ROXO 150

Israel - English - Ministry of Health

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Active ingredient:
ROXITHROMYCIN
Available from:
UNIPHARM LTD, ISRAEL
ATC code:
J01FA06
Pharmaceutical form:
TABLETS
Composition:
ROXITHROMYCIN 150 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
Therapeutic group:
ROXITHROMYCIN
Therapeutic area:
ROXITHROMYCIN
Therapeutic indications:
For the treatment of infections caused by microorganisms sensitive to roxithromycin e.g: ENT bronchopulmonary, genital and skin manifestations.
Authorization number:
134 98 30273 00
Authorization date:
2011-08-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

15-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

20-02-2017

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

This medicine is dispensed with a doctor’s

prescription only.

Roxo 150

Tablets

Active ingredient:

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

FOR?

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.,

erythromycin).

∙ if you are being concomitantly treated

with ergot derivatives for treatment

of migraine )such as ergotamine and

dihydroergotamine).

∙ if you are being concomitantly treated

with colchicine )to treat gout).

∙ if you are being concomitantly treated

with

medicines

that

cause

arrhythmias, such as: cisapride )for

treatment of esophageal reflux), pimozide

)a neuroleptic

medicine

) or medicines

for treatment of allergies containing

terfenadine or astemizole.

∙ when you are breastfeeding and your

baby is being treated with the medicine

cisapride.

Special warnings regarding use of the

medicine:

Before treatment with Roxo 150, tell the

doctor if:

- you have an intolerance to certain

sugars.

- you are pregnant or breastfeeding.

- you are suffering, or have suffered in the

past, from:

∙ impaired liver function or any other

liver disease – liver function should be

monitored.

∙ heart rhythm problems )e.g., prolongation

of the QT interval, that is diagnosed by

E.C.G.).

∙ 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

pseudomembranous enterocolitis).

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-

threatening.

Monitoring of liver and kidney function and

blood count are recommended in the case

of prolonged treatment )more than two

weeks).

There is no need for dosage adjustments

for elderly patients or patients with kidney

problems.

If you are sensitive to any type of food or

medicine, inform the doctor before taking

the medicine.

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

taking:

∙ colchicine )to treat gout)

∙ ergotamine or dihydroergotamine )to treat

migraines)

∙ 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

are breastfeeding.

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

infant

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

disorders

)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

MEDICINE?

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

of treatment.

If necessary, the tablets can be halved or

crushed for immediate use.

This medicine is not intended for infants

and children.

If you forgot to take the medicine at the

scheduled time, take a dose as soon as

you remember, but never take two doses

together!

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!

Adhere

to

the

treatment

regimen

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.

When

concomitantly

taken

with

anticoagulants, INR monitoring should be

performed.

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

pharmacist.

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,

stomach pain.

Pain in the upper digestive system, digestive

disorders, lack of appetite, pancreatitis and

bloody diarrhea have also

been reported.

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

jaundice).

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

immediately.

Blood

and

lymphatic

system

disorders:

Uncommon: high levels of certain white

blood cells )eosinophilia), reduced count

of blood platelets )thrombocytopenia) and

of certain white blood cells )neutropenia,

agranulocytosis).

Superinfection

)in long-term use)

with severe inflammation of the bowel

)pseudomembranous enterocolitis).

Psychiatric disorders:

Hallucinations, confusion.

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.

Alternatively, they

can be reported to “Unipharm Ltd.”.

5. HOW SHOULD THE MEDICINE BE

STORED?

∙ 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

side.

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

Ltd.,

Kibbutz Maabarot.

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

0816E

119208010

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