TEGRETOL RETARD 200MG TABLETS

Active substance: CARBAMAZEPINE

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CUSTOMER: Waymade

PRE-PRESS NO.:

PRODUCT:

Tegretol Retard 200mg 400mg tabs

06 1257

ARTWORKER:

DT

DATE OF PROOF
CODE:

6464/2184 2185E

07/07/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.2 - waymade - 07/07/04

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED MARCH 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

5. How to store Tegretol Retard Tablets
Tegretol Retard Tablets should not be stored above 25°C. Store in a dry place, in the original container.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take Tegretol Retard Tablets after the expiry date which is printed on the outside of the pack.
If your doctor tells you to stop taking the tablets, please take any unused tablets 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.
If your tablets become discoloured or show any other signs of deterioration, you should seek the advice of
your doctor or pharmacist who will advise you what to do.

6. Further information
Your medicine is called Tegretol Retard Tablets. Each film-coated tablet contains either 200mg or 400mg of
the active ingredient, carbamazepine in a modified release formulation.
Tegretol Retard 200mg Tablets are brown-orange capsule-shaped and marked 'H’ breakline ‘C’ on one side
and 'C' breakline ‘G’ on the reverse.
Tegretol Retard 400mg Tablets are brown-orange capsule-shaped and marked 'ENE' either side of the
breakline on one side and 'CG' either side of the breakline on the reverse.
A modified release tablet is formulated to deliver the active ingredient over a longer period of time than an
ordinary tablet once swallowed.
Tegretol Retard Tablets also contain the following:
Colloidal silicon dioxide, ethyl cellulose aqueous dispersion, polyethoxylated castor oil, microcrystalline
cellulose, magnesium stearate, titanium dioxide (E171), carmellose sodium, yellow iron oxide (E172), red iron
oxide (E172), methacrylic acid copolymer, hypromellose and talc.
Tegretol Retard 200mg Tablets are available in blister packs of 50 tablets.
Tegretol Retard 400mg Tablets are available in blister packs of 30 and 60 tablets.
POM

PL/PI: 6464/2184 Tegretol Retard 200mg Tablets
PL/PI: 6464/2185 Tegretol Retard 400mg Tablets

These products are manufactured by Novartis Farma S.p.A., Via Prov. Schito, 131, Torre Annunziate (NA),
Italy and are procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 4.7.2014
Tegretol is a registered trademark of NOVARTIS AG.

TEGRETOL®
TEGRETOL®

RETARD 200 mg TABLETS
RETARD 400 mg TABLETS

(Carbamazepine)
Patient Information leaflet

This product is available in two different strengths 200mg and 400mg tablets. Throughout this leaflet these
products will be collectively referred to as Tegretol Retard Tablets.
What you need to know about Tegretol Retard Tablets
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. 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 Retard Tablets are and what they are used for
2. Things to consider before you start to take Tegretol Retard Tablets
3. How to take Tegretol Retard Tablets
4. Possible side effects
5. How to store Tegretol Retard Tablets
6. Further information

1. What Tegretol Retard Tablets are and what they are used for
Tegretol Retard Tablets are specially formulated to release the active ingredient gradually. Carbamazepine,
the active ingredient, can affect the body in several different ways. It is an anti-convulsant medicine (prevents
fits), it can also modify some types of pain and can control mood disorders.
Tegretol Retard Tablets are used

To treat some forms of epilepsy

To treat a painful condition of the face called trigeminal neuralgia

To help control serious mood disorders when some other medicines don’t work.

2. Things to consider before you start to take Tegretol Retard Tablets
Some people MUST NOT take Tegretol Retard Tablets. Talk to your doctor 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 Retard Tablets (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,

you have taken drugs called monoamine oxidase inhibitors (MAOIs), used 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 taking Tegretol Retard Tablets.
If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist
because Tegretol Retard Tablets 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?
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade
Tegretol Retard 200mg 400mg tabs

CODE:

6464/2184 2185E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF

PRODUCT:

07/07/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.2 - waymade - 07/07/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED MARCH 2014
REPORTING OF SIDE EFFECTS

Pg 2

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).

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 while you’re taking Tegretol Retard Tablets 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 taking Tegretol Retard Tablets.
Mothers taking Tegretol Retard Tablets 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 Retard Tablets 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 start taking Tegretol and from
time to time during your treatment. This is quite usual and nothing to worry about.

3. How to take Tegretol Retard Tablets
The doctor will tell you how many Tegretol Retard Tablets to take and when to take them. Always
follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label
carefully. It is important to take the tablets at the right times. If you are not sure, ask your doctor or
pharmacist. Keep taking your tablets for as long as you have been told, unless you have any
problems. In that case, check with your doctor.
Your doctor will usually start Tegretol at a fairly low dose which can then be increased to suit you individually.
The dose needed varies between patients. You can take Tegretol Retard Tablets during, after or between
meals. Swallow the tablets with a drink. Do not chew them. You are usually told to take a dose two or
three times a day. If necessary you may break the tablets in half along the scored line.
To treat epilepsy the usual doses are:
Adults: 800–1,200 mg a day, although higher doses may be necessary. If you are elderly you might require a
lower dose.
Children:
Aged 5–10 years: 400–600 mg a day
Aged 10–15 years: 600–1,000 mg a day.
Tegretol Retard Tablets are not recommended for children under 5.

Pg 3

What if you forget to take 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.
What if you take too many tablets?
If you accidentally take too many Tegretol Retard Tablets, tell your doctor or your nearest hospital casualty
department.
Take your medicine pack with you so that people can see what you have taken.

4. Possible side effects
Tegretol Retard Tablets do not usually cause problems, but like all medicines, they can sometimes cause side
effects.
Some side effects can be serious
Stop taking Tegretol Retard Tablets 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.
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 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 take Tegretol Retard Tablets 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.

To treat trigeminal neuralgia the usual dose is: 600–800 mg a day.
The maximum dose is 1200mg a day. If you are elderly you might require a lower dose.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

To treat mood swings the usual dose is: 400–600 mg a day

By reporting side effects you can help provide more information on the safety of this medicine.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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