PATIENT INFORMATION LEAFLET

Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300 mg Tablets (Cipla Ltd), HA439 WHOPAR part 3 February 2012 PATIENT INFORMATION LEAFLET Page 1...
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Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300 mg Tablets (Cipla Ltd), HA439

WHOPAR part 3

February 2012

PATIENT INFORMATION LEAFLET

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Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300 mg Tablets (Cipla Ltd), HA439

WHOPAR part 3

February 2012

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Tenvir EM * emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg film-coated tablets Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. -

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, health care provider or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or health care provider. This includes any possible side effects not listed in this leaflet.

What is in this leaflet 1. 2. 3. 4. 5. 6.

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What Tenvir EM is and what it is used for What you need to know before you take Tenvir EM How to take Tenvir EM Possible side effects How to store Tenvir EM Contents of the pack and other information

WHAT TENVIR EM IS AND WHAT IT IS USED FOR

Tenvir EM is a treatment for Human Immunodeficiency Virus (HIV) infection in adults over 18 years of age. Tenvir EM contains the active substances emtricitabine and tenofovir disoproxil fumarate. Both of these are antiretroviral medicines for the treatment of HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both active substances work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself. To prevent the virus from becoming resistant, Tenvir EM should always be given in combination with other antiretrovirals when treating HIV. This medicine is not a cure for HIV infection. While taking Tenvir EM you may still develop infections or other illnesses associated with HIV infection.

*

Trade names are not prequalified by WHO. This is under local drug regulatory authority’s responsibility. Throughout this WHOPAR the proprietary name is given as an example only. Page 2 of 8

Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300 mg Tablets (Cipla Ltd), HA439

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WHOPAR part 3

February 2012

WHAT YOU NEED TO KNOW BEFORE YOU TAKE TENVIR EM

Do not take Tenvir EM: If you are allergic (hypersensitive) to emtricitabine, tenofovir disoproxil fumarate or any of the other ingredients of Tenvir EM listed at the end of this leaflet. If this applies to you, tell your doctor immediately and don’t take Tenvir EM. Warnings and precautions Kidney disease Tell your doctor if you have had kidney disease or if tests have shown problems with your kidneys. Tenvir EM may affect your kidneys. Before starting this medicine you may need blood tests to check how well your kidneys are working. The tests can help to decide how you should take your medicine. Blood tests may also be required during treatment to check the health of your kidneys. Tenvir EM is not usually taken with other medicines that can damage your kidneys (see “Other medicines and Tenvir EM”). If this is unavoidable, you may need regular tests to check how well your kidneys are working. Tenvir EM should not be used by children or adolescents under 18 years of age. Liver disease Talk to your doctor or health care provider if you have a history of liver disease, including hepatitis. HIV-infected patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you are infected with HIV and hepatitis B virus, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests to monitor your liver function. Lactic acidosis Females, particularly if very overweight, and patients with liver disease may be more at risk of getting a rare, but serious side effect called lactic acidosis, a build up of lactic acid in the body. If lactic acidosis occurs, it usually develops after a few months of treatment. Deep rapid breathing, drowsiness and non-specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of this condition (see section 3). While you are being treated with Tenvir EM your doctor or health care provider will monitor you for any signs of lactic acidosis. If you think you may have lactic acidosis, contact your doctor immediately. Fat distribution Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor or health care provider if you notice changes in your body shape. Immune Reactivation Syndrome In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-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 previously with no obvious symptoms. If you notice any symptoms of infection, inform your doctor or health care provider immediately.

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February 2012

Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue). The risk of developing this disease may be higher, e.g. when the immune system is severely compromised or when drinking alcohol regularly. If you notice joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement, inform the doctor or health care provider. Bone problems (sometimes resulting in fractures) may also occur due to damage to the kidney cells (see section 4, “Possible side effects”). General Take care not to infect other people. Tenvir EM does not eliminate the risk of passing on HIV to others through sexual contact or contamination with blood. You must continue to take precautions to avoid this. Other medicines and Tenvir EM Tell your doctor, pharmacist or health care provider if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not take Tenvir EM if you are already taking other medicines containing tenofovir disoproxil fumarate, emtricitabine, lamivudine or zalcitabine. Do not take Tenvir EM and adefovir dipivoxil at the same time. It is very important to tell your doctor or health care provider if you are taking other medicines that may damage your kidneys. These include: • aminoglycosides or vancomycin (for bacterial infection) • amphotericin B or pentamidine (for fungal infection) • foscarnet, ganciclovir, or cidofovir (for viral infection) • adefovir dipivoxil (for HBV) • tacrolimus (for suppression of the immune system) Other medicines containing didanosine (for HIV infection): Taking Tenvir EM with medicines that contain didanosine can raise the levels of didanosine in your blood. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil fumarate and didanosine were taken together. Combining tenofovir with didanosine can also reduce the effects of antiretroviral therapy. Your doctor will carefully consider whether to treat you with a combination of tenofovir and didanosine. Tenvir EM with food and drink Take Tenvir EM with a meal. Pregnancy and breast-feeding Pregnant or breast-feeding mothers should not take Tenvir EM unless specifically directed by the doctor. Be sure to tell your doctor immediately if you are or may be pregnant. If you are interested in breastfeeding your baby, you should discuss the risks and benefits with your doctor or healthcare provider. Driving and using machines Tenvir EM can cause dizziness. If you feel dizzy while taking Tenvir EM, do not drive and do not use hazardous tools or machines.

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Tenvir EM contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or health care provider before taking this medicinal product. 3.

HOW TO TAKE TENVIR EM

Always take Tenvir EM exactly as your doctor or health care provider has told you. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. You should check with your doctor, pharmacist or health care provider if you are not sure. Always take the dose recommended by your doctor or health care provider. Do not change the dose unless your doctor tells you to. The usual dose for adults is one tablet each day. Tenvir EM should be taken on with a meal. Swallow Tenvir EM whole with water or another liquid. If you cannot swallow the tablet, you can use the tip of a spoon to crush the tablet. Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately. This product is not for use by children and adolescents (under 18 years of age). If your doctor decides to stop one of the components of Tenvir EM or change the dose of Tenvir EM, you may be given emtricitabine and/or tenofovir separately instead of the combined medicine or other medicines for the treatment of HIV infection. Your doctor will prescribe Tenvir EM with other antiretroviral medicines. Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines. If you have problems with your kidneys, your doctor or health care provider may advise you to take Tenvir EM less frequently. If you take more Tenvir EM than you should: If you accidentally take too many Tenvir EM tablets, contact your doctor or nearest emergency department for advice. Take the tablet container with you so that you can easily describe what you have taken. If you forget to take Tenvir EM: It is important not to miss a dose of Tenvir EM. If you miss a dose of Tenvir EM, take it as soon as you can, and then take your next dose at its regular time. However, if your next dose is due within 6 hours, 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 tablet. If you vomit less than 1 hour after taking Tenvir EM, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Tenvir EM. If you stop taking Tenvir EM: Don’t stop taking Tenvir EM without your doctor’s or health care provider’s advice. Stopping treatment with Tenvir EM may reduce the effectiveness of the treatment. Talk to your doctor or health care provider before you stop taking Tenvir EM for any reason, particularly if you are experiencing any side effects or you have another illness. Contact your doctor or health care provider before you restart taking Tenvir EM.

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Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300 mg Tablets (Cipla Ltd), HA439

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February 2012

If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenvir EM treatment without talking to your doctor or health care provider first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Tenvir EM. You may require blood tests for several months after stopping treatment. Tell your doctor or health care provider immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection. If you have any further questions on the use of this product, ask your doctor, health care provider or pharmacist. 4.

POSSIBLE SIDE EFFECTS

Like all medicines, Tenvir EM can cause side effects, although not everybody gets them. Tell your doctor about any of the following side effects: Very common side effects (These can affect at least 10 in every 100 patients treated) • dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting), weakness Tests may also show: • abnormally low levels of phosphate in the blood Common side effects (These can affect 1 to 10 in every 100 patients treated) • stomach pain • difficulty sleeping, abnormal dreams • problems with digestion resulting in discomfort after meals, flatulence • rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches • other allergic reactions, such as wheezing, swelling or feeling light-headed Tests may also show: • low white blood cell count (a reduced white blood cell count can make you more prone to infection) • increased triglycerides (fatty acids), bile or sugar in the blood • liver and pancreas problems Uncommon side effects (These can affect at least 1 in every 1,000 patients treated, but less than 1 in every 100 patients treated) • anaemia (low red blood cell count) • pain in the abdomen caused by inflammation of the pancreas • breakdown of muscle, muscle pain or weakness • swelling of the face, lips, tongue or throat Tests may also show • decreases in potassium in the blood • increased creatinine in your blood • changes to your urine

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Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300 mg Tablets (Cipla Ltd), HA439

WHOPAR part 3

February 2012

Rare side effects (These can affect at least 1 in every 10,000 patients treated, but less than 1 in every 1,000 patients treated) • excess lactic acid in the blood (lactic acidosis), a serious side effect that can be fatal. The following side effects may be signs of lactic acidosis: - deep rapid breathing - drowsiness - feeling sick (nausea), being sick (vomiting) and stomach pain (see also “Warnings and precautions”) • back pain caused by kidney problems, including kidney failure • yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver • inflammation of the kidney, passing a lot of urine and feeling thirsty • softening of the bones (with bone pain and sometimes resulting in fractures) Tests may also show: • damage to kidney tubule cells The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells. Other possible effects The following side effects have been reported in HIV infected patients treated with medicines of the group of NRTIs, to which Tenvir EM belongs: - changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen and internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump'). - increases in blood fats (hyperlipaemia) and an abnormal increase in blood sugar. Your doctor will test for these changes. - appearance of infection as part of ‘immune reactivation syndrome’ (see “Warnings and precautions”). If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or health care provider. 5.

HOW TO STORE TENVIR EM

Keep this medicine out of the sight and reach and of children. Do not use Tenvir EM after the expiry date which is stated on the bottle after {EXP}. The expiry date refers to the last day of that month. Do not store above 30°C. 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

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WHOPAR part 3

February 2012

CONTENTS OF THE PACK AND OTHER INFORMATION

What Tenvir EM contains The active ingredients are 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil or 136 mg of tenofovir). The other ingredients are: Core tablet: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinised starch. Film coat (Opadry Blue II 32K80963): FD&C Blue #2 Aluminium lake (Indigo Carmine), hypromellose, lactose monohydrate, titanium dioxide and triacetin. What Tenvir EM looks like and contents of the pack Tenvir EM are blue coloured, capsule shaped, biconvex, film-coated tablets plain on both sides. The tablets should not be divided. The primary packs are induction-sealed, 50cc HDPE bottles fitted with 38mm non-CRC PP caps provided with four (4) silica gel bags of 1g each. Pack size: bottle of 30 tablets.

Supplier Cipla Ltd 289 JBB Marg Mumbai Central Mumbai 400 008 Maharasthra, India Tel: +9122 23082891, 23095521

and Manufacturer Cipla Ltd Unit VII, III, IV Plot No: L-139 to L-146 and L-147 to L147-1 Verna Industrial Estate Goa – 403722, India

For any information about this medicinal product, please contact the supplier. This leaflet was last approved in January 2012.

Detailed information on this medicine is available on the World Health Organization (WHO) web site: http://www.who.int/prequal/ .

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