Neoral 100mg capsules

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Ciclosporin
Available from:
CST Pharma Ltd
ATC code:
L04AD01
INN (International Name):
Ciclosporin
Dosage:
100mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 10010300; GTIN: 5055946800998

Uncommon side effects: These side effects may affect between 1

and 10 in every 1,000 people.

Symptoms of brain disorders including sudden fits, mental

confusion, sleeplessness, disorientation, disturbance of vision,

unconsciousness, sense of weakness in the limbs, impaired

movements.

Rash.

General swelling.

Weight gain.

Low level of red blood cells, low level of platelets in your blood

which could increase the risk of bleeding.

If any of these affects you severely, tell your doctor.

Rare side effects: These side effects may affect between 1 and 10

in every 10,000 people.

Nerve problems with numbness or tingling in fingers and toes.

Inflammation of the pancreas with severe upper stomach pain.

Muscle weakness, loss of muscle strength, pain in muscles of

the legs or hands or anywhere in the body.

Destruction of red blood cells, involving kidney problems with

symptoms such as swelling of the face, stomach, hands and/or

feet, decreased urination, breathing difficulty, chest pain, fits,

unconsciousness.

Changes in menstrual cycle, breast enlargement in men.

If any of these affects you severely, tell your doctor.

Very rare side effects: These side effects may affect between 1

and 10 in every 100,000 people.

Swelling at the back of the eye which may be associated with

an increase in pressure inside the head and eyesight

disturbances.

If this affects you severely, tell your doctor.

Other side effects with frequency not known: Frequency cannot

be estimated from the available data.

Serious liver problems both with and without yellowing of the

eyes or skin, nausea (feeling sick), loss of appetite, dark

coloured urine, swelling of the face, feet, hands and/or the

whole body.

Bleeding underneath the skin or purple skin patched, sudden

bleeding with no apparent cause.

Migraine or severe headache often with feeling and being sick

(nausea, vomiting) and being sensitive to light.

Pain in legs and feet

If any of these affects you severely, tell your doctor.

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet.

Additional side effects in children and adolescents

There are no additional side effects to be expected in children and

adolescents compared to adults.

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 Neoral capsules

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store the capsules in the aluminium blisters, only remove one

when you are going to take it. Do not store above 25°C. Protect

from moisture.

Do not take after the date shown on the pack.

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.

If the capsules become discoloured or show any other signs of

deterioration, you should seek the advice of your pharmacist

who will tell you what to do.

Do not throw them away with your normal household water or

waste. This will help to protect the environment.

6. Contents of the pack and other information

What Neoral Capsules contains

Each Neoral Soft Gelatin Capsule contains 100mg of active

ingredient, ciclosporin.

The capsules also contain DL-α-tocopherol, absolute ethanol,

propylene glycol, corn oil mono-, di- and triglycerides, polyoxyl

40 hydrogenated castor oil. The capsule shell is made of

gelatin, glycerol 85%, propylene glycol and titanium dioxide.

The 100mg capsule shells also contain black iron oxide. The

capsules are marked with red printing ink.

What Neoral Capsules look like and contents of the pack

Neoral Soft Gelatin Capsules are elongated grey opaque, soft

gelatin capsules marked with the ‘NVR’ and ‘100mg’ in red.

Neoral Soft Gelatin Capsules 100mg is available as blister strips of

5 capsules packed in cartons containing 30 or 50 capsules.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import

Product Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, Middlesex, HA0 1DX.

Manufacturer

This product is manufactured by either of the following

manufacturers:

Novartis Farmaceutica, S.A. Ronda Santa Maria, 158, 08210 –

Barbera del valles, Barcelona, Spain; or

Novartis Farma – Produtos Farmaceuticos, S.A., Rua do Centro

Empresarial, Edificio 8, Quinta da Beloura, 2710-444 Sintra,

Portugal.

PLPI 19488/1465

Leaflet revision date: 10 September 2015

Neoral is a registered trade mark of Novartis AG, Switzerland.

S1465 LEAFLET Neoral 20150910

S1465 LEAFLET Neoral 20150910

PACKAGE LEAFLET: INFORMATION FOR THE USER

NEORAL SOFT GELATIN CAPSULES 100mg

(ciclosporin)

Your medicine is known as NEORAL SOFT GELATIN CAPSULES

100mg but will be referred to as Neoral Capsules or Neoral in this

leaflet.

Information for other strengths of Neoral Capsules also may be

present in this leaflet.

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.

What is in this leaflet

What Neoral is and what it is used for

What you need to know before you take Neoral

How to take Neoral

Possible side effects

How to store Neoral

Contents of the pack and other information

1. What Neoral is and what it is used for

What Neoral is

The name of your medicine is Neoral. It contains the active

substance ciclosporin. This belongs to a group of medicines known

as immunosuppressive agents. These medicines are used to lower

the body’s immune reactions.

What Neoral is used for and how Neoral works

If you have had an organ transplant, bone marrow and

stem cell transplantation, the function of Neoral is to control

your body’s immune system. Neoral prevents rejection of

transplanted organs by blocking the development of certain

cells which would normally attack the transplanted tissue.

If you have an autoimmune disease, in which your body’s

immune response attacks your body’s own cells, Neoral stops

this immune reaction. Such diseases include eye problems

which threaten your vision (endogenous uveitis, including

Behçet’s uveitis), severe cases of certain skin diseases (atopic

dermatitis, or eczema and psoriasis), severe rheumatoid

arthritis and a kidney disease called nephrotic syndrome.

2. What you need to know before you take Neoral

If you are taking Neoral following a transplant it will only be

prescribed for you by a doctor with experience in transplants and/or

autoimmune diseases.

The advice in this leaflet may vary depending on whether you are

taking the medicine for a transplant or for an autoimmune disease.

Follow all your doctor’s instructions carefully. They may differ from

the general information contained in this leaflet.

Do not take Neoral:

if you are allergic to ciclosporin or any of the other ingredients

of this medicine (listed in section 6).

with products containing Hypericum perforatum (St John´s

Wort).

with products containing dabigatran etexilate (used to avoid

blood clots after surgery) or bosentan and aliskiren (used to

reduce high blood pressure).

Do not take Neoral and tell your doctor if the above applies to you.

If you are not sure, talk to your doctor before taking Neoral.

Warnings and precautions

Before and during treatment with Neoral, tell your doctor

straight away:

if you have any signs of infection, such as fever or a sore throat.

Neoral suppresses the immune system and may also affect

your body’s ability to fight against infection.

if you have liver problems.

if you have kidney problems. Your doctor will carry out regular

blood tests and may change your dose if necessary.

if you develop high blood pressure. Your doctor will check your

blood pressure regularly and may give you a medicine to lower

blood pressure if necessary.

if you have low levels of magnesium in your body. Your doctor

may give you magnesium supplements to take, especially just

after your operation if you have had a transplant.

if you have high levels of potassium in your blood.

if you have gout.

if you need to have a vaccination.

If any of the above applies to you before or during treatment with

Neoral, tell your doctor straight away.

Sunlight and sun protection

Neoral suppresses your immune system. This increases your risk of

developing cancers, particularly of the skin and lymphoid system.

You should limit your exposure to sunlight and UV light by:

Wearing appropriate protective clothing.

Often applying a sunscreen with a high protection factor.

Talk to your doctor before taking Neoral:

if you have or have had alcohol-related problems.

if you have epilepsy.

if you have any liver problems.

if you are pregnant.

if you are breast-feeding.

if this medicine is being prescribed for a child.

If any of the above apply to you (or you are not sure), tell your

doctor before taking Neoral. This is because this medicine contains

alcohol (see section below “Neoral contains ethanol”).

Monitoring during your treatment with Neoral

Your doctor will check:

the levels of ciclosporin in your blood, especially if you have

had a transplant,

your blood pressure before the start of your treatment and

regularly during treatment,

how well your liver and kidneys are working,

your blood lipids (fats).

If you have any questions about how Neoral works or why this

medicine has been prescribed for you, ask your doctor.

In addition if you are taking Neoral for a non-transplant disease

(intermediary or posterior uveitis and Behçet’s uveitis, atopic

dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do

not take Neoral:

if you have kidney problems (except for nephrotic syndrome).

if you have an infection which is not under control with

medication.

if you have any type of cancer.

if you have high blood pressure (hypertension) which is not

under control with medication. If you get high blood pressure

during treatment and it cannot be controlled, Neoral should be

stopped by your doctor.

Do not take Neoral if any of the above applies to you. If you are not

sure, talk to your doctor or pharmacist before taking Neoral.

If you are being treated for Behçet`s uveitis, your doctor will monitor

you particularly carefully if you have neurological symptoms (for

example: increased forgetfulness, personality changes noticed over

time, psychiatric or mood disorders, burning sensation in limbs,

decreased sensation in limbs, tingling sensation in limbs, weakness

of limbs, walking disturbances, headache with or without nausea

and vomiting, vision disturbances including restricted movement of

eyeball).

Your doctor will closely monitor you if you are elderly and are being

treated for psoriasis or atopic dermatitis. If you have been

prescribed Neoral to treat your psoriasis or atopic dermatitis, you

must not be exposed to any UVB-rays or phototherapy during

treatment.

Children and adolescents

Neoral should not be given to children for a non-transplant disease,

except for treatment of nephrotic syndrome.

Elderly population (65 years of age and older)

There is limited experience with Neoral in elderly patients. Your

doctor should monitor how well your kidneys work. If you are over

65 and have psoriasis or atopic dermatitis, you should only be

treated with Neoral if your condition is particularly severe.

Other medicines and Neoral

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines.

In particular tell your doctor or pharmacist if you are taking any of

the following medicines before or during Neoral treatment:

Medicines that may affect your potassium levels. These include

medicines which contain potassium, potassium supplements,

water tablets (diuretics) called potassium-sparing diuretics and

some medicines which lower your blood pressure.

Methotrexate. This is used to treat tumours, severe psoriasis

and severe rheumatoid arthritis.

Medicines which may increase or decrease the level of

ciclosporin (the active substance of Neoral) in your blood. Your

doctor might check the level of ciclosporin in your blood when

starting or stopping treatment with other medicines.

Medicines which may increase the level of ciclosporin in

your blood include: antibiotics (such as erythromycin or

azythromycin), anti-fungals (voriconazole, itraconazole),

medicines used for heart problems or high blood pressure

(diltiazem, nicardipine, verapamil, amiodarone),

metoclopramide (used to stop sickness), oral

contraceptives, danazol (used to treat menstrual problems),

medicines used to treat gout (allopurinol), cholic acid and

derivatives (used to treat gallstones), protease inhibitors

used to treat HIV, imatinib (used to treat leukaemia or

tumours), colchicine, telaprevir (used to treat hepatitis C).

Medicines which may decrease the level of ciclosporin in

your blood include: barbiturates (used to help you to sleep),

some anti-convulsant medicines (such as carbamazepine or

phenytoine), octreotide (used to treat acromegaly or

neuroendocrine tumours in the gut), anti-bacterial

medicines used to treat tuberculosis, orlistat (used to help

weight loss), herbal medicines containing St. John’s wort,

ticlopidine (used after a stroke), certain medicines which

lower blood pressure (bosentan), and terbinafine (an anti-

fungal medicine used to treat infections of the toes and

nails).

Medicines which may affect your kidneys. These include: anti-

bacterial medicines (gentamycin, tobramycin, ciprofloxacin),

anti-fungal medicines which contain amphotericin B, medicines

used for urinary tract infections which contain trimethoprim,

medicines for cancer which contain melphalan, medicines used

to lower the amount of acid in your stomach (acid secretion

inhibitors of the H2-receptor antagonist type), tacrolimus, pain

killers (non-steroid anti-inflammatory medicines such as

diclofenac), fibric acid medicines (used to lower the amount of

fat in the blood).

Nifedipine. This is used to treat high blood pressure and heart

pain. You might get swollen gums that might grow over your

teeth if you are taking nifedipine during your treatment with

ciclosporin.

Digoxin (used to treat heart problems), medicines which lower

cholesterol (HMG-CoA reductase inhibitors also called statins),

prednisolone, etoposide (used to treat cancer), repaglinide (oral

anti-diabetic medicine), immunosuppressives (everolimus,

sirolimus), ambrisentan and specific anti-cancer medicines

called anthracyclines (such as doxorubicin).

If any of the above applies to you (or you are not sure), talk to your

doctor or pharmacist before taking Neoral.

Neoral with food and drink

Do not take Neoral with grapefruit or grapefruit juice. This is

because these can affect how Neoral works.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this

medicine. Your doctor will discuss with you the potential risks of

taking Neoral during pregnancy.

Tell your doctor if you are pregnant or intend to become

pregnant. Experience with Neoral in pregnancy is limited. In

general, Neoral 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 potential risks of taking it during

pregnancy.

Tell your doctor if you are breast-feeding. Breast-feeding is

not recommended during treatment with Neoral. This is

because ciclosporin, the active substance, passes into breast

milk. This may affect your baby.

Driving and using machines

Neoral contains alcohol. This may affect your ability to drive and

use machines.

Neoral contains ethanol

Neoral contains approximately 12.0 vol. % ethanol (alcohol), which

corresponds to up to 500 mg per dose used in transplant patients.

This is equivalent to nearly 15 ml beer or 5 ml wine per dose.

Alcohol may be harmful if you have alcohol-related problems,

epilepsy, brain injury, liver problems or if you are pregnant or

breast-feeding. It may also be harmful if this medicine is given to

children.

Neoral contains castor oil

Neoral contains castor oil, which may cause stomach discomfort

and diarrhoea.

3. How to take Neoral

Always take this medicine exactly as your doctor has told you.

Check with your doctor if you are not sure.

Do not take more than the recommended dose.

The dose of this medicine will be carefully adjusted to your

individual needs by your doctor. Too much of the medicine can

affect your kidneys. You will have regular blood tests and visits to

the hospital, especially after a transplant. This will give you the

chance to talk to your doctor about your treatment and talk about

any problems you may be having.

How much Neoral to take

Your doctor will work out the correct dose of Neoral for you. This

depends on your body weight and what you are taking the medicine

for. Your doctor will also tell you how often to take your medicine.

In adults:

Organ, bone marrow and stem cell transplantation

The total dose each day is usually between 2 mg and 15

mg per kilogram body weight. This is divided in two doses.

Usually, higher doses are used before and just after your

transplant. 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, your doctor may need to do some blood tests.

Endogenous uveitis

The total dose each day is usually between 5 mg and 7 mg

per kilogram body weight. This is divided in two doses.

Nephrotic syndrome

The total dose each day for adults is usually 5 mg per

kilogram body weight. This is divided in two doses. In

patients with kidney problems, the first dose taken each day

should not be more than 2.5 mg per kilogram body weight.

Severe rheumatoid arthritis

The total dose each day is usually between 3 mg per

kilogram of your body weight and 5 mg per kilogram body

weight. This is divided in two doses.

Psoriasis and atopic dermatitis

The total dose each day is usually between 2.5 mg per

kilogram of your body weight and 5 mg per kilogram body

weight. This is divided in two doses.

In children:

Nephrotic syndrome

The total dose each day for children is usually 6 mg per

kilogram body weight. This is divided in two doses. In

patients with kidney problems, the first dose taken each day

should not be more than 2.5 mg per kilogram body weight.

Follow your doctor’s instructions exactly and never change the dose

yourself, even if you feel well.

Switch from Sandimmun to Neoral

You may have already been taking another medicine called

Sandimmun Soft Gelatin Capsules or Sandimmun Oral Solution.

Your doctor may decide to change to this medicine, Neoral Soft

Gelatin Capsules.

These medicines all contain ciclosporin as the active ingredient.

Neoral is a different, improved formulation of ciclosporin

compared to Sandimmun. Ciclosporin is absorbed into your

blood better with Neoral and absorption is less likely to be

affected by taking the medicine with food. This means that the

levels of ciclosporin in your blood stay more constant with

Neoral than with Sandimmun.

If your doctor changes you from Sandimmun to Neoral:

Do not go back to taking Sandimmun unless your doctor tells

you to.

Following your transfer from Sandimmun to Neoral, your doctor

will monitor you more closely for a short time. This is because of

the change in how ciclosporin is absorbed into your blood. Your

doctor will make sure that you get the right dose for your

individual needs.

You may have some side effects. If this happens, tell your

doctor or pharmacist. Your dose may need to be lowered.

Never lower your dose yourself, unless a doctor has told you to.

If your doctor switches you from one oral formulation of

ciclosporin to another

After you change from one oral formulation of ciclosporin to

another:

Your doctor will monitor you more closely for a short time.

You may have some side effects. If this happens, tell your

doctor or pharmacist. Your dose may need to be changed.

Never change your dose yourself, unless a doctor has told you

When to take Neoral

Take Neoral at the same time every day. This is very important if

you have had a transplant.

How to take Neoral

Your daily doses should always be taken in 2 divided doses.

Remove the capsules from the blister. Swallow the capsules whole

with water.

How long to take Neoral

Your doctor will tell you how long you need to take Neoral for. This

depends on whether you are taking it after a transplant or for the

treatment of a severe skin condition, rheumatoid arthritis, uveitis or

nephrotic syndrome. For severe rash, the treatment usually lasts for

8 weeks.

Keep taking Neoral for as long as your doctor tells you.

If you have questions about how long to take Neoral, talk to your

doctor or your pharmacist.

If you take more Neoral than you should

If you accidentally take too much of your medicine, tell your doctor

immediately or go to your nearest hospital emergency unit. You

may need medical attention.

If you forget to take Neoral

If you forget to take a dose, take it as soon as you remember it.

However, if it is almost time for your next dose, skip the missed

dose. Then go on as before.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Neoral

Do not stop taking Neoral unless your doctor tells you to.

Keep taking Neoral even if you feel well. Stopping your treatment

with Neoral may increase the risk of your transplanted organ being

rejected.

If you have any further questions on the use of this medicine, ask

your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Some side effects could be serious

Tell your doctor straight away if you notice any of the following

serious side effects:

Like other medicines that act on the immune system,

ciclosporin may influence your body’s ability to fight against

infection and may cause tumours or other cancers, particularly

of the skin. Signs of infection might be fever or sore throat.

Changes in your sight, loss of coordination, being clumsy,

memory loss, difficulty speaking or understanding what others

say, and muscle weakness. These might be signs of an

infection of the brain called progressive multifocal

leukoencephalopathy.

Brain problems with signs such as seizures, confusion, feeling

disorientated, being less responsive, personality changes,

feeling agitated, sleeplessness, changes to your sight,

blindness, coma,

paralysis of part or all of the body, stiff neck,

loss of coordination with or without unusual speech or eye

movements.

Swelling at the back of the eye. This may be associated with

blurred vision. It may also affect your sight because of the

higher pressure inside your head (benign intracranial

hypertension).

Liver problems and damage with or without yellow skin and

eyes, nausea, loss of appetite and dark urine.

Kidney problems which may greatly reduce the amount of urine

you produce.

Low level of red blood cells or platelets. The signs include pale

skin, feeling tired, being breathless, having dark urine (this is a

sign of the breakdown of red blood cells), bruising or bleeding

with no obvious reasons, feeling confused, feeling

disorientated, being less alert and having kidney problems.

Other side effects include:

Very common side effects: These side effects may affect more

than 1 in 10 people.

Kidney problems.

High blood pressure.

Headache.

Shaking of your body which you cannot control.

Excessive growth of body and facial hair.

High level of lipids in your blood.

If any of these affects you severely, tell your doctor.

Common side effects: These side effects may affect between 1

and 10 in every 100 people.

Fits (seizures).

Liver problems.

High level of sugar in your blood.

Tiredness.

Loss of appetite.

Nausea (feeling sick), vomiting, abdominal pain, constipation,

diarrhoea.

Excessive hair growth.

Acne, hot flushes.

Fever.

Low level of white blood cells.

Feeling numb or tingling.

Pain in your muscles, muscle spasm.

Stomach ulcer.

Gum tissue overgrowing and covering your teeth.

High level of uric acid or patassium in your blood, low levels of

magnesium in your blood.

If any of these affects you severely, tell your doctor.

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