Patient Medication Information: uses, side effects, how to take - Sandoz Dolutegravir
What is Sandoz Dolutegravir used for?
Sandoz Dolutegravir is used for treatment of HIV-1 (Human Immunodeficiency Virus) infection in adults and children at least 6 years of age and weighing ≥40 kg.
Sandoz Dolutegravir is a type of anti-HIV medicine called an integrase inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
Sandoz Dolutegravir is used in combination with other anti-HIV medicines. To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your healthcare professional tells you otherwise.
How does Sandoz Dolutegravir work?
Sandoz Dolutegravir blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that Sandoz Dolutegravir blocks is called HIV integrase. This helps control HIV infection.
When used with other anti-HIV medicines, Sandoz Dolutegravir may do two things:
- 1. It may reduce the amount of HIV in your blood. This is called your “viral load”.
-Reducing the amount of HIV in the blood may keep your immune system healthy.
-This in turn, can help your immune system to fight infection.
- 2. It may also increase the number of white blood cells, called CD4 (T) cells, that help fight the virus (HIV).
What are the ingredients in Sandoz Dolutegravir?
Medicinal ingredients: dolutegravir (as dolutegravir sodium)
Non-medicinal ingredients:
Sandoz Dolutegravir tablets: Ethylene glycol, Ferric oxide red, Ferric oxide yellow, Mannitol, Microcrystalline cellulose, Povidone, Sodium starch glycolate, Sodium stearyl fumarate, Titanium dioxide and Vinyl alcohol graft copolymer.
Sandoz Dolutegravir comes in the following dosage forms:
film-coated tablets: 50 mg
Do not use Sandoz Dolutegravir if:
- you are allergic to dolutegravir or any of the other ingredients in Sandoz Dolutegravir (see What are the ingredients in Sandoz Dolutegravir?)
- you are taking dofetilide to treat heart conditions, or fampridine (also known as dalfampridine) to treat multiple sclerosis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Dolutegravir. Talk about any health conditions or problems you may have, including if you:
- have liver problems, including hepatitis B or C
- have a history of depression or other mental health problems
- have any other medical condition
Other warnings you should know about:
Serious Liver Problems: Serious liver problems including liver injury and liver failure have been seen in patients taking medicines containing dolutegravir. In some cases the liver injury has led to a liver transplant. While you are being treated with Sandoz Dolutegravir your healthcare professional will monitor you closely for any signs of liver problems. See the Serious Side Effects and What To Do About Them table, below for information on this and other serious side effects.
Pregnancy and Breastfeeding:
- You should not take Sandoz Dolutegravir if you are pregnant or planning to become pregnant.
- Your healthcare professional will ask you to do a pregnancy test before starting treatment with Sandoz Dolutegravir to make sure you are not pregnant.
- If you are a woman who is able to get pregnant you must use a reliable method of birth control while you are taking Sandoz Dolutegravir. Talk to your healthcare professional about the birth control options that are right for you.
- Sandoz Dolutegravir can harm your unborn baby. If you take Sandoz Dolutegravir during the first 12 weeks of your pregnancy your baby is at risk for a type of birth defect called a neural tube defect, such as spina bifida, where the spinal cord has not formed correctly.
- Tell your healthcare professional immediately if you become pregnant while taking Sandoz Dolutegravir. If you take Sandoz Dolutegravir while you are pregnant, talk to your healthcare professional about enrolling in the Antiretroviral Pregnancy Registry.
Talk to your healthcare professional if you are breastfeeding or plan to breastfeed. Women who are HIV positive should not breastfeed because HIV infection can pass into
- breastmilk. It is not known if Sandoz Dolutegravir can pass into breastmilk. You should not breastfeed while you are taking Sandoz Dolutegravir.
Passing HIV to Others: Sandoz Dolutegravir will not stop you from passing HIV to others, although this risk is lower if you take your HIV medicine as instructed by your healthcare professional. You should take steps to avoid this by:
- using condoms when you have oral or penetrative sex,
- not reusing or sharing needles, syringes, or other injection equipment.
Immune System Changes:
- Changes to your immune system, called Immune Reconstitution Inflammatory Syndrome, can happen when you start taking medicines for HIV infection. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
- Autoimmune disorders, when the immune system attacks healthy body tissue, can also happen after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders can happen many months after you start taking Sandoz Dolutegravir.
- See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.
Blood Tests: Sandoz Dolutegravir can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Diving and Using Machines: Use caution when driving and using machines until you know how you respond to Sandoz Dolutegravir.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sandoz Dolutegravir:
- metformin, to treat diabetes
- medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Sandoz Dolutegravir, or for at least 2 hours after you take it.
calcium and iron supplements. Do not take a calcium or iron supplement during the 6 hours before you take Sandoz Dolutegravir, or for at least 2 hours after you take it. If you take Sandoz Dolutegravir with food, you can take a calcium or iron supplement at the same time as Sandoz Dolutegravir.
- etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
- rifampin, to treat tuberculosis (TB) and other bacterial infections
- phenytoin and phenobarbital, to treat epilepsy
- oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder
- St. John’s wort, (Hypericum perforatum), a herbal remedy to treat depression
How to take Sandoz Dolutegravir:
Always take Sandoz Dolutegravir exactly as your healthcare professional has told you to. Check with your healthcare professional if you're not sure. Do not change your dose or stop taking Sandoz Dolutegravir without talking with your healthcare professional.
Sandoz Dolutegravir tablets can be taken with or without food.
Be sure to keep a supply of your anti-HIV medicines. When your Sandoz Dolutegravir supply starts to run low, get more from your healthcare professional or pharmacy. Do not wait until your medicine runs out to get more.
Usual dose:
Adults:
- The usual dose is one 50 mg tablet, once a day.
- For adults with HIV infection that is resistant to other HIV medicines similar to Sandoz Dolutegravir, the usual dose is one 50 mg tablet, twice a day.
Children at least 6 years of age and weighing ≥40 kg: Your healthcare professional will decide on the correct dose of Sandoz Dolutegravir for your child, depending on the weight of the child.
The tablet(s) should be swallowed whole with some liquid. To reduce the risk of choking, do not let your child swallow more than one tablet at a time.
Children should see their healthcare professional regularly because their Sandoz Dolutegravir dose may change as they get older or gain weight.
Antacid medicines
Antacids, to treat indigestion and heartburn, can stop Sandoz Dolutegravir from being absorbed into your body and make it less effective.
Do not take an antacid during the 6 hours before you take Sandoz Dolutegravir, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Sandoz Dolutegravir. Talk to your healthcare professional for further advice on taking acid-lowering medicines with Sandoz Dolutegravir.
Calcium or iron supplements
Calcium or iron supplements can stop Sandoz Dolutegravir from being absorbed into your body and make it less effective.
Do not take a calcium or iron supplement during the 6 hours before you take Sandoz Dolutegravir, or for at least 2 hours after you take it. If you take Sandoz Dolutegravir with food, then you can take calcium and iron supplements at the same time as Sandoz Dolutegravir.
Overdose:
If you think you, or a person you are caring for, have taken too much Sandoz Dolutegravir, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose, take it as soon as you remember, but if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. DO NOT take a double dose of your medicine to make up for a missed dose.
What are possible side effects from using Sandoz Dolutegravir?
These are not all the possible side effects you may have when taking Sandoz Dolutegravir. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea
- headache
- trouble sleeping (insomnia), abnormal dreams
- nausea, vomiting
- stomach pain, stomach discomfort
- gas
- lack of energy (fatigue)
- rash
- itching
- joint pain, muscle pain
- weight gain
- dizziness
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| UNCOMMON | |||
Allergic reaction: skin rash, fever, lack of energy, swelling of the mouth or face causing difficulty in breathing, muscle or joint aches | ✓ | ||
| Liver problems (Hepatitis): nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs, yellowing of the skin or whites of the eyes, dark or tea coloured urine, pale coloured stools/ bowel movements | ✓ | ||
Mental health problems: depression (feelings of deep sadness and unworthiness, lack of interest in activities, fatigue, loss of appetite), anxiety, suicidal thoughts and behaviours | ✓ | ||
| RARE | |||
Liver failure: nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs, yellowing of the skin and the whites of the eyes, dark or tea coloured urine, pale coloured stools/bowel movements. | ✓ | ||
| FREQUENCY NOT KNOWN | |||
| Immune Reconstitution Inflammatory Syndrome: fever, redness, rash or swelling, fatigue, joint or muscle pain, numbness, tingling, or weakness beginning in | |||
| the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heartbeat, yellowing of the skin or eyes, anxiety and irritability accompanied by tremor of your hands or fingers, muscle weakness in your hips, thighs, shoulders, upper arms and neck | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store Sandoz Dolutegravir 50 mg at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
If you want more information about Sandoz Dolutegravir:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
- products/drug-product-database.html; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.
Last Revised: APR 29, 2026
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