Cicloral

Main information

  • Trade name:
  • Cicloral Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cicloral Capsule
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20041273, MAL20041274, MAL20041275
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer Medication Information Leaflet (RiMUP)

CICLORAL

®

CAPSULE

Ciclosporin (25mg, 50mg, 100mg)

1

What is in the leaflet

What Cicloral is used for

How Cicloral works

Before you use Cicloral

How to use Cicloral

While you are using it

Side effects

Storage and Disposal of Cicloral

Product Description

Manufacturer and Product Registration

Holder

Date of Revision

What Cicloral is used for

Cicloral

used

control

body’s

immune

system

following

organ

bone

marrow transplantation. Cicloral is used for

other

autoimmune

diseases

such

problems

which

threaten

your

vision

(endogenous uveitis), severe cases of certain

skin diseases (atopic dermatitis, or psoriasis),

severe

rheumatoid

arthritis

kidney

disease

called

nephrotic

syndrome

which

does not respond sufficiently to conventional

therapies.

If you have any questions about how Cicloral

works

or

why

this

medicine

has

been

prescribed for you, consult your doctor.

How Cicloral works

Cicloral

contains

active

ingredient

ciclosporin.

This

belongs

group

medicine

known

immunosuppressant.

These medicines are used to suppress the

body’s

immune

reactions.

prevents

rejection of transplanted organs by blocking

the development of certain cells which would

normally

attack

transplanted

tissue.

Cicloral suppresses the immune reaction in

which your body’s own immune response

attacks the cells in your body (autoimmune

disease).

Before you use Cicloral

Cicloral will only be prescribed for you by a

doctor with experience in transplants and/or

autoimmune disease.

advice

this

leaflet

vary

depending on whether you are taking this

medicine

transplant

autoimmune

disease.

Follow

your

doctor’s

instructions

carefully.

They

differ from the general information contained

in this leaflet.

When you must not use it

Do not take Cicloral:

have

known

hypersensitivity

ciclosporin or any ingredients listed at the

end of this leaflet.

Cicloral should not be given to children and

adolescents (under 16 years of age) for a

non-transplant disease, except for treatment

of nephrotic syndrome.

Ask your doctor or pharmacist for advice

before taking any medicine.

Before you start to use it

Tell your doctor if you are pregnant or

intent to become pregnant. Cicloral should

taken

during

pregnancy.

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 breastfeeding.

Breastfeeding

recommended

during

treatment

with

Cicloral

active

ingredient ciclosporin passes into breast milk

and may affect your baby.

Cicloral suppresses the immune system and

affect

your

body’s

ability

fight

against infection. If you have any signs of

infection

(e.g.

fever,

sore

throat),

inform

your doctor immediately.

Your

risk

developing

cancers

increase as Cicloral suppresses your immune

system, particularly of the skin and lymphoid

system. You should limit your exposure to

sunlight and UV light by wearing appropriate

protective clothing and applying sunscreen

with high protection factor in regular.

Cicloral

affect

levels

magnesium and/or potassium in your body.

Hence,

should

avoid

high

dietary

potassium

intake

given

medicines

containing

magnesium

and/or

potassium.

Talk to your doctor:

If you have liver and/or 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

give

medicine

lower blood pressure if necessary.

If you need to have a vaccination.

taking

Cicloral

non-

transplant disease (autoimmune disease), do

not take Cicloral if you have:

Kidney

problems

(except

nephrotic

syndrome).

Uncontrolled infections.

History or diagnosed of any type of cancer

except skin changes.

Uncontrolled high blood pressure. If this

condition develops during therapy, Cicloral

should be stopped.

treated

with

Cicloral

psoriasis or atopic dermatitis, you should not

concurrently

receive

UVB-

rays

phototherapy.

Taking other medicines

Please tell your doctor or pharmacist if you

taking

other

medicines,

including

medicines obtained without a prescription,

herbal medicines or natural products.

Some

medications

might

cause

complications

when

taken

together

with

Cicloral, for example:

Medicines/supplements

with

potassium-

sparing

diuretics

containing

potassium

(may affect your potassium levels).

Reduced

clearance

prednisolone,

colchicine, digoxin and lovastatin has been

observed when used with ciclosporin.

Medicines which may increase the level of

ciclosporin in your blood - antibiotics (e.g.

erythromycin,

josamycin),

antifungals

(ketoconazole,

fluconazole,

itraconazole),

medicines used for heart problems or high

blood

pressure

(diltiazem,

nicardipine,

verapamil,

amiodarone),

metoclopramide

(used to stop sickness), oral contraceptives,

nifedipine (used to treat high blood pressure

chest

pain),

danazol

(used

treat

menstrual problems), medicines used to treat

gout

(allopurinol),

cholic

acid

derivatives

(used

treat

gallstones),

protease inhibitors used to treat HIV.

Medicines which may decrease the level of

ciclosporin in your blood - barbiturates (used

to help you to sleep), some anticonvulsant

medicines (e.g. carbamazepine, phenytoin),

octreotide

(used

treat

severe

watery

diarrhoea or flushing of the face and neck

caused by certain types of tumours), herbal

medicines

containing

John’s

wort,

Consumer Medication Information Leaflet (RiMUP)

2

ticlopidine (used after stroke).

Medicines which may affect your kidneys -

antibacterial agents (gentamicin, tobramycin,

ciprofloxacin), antifungal agents containing

amphotericin B, agents against urinary tract

infection

containing

trimethoprim,

anti-

cancer

agents

containing

melphalan,

medicines used to reduce the amount of acid

in your stomach (cimetidine, ranitidine), pain

killers (non-steroid anti-inflammatory drugs

such as diclofenac), fibric acid derivatives

(used to lower fat in the blood).

take

Cicloral

with

grapefruit

grapefruit

juice

since

this

influence

Cicloral’s effects.

How to use Cicloral

Take

Cicloral

exactly

according

instructions given to you by your doctor. Do

not exceed the recommended dosage. If you

are unsure, check with your doctor.

How much to use

Your doctor will work out the correct dose of

Cicloral for you. This depends on your body

weight and what you are being given the

medicine for. Your doctor will also tell you

how often to take your medicine.

As the ciclosporin clearance rate is greater

in children as compared to adults, a higher

dose may be prescribed for your child by

your doctor.

Organ transplantation

Generally, higher doses are used before and

just

after

your

transplant

(between

10-15

mg/kg body weight per day divided in two

doses).

Lower

doses

used

once

your

transplanted

organ

stabilised,

with

daily maintenance dose of 2–6mg/kg body

weight.

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.

Bone marrow transplantation

Ciclosporin is used over a short term in

combination with methotrexate in order to

prevent GVHD and is then discontinued.

The total daily dose is usually between 2.5-

12.5 mg/kg body weight.

Acute Graft-versus-Host Disease (GVHD)

The initial dose is between 12.5-15 mg/kg

body weight per day, and can be reduced by

5% at weekly intervals before ciclosporin is

discontinued.

GVHD

recurs

after

discontinuation of ciclosporin, therapy with

ciclosporin can be reinitiated.

Severe endogenous uveitis

The total daily dose is usually between 5-10

mg/kg

body

weight.

maintenance

treatment, the daily dose should not exceed

5mg/kg per day.

Severe psoriasis and atopic dermatitis

The total daily dose is usually between 2.5-

5 mg/kg body weight divided in two doses.

Nephrotic syndrome

The total daily dose is depending on your

kidney function and usually for adult is 5

mg/kg body weight and children is 6 mg/kg

body

weight.

people

with

kidney

problems, the initial dose should not exceed

2.5 mg/kg body weight.

Severe rheumatoid arthritis

The total daily dose is usually between 2.5-

4 mg/kg body weight divided in two doses.

If your doctor switched you from one oral

formulation of ciclosporin to another:

Your doctor will monitor you more closely

for a short time.

You may have 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 to.

When and how to use it

Take Cicloral at the same time every day.

This is very important if you have had a

transplant.

Your daily doses should always be taken in

divided

doses.

Remove

capsules

from the blister. Swallow the capsules whole

with water.

How long to use it

Your doctor will tell you how long you

need

take

Cicloral

for,

depending

whether you are taking it after a transplant or

for the treatment of autoimmune disease.

Keep taking Cicloral for as long as your

doctor tells you.

If you have any questions on the use of

Cicloral, ask your doctor or pharmacist.

If you forget to use it

Take

missed

dose

soon

remember. If it is almost time for your next

dose, wait until then to take the medicine and

skip the missed dose. Do not take a double

dose to make up for the missed dose

If you use too much (overdose)

Contact your doctor immediately or go to

the Emergency Department of your nearest

hospital, if you think you or anyone else

may have taken too much of this medicine.

this

even

there

signs

discomfort

poisoning.

need

urgent medical attention. The symptoms of

overdose may include vomiting, sleepiness,

headache,

rapid

heartbeat

and,

some

people, moderate reversible kidney failure

have been observed.

While you are using it

Things you must do

Tell

doctors,

dentists

pharmacists treating you that you are taking

Cicloral.

Tell

your

doctor

immediately

become pregnant while taking this medicine.

Monitoring

during

your

treatment

with

Cicloral

Your doctor will check:

The levels of ciclosporin in your blood,

especially if you have had a transplant.

Your blood pressure before initiation of

treatment and regularly during treatment.

Your liver and kidneys function.

Your blood lipids/fats.

Things you must not do

Do not stop taking Cicloral unless your

doctor tells you to.

Keep taking Cicloral even if you feel well.

Stopping your treatment with Cicloral may

increase the risk of your transplanted organ

being rejected.

Do not take any new medicines without

consulting your doctor or pharmacist.

Things to be careful of

Driving and using machines

This

medicine

affect

your

ability

drive or use machines. If the tablets make

you feel sick, dizzy or tired, or give you a

headache, do not drive or use machines and

contact your doctor immediately.

Side effects

Like all medicines, Cicloral can cause side

effects, although not everybody gets them.

Some side effects could be serious. Tell your

doctor if you notice any of the following

symptoms:

Consumer Medication Information Leaflet (RiMUP)

3

Kidney and/or liver problems

High blood pressure

Headache

Seizure

Involuntary shaking of the body

Excessive growth of body and facial hair

Gastrointestinal disturbances (e.g. loss of

appetite. nausea, vomiting, abdominal pain,

diarrhoea, stomach ulcer)

High level of lipids in your blood

Tiredness

Acne

Fever

Burning sensation in hands and feet

(usually during the first week of treatment)

Gum tissue overgrowing and covering teeth

Rashes (possibly allergic)

Weight gain

Inflammation of the pancreas with severe

upper stomach pain

Muscle weakness

level

blood

cells

platelets

which

associated

with

pale

skin,

tiredness, breathlessness, dark urine (sign of

breakdown of red blood cells), bruising or

bleed

with

obvious

reasons,

confusion

and decreased alertness.

Visit your doctor or pharmacist immediately

experience

side

effects

after

taking this medicine.

You may report any side effects or adverse

drug reactions directly to the National Centre

for Adverse Drug Reaction Monitoring by

calling

Tel:

03-78835550,

visiting

website

npra.moh.gov.my

Public

–>

Reporting Medicinal Problems / Side Effects

/ AEFI / Vaccine Safety

Storage and Disposal of Cicloral

Storage

Do not store above 25 °C.

Protect from light.

Keep out of reach of children.

Disposal

The expiry date of Cicloral is printed on the

carton and blister. Do not use if after expiry

date.

Medicines

should

disposed

wastewater

household

waste.

your

doctor tells you to stop taking Cicloral or the

expiry date has passed, ask your pharmacist

dispose

medicines

longer

required. These measures will help to protect

the environment.

Product Description

What it looks like

Cicloral

25mg

Capsule:

brown

soft

gelatine capsule contains clear solution, 5

minims oval, printed with 25 and HEXAL

logo.

Cicloral

50mg

Capsule:

brown

soft

gelatine capsule contains clear solution, 9.5

minims oblong, printed with 50 and HEXAL

logo.

Cicloral

100mg

Capsule:

brown

soft

gelatine capsule contains clear solution, 20

minims

oblong,

printed

with

HEXAL logo.

Ingredients

Active ingredient

Ciclosporin

Inactive ingredients

Vitamin

TPGS,

ethanol

absolute,

polyethylene

glycol

400,

macrogolglycerol

hydroxystearate,

succinylated

gelatin,

purified water, sorbitol 70%, glycerol and

ferric oxide red (E172).

Packing

Blister pack of 5 capsules, pack in box of 10

and 20 strips.

MAL Number

CICLORAL 25MG CAPSULE

(MAL20041273ACZ)

CICLORAL 50MG CAPSULE

(MAL20041274ACZ)

CICLORAL 100MG CAPSULE

(MAL20041275ACZ)

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

D-39179 Barleben,

Germany.

Product Registration Holder

IMEKS Pharma Sdn. Bhd.

No. 5 & 9, Jalan Udang Harimau 2,

Medan Niaga Kepong,

51200 Kuala Lumpur.

Date of revision

24/10/2017

Serial number

NPRA(R4/1)171017/00275