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ICTADY 245MG FILM-COATED TABLETS

Active substance(s): 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  What 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.

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:
- a minoglycosides, pentamidine or vancomycin
(for bacterial infection)
- amphotericin B (for fungal infection),
- f oscarnet, ganciclovir, or cidofovir (for viral
infection)
- interleukin-2 (to treat cancer)
- adefovir dipivoxil (for HBV)
- t acrolimus (for suppression of the immune
system)
-n
 on-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.
Ictady with food and drink
Take Ictady with food (for example, a meal or a
snack).

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.

Pregnancy and breast-feeding

•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.

•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.

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.

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Tenofovir Disoproxil (Ictady) 245mg 30 Tablets PIL - UK
item no: AAAI8648

dimensions: 157 x 490

print proof no: 5

pharmacode:

origination date: 15.03.16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 31.03.16

Technical Approval

revised by: S.Anson

date sent: 15.03.16 + 29.03.16

supplier: Remedica Ltd

technically app. date:

Non Printing Colours
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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 the virus
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.

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
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.

Other possible serious side effects

The following side effect is uncommon (this can
affect up to 1 in every 100 patients):
•p
 ain in the tummy (abdomen) caused by
inflammation of the pancreas.
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, damage to kidney
tubule cells
• 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

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.

•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.

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.

If you take more Ictady than you should

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

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.
• Talk to your doctor before you stop taking
Ictady 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
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 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

By reporting side effects you can help provide
more information on the safety of this medicine.

5 How to store Ictady
•K
 eep this medicine out of the sight and reach
of children.
•D
 o 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.
• T his medicine does not require any special
storage conditions.
•U
 se within 30 days after first opening; store
under 25oC.
•D
 o 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 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 March 2016

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

Continued top of next column
AAAI8648

Actavis, Barnstaple, EX32 8NS, UK

Tenofovir Disoproxil (Ictady) 245mg 30 Tablets PIL - UK
item no: AAAI8648

dimensions: 157 x 490

print proof no: 5

pharmacode:

origination date: 15.03.16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 31.03.16

Technical Approval

revised by: S.Anson

date sent: 15.03.16 + 29.03.16

supplier: Remedica Ltd

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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