Skip to Content

ICTASTAN 200MG/ 245MG FILM-COATED TABLETS

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL SUCCINATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
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.
Contents of the pack and other information

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.
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.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney
tubule cells (see section 4, Possible side effects).

Children and adolescents
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.

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.



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

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):
• Lactic 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.
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.
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, headache, rash

feeling weak.
Tests may also show:

decreases in phosphate in the blood

increased creatine kinase.
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.
Ictastan may change your body shape, by changing the way body fat is distributed. You may
lose fat from your legs, arms and face; gain fat around the abdomen (tummy) and internal
organs; get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’). The cause
and the long-term effects of these changes are not yet known.
Ictastan may also cause hyperlipaemia (increased fats in the blood) and resistance to insulin.
Your doctor will test for these changes.
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 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 19.3 mm 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
90 (3 x 30) film-coated tablets

Not all pack sizes may be marketed.
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.

Pil Spec no

Logo Actavis
Actavis, Barnstaple, EX32 8NS, UK

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.

Hide