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LORATADINE 5 MG/5 ML ORAL SOLUTION

Active substance(s): LORATADINE

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PIL Size 140 x 250 mm
Loratadine 5 mg/5 ml -Oral Solution PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine 5mg/5ml Oral Solution
Loratadine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Loratadine 5 mg/5 ml
oral solution carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Loratadine 5 mg/5 ml oral solution is and what it is used for
2. Before you take Loratadine 5 mg/5 ml oral solution
3. How to take Loratadine 5 mg/5 ml oral solution
4. Possible side effects
5. How to store Loratadine 5 mg/5 ml oral solution
6. Further information

1. WHAT LORATADINE 5 mg/5 ml ORAL SOLUTION IS AND WHAT IT
IS USED FOR
This medicine belongs to a group of medicines called antihistamines. Throughout this leaflet, your
medicine is called Loratadine oral solution.
Loratadine oral solution is used in both adults and children over 2 years of age to relieve the symptoms
of hayfever such as sneezing, runny nose and burning, itchy eyes. It may also used for skin allergies such
as rash, itching or urticaria (hives).

2. BEFORE YOU TAKE LORATADINE ORAL SOLUTION
Do not take Loratadine oral solution
if you are allergic (hypersensitive) to Loratadine or any of the other ingredients of Loratadine
oral solution.
if you are pregnant, planning to become pregnant or are breast-feeding.
Take special care with Loratadine oral solution
if you have had an allergic reaction to antihistamines in the past
if you have severe liver disease
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is particularly important if you are taking
Cimetidine (for stomach problems)
Erythromycin (an antibiotic)
Ketoconazole or fluconazole (for fungal infections)
Taking Loratadine oral solution with food and drink
This medicine may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The safe use of loratadine during pregnancy has not been established. The use of Loratadine oral solution
during pregnancy is therefore not recommended.
Loratadine, the active substance in this medicine is excreted in breast milk, therefore the use of loratadine
oral solution is not recommended in breast-feeding women.
Driving and using machines
Loratadine very rarely causes drowsiness at the recommended dosage. However, individuals react
differently, so if affected, do not drive or use any tools or machines.
Important information about some of the ingredients of Loratadine oral solution
This medicinal product contains maltitol and sucralose. If you have been told by your doctor that you
have intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE LORATADINE ORAL SOLUTION

Loratadine oral solution is for oral use only. Shake the bottle well before use.
The usual dose is as shown in the table below:
Adults and Children over 12 years of age

10ml (10mg) of the oral solution once daily

Children 2 to 12 years of age with:
Body weight more than 30 kg
Body weight 30 kg or less

10ml (10mg) of the oral solution once daily
5ml (5mg) of the oral solution once daily

If you take more Loratadine oral solution than you should
If you may have taken more Loratadine oral solution than you should, talk to a doctor or pharmacist
immediately. Overdose may cause sleepiness or a faster heart beat. Immediate medical attention should
be sought in the event of an overdose.
If you forget to take Loratadine oral solution
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for the next dose.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Loratadine oral solution can cause side effects, although not everybody gets them.
If any of the following side effects happen, stop taking Loratadine oral solution and tell your doctor
immediately or go to the casualty department at your nearest hospital:
severe allergic reaction which causes difficulty in breathing or dizziness
hair loss
liver problems
faster heart beats
fainting
rash
fatigue
headache
nausea (feeling sick)
gastritis (an inflammation of the lining of the stomach)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5. HOW TO STORE LORATADINE ORAL SOLUTION
-

Keep out of the reach and sight of children
Do not use Loratadine oral solution after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Shelf life after first opening container is 3 months.
Do not use Loratadine oral solution if you notice any defects or signs of deterioration.
If unsure, consult your doctor or pharmacist before taking it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Loratadine oral solution contains
The active substance is Loratadine.
The other ingredients are propylene glycol (E1520), sodium benzoate (E211), disodium edetate,
maltitol (lycasin 80/55), glycerol (E422), citric acid monohydrate, menthol, flavour peach
and sucralose.
What Loratadine oral solution looks like and contents of the pack
Loratadine oral solution is a clear, colourless liquid contained in either amber coloured glass bottles with
a tamper proof child resistance cap or amber coloured transparent PET bottles with a tamper proof child
resistance cap.
Pack size: 100ml
Marketing Authorisation Holder:
APTIL Pharma Limited,
9th floor, CP. House, 97-107 Uxbridge Road, Ealing, London W5 5TL
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, CP. House, 97-107 Uxbridge Road, Ealing, London W5 5TL

This leaflet was last amended 04/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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