TEGRETOL 125MG SUPPOSITORIES

Active substance: CARBAMAZEPINE

View full screen / Print PDF » Download PDF ⇩

Transcript
Dummy Code

4. Possible side effects
5. How to store Tegretol Suppositories
6. Further information

Package Leaflet: Information for the User

TEGRETOL®
125 and 250 mg
Suppositories

1. What Tegretol Suppositories are and what they are
used for
Carbamazepine, the active ingredient in Tegretol Suppositories is an
anti-convulsant 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. Things to consider before you are treated with
Tegretol Suppositories
Some people MUST NOT have Tegretol Suppositories. Make sure
your doctor knows if:
• you think you may be hypersensitive (allergic) to carbamazepine or
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.
• you think you may be allergic to any of the other ingredients of
Tegretol 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,

1245186_GB_p1_LFT.indd 1

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

Live Text:
WO:
Comp. Description:

x Yes
/
No
1245186
Leaflet TEGRETOL INC.CR/XR SUP
125MG + 250MG GB

Comp. Number New:
Comp. Number Old:
Format/Dimension:
Tech. Drawing Number:

1245186_GB
5028864 GB
594 x 148 mm
5028864_GB_TS_LFT
9.0pt
14/07/2014

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?

Dummy Code

The Maltings

Minimum Font Size:
Proof Number: 1
Braille:

• you have taken drugs called monoamine oxidase inhibitors
(MAOIs), used to treat depression, within the last 14 days.

Production Site:
CTM:
Printing Colours:

Delpharm
Andersen, Claire
PANTONE 314 C

Technical Colours: Cutting
Dimensions

Laura Broadbent

! P LEASE TU R N OV E R P R I NT I N G O N !
539334_0

Dummy Code

• Do you have liver problems?
• Do you have kidney problems associated with low sodium blood
level or do you have kidney problems and you are taking certain
medicines that lower sodium blood levels (diuretics such as
hydrochlorothiazide, furosemide)?
• Are you elderly?
• Do you have any eye problems such as glaucoma (increased
pressure in the eye) or do you have difficulty retaining your urine?
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.
• Corticosteroids (‘steroids’). You might be taking these for
inflammatory conditions such as asthma, inflammatory bowel
disease, muscle and joint pains.
• Anticoagulants to stop your blood clotting.
• Antibiotics to treat infections including skin infections and TB
(e.g. ciprofloxacillin).

Dummy Code

• Antifungals to treat fungal infections.
• Painkillers containing paracetamol, dextropropoxyphene, tramadol,
methadone or buprenorphine.
• 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).
• Acetazolamide (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).
• Ciclosporin, 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).
• 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, skin
reaction or yellow skin and eyes, dark urine or pale stools.
Will there be any problems with driving or using machinery?
Tegretol Suppositories can make you feel dizzy or drowsy, or may cause
blurred vision, double vision, or you may have a lack of muscular
coordination, 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
• Drinking alcohol may affect you more than usual. Discuss
whether you should stop drinking with your doctor.
• Eating grapefruit, or drinking grapefruit juice, may increase your
chance of experiencing side effects.
• Your doctor may want you to have a number of blood tests before
you are 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

1245186_GB

14/07/2014 10:20

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.
For how to insert the suppositories see the end of the leaflet.
Your doctor will work out the dose that you need. It varies from
person to person.
The maximum dose is 1,000 mg per day. Elderly people might need
a lower dose.

• Mouth ulcers or unexplained bruising or bleeding

Up to 1 in 100 people have reported:

• Sore throat or high temperature, or both
• Yellowing of your skin or the whites of your eyes

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

• Swollen ankles, feet or lower legs

Up to 1 in 1,000 people have reported:

• Any signs of nervous illness or confusion
• Pain in your joints and muscles, a rash across the bridge of the
nose and cheeks and problems with breathing (these may be the
signs of a rare reaction known as lupus erythematosus)

What if you forget a dose?

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

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.

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

Using too many suppositories

• Pain in the area near the stomach.

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.

The side effects listed below have also been reported.

4. Possible side effects
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:
• Serious skin reactions such as rash, red skin, blistering of the lips,
eyes or mouth, or skin peeling accompanied by fever. These
reactions may be more frequent in patients of Chinese or Thai origin

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.
Up to 1 in 10 people have experienced:
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.

1245186_GB_p1_LFT.indd 2

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

Live Text:
WO:
Comp. Description:

x Yes
/
No
1245186
Leaflet TEGRETOL INC.CR/XR SUP
125MG + 250MG GB

Comp. Number New:
Comp. Number Old:
Format/Dimension:
Tech. Drawing Number:

1245186_GB
5028864 GB
594 x 148 mm
5028864_GB_TS_LFT
9.0pt
14/07/2014

Up to 1 in 10,000 people have 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.

Severe skin reactions, accompanied by feeling unwell and changes in
blood results. Diarrhoea, abdominal pain, and fever (signs of
inflammation of the colon), reactivation of herpes virus infection (can be
serious when immune system is depressed), complete loss of nails,
fracture, decrease in the measure of the bone density, drowsiness,
memory loss, purple or reddish-purple bumps that may be itchy.
Do not be alarmed by this list. Most people use Tegretol
Suppositories without any problems.
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
Protect from heat (store 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.

• Lower your legs and, if possible, stay still for a few minutes.
• If you feel as if you need to push the 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.
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 July 2014.

• Empty your bowels before inserting a
suppository.

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.

• 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.
• Lie on one side with your knees
pulled up towards your chest.
• Gently push the suppository pointed
end first into your back passage
(rectum) with your finger. Push the
suppository in as far as possible as
shown in the diagram.

TEGRETOL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

1245186_GB

14/07/2014 10:20

The Maltings

Minimum Font Size:
Proof Number: 1
Braille:

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.

The following have also been reported, but the frequency cannot be
estimated from the available information:

Production Site:
CTM:
Printing Colours:

Delpharm
Andersen, Claire
PANTONE 314 C

Technical Colours: Cutting
Dimensions

Laura Broadbent

! P LEASE TU R N OV E R P R I NT I N G O N !
539334_0

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
(web2)