Edurant 25 mg Film-Coated Tablets

EDURANT is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called non - nucleoside reverse transcriptase inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. EDURANT is always used in combination with other HIV medicines to treat patients 12 years of age and older who are infected by HIV and who have never been treated before with HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

Do not take EDURANT • If you are allergic (hypersensitive) to rilpivirine or any of the other ingredients of EDURANT. • EDURANT is not for use in children aged less than 12 years because safety and efficacy have not been proven in this age group. Do not take EDURANT with any of the following medicines as they may affect the way EDURANT or the other medicine works. Some of these medicines may be obtained without a prescription and some of these may be available under other names. It is important that you carefully read the package leaflets that are provided with these medicines: • Non - nucleoside reverse transcriptase inhibitors (NNRTIs) (HIV medicines) • rifampicin and rifapentine (medicines to treat some bacterial infections such as tuberculosis) • carbamazepine, oxcarbazepine, phenobar bital, phenytoin (medicines to treat epilepsy and prevent seizures) • dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose • products that contain St John’s Wort ( Hypericum perforatum ) (a n herbal product used for depression) • omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole (medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) If you are taking any of thes e, ask your doctor about alternatives.

Warnings and precautions

EDURANT must be taken together with other antiretrovirals as prescribed by your doctor and with a meal. EDURANT is not a cure for HIV infection. It is part of a treatment reducing the amount of virus in the blood. EDURANT does not reduce the risk of passin g HIV to others through sexual contact or contamination with blood or other bodily secretions. Therefore, you must continue to use appropriate precautions (e.g. a condom) to lower the chance of sexual contact with any body fluids such as semen, vaginal sec retions or blood. People taking EDURANT may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor. Make sure that you check the following points and tell your doctor if any of these a pply to you. • Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take EDURANT. • Tell your doctor if you notice changes in bod y shape or fat. A gain, loss or redistribution of body fat may occur if you take a combination of HIV medicines. These changes can happen in patients taking HIV medicine. The changes may include an increased amount of fat in the upper back and neck, breast and around the back, chest and stomach area. Loss of fat from the legs, arms and face may also happen. The exact cause and long - term health effects of these conditions are not known. • Tell your doctor immediately if you notice any symptoms of infections. A condition called Immune Reconstitution Inflammatory Syndrome can happen in some patients with advanced HIV infection (AIDS) when HIV treatment is started. In some patients with advanced HIV - infection and a history of opportunistic infections, signs and sy mptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

Do not share medicines prescribed for you with any other person. Always use EDURANT exactly as your doctor has told you. You must check with your doctor or pharmacist if you are not sure. Instructions for proper use in adults and children (12 to less than 18 years of age) : The usual dose of EDURANT is one tablet once a day. Always take EDURANT with a meal. A meal is important to get the right medicine blood levels in your body. A protein drink alone does not replace a meal. Do not change your dose of EDURANT without first talking to your doctor. See your doctor regularly while taking EDURANT. • When your supply of EDURANT starts to run low, get more from your doctor or pharmacy. It is important not to run out of EDURANT. The amount of HIV in your blood may increase if the medicine is stopped even for a short time. • If you take an antacid (a medicine to treat heartburn from acid reflux such as aluminium/magnesium hydroxide , calcium carbonate), take the antacid either at least 12 hours before or at least 4 hours after EDURANT. If you take an H 2 - receptor antagonist (medicines used to treat stomach ulcers, heartburn or acid reflux disease such as cimetidine, famotidine, nizati dine or ranitidine), take the H 2 - receptor antagonist at least 12 hours before or at least 4 hours after EDURANT. • If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day. When you stop taking rifabutin, take one tablet of EDURANT once a day. Talk to your doctor or pharmacist if you are not sure . Do not stop using EDURANT without talking to your doctor first. HIV therapy may increase your sense of well - being. Even if you feel better, do not stop taking EDURANT or your other HIV medicines. Doing so could increase the risk of the virus developing resistance. Talk to your doctor first. Removing the child - resistant cap The plastic bottle comes with a child - resistant cap and should be opened as fo llows: - Push the plastic screw cap down while turning it counter clockwise. - Remove the unscrewed cap. If you take more EDURANT than you should

EDURANT can have side effects. Frequent side effects: • decreased appetite • depression • difficulty falling asleep (insomnia), abnormal dreams, sleep disorders • headache • stomach pain, nausea • rash • tiredness • changes in your routine liver tests Less frequent side effects: • depressed mood • dizziness, drowsiness • vomiting, stomach discomfort Tell your doctor right away if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet. If the any of the side effects do not go away or worsen, get medical help. Tell your doctor rig ht away about these or any other unusual symptoms. If the condition does not go away or worsens, get medical help. Not all side effects reported for EDURANT are included in this leaflet. Should your general health worsen while taking EDURANT, please consu lt your healthcare provider for advice. R eporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/index/8 . By reporting side effects, you can help provide more information on the safety of EDURANT.

Store at or below 30 °C in the original bottle in order to protect from light. Keep the bottle tightly closed. Keep in original packaging until required for use. Do not use EDURANT after the expiry date which is stated on the label. Do not store in a bathroom. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
STORE ALL MEDICINES OUT OF THE REACH OF CHILDREN.