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CARBAMAZEPINE ESSENTIAL PHARMA 250MG SUPPOSITORIES

Active substance(s): CARBAMAZEPINE / CARBAMAZEPINE / CARBAMAZEPINE

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1. What Carbamazepine Essential Pharma
Suppositories are and what they are used for
Package Leaflet: Information for the User

Carbamazepine Essential Pharma
125 and 250 mg Suppositories
(carbamazepine)

What you need to know about Carbamazepine Essential
Pharma 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.

Carbamazepine, the active ingredient in Carbamazepine
Essential Pharma Suppositories, is an anti-convulsant medicine
(prevents fits).
Carbamazepine Essential Pharma 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.

2. Things to consider before you are treated with
Carbamazepine Essential Pharma Suppositories

Some people MUST NOT have Carbamazepine Essential
Pharma 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 Carbamazepine Essential Pharma 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,
In this leaflet:
• you have ever had problems with your bone marrow,
1. What Carbamazepine Essential Pharma Suppositories are
• you have a blood disorder called porphyria,
and what they are used for
2. Things to consider before you are treated with
• you have taken drugs called monoamine oxidase inhibitors
Carbamazepine Essential Pharma Suppositories
(MAOIs), used to treat depression, within the last 14 days.
3. How to use Carbamazepine Essential Pharma Suppositories
A small number of people being treated with anti-epileptics
4. Possible side effects
such as carbamazepine have had thoughts of harming or killing
5. How to store Carbamazepine Essential Pharma Suppositories themselves. If at any time you have these thoughts,
6. Further information
immediately contact your doctor.

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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
Carbamazepine Essential Pharma Suppositories. If the answer
to any of these questions is YES, discuss your treatment with
your doctor or pharmacist because Carbamazepine Essential
Pharma 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?
• 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 Carbamazepine Essential Pharma
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. Carbamazepine Essential Pharma 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). Carbamazepine
Essential Pharma 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).
• 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 Carbamazepine Essential Pharma Suppositories.
Mothers being treated with Carbamazepine Essential Pharma
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?
Carbamazepine Essential Pharma 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 Carbamazepine and sometimes
during your treatment. This is quite usual and nothing to
worry about.

3. How to use Carbamazepine Essential Pharma
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.
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.

Car125-250mgSupp-PL-UK-3

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
Carbamazepine Essential Pharma 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
• Mouth ulcers or unexplained bruising or bleeding
• Sore throat or high temperature, or both
• Yellowing of your skin or the whites of your eyes
• Swollen ankles, feet or lower legs
• 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)
• Fever, skin rash, joint pain, and abnormalities in blood and
liver function tests (these may be the signs of a multi-organ
sensitivity disorder)



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)
• Pain in the area near the stomach.
The side effects listed below have also been reported.
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.
Up to 1 in 100 people have reported:
Abnormal involuntary movements including tremor or tics;
abnormal eye movements; diarrhoea; constipation.
Up to 1 in 1,000 people have reported:
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.
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.
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. 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
Carbamazepine Essential Pharma 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.
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 Carbamazepine Essential Pharma
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:
Essential Pharma Ltd, 7 Egham Business Village, Crabtree
Road, Egham, Surrey, TW20 8RB, United Kingdom.

Manufacturer
Delpharm Huningue SAS - Huningue
26 rue de la Chapelle,
68330 Huningue
France
How to insert the suppositories
• Empty your bowels before
inserting a suppository.
• Wash your hands.
• Take out the strip of suppositorie
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.
• 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.
This leaflet was revised in August 2016.

Car125-250mg-Supp-PL-UK-3

Expand Transcript

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.

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