INTRODUCTION

EFAMAT 600MG contains Efavirenz which belongs to the class of medicines called non-nucleoside reverse transcriptase inhibitors. It is an antiretroviral medicine used to treat human immunodeficiency virus (HIV-1) infection. It acts by reducing the amount of the virus present in the blood. It also strengthens your immune system and reduces the risk of developing illness linked to HIV infection. It must be taken in combination with other antiretroviral agents for effective results. Efavirenz is only virustatic in nature and so, you can still pass on the infection to other people. Discuss all the necessary precautions and preventive measures to avoid infecting other people with your doctor.

Prior to the treatment, your doctor may conduct several blood tests to check the functioning of your liver. Please inform your doctor if you have severe liver disease, because the use of efavirenz may lead to potentially life-threatening liver problems in such patients. Take this medicine on an empty stomach at bedtime. Avoid drinking grapefruit juice while taking this medicine. The most common side effects of this medicine are dizziness, difficulty in sleeping, drowsiness or abnormal dreaming. These side effects are usually temporary and will disappear after 2 to 4 weeks of therapy. Before taking this medicine inform your doctor if you have any heart disease, mental disorders or history of convulsion. This medicine is strictly not recommended for use in pregnant or breastfeeding women. Consult your doctor before taking this medicine.

USES OF EFAMAT 600MG

• Treat HIV infection

HOW EFAMAT 600MG WORKS

Following oral administration, efavirenz effectively inhibits the activity of viral reverse transcriptase (RNA-directed DNA polymerase) enzyme, which decreases the generation of DNA copies of viral RNA and synthesis of new virions. This reduces the level of HIV (viral load) in the blood.

DIRECTIONS FOR USE

Take EFAMAT 600MG as directed by your physician. Swallow the medicine as whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results. Avoid drinking grapefruit juice while taking this medicine.

SIDE EFFECTS OF EFAMAT 600MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

Dizziness:

Try to rest and relax. Try to get enough sleep. Avoid travelling or driving while you feel dizzy.

WARNING & PRECAUTIONS

INTERACTIONS

Tell your doctor, if you are taking,

• other medicines used to treat HIV infections
• medicines used to treat hepatitis C viral infection
• ergot alkaloids (medicines used to treat migraine and cluster headaches)
• medicines used to treat epilepsy (e.g. carbamazepine, phenobarbital and phenytoin)
• medicines used to treat depression (e.g. pimozide, sertraline, bupropion, imipramine, amitriptyline or clomipramine)
• flecainide, metoprolol (used to treat irregular heartbeat)
• medicines used to treat fungal infections
• medicines used to treat malarial or bacterial infections
• medicines used to lower high blood cholesterol levels (e.g. atorvastatin, pravastatin or simvastatin)
• medicines used to suppress immune system and prevent graft rejection (e.g. cyclosporine, sirolimus, or tacrolimus)
• medicines used to reduce blood clotting (e.g. warfarin or acenocoumarol)
• astemizole or terfenadine (used to treat symptoms of allergy)
• medicines used to treat high blood pressure or heart problems
• cisapride (used to treat heartburn)
• midazolam or triazolam (used to induce sleep)
• St. John’s wort (an herbal medicine used for depression and anxiety)
• methadone (used to treat opiate addiction)
• Ginkgo biloba extracts (an herbal preparations)
• birth control pills

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT EFAMAT 600MG

Can EFAMAT 600MG be used in pregnant women?

It is strictly not recommended for use in pregnant or breastfeeding women. Consult your doctor before taking.

Can EFAMAT 600MG be used in children?

Yes. It can be used in adolescents and in children aged 3 months or older (weighing at least 3.5 kg). However, consult your doctor before taking.

Can EFAMAT 600MG be taken with food?

No. Take this medicine on an empty stomach preferably at bedtime to avoid undesirable side effects.

REFERENCES

1. KD. Tripathi. Antiviral drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 808-809.

2. Charles Flexner. Antiretroviral agents and treatment of HIV infection. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York Mc Graw Hill Medical 2011. Page – 1643-1644.

3. Gerald G. Briggs and Roger K. Freeman. E. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page - 1312-1315.

4. Dupont Merck. A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on June 2005] [Accessed 11th November 2020] https://clinicaltrials.gov/ct2/show/NCT00002227

5. Natella Y. Rakhmanina and John N. van den Anker. Efavirenz in the Therapy of HIV Infection. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2011. [Accessed 11th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810555/

6. APL Swift Services (Malta) Limited or Milpharm Limited. Electronic Medicines Compendium (EMC); [Revised on April 2019] [Accessed 11th November 2020] https://www.medicines.org.uk/emc/files/pil.7070.pdf

7. Bristol-Myers Squibb S.r.l or Aesica Queenborough Limited. Electronic Medicines Compendium (EMC); [Revised on February 2019] [Accessed 11th November 2020] https://www.medicines.org.uk/emc/files/pil.7734.pdf

8. Pharmadox HeaIthcare Ltd. Electronic Medicines Compendium (EMC); [Revised on March 2019] [Accessed 11th November 2020] https://www.medicines.org.uk/emc/files/pil.2066.pdf

9. Generics [UK] Limited and Gerard Laboratories. Electronic Medicines Compendium (EMC); [Revised on September 2018] [Accessed 11th November 2020] https://www.medicines.org.uk/emc/files/pil.719.pdf

10. Bristol-Myers Squibb Company. U.S. Food & Drug Administration. [Revised on March 2016] [Accessed 11th November 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf

USEFUL DIAGNOSTIC TESTS

• HIV 1 & 2, Ab Western Blot
• HIV 1 And 2 Antibody - Chromatography
• HIV 1 And 2 Antibody - ELISA