LOZANOC 50 MG HARD CAPSULES

Package leaflet: Information for the user

50 mg
Hard Capsules Itraconazole

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.

In this leaflet
1 What Lozanoc is and what it is used
for
2 What you need to know before you
take Lozanoc
3 How to take Lozanoc
4 Possible side effects
5 How to store Lozanoc
6 Contents of the pack and further
information

1 What Lozanoc is and
what it is used for
Lozanoc belongs to a group of medicines
called antimycotics for systemic use, also
called anti-fungal medicines.
Lozanoc is used to treat fungal infections,
including those caused by yeasts. These
infections may affect:
• the skin
• the lungs
• the nails
• internal organs

2 What you need to
know before you
take Lozanoc
Don’t take Lozanoc:
• if you are allergic (hypersensitive)
to itraconazole or any of the other
ingredients of Lozanoc (listed in
Section 6)
• if you are taking any of the medicines
in the first list under ‘Other medicines
and Lozanoc’, below.
➢ Check with your doctor if you think
either of these applies to you.
Warnings and precautions
Tell your doctor before you start to take
Lozanoc:
• if you have, or have had, a problem
with your liver. If your doctor decides to
prescribe Lozanoc, your dose may need
to be adjusted. You will also need to
look out for symptoms that may appear
while you’re taking Lozanoc. Read
Section 4, ‘Possible side effects’, for
more information. If you take Lozanoc
for more than one month continuously,
your doctor may ask you to have regular
blood tests.
• if you have, or have had, a problem
with your heart. If your doctor decides
to prescribe Lozanoc, you will need to
look out for symptoms that may appear
while you’re taking it. Read Section
4, ‘Possible side effects’, for more
information.
• if you have, or have had, a problem with
your kidneys. If your doctor decides to
prescribe Lozanoc, your dose may need
to be adjusted.
• if you are HIV-positive, or have acquired
immune deficiency syndrome (AIDS),
or any condition which means your
immune system isn’t working as well as
it should be.
• if you have ever had an allergic
reaction to any other anti-fungal
medicine.
Lozanoc can, very rarely, cause hearing
loss, which usually gets better when you
stop taking it, but can be permanent.

Other medicines and Lozanoc
Tell your doctor or pharmacist before
taking Lozanoc if you’re taking, have
recently taken, or might take any other
medicines, including herbal medicines
or other medicines you bought without a
prescription.
Don’t take Lozanoc if you are taking
any of the following medicines:
• antihistamines for hay fever or
allergies, containing terfenadine,
astemizole or mizolastine
• some medicines to treat angina or
high blood pressure, such as bepridil
or nisoldipine
• some medicines (statins) to lower
cholesterol, such as lovastatin or
simvastatin
• some medicines to treat anxiety or to
help you sleep (tranquilisers), such as
midazolam (by mouth) or triazolam
• eletriptan, to treat migraine
• some medicines (ergot alkaloids) to
treat migraine, such as ergotamine and
dihydroergotamine
• some medicines (ergot alkaloids) given
after childbirth, such as asergotamine
(ergonovine) and methylergometrine
(methylergonovine)
• some medicines to treat mental health
problems, such as pimozide and
sertindole
• some medicines to treat irregular heart
rhythms, such as quinidine, dofetilide
and dronedarone
• levacetylmethadol, to treat drug
addiction (opioid dependency)
• cisapride, to treat some digestive
problems.
➢ Tell your doctor and don’t take
Lozanoc, if you are taking any of
these or if you are not sure.
Some medicines may make Lozanoc
work less effectively:
• some medicines to treat epilepsy,
such as carbamazepine, phenytoin and
phenobarbital
• some medicines to treat tuberculosis
(TB), such as rifampicin, rifabutin and
isoniazid

➢ Tell your doctor if you are taking any
of these, as your dose of Lozanoc may
need to be adjusted.
With some medicines and Lozanoc,
your dose may need to be adjusted:
If you take Lozanoc at the same time
as some medicines, either your dose
of Lozanoc or your dose of the other
medicine may need to be adjusted. These
medicines include:
• antibiotics for bacterial infections
called clarithromycin or erythromycin
• some drugs that act on the heart and
blood vessels (digoxin, disopyramide
and some calcium channel blockers
such as dihydropyridines, verapamil
and cilostazol)
• medicines that thin the blood (reduce
blood clotting), such as warfarin and
dabigatran
• some medicines given by mouth
or injection to treat inflammation,
asthma and allergies, such as
methylprednisolone, budesonide,
fluticasone and dexamethasone
• medicines given after an organ
transplant, to prevent rejection,
such as ciclosporin, tacrolimus and
rapamycin (also named sirolimus)
• some medicines to treat viral
infections, such as ritonavir, indinavir
and saquinavir
• some medicines to treat cancer,
such as busulphan, docetaxel and
trimetrexate and vinca alkaloids
• some medicines to treat anxiety or to
help you sleep (tranquilisers), such as
buspirone, alprazolam and brotizolam
• fentanyl, a strong painkiller
• alfentanil, a painkiller
• atorvastatin, to lower cholesterol
• halofantrine, to treat malaria
• repaglinide, to treat diabetes
• ebastine, to treat allergies
• reboxetine, to treat depression
• midazolam, to treat anxiety or to help
you sleep (tranquiliser), when given by
intravenous injection.
➢ Tell your doctor if you are taking any
of these or if you are not sure.

Lozanoc with food and drink
Lozanoc capsules may be taken with
or without food (although you may have
previously been told you should take other
anti-fungal medicines after a full meal).
Pregnancy and breast-feeding
Don’t take Lozanoc if you are pregnant
Tell your doctor and don’t take
Lozanoc if you are pregnant, if you
think you may be pregnant or if you are
planning to have a baby.
If you could become pregnant, use
reliable contraception (birth control)
while you are taking Lozanoc. After you
have finished your course of Lozanoc,
carry on using reliable contraception
until after your next menstrual period.
If you are breast-feeding
➢ Ask your doctor before you take
Lozanoc. Small amounts of the
medicine can pass into breast milk.
Children and older people
Lozanoc is not recommended for children
or older people unless the potential
benefits outweigh the risks.
Driving and using machines
Taking Lozanoc will not usually affect
your ability to drive or use machines. But,
very rarely, Lozanoc can cause dizziness,
ringing in the ears (tinnitus) and hearing
loss. Don’t drive or use machines unless
you are feeling well.

3 How to take Lozanoc
Always take Lozanoc exactly as your
doctor has told you to. Check with your
doctor or pharmacist if you are not sure.
Swallow the capsules with water. Lozanoc
can be taken with or without food.
How much to take
Lozanoc capsules give you twice as much
of the active medicine, itraconazole, as
other anti-fungal capsules you may have
taken before. So a 50 mg capsule
of Lozanoc gives you as much medicine
as other brands of 100 mg itraconazole
capsule.
TURN OVER

What to expect from Lozanoc
treatment
Don’t worry if you don’t see an immediate
improvement after your treatment.
• With skin infections, the marks or
spots (lesions) typically disappear a
few weeks after you finish the course.
Although the medicine kills the fungus,
the marks don’t disappear until after
new skin has grown.
• With nail infections, marks on the nail
may take 6 to 9 months to disappear,
because new nail needs to grow.
➢ Ask your doctor or pharmacist if
you’re not sure whether the treatment
is working.
Type of infection

If you take more Lozanoc than
you should
Contact your nearest hospital
Emergency department or your
doctor immediately:
• if you (or someone else) swallow a lot of
Lozanoc capsules
• if you think a child has swallowed any
Lozanoc capsules.
Take this leaflet, any remaining
capsules and the container with you to
the hospital or doctor, so they know what
medicine was swallowed.
If you forget to take Lozanoc
If you forget to take a dose, take the next
dose as usual. Then continue with the
course until all the capsules are finished.
Don’t take a double dose to make up for a
missed dose.
If you stop taking Lozanoc
If you stop taking Lozanoc before you
have finished all the capsules in your
course, your infection may not be fully
treated and may come back.
Don’t stop until you have finished the
course, even if you feel better.

How many capsules?
(see the note above)

How long to take
Lozanoc

Pityriasis versicolor (tinea
versicolor, a skin infection,
usually on the chest and back)

2 capsules once a day

7 days

Skin infection in the
groin, arms or legs

1 capsule once a day

2 weeks

Athlete’s foot
Skin infection on the hand

1 capsule once a day

4 weeks

Infections of the nails

2 capsules once a day

12 weeks

Internal infections

1 to 2 capsules once or
twice a day

Depends on how the
infection responds.
Your doctor will advise.

4 Possible side effects
Like all medicines, Lozanoc can cause
side effects, although not everyone gets
them.
Symptoms that need
immediate attention

Stop taking Lozanoc and contact
a doctor immediately, or go to
your nearest hospital’s Emergency
department if you get:
• swelling of the lips, face or neck
• severe difficulty in breathing
• itchy, lumpy skin rash (hives)

These can be signs of a very rare but very
serious allergic reaction. You might need to
be treated in hospital.
Stop taking Lozanoc and contact a
doctor immediately if you get:
• yellowing of the skin or eyes (jaundice)
• loss of appetite, feeling sick (nausea),
being sick (vomiting)
• abdominal (stomach) pain
• tiredness, muscle weakness
• darker urine or paler stools (poo) than
normal
• hair loss
• a tingling sensation, numbness or
weakness in the arms or legs
• a severe skin rash
• shortness of breath
• rapid, unexpected weight gain
• swelling of the legs or abdomen
• unusual tiredness
• waking up more than usual during the
night
These could be signs of very rare effects
on your liver or your heart.
It is especially important to look out for
these symptoms if you have already had
problems with your liver or your heart.
Common side effects
These may affect up to 1 in 10 people:
• stomach ache, feeling sick (nausea)
Uncommon side effects
These may affect up to 1 in 100 people:
• problems with periods
• headache, dizziness
• constipation, diarrhoea, wind, being sick
(vomiting), indigestion, change in taste.
• swelling due to fluid under the skin
• unusual hair loss or thinning (alopecia)
Rare side effects
These may affect up to 1 in 1000 people:
• increases in liver function tests (shown
by blood tests)
• unexpected passing of urine or need to
urinate (pass water) more often
• problems with sight including blurred
vision and double vision

• certain blood disorders which may
increase the risk of bleeding, bruising
or infections
• ringing in your ears
• severe upper stomach pain, often with
nausea and vomiting
• fever or high temperature
The following side effects have been
reported, however the precise frequency
cannot be estimated from the available
data and is classed as unknown:
• high levels of triglycerides in the blood
(shown by blood tests)
• muscle pain, painful joints
• red, itchy, flaking or peeling skin
• erection difficulties
• sensitivity of the skin to light hearing
loss (may be permanent)
• lower levels of potassium in your blood
(shown by blood tests)
If you get any side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
side effects not listed in this leaflet.

5 How to store Lozanoc
Keep Lozanoc out of the sight and reach
of children.
HDPE Bottles and Soft Temper
Aluminium foil blisters:
This medicinal product does not require
any special temperature storage
conditions.
Store in the original package in order to
protect from light and moisture.
Triplex blister:
Do not store above 25°C.
Store in the original package in order to
protect from light and moisture.
Don’t take Lozanoc after the expiry date
which is stated on the outer packaging.
The expiry date refers to the last day of
that month.
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 Further information
What Lozanoc contains
The active substance is itraconazole.
Each hard capsule contains 50 mg
itraconazole.
The other ingredients are hypromellose
phthalate, sodium starch glycolate (Type
A), silica colloidal anhydrous, magnesium
stearate.
The capsule is made from gelatin and the
colours FD&C Blue FC (E133), titanium
dioxide (E171).
The capsule is printed with black Ink (SW9008), consisting of shellac, potassium
hydroxide, black iron oxide (E172), and
purified water.
What Lozanoc looks like and
contents of the pack
Lozanoc 50 mg hard capsules are hard
gelatin light-blue capsules (size 1) with
i-50 printed in black ink.
Lozanoc is available in blister pack sizes
of 4, 6, 7, 8, 14, 15, 18, 28, 30 and 60
capsules.
Lozanoc is available in bottle pack sizes of
15, 30, 60 and 90 capsules.
Not all pack sizes and container types may
be marketed.
Marketing Authorisation
Holder and Manufacturer
Marketing Authorisation Holder
MAYNE PHARMA UK LIMITED
London WC2A 3LH, UK
Manufacturer
Medicofarma S.A.
Tarnobrzeska 13, Radom, 26-613, Poland
Distributed by
Glenmark Generics (Europe) Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire, WD18 8YA,
UK
[email protected]
medicinal product is authorised in the
Member States of the EEA under the
following names:
LOZANOC: United Kingdom
MYTRA: Austria
ITRAGERM Spain,Portugal, Italy
ITRAISDIN: Germany,Belgium

501220/2

Only take as many Lozanoc capsules
as you have been prescribed, and
ask your doctor or pharmacist if you
are not sure.
The usual dose of Lozanoc depends on
the type of fungal infection you have: see
the table below.
Your doctor may prescribe different doses
for different lengths of time, depending on
your condition. It is important to take the
full course your doctor has prescribed.

this leaflet was last approved in DDMMYYYY