Package leaflet: Information for the patient

Carbamazepine SUN 100 mg/5 ml Oral Suspension

carbamazepine

Read all of this leaflet carefully before you take this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Carbamazepine SUN Oral Suspension is and what it is used for

2.    What you need to know before you take Carbamazepine SUN Oral Suspension

3.    How to take Carbamazepine SUN Oral Suspension

4.    Possible side effects

5.    How to store Carbamazepine SUN Oral Suspension

6.    Contents of the pack and other information

1.    What Carbamazepine SUN Oral Suspension is

and what it is used for

Carbamazepine SUN Oral Suspension is a pale orange suspension that contains carbamazepine, the active ingredient. Carbamazepine SUN Oral Suspension is an anti-convulsant medicine (prevents fits). Carbamazepine can also modify some types of pain and can control mood disorders

Carbamazepine is used:

-    to treat some forms of epilepsy

-    to treat a painful condition of the face called trigeminal neuralgia

-    to help control serious manic depression when another medicine (lithium) doesn't work.

2.    What you need to know before you take Carbamazepine SUN Oral Suspension

Do not take Carbamazepine SUN Oral Suspension:

-    if you are allergic to carbamazepine or any of the other ingredients of this medicine (listed in section 6)

-    if you are allergic to similar drugs such as oxcarbazepine, or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or desipramine)

-    if you have any heart problems such as conduction disorders

-    if you have ever had problems with your bone marrow

-    if you have a disorder called porphyria (an inherited enzyme disorder)

-    if you are taking or have taken within the last 14 days, drugs called monoamine oxidase inhibitors (used to treat depression).

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbamazepine SUN Oral Suspension if:

-    you suffer from the sort of epilepsy where you get mixed seizures which include absences

-    you have any mental illness

-    you are allergic to phenytoin (another epilepsy treatment)

-    you have liver or kidney problems

-    you are elderly

-    you have eye problems such as glaucoma (increased pressure in the eye).

You should talk to your doctor if you think any of the above could apply to you.

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.

Avoid excessive exposure to sunlight as you may be at increased risk of sunburn.

Other medicines and Carbamazepine SUN Oral Suspension

Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.

Taking some medicines together can be harmful. Remember that the doctor at the hospital may not have been informed if you have recently begun a course of treatment for another illness.

In particular tell your doctor if you are taking:

-    other drugs for epilepsy and trigeminal neuralgia, such as clobazam, clonazepam, phenytoin, phenobarbitone, primidone, tiagabine, lamotrigine, topiramate, ethosuximide, valproic acid, felbamate or oxcarbazepine

-    drugs to treat major psychiatric and related disorders, such as alprazolam, viloxazine, fluoxetine, desipramine fluvoxamine

-    imipramine, lithium, clozapine, olanzapine, risperidone, haloperidol or thioridazine

-    painkillers containing methadone, tramadol or dextropropoxyphene

-    oral contraceptives. These may not work as well and you may notice breakthrough bleeding or spotting, and your doctor may consider an alternative form of contraception would be best for you

-    Hormone Replacement Therapy such as tibolone. Carbamazepine SUN Oral Suspension can make HRT less effective

-    drugs for the treatment of endometriosis such as danazol or gestrinone

-    drugs used to treat blood pressure or heart problems, such as digoxin, felodipine, nifedipine, nilvadipine, frusemide, warfarin, verapamil or diltiazem

-    drugs to treat gastro-intestinal problems such as cimetidine or metoclopramide

-    antibiotics and medicines to treat TB (tuberculosis) such as doxycycline, rifampicin, erythromycin, clarithromycin, or isoniazid

-    antifungal drugs such as itraconazole, fluconazole, ketoconazole or voriconazole

-    drugs which depress your immune system such as corticosteroids or cyclosporin

-    drugs to treat HIV such as indinavir, saquinavir or ritonavir

-    anti-cancer drugs such as toremifene, cisplatin or doxorubicin

-    drugs to treat allergies such as loratadine or terfenadine

-    theophylline to treat asthma

-    acetazolamide to treat glaucoma

-    isotretinoin to treat acne

-    mefloquine to treat malaria

-    thyroxine to treat hypothyroidism

-    any vitamin B supplements

-    St. John's wort (a herbal remedy).

Carbamazepine with food and drink and alcohol

Drinking alcohol may affect you more than usual. Discuss with your doctor whether you should stop drinking.

Eating grapefruit, or drinking grapefruit juice,

may increase your chance of having side effects. You can take Carbamazepine during, after or between meals.

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

A small amount of carbamazepine can get into breast milk. If you think that the baby is suffering side effects such as excessive sleepiness or skin reactions tell your doctor straight away.

Driving and using machines

Carbamazepine SUN Oral Suspension 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.

Carbamazepine SUN Oral Suspension contains sorbitol, potassium sorbate (E202) and sunset yellow (E110)

This medicine contains:

-    sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

-    potassium sorbate (E202). Each 5 ml of suspension contains less than 1 mmol (39 mg) of potassium, i.e. essentially "potassium free”.

-    sunset yellow (E110), which may cause allergic reactions.

3. How to take Carbamazepine SUN Oral Suspension

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Epilepsy

-    Adults: The usual dose is 800-1,200 mg a day, although higher doses may be necessary.

-    Elderly: You might need a lower starting dose.

-    Children: the usual dose is as below in several divided doses.

Age:

up to 1 year: 5 - 10 ml per day 1 - 5 years: 10 - 20 ml per day 5 - 10 years: 20 - 30 ml per day 10 - 15 years: 30 - 50 ml per day

Trigeminal neuralgia

The usual dose is 600-800 mg, (100 mg starting dose for elderly) a day. Once the pain is controlled your doctor will probably reduce the dose.

Manic depression

The usual dose is: 400-600 mg a day.

Method of administration

Your doctor will usually start Carbamazepine SUN Oral Suspension at a low dose, which can then be increased to suit you. Shake the bottle before you measure out your dose. You are usually told to take a dose two or three times a day. Carbamazepine SUN Oral Suspension is given orally, either before, during or between meals.

If you take more Carbamazepine SUN Oral Suspension than you should

If you accidentally take too much Carbamazepine Oral Suspension, tell your doctor or your nearest hospital casualty department.

If you forget to take Carbamazepine SUN Oral Suspension

If you forget to take a dose, take one as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Carbamazepine SUN Oral Suspension

Do not stop taking your medicine suddenly, as this’ may result in you having a seizure. Only stop taking your medicine if your doctor tells you to do so.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you get any

sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects

If you develop any of the following side effects, stop taking Carbamazepine SUN Oral Suspension and contact your doctor immediately:

-    fever, rash, sore throat, unusual/unexpected bleeding or bruising, joint pains

-    skin reactions with inflammation, blistering, sloughing of the skin, and/or inflammation of eyes, mouth or tongue. These may be severe and be accompanied by feeling generally unwell

-    yellowing of skin and eyes, pale stools and dark urine and/or upper abdominal pain or swelling as these may indicate liver damage.

-    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported

(see section 2).

Side effects can be listed according to how often they occur:

Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people

The following side effects have also been reported:

Very common

-    reduction in the number of white blood cells

-    changes in liver enzyme levels (your doctor can detect these with a blood test)

-    dizziness

-    tiredness

-    feeling unsteady or finding it difficult to control movements

-    feeling sick

-    vomiting

-    skin reactions

-    urticaria (hives) and fatigue

loss of appetite restlessness aggression agitation speech disorders

numbness or tingling in the hands and feet

muscle weakness

changes in heart beat

stomach pain

liver problems

rashes

partial immobility (partial paralysis)

Very rare

-    changes in the blood including anaemia

-    meningitis (inflammation of the brain lining)

-    swelling of the breasts and discharge of milk which may occur in both male and females

-    abnormal thyroid function tests

-    pain on walking and bow legs

-    brittle bones

-    increased blood fat levels

-    taste disturbances

-    red eyes

-    glaucoma (increased pressure in the eyes)

-    cataracts

-    hearing disorders

-    heart and circulatory problems including deep vein thrombosis (DVT)

-    lung or breathing problems

-    sore mouth or tongue

-    liver failure

-    increased sensitivity of the skin to sunlight

-    changes in skin colour

-    acne

-    sweating

-    hair loss

-    increased hair growth on the body and face

-    muscle pain or spasm

-    sexual problems including reduced male fertility

-    loss of sex drive or failure to get an erection

-    kidney failure

-    blood spots in the urine

-    increased or decreased desire to pass urine or difficulty in passing urine

-    skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis)

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

5.    How to store Carbamazepine SUN Oral Suspension

Keep this medicine out of the sight and reach of children.

Store below 25°C. Keep the bottle tightly closed between doses.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Carbamazepine SUN Oral Suspension contains

The active substance is carbamazepine. 5ml of suspension contains 100 mg of carbamazepine. The other ingredients are: poloxamer 188, sucralose (E955), xanthan gum, potassium sorbate, propylene glycol, citric acid monohydrate, sunset yellow (E110), sorbitol, flavour orange natural and artificial and purified water.

Common

-    changes in the number of white blood cells and platelets

-    low blood sodium (your doctor can detect these with a blood test)

-    fluid retention and swelling

-    drowsiness (lethargy)

-    weight increase

-    headache

-    double or blurred vision

-    dry mouth

-    vomiting

-    mental confusion

-    liver disorders

What Carbamazepine SUN Oral Suspension looks like and content of the pack

Amber bottles with a child resistant plastic cap. Pack size: 300 ml and 500 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp The Netherlands

Uncommon

-    abnormal movements such as tremor or tics

-    abnormal eye movements

-    diarrhoea

-    constipation

-    skin problems

Rare

-    disease of the lymph glands

-    folic acid deficiency (can be detected with a blood test by your doctor) hallucinations

-    depression

This leaflet was last revised in 06/2016

PL 31750/0096