LORASTINE TABLETS

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
LORATADINE
Available from:
BAYER ISRAEL LTD
ATC code:
R06AX
Pharmaceutical form:
TABLETS
Composition:
LORATADINE 10 MG
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
SCHERING-PLOUGH LABO. N.V , BELGIUM
Therapeutic group:
OTHER ANTIHISTAMINES FOR SYSTEMIC USE
Therapeutic indications:
Seasonal allergic rhinitis, perennial allergic rhinitis, chronic urticaria.
Authorization number:
133 25 25872 00
Authorization date:
2016-06-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

24-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

16-08-2020

Patient leaflet in accordance with the

Pharmacists’ Regulations (Preparations) – 1986

This medicine is dispensed without a doctor’s prescription

Lorastine Tablets, 10 mg

Each tablet contains:

Loratadine 10 mg

See section 6 for a list of inactive ingredients. See also section 2 under ’Important information

about some of this medicine’s ingredients’.

Read the entire leaflet carefully before you start using this medicine.

This leaflet contains concise information about this medicine. If you have any further

questions, consult your doctor or pharmacist.

Take this medicine according to the instructions in the section about dose in this leaflet.

Consult your pharmacist if you need further information.

Consult your doctor if your symptoms of illness get worse or do not get better.

1.

What is this medicine intended for?

Lorastine Tablets are used to treat allergic rhinitis and the symptoms associated with it, such

as sneezing, runny or itchy nose, and burning or itchy eyes. They are also used to treat

allergy of the skin - hives )urticaria(.

How this medicine works

Lorastine Tablets relieve your allergy symptoms by preventing the effects of a substance

called histamine, which is produced by the body when you are allergic to something.

Therapeutic group: This medicine contains the active ingredient loratadine which belongs

to a class of medicines called “antihistamines”.

2. Before using this medicine

X Do not use this medicine if:

You are allergic )sensitive( to loratadine or to any of the other ingredients of this medicine

)see section 6 for a list of inactive ingredients(.

Special warnings about using this medicine

! Talk to your doctor, pharmacist, or nurse before taking Lorastine Tablets if:

You have liver disease.

You are about to have any skin tests for allergies. Do not take Lorastine Tablets for two

days before having these tests. This is because the medicine may affect the test results.

If any of the conditions described above apply to you )or if you are not sure(, consult your

doctor, pharmacist, or nurse before taking Lorastine Tablets.

! Children and adolescents

Do not give Lorastine Tablets to children and infants younger than 6 years old or to children

who weigh less than 30 kg. There are other formulations more suitable for children who are

under 6 years old or who weigh less than 30 kg.

Children under 2 years old:

There are no safety and efficacy data for Lorastine Tablets in this age group.

! Other medicines and Lorastine Tablets:

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

medications and dietary supplements, tell your doctor, pharmacist, or nurse.

The risk of side effects is greater when taking Lorastine Tablets together with medicines

that affect the activity of liver enzymes responsible for metabolism of medicines in the liver.

However, in clinical studies, no increase in side effects was seen despite taking medicines

that affect the activity of these enzymes.

! Using this medicine and food

You can take Lorastine Tablets with or without food.

! Using this medicine and alcohol consumption

Lorastine Tablets have not been shown to increase the effects of an alcoholic beverage.

! Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your

doctor or pharmacist for advice before taking this medicine. Based on existing data, no harm

to unborn babies or newborns was observed following use of the medicine, but it is better to

avoid taking it during pregnancy.

Loratadine, the active ingredient in this medicine, passes into breast milk so avoid taking this

medicine when breastfeeding.

! Driving and using machines

In clinical trials that assessed driving ability, no impairment was observed in patients taking

loratadine. At the recommended dose, Lorastine Tablets are not expected to cause you to

be drowsy or less alert.

However, very rarely some people experience drowsiness, which may affect their ability to

drive or use machines.

! Important information about some of this medicine’s ingredients

This medicine contains lactose, so 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 ’Additional information’(.

3. How to use Lorastine Tablets?

Check with your doctor or pharmacist if you are not sure about your dose or about how to

take this medicine.

The recommended dosage is usually:

Adults and children over 6 years old who weigh over 30 kg:

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

It is important to know your child’s body weight in order to make sure that the dosage is

appropriate for him. If you are not sure about your child’s weight, weigh the child before

using the medicine.

Body weight of 30 kg or less:

Do not give Lorastine Tablets. There is another formulation that is more suitable for children

under 6 years old or for those who weigh 30 kg or less.

Lorastine Tablets are not intended for children under 2 years old or for those with body

weight of 30 kg or less.

Adults and children with serious liver problems:

If you have severe liver problems, consult your doctor or pharmacist who may advise you to

take the recommended dose every other day, with a glass of water, with or without food. If

this applies to you, follow their instructions.

Do not exceed the recommended dose.

Method of administration:

The score line on the tablets is only there to help you break the tablet so it is easier to

swallow. You must take all the tablet pieces at the same time.

If you have accidentally taken a higher dose, consult your doctor or pharmacist immediately.

No serious problems are expected; however, you may get a headache, have a rapid

heartbeat or feel sleepy.

If you have taken an overdose, or if a child has accidentally swallowed some medicine,

immediately see a doctor or go to a hospital emergency room and bring the medicine

package with you.

If you forget to take the medicine at the scheduled time, take a dose as soon as you

remember and then continue taking the medicine as usual. Never take a double dose to

make up for a forgotten dose.

Do not take medicines in the dark! Check the label and dose every time you take

medicine. Wear glasses if you need them.

If you have any further questions about using this medicine, consult your doctor or

pharmacist.

4. Side effects

Like with all medicines, using Lorastine Tablets may cause side effects in some users.

Do not be alarmed by this list of side effects; you may not experience any of them.

The most commonly reported side effects in adults and children over 12 years old are:

drowsiness

headaches

increased appetite

difficulty sleeping

The most commonly reported side effects in children aged 2 to 12 years old are:

headaches

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 )including swelling(

dizziness

convulsion

fast or irregular heartbeat

nausea

dry mouth

upset stomach

liver problems

hair loss

rash

tiredness

The frequency of the following side effect is not known:

weight gain

If you experience any side effect, if any side effect gets worse, or if you experience a

side effect not mentioned in this leaflet, consult your doctor.

Reporting side effects:

You can report side effects to the Ministry of Health by following the link ’Reporting Side

Effects of Drug Treatment’ on the Ministry of Health home page (www.health.gov.il( which

links to an online form for reporting side effects. You can also use this link:

https://sideeffects.health.gov.il

5. How to store Lorastine Tablets?

Prevent poisoning! To prevent poisoning, keep this, and all other medicines, in a closed

place, out of the reach and sight of children and/or infants. Do not induce vomiting unless

explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry date )exp. date( which is stated on the package.

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

Storage conditions: Store below 25°C.

Do not take this medicine of you notice any change in the appearance of the tablet.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist

how to dispose of medicines you no longer use. These measures will help protect the

environment.

6. Additional information

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

Lactose monohydrate, maize starch, magnesium stearate.

Each tablet contains 71.3 mg lactose )see also section 2, ’Important information about

some of this medicine’s ingredients’(.

What the medicine looks like and contents of the pack:

White to off-white, oval tablet embossed with a flask and bowl, a score line, and ’10’ on one

side and plain on the other side.

Authorized pack sizes: 7, 10, or 20 tablets in a pack. Not all pack sizes may be marketed.

Registration holder’s name and address:

Bayer

Israel

Ltd.,

Hacharash

Street,

Hasharon 45240.

Manufacturer’s name and address: Schering-Plough, Labo N.V., Belgium, IndustriePark

30, B-2220, Heist-Op-den-Berg.

Revised in June 2020.

Registration number of the medicine in the Ministry of Health’s National Drug Registry:

133-25-25872-00

что «Лорастин Таблетки» вызовет сонливость или нарушение внимания.

Вместе с тем, в исключительно редких случаях некоторые люди ощущают сонливость,

что может повлиять на их способность водить автомобиль или работать с механическим

оборудованием.

! Важная информация о некоторых компонентах препарата

Данный препарат содержит лактозу. Поэтому если ваш врач сказал вам, что вы страдаете

непереносимостью определенных сахаридов, то свяжитесь со своим врачом до начала

приема этого препарата )см. также раздел 6, «Дополнительная информация»(.

3. Как принимать «Лорастин Таблетки»?

Нужно проконсультироваться с врачом или фармацевтом, если вы не уверены в

отношении дозировки и способа применения препарата.

Обычной дозировкой препарата является:

Взрослые и дети старше 6 лет, вес тела которых превышает 30 кг:

Одна таблетка в день со стаканом воды, с едой или без нее.

Важно знать, сколько весит ваш ребенок, с тем чтобы позаботиться о правильной

дозировке препарата для него. Если вы не уверены, сколько весит ваш ребенок,

следует взвесить его перед приемом препарата.

Вес тела 30 кг или меньше:

Не следует давать «Лорастин Таблетки». Существуют другие формы дозировки препарата,

которые подходят для детей в возрасте до 6 лет или которые весят меньше 30 кг.

«Лорастин Таблетки» не предназначены для детей в возрасте до 2 лет или для людей,

вес тела которых 30 кг или меньше.

Дети и взрослые с серьезным поражением печени:

Если вы страдаете серьезным поражением печени, вам следует обратиться к врачу

или фармацевту. Возможно, что вам рекомендуют принимать обычную дозировку

препарата один раз в два дня )через день( со стаканом воды, с едой или без нее.

Не следует превышать рекомендуемую дозировку.

Форма приема препарата:

Линия разлома в таблетках предназначена исключительно для того, чтобы помочь вам

разломить таблетку, чтобы вам было легче принять ее. Все части таблетки следует

принимать одновременно.

Если по ошибке вы приняли более высокую дозу препарата, чем требуется, вам

следует немедленно обратиться к врачу или фармацевту.

Не ожидается, что у вас возникнут какие-либо серьезные проблемы, однако вы можете

страдать головными болями, учащением пульса или ощущением сонливости.

Если вы приняли слишком высокую дозу препарата, или если по ошибке препарат

проглотил ребенок, немедленно обратитесь к врачу или в приемный покой больницы и

принесите с собой упаковку от препарата.

Если вы забыли принять дозу препарата в назначенное время, следует принять ее

немедленно после того, как вы вспомните об этом, и продолжать принимать препарат

обычным способом. Ни в коем случае не следует принимать двойную дозу препарата,

чтобы восполнить забытую дозу.

Не следует принимать лекарства в темноте! Необходимо проверить этикетку

препарата и его дозу при каждом приеме. Если вы пользуетесь очками, наденьте

их перед приемом лекарства.

Если у вас возникли дополнительные вопросы относительно приема препарата,

обратитесь с ними к врачу или фармацевту.

4.

Побочные явления

Как и в случае с любым другим препаратом, прием «Лорастина Таблетки» может

вызывать побочные явления у некоторых пользователей.

Не пугайтесь, читая перечень этих явлений. Возможно, что вы не испытаете ни одно из них.

Широко распространенные побочные явления, которые отмечались у взрослых и

детей старше 12 лет:

Сонливость

Головные боли

Повышенный аппетит

Трудности с засыпанием

Широко распространенные побочные явления, которые отмечались у детей в возрасте

2-12 лет:

Головные боли

Нервозность

Утомляемость

Очень редкие побочные явления (побочные явления, которые встречаются у одного из

10000 пациентов(, которые также наблюдались при использовании лоратадина:

Серьезные аллергические реакции (включая отеки(

Головокружение

Судороги

Учащение или нарушения сердечного ритма

ошнота

ость во рту

ушения пищеварения

ечени

волос

ания

омляемость

Побочные явления, распространенность которых пока не установлена:

величение веса тела

При

появлении

побочного

явления,

а

также если

какое-либо

из

побочных

ений усугубляется или если вы страдаете побочным явлением, не указанным

укции, вам следует проконсультироваться у врача.

Сообщение о побочных явлениях:

ожно сообщить о побочных явлениях в Министерство здравоохранения, нажав

на ссылку

«Сообщение о побочных эффектах от лекарств», которая находится на

интернет-сайте Министерства здравоохранения )www.health.gov.il(, чтобы перейти на

тронный бланк сообщения о побочных явлениях, или перейдя по ссылке:

https://sideeffects.health.gov.il

Как хранить «Лорастин Таблетки»?

отравитесь! Этот препарат, как и любое другое лекарство, следует хранить в

закрытом месте, недоступном для детей и )или( младенцев (и вне поля их зрения(.

Таким образом,

вы сможете предотвратить отравление препаратом. Не вызывайте

рвоту без соответствующего указания врача.

следует

принимать

препарат

по

истечении

срока

его

годности

)exp.

date(,

указанного на упаковке. Срок годности препарата оканчивается в последний день

указанного на упаковке месяца.

словия хранения: Следует хранить препарат при температуре ниже 25°С.

следует использовать препарат, если вы заметили какие-либо изменения во

внешнем виде таблетки.

следует

выбрасывать

препарат

канализацию

или

бытовым мусором.

Проконсультируйтесь у фармацевта, каким образом следует выбрасывать препараты,

которые более не используются. Это поможет сохранить окружающую среду.

Дополнительная информация

мо активного вещества данный препарат содержит следующие компоненты:

Lactose monohydrate, maize starch, magnesium stearate.

Каждая таблетка содержит 71.3 мг лактозы )см. также раздел 2 инструкции, пункт

«Важная информация о некоторых из компонентов препарата»(.

ак выглядит препарат, и каково содержимое его упаковки:

Овальная таблетка от белого до кремового цвета, с отпечатком флакона с миской,

линией разлома и «10» с одной стороны и гладкой поверхностью с другой стороны.

зрешенные размеры упаковки: 7, 10 и 20 таблеток в упаковке. Возможно, что

препарат не будет продаваться во всех указанных размерах упаковки.

Владелец регистрации и его адрес: «Байер Исраэль ЛТД», ул. Ха-Хараш 36, Ход

Ха-Шарон 45240.

Название и адрес производителя: Шеринг-Плау, Лабо Эн.Ви., Бельгия, ИндустриПарк

30, B-2220, Хейст-Оп-ден-Берг.

Отредактировано в июне 2020 года.

Регистрационный номер препарата в государственном реестре лекарственных

препаратов Министерства здравоохранения: 133-25-25872-00

DOR-LOR-TABS-0520-05

Revised in April 2020

1.

NAME OF THE MEDICINAL PRODUCT

LORASTINE

®

TABLETS

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10 mg loratadine.

Excipients with known effect:

The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 71.3 mg.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

White to off-white, oval tablet with flask and bowl, score and “10” on one side, plain on the

other side.

The score line of the tablet is only to facilitate breaking for ease of swallowing and not to divide

into equal doses.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Lorastine tablets are indicated for:

Seasonal allergic rhinitis, perennial allergic rhinitis, chronic urticaria.

4.2

Posology and method of administration

Posology

Adults:

One tablet once daily.

Paediatric population:

Children 6 years of age and older with a body weight greater than 30 kg:

One tablet once daily.

For appropriate dosing in children younger than 6 years or with body weight of 30 kg

or less, there are other formulations more suitable.

Children under 2 years of age:

The safety and efficacy of Lorastine Tablets have not been established. No data are available.

Patients with hepatic impairment

Patients with severe liver impairment should be administered a lower initial dose because they

may have reduced clearance of loratadine. An initial dose of 10 mg every other day is

recommended for adults and children weighing more than 30 kg.

Patients with renal impairment

No dosage adjustments are required in patients with renal insufficiency.

Elderly

No dosage adjustments are required in the elderly.

Method of administration

Oral use. The tablet may be taken without regard to meal time.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use

Lorastine Tablets should be administered with caution in patients with severe liver impairment

(see section 4.2).

This medicinal product contains lactose; thus patients with rare hereditary problems of

galactose

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

should not take this

medicine.

The administration of Lorastine tablets should be discontinued at least 48 hours before skin

tests since antihistamines may prevent or reduce otherwise positive reactions to dermal

reactivity index.

4.5

Interaction with other medicinal products and other forms of interaction

When administered concomitantly with alcohol, Lorastine Tablets have no potentiating effects

as measured by psychomotor performance studies.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in

elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse

events.

Increase in plasma concentrations of loratadine has been reported after concomitant use

with

ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically

significant changes (including electrocardiographic).

Paediatric population

Interaction studies have only been performed in adults.

4.6

Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no

malformative nor feto/neonatal toxicity of loratadine. Animal studies do not indicate direct or

indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary

measure, it is preferable to avoid the use of Lorastine Tablets during pregnancy.

Breastfeeding

Loratadine is excreted in breast milk. Therefore, the use of Lorastine Tablets is not

recommended in breastfeeding women.

Fertility

There are no data available on male and female fertility.

4.7

Effects on ability to drive and use machines

In clinical trials that assessed driving ability, no impairment was observed in patients receiving

loratadine. Lorastine Tablets have no or negligible influence on the ability to drive and use

machines. However, patients should be informed that very rarely some people experience

drowsiness, which may affect their ability to drive or use machines.

4.8

Undesirable effects

Summary of the safety profile

In clinical trials involving adults and adolescents in a range of indications including allergic

rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg daily,

adverse reactions with loratadine were reported in 2% of patients in excess of those treated

with placebo. The most frequent adverse reactions reported in excess of placebo were

somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).

Tabulated list of adverse reactions

The following adverse reactions reported during the post-marketing period are listed in the

following table by System Organ Class. Frequencies are defined as very common (≥ 1/10),

common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <

1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available

data).

Within each frequency grouping, adverse reactions are presented in order of decreasing

seriousness.

System Organ Class

Frequency

Adverse Experience Term

Immune system disorders

Very rare

Hypersensitivity reactions

(including angioedema and

anaphylaxis)

Nervous system disorders

Very rare

Dizziness, convulsion

Cardiac disorders

Very rare

Tachycardia, palpitation

Gastrointestinal disorders

Very rare

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Very rare

Abnormal hepatic function

Skin and subcutaneous tissue disorders

Very rare

Rash, alopecia

General disorders and administration

site conditions

Very rare

Fatigue

Investigations

Not Known

Weight increase

Paediatric population

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse

reactions

reported in excess of placebo were headache (2.7%), nervousness (2.3%), and

fatigue (1%).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions to the Ministry of Health

according to the National Regulation by using an online form

https://sideeffects.health.gov.il

4.9

Overdose

Overdosage with loratadine increased the occurrence of anticholinergic symptoms.

Somnolence,

tachycardia, and headache have been reported with overdoses.

In the event of overdose, general symptomatic and supportive measures are to be instituted

and maintained for as long as necessary. Administration of activated charcoal as a slurry with

water may be attempted. Gastric lavage may be considered. Loratadine is not removed by

haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical

monitoring of the patient is to be continued after emergency treatment.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H

antagonist, ATC code: R06A X13.

Mechanism of action

Loratadine, the active ingredient in Lorastine tablets, is a tricyclic antihistamine with

selective,

peripheral H

-receptor activity.

Pharmacodynamic effects

Loratadine has no clinically significant sedative or anticholinergic properties in the majority of

the population and when used at the recommended dosage.

During long-term treatment there were no clinically significant changes in vital signs, laboratory

test values, physical examinations or electrocardiograms.

Loratadine has no significant H

-receptor activity. It does not inhibit norepinephrine uptake and

practically no influence on cardiovascular function or on intrinsic cardiac pacemaker

activity.

Human histamine skin wheal studies following a single 10 mg dose has shown that the

antihistamine effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in

excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing

with loratadine.

Clinical efficacy and safety

Over 10,000 subjects (12 years and older) have been treated with loratadine 10 mg tablets in

controlled clinical trials. Loratadine 10 mg tablets once daily was superior to placebo and

similar to

clemastine in improving the effects on nasal and non-nasal symptoms of AR. In

these studies somnolence occurred less frequently with loratadine than with clemastine and

about the same

frequency as terfenadine and placebo.

Among these subjects (12 years and older), 1000 subjects with CIU were enrolled in placebo

controlled studies. A once daily 10 mg dose of loratadine was superior to placebo in the

management of CIU as demonstrated by the reduction of associated itching, erythema and

hives. In these studies the incidence of somnolence with loratadine was similar to placebo.

Paediatric population

Approximately 200 paediatric subjects (6 to 12 years of age) with seasonal allergic rhinitis

received

doses of loratadine syrup up to 10 mg once daily in controlled clinical trials. In another

study, 60 paediatric subjects (2 to 5 years of age) received 5 mg of loratadine syrup once daily.

No unexpected adverse events were observed.

The paediatric efficacy was similar to the efficacy observed in adults.

5.2

Pharmacokinetic properties

Absorption

Loratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the

absorption of loratadine but without influencing the clinical effect. The bioavailability parameters

of loratadine and of the active metabolite are dose proportional.

Distribution

Loratadine is highly bound (97 % to 99 %) and its active metabolite desloratadine (DL) moderately

bound (73 % to 76 %) to plasma proteins.

In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are

approximately 1 and 2 hours, respectively.

Biotransformation

After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first

pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite -desloratadine (DL)- is

pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL

achieve maximum plasma concentrations (T

) between 1–1.5 hours and 1.5–3.7 hours after

administration, respectively.

Elimination

Approximately 40 % of the dose is excreted in the urine and 42 % in the faeces over a 10 day

period and mainly in the form of conjugated metabolites. Approximately 27 % of the dose is

eliminated in the urine during the first 24 hours. Less than 1 % of the active substance is excreted

unchanged in the active form, as loratadine or DL.

The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for

loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.

Renal impairment

In patients with chronic renal impairment, both the AUC and peak plasma levels (C

) increased

for loratadine and its active metabolite as compared to the AUCs and peak plasma levels (C

) of

patients

with normal renal function. The mean elimination half-lives of loratadine and its active

metabolite were

not significantly different from that observed in normal subjects. Haemodialysis

does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects

with chronic renal impairment.

Hepatic impairment

In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (C

) of

loratadine

were double while the pharmacokinetic profile of the active metabolite was not

significantly changed

from that in patients with normal liver function. The elimination half-lives for

loratadine and its active

metabolite were 24 hours and 37 hours, respectively, and increased with

increasing severity of liver disease.

Elderly

The pharmacokinetic profile of loratadine and its active metabolite is comparable in healthy adult

volunteers and in healthy geriatric volunteers.

5.3

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of

safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged

parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10

times higher than those achieved with clinical doses.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate, maize starch, magnesium stearate.

6.2

Incompatibilities

Not applicable

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4

Special precautions for storage

Store below 25°C.

6.5

Nature and contents of container

Blister strip consisting of aluminium foil with vinyl heat seal coating and a clear, transparent

polyvinylchloride (PVC) film or polyvinylchloride (PVC) film with polyvinylidenechloride (PVDC)

coating.

Pack sizes of 7, 10, 20, tablets.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

Manufacturer:

Schering-Plough Labo. NV Belgium

Marketing Authorisation Holder:

Bayer Israel Ltd. 36 Hacharash St., Hod Hasharon 45240

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

01.06.2015

םש

רישכת

תילגנאב

רפסמו

םושירה

(

133.21.28216.00

)

LORASTINE

®

Syrup

(

133.25.25872.00

)

LORASTINE

®

Tablets

םש

לעב

םושירה

BAYER ISRAEL LTD

.

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Adverse events

In clinical trials in a pediatric population,

children aged 2 through 12 years, common

adverse reactions reported in excess of

placebo

were

headache

(2.7%),

nervousness (2.3%), and fatigue (1%).

clinical

trials

involving

adults

adolescents in a range of indications

including

CIU,

recommended

dose

daily,

adverse reactions with loratadine were

reported in 2 % of patients in excess of

those treated with placebo. The most

frequent adverse reactions reported in

excess

placebo

were

somnolence

(1.2%),

headache

(0.6%),

increased

appetite (0.5%) and insomnia (0.1%).

Other adverse reactions reported very

rarely during the post-marketing period are

listed in the following table.

Summary of the safety profile

In clinical trials involving adults and adolescents in a range

of indications including allergic rhinitis (AR) and chronic

idiopathic urticaria (CIU), at the recommended dose of 10

mg daily, adverse reactions with loratadine were reported in

2% of patients in excess of those treated with placebo. The

most frequent adverse reactions reported in excess of

placebo were somnolence (1.2%), headache (0.6%),

increased appetite (0.5%) and insomnia (0.1%).

Tabulated list of adverse reactions

The following adverse reactions reported during the post-

marketing period are listed in the following table by System

Organ Class. Frequencies are defined as very common (

1/10), common (

1/100 to < 1/10), uncommon (

1/1,000

to < 1/100), rare (

1/10,000 to < 1/1,000), very rare (<

1/10,000) and not known (cannot be estimated from the

available data).

Within each frequency grouping, adverse reactions are

presented in order of decreasing seriousness.

Immune system

disorders

Anaphylaxis

Nervous system

disorders

Dizziness

Cardiac disorders

Tachycardia,

palpitation

Gastrointestinal

disorders

Nausea, dry

mouth, gastritis

Hepatobiliary

disorders

Abnormal

hepatic

function

Skin and

subcutaneous

tissue disorders

Rash, alopecia

General disorders

and administration

site conditions

Fatigue

ב"צמ

ובש ,ןולעה

נמוסמ תו

תורמחהה

שקובמה תו

לע

עקר

בוהצ

.

םייוניש

םניאש

רדגב

תורמחה

ונמוס

)ןולעב( לע

עקר

קורי

System Organ

Class

Frequency

Adverse Experience

Term

Immune system

disorders

Very rare

Anaphylaxis

Nervous system

disorders

Very rare

Dizziness,

convulsion

Cardiac

disorders

Very rare

Tachycardia,

palpitation

Gastrointestinal

disorders

Very rare

Nausea, dry mouth,

gastritis

Hepatobiliary

disorders

Very rare

Abnormal hepatic

function

Skin and

subcutaneous

tissue disorders

Very rare

Rash, alopecia

General

disorders and

administration

site conditions

Very rare

Fatigue

העדוה

לע

הרמחה

עדימ

ןולעב )תוחיטב

ןכרצל ךיראת

01.06.2015

םש

רישכת

תילגנאב

רפסמו

:םושירה

)

133.25.25872.00

(

Lorastine

®

Tablets

םש

לעב

םושירה

BAYER ISRAEL LTD

.

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח דציכ

שמתשת :הפורתב :ןונימ ןונימה

לבוקמה

:אוה םירגובמ

םידליו

לעמ

ליג

םינש

הילבט

תחא

םעפ

תחא

לע ,םויב הביק

.הקיר ןיא

רובעל

לע

הנמה

.תצלמומה הפורת

וז

הניא

תדעוימ

ךרדב

ללכ םידליל

תחתמ

ליגל

6

םינש

םא

תחכש

לוטיל

הפורת

וז

ןמזב שי ,בוצקה

לוטיל

הנמ

דימ

:תרכזנשכ ךא

םושב

ןפוא

ןיא

לוטיל

יתש

תונמ !דחיב ןפוא

שומישה

שי

לוטיל

הפורתה ינפל

.החורא תחלצהל עייסל י/לכות דציכ ? לופיטה ץלמוהש לופיטה תא םילשהל ךילע רופיש לח םא םג.אפורה ידי-לע לופיטה קיספהל ןיא ,ךתואירב בצמב .אפור םע תוצעייתה אלל הפורתב י/ענמ

!הלערה

שי תרחא הפורת לכו וז הפורת םדי גשיהל ץוחמ רוגס םוקמב רומשל ךכ ידי לעו תוקונית וא/ו םידלי לש רתי תנמ תלטנ םא.הלערה י/ענמת ,הפורתה ןמ דלי עלב תועטב םא וא ,םילוח תיב לש ןוימ רדחל דימ י/הנפ ןיא.ךתא הפורתה תזירא י/אבהו תשרופמ הארוה אלל האקהל םורגל !אפורהמ

ךילע

קודבל

םע

אפורה

וא

חקורה

םא

ךניא חוטב

ןונימה

לבוקמה

ךרדב

ללכ

אוה

ליג לעמ םידליו םירגובמ

12

:םינש וא םע ,םימ סוכ םע םויב םעפ תחא הילבט .לכוא ילב יאליגב םידליל ןונימה

2-12

יפל וניה םינש :לקשמ לעמ ףוג לקשמ

30

:ג"ק וא םע ,םימ סוכ םע םויב םעפ תחא הילבט .לכוא ילב ףוג לקשמ

30

:תוחפ וא ג"ק תתל ןיא תוילבט ןיטסרול תויצלומרופ ןנשי . ינב םידליל רתוי תומיאתמה תורחא

2-12

םילקושה ,םינש

.תוחפ וא ג"ק תוילבט ןיטסרול םידליל תדעוימ הניא םייתנש ליגל תחתמ :תורומח דבכ תויעב םע םידליו םירגובמ לעמ םילקושה םידליו םירגובמ

30

:ג"ק ,ןכ םוי) םיימויב םעפ תחא הילבט לוטיל שי םע .לכוא ילב וא םע ,םימ סוכ םע (אל םוי חקורה וא ךלש אפורה לא תונפל ךילע ,תאז .וז הפורת תליטנ ינפל ןתינ

רובשל לע לקהל תנמ לע היילבטה תא יקלח לכ תא תינמז וב לוטיל שי ךא ,התעילב .היילבטה .תצלמומה הנמה לע רובעל ןיא םא

תלטנ

תועטב הובג ןונימ רתוי

לא הנפ .דימ חקורה וא ךלש אפורה אל

תויעב תויופצ תורומח

םלוא , ןכתיי לובסתו

באכמ ריהמ קפוד ,שאר וא

תשוחת תוינונשי

דלי עלב תועטב םא וא רתי תנמ תלטנ םא ,הפורתה ןמ הנפ דימ אפורל ןוימ רדחל וא .ךתיא הפורתה תזירא אבהו םילוח תיב לש תועפות

יאוול ףסונב

תוליעפל

היוצרה

לש ןמזב ,הפורתה

שומישה

הב

תולולע עיפוהל

תועפשה

יאוול

שבוי :ןוגכ שוטשיט ,הפב

,םונמנ,הליחב ,היאר באכ

.תופייע ,שאר םא

תועפות

ולא

תוכשמנ

וא

תודירטמ שי

תונפל

אפורל

תועפות

תובייחמה

תוסחייתה בצק :תדחוימ

בל

ץאומ

תשוחתו קפוד

,ריהמ

םימוטפמיס

לש

העיגפ :דבכב

רוע

םייניעו

םיבוהצ

רידנ( הרקמב - )דואמ

הז

שי

קיספהל

תא לופיטה

תונפלו

אפורל

.דימ לכב

הרקמ

ובש

ךניה

ה/שיגרמ תועפות

יאוול

אלש

וניוצ

ןולעב

הז

וא םא

לח

יוניש

ךתשגרהב

,תיללכה ךילע

ץעייתהל

םע

אפורה

.דימ ומכ

שומישה ,הפורת לכב

ןיטסרול תוילבט

לולע קלחב יאוול תועפותל םורגל .םישמתשמהמ לא

להבית

ארקמל

תמישר

תועפות

יאוולה

ןכתי

אלו

לובסת

ףאמ

תחא

ןהמ

תועפות

יאוולה

תוצופנה

רתויב

וחוודש םירגובמב

םידליו

לעמ

ליג

םינש

ןה

םונמנ

שאר באכ

רבגומ ןובאית

ןושיל ישוק

תועפות

יאוולה

תוצופנה

רתויב

וחוודש םידליב

יאליגב

2-12

םינש

ןה

שאר באכ

תונבצע

תופייע תועפות יאוול תורידנ

דואמ ע) ולול עיפשהל ת ךותמ דחא םדא דע לע

10,000

ופצנ (םישנא לש קווישה ךלהמב ןה םג ןידטארול

הרומח תיגרלא הבוגת

תרוחרחס

בצק בל ץאומ

רידס אל וא

הפב שבוי

הליחב

לוכיעה תכרעמב תוערפה

דבכב תויעב

רעיש תרישנ

החירפ

תופייע

סוכרפ םא

העיפוה

תעפות

יאוול

םא

תחא תועפותמ

יאוולה

הרימחמ

וא

רשאכ

התא לבוס

תעפותמ

יאוול

אלש

הניוצ

ןולעב ,הז ךילע

ץעייתהל

םע

אפורה .ךלש ב"צמ

ובש ,ןולעה

נמוסמ תו

תורמחהה

שקובמה תו

לע

עקר

.בוהצ םייוניש

םניאש

רדגב

תורמחה

ונמוס

)ןולעב( לע

עקר

קורי

העדוה

לע

הרמחה

עדימ

ןולעב )תוחיטב

ןכרצל ךיראת

01.06.2015

םש

רישכת

תילגנאב

רפסמו

:םושירה

(

133.21.28216.00

)

Lorastine

®

syrup

םש

לעב

םושירה

BAYER ISRAEL LTD

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח דציכ

שמתשת :הפורתב :ןונימ :אוה לבוקמה ןונימה ליג לעמ םידליו םירגובמ

:םינש

) תוליוכמ תויפכ יתש

םעפ (ל"מ .הקיר הביק לע ,םויב תחא

םידלי

:םינש

תליוכמ תחא תיפכ

הביק לע ,םויב תחא םעפ (ל"מ .הקיר .תצלמומה הנמה לע רובעל ןיא ללכ ךרדב תדעוימ הניא וז הפורת ליגל תחתמ םידלילו

תוקוניתל .םייתנש ןמזב וז הפורת לוטיל תחכש םא :תרכזנשכ דימ הנמ לוטיל שי ,בוצקה תונמ יתש לוטיל ןיא ןפוא םושב ךא !דחיב םיש י/ :בל תיפכב הנמה תדידמ לע דיפקהל שי ,תדחוימ הדידמ תיסוכב וא הדימ .'וכו ףלזמ :שומישה ןפוא .החורא ינפל הפורתה לוטיל שי תחלצהל עייסל י/לכות דציכ ? לופיטה ץלמוהש לופיטה תא םילשהל ךילע .אפורה ידי-לע ןיא ,ךתואירב בצמב רופיש לח םא םג אלל הפורתב לופיטה קיספהל .אפור םע תוצעייתה ךילע

קודבל

םע

אפורה

וא

חקורה

םא

ךניא חוטב

ןונימה

לבוקמה

ךרדב

ללכ

אוה

ליג לעמ םידליו םירגובמ

12

:םינש

) תויפכ

.םויב םעפ (ל"מ יאליגב םידליל ןונימה

2-12

יפל וניה םינש :לקשמ לעמ ףוג לקשמ

30

:ג"ק

) תויפכ

(ל"מ .םויב םעפ ףוג לקשמ

30

:תוחפ וא ג"ק ) תחא תיפכ

.םויב םעפ (ל"מ ןיטסרול וניא פוריס דעוימ

םידליל

תחתמ

ליג םייתנש

:תורומח דבכ תויעב םע םידליו םירגובמ לעמ םילקושה םידליו םירגובמ

30

:ג"ק

) תויפכ

םוי ,ןכ םוי) םיימויב םעפ (ל"מ .(אל םילקושה םידלי

30

:תוחפ וא ג"ק תיפכ ) תחא

.(אל םוי ,ןכ םוי) םיימויב םעפ (ל"מ וא ךלש אפורה לא תונפל ךילע ,תאז םע .וז הפורת תליטנ ינפל חקורה :בל םיש וא הדימ תיפכב הנמה תדידמ לע דיפקהל שי .'וכו ףלזמ ,תדחוימ הדידמ תיסוכב .תצלמומה הנמה לע רובעל ןיא םא

תלטנ

תועטב הובג ןונימ רתוי

לא הנפ .דימ חקורה וא ךלש אפורה אל

תויעב תויופצ תורומח

םלוא , ןכתיי לובסתו

באכמ ריהמ קפוד ,שאר וא

תשוחת תוינונשי

דלי עלב תועטב םא וא רתי תנמ תלטנ םא ,הפורתה ןמ הנפ דימ אפורל ןוימ רדחל וא .ךתיא הפורתה תזירא אבהו םילוח תיב לש תועפות

יאוול ףסונב

תוליעפל

היוצרה

לש הפורתה

ןמזב

שומישה

הב

תולולע עיפוהל

תועפשה

יאוול

שבוי :ןוגכ שוטשיט ,הפב

,םונמינ ,הליחב ,היאר באכ

.תופייע ,שאר םא

תועפות

ולא

תוכשמנ

וא

תודירטמ שי

תונפל

.אפורל

תועפות

תובייחמה

תוסחייתה תדחוימ בצק :

בל

ץאומ

תשוחתו קפוד

םימוטפמיס ,ריהמ

לש

העיגפ דבכב

רוע:

םייניעו

םיבוהצ

רידנ( הרקמב - )דואמ

הז

שי

קיספהל

תא לופיטה

תונפלו

אפורל

.דימ לכב

הרקמ

ובש

ךניה

ה/שיגרמ תועפות

יאוול

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