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ICTADY 245MG FILM-COATED TABLETS

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

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Package leaflet: Information for the patient

Ictady 245mg Film-coated Tablets
Tenofovir disoproxil
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• K eep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
•  T his 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.

What is in this leaflet
1 What Ictady is and what it is used for
2 W
 hat you need to know before you
take Ictady
3 How to take Ictady
4 Possible side effects
5 How to store Ictady
6 C
 ontents of the pack and other
information
If Ictady 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 Ictady is and what it is used for
Ictady contains the active substance tenofovir
disoproxil succinate. 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 Ictady should always
be used combined with other medicines to treat
HIV infection.
Ictady 245mg tablets are a treatment for HIV
(Human Immunodeficiency Virus) infection. The
tablets are suitable for:
• adults
• a dolescents 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.
Ictady 245mg 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
Ictady for HBV.
This medicine is not a cure for HIV infection. While
taking Ictady 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 Ictady

Do not take Ictady

• I f you are allergic to tenofovir, tenofovir
disoproxil succinate 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 Ictady.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Ictady.
•T
 ake 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. Ictady 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.
•T
 alk to your doctor or pharmacist if you have
had kidney disease or if tests have shown
problems with your kidneys. Ictady should
not be given to adolescents with existing kidney
problems. Before starting treatment, your doctor
may order blood tests to assess your kidney
function. Ictady 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.
Ictady is not usually taken with other medicines
that can damage your kidneys (see Other
medicines and Ictady). If this is unavoidable, your
doctor will monitor your kidney function once a
week.
•B
 one 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 (sometimes resulting in fractures)
may also occur due to damage to kidney tubule
cells (see section 4, Possible side effects).

•T
 alk 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.
• L ook 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 Ictady
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 Ictady. 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.
•T
 alk to your doctor or pharmacist if you are
over 65. Ictady has not been studied in patients
over 65 years of age. If you are older than this and
are prescribed Ictady, your doctor will monitor
you carefully.

Children and adolescents
Ictady 245mg tablets are suitable for:
•H
 IV-1 infected adolescents aged 12 to less
than 18 years who weigh at least 35kg 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.
•H
 BV infected adolescents aged 12 to less than
18 years who weigh at least 35kg.
Ictady 245mg tablets are not suitable for the
following groups:
•N
 ot for HIV-1 infected children under 12 years
of age
•N
 ot for HBV infected children under 12 years
of age.
For dosage see section 3, How to take Ictady.

Other medicines and Ictady

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
•D
 on’t stop any anti-HIV medicines prescribed
by your doctor when you start Ictady if you have
both HBV and HIV.
•D
 o not take Ictady if you are already taking other
medicines containing tenofovir disoproxil. Do not
take Ictady together with medicines containing
adefovir dipivoxil (a medicine used to treat
chronic hepatitis B).
• I t 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).
•O
 ther medicines containing didanosine (for
HIV infection): Taking Ictady 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.
• I t is also important to tell your doctor if you are
taking ledipasvir/sofosbuvir to treat hepatitis C
infection.
Ictady with food and drink
Take Ictady 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.
•Y
 ou must not take Ictady during pregnancy
unless specifically discussed with your doctor.
Although there are limited clinical data on the
use of Ictady in pregnant women, it is not usually
used unless absolutely necessary.
•T
 ry to avoid getting pregnant during treatment
with Ictady. You must use an effective method of
contraception to avoid becoming pregnant.
• I f you become pregnant, or plan to become
pregnant, ask your doctor about the potential
benefits and risks of your antiretroviral therapy to
you and your child.
• I f you have taken Ictady 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 medicines like Ictady (NRTIs) during
pregnancy, the benefit from the protection
against HIV outweighed the risk of side effects.

Continued top of next column

Continued over page

Tenofovir Disoproxil (Ictady) 245mg PIL - UK/Ireland
BBBA0435

04

157 x 490

C.Grant
17/01/17
0/01/17
C.Grant

9pt
Remedica Ltd
17/01/17
25/01/17

1. Black

1.

2.

2.

3.

3.

4.

4.

5.

5.

6.

6.

•D
 o not breast-feed during treatment with
Ictady. 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 breastfeed, to avoid passing the virus to the baby in
breast milk.

Driving and using machines

Ictady can cause dizziness. If you feel dizzy while
taking Ictady, do not drive or ride a bicycle and
do not use any tools or machines.

Ictady contains lactose

Tell your doctor before taking Ictady if
you cannot tolerate lactose or if you have an
intolerance to any other sugars.

3 How to take Ictady

• c hanges to your urine and back pain caused by
kidney problems, including kidney failure
• s oftening 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):
•d
 iarrhoea, being sick (vomiting), feeling sick
(nausea), dizziness, rash, feeling weak
Tests may also show:
- decreases in phosphate in the blood.

Other possible side effects

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:

•A
 dults: 1 tablet each day with food (for example,
a meal or a snack).
•A
 dolescents aged 12 to less than 18 years who
weigh at least 35kg: 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 100ml (half a glass)
of water, orange juice or grape juice and drink
immediately.
•A
 lways 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.
• I f you are an adult and have problems with
your kidneys, your doctor may advise you to
take Ictady 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.

If you take more Ictady than you should

If you accidentally take too many Ictady 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 Ictady

It is important not to miss a dose of Ictady. If you
miss a dose, work out how long since you should
have taken it.
• I f 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.
• I f 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
Ictady, take another tablet. You do not need to
take another tablet if you were sick more than 1
hour after taking Ictady.

If you stop taking Ictady

Don’t stop taking Ictady without your doctor’s
advice. Stopping treatment with Ictady 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 Ictady treatment without talking to your
doctor first. Some patients have had blood tests
or symptoms indicating that their hepatitis has got
worse after stopping Ictady. 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.
• T alk to your doctor before you stop taking Ictady
for any reason, particularly if you are experiencing
any side effects or you have another illness.
• T ell 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
Ictady 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

• L actic 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
- f eeling 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):
•p
 ain in the tummy (abdomen) caused by
inflammation of the pancreas.
•d
 amage 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

The following side effects are common (these can
affect up to 10 in every 100 patients):
•h
 eadache, 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):
•b
 reakdown 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):
•p
 ain 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace , IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5 How to store Ictady
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.
This medicine does not require any special storage
conditions.
 se within 30 days after first opening; store under
U
25oC.
 o not throw away any medicines via wastewater
D
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 Ictady contains
•T
 he active substance is tenofovir.
Each Ictady tablet contains 245mg of tenofovir
disoproxil (as succinate).
•T
 he other ingredients are:
lactose anhydrous, microcrystalline cellulose
112 (E460), pregelatinised starch, croscarmellose
sodium and magnesium stearate (E470b) which
make up the tablet core, and Indigo Carmine
Aluminium Lake (E132), titanium dioxide (E171),
Poly(Vinyl Alcohol) (E1203), Macrogol 4000
(E1521) and Talc (E553b) which make up the
tablet coating. Refer to section 2 “Ictady contains
lactose”.

What Ictady looks like and contents of the
pack

Ictady 245mg Film-coated Tablets are light blue,
almond-shaped, with dimensions of approximately
17.0mm x 10.5mm.
Ictady 245mg Film-coated Tablets are supplied in
bottles containing 30 tablets. Each bottle contains
a silica gel desiccant that must be kept in the bottle
to help protect your tablets. The silica gel desiccant
is contained in a separate canister and should not
be swallowed.
The following pack size is available:
30 (1 x 30) film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Remedica Ltd
Aharnon Street
Limassol Industrial Estate
Limassol
3056
Cyprus
This leaflet was last revised in January 2017

If you would like a
leaflet with larger
text, please contact
UK: 01271 385257
IE: 1890 333231

Continued top of next column
BBBA0435

Actavis, Barnstaple, EX32 8NS, UK
Actavis Ireland, Euro Hs, Little Island, Cork

Tenofovir Disoproxil (Ictady) 245mg PIL - UK/Ireland
BBBA0435

04

157 x 490

C.Grant
17/01/17
0/01/17
C.Grant

9pt
Remedica Ltd
17/01/17
25/01/17

1. Black

1.

2.

2.

3.

3.

4.

4.

5.

5.

6.

6.

Package leaflet: Information for the patient

Ictady 245mg Film-coated Tablets
Tenofovir disoproxil
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K
 eep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
•  T his 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.

What is in this leaflet
1 What Ictady is and what it is used for
2 W
 hat you need to know before you
take Ictady
3 How to take Ictady
4 Possible side effects
5 How to store Ictady
6 C
 ontents of the pack and other
information
If Ictady 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 Ictady is and what it is used for
Ictady contains the active substance tenofovir
disoproxil succinate. 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 Ictady should
always be used combined with other medicines
to treat HIV infection.
Ictady 245mg tablets are a treatment for HIV
(Human Immunodeficiency Virus) infection. The
tablets are suitable for:
• adults
•a
 dolescents 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.
Ictady 245mg 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
Ictady for HBV.
This medicine is not a cure for HIV infection. While
taking Ictady 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 Ictady

Do not take Ictady

• I f you are allergic to tenofovir, tenofovir
disoproxil succinate 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 Ictady.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Ictady.
•T
 ake 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. Ictady 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.
•T
 alk to your doctor or pharmacist if you have
had kidney disease or if tests have shown
problems with your kidneys. Ictady should
not be given to adolescents with existing kidney
problems. Before starting treatment, your
doctor may order blood tests to assess your
kidney function. Ictady 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.
Ictady is not usually taken with other medicines
that can damage your kidneys (see Other
medicines and Ictady). If this is unavoidable,
your doctor will monitor your kidney function
once a week.
•B
 one 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 (sometimes resulting in fractures)
may also occur due to damage to kidney tubule
cells (see section 4, Possible side effects).
•T
 alk 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.
• L ook 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
Ictady 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 Ictady. 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.
•T
 alk to your doctor or pharmacist if you are
over 65. Ictady has not been studied in patients
over 65 years of age. If you are older than this
and are prescribed Ictady, your doctor will
monitor you carefully.

Children and adolescents
Ictady 245mg tablets are suitable for:
•H
 IV-1 infected adolescents aged 12 to less
than 18 years who weigh at least 35kg 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.
•H
 BV infected adolescents aged 12 to less
than 18 years who weigh at least 35kg.
Ictady 245mg tablets are not suitable for the
following groups:
•N
 ot for HIV-1 infected children under 12 years
of age
•N
 ot for HBV infected children under 12 years
of age.
For dosage see section 3, How to take Ictady.

Other medicines and Ictady

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
•D
 on’t stop any anti-HIV medicines prescribed
by your doctor when you start Ictady if you have
both HBV and HIV.
•D
 o not take Ictady if you are already taking
other medicines containing tenofovir disoproxil.
Do not take Ictady together with medicines
containing adefovir dipivoxil (a medicine used
to treat chronic hepatitis B).
• I t 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).
•O
 ther medicines containing didanosine
(for HIV infection): Taking Ictady 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.
• I t is also important to tell your doctor if you
are taking ledipasvir/sofosbuvir to treat hepatitis
C infection.
Ictady with food and drink
Take Ictady 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.
•Y
 ou must not take Ictady during pregnancy
unless specifically discussed with your doctor.
Although there are limited clinical data on
the use of Ictady in pregnant women, it is not
usually used unless absolutely necessary.
•T
 ry to avoid getting pregnant during
treatment with Ictady. You must use an effective
method of contraception to avoid becoming
pregnant.
• I f you become pregnant, or plan to become
pregnant, ask your doctor about the potential
benefits and risks of your antiretroviral therapy
to you and your child.

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• I f you have taken Ictady 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 medicines like
Ictady (NRTIs) during pregnancy, the benefit
from the protection against HIV outweighed the
risk of side effects.
•D
 o not breast-feed during treatment with
Ictady. 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.

Other possible serious side effects

Ictady can cause dizziness. If you feel dizzy while
taking Ictady, do not drive or ride a bicycle and
do not use any tools or machines.

The following side effects are uncommon (this
can affect up to 1 in every 100 patients):
•p
 ain in the tummy (abdomen) caused by
inflammation of the pancreas.
•d
 amage 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
• c hanges to your urine and back pain caused
by kidney problems, including kidney failure
• s oftening 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.

Ictady contains lactose

Most frequent side effects

Driving and using machines

Tell your doctor before taking Ictady if
you cannot tolerate lactose or if you have an
intolerance to any other sugars.

3 How to take Ictady
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:

•A
 dults: 1 tablet each day with food (for
example, a meal or a snack).
•A
 dolescents aged 12 to less than 18 years
who weigh at least 35kg: 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 100ml (half a
glass) of water, orange juice or grape juice and
drink immediately.
•A
 lways 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.
• I f you are an adult and have problems with
your kidneys, your doctor may advise you to
take Ictady 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.

If you take more Ictady than you should

If you accidentally take too many Ictady 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 Ictady

It is important not to miss a dose of Ictady. If you
miss a dose, work out how long since you should
have taken it.
• I f 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.
• I f 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
Ictady, take another tablet. You do not need to
take another tablet if you were sick more than 1
hour after taking Ictady.

If you stop taking Ictady

Don’t stop taking Ictady without your doctor’s
advice. Stopping treatment with Ictady 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 Ictady treatment without talking
to your doctor first. Some patients have had
blood tests or symptoms indicating that their
hepatitis has got worse after stopping Ictady.
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.
• T alk to your doctor before you stop taking
Ictady for any reason, particularly if you are
experiencing any side effects or you have
another illness.
• T ell 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
Ictady 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

• L actic 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
- f eeling sick (nausea), being sick (vomiting) and
stomach pain.
If you think that you may have lactic acidosis,
contact your doctor immediately.

The following side effects are very common
(these can affect at least 10 in every 100 patients):
•d
 iarrhoea, 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):
•h
 eadache, 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):
•b
 reakdown 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):
•p
 ain 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the 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 Ictady
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.
This medicine does not require any special
storage conditions.
 se within 30 days after first opening; store
U
under 25oC.
 o not throw away any medicines via wastewater
D
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 Ictady contains
•T
 he active substance is tenofovir.
Each Ictady tablet contains 245mg of tenofovir
disoproxil (as succinate).
•T
 he other ingredients are:
lactose anhydrous, microcrystalline cellulose
112 (E460), pregelatinised starch, croscarmellose
sodium and magnesium stearate (E470b) which
make up the tablet core, and Indigo Carmine
Aluminium Lake (E132), titanium dioxide
(E171), Poly(Vinyl Alcohol) (E1203), Macrogol
4000 (E1521) and Talc (E553b) which make up
the tablet coating. Refer to section 2 “Ictady
contains lactose”.

What Ictady looks like and contents of
the pack
Ictady 245mg Film-coated Tablets are light
blue, almond-shaped, with dimensions of
approximately 17.0mm x 10.5mm.

Ictady 245mg Film-coated Tablets are supplied
in bottles containing 30 tablets. Each bottle
contains a silica gel desiccant that must be kept
in the bottle to help protect your tablets. The
silica gel desiccant is contained in a separate
canister and should not be swallowed.
The following pack size is available:
30 (1 x 30) film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Remedica Ltd
Aharnon Street
Limassol Industrial Estate
Limassol
3056
Cyprus
This leaflet was last revised in September
2016

If you would like a
leaflet with larger text,
please contact
01271 385257.

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BBBA0027

Actavis, Barnstaple, EX32 8NS, UK

Tenofovir Disoproxil (Ictady) 245mg PIL - UK
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27/09/16
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Remedica Ltd
19/09/16
23/09/16

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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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