---

Generated Narrative: Composition

status: FINAL

type: Package Leaflet (#100000155538)

date: 2022-04-29 01:28:17+0000

author: Organization/cfsb1651149636159 "ViiV Healthcare BV"

title: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets

confidentiality: U

Attesters

-	Mode	Time
*	Official (CompositionAttestationMode#official)	2002-08-01 01:28:17+0000

---

Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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. See section 4.

What in this leaflet

1. What Dovato is and what it is used for
2. What you need to know before you take Dovato
3. How to take Dovato
4. Possible side effects
5. How to store Dovato
6. Contents of the pack and other information

1. What Dovato is and what it is used for Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.2. What you need to know before you take Dovato Do not take Dovato

• if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).

How to take Dovato

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure

• The recommended dose of Dovato is one tablet once a day.
• If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them,so it is very important to talk to your doctor about any changes in your health

5. How to store Dovato

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 bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information What Dovato contains

• The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
• The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
• This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.

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Additional Document Content

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name: GLAXO WELLCOME, S.A.

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TargetSpecies

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Manufacturers

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Manufacturers

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