necessary for you to take this medicine, your doctor will
discuss with you the benefits and risks of taking it during pregnancy.
Tell your doctor if you are breast-feeding. Breast-feeding is not recommended during treatment with Neoral Capsules since
ciclosporin, the active ingredient in Neoral capsules, passes into breast milk and may affect your baby.
Will there be any problems with driving or using machinery?
No problems have been reported. However, Neoral capsules do contain a small amount of alcohol.
See the section overleaf containing information on some of the ingredients of Neoral capsules.
Other special warnings
• The dose of this medicine needs to be carefully adjusted by your doctor. You will, therefore, have regular blood tests and
visits to the hospital. This will give you the chance to talk to your doctor about your treatment and mention any problems
you are having.
• Ciclosporin can affect how the liver and kidneys work. It can also affect blood pressure and the composition of the blood.
Your doctor will want to perform tests from time to time while you are being treated with Neoral capsules.
• Because ciclosporin dampens down the immune system you are more prone to catch infections and they can become very
serious. If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or
understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain
called progressive multifocal leukoencephalopathy. Contact your doctor as soon as you feel unwell.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet:
1. What Neoral capsules are and what they are used for
2. Things to consider before you start to take Neoral capsules
3. How to take Neoral capsules
4. Possible side effects
5. How to store Neoral capsules
6. Further information

PROOF HISTORY:
v.2 - waymade - 24/05/12

Leaflet Flat Size = 180 x 429

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their
symptoms seem to be 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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

WARNING!

(ciclosporin)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

NEORAL® 50mg CAPSULES
NEORAL® 100mg CAPSULES

27mm







ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

3. How to take Neoral capsules
Your doctor will work out the correct dose of Neoral capsules for you depending on your body weight and your condition. Your doctor
will also tell you how often to take your medicine. Always follow his/her instructions carefully. The dose will be on the pharmacist’s
label. Check the label carefully. If you are not sure, ask your doctor or pharmacist. Do not change the dose, however well you feel.
Keep taking your medicine for as long as you have been told, unless you have any problems. In that case, check with your doctor.
Swallow the capsules whole with a mouthful of water. You may drink more water afterwards. You are usually advised to take Neoral
capsules twice a day.
If you have had an organ or bone marrow transplant the total dose is usually within the range of 2 to 15 mg/kg body weight per
day. Generally, higher doses are used just after your transplant operation and lower doses are used once your transplanted organ or
bone marrow has stabilised.
Your doctor will adjust your dose to one that is ideal for you. To do this, he may need to do some blood tests.
For the treatment of severe psoriasis and eczema the total dose is usually within the range of 2.5 to 5 mg/kg body weight per day.

PROOF HISTORY:
v.2 - waymade - 24/05/12

For the treatment of severe rheumatoid arthritis the total dose is usually within the range of 2.5 to 4 mg/kg body weight per day.
For the treatment of nephrotic syndrome, the total dose is usually within the range of 2.5 to 5 mg/kg body weight per day in
adults and 2.5 to 6 mg/kg body weight per day in children.
Has your treatment been switched from other ciclosporin brands to Neoral?
The absorption of ciclosporin into the blood stream will vary from brand to brand. Consistent blood levels of ciclosporin are thought
to be particularly important in the prevention of rejection following transplantation, especially in the longer term.
Because of the difference in absorption of ciclosporin, your doctor will probably want to monitor you more closely for a short period
if you change to Neoral, to make sure that you get the ideal dose for you. If your doctor transfers you to Neoral, you should not go
back to another ciclosporin brand unless your doctor tells you to.
What if you forget to take a dose?
If you forget to take a dose, take another one as soon as you remember, unless it is almost time for your next dose. Then go on as
before.

4. Possible side effects
Most people who are prescribed Neoral capsules benefit. Like all medicines though, it can sometimes cause side effects in some
people.
If you develop a sore throat, any infections or begin to feel generally unwell, see your doctor immediately.
The following side effects have been reported:
More than 10% of people have experienced:
Kidney problems, high blood pressure, headache including migraine, tremor, increased levels of lipids (for example cholesterol) in
the blood, chest infections, urinary infections and infection with CMV (cytomegalovirus).

DATE:
24/05/12
DATE OF PROOF:

Up to 1 in 1,000 people have experienced:
Problems with the nerves that control muscles, inflammation of the pancreas, high levels of glucose in the blood, muscle
weakness, wasting of muscles, destruction of red blood cells which may be associated with kidney problems, changes in the
menstrual cycle in women and slight enlarging of the breasts in men.

TO UK PIL DATED OCTOBER 2011

Up to 1 in 10,000 people have experienced:
Swelling at the back of the eye which may be associated with an increase in pressure inside the head (benign intracranial
hypertension) and visual disturbances.

6464/0818 0819F

DT

Up to 1 in 100 people have experienced:
Seizures, confusion, disorientation, decreased responsiveness, agitation, sleeplessness, visual disturbances, blindness, coma,
partial paralysis, loss of co-ordination, changes in blood (for example anaemia), allergic rash, water retention which may cause
swelling and weight increase.

CODE:

Q.A.
APPROVED:
04-1957

ARTWORKER:
Neoral 50mg 100mg caps
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

Up to 1 in 10 people have experienced:
Numbness or tingling, loss of appetite, feeling or being sick, stomach pain, diarrhoea, swollen gums, liver disorders, high level of
uric acid or potassium in the blood, low levels of magnesium in the blood, muscle pain or cramp, increased hair growth on the
body, tiredness, herpes infection, candida infection, blood poisoning, skin disorders and cancers and over production of white
blood cells.

Like other medicines that dampen down the immune system, ciclosporin may cause tumours or other malignancies, particularly of
the skin. It may also make you more likely to get infections which may be serious. If you experience vision changes, loss of
coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be
the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy.
A few people have had serious liver problems that have happened both with and without yellowing of the eyes or skin.
Tell your doctor or pharmacist if you suffer from any of these effects, or from any other side effects not mentioned in this leaflet.






5. How to store Neoral capsules
It is important that Neoral capsules should be stored below 25°C, in the manufacturer’s original packaging.
Do not use after the expiry date printed on the carton, label or blister strip.
Keep out of the reach of children.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep
the capsules if your doctor tells you to. Do not throw them away with your normal household water or waste. This will help
to protect the environment.
If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist before taking them.

6. Further Information
Your medicine is called Neoral capsules.
Each Neoral 50mg capsule is yellow-white and marked with the Sandoz logo and ‘50mg’ in purple and contains 50mg of the active
ingredient ciclosporin.
Each Neoral 100mg capsule is blue-grey and marked with the Sandoz logo and ‘100mg’ and contains 100mg of the active
ingredient ciclosporin.
Each Neoral capsule also contains the following: DL-α-tocopherol, propylene glycol, corn oil-mono-di-triglycerides, polyoxyl 40
hydrogenated castor oil, titanium dioxide (E171), glycerol, gelatin, absolute alcohol and red printing ink.
In addition: Neoral 100mg capsules also contain black iron oxide (E172).
Neoral capsules are available as blister packs of 30 and 50 capsules.
POM

PL No: 6464/0818 50mg
PL No: 6464/0819 100mg

These products are manufactured by R.P. Scherer GmbH, Eberbach, Germany and are procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date: (Ref.) 22.5.2012
Neoral® is a registered trademark of Novartis AG.

WARNING!

DATE:

CUSTOMER
APPROVED:

What if you take too many capsules?
If you accidentally take too much of your medicine, tell your doctor immediately, or go to your nearest casualty department.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 180 x 429

Important information about some of the ingredients of Neoral capsules
Neoral capsules contain:
• Polyoxyl 40 hydrogenated castor oil which may cause stomach upsets and diarrhoea.
• 11.8% ethanol (alcohol). A 500 mg dose of Neoral capsules contains 500 mg of ethanol equivalent to nearly three
teaspoons of beer or one teaspoon of wine. This may be harmful if you are suffering from alcoholism and should be taken
into account if you are pregnant or breast feeding, or if you have liver disease or epilepsy, or if this medicine is being given
to a child.

WARNING!



There have been very rare reports of people developing a condition called Benign Intracranial Hypertension when they are
being treated with ciclosporin. Tell your doctor as soon as possible if you start to feel nauseous, develop tinnitus (ringing in
your ears), or get pains in your head, neck or back, or problems with your sight, balance or memory.
Before giving you Neoral capsules to treat psoriasis, the doctor will examine you to make sure that you do not have any
skin cancers or pre-cancers.
You must not have light treatment (PUVA or other UV treatment) for psoriasis while you are taking Neoral capsules.
Do not go out into the sun too much without protecting your skin.
You must not eat grapefruit or drink grapefruit juice in the hour before you take the capsules.
If you have recently had a vaccination or are planning to have any vaccinations make sure the doctor or nurse knows you
are taking Neoral capsules.
You must visit the dentist regularly while you are taking Neoral capsules to make sure that your gums remain healthy.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.



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
(web4)