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DRELBISTA 245 MG FILM-COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL FUMARATE / TENOFOVIR DISOPROXIL FUMARATE

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Drelbista 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.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor 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 or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

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What is in this leaflet:
1. What Drelbista is and what it is used for
2. What you need to know before you take Drelbista
3. How to take Drelbista
4. Possible side effects
5. How to store Drelbista
6. Contents of the pack and other information
If Drelbista 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 Drelbista is and what it is used for
Drelbista 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 should always be used combined with other medicines to treat HIV
infection.

Drelbista 245 mg film-coated tablets
tenofovir disoproxil

Pharmacode
Area

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This medicine is used for treatment for HIV (Human Immunodeficiency Virus) infection. The
tablets are suitable for:
• adults
• adolescents aged 12 to 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.
This medicine is also used for the treatment for chronic hepatitis B, an infection caused by
HBV (hepatitis B virus). These tablets are suitable for:
• adults
• adolescents aged 12 to 18 years.
You do not have to have HIV to be treated with Tenofovir disoproxil for HBV.
This medicine is not a cure for HIV infection. While taking Drelbista 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.

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2. What you need to know before you take Drelbista

Pharmacode
Area
Drelbista 245 mg film-coated tablets
tenofovir disoproxil

Do not take Drelbista
• If you are allergic to Tenofovir alafenamide, 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 don’t take Drelbista.
Warnings and precautions
Talk to your doctor or pharmacist before taking Drelbista

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• 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 you need to take to avoid infecting other people. Drelbista
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 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 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 is not usually taken with other medicines that can damage your kidneys
(see Other medicines and Drelbista). If this is unavoidable, your doctor will monitor your
kidney function once a week.

Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney
tubule cells (see section 4. Possible side effects).
• 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 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. 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.
Elderly
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 this medicine
your doctor will monitor you carefully.
Children and adolescents
This medicine is suitable for:
• HIV-1 infected adolescents aged 12 to 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 18 years who weigh at least 35 kg.

Pregnancy
You must not take Drelbista during pregnancy unless specifically discussed with your doctor.
Although there are limited clinical data on the use of Tenofovir disoproxil in pregnant women,
it is not usually used unless absolutely necessary.
Try to avoid getting pregnant during treatment with Tenofovir disoproxil. You must use an
effective method of contraception to avoid becoming pregnant.
If you become pregnant, or plan to become pregnant, ask your doctor about the potential
benefits and risks of your antiretroviral therapy for you and your child.
If you have taken Drelbista 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 the virus
outweighed the risk of side effects.
Breast-feeding
Do not breast-feed during treatment with Drelbista. This is because the active substance in
this medicine passes into human breast milk.
If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby
in breast milk.
Driving and using machines
Drelbista can cause dizziness. If you feel dizzy while taking this medicine, do not drive or ride
a bicycle and do not use any tools or machines.
Drelbista contains lactose
Tell your doctor before taking Drelbista if you cannot tolerate lactose or if you have an
intolerance to any other sugars.

3. How to take Drelbista
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 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.

This medicine is 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.

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.

For dosage see section 3, How to take Drelbista

If you are an adult and have problems with your kidneys, your doctor may advise you to take
Tenofovir disoproxil less frequently.

Other medicines and Drelbista
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
• Do not stop any anti-HIV medicines prescribed by your doctor when you start Drelbista if
you have both HBV and HIV.
• Do not take Drelbista if you are already taking other medicines containing tenofovir
disoproxil or Tenofovir alafenamide. Do not take this medicine 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
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 fumarate 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 or
sofosbuvir/velpatasvir to treat hepatitis C infection.
Drelbista with food and drink
Take Drelbista 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.

If you have HBV your doctor may ask you to have 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.
If you take more Drelbista than you should
If you accidentally take too many Tenofovir disoproxil 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 Drelbista
It is important not to miss a dose of Tenofovir disoproxil. If you miss a dose, work out how long
it is 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 Drelbista, take another tablet. You do not
need to take another tablet if you were sick more than 1 hour after taking Tenofovir disoproxil.
If you stop taking Drelbista
Do not stop taking Tenofovir disoproxil without your doctor’s advice. Stopping treatment with
this medicine 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 treatment without talking to your doctor first. Some patients
have had blood tests or symptoms indicating that their hepatitis has got worse after stopping to
take this medicine. You may be required to have blood tests for several months after stopping
treatment with this medicine. In some patients with advanced liver disease or cirrhosis, stopping
treatment is not recommended as this may lead to worsening of their hepatitis.
• Talk to your doctor before you stop taking Tenofovir disoproxil 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 tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Package leaflet: information for the user

• 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.

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During HIV therapy you may have 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.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

What Drelbista contains

Possible serious side effects: tell your doctor immediately

The active substance is tenofovir. Each Drelbista tablet contains 245 mg of tenofovir disoproxil
(as fumarate).

• 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

The other ingredients are Magnesium stearate, Microcrystalline cellulose, Croscarmellose
sodium which make up the tablet core, and Lactose monohydrate, Hypromellose (E464),
Titanium dioxide (E171), Triacetin, Indigo Carmine Aluminium lake (E132) which make up the
tablet coating. Refer to section 2 “Drelbista contains lactose”.
What Drelbista looks like and contents of the pack
Drelbista 245 mg film-coated tablets are Blue, Oval shaped, biconvex film coated tablets
debossed with '300' on one side and plain on other side
The carton contains a high density polyethylene (HDPE) bottle[s] with a tamper evident seal
across the neck of the bottle. The bottle is closed with a child-resistant screw cap. Each bottle
contains two or three silica gel desiccants in amongst the tablets to protect them from
moisture and should not be eaten or removed once the bottle is opened.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated
tablets, 1 bottle of 100 film-coated tablets and outer cartons containing 90 (3 bottles of 30)
film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufaturer
Lupin (Europe) Ltd
Victoria Court, Bexton Road,
Knutsford, Cheshire
WA16 0PF
United Kingdom
This leaflet was last approved in July 2017

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4. Possible side effects

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 MHRA Yellow
Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Drelbista
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.
Store below 25°C.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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