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ICTASTAN 200MG/ 245MG FILM-COATED TABLETS

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL SUCCINATE

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Package leaflet: Information for the user

Ictastan 200mg/245mg Film-coated Tablets
emtricitabine/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.

Bone problems. Some patients 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 inform your doctor.

What is in this leaflet
1 What Ictastan is and what it is used for
2 What you need to know before you
take Ictastan
3 How to take Ictastan
4 Possible side effects
5 How to store Ictastan
6 C
 ontents of the pack and other
information

Children and adolescents

1  What Ictastan is and what it is used for
Ictastan is a treatment for Human
Immunodeficiency Virus (HIV) infection in
adults aged 18 years and over.
Ictastan contains two active substances,
emtricitabine and tenofovir disoproxil
succinate. Both of these active substances are
antiretroviral medicines which are used to treat
HIV infection. Emtricitabine is a nucleoside
reverse transcriptase inhibitor and tenofovir is
a nucleotide reverse transcriptase inhibitor.
However, both are generally known as NRTIs
and they work by interfering with the normal
working of an enzyme (reverse transcriptase)
that is essential for the virus to reproduce itself.
Ictastan should always be used combined with
other medicines to treat HIV infection. Ictastan
can be administered in place of emtricitabine and
tenofovir disoproxil used separately at the same
doses.
This medicine is not a cure for HIV infection.
While taking Ictastan you may still develop
infections or other illnesses associated with HIV
infection. 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.

2  What you need to know before you

take Ictastan

Do not take Ictastan

• If you are allergic to emtricitabine, 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.

Warnings and precautions

• Tell your doctor if you have had kidney
disease, or if tests have shown problems
with your kidneys. Ictastan may affect your
kidneys. Before starting treatment, your
doctor may order blood tests to assess kidney
function. Your doctor may also order blood tests
during treatment to monitor your kidneys and
may advise you to take the tablets less often.
Ictastan is not recommended if you have severe
kidney disease or are receiving haemodialysis.
Ictastan is not usually taken with other medicines
that can damage your kidneys (see Other
medicines and Ictastan). If this is unavoidable,
your doctor will monitor your kidney function
once a week.
• Talk to your doctor if you are over 65.

Ictastan has not been studied in patients over
65 years of age. If you are older than this and
are prescribed Ictastan, your doctor will monitor
you carefully.
• 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 regimen for you. Both active
substances in Ictastan show some activity
against hepatitis B virus although emtricitabine
is not approved for the treatment of hepatitis B
infection. If you have a history of liver disease
or chronic hepatitis B infection your doctor may
conduct blood tests in order to carefully monitor
liver function.

Other precautions

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 Ictastan
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 Ictastan. 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.

Continued top of next column

Bone problems (sometimes resulting in fractures)
may also occur due to damage to kidney tubule
cells (see section 4, Possible side effects).
Ictastan is not for use in children and adolescents
under 18 years of age.

Other medicines and Ictastan

You should not take Ictastan if you are
already taking other medicines that contain
the components of Ictastan emtricitabine
and tenofovir disoproxil, or any other antiviral
medicines that contain lamivudine or adefovir
dipivoxil.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
• It is especially important to tell your doctor
if you are taking other medicines which may
damage your kidneys.
These include:
• aminoglycosides (for bacterial infection)
• amphotericin B (for fungal infection)
• foscarnet (for viral infection)
• ganciclovir (for viral infection)
• pentamidine (for infections)
• vancomycin (for bacterial infection)
• interleukin-2 (to treat cancer)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs,
to relieve bone or muscle pains).
• Other medicines containing didanosine
(for HIV infection): Taking Ictastan 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 causes death, have been
reported when medicines containing tenofovir
disoproxil and didanosine were taken together.
Your doctor will carefully consider whether to
treat you with combinations of tenofovir and
didanosine.
It is also important to tell your doctor if you are
taking ledipasvir/sofosbuvir to treat hepatitis C
infection.
Do not stop your treatment without
contacting your doctor.

Ictastan with food and drink

• Ictastan should be taken with food.

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.
• You must not take Ictastan during
pregnancy unless specifically discussed with
your doctor. Although there are limited clinical
data on the use of Ictastan in pregnant women,
it is not usually used unless absolutely necessary.
• If you are a woman who could get pregnant
during treatment with Ictastan, 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 therapy with Ictastan to you
and your child.
If you have taken Ictastan during your pregnancy,
your doctor may request regular blood tests
and other diagnostic tests to monitor the
development of your child. In children whose
mothers took NRTIs during pregnancy, the benefit
from the protection against HIV outweighed the
risk of side effects.
• Do not breast-feed during treatment with
Ictastan. This is because the active
substances in this medicine pass into human
breast milk.
• If you are a woman with HIV it is recommended
that you do not breast-feed, to avoid passing the
virus to the baby in breast milk.

Driving and using machines

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

Ictastan contains lactose

Tell your doctor if you are lactose-intolerant
or intolerant to other sugars. Ictastan contains
lactose monohydrate. If you know you are
lactose-intolerant, or if you have been told that
you have an intolerance to any other sugars, talk
to your doctor before taking this medicine.

3 How to take Ictastan
• Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is:
• Adults: one tablet each day with food.
If you have difficulty swallowing, you can use
the tip of a spoon to crush the tablet. Then mix
the powder with about 100 ml (half a glass) of
water, orange juice or grape juice, and drink
immediately.
• Always take the dose recommended by your
doctor. This is to make sure that your
medicine is fully effective, and to reduce the risk
of developing resistance to the treatment. Do
not change the dose unless your doctor tells
you to.
Continued over page

Emtricitabine Tenofovir 200mg & 245mg Film-coated Tablets PIL - UK/IE
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Supplier:
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18.12.17
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• If you have problems with your kidneys,
your doctor may advise you to take Ictastan less
frequently.
• If your doctor decides to stop one of the
components of Ictastan or change the dose of
Ictastan, you may be given emtricitabine and/
or tenofovir separately instead of the combined
medicine or other medicines for the treatment
of HIV infection.
• Your doctor will prescribe Ictastan with other
antiretroviral medicines. Please refer
to the patient information leaflets of the other
antiretrovirals for guidance on how to take
those medicines.

If you take more Ictastan than you should
If you accidentally take more than the
recommended dose of Ictastan, 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 Ictastan

It is important not to miss a dose of Ictastan.
If you do miss a dose of Ictastan within 12
hours of when it is usually taken, take it as soon
as you can, and then take your next dose at its
regular time.
If it is almost time (less than 12 hours) for your
next dose anyway, 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
Ictastan, take another tablet. You do not need to
take another tablet if you were sick more than 1
hour after taking Ictastan.

If you stop taking Ictastan

• Stopping treatment with Ictastan may reduce
the effectiveness of the anti-HIV therapy
recommended by your doctor. Speak with your
doctor before you stop taking Ictastan for any
reason, particularly if you are experiencing any
side effects or you have another illness. Contact
your doctor before you restart taking Ictastan
tablets.
• If you have HIV infection and hepatitis
B, it is especially important not to stop your
Ictastan treatment without talking to your
doctor first. Some patients have had blood
tests or symptoms indicating that their hepatitis
has got worse after stopping Emtricitabine/
Tenofovir disoproxil. You may require blood
tests for several months after stopping
treatment. In some patients with advanced liver
disease or cirrhosis, stopping treatment is not
recommended as this may lead to worsening of
your hepatitis.
Tell your doctor immediately about new or
unusual symptoms after you stop treatment,
particularly symptoms you associate with
hepatitis B infection.
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 lifestyle,
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.
Tell your doctor about any of the following
side effects:
Possible serious side effects: tell a doctor
immediately
The following side effect is rare (this can affect up
to 1 in every 1,000 patients):
•L
 actic acidosis (excess lactic acid in the blood)
is a serious side effect that can be life threatening.
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 you may have lactic acidosis,
contact your doctor immediately.

Other possible serious side effects
The following side effects are uncommon (these
can affect up to 1 in every 100 patients):
• pain in the abdomen (tummy) caused by
inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• damage to kidney tubule cells.
The following side effects are rare (these can
affect up to 1 in every 1,000 patients):
• fatty liver
• yellow skin or eyes, itching, or pain in the
abdomen (tummy) caused by inflammation of
the liver
• inflammation of the kidney, passing a lot of
urine and feeling thirsty, kidney failure,
damage to kidney tubule cells. Your doctor may
do blood tests to see if your kidneys are working
properly
• softening of the bones (with bone pain and
sometimes resulting in fractures).
Damage to kidney tubule cells may be associated
with 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.
If you think that you may have any of these
serious side effects, talk to your doctor.

Other possible side effects
The following side effects are common (these can
affect up to 10 in every 100 patients):
• pain, stomach pain
• difficulty sleeping, abnormal dreams
• problems with digestion resulting in discomfort
after meals, feeling bloated, flatulence
• rashes (including red spots or blotches
sometimes with blistering and swelling of the
skin), which may be allergic reactions, itching,
changes in skin colour including darkening of
the skin in patches
• other allergic reactions, such as wheezing,
swelling or feeling light-headed.

Tests may also show:

• low white blood cell count (a reduced white
blood cell count can make you more prone to
infection)
• increased triglycerides (fatty acids), bile or sugar
in the blood
• liver and pancreas problems.
The following side effects are uncommon (these
can affect up to 1 in every 100 patients):
• anaemia (low red blood cell count)
• breakdown of muscle, muscle pain or weakness
which may occur due to damage to the
kidney tubule cells.

Tests may also show:

• decreases in potassium in the blood
• increased creatinine in your blood
• changes to your urine.
The following side effects are rare (these can
affect up to 1 in every 1,000 patients):
• back pain caused by kidney problems.

Other possible effects

Children who were administered emtricitabine,
one of the components of Ictastan, also
experienced anaemia (low red blood cell count),
commonly and changes in skin colour including
darkening of the skin in patches, very commonly.
If the production of red blood cells is reduced,
a child may have symptoms of tiredness or
breathlessness.

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
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace,
Dublin 2 - IRL
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
United Kingdom
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 Ictastan
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 in the original package in order to protect
from moisture.
Keep the container tightly closed.
Use within 30 days after first opening; store under
25 oC.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6  Contents of the pack and other

information

What Ictastan contains

• The active substances are emtricitabine and
tenofovir.
Each Ictastan 200mg/245mg Film-coated Tablet
contains 200mg of emtricitabine and 245mg of
tenofovir disoproxil (equivalent to 300.6mg of
tenofovir disoproxil succinate).
• The other ingredients are lactose
monohydrate, microcrystalline cellulose (E460),
starch pregelatinised maize, croscarmellose
sodium, magnesium stearate (E470b), poly(vinyl
alcohol) (E1203), titanium dioxide (E171),
macrogol 4000 (E1521), talc (E553b), indigo
carmine aluminium lake (E132).

What Ictastan looks like and contents of
the pack

Ictastan 200mg/245mg Film-coated Tablets
are blue coloured, capsule shaped film-coated
tablets, plain on both sides. The dimensions of the
tablet are 19.3mm x 8.8mm± 5%.
Ictastan 200mg/245mg Film-coated Tablets are
supplied in HDPE bottles of 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.
30 (1 x 30) film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

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, headache, rash
• feeling weak.

Manufacturer
Remedica Ltd
Aharnon Street
Limassol Industrial Estate
Limassol
3056
Cyprus

Tests may also show:

This leaflet was last revised in November 2017

Most frequent side effects

• decreases in phosphate in the blood
• increased creatine kinase.

Continued top of next column

If you would like a
leaflet with larger text,
please contact
+44 (0) 1271 385257
Actavis, Barnstaple, EX32 8NS, UK
Actavis Ireland, Euro Hs, Little Island, Cork

BBBA1516

Emtricitabine Tenofovir 200mg & 245mg Film-coated Tablets PIL - UK/IE
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

4

BBBA1516
Dimensions:
157 x 490
Min Body Text Size: 9pt
Supplier:
Remedica Ltd

C. Grant
27/11/17
18.12.17
S.Anson

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
27/11/17
Date received: 18.12.17

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Version 2
01.11.2017

+ 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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