Patient leaflet - Tenofovir disoproxil Mylan
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Tenofovir disoproxil Mylan 245 mg film-coated tablets tenofovir disoproxil
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Tenofovir disoproxil Mylan is and what it is used for
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2. What you need to know before you take Tenofovir disoproxil Mylan
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3. How to take Tenofovir disoproxil Mylan
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4. Possible side effects
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5. How to store Tenofovir disoproxil Mylan
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6. Contents of the pack and other information
If this medicine has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
1. What Tenofovir disoproxil Mylan is and what it is used for
Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both.
Tenofovir is a nucleotide reverse transcriptase inhibitor , generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase ; in hepatitis B DNA polymerase ) that are essential for the viruses to reproduce themselves. In HIV Tenofovir disoproxil Mylan should always be used combined with other medicines to treat HIV infection.
Tenofovir disoproxil Mylan 245 mg tablets are a treatment for HIV (Human Immunodeficiency
Virus) infection. The tablets are suitable for:
- adults
- adolescents aged 12 to less than 18 years who have already been treated with other HIV
medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Tenofovir disoproxil Mylan 245 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus). The tablets are suitable for:
- adults
- adolescents aged 12 to less than 18 years.
You do not have to have HIV to be treated with Tenofovir disoproxil Mylan for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil Mylan you may still develop infections or other illnesses associated with HIV infection. You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
2. What you need to know before you take Tenofovir disoproxil Mylan
Do not take Tenofovir disoproxil Mylan:
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- If you are allergic to tenofovir, tenofovir disoproxil or any of the other ingredients of this
medicine listed in section 6.
If this applies to you, tell your doctor immediately and do not take Tenofovir disoproxil Mylan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir disoproxil Mylan
- Take care not to infect other people. You can still pass on HIV when taking this medicine,
although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. Tenofovir disoproxil Mylan does not reduce the risk of passing on HBV to others through sexual contact or blood contamination. You must continue to take precautions to avoid this.
- Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown
problems with your kidneys. Tenofovir disoproxil Mylan should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may order blood tests to assess your kidney function. Tenofovir disoproxil Mylan may affect your kidneys during treatment. Your doctor may order blood tests during treatment to monitor how your kidneys work. If you are an adult, your doctor may advise you to take the tablets less often. Do not reduce the prescribed dose, unless your doctor has told you to do so.
Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Mylan ). If this is unavoidable, your doctor will monitor your kidney function once a week.
- Bone problems. Some adult patients with HIV taking combination antiretroviral therapy may
develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms tell your doctor.
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 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 for fractures.
- Talk to your doctor if you have a history of liver disease, including hepatitis. 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 have hepatitis B infection,
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.
- Look out for infections. If you have advanced HIV infection (AIDS) and have an infection,
you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Tenofovir disoproxil Mylan is started. These symptoms may indicate that your body’s improved immune system is fighting infection. Look out for signs of inflammation or infection soon after you start taking Tenofovir disoproxil Mylan. If you notice signs of inflammation or infection, tell your doctor at once.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice 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, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
- Talk to your doctor or pharmacist if you are over 65. Tenofovir disoproxil has not been
studied in patients over 65 years of age. If you are older than this and are prescribed Tenofovir disoproxil Mylan, your doctor will monitor you carefully.
Children and adolescents
Tenofovir disoproxil Mylan 245 mg tablets are suitable for:
- HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who
have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
- HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Tenofovir disoproxil Mylan 245 mg tablets are not suitable for the following groups:
- Not for HIV-1 infected children under 12 years of age
- Not for HBV infected children under 12 years of age.
For dosage see section 3, How to take Tenofovir disoproxil Mylan.
Other medicines and Tenofovir disoproxil Mylan
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.
Don’t stop any anti-HIV medicines prescribed by your doctor when you start Tenofovir disoproxil Mylan if you have both HBV and HIV.
- Do not take Tenofovir disoproxil Mylan if you are already taking other medicines
containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Mylan together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
- It is very important to tell your doctor if you are taking other medicines that may damage
your kidneys.
These include:
- aminoglycosides, pentamidine or vancomycin (for bacterial infection),
- amphotericin B (for fungal infection),
- foscarnet, ganciclovir, or cidofovir (for viral infection),
- interleukin-2 (to treat cancer),
- adefovir dipivoxil (for HBV),
- tacrolimus (for suppression of the immune system),
- non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
- Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil
Mylan 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 caused 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.
- 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.
Tenofovir disoproxil Mylan with food and drink
Take Tenofovir disoproxil Mylan with food (for example, a meal or a snack).
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.
- Try to avoid getting pregnant during treatment with Tenofovir disoproxil Mylan. You must
use an effective method of contraception to avoid becoming pregnant.
- If you have taken Tenofovir disoproxil Mylan 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.
- If you are a mother with HBV, and your baby has been given treatment to prevent hepatitis B
transmission at birth, you may be able to breast-feed your infant, but first talk to your doctor to get more information.
- If you are a mother with HIV do not breast-feed, to avoid passing the virus to the baby in breast
milk.
Driving and using machines
Tenofovir disoproxil can cause dizziness. If you feel dizzy while taking Tenofovir disoproxil Mylan, do not drive or ride a bicycle and do not use any tools or machines.
Tenofovir disoproxil Mylan contains lactose
Tell your doctor before taking Tenofovir disoproxil Mylan. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Tenofovir disoproxil Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
- Adults: 1 tablet each day with food (for example, a meal or a snack).
- Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day
with food (for example, a meal or a snack).
If you have particular difficulty swallowing, 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
- 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 are an adult and have problems with your kidneys, your doctor may advise you to
take Tenofovir disoproxil Mylan less frequently.
- If you have HBV your doctor may offer you an HIV test to see if you have both HBV and
HIV. Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
- Other forms of this medicine may be more suitable for patients who have difficulty
swallowing; ask your doctor or pharmacist.
If you take more Tenofovir disoproxil Mylan than you should
If you accidentally take too many Tenofovir disoproxil Mylan tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects ).
Contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
If you forget to take Tenofovir disoproxil Mylan
It is important not to miss a dose of Tenofovir disoproxil Mylan. If you miss a dose, work out how long since you should have taken it.
- If it is less than 12 hours after it is usually taken, take it as soon as you can, and then take
your next dose at its regular time.
- If it is more than 12 hours since you should have taken it, 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 throw up less than 1 hour after taking Tenofovir disoproxil Mylan, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Tenofovir disoproxil Mylan
If you stop taking Tenofovir disoproxil Mylan
Don’t stop taking Tenofovir disoproxil Mylan without your doctor’s advice. Stopping treatment with Tenofovir disoproxil Mylan may reduce the effectiveness of the treatment recommended by your doctor.
If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenofovir disoproxil Mylan treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping tenofovir disoproxil. 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.
- Talk to your doctor before you stop taking Tenofovir disoproxil Mylan for any reason,
particularly if you are experiencing any side effects or you have another illness.
- Tell your doctor immediately about new or unusual symptoms after you stop treatment,
particularly symptoms you associate with hepatitis B infection.
- Contact your doctor before you restart taking Tenofovir disoproxil Mylan tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
During HIV therapy 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects: tell your doctor immediately
- Lactic acidosis (excess lactic acid in the blood) is a rare (can affect up to 1 in every 1,000
patients) but 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
If you think that you may have lactic acidosis, contact your doctor immediately.
Other possible serious side effects
The following side effects are uncommon (this can affect up to 1 in every 100 patients):
- pain in the tummy (abdomen) caused by inflammation of the pancreas
- damage to kidney tubule cells
The following side effects are rare (these can affect up to 1 in every 1,000 patients):
- inflammation of the kidney, passing a lot of urine and feeling thirsty
- changes to your urine and back pain caused by kidney problems, including kidney failure
- softening of the bones (with bone pain and sometimes resulting in fractures), which may
occur due to damage to kidney tubule cells
- fatty liver
If you think that you may have any of these serious side effects, talk to your doctor.
Most frequent side effects
The following side effects are very common (these can affect at least 10 in every 100 patients):
- diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash, feeling weak
Tests may also show:
- decreases in phosphate in the blood
Other possible side effects
The following side effects are common (these can affect up to 10 in every 100 patients):
- headache, stomach pain, feeling tired, feeling bloated, flatulence
Tests may also show:
liver problems
The following side effects are uncommon (these can affect up to 1 in every 100 patients):
- breakdown of muscle, muscle pain or weakness
Tests may also show:
- decreases in potassium in the blood
- increased creatinine in your blood
- pancreas problems
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.
The following side effects are rare (these can affect up to 1 in every 1,000 patients):
- pain in the tummy (abdomen) caused by inflammation of the liver
- swelling of the face, lips, tongue or throat
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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tenofovir disoproxil Mylan
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 bottle and carton after {EXP}. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
For bottles: after first opening the bottle use within 90 days.
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 Tenofovir disoproxil Mylan contains
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– The active substance is tenofovir disoproxil. Each Tenofovir disoproxil Mylan tablet contains
245 mg of tenofovir disoproxil (as maleate).
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– The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2,
What Tenofovir disoproxil Mylan looks like and contents of the pack
Tenofovir disoproxil Mylan 245 mg film-coated tablets are light blue, round, biconvex, debossed with ‘TN245’ on one side and ‘M’ on other side.
This medicine is available in plastic bottles with a child resistant cap and wad containing 30 film-coated tablets and in multipacks of 90 film-coated tablets comprising 3 bottles, each containing 30 film-coated tablets. The bottles also contain desiccant. Do not eat the desiccant.
The tablets are also available in blister packs containing 10, 30 or 30 × 1 (unit dose) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.A.S
117 Allée des Parcs
69800 Saint-Priest
France
Manufacturer
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft
Mylan utca 1,
Komarom, H-2900,
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe,
Benzstrasse 1, Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 | Lietuva Mylan Healthcare UAB Tel: + 370 5 205 1288 |
| Efc^rapufl MaöaaH EOOfl Tea: + 359 2 44 55 400 | Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) |
| Česká republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400 | Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100 |
| Danmark Mylan Denmark ApS Tlf: + 45 28 11 69 32 | Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 |
| Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800 | Nederland Mylan BV Tel: + 31 (0)20 426 3300 |
| Eesti BGP Products Switzerland GmbH Eesti filiaal | Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00 |
Tel: + 372 6363 052
| EMáSa Generics Pharma Hellas EnE Tql: +30 210 993 6410 | Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418 |
| España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712 | Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00 |
| France Mylan S.A.S Tel: +33 4 37 25 75 00 | Portugal Mylan, Lda. Tel: + 351 21 412 72 56 |
| Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599 | Romania BGP Products SRL Tel: + 40 372 579 000 |
| Ireland Mylan Ireland Limited Tel: + 353 (0) 87 1684982 | Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180 |
| Ísland Icepharma hf Tel: + 354 540 8000 | Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100 |
| Italia Mylan Italia S.r.l. Tel: + 39 02 612 46921 | Suomi/Finland Mylan Finland OY Puh/Tel: + 358 20 720 9555 |
| Kúnpog Varnavas Hadjipanayis Ltd. Tql: + 357 2220 7700 | Sverige Mylan AB Tel: + 46 855 522 750 |
| Latvija Mylan Healthcare SIA Tel: + 371 676 055 80 | United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: + 353 18711600 |
This leaflet was last revised in {MM/YYYY }.
Detailed information on this medicine is available on the European Medicines Agency web site:
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