ALLERGYX

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
LORATADINE
Available from:
ABIC LTD.
ATC code:
R06AX
Pharmaceutical form:
TABLETS
Composition:
LORATADINE 10 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY
Therapeutic group:
OTHER ANTIHISTAMINES FOR SYSTEMIC USE
Therapeutic indications:
Relief of symptoms of allergy in seasonal allergic rhinitis, perennial allergic rhinitis, chronic urticaria.
Authorization number:
124 58 30421 00
Authorization date:
2012-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

23-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-09-2020

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed without a doctor’s prescription

AllergyX

Tablets

Each tablet contains:

Loratadine 10 mg

For a list of the inactive ingredients, see section 6. See also section 2,

subsection “Important information about some of the ingredients of

the medicine”.

Read this leaflet carefully in its entirety before using the medicine.

∙ This leaflet contains concise information about AllergyX Tablets. If you

have further questions, refer to the doctor or pharmacist.

∙ This medicine is not intended for patients weighing less than 30 kg and

for children under two years of age. Below this age, refer to a doctor.

∙ Take the medicine in the correct manner. Consult a pharmacist if you

need further information.

∙ Refer to the doctor if symptoms of the illness worsen or do not improve,

or if you feel worse.

1. WHAT IS THE MEDICINE INTENDED FOR?

For the relief of allergy symptoms: in seasonal and perennial allergic rhinitis

with accompanying symptoms: sneezing, itching and watery eyes as well

as for the treatment of allergy of the skin – urticaria.

Therapeutic group: The medicine contains the active ingredient loratadine,

which belongs to the group of medicines called “antihistamines”.

2. BEFORE USING THE MEDICINE

Do not use the preparation if:

You are allergic )sensitive) to loratadine or to any of the other

ingredients of this medicine )for the list of inactive ingredients, see

section 6).

Special warnings regarding use of AllergyX

Before treatment with AllergyX Tablets, tell your doctor if:

- You are sensitive to any food or medicine.

- You are suffering from a liver disease.

- You are about to undergo a skin test for allergies. Do not take AllergyX

two days before these tests. This is because the medicine may affect

the test results.

Do not use this medicine frequently or for a prolonged period without

consulting the doctor.

If you are taking, or have recently taken, other medicines, including

non-prescription medicines and nutritional supplements, tell the

attending doctor or pharmacist.

Use of AllergyX and food

AllergyX can be taken with or without food.

Use of AllergyX and alcohol consumption

AllergyX has not been shown to increase the effects of alcoholic

beverages.

Pregnancy and breastfeeding

There is not sufficient information regarding the safety of use of the

medicine during pregnancy; therefore, use of AllergyX during pregnancy

is not recommended. Nonetheless, the doctor will instruct you to use

AllergyX during pregnancy if he/she decides that the benefit outweighs

the potential risks to the unborn baby.

The active ingredient in the medicine, loratadine, is secreted into breast

milk and harm to newborns or babies cannot be ruled out. Therefore,

avoid using the medicine when breastfeeding.

Driving and operating machinery

At the recommended dosage, AllergyX is not expected to cause

drowsiness or decreased alertness.

Nevertheless, very rarely, some people feel drowsy, which may affect their

ability to drive or operate machinery.

Important information about some of the ingredients of the

medicine

The medicine contains lactose and may cause an allergy among people

sensitive to lactose; therefore, if you have been told by your doctor that

you have an intolerance to certain sugars, contact your doctor before

taking this medicine )see also section 6, “Further Information”).

Children

Do not give AllergyX Tablets to children and infants under two years of

age or to children of ages 2-12 who weigh less than 30 kg. There are

other formulations that are more appropriate for children of ages 2-12

who weigh less than 30 kg.

3. HOW SHOULD YOU USE ALLERGYX TABLETS?

Check with the doctor or pharmacist if you are uncertain.

The usual dosage is generally:

Adults and children over 12 years of age:

One tablet, once a day, with a glass of water, with or without food.

The dosage for children aged 2-12 is according to weight:

Body weight over 30 kg:

One tablet, once a day, with a glass of water, with or without food.

Body weight of 30 kg or less:

Do not give AllergyX Tablets.

There are loratadine-containing preparations of other formulations

)syrup) that are more appropriate for children of ages 2-12 who weigh

30 kg or less.

AllergyX Tablets is not intended for children under two years of age.

Adults and children with severe liver problems:

Adults and children weighing over 30 kg:

Take one tablet, once every other day, with a glass of water, with or

without food. However, refer to your doctor or pharmacist before taking

this medicine.

Do not chew or crush! The tablet can be halved along the score line to ease

swallowing, but all the parts of the tablet should be taken simultaneously.

Do not exceed the recommended dose.

If you accidentally took a higher dosage, refer to your doctor or

pharmacist immediately.

No severe problems are expected, but you may suffer from a headache,

rapid heartbeat or a feeling of sleepiness.

If you took an overdose, or if a child has accidentally swallowed the

medicine, refer immediately to a doctor or proceed to a hospital emergency

room and bring the package of the medicine with you.

If you forgot to take AllergyX Tablets If you forgot to take this medicine

at the required time, take a dose as soon as you remember and consult

a doctor. Never take a double dose.

Do not take medicines in the dark! Check the label and the dose each

time you take a medicine. Wear glasses if you need them.

If you have further questions regarding use of the medicine, consult a

doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of AllergyX Tablets may cause side effects in

some users. Do not be alarmed by reading the list of side effects. You

may not suffer from any of them.

The most common side effects reported by adults and children over 12

years of age are:

∙ drowsiness

∙ headache

∙ increased appetite

∙ difficulty sleeping

The most commonly reported side effects in children aged 2-12 years

are:

∙ headache

∙ nervousness

∙ tiredness

Very rare side effects )may affect up to 1 in 10,000 people) have also been

seen during the marketing of loratadine:

∙ severe allergic reaction

∙ dizziness

∙ accelerated or irregular heartbeat

∙ dry mouth

∙ nausea

∙ digestive system disturbances

∙ liver problems

∙ hair loss

∙ rash

∙ tiredness

∙ seizure

If a side effect occurs, if any of the side effects worsen, or if you

are suffering from a side effect not mentioned in the leaflet, consult

your doctor.

Reporting side effects:

Side effects can be reported to the Ministry of Health by clicking on the

link “Reporting side effects following drug treatment” found on the Ministry

of Health homepage )www.health.gov.il) that directs you to the online form

for reporting side effects.

5. HOW SHOULD ALLERGYX TABLETS BE STORED?

∙ Avoid poisoning! This medicine and any other medicine should be kept

in a safe place out of the reach and sight of children and/or infants

in order to avoid poisoning. Do not induce vomiting without explicit

instruction from the doctor.

Do not use AllergyX Tablets after the expiry date )exp. date) that appears

on the package. The expiry date refers to the last day of that month.

∙ Storage conditions: Store the medicine in a dry place, below 25°C.

∙ Do not take this medicine if you notice any change in the appearance

of the tablet.

∙ Do not throw medicines into the wastewater or household waste bin.

Ask the pharmacist how to dispose of medicines no longer in use. These

measures will help protect the environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine also contains:

Lactose monohydrate, pregelatinised starch, maize starch, magnesium

stearate

Each AllergyX tablet contains 62.5 mg lactose monohydrate. See also

section 2 “Important information about some of the ingredients of the

medicine”.

What the medicine looks like and the contents of the package:

An oval, white tablet. One side of the tablet has a score line debossed with

“10” and “L” on its sides. The other side of the tablet is plain.

Authorized package sizes: 7, 10 or 20 tablets per pack. Not all package

sizes may be marketed.

Registration holder and address:

Abic Ltd., P.O.B. 8077, Netanya.

Manufacturer and address:

Teva Pharmaceutical Industries Private Company Ltd., Hungary.

This leaflet was checked and approved by the Ministry of Health in

November 2015.

Registration number of the medicine in the National Drug Registry

of the Ministry of Health: 124.58.30421.00

ALLE TAB PL SH 200116

ALLE TAB PL SH 200116

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ןכרצל ןכרצל

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

6

,רבמטפס

2015

םש

רישכת

תילגנאב

רפסמו

םושירה

ALLERGYX 124 58 30421 00

םש

לעב

םושירה

ABIC LTD

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה

קרפ

ןולעב טסקט

יחכונ טסקט

שדח המדקה הפורת

וז

הניא

תדעוימ

םילפוטמל

םע

לקשמ ךומנ

"

םידלילו

תחתמ

ליגל

םייתנש

תחתמ

ליגל

הז

שי

תונפל

אפורל

:תורהזא

םידלי ןיא

תתל

גרלא

'

י

X

תוילבט

םידליל

תוקוניתו

תחתמ

ליגל םייתנש

וא

םידליל

ינב

2-12

םינש

םילקושה

תוחפ

"

ןנשי

תורוצ

ןתמ

תורחא

תומיאתמה

רתוי

םידליל

2-12

םינש

םילקושה

תוחפ

"

דציכ

שמתשת הפורתב ןונימ

לבוקמ

רדעהב

הארוה תרחא

:אפורהמ םירגובמ

םידליו

לעמ

ליג

:םינש הילבט

תחא

םעפ

.םויב לעופ

ךות העש

דע

תועש

ךשמלו

.תועש ןיא

רובעל

לע

הנמה

תצלמומה

הדימב

הפורתהו

הניא

תרזוע תומלעהל

י/הנפ ,םימוטפמיסה .אפורל הפורת

וז

הניא

תדעוימ

ךרדב

ללכ םידליל

תחתמ

ליגל

.םינש

ןונימה

לבוקמה

ךרדב

ללכ

אוה

םירגובמ

םידליו

לעמ

ליג

12

םינש

:

הילבט

תחא

םעפ

םויב

םע

סוכ

םימ

םע

וא

ילב

לכוא

ןונימה

םידליל

יאליגב

2-12

םינש

וניה

יפל

לקשמ לקשמ

ףוג

לעמ

30

ק

"

ג

:

הילבט

תחא

םעפ

םויב

םע

סוכ

םימ

םע

וא

ילב

לכוא

לקשמ

ףוג

30

ק

"

ג

וא

תוחפ

:

ןיא

תתל

גרלא

'

י

X

תוילבט

שי

םירישכת

םיליכמה

ןידטארול

תרוצב

ןתמ

המיאתמה רתוי

םידליל

ינב

2-12

םינש

םילקושה

"

וא

תוחפ אמגודל (

פוריס

...

םירגובמ

םידליו

םע

תויעב

דבכ

תורומח

:

םירגובמ

םידליו

םילקושה

לעמ

30

ק

"

ג

:

שי

לוטיל

הילבט

תחא

םעפ

םיימויב

םוי

ןכ

םוי

אל

םע

סוכ

םימ

םע

וא

ילב

לכוא

םע

תאז

ךילע

תונפל לא

אפורה

ךלש

וא

חקורה

ינפל

תליטנ

הפורת

וז

םא

תלטנ

תועטב

ןונימ

הובג

רתוי

הנפ

לא

אפורה

ךלש וא

חקורה

דימ

אל

תויופצ

תויעב

תורומח

םלוא

ןכתיי

לובסתו

באכמ

קפוד

ריהמ

וא

תשוחת

תוינונשי

תועפות

:יאוול תועפות

יאוול ףסונב

תוליעפל

היוצרה

לש ןמזב ,הפורתה

שומישה

הב תולולע

עיפוהל

תועפשה

יאוול שבוי :ןוגכ

,םונמנ ,הליחב ,הפב באכ

תופייע ,שאר

וא

שוטשט היאר באכ ,תונבצע ,

הילע ,ןטב .ןובאתב םא

תועפות

ולא

תוכשמנ

וא שי ,תודירטמ

תונפל

.אפורל תועפות

תובייחמה

תוסחייתה תדחוימ ונכתי

תומיעפ

בל

תוריהמ

:)רידנ( שי

תונפל

.אפורל םימוטפמיס

לש

העיגפ

רוע :דבכב םייניעו

םיבוהצ

רידנ(

- )דואמ הרקמב

הז

שי

קיספהל

תא

לופיטה תונפלו

אפורל

!דימ םינמיס

םיימואתפ

וא

םירומח

לש היגרלא

ןוגכ

החירפ

,דוריג ,תירוע תוחפנתה ,תלרח

,םינפה ןושלה ,םייתפשה

וא

םירוזא םירחא

רצוק ,ףוגב

,המישנ םיפוצפצ

וא

תויעב

:המישנב י/קספה

לופיט

י/הנפו

אפורל

דימ תועפות

יאוולה

תוצופנה

רתויב

וחוודש

םירגובמב

םידליו לעמ

ליג

םינש

ןה

םונמנ

באכ

שאר

ןובאית

רבגומ

ישוק

ןושיל

....

תועפות

יאוול

תורידנ

דואמ

תולולע

עיפשהל

לע

דע

םדא דחא

ךותמ

10,000

םישנא

ופצנ

םג

ןה

ךלהמב

קווישה לש

ןידטארול

הבוגת

תיגרלא

הרומח

תרוחרחס

בצק

בל

ץאומ

וא

אל

רידס

שבוי

הפב

הליחב

תוערפה

תכרעמב

לוכיעה

תויעב

דבכב

תרישנ

רעיש

החירפ

תופייע

סוכרפ

Similar products

Search alerts related to this product

View documents history

Share this information