TEGRETOL 125MG SUPPOSITORIES

Active substance: CARBAMAZEPINE

View full screen / Print PDF » Download PDF ⇩

Transcript
code read direction
64

4. Possible side effects

5. How to store Tegretol Suppositories

Package Leaflet: Information for the User

6. Further information

TEGRETOL
125 and 250 mg
Suppositories
®

1.  hat Tegretol Suppositories are and what they are used for
W
Carbamazepine, the active ingredient in Tegretol Suppositories is an anticonvulsant medicine (prevents fits).
Tegretol Suppositories are used to treat some forms of epilepsy. They are
useful in the short term, (maximum 7 days), for patients who cannot take
medicines by mouth, e.g. after surgery or if unconscious.

(carbamazepine)

What you need to know about Tegretol Suppositories
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to use the
suppositories. 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.
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.
In this leaflet:
1. What Tegretol Suppositories are and what they are used for

2. Things to consider before you are treated with Tegretol Suppositories
3. How to use Tegretol Suppositories

2. hings to consider before you are treated with Tegretol
T
Suppositories
Some people MUST NOT have Tegretol Suppositories. Make sure your
doctor knows if:
•  ou think you may be hypersensitive (allergic) to carbamazepine or
y
similar drugs such as oxcarbazepine (Trileptal), or to any of a related
group of drugs known as tricyclic antidepressants (such as amitriptyline
or imipramine). If you are allergic to carbamazepine there is a one in four
(25%) chance that you could also have an allergic reaction to oxcarbazepine.
•  think you may be allergic to any of the other ingredients of Tegretol
you
Suppositories (these are listed at the end of the leaflet). Signs of a
hypersensitivity reaction include swelling of the face or mouth (angioedema),
breathing problems, runny nose, skin rash, blistering or peeling.
• you have any heart problems,
• you have ever had problems with your bone marrow,
• you have a blood disorder called porphyria,
•  ou have taken drugs called monoamine oxidase inhibitors (MAOIs), used
y
to treat depression, within the last 14 days.

A small number of people being treated with anti-epileptics such as
carbamazepine have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.
Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis)
have been reported with the use of carbamazepine. Frequently, the rash can
involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and
swollen eyes). These serious skin rashes are often preceded by influenza-like
symptoms fever, headache, body ache (flu-like symptoms). The rash may
progress to widespread blistering and peeling of the skin. The highest risk for
occurrence of serious skin reactions is within the first months of treatment.
These serious skin reactions can be more common in people from some
Asian countries. The risk of these reactions in patients of Han Chinese or
Thai origin may be predicted by testing a blood sample of these patients.
Your doctor should be able to advise if a blood test is necessary before taking
carbamazepine.
If you develop a rash or these skin symptoms, stop taking carbamazepine and
contact your doctor immediately.
You should also ask yourself these questions before you have Tegretol
Suppositories. If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because Tegretol
Suppositories might not be the right medicine for you.
• Are you pregnant or planning to become pregnant?
• Are you breastfeeding?
• Do you suffer from the sort of epilepsy where you get mixed seizures which
include absences?
• Do you have any mental illness?
• Are you allergic to an epilepsy medicine called phenytoin?
• Do you have liver problems?

code read direction
64

• Are you elderly?
• Do you have any eye problems such as glaucoma (increased pressure in
the eye)?
Are you taking other medicines?
Because of the way that Tegretol works, it can affect, and be affected by, lots
of other things that you might be eating or medicines that you are taking. It is
very important to make sure that your doctor knows all about what else you are
taking, including anything that you have bought from a chemist or health food
shop. It may be necessary to change the dose of some medicines, or stop taking
something altogether.
Tell the doctor if you are taking:
• 
Hormone contraceptives, e.g. pills, patches, injections or implants. Tegretol
affects the way the contraceptive works in your body, and you may get
breakthrough bleeding or spotting. It may also make the contraceptive
less effective and there will be a risk of getting pregnant. Your doctor will
be able to advise you about this, and you should think about using other
contraceptives.
• Hormone Replacement Therapy (HRT). Tegretol can make HRT less effective.
• Any medicines for depression or anxiety.
•  orticosteroids (‘steroids’). You might be taking these for inflammatory
C
conditions such as asthma, inflammatory bowel disease, muscle and
joint pains.
• Anticoagulants to stop your blood clotting.
•  ntibiotics to treat infections including skin infections and TB
A
(e.g. ciprofloxacillin).
• Antifungals to treat fungal infections.
•  ainkillers containing paracetamol, dextropropoxyphene, tramadol,
P
methadone or buprenorphine.

5025467_GB_p1_LFT.indd 1













Other medicines to treat epilepsy.
Medicines for high blood pressure or heart problems.
Antihistamines (medicines to treat allergy such as hayfever, itch, etc).
Diuretics (water tablets).
Cimetidine or omeprazole (medicines to treat gastric ulcers).
Isotretinoin (a medicine for the treatment of acne).
Metoclopramide or aprepitant (anti-sickness medications).
A
 cetazolamide (a medicine to treat glaucoma - increased pressure in the eye).
Danazol or gestrinone (treatments for endometriosis).
Theophylline or aminophylline (used in the treatment of asthma).
C
 iclosporin, tacrolimus or sirolimus (immunosuppressants, used after
transplant operations, but also sometimes in the treatment of arthritis or
psoriasis).
Drugs to treat schizophrenia (e.g. paliperidone, aripiprazole).
Cancer drugs (e.g. temsirolimus, cyclophasphamide, lapatinib).
The anti-malarial drug, mefloquine.
Drugs to treat HIV.
Levothyroxine (used to treat hypothyroidism).
Muscle relaxant drugs.
Tadalafil (used to treat impotence).
Albendazole (used to treat worms).
Bupropion (used to help stop smoking).
A herbal remedy called St John’s Wort or Hypericum.
Drugs or supplements containing Vitamin B (nicotinamide).

Pregnancy and breastfeeding
You must discuss your epilepsy treatment with your doctor well before you become
pregnant. If you do get pregnant you must tell the doctor straightaway. It is

important that your epilepsy remains well controlled, but, as with other anti-epilepsy
treatments, there is a risk of harm to the foetus. Make sure you are very clear about
the risks and the benefits of being treated with Tegretol Suppositories.
Mothers being treated with Tegretol Suppositories can breastfeed their babies,
but you must tell the doctor as soon as possible if you think that the baby is
suffering side effects such as excessive sleepiness or skin reactions because
you are being treated with Tegretol Suppositories.
Will there be any problems with driving or using machinery?
Tegretol Suppositories can make you feel dizzy or drowsy, especially at the
start of treatment or when the dose is changed. If you are affected in this way,
or if your eyesight is affected, you should not drive or operate machinery.
Other special warnings
•  rinking alcohol may affect you more than usual. Discuss whether you
D
should stop drinking with your doctor.
•  ating grapefruit, or drinking grapefruit juice, may increase your chance of
E
experiencing side effects.
•  our doctor may want you to have a number of blood tests before you are
Y
treated with Tegretol and sometimes during your treatment. This is quite
usual and nothing to worry about.

3. How to use Tegretol Suppositories
The doctor will tell you the dose you need. Always follow his/her
instructions carefully. The dose will be on the pharmacist’s label. Check
the label carefully. It is important to use the suppositories at the right
times. If you are not sure, ask your doctor or pharmacist. Keep using
the suppositories for as long as you have been told, unless you have any
problems. In that case, check with your doctor.
Suppositories are designed to be inserted into the back passage (rectum).
Never take them by mouth.
5025467 GB

02/07/2013 16:02
code read direction
64

The Maltings

824868 / Hauser, Sascha

PANTONE 314 C

5025467 GB
5023694 GB 12 A/H
Leaflet_TEGRETOL INC.CR/XR_SUP_125MG +
250MG_GB
GB
64

Cutting, Dimensions

Laetuscode
N/A
N/A

594 x 148mm

Delpharm

5025467_GB_TS_LFT

02/07/2013
News Gothic MT, News Gothic MT Bold, News Gothic Bold

1. Proof













K.Jerrum

7pt
Smallest code font size: 6pt
N/A

SGS Number: 450710_1

Page 1/2

code read direction
64

For how to insert the suppositories see the end of the leaflet.

• Any signs of nervous illness or confusion

Up to 1 in 1,000 people have reported:

Your doctor will work out the dose that you need. It varies from person to person.

•  ain in your joints and muscles, a rash across the bridge of the nose and
P
cheeks and problems with breathing (these may be the signs of a rare
reaction known as lupus erythematosus)

•  ronchospasm with wheezing and coughing, difficulty in breathing, feeling
B
faint, rash, itching or facial swelling (these may be the signs of a severe
allergic reaction)

Disease of the lymph glands; folic acid deficiency; a generalised allergic
reaction including rash, joint pain, fever, problems with the liver, kidneys
and other organs; hallucinations; depression; loss of appetite; restlessness;
aggression; agitation; confusion; speech disorders; numbness or tingling in
the hands and feet; muscle weakness; high blood pressure (which may make
you feel dizzy, with a flushed face, headache, fatigue and nervousness); low
blood pressure (the symptoms of which are feeling faint, light headed, dizzy,
confused, having blurred vision); changes to heart beat; stomach pain; liver
problems including jaundice; symptoms of lupus.

• Pain in the area near the stomach.

Up to 1 in 10,000 people have reported:

The side effects listed below have also been reported.

Changes to the composition of the blood including anaemia; porphyria;
meningitis; swelling of the breasts and discharge of milk which may occur
in both male and females; abnormal thyroid function tests; osteomalacia
(which may be noticed as pain on walking and bowing of the long bones
in the legs); osteoporosis; increased blood fat levels; taste disturbances;
conjunctivitis; glaucoma; cataracts; hearing disorders; heart and circulatory
problems including deep vein thrombosis (DVT), the symptoms of which could
include tenderness, pain, swelling, warmth, skin discoloration and prominent
superficial veins; lung or breathing problems; severe skin reactions including
Stevens-Johnson syndrome (These reactions may be more frequent in patients
of Chinese or Thai origin); sore mouth or tongue; liver failure; increased
sensitivity of the skin to sunlight; alterations in skin pigmentation; acne;
excessive sweating; hair loss; increased hair growth on the body and face;
muscle pain or spasm; sexual difficulties which may include reduced male
fertility, loss of libido or impotence; kidney failure; blood spots in the urine;
increased or decreased desire to pass urine or difficulty in passing urine.

The maximum dose is 1,000 mg per day. Elderly people might need a lower
dose.
What if you forget a dose?
If you forget to take a dose, take one as soon as you remember. If it is nearly
time for your next dose, though, just take the next dose and forget about the one
you missed.
Using too many suppositories
If you accidentally insert too many suppositories, or if anyone swallows any
suppositories, tell your doctor or your nearest hospital casualty department.
Take your pack with you so that people can see what medicine you are having.

4. Possible side effects

•  ever, skin rash, joint pain, and abnormalities in blood and liver function
F
tests (these may be the signs of a multi-organ sensitivity disorder)

More than 1 in 10 people have experienced:
Leucopenia (a reduced number of the cells which fight infection making it
easier to catch infections); dizziness and tiredness; feeling unsteady or
finding it difficult to control movements; feeling or being sick; changes in liver
enzyme levels (usually without any symptoms); skin reactions which may be
severe.

Tegretol Suppositories do not usually cause problems, but like all medicines,
they can sometimes cause side effects.
Some side effects can be serious
Stop using the suppositories and tell your doctor straight away if
you notice:

Up to 1 in 10 people have experienced:

• Mouth ulcers or unexplained bruising or bleeding

Changes in the blood including an increased tendency to bruise or bleed; fluid
retention and swelling; weight increase; low sodium in the blood which might
result in confusion; headache; double or blurred vision; dry mouth; rectal
irritation.

• Sore throat or high temperature, or both

Up to 1 in 100 people have reported:

• Yellowing of your skin or the whites of your eyes

Abnormal involuntary movements including tremor or tics; abnormal eye
movements; diarrhoea; constipation.

•  erious skin reactions such as rash, red skin, blistering of the lips, eyes or
S
mouth, or skin peeling accompanied by fever. These reactions may be more
frequent in patients of Chinese or Thai origin

• Swollen ankles, feet or lower legs

The following have also been reported, but the frequency cannot be estimated
from the available information:
Severe skin reactions, accompanied by feeling unwell and changes in blood results.

5025467_GB_p1_LFT.indd 2

If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
There have been reports of bone disorders including osteopenia and
osteoporosis (thinning of the bone) and fractures. Check with your doctor or
pharmacist if you are on long-term antiepileptic medication, have a history of
osteoporosis, or take steroids.

5. How to store Tegretol Suppositories
Tegretol Suppositories must be stored below 30ºC.
Keep out of the reach and sight of children.
Do not use the suppositories after the expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop using the suppositories, please take any left over
back to your pharmacist to be destroyed. Do not throw them away with your
normal household water or waste. This will help to protect the environment.

6. Further information
The suppositories are white or off-white in colour and come in two strengths.
The active ingredient is carbamazepine, and they also contain the inactive
ingredients hydroxypropyl methylcellulose and suppository mass 15. The lower
dose contains 125 mg of carbamazepine and the suppository weighs about
1 gram. The higher dose contains 250 mg of carbamazepine and the
suppository weighs about 2 grams.
There are 5 suppositories in each pack.

Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley,
Surrey GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex,
RH12 5AB, England, United Kingdom and Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England, United Kingdom.

The procedure is the same for a child. Once they have emptied their bowels,
get them to lie down on their front or side. Gently push the suppository into the
child’s back passage until it disappears. Try and stop the child moving around
for a few minutes to reduce the risk of the suppository coming out.
If a doctor or nurse is giving the suppository to an unconscious patient, the
procedure will be similar to that described above.

How to insert the suppositories

This leaflet was revised in May 2013.

•  mpty your bowels before inserting a
E
suppository.
• Wash your hands.
• Take out the strip of suppositories and tear
off one along the perforation.
• Tear the foil wrapping apart at the notch
and take out the suppository.
•  ie on one side with your knees pulled up towards your chest.
L
•  ently push the suppository pointed end
G
first into your back passage (rectum) with
your finger. Push the suppository in as far
as possible as shown in the diagram.
•  ower your legs and, if possible, stay still
L
for a few minutes.

If you would like any more information, or would like the leaflet in a different
format, please contact Medical Information at Novartis Pharmaceuticals UK
Ltd, telephone number 01276 698370.

• you feel as if you need to push the
If
suppository out, try to resist this by
lying still with your buttocks pressed together. It is important to keep the
suppository in the rectum to allow it to melt and the medicine to be absorbed.
Pushing the suppository high into the rectum with your finger will help to
reduce this feeling.
• Wash your hands.

TEGRETOL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

5025467 GB

02/07/2013 16:02

The Maltings

824868 / Hauser, Sascha

PANTONE 314 C

5025467 GB
5023694 GB 12 A/H
Leaflet_TEGRETOL INC.CR/XR_SUP_125MG +
250MG_GB
GB
64

Cutting, Dimensions

Laetuscode
N/A
N/A

594 x 148mm

Delpharm

5025467_GB_TS_LFT

02/07/2013
News Gothic MT, News Gothic MT Bold, News Gothic Bold

1. Proof

Do not be alarmed by this list. Most people use Tegretol Suppositories
without any problems.

K.Jerrum

7pt
Smallest code font size: 6pt
N/A

SGS Number: 450710_1

Page 2/2

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)