Claritine Syrup Product Characteristics Summary

SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
1
Claritine Syrup - March 2018
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
Claritine 1 mg/ml syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 1 mg loratadine.
Excipients with known effect:

Contains maltitol liquid, sorbitol, propylene glycol and sodium benzoate.
This medicine contains:
• 2.5 mg sodium benzoate in each 5 ml of the syrup which is equivalent to 0.5 mg/ml
• 3 g maltitol liquid in each 5 ml of the syrup which is equivalent to 600.69 mg/ml
• 250 mg propylene glycol in each 5 ml of the syrup which is equivalent to 50 mg/ml
• less than 1 mmol sodium (23 mg) per 5 ml of the syrup that is to say essentially ‘sodium-free’
• 700 mg sorbitol in each 5 ml of the syrup which is equivalent to 140 mg/ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup.
Clear, colourless to light yellow syrup.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Claritine is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria
in adults and children over the age of 2 years.
4.2 Posology and method of administration
Posology
Adults and children over 12 years of age: 10 ml (10 mg) of the syrup once daily.
Paediatric population
Children 2 to 12 years of age are dosed by weight:
Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily.
Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily.
The safety and efficacy of Claritine in children under 2 years of age 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, and for children weighing 30 kg or less, 5 ml (5 mg)
every other day is recommended.
Patients with renal impairment

No dosage adjustments are required in patients with renal insufficiency.
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Elderly
No dosage adjustments are required in the elderly.
Method of administration
Oral use. The syrup may be taken without regard to mealtime.
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
Claritine should be administered with caution in patients with severe liver impairment
(see section 4.2).
This medicinal product contains maltitol and sorbitol; thus patients with rare hereditary problems of
fructose intolerance should not take this medicine.
The administration of Claritine 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, Claritine has 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).
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 Claritine during pregnancy.
Breastfeeding
Loratadine is excreted in breast milk.. Therefore, the use of Claritine is not recommended in breast-
feeding 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. Claritine has no or negligible influence on the ability to drive and use machines. However,
4
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 Very rare Rash, alopecia

tissue disorders
General disorders and administration Very rare Fatigue

site conditions
Investigations Not known Weight increased
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 via the national reporting system
listed in Appendix V.
4.9 Overdose
Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence,

tachycardia, and headache have been reported with overdoses.
5
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 – H1 antagonist, ATC code: R06A X13.
Mechanism of action
Loratadine, the active ingredient in Claritine, is a tricyclic antihistamine with selective, peripheral H 1 -
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 2 -receptor activity. It does not inhibit norepinephrine uptake and has
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.
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
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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 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 (Tmax) 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 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 (Cmax) increased for
loratadine and its active metabolite as compared to the AUCs and peak plasma levels (Cmax) 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 (Cmax) 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
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6.1 List of excipients
Disodium edetate (E386)

Sodium dihydrogen phosphate dihydrate (E339)
Maltitol liquid (E965)
Propylene glycol (E1520)
Glycerol (E422)
Phosphoric acid (E338) (to adjust pH)
Sodium benzoate (E211)
Sucralose (E955)
Sorbitol liquid (E420)
Artificial mixed berry flavour
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months; after first opening, the syrup is stable for 1 month.
6.4 Special precautions for storage
Do not freeze. Keep the bottle in the outer carton in order to protect from light.
6.5 Nature and contents of container
Opaque white plastic bottles of 60, 120 or 150 ml with a tamper-evident, child-proof plastic cap. A
measuring cup with 5 ml and 10 ml dosing lines is included.
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.
7. MARKETING AUTHORISATION HOLDER
[To be completed nationally]
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
8
9
LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
BOTTLE OF 60, 120, 150 ML

Loratadine
2. STATEMENT OF ACTIVE SUBSTANCE(S)
3. LIST OF EXCIPIENTS

See package leaflet for more information.
4. PHARMACEUTICAL FORM AND CONTENTS
Syrup
60 ml with a measuring cup with 5 ml and 10 ml dosing lines
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
Claritine syrup is to be used within 1 month after opening.

EXP: month/year
9. SPECIAL STORAGE CONDITIONS
11
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing authorisation holder:

{Name and Address}
<{tel}>
<{fax}>
<{e-mail}>
13. BATCH NUMBER
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE

Relieves symptoms of allergic rhinitis (eg, hay fever) such as sneezing, runny or itchy nose, and
burning or itchy eyes.
Relieves the symptoms of urticaria such as itching, redness and number and size of hives.
Children from 2-12 years old:

Body weight: 30 kg or less: once daily 5 ml (measuring cup filled to 5 ml line)
Body weight: above 30 kg: once daily 10 ml (measuring cup filled to 10 ml line) Adults and children
of 12 years and older: once daily 10 ml (measuring cup filled to 10 ml line) Claritine is not
recommended for infants younger than 2 years old.
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
12
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
BOTTLE OF 60, 120, 150 ML

Loratadine
2. STATEMENT OF ACTIVE SUBSTANCE(S)
3. LIST OF EXCIPIENTS

See package leaflet for more information.
4. PHARMACEUTICAL FORM AND CONTENTS
Syrup
60 ml with a measuring cup with 5 ml and 10 ml dosing lines 120 ml with a measuring cup with 5 ml
and 10 ml dosing lines
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
Claritine syrup is to be used within 1 month after opening.

EXP: month/year
14
9. SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing authorisation holder:

{Name and Address}
<{tel}>
<{fax}>
<{e-mail}>
13. BATCH NUMBER
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
15
PACKAGE LEAFLET
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Package leaflet: Information for the User
Loratadine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse
has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse. See section 4.
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:

1. What Claritine is and what it is used for
2. What you need to know before you take Claritine
3. How to take Claritine
4. Possible side effects
5 How to store Claritine
6. Contents of the pack and other information
1. What Claritine is and what it is used for
The full name of your medicine is Claritine syrup.
What Claritine is
Claritine syrup contains the active substance loratadine which belongs to a class of medicines called
“antihistamines”.
How Claritine works

Claritine helps to reduce your allergy symptoms by stopping the effects of a substance called
“histamine”, which is produced in the body when you are allergic to something.
When Claritine should be taken

Claritine relieves symptoms associated with allergic rhinitis (for example, hay fever), such as
sneezing, runny or itchy nose, and burning or itchy eyes in adults and children over the age of 2 years.
Claritine may also be used to help relieve symptoms of urticaria (itching, redness and number and size
of hives).
The effect of Claritine will last a whole day and should help you to continue your normal daily
activities and sleep.
You must talk to a doctor if you do not feel better or if you feel worse.
17
2. What you need to know before you take Claritine
Do not take Claritine if

 you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Claritine if:
 you have liver disease
 you are scheduled to have any skin tests for allergies. Do not take Claritine for two days before
having these tests. This is because it may affect test results.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before
taking Claritine.
Children
Do not give Claritine to children younger than 2 years old.
Other medicines and Claritine

The side effects of Claritine may increase when used together with medicines that alter the
performance of some enzymes responsible for drug-metabolism in the liver. However, in clinical
studies, no increase in side effects of loratadine was seen with products that altered the performance of
these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines. This includes medicines obtained without a prescription.
Claritine with alcohol

Claritine has not been shown to add to the effects of an alcoholic drink.
Pregnancy and breast-feeding

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.
As a precautionary measure, it is preferable to avoid the use of Claritine during pregnancy. Do not take
Claritine if you are breast-feeding. Loratadine is excreted in breast milk.
Driving and using machines

In clinical trials that assessed driving ability, no impairment was observed in patients receiving
loratadine. At the recommended dose, Claritine is 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.
Claritine contains:
Maltitol liquid: This medicine contains 3 g maltitol liquid in each 5 ml of the syrup which is
equivalent to 600.69 mg/ml. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Sorbitol: This medicine contains 700 mg sorbitol in each 5 ml of the syrup which is equivalent to 140
mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an
intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a
rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or
your child) take or receive this medicine.
Propylene glycol: This medicine contains 250 mg propylene glycol in each 5 ml of the syrup which is
equivalent to 50 mg/ml.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5 ml of the syrup , that is to say
essentially ‘sodium-free’.
18
Sodium benzoate: This medicine contains 2.5 mg sodium benzoate in each 5 ml of the syrup which is
equivalent to 0.5 mg/ml.
3. How to take Claritine
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse
has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
How much to take :
Adults and children over 12 years of age:

Take once daily 10 ml (measuring cup filled to 10 ml line)
Children aged 2 to 12 years are dosed by weight:
Body weight more than 30 kg:
Give once daily 10 ml (measuring cup filled to 10 ml line)
Body weight 30 kg or less:
Give once daily 5 ml (measuring cup filled to 5 ml line) Claritine is not recommended for children
younger than 2 years old.
Adults and children with severe liver problems:

Adults and children who weigh more than 30 kg:
Take once every other day 10 ml (measuring cup filled to 10 ml line)
Children who weigh 30 kg or less:

Give once every other day 5 ml (measuring cup filled to 5 ml line)
However, you should talk to your doctor, pharmacist or nurse before taking this medicine.
Taking this medicine

 Water or other liquid is not needed to swallow the syrup
 The syrup may be taken with or without food.
If you take more Claritine than you should

If you take more Claritine than you should, talk to your doctor or pharmacist straight away.
No serious problems are expected however, you may get a headache, have a rapid heartbeat or feel
sleepy.
If you forget to take Claritine

 If you forget to take your dose, take it as soon as you remember, then continue to take it as usual.
 Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor,pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are:
 drowsiness
 headache
 increased appetite
 difficulty sleeping.
19
The most commonly reported side effects in children aged 2 through 12 years are:
 headache
 nervousness
 tiredness.
The following 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 (feeling sick)
● dry mouth
● upset stomach
● liver problems
● hair loss
● rash
● tiredness.
The frequency of the following side effect is not known (frequency cannot be estimated from the
available data):
● weight increased.
Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Claritine
 Keep this medicine out of the sight and reach of children.

 Do not freeze. Keep the bottle in the outer carton in order to protect from light.
 Do not use this medicine after the expiry date which is stated on the bottle after {abbreviation
used for expiry date}. The expiry date refers to the last day of that month.
 Claritine syrup is to be used within 1 month after opening.
 Do not use this medicine if you notice any change in the appearance of the syrup.
 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.
6. Contents of the pack and other information
What Claritine contains

 The active substance is loratadine. Each 10 ml of the syrup contains 10 mg loratadine.
 The other ingredients are disodium edetate (E386), sodium dihydrogen phosphate dihydrate
(E339), maltitol liquid (E965), propylene glycol (E1520), glycerol (E422), phosphoric acid
(E338), sodium benzoate (E211), sorbitol liquid (E420), sucralose (E955), artificial mixed berry
flavour and purified water.
What Claritine looks like and contents of the pack
Syrup.
20
Clear colourless to light yellow syrup.
Claritine syrup is available in opaque white plastic bottles of 60, 120 or 150 ml with a tamper-evident,
child-proof plastic cap. A measuring cup with 5 ml and 10 ml dosing lines is included.
Not all bottle sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

{Name and address}
Manufacturer:
Berlimed S.A.
Poligono Industrial Santa Rosa
Calle Francisco Alonso No.7
28806 Alcalá de Henares (Madrid)
Spain
This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium, Luxemburg, Netherlands, Portugal: Claritine

Ireland, Italy, Sweden: Clarityn
France, Greece, Spain: Clarityne
UK: Clarityn (Allergy)
This leaflet was last approved in {MM/YYYY}.
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Claritine Syrup Product Characteristics Summary

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SUMMARY OF PRODUCT CHARACTERISTICS,

LABELLING AND PACKAGE LEAFLET

Claritine 1 mg/ml syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of syrup contains 1 mg loratadine.

Excipients with known effect:

4.1 Therapeutic indications

4.2 Posology and method of administration

Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily.

Patients with hepatic impairment

Patients with renal impairment

4.4 Special warnings and precautions for use

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Summary of the safety profile

Tabulated list of adverse reactions

System Organ Class Frequency Adverse Experience Term

Cardiac disorders Very rare Tachycardia, palpitation

Gastrointestinal disorders Very rare Nausea, dry mouth, gastritis

Hepatobiliary disorders Very rare Abnormal hepatic function

Skin and subcutaneous Very rare Rash, alopecia

General disorders and administration Very rare Fatigue

Investigations Not known Weight increased

Reporting of suspected adverse reactions

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence,

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X13.

Clinical efficacy and safety

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

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

Disodium edetate (E386)

6.3 Shelf life

36 months; after first opening, the syrup is stable for 1 month.

6.4 Special precautions for storage

6.5 Nature and contents of container

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

7. MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10. DATE OF REVISION OF THE TEXT

BOTTLE OF 60, 120, 150 ML

1. NAME OF THE MEDICINAL PRODUCT

Claritine 1 mg/ml syrup

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each ml of syrup contains 1 mg loratadine.

Contains maltitol liquid, sorbitol, propylene glycol and sodium benzoate.

4. PHARMACEUTICAL FORM AND CONTENTS

5. METHOD AND ROUTE(S) OF ADMINISTRATION

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Claritine syrup is to be used within 1 month after opening.

9. SPECIAL STORAGE CONDITIONS

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally]

Marketing authorisation holder: