Teevir 300 mg/600 mg/200 mg Film-Coated Tablets

Teevir is used to treat Human Immunodeficiency Virus (HIV-1) infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Teevir can be given alone or in combination with other antiretrovirals.

Do not take Teevir:

• If you are allergic to tenofovir disoproxil fumate or emtricitabine or efavirenz or any of the other ingredients contained in the tablets (See “What Teevir contains”, for a complete list of ingredients)
• If you have severe liver disease
• If you are currently taking any of the following medicines:
• astemizole (used to treat hay fever and other allergies)
• bepridil (used to treat heart disease)
• cisapride (used to treat heart burn)
• ergot alkaloids (used to treat migraines and cluster headaches)
• midazolam and triazolam (used to help you sleep)
• pimozide (used to treat certain mental conditions)
• St John’s Wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
• voriconazole (used to treat fungal infections)
• If you have kidney problems or are undergoing kidney dialysis treatment
• If you are pregnant or planning to become pregnant
• If you are breast-feeding your baby
• If you are younger than 18 years of age as safety and efficacy has not been established in paediatric and adolescent patients

Do not take Teevir if you are already taking lamivudine/zidovudine, lamivudine, abacavir sulphate/lamivudine, abacavir sulphate/lamivudine/zidovudine, tenofovir disoproxil fumarate, efavirenz, emtricitabine or adefovir dipivoxil because these medicines contain the same or similar active ingredients.

Warnings and precautions

Take special care with Teevir:

• If you have bone problems, including previous bone breaks
• If you have liver problems, including hepatitis B infection
• If you have ever had mental illness or are using medicines for mental illness
• If you have ever had seizures or are taking medicines for seizures
• If you are older that 65 years of age
• If you are taking other medicines, as Teevir may interact with these other medicines
• If you use medicines that may affect your kidney function since use of such medicines in combination with Teevir will require careful monitoring of your kidney function. Speak to your doctor about this.
• If you have serious nervous system and psychiatric symptoms

Teevir will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. Teevir will not keep you from spreading HIV to other people.

To protect other people from becoming infected with HIV:

• use a condom when you have oral or penetrative sex
• do not risk blood transfer – for example, do not share needles

Children and adolescents

Do not give Teevir to children who are younger than 18 years of age as safety and efficacy has not been established in paediatric and adolescent patients.

Other medicines and Teevir

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines).

The following medicines should not be taken with Teevir:

• Other products which contain tenofovir disoproxil fumarate, efavirenz, emtricitabine, or lamivudine either alone or as combination pills. Teevir should not be used with those medicines because they contain the same or similar active ingredients as found in Teevir.
• Adefovir dipivoxil for the treatment of Hepatitis B infection due to the increased risk of kidney damage if combined with Teevir.
• Medicines that contain didanosine (another antiretroviral). Tenofovir disoproxil fumarate (a component of Teevir) may increase the amount of didanosine in your blood, and the risk of side effects.
• Atazanavir sulphate or atazanavir/ritonavir in a combination pill. These medicines may increase the amount of tenofovir disoproxil fumarate (a component of Teevir) in the blood, which could result in more side effects.
• St John’s Wort
• Astemizole, cisapride, midazolam, triazolam, or ergot derivatives as efavirenz (a component of Teevir) could prevent break down of these medicines and may cause side effects such as abnormal heart rhythm and breathing problems.
• Other medicines used for HIV infection: amprenavir, indinavir, lopinavir/ritonavir combination pill, ritonavir, or saquinavir
• Medicines used to treat fungal infections (antifungals): Itraconazole and ketoconazole since no dosage recommendations are available when used in combination with Teevir.
• Voriconazole
• Medicines called calcium channel blockers could be affected by Teevir if taken together. These include diltiazem, and other calcium channel blockers such as verapamil, felodipine, nifedipine and nicardipine.
• Medicines such as cidofovir, acyclovir, valacyclovir, ganciclovir and valganciclovir. These compete for excretion by the kidney.
• Selective serotonin reuptake inhibitors (SSRI’s) for the treatment of depression.
• Medicines used to lower blood fats (also called statins): atorvastatin, simvastatin and pravastatin. Teevir can reduce the amount of statins in your blood.
• Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin and phenobarbital. Teevir can reduce the amount of anticonvulsant medicine in your blood. Carbamazepine can reduce the amount of efavirenz, one of the components of Teevir, in your blood.
• Medicines used to treat bacterial infections, including tuberculosis and AIDs-related infections: clarithromycin, rifabutin and rifampicin.
• Indinavir (another antiretroviral).
• Hormonal contraceptives (e.g. the pill or contraceptive implant). Because the potential for efavirenz, one of the components of Teevir, to interact with hormonal contraceptives has not been fully studied, a reliable method of barrier contraception (e.g. a condom) should always be used in addition to the hormonal contraceptive (see Pregnancy and breast-feeding).
• Methadone, a medicine used to treat opiate addiction.
• Sertraline, a medicine used to treat depression.

Teevir with food and drink

Teevir must be swallowed whole with water on an empty stomach.

Do not share medicines prescribed for you with any other person.

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

The usual dose is one tablet taken once daily without food. Take Teevir at bedtime which will make some side effects less bothersome.

Your doctor will tell you how long your treatment with Teevir will last.

Do not run out of Teevir tablets. The virus in your blood may increase and the virus may become harder to treat.

If you have the impression that the effect of Teevir is too strong or too weak, tell your doctor or pharmacist.

If you take more Teevir than you should

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

If you forget to take Teevir

Do not take a double dose to make up for forgotten individual doses. Do not miss a dose of Teevir. If you miss a dose of Teevir take it as soon as you remember.

If you stop taking Teevir

You should not stop treatment unless your doctor instructs you to. When your Teevir supply starts to run low, get more from your healthcare provider or pharmacy. This is very important as the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Teevir and become harder to treat.

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

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

• Swelling of the mouth, face, lips or tongue
• Difficulty in swallowing or breathing

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Teevir. You may need urgent medical attention or hospitalisation.

Lactic acidosis (build up of an acid in the blood)

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• You feel weak and tired
• You have unusual muscle pain
• You have stomach pain with nausea and vomiting
• You feel cold especially in your arms and legs
• You feel dizzy and lightheaded
• You have a fast and irregular heartbeat

These could be a sign of lactic acidosis. Lactic acidosis can be a medical emergency and may need to be treated in hospital.

Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis)

Call your doctor right away if you get any of the following signs of liver problems:

• Yellow discolouration of the skin and the white part of your eyeballs
• Darkening of your urine
• Your bowel movements turn lighter in colour
• You feel sick to your stomach (nausea)
• You have stomach pain

Worsening of hepatitis B virus infection

Teevir tablets are not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (HBV) infection and take Teevir tablets, your HBV may get worse (flare-up) if you stop taking Teevir tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

Serious psychiatric problems

Some patients may experience severe depression, strange thoughts, and thoughts of suicide or angry behaviour while taking Teevir. Contact your doctor right away if you think you are having these psychiatric symptoms.

Kidney problems

Should you notice blood in your urine, have difficulty or painful urination, and pain in the lower back, contact your doctor immediately.

Other side-effects include:

• Headache
• Asthenia (low muscle strength)
• Increased cough
• Rhinitis (stuffy nose)
• Nausea
• Diarrhoea
• Vomiting
• Dizziness
• Problems concentrating
• Sleepiness
• Inability to sleep
• Rash
• Itch
• Increased sweating
• Fatigue (lack of energy)
• Pain
• Low bone mineral density

• Neuritis (inflammation of a nerve causing pain)
• Paraesthesia (pins and needles)
• Peripheral neuropathy (weakness, numbness and pain from nerve damage, usually in the hands and feet)
• Depression
• Abnormal dreams
• Abdominal pain (belly ache)
• Dyspepsia (indigestion)
• Changes in skin colour
• Arthralgia (joint pain)
• Myalgia (muscle pain)
• Anorexia (loss of appetite)

The following side effects are reported but the frequency is not known:

• Neutropenia (low number of white blood cells)
• Anaemia (low number of red blood cells)
• Lactic acidosis (low acidity in the bloodstream)
• A high level of a certain type of fat (triglycerides) in the blood
• Hyperglycaemia (high blood sugar levels)
• Blood in urine
• Allergic reactions
• Increased levels of phosphate in the blood
• Anxiety
• Chest pain
• Lung infection
• Difficulty breathing
• Pancreatitis (inflammation of the pancreas causing belly ache)
• Inflammation of the liver
• Back pain
• Kidney problems
• Fever
• Weight loss
• Weight gain
• Problems with balance and coordination
• Fits
• Tremor (shaking)
• Amnesia (memory loss)
• Increased appetite
• Confusion
• Impotence (loss of male sexual ability)
• Changes in sexual drive
• Neuralgia (nerve pain)
• Speech problems
• Vertigo (spinning sensation)
• Apathy (lacking emotion)
• Emotional behaviour
• Seeing things that aren’t there
• Problems with eye sight
• Ringing or buzzing noise in the ears
• Reddening of the skin
• Palpitations (fast, irregular heartbeat)
• Tachycardia (fast heartbeat)
• Asthma
• Sinusitis
• Gastritis (stomach inflammation)
• Gastro-enteritis (stomach flu)
• Gastro-oesophageal reflux (stomach acid irritates the food pipe lining)
• Constipation
• Malabsorption (poor absorption of nutrients)
• Change in sense of taste
• Acne
• Hair loss
• Eczema (itchy inflammation of the skin)
• Infection of the pockets from which hair grows (follicles)
• Seborrhea (scaly patches and red skin, mainly on the scalp)
• Skin peeling
• Erythema multiforme (skin or mouth lesions that have a pink-red centre surrounded by a pale ring border and an outer pink-red ring)
• Nail problems
• Stevens-Johnson syndrome (Flu-like symptoms appear first. A painful rash that spreads and blisters follow)
• Myopathy (muscle disease resulting in muscular weakness)
• Alcohol intolerance
• Flu-like symptoms
• Malaise (general sense of being unwell)
• Fainting
• Redistribution/accumulation of body fat

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. 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. By reporting side effects, you can help provide more information on the safety of Teevir.

Store all medicines out of reach of children.

Store at or below 30 °C.

Store in the original container. Do not remove from the carton until required for use. Keep the bottle tightly closed.