INTRODUCTION

TEGRITAL contains Carbamazepine which belongs to the group of medicines called Anticonvulsants. It is used to manage certain forms of epilepsy (fits or seizures) and trigeminal neuralgia (painful condition of the face). It can also be used to control the symptoms of bipolar disorder if other medicines are not effective. Bipolar disorder (also known as manic depression) is a mental disorder characterized by alternative episodes of mania (sudden unusual extreme sense of happiness) and depression.

Carbamazepine controls seizure (fits) by reducing the abnormal activity of the nerve cells in the brain. It also reduces pain by blocking the transmission of pain signals across the nervous system. It can stabilize your mood by reducing the activation of nerve cells at certain regions of the brain that causes abnormal mood changes. During and prior to the management, your doctor would recommend you several blood tests to understand your existing condition.

Before taking TEGRITAL inform your doctor if you have any liver or kidney diseases. TEGRITAL is not recommended for use in patients who have or ever had porphyria (a blood disorder), any heart problems, or problems in bone marrow. Avoid consumption of alcohol or grapefruit juice while taking TEGRITAL as it may lead to unwanted side effects.

TEGRITAL should be used in pregnant and breastfeeding women only if it is considered necessary by the physician. It is not recommended for use in children aged below 5 years. The most common side effects of taking TEGRITAL are nausea, vomiting, increased bleeding tendency, headache, weight gain, dizziness, and blurred vision. Consult your doctor if any of the side effect worsen. Also, inform your doctor immediately if your mood becomes excessively depressed along with thoughts of self-harming or killing.

USES OF TEGRITAL

• Manages certain forms of epilepsy (fits or seizures) and trigeminal neuralgia (painful condition of the face)
• Controls bipolar disorder if other medicines are not effective

HOW TEGRITAL WORKS

TEGRITAL controls seizures by stopping the abnormal build-up of electrical signals within the brain. It acts as a specific analgesic for trigeminal neuralgia, by blocking various pain reflexes caused by stimulation of nerves in the face. It also acts as a mood stabilizer by reducing the activation of nerve cells at certain regions of the brain that causes abnormal mood changes.

DIRECTIONS FOR USE

Take TEGRITAL as advised by your physician. Shake well before use. It can be taken with or without meals. Your doctor will decide the suitable dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking TEGRITAL without consulting your doctor as it may make your symptoms to reappear.

SIDE EFFECTS OF TEGRITAL

HOW TO MANAGE SIDE EFFECTS

Nausea and Vomiting:

Take TEGRITAL with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

Diarrhea:

Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not self-manage diarrhea on your own. Consult your doctor if your diarrhea becomes uncontrollable.

Headache:  

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Constipation:

Eat plenty of fibre rich foods such as fresh fruits, vegetables, and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before taking TEGRITAL, inform your doctor if you are taking any of the following:

• hormonal contraceptives Ex. estradiol, dydrogesterone
• hormone replacement therapy (used to manage hormonal imbalances) Ex. oestrogen, progestins
• medicines used to manage depression and anxiety (Ex. viloxazine, citalopram, escitalopram, midazolam, clonazepam, lorazepam)
• corticosteroids (medicines used to manage pain and inflammation) Ex. methylprednisolone, prednisolone, dexamethasone
• anti-coagulants (medicines used to control blood clotting) Ex. heparin, warfarin
• medicine used to manage skin infections (Ex. ciprofloxacin)
• antifungals (medicines used to manage fungal infections) Ex. fluconazole, itraconazole
• medicines used to manage pain (Ex. paracetamol, dextropropoxyphene, tramadol, methadone, buprenorphine)
• other medications used to manage epilepsy (Ex. phenobarbital, phenytoin)
• antihistamines (medicines used to manage allergic reactions) Ex. cetirizine, fexofenadine
• medicines used to manage high blood pressure (Ex. captopril, enalapril)
• diuretics (medicines used to increase urine output) Ex. hydrochlorothiazide and furosemide
• cimetidine and omeprazole (medicines used to manage stomach ulcers)
• isotretinoin (a medicine used to manage acne)
• metoclopramide or aprepitant (medicines used to manage nausea and vomiting)
• acetazolamide (a medicine used to manage glaucoma)
• danazol or gestrinone (medicines used to manage excessive tissue growth in the uterus)
• medicines used to manage asthma (Ex. theophylline or aminophylline)
• immunosuppressants (medicines used to suppress immune system and to prevent graft rejection) Ex. ciclosporin, tacrolimus, sirolimus
• medicines used to manage schizophrenia (Ex. paliperidone, aripiprazole)
• medicines used to manage cancer (Ex. temsirolimus, cyclophosphamide, lapatinib)
• mefloquine (a medicine used to manage malaria)
• medicines used to manage HIV infections (Ex. indinavir, ritonavir)
• levothyroxine (a medicine used to manage thyroid deficiency)
• tadalafil (a medicine used to manage infertility in men)
• medicines used to manage worm infections (Ex. albendazole)
• bupropion (a medicine used to quit smoking)
• St John’s Wort (an herbal medicine used to manage depression)
• medicines or other supplements containing vitamin B (Ex. nicotinamide)

B. Drug-Food Interaction: 

Avoid drinking grapefruit juice while taking TEGRITAL as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally took more TEGRITAL, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep TEGRITAL out of reach of children
• Store at room temperature

FAQs ABOUT TEGRITAL

How to take TEGRITAL?

Take TEGRITAL as advised by your physician. Shake well before use. It can be taken with or without meals. Your doctor will decide the suitable dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking TEGRITAL without consulting your doctor as it may make your symptoms to reappear.

What does TEGRITAL do to your brain?

TEGRITAL controls seizures by stopping the abnormal build-up of electrical signals within the brain. It acts as a specific analgesic for trigeminal neuralgia, by blocking various pain reflexes caused by stimulation of nerves in the face. It also acts as a mood stabilizer by reducing the activation of nerve cells at certain regions of the brain that causes abnormal mood changes.

What are the common side effects of taking TEGRITAL?

The most common side effects of taking TEGRITAL are nausea, vomiting, increased bleeding tendency, headache, weight gain, dizziness, and blurred vision. In some people, it may also cause severe depression along with suicidal thoughts. Inform your doctor immediately if you experience any such side effects.

Is TEGRITAL safe to use in children?

TEGRITAL should be used with caution in children and adolescents (below 18 years). Therefore, consult your doctor before taking it.

How long should I take TEGRITAL?

You are advised to take TEGRITAL until your doctor suggests you discontinue the medicine. Do not stop taking TEGRITAL without consulting your doctor as it may make your symptoms to reappear.

Can TEGRITAL taken along with alcohol?

No. Avoid consumption of alcohol while taking TEGRITAL as it might make you feel dizzier and may cause accidental injuries.

Can pregnant women take TEGRITAL?

TEGRITAL should not be used in pregnant women unless considered necessary by the physician. Therefore, consult your doctor before taking. It is also not recommended for use in women who are planning to become pregnant. Women of childbearing potential should use a suitable non-hormonal contraceptive method to avoid pregnancy while undergoing therapy with TEGRITAL.

Will taking a higher dose of TEGRITAL be more effective?

No. Do not take a higher dose of TEGRITAL than the prescribed one without consulting your doctor. Taking a higher dose of TEGRITAL may not be beneficial. Instead, it can cause serious side effects. If the prescribed dose is not effective for you, consult your doctor. Your doctor may prescribe a suitable higher dose or suggest an alternative therapy after evaluating your disease condition.

Can I take painkillers along with TEGRITAL?

No. Avoid concomitant use of any pain killers like paracetamol, tramadol, dextropropoxyphene, methadone, and buprenorphine while taking TEGRITAL as it may lead to unwanted reactions. Consult your doctor before taking it.

What should I do if I forget to take a dose of TEGRITAL?

If your forgot to take a dose of TEGRITAL, take it as soon as you remember. However, if it is time to take the next dose, skip the missed one and take the regular dose. Do not take a double dose to compensate the missed dose.

REFERENCES

1. James O. McNamara. Pharmacotherapy of the Epilepsies. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 594-596.

2. Jasdave S. Maan; Truc vi H. Duong, Abdolreza Saadabadi Carbamazepine. NIH National Library of Medicine, National center for biotechnology information. [Revised on 2nd May 2022] [Accessed on 10th May 2022] https://www.ncbi.nlm.nih.gov/books/NBK482455/

3. Novartis Pharmaceuticals UK Limited and Novartis Farma S.p.A. Electronic Medicines Compendium (EMC). [Revised in October 2020] [Accessed on 10th May 2022] https://www.medicines.org.uk/emc/product/1041/pil

4. Novartis Pharmaceuticals Corporation. U.S. Food & Drug Administration. [Revised in February 2009] [Accessed on 11th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Glycosylated Haemoglobin