Tegretol Side Effects

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Answer the side-effect intent for tegretol without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Tegretol?

Tegretol contains the active ingredient Carbamazepine.

• Active ingredient — Carbamazepine
• Registration number — D/2.5/204; V/2.5/321; V/2.5/322
• Registration holder — Novartis South Africa (Pty) Ltd

It is approved for:

• 2 What you need to know before you take TEGRETOL 3 How to take TEGRETOL 4 Possible side effects 5 How to store TEGRETOL 6 Contents of the pack and other information 1
• What TEGRETOL is and what it is used for What TEGRETOL is The active substance of TEGRETOL is carbamazepine
• TEGRETOL belongs to a group of medicines called antiepileptics (medicine for seizures)
• TEGRETOL is used to treat certain types of seizures (epilepsy)

Common side effects of Tegretol

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• If you have swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalised itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness (signs of angioedema and severe allergic reactions)
• If you have fever, sore throat, rash, ulcers in the mouth, swollen glands or more easily getting infections (signs of lack of white blood cells)
• If you have tiredness, headache, being short of breath when exercising, dizziness, looking pale, frequent infections leading to fever, chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal, nose bleeds (lack of all blood cells)
• If you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of systemic lupus erythematosus)
• If you have any yellowing of the white of your eyes or your skin (signs of hepatitis)
• If you have darkening of urine (signs of porphyria or hepatitis)
• If you have severe decreased urine output due to kidney disorders, blood in the urine
• If you have severe upper abdominal pain, vomiting, loss of appetite (signs of pancreatitis)
• If you have skin rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, accompanied by fever, chills, headache, cough, body aches (signs of serious skin reactions)
• If you have lethargy, confusion, muscular twitching or significant worsening of convulsions (symptoms that may be linked to low sodium levels in the blood)
• If you have fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light (signs of meningitis)
• If you have muscular stiffness, high fever, altered consciousness, high blood pressure, excessive salvation (signs of neuroleptic malignant syndrome)
• If you have irregular heartbeat, chest pain
• If you have disturbed consciousness, fainting
• If you have diarrhoea, abdominal pain and fever (signs of an inflammation of the colon). The frequency of this side effect is not known
• If you experience a fall due to dizziness, drowsiness, decrease in blood pressure, confusion
• These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to TEGRETOL. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: Frequent: loss of muscle coordination, allergic skin reactions Less frequent: swelling of the ankles, feet or lower legs (oedema), changes in behaviour, confusion, weakness, increase in seizures (fits, due to insufficient amount of sodium in your body), blurred vision, double vision, itching with redness and swelling of the eye (conjunctivitis), feeling pressure/pain in the eye (signs of increased pressure in the eye), trembling, uncontrolled body movements, muscle spasms, uncontrolled eye movements, itching, swollen glands, agitation or hostility (especially in the elderly), fainting, difficulty in speaking or slurred speech, depression with restlessness, nervousness or other mood or mental changes, hallucinations (seeing/hearing things that are not there), ringing or other unexplained sounds in the ears, decreased hearing, troubled breathing, chest pain, fast or unusually slow heartbeat, numbness, tingling in hands and feet, frequent urination, sudden decrease in amount of urine, taste disturbances, unusual secretion of breast milk, breast enlargement in men, swelling and redness along a vein which is extremely tender when touched, often experienced as painful (thrombophlebitis), increased sensitivity of the skin to sun, softening or thinning or weakening of bones causing an increased risk of broken bones (lack of vitamin D, osteoporosis). Some side effects are of unknown frequency: reactivation of herpes virus infection (can be serious when the immune system is depressed), complete loss of the nails, bone fracture, decrease in the bone density. These are all serious side-effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequent side effects: vomiting, nausea, dizziness, sleepiness, unsteadiness, weight gain. Less frequent side effects: headache, dry mouth, constipation, diarrhoea, abdominal pain, aching joints or muscles, increased sweating, loss of appetite, loss of hair, sexual disturbances, male infertility, red and sore tongue, mouth sores, alterations in skin pigmentation, acne. Some side effects are of not known frequency: drowsiness, memory loss, purple or reddish- purple bumps that may be itchy. If any of these affects you severely, tell your doctor

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic (hypersensitive) to carbamazepine or to any of the other ingredients of TEGRETOL listed in this leaflet. Signs of a hypersensitivity reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling
• If you have severe heart disease
• If you have had serious blood illnesses in the past
• If you have a disturbance in the production of porphyrin, a pigment important for liver function and blood formation (also called ‘porphyria’)
• If you have taken medicines belonging to a group of antidepressants called monoamine-oxidase inhibitors (MAOIs), within the last 14 days
• Do not breastfeed your baby if you are taking TEGRETOL
• If you previously developed a serious skin rash (Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If this applies to you, tell your doctor before taking TEGRETOL. If you think you may be allergic, ask your doctor for advice

Use with care, and tell your doctor, if

• If you have blood illnesses (including those caused by other medicines)
• If you have ever shown unusual sensitivity (rash or any other signs of allergy) to carbamazepine, oxcarbazepine or to any other medicines. It is important to note that if you are allergic to carbamazepine, the chances are approximately 1 in 4 (25 %) that you could also have an allergic reaction to oxcarbazepine
• If you have or have had heart, liver or kidney disease in the past
• If you have increased pressure in the eye (glaucoma) or if you have difficulty or pain when passing urine
• If you were told by your medical practitioner that you suffer from a mental disorder called psychosis that may be accompanied by confusion or agitation
• If you are a female of childbearing age, you should use an effective method of contraception throughout your treatment and for 2 weeks after your last dose. If you are taking a hormonal contraceptive (birth control medicine), TEGRETOL may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking TEGRETOL. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or health professional. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss with you the potential risk of taking TEGRETOL during pregnancy since it may cause harm or abnormalities in the unborn child. If any of the following applies to you, tell your doctor immediately
• If an allergic reaction happens, such as swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital
• 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
• If you develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately or go to the emergency department at your nearest hospital
• These reactions may be more frequent in patients from some Asian countries (e.g. Taiwan, Malaysia and the Philippines) and in patients with Chinese ancestry. Studies found a strong correlation between serious skin reactions associated with TEGRETOL and the presence in these patients of the Human Leukocyte Antigen HLA-B*1502 allele
• If you are a patient with a genetically at-risk population (populations for example, patients of the Japanese and Caucasian populations, patients who belong to the indigenous populations of the Americas, Hispanic populations, people of southern India, and people of Arabic descent), consider testing for the presence of HLA-A*3101. Before starting you on TEGRETOL your doctor should consider testing for the presence of HLA-B*1502 allele if you have ancestry in genetically at-risk populations
• If you experience an increase in the number of seizures, tell your doctor immediately
• If you notice symptoms suggestive of hepatitis, such as jaundice (yellowing of skin and eyes), tell your doctor immediately
• 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
• If you have kidney problems associated with low sodium blood level or if you have kidney problems and you are taking also certain medicines that lower sodium blood level (diuretics such as hydrochlorothiazide, furosemide)
• If you experience dizziness, drowsiness, decrease in blood pressure, confusion, due to TEGRETOL treatment, which may lead to falls. Do not stop your treatment with TEGRETOL without first checking with your doctor. To prevent sudden worsening of your seizures, do not discontinue your medicine abruptly

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking TEGRETOL, as TEGRETOL may harm your baby
• It is important to control epileptic seizures during pregnancy
• However, there is a possible risk to your baby if you take antiepileptic medication (medicine for seizures) including TEGRETOL during pregnancy
• Risk of neurodevelopmental disorders cannot be excluded among children born to women with epilepsy treated with carbamazepine alone or in combination with other antiepileptic medicines during pregnancy
• Your doctor will discuss with you the potential risk of taking TEGRETOL during pregnancy
• Do not stop your treatment with TEGRETOL during pregnancy without first checking with your doctor

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines that can raise carbamazepine levels: ibuprofen, danazol, macrolide antibiotics (e.g. erythromycin, clarithromycin), ciprofloxacin, desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, stiripentol, vigabatrin, azoles (e.g. itraconazole, ketoconazole, fluconazole, voriconazole), olanzapine, isoniazid, acetazolamide, diltiazem, verapamil, cimetidine, omeprazole. Oxybutynin, dantrolene, ticlopidine, nicotinamide
• Medicine that may raise the active metabolite 10,11–epoxide levels: loxapine, quetiapine, primidone, progabide, valproic acid, valnoctamide, valpromide and brivaracetam
• Medicine that may decrease carbamazepine and/or carbamazepine-10,11-epoxide plasma levels: felbamate, methsuximide, oxcarbazepine, phenobarbitone, phensuximide, phenytoin, primidone, clonazepam, cisplatin, doxorubicin, rifampicin, theophylline, aminophylline, isotretinoin, St John’s Wort
• The dosage of the following medicines may have to be adjusted to clinical requirements: buprenorphine, methadone, paracetamol, oral anticoagulants (e.g. warfarin, rivaroxaban and dabigatran), bupropion, citalopram, mianserin, nefazodone, trazodone, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortriptyline, clomipramine), aprepitant, clobazam, clonazepam, ethosuximide, felbamate, lamotrigine, primidone, tiagabine, topiramate, valproic acid, zonisamide, phenytoin, itraconazole, praziquantel, albendazole, imatinib, cyclophosphamide, lapatinib, temsirolimus, clozapine, haloperidol and bromperidol, quetiapine, risperidone, ziprasidone, olanzapine, aripiprazole, paliperidone, alprazolam, theophylline, hormonal contraceptives, calcium channel blockers (felodipine, digoxin), corticosteroids, tadalafil, ciclosporin, everolimus, tacrolimus, sirolimus
• You may need a change in your dose or, sometimes, to stop one of the medicines. Irregularity of the menstrual period may occur in women taking hormonal contraceptives (birth control medicines) and TEGRETOL. Hormonal contraceptives may become less effective, and you should consider using other effective contraceptive methods (non- hormonal). TEGRETOL with food and drink: Do not drink alcohol when you are on TEGRETOL. Do not drink grapefruit juice or eat grapefruit since this can increase the effect of TEGRETOL. Other juices, like orange juice or apple juice, do not have this effect

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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