Document Content
identifier: http://ema.europa.eu/identifier/EU/1/16/1151/001 - 28 film-coated tablets
status: Final
type: Package Leaflet
category: Raw
date: 2022-02-16 13:28:17+0000
author: Organization ACME industry
title: TEST PURPOSES ONLY - emtricitabinetenofovir
Attesters
| - | Mode | Time |
| * | Official | 2022-02-16 13:28:17+0000 |
B. Package Leaflet
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Package leaflet: Information for the user
What is in this leaflet
What is in this leaflet
- What Emtricitabine/Tenofovir disoproxil Krka is and what it is used for
- What you need to know before you take Emtricitabine/Tenofovir disoproxil Krka
- How to take Emtricitabine/Tenofovir disoproxil Krka
- Possible side effects
- How to store Emtricitabine/Tenofovir disoproxil Krka
- Contents of the pack and other information
1. What emtricitabinetenofovir is and what it is used for
Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Emtricitabine/Tenofovir disoproxil Krka is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults.
It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Emtricitabine/Tenofovir disoproxil Krka should always be used combined with other medicines to treat HIV infection.
Emtricitabine/Tenofovir disoproxil Krka can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses. This medicine is not a cure for HIV infection. While taking Emtricitabine/Tenofovir disoproxil Krka you may still develop infections or other illnesses associated with HIV infection.
Emtricitabine/Tenofovir disoproxil Krka is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg, when taken daily, together with safer sex practices: See section 2 for a list of precautions to take against HIV infection.
2. What you need to know before you take emtricitabinetenofovir
You must be HIV negative before you start to take Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV. You must get tested to make sure that you do not already have HIV infection. Do not take Emtricitabine/Tenofovir disoproxil Krka to reduce your risk unless you are confirmed to be HIV negative. People who do have HIV must take Emtricitabine/Tenofovir disoproxil Krka in combination with other drugs.
Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean you have recently been infected with HIV. These may be signs of HIV infection:
tiredness
fever
joint or muscle aches
headache
vomiting or diarrhoea
rash
night sweats
enlarged lymph nodes in the neck or groin Tell your doctor about any flu-like illness either in the month before starting Emtricitabine/Tenofovir disoproxil Krka, or at any time while taking Emtricitabine/Tenofovir disoproxil Krka. Warnings and precautions While taking Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV:
Take Emtricitabine/Tenofovir disoproxil Krka every day to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any doses of Emtricitabine/Tenofovir disoproxil Krka, or stop taking it. Missing doses may increase your risk of getting HIV infection.
Get tested for HIV regularly.
If you think you were infected with HIV, tell your doctor straight away. They may want to do more tests to make sure you are still HIV negative.
Just taking Emtricitabine/Tenofovir disoproxil Krka may not stop you getting HIV.
Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
Do not share or re-use needles or other injection or drug equipment.
Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you. Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV to other people. While taking Emtricitabine/Tenofovir disoproxil Krka to treat HIV or to reduce the risk of getting HIV:
Emtricitabine/Tenofovir disoproxil Krka may affect your kidneys. Before and during treatment, your doctor may order blood tests to measure kidney function. Tell your doctor if you have had kidney disease, or if tests have shown kidney problems. Emtricitabine/Tenofovir disoproxil Krka should not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine/Tenofovir disoproxil Krka or, if you already have HIV, to take Emtricitabine/Tenofovir disoproxil Krka less frequently. Emtricitabine/Tenofovir disoproxil Krka is not recommended if you have severe kidney disease or are on dialysis.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures. Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated for HIV with tenofovir disoproxil in combination with a boosted protease inhibitor. Overall, the effects of tenofovir disoproxil on long term bone health and future fracture risk in adult and paediatric patients are uncertain. Tell your doctor if you know you suffer from osteoporosis. Patients with osteoporosis are at a higher risk of fractures.
Talk to your doctor if you have a history of liver disease, including hepatitis. Patients infected with HIV who also have 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 have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.
Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil Krka. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Krka, whether or not you also have HIV. It is important not to stop taking Emtricitabine/Tenofovir disoproxil Krka without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir disoproxil Krka.
Talk to your doctor if you are over 65. Emtricitabine/Tenofovir disoproxil Krka has not been studied in patients over 65 years of age.
Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Krka contains lactose later in this section). Children and adolescents Emtricitabine/Tenofovir disoproxil Krka is not for use in children under 12 years of age. Other medicines and Emtricitabine/Tenofovir disoproxil Krka Do not take Emtricitabine/Tenofovir disoproxil Krka if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil Krka (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil. Taking Emtricitabine/Tenofovir disoproxil Krka with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including
aminoglycosides (for bacterial infection)
amphotericin B (for fungal infection)
foscarnet (for viral infection)
ganciclovir (for viral infection)
pentamidine (for infections)
vancomycin (for bacterial infection)
interleukin-2 (to treat cancer)
cidofovir (for viral infection)
non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains) If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function. It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection. Taking Emtricitabine/Tenofovir disoproxil Krka with other medicines containing didanosine (for treatment of HIV infection): Taking Emtricitabine/Tenofovir disoproxil Krka with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine. Tell your doctor if you are taking any of these medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Emtricitabine/Tenofovir disoproxil Krka with food and drink
Whenever possible, Emtricitabine/Tenofovir disoproxil Krka should be taken with food. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you have taken Emtricitabine/Tenofovir disoproxil Krka during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Krka. This is because the active substances in this medicine pass into human breast milk.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible. Driving and using machines Emtricitabine/Tenofovir disoproxil Krka can cause dizziness. If you feel dizzy while taking Emtricitabine/Tenofovir disoproxil Krka, do not drive and do not use any tools or machines. Emtricitabine/Tenofovir disoproxil Krka contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Emtricitabine/Tenofovir disoproxil Krka contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium- free .
3. How to take emtricitabinetenofovir
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose of Emtricitabine/Tenofovir disoproxil Krka to treat HIV is:
Adults: one tablet each day, where possible, with food.
Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food The recommended dose of Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV is:
Adults: one tablet each day, whenever possible with food.
Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.
If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil Krka, take the tablet preferably with food as soon as possible. Then take the next dose at your usual time.
If you notice 12 hours or more after the time you usually take Emtricitabine/Tenofovir disoproxil Krka, forget about the missed dose. Wait and take the next dose, preferably with food, at your usual time. If you vomit less than 1 hour after taking Emtricitabine/Tenofovir disoproxil Krka, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Krka. Do not stop taking Emtricitabine/Tenofovir disoproxil Krka
If you take Emtricitabine/Tenofovir disoproxil Krka for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
If you are taking Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV, do not stop taking Emtricitabine/Tenofovir disoproxil Krka or miss any doses. Stopping use of Emtricitabine/Tenofovir disoproxil Krka, or missing doses, may increase your risk of getting HIV infection. Do not stop taking Emtricitabine/Tenofovir disoproxil Krka without contacting your doctor. If you have hepatitis B, it is especially important not to stop your Emtricitabine/Tenofovir disoproxil Krka treatment without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening. Tell your doctor 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible serious side effects:
Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect. Lactic acidosis occurs more often in women, particularly if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
deep rapid breathing
drowsiness
feeling sick (nausea), being sick (vomiting)
Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is thought 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.
Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
muscle weakness
weakness beginning in the hands and feet and moving up towards the trunk of the body
diarrhoea, being sick (vomiting), feeling sick (nausea)
dizziness, headache
rash
feeling weak Tests may also show:
decreases in phosphate in the blood
increased creatine kinase Common side effects (may affect up to 1 in 10 people)
pain, stomach pain
difficulty sleeping, abnormal dreams
problems with digestion resulting in discomfort after meals, feeling bloated, 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 (may affect up to 1 in 100 people)
pain in the abdomen (tummy) caused by inflammation of the pancreas
swelling of the face, lips, tongue or throat
anaemia (low red blood cell count)
breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells Tests may also show:
decreases in potassium in the blood
increased creatinine in your blood
changes to your urine Rare side effects (may affect up to 1 in 1 000 people)
Lactic acidosis (see Possible serious side effects)
fatty liver
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, kidney failure, damage to kidney tubule cells
softening of the bones (with bone pain and sometimes resulting in fractures)
back pain caused by kidney problems Damage to kidney tubule cells may be associated with 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. If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist. The frequency of the following side effects is not known.
Bone problems. Some patients taking combination antiretroviral medicines such as emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
joint stiffness
joint aches and pains (especially of the hip, knee and shoulder)
difficulty with movement If you notice any of these symptoms tell your doctor. During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. Other effects in children
Children given emtricitabine very commonly experienced changes in skin colour including
darkening of the skin in patches
Children commonly experienced low red blood cell count (anaemia)
this may cause the child to be tired or breathless If you notice any of these symptoms tell your doctor. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store emtricitabinetenofovir
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month. Blisters Do not store above 30 C. Store in the original blister in order to protect from moisture and light. Bottle Do not store above 30 C. Keep the bottle tightly closed in order to protect from moisture and light. Shelf life after first opening of the bottle: 2 months. 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.
6. Contents of the pack and other information
What Emtricitabine/Tenofovir disoproxil Krka contains
The active substances are emtricitabine and tenofovir disoproxil. Each tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.7 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).
The other ingredients are: Tablet core: pregelatinized starch, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, stearic acid. Film coating: hypromellose 5 cP, titanium dioxide (E171), macrogol, indigo carmine aluminium lake (E132). See section 2 "Emtricitabine/Tenofovir disoproxil Krka contains lactose", "Emtricitabine/Tenofovir disoproxil Krka contains sodium". What Emtricitabine/Tenofovir disoproxil Krka looks like and contents of the pack Emtricitabine/Tenofovir disoproxil Krka film-coated tablets (tablets) are blue, oval, biconvex tablets, of dimensions 20 mm x 10 mm. Emtricitabine/Tenofovir disoproxil Krka is available in carton boxes of 28, 84 film-coated tablets and 28 x 1 film-coated tablet in blisters. Emtricitabine/Tenofovir disoproxil Krka is available also in bottles of 30 tablets, with a child-resistant tamper evident plastic closure with integrated a silica gel desiccant, which helps to protect your tablets. The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia Manufacturers KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Stra e 5, 27472 Cuxhaven, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: +32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27
Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: +32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Nederland KRKA Belgium, SA. Tel: + 49 (0) 4721 606-0 Tel: +32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)
KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: +358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site:
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The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
