Active ingredient
- emtricitabine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/03/261/003 .
Emtriva 10 mg/ml oral solution
Package leaflet: Information for the user
Emtriva 10 mg/mL oral solution
emtricitabine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Emtriva is and what it is used for
2. What you need to know before you take Emtriva
3. How to take Emtriva
4. Possible side effects
5. How to store Emtriva
6. Contents of the pack and other information
1. What Emtriva is and what it is used for
Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants aged 4 months and over. Emtriva oral solution is particularly suitable for people who have difficulty in swallowing Emtriva hard capsules.
Emtriva contains the active substance emtricitabine. This active substance is an antiretroviral medicine which is used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) which works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the HIV virus to reproduce itself. Emtriva may lower the amount of HIV in the blood (viral load). It may also help to increase the number of T cells called CD4 cells. Emtriva should always be combined with other medicines to treat HIV infection.
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
This medicine is not a cure for HIV infection. While taking Emtriva you may still develop infections or other illnesses associated with HIV infection.
2. What you need to know before you take Emtriva
Do not take Emtriva
Warnings and precautions
Children and adolescents
Do not give Emtriva to infants under 4 months of age.
Other medicines and Emtriva
You should not take Emtriva if you are already taking other medicines that contain emtricitabine or lamivudine, which are also used to treat HIV infection, unless otherwise directed by your doctor.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not stop your treatment without contacting your doctor.
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 or pharmacist for advice before taking this medicine.
If you have taken Emtriva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Driving and using machines
Emtriva may cause dizziness. If you experience dizziness while taking Emtriva, do not drive and do not use any tools or machines.
Emtriva oral solution contains:
Sunset yellow (E110) may cause allergic reactions. The methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). This medicine contains 36 mg of sodium (main component of cooking/table salt) per 24 mL dose.This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine also contains 480 mg propylene glycol per 24 mL (maximum single dose) which is equivalent to a maximum of 12 mg/kg/day.
3. How to take Emtriva
The recommended dose is:
Make sure that you understand how to measure and give the right amount of oral solution according to the weight of the person being treated. Use the measuring cup provided in the carton to measure the correct dose. The cup has lines to indicate each mL of solution.
If you are unsure how much Emtriva you should take ask your doctor or pharmacist.
Emtriva is also available as hard capsules. These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules. The blood levels obtained after taking one Emtriva 200 mg hard capsule are similar to those obtained after taking 24 mL of the oral solution. If you would like to switch from taking Emtriva oral solution to Emtriva hard capsules, please talk to your doctor.
If you take more Emtriva than you should
If you accidentally take too much Emtriva oral solution, contact your doctor or nearest emergency department for advice. Keep the oral solution bottle with you so that you can easily describe what you have taken.
If you forget to take Emtriva
It is important not to miss a dose of Emtriva.
If you do miss a dose of Emtriva within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
If it is almost time (less than 12 hours) for your next dose anyway, forget about the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.
If you are sick (vomit)
If it’s less than an hour since you took Emtriva, take another dose. You do not need to take another dose if you were sick more than an hour after taking Emtriva.
If you stop taking Emtriva
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor about any of the following side effects:
Most frequent side effects
The following side effects are very common (these can affect at least 10 in every 100 patients):
Other possible side effects
The following side effects are common (these can affect up to 10 in every 100 patients):
Tests may also show:
The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Other possible effects
Children given emtricitabine also experienced changes in skin colour including darkening of the skin in patches, very commonly and anaemia (low red blood cell count), commonly. If the production of red blood cells is reduced, a child may have symptoms of tiredness or breathlessness.
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:
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
Malta
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Emtriva
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 bottle and carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C) until opened.
After opening the bottle, do not store above 25°C. The content of the bottle should be used up within 45 days of opening. It is advised to write the date of removal from the refrigerator on the package.
If there is any solution left in the bottle after 45 days, this should be disposed of in accordance with local requirements or returned to the pharmacy.
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 Emtriva contains
What Emtriva looks like and contents of the pack
Emtriva oral solution is a clear, orange to dark orange solution that comes in bottles containing 170 mL with a measuring cup.
Emtriva is also available as hard capsules. These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules. There is a separate Package Leaflet for Emtriva 200 mg hard capsules.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 06/2020.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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