Israel - English - Ministry of Health
PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s
Each tablet contains:
Roxithromycin 150 mg
Inactive ingredients )see section 6).
Read this leaflet carefully in its entirety
before using the medicine. Keep this leaflet;
you may need to read it again.
This leaflet contains concise information about
the medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them even if it seems to you that their
medical condition is similar.
If a side effect worsens or if a side effect not
mentioned in this leaflet occurs, please refer
to a doctor or pharmacist.
1. WHAT IS THE MEDICINE INTENDED
The medicine is intended for the treatment
of infections caused by bacteria susceptible
to roxithromycin, such as infections of the
respiratory tract, including nose, ear and
throat, infections of the skin and genitals.
Therapeutic group: Macrolide antibiotic.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
∙ if there is a known sensitivity to
roxithromycin or to any of the other
ingredients of the medicine, or to another
medicine of the macrolide group )e.g.,
∙ if you are being concomitantly treated
with ergot derivatives for treatment
of migraine )such as ergotamine and
∙ if you are being concomitantly treated
with colchicine )to treat gout).
∙ if you are being concomitantly treated
arrhythmias, such as: cisapride )for
treatment of esophageal reflux), pimozide
) or medicines
for treatment of allergies containing
terfenadine or astemizole.
∙ when you are breastfeeding and your
baby is being treated with the medicine
Special warnings regarding use of the
Before treatment with Roxo 150, tell the
- you have an intolerance to certain
- you are pregnant or breastfeeding.
- you are suffering, or have suffered in the
∙ impaired liver function or any other
liver disease – liver function should be
∙ heart rhythm problems )e.g., prolongation
of the QT interval, that is diagnosed by
∙ risk factors for heart rhythm problems,
such as low and unbalanced blood
potassium or magnesium levels.
∙ slow heart rate )bradycardia).
- you are being treated with ergot alkaloids –
medicines that may prolong the QT interval
)see later in this section).
- you are suffering from a neuromuscular
disease called myasthenia, since this
medicine may worsen your disease.
- you are suffering from diarrhea after
treatment with Roxo 150, especially if the
diarrhea is severe, prolonged or bloody
)risk of damage to the intestines called
Significant narrowing of blood vessels that
can cause possible damage to the tissues
of the limbs )necrosis), has been reported
for macrolide antibiotics taken together with
certain medicines for migraine )ergotamine
and dihydroergotamine). Before using Roxo
150, make sure that you are not using these
medicines )see further on in this section).
If a widespread, severe skin rash appears,
including: skin blistering or peeling, as well
as signs of flu and fever )Stevens-Johnson
syndrome) or a general unwell feeling, fever,
chills and muscle aches )toxic epidermal
necrolysis), refer to a doctor immediately
since these skin effects may be life-
Monitoring of liver and kidney function and
blood count are recommended in the case
of prolonged treatment )more than two
There is no need for dosage adjustments
for elderly patients or patients with kidney
If you are sensitive to any type of food or
medicine, inform the doctor before taking
If you are taking, or have recently taken
other medicines, including non-prescription
medicines and nutritional supplements,
tell the doctor or pharmacist.
Do not use Roxo 150 if you are already
∙ colchicine )to treat gout)
∙ ergotamine or dihydroergotamine )to treat
∙ cisapride )to treat heartburn)
It is especially important to inform the doctor
or pharmacist if you are taking:
dopaminergic ergot alkaloids such as
bromocriptine and pergolide )primarily used
to treat Parkinson’s disease) or cabergoline
or lisuride )primarily used to prevent the
secretion of breast milk), ciclosporin,
disopyramide, digoxin, glycosides to
treat heart problems, class I and class II
antiarrhythmics, midazolam, theophylline,
oral anticoagulants such as warfarin
)Coumadin), medicines to lower cholesterol
level )atorvastatin, simvastatin).
Use of the medicine and food
Do not chew! Swallow the medicine with
water about one hour before a meal or on
an empty stomach.
If gastrointestinal side effects occur – take
the medicine with or after a meal.
Pregnancy and breastfeeding
Do not use the medicine without consulting
a doctor if you are pregnant, think you may
be pregnant, are planning a pregnancy or
It has been found that most macrolides
are secreted into breast milk, at equal or
higher concentrations than in the mother’s
blood. Nonetheless, the amount of medicine
absorbed by the newborn is low. If the
has signs of digestive problems )diarrhea,
fungal infection), stop breastfeeding and
consult the doctor quickly.
Do not breastfeed if the infant is taking
cisapride, due to concern for potential
interaction that can cause heart rhythm
)Torsades de pointes) )See section 2
“Before using the medicine”).
Driving and use of machinery
Use of this medicine may cause dizziness
and therefore, caution should be exercised
when driving or operating machinery.
Important information regarding some
of the ingredients of the medicine
This medicine contains 0.9 mg dextrose and
therefore, do not use it if you are suffering from
problems in absorbing glucose and galactose.
3. HOW SHOULD YOU USE THE
Always use according to the doctor’s
instructions. Check with the doctor or
pharmacist if you are uncertain.
The dosage and treatment regimen will
be determined by the doctor only. Do not
exceed the recommended dose or duration
If necessary, the tablets can be halved or
crushed for immediate use.
This medicine is not intended for infants
If you forgot to take the medicine at the
scheduled time, take a dose as soon as
you remember, but never take two doses
If you accidentally took a higher dosage
or if a child has accidentally swallowed the
medicine, immediately refer to a doctor or
proceed to a hospital emergency room,
and bring the package of the medicine with
you. Do not induce vomiting unless explicitly
instructed to do so by the doctor!
recommended by the doctor.
Even if there is an improvement in your
health, do not stop treatment with the
medicine without consulting the doctor, and
even then, it should be done gradually.
Tests and follow-up
In the case of prolonged treatment or high
dosages, blood tests and liver function tests
should be performed.
In patients suffering from a liver function
problem, and are taking this medicine, liver
function should be monitored.
E.C.G. monitoring should be performed
in patients suffering from heart rhythm
problems )e.g., prolongation of the QT
interval in E.C.G.).
When concomitantly taking roxithromycin
with disopyramide or digoxin and other
glycosides for treatment of the heart, E.C.G.
monitoring should be performed and, if
possible, blood disopyramide or glycoside
levels should be monitored.
anticoagulants, INR monitoring should be
Do not take medicines in the dark! Check
the label and the dose each time you take
medicine. Wear glasses if you need them.
If you have further questions regarding
use of the medicine, consult the doctor or
This medicine was prescribed to treat your
ailment. In another patient, it could be
harmful. Do not give this medicine to your
relatives, neighbors or acquaintances.
4. SIDE EFFECTS
As with any medicine, use of Roxo 150 may
cause side effects in some users.
Do not be alarmed when reading the list of side
effects. You may not suffer from any of them.
∙ Digestive disorders:
Common: diarrhea, nausea, vomiting,
Pain in the upper digestive system, digestive
disorders, lack of appetite, pancreatitis and
bloody diarrhea have also
∙ Cardiac disorders:
Prolongation of the QT interval, heart
rhythm disorders, cardiac arrest.
∙ Nervous system disorders:
Common: dizziness, headaches, tiredness,
numbness/tingling, disturbances in senses
of taste and smell.
∙ Liver disorders:
Increase in liver enzymes, hepatitis
)liver damage possibly manifested by
∙ Allergic effects:
Common: skin rash.
Uncommon: hives )red patches on the skin
that cause itching), blisters on the skin.
Bruising or small red marks on the skin
and severe allergic reactions such as
angioedema )sudden swelling of the
face and neck), difficulty breathing and
anaphylactic shock, widespread severe
skin rash, including: skin blistering or
peeling, as well as signs of flu and fever
)Stevens-Johnson syndrome) or a general
unwell feeling, fever, chills and muscle
aches )toxic epidermal necrolysis), have
also been reported. Bronchospasm.
∙ Ear disorders:
Impaired hearing, temporary hearing loss,
dizziness )vertigo), abnormal buzzing or
whistling in the ears )tinnitus).
If any of the above signs occur, stop
treatment and refer to the doctor
Uncommon: high levels of certain white
blood cells )eosinophilia), reduced count
of blood platelets )thrombocytopenia) and
of certain white blood cells )neutropenia,
)in long-term use)
with severe inflammation of the bowel
∙ Psychiatric disorders:
In these cases, refer to your doctor, who will
direct you how to continue treatment.
In the event that you experience a side effect
not mentioned in this leaflet, or if there is a
change in your general health, consult with
the doctor immediately.
Side effects can be reported to the Ministry
of Health by clicking on the link “Report Side
Effects of Drug Treatment” found on the
Ministry of Health homepage )www.health.
gov.il), which directs you to the online form
for reporting side effects.
can be reported to “Unipharm Ltd.”.
5. HOW SHOULD THE MEDICINE BE
∙ Avoid poisoning! This medicine and any
other medicine must be kept in a safe
place out of the reach of children and/or
infants to avoid poisoning. Do not induce
vomiting unless explicitly instructed to do
so by the doctor!
∙ Do not use the medicine after the expiry
date )exp. date) that appears on the
package. The expiry date refers to the last
day of that month.
∙ Store the medicine at a temperature below
25°C and in a place protected from light.
6. FURTHER INFORMATION
In addition to the active ingredient, the
medicine also contains:
Microcrystalline cellulose, pregelatinized
starch, carmellose sodium LS, povidone,
glyceryl behenate, magnesium stearate,
colloidal silicon dioxide, poloxamer 188,
opadry Y-1-7000 )white), dextrose.
What the medicine looks like and the
contents of the package:
Roxo 150 is packaged in trays )blisters)
inserted into a carton package. Each
package of Roxo 150 contains 20 tablets.
Roxo 150 tablets are white, film-coated,
round, biconvex, with a score line on one
This leaflet does not contain all the
information about the preparation. If you
have any question, or are uncertain about
something, please refer to the doctor.
Registration holder: Unipharm Ltd., P.O.B.
21429, Tel Aviv 6121301.
Manufacturer and address: Trima
This leaflet was checked and approved
by the Ministry of Health in March 2016.
Registration number of the medicine in
the National Drug Registry of the Ministry
of Health: 134 98 30273 00