INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). INTELENCE works by reducing the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.
INTELENCE is used to treat adults who are infected by HIV and who have used other anti-HIV medicines before. INTELENCE can be used by patients infected with HIV that is resistant to other NNRTIs.
INTELENCE must be taken in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.
Ask your doctor if you have any questions about why INTELENCE has been prescribed for you.
This medicine is available only with a doctor's prescription.
Do not take INTELENCE:
Do not take INTELENCE:
Do not combine INTELENCE with any of the following medicines:
If you are taking any of these, ask your doctor for advice.
There are other medicines that you need to be careful of when taking INTELENCE (see Taking other medicines).
Take special care with INTELENCE:
INTELENCE is not a cure for HIV infection. It is part of a treatment reducing the amount of virus in the blood.
INTELENCE does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Therefore, you must continue to use appropriate precautions (a condom or other barrier method) to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood.
People taking INTELENCE may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor and to monitor your health while taking INTELENCE.
INTELENCE is not for use in children or adolescents, because it has not been sufficiently studied in patients under 18 years of age. INTELENCE has only been used in a limited number of patients aged 65 years or older. If you belong to this age group, discuss the use of INTELENCE with your doctor.
Tell your doctor if you have or have had any medical conditions, especially the following:
Tell your doctor immediately if you are pregnant or breast-feeding, or intend to become pregnant or breast-feed.
HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV
During pregnancy and breast-feeding you should not take INTELENCE, unless it is specifically approved by your doctor.
If you have not told your doctor about any of the above, tell them before you start treatment with INTELENCE.
INTELENCE might interact with other medicines. Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
INTELENCE can be combined with most other anti-HIV medicines belonging to another class. However, some combinations are not recommended. In other cases, increased monitoring and/or a change in the dose of the medicine may be needed. Therefore, always tell your doctor which other anti-HIV medicines you take. Carefully follow your doctor's instructions, on which medicines can be combined.
In particular, tell your doctor or pharmacist if you are taking any of the following:
Always take INTELENCE exactly as your doctor has told you. You must check with your doctor if you are not sure.
The usual dose of INTELENCE is 200 mg twice daily.
If you are taking INTELENCE 100 mg tablets:
In the morning, take two 100 milligram INTELENCE tablets, following a meal.
In the evening, take two 100 milligram INTELENCE tablets, following a meal.
If you are taking INTELENCE 200 mg tablets:
In the morning, take one 200 milligram INTELENCE tablet, following a meal.
In the evening, take one 200 milligram INTELENCE tablet, following a meal.
Make sure that you always have enough INTELENCE available so that you don't run out. For example in case you cannot return home, need to travel or stay in a hospital.
The plastic bottle comes with a child resistant cap and should be opened as follows:
If you notice within 6 hours, you must take the tablets immediately. Always take the tablets following a meal. If you notice after 6 hours, then skip the dose and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.
If you think you or anybody else has taken too much INTELENCE, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
Do not stop taking INTELENCE without talking to your doctor first
HIV therapy may increase your sense of well being. Even if you feel better, do not stop taking INTELENCE or your other anti-HIV medicines. Doing so could increase the risk of the virus developing resistance. Talk to your doctor first.
Be sure to keep all your doctor's appointments so your progress can be checked.
Your doctor will want to do some blood, urine and other tests from time to time to check on your progress.
Be sure to follow up your doctor's instructions about other medicines you should take, and other things you should do.
Ask your doctor or pharmacist if you have any questions.
Tell any other doctors and pharmacists who are treating you that you are taking INTELENCE. If you are undergoing anaesthesia, tell your anaesthetist that you are taking INTELENCE.
If you are about to be started on any new medicines, tell your doctor or pharmacist that you are taking INTELENCE.
If you become pregnant while taking INTELENCE, tell your doctor immediately.
If you have any further questions on the use of this product, ask your doctor.
Driving and using machines
No studies on the effects of INTELENCE on the ability to drive and use machines have been performed. However, you should take into account the possible side effects of INTELENCE before considering driving or using machines.
Like all medicines, INTELENCE can have side effects. Some of these effects may be serious.
Tell your doctor or pharmacist if you do not feel well while you are being treated with INTELENCE.
When treating HIV infection, it is not always easy to identify what side effects are caused by INTELENCE, which are caused by other medicines you are taking, or which are caused by the HIV infection itself.
The most common side effects are:
Other side effects of INTELENCE, which can be serious, include muscle pain, tenderness or weakness.
Some side effects are typical for combination anti-HIV therapy. These are:
If you experience any of these side effects and they worry you, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tell your doctor if you notice signs or symptoms of infections, such as a fever or rashes. Some people with HIV who have had infections in the past may experience a return of symptoms soon after taking anti-HIV medicines.
Other side effects not listed above may also occur in some people.
INTELENCE tablets should be kept out of reach of children, in a location where the temperature stays below 30°C.
INTELENCE tablets should be stored in the original bottle. Keep the bottle tightly closed in order to protect from moisture. The bottle contains 3 little pouches (desiccants) to keep the tablets dry. These pouches should stay in the bottle all the time and are not to be eaten.
INTELENCE 100 mg tablets are white to off-white, oval tablet, with "T125" on one side and "100" on the other side. Each plastic bottle contains 120 tablets. The 100 mg tablets are no longer marketed.
INTELENCE 200 mg tablets are white to off-white, biconvex, oblong tablet, with "T200" on one side. Each plastic bottle contains 60 tablets.
What INTELENCE 100 mg tablets contain
The active substance is etravirine. Each 100 mg tablet of INTELENCE contains 100 mg of etravirine.
The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate and lactose monohydrate.
What INTELENCE 200 mg tablets contain
The active substance is etravirine. Each 200 mg tablet of INTELENCE contains 200 mg of etravirine.
The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate.