Patient Information Leaflet (PIL)

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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.

What this medicine is and what it is used for

Dolutegravir (brand name TAPIVIR) is an antiretroviral medicine used to treat Human Immunodeficiency Virus (HIV) infection.

It belongs to a class of medicines called integrase strand transfer inhibitors (INSTIs). It works by blocking the action of an enzyme called integrase, which HIV uses to multiply and spread to other cells in your body.

This medicine is used to treat HIV in:

• Adults
• Children and adolescents weighing at least 3 kg

Dolutegravir must always be used in combination with other antiretroviral medicines.

Before you take this medicine

How to Take Dolutegravir

if you:

• Are allergic to dolutegravir or any other ingredients of this medicine
• Are taking a medicine called dofetilide (used for heart rhythm problems)

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• Have liver problems or hepatitis B
• Have kidney problems
• Are pregnant or planning to become pregnant
• Are breastfeeding
• Have a history of mental health problems
• Have heart problems or take medicines for heart rhythm

Other medicines and Dolutegravir

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

• Antacids containing aluminum or magnesium
• Calcium or iron supplements
• Rifampicin (for tuberculosis)
• Phenytoin, carbamazepine, or phenobarbital (for seizures)
• St. John's Wort (herbal supplement)
• Other HIV medicines

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 for advice before taking this medicine.

Dolutegravir can be used during pregnancy. However, discuss with your doctor about the best treatment for you and your baby.

Do not breast-feed if you have HIV, as HIV can be passed to your baby through breast milk.

Driving and using machines

Dolutegravir is not expected to affect your ability to drive or use machines.

How to take this medicine

How to Take Dolutegravir

Always take this medicine exactly as your doctor has told you

How much to take

For adults: The usual dose is 50 mg once daily. However, if you are taking certain other medicines, your doctor may prescribe 50 mg twice daily.

For children: The dose depends on the child's weight. Your doctor will calculate the correct dose.

How to take it

• Swallow the tablets whole with water
• You can take it with or without food
• Try to take it at the same time each day

If you take more Dolutegravir than you should

Contact your doctor or go to the nearest hospital emergency room right away. Take the medicine container with you.

If you forget to take Dolutegravir

Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Before Taking Dolutegravir

Do not stop taking this medicine without talking to your doctor first. Stopping treatment may cause the virus to multiply again and your condition to get worse.

Patient Information Leaflet

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

Very common side effects (may affect more than 1 in 10 people):

• Headache
• Nausea
• Diarrhea

Common side effects (may affect up to 1 in 10 people):

• Fatigue or tiredness
• Insomnia (difficulty sleeping)
• Dizziness
• Vomiting
• Abdominal pain
• Rash

Uncommon side effects (may affect up to 1 in 100 people):

• Allergic reactions (including rash, swelling of face, lips, tongue)
• Liver problems
• Elevated liver enzymes

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store this medicine

• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date which is stated on the carton and blister after 'EXP'. The expiry date refers to the last day of that month
• Store below 30°C
• Keep the container tightly closed in order to protect from moisture
• 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

Contents of the pack and other information

What Dolutegravir contains

TAPIVIR 50: Each tablet contains 50 mg of dolutegravir (as sodium salt)

TAPIVIR DT 10: Each tablet contains 10 mg of dolutegravir (as sodium salt)

What Dolutegravir looks like and contents of the pack

TAPIVIR 50: Pink, round, film-coated tablets with "DTG 50" embossed

TAPIVIR DT 10: White to off-white, round, dispersible tablets with strawberry flavor

Available in blister packs and bottles containing 10, 30, 60, or 90 tablets

Marketing Authorization Holder and Manufacturer

Taj Pharmaceuticals Limited
GIDC Formulation Plant
Vapi, Gujarat 396195
India