Taliphio 25 mg Film-Coated Tablets

TALIPHIO is indicated in combination with other antiretroviral medicines for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1).

Do not take TALIPHIO:

• if you are hypersensitive (allergic) to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of TALIPHIO (listed in section 6)
• in combination with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, dexamethasone (except as a single dose treatment) rifabutin, rifampicin, rifapentine, St. John’s Wort, proton-pump inhibitors (PPIs) such as lansoprazole, dexlansoprazole, omeprazole, rabeprazole, pantoprazole and esomeprazole as co-administration may result in loss of therapeutic effect of TALIPHIO.

Warnings and precautions

Special care should be taken with TALIPHIO:

• if you have pain in joints (osteonecrosis)
• if you have diabetes or have galactose intolerance
• if you have hepatitis B or C
• if you have been diagnosed with a liver disease
• if you have been diagnosed with a kidney disease or have abnormal kidney function
• if you have any HIV-1 mutations

Tell your doctor or health care provider if you develop any of the following symptoms when taking TALIPHIO:

• If you develop changes in body fat as such changes have been seen in some patients taking TALIPHIO. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen.
• Clinical worsening of a known condition or the appearance of a new condition after initiating antiretroviral therapy (immune reconstitution syndrome).
• TALIPHIO does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Therefore, it is important to continue to take appropriate precautions to prevent passing HIV to others. Even if you are receiving treatment for HIV, you are still at risk of contracting other infections and other complications of the HIV infection. Therefore, you should remain under close observation by your doctor.
• An increase in weight or blood lipid tests.
• Your baby has abnormal blood tests or is behaving abnormally.
• Abnormal liver blood tests or symptoms associated with a condition called lactic acidosis such as nausea, vomiting, stomach pain, weight loss and feeling tired.
• If you have existing or develop any infections. Regular monitoring of your CD4 count is required.

Children and adolescents

The safety of TALIPHIO in children younger than the age of 18 is not known. TALIPHIO is therefore not recommended for patients younger than 18 years of age.

Other medicines and TALIPHIO

Always tell your health care provider if you are taking any other medicines. (This includes all complementary or traditional medicines).

The following medicines or substances may increase or decrease blood levels and increase the risk of adverse events associated with TALIPHIO, please inform your doctor if you are taking any of the following medicines before you start treatment with TALIPHIO:

• atazanavir and cobicistat
• tenofovir alafenamide
• atazanavir and ritonavir
• darunavir and ritonavir
• lopinavir and ritonavir
• tipranavir and ritonavir
• dolutegravir
• rilpivirine
• efavirenz
• maraviroc, nevirapine, raltegravir
• oxcarbazepine, phenytoin, phenobarbital
• carbamazepine
• sertraline
• St. John’s wort
• ciclosporin
• norgestimate
• midazolam
• didanosine
• delavirdine, efavirenz, etravirine, nevirapine
• lopinavir, ritonavir, fosamprenavir, saquinavir, tipranavir, indinavir, nelfinavir
• antacids containing magnesium, aluminium or calcium
• ketoconazole, fluconazole, itraconazole, isavuconazole, posaconazole, voriconazole
• rifabutin, rifampicin, rifapentine
• ledipasvir, sofosbuvir, velpatasvir, voxilaprevir
• clarithromycin, erythromycin, troleandomycin
• dexamethasone
• omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole
• famotidine, cimetidine, nizatidine, ranitidine
• paracetamol.

Current antiretroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood, other bodily secretion or sexual contact. Appropriate precautions to prevent transmission of HIV should continue to be employed. TALIPHIO may reduce the effect of the following medicine:

• methadone.

Do not share medicines prescribed for you with any other person. Always take TALIPHIO exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose of TALIPHIO is one tablet once a day with meals.

Your doctor will tell you how long your treatment with TALIPHIO will last. Do not stop treatment early. If you have the impression that the effect of TALIPHIO is too strong or too weak, tell your doctor or pharmacist.

If you take more TALIPHIO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take TALIPHIO

Do not take a double dose to make up for the forgotten individual doses.

TALIPHIO can have side effects. Not all side effects reported for TALIPHIO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TALIPHIO, please consult your health care provider for advice.

If any of the following happens, stop taking TALIPHIO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all serious side effects. If you have them, you may have had a serious reaction to TALIPHIO. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache, dizziness, abnormal dreams
• nausea, diarrhoea, vomiting, passing of gas, upper stomach pain
• feeling tired
• abnormal blood results of the liver and pancreas
• depression
• difficulty falling asleep.

Less frequent side effects:

• worsening of a known condition or the appearance of a new condition after initiating TALIPHIO
• inflammation of the liver
• abnormal blood tests
• decreased appetite
• sleep disorders, depressed mood
• symptoms such as feeling weak, tired, pale or yellowish skin, cold hands and feet (anaemia)
• feeling of indigestion
• joint pain.

Side effects with unknown frequency:

• increased creatinine blood levels
• change in total cholesterol, LDL- cholesterol, HDL - cholesterol and triglycerides associated with redistribution of body fat
• change in weight and blood sugar levels.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of TALIPHIO.

Store at or below 30 °C. Store all medicines out of reach of children. Store in the original container. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).