Prospecto:Information for the Patient

Tenofovir Disoproxil Glenmark 245 mg Film-Coated Tablets

tenofovir disoproxil

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this prospectus. See section 4.

1.What is Tenofovir Disoproxil Glenmark and what is it used for

2.What you need to knowbeforestarting totakeTenofovir Disoproxil Glenmark

3.How to take Tenofovir Disoproxil Glenmark

4.Possible adverse effects

5Storage of Tenofovir Disoproxil Glenmark

6.Contents of the package and additional information

If tenofovir has been prescribed to your child, please note that all the information in this prospectus is directed at your child (in this case, read “your child” instead of “you”).

Tenofovir contains the active ingredienttenofovir disoproxil fumarate. This active ingredient is anantiretroviralor antiviral medicationused to treat HIV infection, or HBV, or both.Tenofovir isanucleotide reverse transcriptase inhibitor,commonly known asNRTI, and acts by interfering with the normal function of certain enzymes (in the case of HIV thereverse transcriptaseand in hepatitis B theDNA polymerase) essential for viral replication. Forthe treatment of HIV infection, tenofovir must be used always in combination withother medications.

Tenofovir is a medication used to treat HIV(Human Immunodeficiency Virus)infection.

The tablets are suitablefor:

• adults,
• adolescents between 12 and less than 18 years who have already been treatedwithothermedications against HIV which are no longer fully effective due to the developmentofresistances, or that have caused adverseeffects.

Tenofovir is also used to treat chronic hepatitis B, ainfectioncaused by the HBV(hepatitis B virus). The tablets are suitablefor:

• adults,
• adolescents between 12 and less than 18 years.

No HIV infection is required to be treated with Tenofovir for HBV.

This medication is not a cure for HIV infection. While taking tenofoviryou maycontinue to have infections or other diseases associated with HIV infection. You may alsocontinue to transmit HIV or HBV to others. Therefore, it is essential that you take precautionstoavoid infecting others.

Do not takeTenofovir Disoproxilo Glenmark:

• If you are allergicto tenofovir, tenofovir disoproxilo, or any of the other ingredients of this medicine listed in section 6.

If this is the case, inform your doctor immediately and do not take tenofovir disoproxilo.

Warnings andprecautions

Tenofovir does not reduce the risk of transmission of HBV through sexual contact or blood contamination.Continue to take precautions to avoid it.

Consult your doctor or pharmacist before starting to take tenofovir.

• If you have had kidney disease or if your blood tests have shown kidney problems.Tenofovir should not be administered to adolescents with existing kidney problems.Before starting treatment, your doctor may request that you have some blood tests to evaluate the function of your kidneys.Tenofovir may affect your kidneys during treatment.Your doctor may request that you have some blood tests during treatment to control the function of your kidneys.If you are an adult, your doctor may advise you to take the tablets less frequently.Do not reduce the prescribed dose, unless your doctor has told you to.

Tenofovir is usually not taken with other medicines that may damage your kidneys (see Tenofovir Disoproxilo Glenmark with other medicines).If this is unavoidable, your doctor will monitor the function of your kidneys once a week.

• If you have osteoporosis, a history of bone fractures, or bone problems

You may also experience bone problems (which manifest as persistent bone pain or worsening and sometimes ending in fractures) due to damage to renal tubular cells (see section 4, Possible adverse effects).Inform your doctor if you have bone pain or fractures.

Tenofovir disoproxilo may also cause bone loss.The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxilo in combination with a boosted protease inhibitor.

The long-term effects of tenofovir disoproxilo on bone health and the future risk of fractures in adult and pediatric patients are imprecise.

Some adult patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone).Among the numerous risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and a high body mass index.The symptoms of osteonecrosis are: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving.If you notice any of these symptoms, inform your doctor.

• Speak to your doctor if you have a history of liver disease, includinghepatitis.

Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals have a higher risk of severe and potentially life-threatening 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 request blood tests to monitor your liver function.

• Infections.If you have advanced HIV infection (AIDS) and present another type of infection,you may develop symptoms of infection and inflammation or worsening of existing infection symptoms when starting treatment with tenofovir.These symptoms may indicate that your improved immune system is fighting the infection.Be aware if you develop signs of inflammation or infection after starting to take tenofovir.If you notice signs of inflammation or infection, inform your doctor immediately.

Aside from opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications for HIV treatment.Autoimmune disorders may appear many months after starting treatment.If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

• If you are over 65 years old, inform your doctor or pharmacist.Tenofovir has not been studied in patients over 65 years old.If you are over this age and have been prescribed tenofovir, your doctor will monitor you carefully.

Children andadolescents

Tenofovir isappropriatefor:

• adolescents infected with HIV-1 between 12 and less than 18 years old who weigh at least 35 kg and who have already been treatedwith other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.
• adolescents infected with HBV between 12 and less than 18 years old who weigh at least 35 kg.

Tenofoviris notappropriate for the following groups:

• not for children infected with HIV-1under 12 years old.
• not for children infected with HBVunder 12 years old.

To know the dose, see section 3, How to take Tenofovir Disoproxilo Glenmark.

Other medicines andTenofovir Disoproxilo Glenmark

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any othermedicine.

• Do not stop taking any HIV medicine prescribed by your doctor when starting treatment with tenofovir if you have HBV andVIH.

• Do not take tenofovir disoproxiloif you are using medicines that already contain tenofovir disoproxilo or tenofovir alafenamide.Do not administer tenofovir with medicines that contain adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

• It is very important that you tell your doctor if you are taking other medicinesthatmay damage yourkidneys.

These medicines include:

• aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections),
• amphotericin B (used to treat fungal infections),
• foscarnet, ganciclovir, or cidofovir (used to treat viral infections),
• interleukin-2 (used to treatcancer),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to produce immune suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines that contain didanosine (for HIV infection):Taking tenofovir with other antiviral medicines that contain didanosine may increase the levels of didanosine in your blood and reduce the CD4 cell count.When taken together, medicines that contain tenofovir disoproxilo and didanosine have been reported in rare cases to cause inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), in some cases fatal.Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• It is also important that you inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Tenofovir Disoproxilo Glenmark with food anddrinks

Take Tenofovir with food(for example, a meal or anappetizer).

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using thismedicine.

• .

• If you have been taking tenofovirduring your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor the development of your child.In children whose mothers took ITIAN during pregnancy, the benefit of protection against HIVwas greater than the risk of adverse effects.

• If you are a mother and have HBV and your baby received treatment to prevent the transmission of hepatitis B at birth, it is possible that you may breastfeed your baby, but you must speak with your doctor first, to get more information.

• If you are a woman and have HIV infection, do not breastfeed your baby to avoid the virus passing to the baby through breast milk.

For pediatric patients:

• If the girl has HBV and her baby is receiving treatment to prevent the transmission of hepatitis B at birth, it is possible that the girl may breastfeed her infant, but first speak with the girl's doctor to get more information.

It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.If you are breastfeeding or plan to breastfeed, you must speak with your doctor as soon as possible

Driving andoperatingmachines

Tenofovir may cause dizziness.Do not drive orride abicycleor operate machinery.

Tenofovir Disoproxilo Glenmark contains lactose

Inform your doctor before taking tenofovirdisoproxilo. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Tenofovir Disoproxilo Glenmark contains phosphates

This medicine contains 46 mg of phosphates in each tablet.

If you suffer severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Yourdoctor or pharmacist.Consult your doctor or pharmacist again in case of doubt.

The recommended dose is:

• Adults:1 tablet per day with food (for example, a meal or an appetizer).
• Adolescents between 12 and less than 18 years who weigh at least 35 kg:1 tablet per day with food (for example, a meal or an appetizer).

If you have special difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then, mix the powder with approximately 100 ml of water (half a glass), orange or grapefruit juice and drink it immediately.

• Always take the recommended dose prescribed by your doctor.This is to ensure that your medication is completely effective, and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

• If you are an adult and have kidney problems,your doctor may advise you to take tenofovir less frequently.

• If you have VHB, your doctor may offer you to undergo a HIV test to see if you have VHB and HIV.

Consult the prospectuses of other antiretrovirals to know how to take these medications.

If you take moreTenofovir Disoproxilo Glenmarkthan you should

If you accidentally took too many tablets of tenofovir, you may be at a higher risk of experiencing possible side effects with this medication (see section 4, Possible side effects).

Consult your doctor or go to the nearest emergency service.

If you have taken more tenofovir than you should, consult your doctor immediately, your pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Carry the packaging of tablets with you so that you can easily describe what you have taken.

If you forgot to takeTenofovir Disoproxilo Glenmark

It is essential not to forget a dose of tenofovir. If you forget a dose, determine how long it has been since you should have taken it.

• If it is less than 12 hourssince when you take it normally, take it as soon as possible, and then take your next dose at your usual time.

• If it is more than 12 hourssince when you should have taken it, do not take the missed dose. Wait and take your next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you vomit before 1 hour after having taken tenofovir,take another tablet.You do not need to take another tablet if you vomited more than an hour after taking tenofovir.

If you interrupt the treatment withTenofovir Disoproxilo Glenmark

Do not stop taking tenofovir without your doctor's advice. Stopping treatment with tenofovir may reduce the effectiveness of the recommended treatment by your doctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection),it is very important that you do not interrupt your treatment with tenofovir without first talking to your doctor. After interrupting treatment with tenofovir, some patients have presented blood test results or symptoms indicating that their hepatitis had worsened. You may need to have blood tests for several months after interrupting treatment. In patients with advanced liver disease or cirrhosis, it is not recommended to interrupt treatment as this may lead to a worsening of their hepatitis.

• Talk to your doctor before stopping taking tenofovir for any reason, particularly if you experience any side effect or have another disease.
• Talk to your doctor immediately if you experience any new or unusual symptom after interrupting your treatment, particularly those symptoms related to the hepatitis virus B infection.
• Contact your doctor before restarting the tablets of tenofovir.

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.andlyípidsintheblood

Like all medications, this medication may produce side effects, although not all people will experience them.

Severe side effects: report to your doctor immediatelyinmediately

• Thelactic acidosis(excess of lactic acid in the blood) is a rare side effect (can affect up to 1 in 1,000 patients) but severe that can be fatal. The following side effects may be signs of lactic acidosis:

• deep andrapid breathing,
• drowsiness,
• nausea, vomiting, and stomach pain.

If you think you may havelactic acidosis, contact your doctor immediately.

Other possible severe side effectsgraves

The following side effects areinfrequent(can affect up to 1 in 100 patients):

• abdominal pain(of the stomach) caused by inflammation of thepancreas,
• damage to the renal tubular cells.

The following side effects arerare(can affect up to 1 in 1,000 patients):

• inflammation of the kidney,increased urine volume and sensation ofthirst,
• changes inyoururineandback paindue to kidney problems, including renal failure,

• weakening of the bones (withbone painand sometimes ending in fractures),whichmay occur due to damage to the renal tubular cells,
• steatosis of the liver.

If you think you may have any of these severe side effects, consult your doctor.

More frequent side effects

The following side effects arevery frequent(can affect more than 1 in 10 patients):

• diarrhea, vomiting, nausea, dizziness, rash, feelingweak.

The tests may also show:

• decrease in blood phosphate levels.

Other possible side effectsadversos

The following side effects arecommon(can affect up to 1 in 10 patients):

• headache, stomach pain, feeling tired, feeling bloated, flatulence, bone loss.

The tests may also show:

• liver problems.

The following side effects areinfrequent(can affect up to 1 in 100 patients):

• muscle rupture, muscle pain or weakness.

The tests may also show:

• decrease in blood potassium levels,
• increase in creatinine levels in blood,
• pancreas problems.

Muscle rupture, bone weakening (with bone pain and sometimes ending in fractures), muscle pain, muscle weakness, and decrease in blood potassium or phosphate levels may occur due to damage to the renal tubular cells.

The following side effects arerare(can affect up to 1 in 1,000 patients):

• abdominal pain (of the stomach) caused by inflammation of theliver,
• swelling of the face, lips, tongue, or throat.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe bottle, packaging or blister packafter CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacyAsk your pharmacist how to dispose of packaging and medicines that you no longer need. This will help protect the environment.

Tenofovir Disoproxilo Glenmark Composition

• The active ingredient istenofovir. Each film-coated tablet contains tenofovir disoproxil phosphate corresponding to 245 mg tenofovir disoproxil.
• The other components are:microcrystalline cellulose, sodium croscarmellose, stearic acid, lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, and aluminium lake indigotin (indigo carmine) (E132).

Appearance of the product and contents of the package

Tenofovir Disoproxilo Glenmark are blue-coated, oval, biconvex film-coated tablets, engraved on one face with “T1” and smooth on the other face, approximately 16.7 x 9.3 mm in size.

Tenofovir Disoproxilo Glenmark is available in plastic bottles. Each bottle contains two silica gel desiccants in bags. The desiccant bags must be kept in the bottle to protect the tablets and must not be swallowed.

The available package sizes are:

• Carton box containing 1 bottle of 30 film-coated tablets.
• Carton box containing 3 bottles of 30 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Ó

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate, Paola,

PL 3000, Malta

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom:Tenofovir Disoproxil Glenmark 245 mg Film-coated Tablets

Germany:Tenofovir Disoproxil Glenmark 245 mg Filmtabletten

Spain:Tenofovir Disoproxilo Glenmark 245 mg comprimidos recubiertos con película EFG

Netherlands:Tenofovir Disoproxil Glenmark 245 mg filmomhulde tabletten

Last review date of this leaflet:July 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)