Claratyne

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Loratadine 10 mg
Available from:
Bayer New Zealand Limited
INN (International Name):
Loratadine 10 mg
Dosage:
10 mg
Pharmaceutical form:
Tablet
Composition:
Active: Loratadine 10 mg Excipient: Lactose monohydrate Magnesium stearate Maize starch
Prescription type:
General sale
Therapeutic indications:
The treatment of seasonal allergic rhinitis in adults and children 12 years of age and older.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 1 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 2 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 5 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-4204a
Authorization date:
2013-10-11

Read the complete document

Claratyne CMI

31 March 2015

Consumer Medicine Information

Claratyne

Claratyne - loratadine 10 mg tablets

Children’s Claratyne – loratadine 1 mg/mL syrup (peach flavour)

Children’s Claratyne – loratadine 5 mg chewable tablets

What is in this leaflet

This leaflet answers some common questions about Claratyne.

It does not contain all the available information. It does not take the place of talking to your

doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of

you taking Claratyne against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or

pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Claratyne is used for

Claratyne relieves symptoms associated with allergic rhinitis (hayfever), such as sneezing,

runny or itchy nose, and burning or itchy eyes.

Claratyne may also be used to relieve symptoms associated with a skin condition called

urticaria (also called hives); these symptoms include itching, redness and lumps on the skin.

Claratyne can be used in adults and children.

Claratyne belongs to a class of medicines known as antihistamines.

Antihistamines help reduce allergic symptoms by preventing the effects of a substance called

histamine. Histamine is produced by the body in response to foreign substances which the

body is allergic to.

Your doctor or pharmacist, however, may prescribe Claratyne for another purpose. Ask

your doctor or pharmacist if you have any questions about why Claratyne has been

prescribed for you.

Claratyne tablets, chewable tablets and syrup can be bought without a doctor’s prescription.

Before you take Claratyne

Claratyne CMI

31 March 2015

Consumer Medicine Information

When you must not take it

Do not take Claratyne if:

you have an allergy to Claratyne, loratadine or any of the ingredients

listed at the end of this leaflet.

Symptoms of an allergic reaction may include skin rash, difficulty in breathing or faintness.

Do not take Claratyne if you are pregnant or breastfeeding unless you and your doctor

or pharmacist has discussed the risks and benefits involved.

Do not give Claratyne to children less than 1 year old.

Do not take Claratyne after the expiry date printed on the pack.

Do not take Claratyne if the packaging is torn or shows signs of tampering.

Before you start to take it

You must tell your doctor or pharmacist:

if you are allergic to any other medicines or any foods, dyes or preservatives

you have liver disease or any other medical conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including

medicines that you buy without a prescription from a pharmacy, supermarket or

health food shop.

How to take Claratyne

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist

for help.

How much to take

Adults and children over 12 years:

One Claratyne tablet or two Children’s Claratyne chewable tablets or 10 mL of Children’s

Claratyne syrup, once daily.

Children 2-12 years of age:

Over 30kg – two Children’s Claratyne chewable tablets or 10 mL of Children’s Claratyne

syrup, or one Claratyne tablet, once daily.

Less than 30kg – one Children’s Claratyne chewable tablet or 5 mL of Children’s Claratyne

syrup, once daily.

Children 1-2 years of age:

Claratyne CMI

31 March 2015

Consumer Medicine Information

2.5 mL of Children’s Claratyne syrup once daily.

Be sure to take Claratyne exactly as your doctor or pharmacist has told you to.

If you do not follow their instructions, you may not get relief from your symptoms.

It does not matter if you take Claratyne before or after food.

Do not take Claratyne more often than recommended.

How to take it

Tablets: Take with a glass of water.

Chewable Tablets: Chew the tablet(s) and then swallow.

Syrup: Measure dose with the measuring spoon provided.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next

dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine

as you would normally.

Do not take a double dose to make up for the dose you missed.

If you take too much (overdose)

Immediately telephone your doctor or the National Poisons Information Centre (0800

POISON or 0800 764 766) for advice or go to your nearest Accident and Emergency

Centre if you think you or anyone else may have taken too much Claratyne.

Do this even if there are no signs of discomfort or poisoning.

You may need medical attention.

While you are taking Claratyne

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking

Claratyne.

Tell your doctor or pharmacist if you become pregnant while you are taking Claratyne.

Things you must not do

Do not give Claratyne to anyone else, even if their symptoms seem similar to yours.

Do not use it to treat any other complaints unless your doctor or pharmacist says to.

Things to be careful of

Stop taking Claratyne 48 hours before you have any skin tests.

Antihistamines may interfere with the results of skin tests.

Claratyne CMI

31 March 2015

Consumer Medicine Information

WARNING: Although the medicine is unlikely to affect your ability to drive or operate

machinery, a few people may be impaired and care should be taken.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you

are using Claratyne.

Claratyne helps most people with allergies, but it may have unwanted effects in a few people.

Like other medicines, Claratyne can cause some side effects. If they occur, they are most

likely to be minor and temporary. However, some may be serious and need medical

attention.

Ask your doctor or pharmacist any questions you may have.

The unwanted events reported by some patients were:

Tablets:

headache

sleepiness

fatigue

dry mouth

dizziness

Syrup:

nervousness

fidgeting

sleepiness

headache

Other unwanted effects may also occur in some people taking Claratyne.

After taking Claratyne

Storage

Keep your tablets and chewable tablets in the blister pack in a dry place until it is time

to take them.

If you take your tablets or chewable tablets out of the blister pack they will not keep well.

Keep your syrup in the bottle until it is time to take it.

Keep your tablets in a cool dry place where the temperature stays below 30

o

C.

Keep your chewable tablets in a cool dry place where the temperature stays below

25

o

C.

Keep your syrup in a cool dry place where the temperature stays below 25

o

C.

Do not leave medicines in the car on hot days or on windowsills.

Claratyne CMI

31 March 2015

Consumer Medicine Information

Keep Claratyne where children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store

medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or its expiry date

has passed, ask your pharmacist what to do with it.

Product description

What it looks like

Claratyne tablets are small white tablets. They come in packs of 5, 10, 30 and 60 tablets.

Children’s Claratyne chewable tablets are slightly speckled and/or mottled, light to medium

purple tablets with a “C” on one side. They come in packs of 10 or 30 chewable tablets.

Children’s Claratyne syrup is a clear syrup. It comes in bottles of 100 mL with a measuring

spoon.

Ingredients

Claratyne tablets contain:

loratadine 10 mg

maize starch

magnesium stearate

lactose

Children’s Claratyne chewable tablets contain:

loratadine 5 mg

mannitol

microcrystalline cellulose

aspartame

artificial grape flavour

citric acid

dye – FD&C Blue #2 aluminium lake

dye – D&C Red #27 aluminium lake

colloidal silicon dioxide

sodium starch glycolate

stearic acid

magnesium stearate

Children’s Claratyne syrup (peach) contains:

loratadine 1 mg/mL

propylene glycol

glycerol

citric acid - anhydrous

sucrose

Claratyne CMI

31 March 2015

Consumer Medicine Information

artificial peach flavour

purified water

sodium benzoate as preservative

Distributor

Claratyne is distributed in New Zealand by:

Bayer New Zealand Limited

3 Argus Place

Hillcrest

North Shore 0627

AUCKLAND

Toll Free: 0800 847 874

This leaflet was prepared on 31 March 2015.

Reference: Claratyne Data Sheet dated 31 March 2015.

= Registered Trademark

Read the complete document

NEW ZEALAND DATA SHEET

CLARATYNE

Claratyne Tablets – loratadine 10 mg

Children’s Claratyne - Chewable Tablets loratadine 5 mg

and Syrup loratadine 1 mg/mL

NAME OF MEDICINE

CLARATYNE and CHILDREN’s CLARATYNE (loratadine)

PRESENTATION

Claratyne Tablets

White to off-white, oval, convex tablets with score on one side and flask and logo above the score and

number 10 below the score. Each tablet contains loratadine 10mg and the inactive ingredients maize starch,

lactose and magnesium stearate.

Children’s Claratyne Chewable Tablets

Light to medium purple slightly speckled/mottled round tablet debossed with ”C” on one side. Each tablet

contains loratadine 5 mg, and the inactive ingredients mannitol, microcrystalline cellulose, aspartame,

anhydrous citric acid, colloidal silicon dioxide, sodium starch glycollate, stearic acid, magnesium stearate,

artificial grape flavour (059145 AP0551), Blue dye #2 FD&C (aluminium lake 09902) and Red dye #27 D&C

(aluminium lake C6527).’

Children’s Claratyne Syrup (peach flavour)

Clear, light yellow coloured, peach flavoured syrup. Each mL of syrup contains loratadine 1mg and the

inactive ingredients propylene glycol, glycerin, citric acid - anhydrous, sodium benzoate, sucrose, peach

flavour and purified water.

Children’s Claratyne Syrup (grape flavour) (not available)

Clear, light yellow coloured, grape flavoured syrup. Each mL of syrup

contains loratadine 1mg/mL, and the

inactive ingredients sodium phosphate monobasic monohydrate, phosphoric acid, disodium edetate,

artificial flavouring grape (856.435), glycerol, propylene glycol, macrogol 400, sucralose, maltitol

solution, sorbitol solution 70%, purified water with sodium benzoate as preservative.

Claratyne Liqui-Gels Liquid Capsules (not available)

Oval, clear blue liquid filled (softgel) capsules printed on one side with a C-10 logo. Each capsule contains

loratadine 10 mg, and the inactive ingredients mono- and di- glycerides, polysorbate 80, povidone, lecithin,

medium chain triglycerides, Opacode WB water based Monogramming Ink, Phosal 53 MCT, and soft gelatin

shell formulation 3 oval N(Z).

USES

Actions

CLARATYNE is a potent long-acting, non-sedating antihistamine, with selective peripheral H

-receptor

antagonistic activity. Loratadine does not readily penetrate into the CNS. Loratadine exhibits greater affinity

for peripheral H

-receptors than for central H

-receptors. These properties account for the observed lack of

sedation. Loratadine does not exhibit anticholinergic activity in animals.

Claratyne Data Sheet

31 March 2015

- 2 -

Pharmacokinetics

Loratadine is well absorbed with peak plasma levels occurring at approximately one hour after dosing. The

medicine is almost totally metabolised. It has an active metabolite (SCH 34117); this metabolite corresponds

to 1% to 2% of the dose.

In man, loratadine is extensively bound to plasma protein (97 to 99%) and SCH 34117 moderately bound (73

to 76%).

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

Approximately 27% of the dose is eliminated in the urine during the first 24 hours. The half-life of loratadine

in normal volunteers is 15 hours while that of SCH 34117 is 12 hours. The terminal elimination phase half-

life, based on plasma radioactivity, is approximately 46 hours.

Indications

CLARATYNE is indicated for the relief of:

Symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge and

itching, and ocular itching and burning.

Symptoms and signs of chronic urticaria and other allergic dermatological disorders.

Onset of action occurs rapidly after oral administration. Symptom relief will begin in as little as 10 to 20

minutes after the first dose, with a mean onset of relief obtainable in 27 minutes in patients receiving 10mg of

loratadine. By 45 minutes, all patients should experience relief.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and over:

One CLARATYNE tablet or two CHILDREN’S CLARATYNE Chewable Tablets or 10mL of CHILDREN’S

CLARATYNE syrup once daily.

Children 2-12 years of age:

bodyweight >30kg:

10mL CHILDREN’S CLARATYNE syrup or two CHILDREN’S CLARATYNE

Chewable Tablets or one CLARATYNE tablet once daily

bodyweight <30kg:

CHILDREN’S

CLARATYNE

syrup

CHILDREN’S

CLARATYNE

Chewable Tablet or ½ CLARATYNE tablet once daily.

Children 1-2 years of age:

2.5mL of CHILDREN’S CLARATYNE syrup once daily.

CONTRAINDICATIONS

CLARATYNE is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to loratadine.

WARNINGS AND PRECAUTIONS

Do not exceed recommended dose.

CLARATYNE is no more likely than placebo to cause sedation. However, individual response should be

determined before driving or performing tasks requiring alertness.

Claratyne Data Sheet

31 March 2015

- 3 -

Patients with severe liver impairment should be administered a lower dose because they may have reduced

clearance of loratadine; an initial dose of 5mg once daily or 10mg every second day is recommended.

Safety and efficacy of CLARATYNE in children younger than 1 year of age has not yet been established.

Use In Pregnancy And Lactation

The safe use of CLARATYNE during pregnancy and lactation has not been established and therefore, the

compound should be used only if the potential benefits to the mother justify the potential risk to the foetus or

the infant.

Since loratadine is excreted in breast milk and because of the increased risk of antihistamines for infants,

particularly newborns and premature infants, a decision should be made whether to discontinue nursing or

discontinue the medicine.

ADVERSE REACTIONS

In worldwide controlled clinical studies, the incidence of adverse effects associated with CLARATYNE tablets

and syrup has been comparable to that of placebo. In these trials, loratadine has shown no clinically

significant sedative or anticholinergic properties. Fatigue, sedation, dry mouth, headache, gastrointestinal

disorders such as nausea, gastritis, and also allergic symptoms like rash were rarely reported events with

CLARATYNE tablets which were also reported with similar incidence in placebo-treated patients. In

controlled paediatric clinical trials with CLARATYNE syrup, the incidence of treatment-related headache,

sedation and nervousness, which were rarely reported events, was similar to that of placebo.

During the marketing of CLARATYNE, alopecia, anaphylaxis, abnormal hepatic function, tachycardia,

palpitations, dizziness and convulsion have been reported rarely.

MEDICINE INTERACTIONS

When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by

psychomotor performance studies.

Increase in plasma concentrations of loratadine have been reported after concomitant use with ketoconazole,

erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including

electrocardiographic).

Laboratory Test Interactions

CLARATYNE should be discontinued approximately 48 hours prior to skin testing procedures since

antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

OVERDOSAGE

Somnolence, tachycardia and headache have been reported with overdoses. In volunteer studies, single

doses of up to 160 mg have been administered without any untoward effects. In the event of overdosage,

until further experience is obtained, it is recommended that supportive and symptomatic treatment be started

immediately. Consider standard measures to remove any unabsorbed medicine in the stomach, such as

adsorption by activated charcoal administered as a slurry with water.

PHARMACEUTICAL PRECAUTIONS

Tablets: Store below 30°C

Liquid-capsules: Store below 25

Claratyne Data Sheet

31 March 2015

- 4 -

Syrup (peach and grape flavour): Store below 25°C

Chewable tablets: Store below 25

MEDICINE CLASSIFICATION

General Sale Medicine

Claratyne 10 mg tablets - packs of 5

Pharmacy Medicine

Claratyne 10 mg tablets - packs 10, 30 and 60

Claratyne Liqui-Gels 10 mg liquid-capsules

Children’s Claratyne 5 mg chewable tablets – packs of 10 and 30

Children’s Claratyne 1 mg/mL syrup

Children’s Claratyne 1 mg/mL syrup, grape flavour

PACKAGE QUANTITIES

Claratyne 10 mg tablets:

Packs of 5, 10, 30 and 60

Claratyne Liqui-Gels 10 mg liquid-capsules

Packs of 10* and 24*

Children’s Claratyne 5 mg chewable tablets:

Packs of 10 and 30

Children’s Claratyne 1 mg/mL syrup:

Bottles of 100 mL

Children’s Claratyne 1 mg/mL syrup, grape flavour:

Bottles of 60 mL* and 120 mL*

*Currently not marketed in New Zealand.

NAME AND ADDRESS

Bayer New Zealand Limited

P. O. Box 2825

Shortland Street

Auckland 1140

Ph: (09) 443 3093 or 0800 847 874

Fax: (09) 443 3094

DATE OF PREPARATION

31 March 2015

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