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LORATADINE 5 MG/5 ML ORAL SOLUTION

Active substance(s): LORATADINE / LORATADINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

If you take more Loratadine oral solution than you should

Loratadine 5 mg/5 ml Oral Solution
Loratadine

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

Read all of this leaflet carefully 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, if you feel worse or if your symptoms change. See section 4.

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.

If you get any of these serious side effects, stop taking this medicine. See a doctor immediately
• Severe allergic reaction which causes difficulty in breathing or dizziness
• Angioedema (Swollen skin of hands, feet, eyes, lips)
• Convulsion

In this leaflet:
1. What Loratadine 5 mg/5 ml oral solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1.

The most commonly reported side effects (may affect up to 1 in 10 people) in adults and children over 12 years of age are:

drowsiness

headache

increased appetite

difficulty sleeping
The most commonly reported side effects (may affect up to 1 in 10 people) 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:

hair loss

liver problems

faster heart beats

rash

fatigue

nausea (feeling sick)

gastritis (an inflammation of the lining of the stomach)

Dizziness

Palpitation (irregular heartbeats)

Dry mouth

WHAT LORATADINE 5 mg/5 ml ORAL SOLUTION IS AND WHAT IT IS USED FOR

Loratadine 5mg/5ml oral solution 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.

WHAT YOU NEED TO KNOW 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 (listed in section 6).
if you are pregnant, planning to become pregnant or are breast-feeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Loratadine oral solution
- If you have severe liver problems
- If you are scheduled to have any skin test for allergies. Do not take Loratadine 5mg/5ml oral solution for 48 hours before
having these tests. This is because it may affect test results
Children

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.

Do not give Loratadine oral solution to children younger than 2 years old.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

Other medicines and Loratadine oral solution
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)
Loratadine oral solution with food and alcohol
This medicine may be taken with or without food. Loratadine oral solution has not been shown to add to the effects of an alcoholic
drink.

5.

HOW TO STORE LORATADINE ORAL SOLUTION

-

Keep out of the sight and reach 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.

Pregnancy and breast-feeding

-

Do not take this medicine if you are pregnant or if you are 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.

-

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.

6.

CONTENTS OF THE PACK AND OTHER 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.

Loratadine oral solution contains maltitol
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3.

POSSIBLE SIDE EFFECTS

Like all medicines, Loratadine oral solution can cause side effects, although not everybody gets them.

HOW TO TAKE LORATADINE ORAL SOLUTION

What Loratadine oral solution looks like and contents of the pack

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your
doctor or pharmacist if you are not sure.

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.

Giving this medicine to children
It is important to know how much your child weighs to make sure that you give the correct amount of medicine. For example, a 9 year
old child weighs about 30kg (4st 7lb). If in doubt weigh your child and then follow the instructions in the table.
Loratadine oral solution is to be taken only by mouth, and is not to be taken by children aged under 2 years..
The spoon provided should be used to measure the required dose. The recommended dose is as shown in the table below:
Adults and Children over 12 years of age
10ml (10mg) of the oral solution once daily (2 x 5ml spoonful)
Children 2 to 12 years of age with:
Body weight more than 30 kg (4st 7lbs)
10ml (10mg) of the oral solution once daily (2 x 5ml spoonful)
Body weight 30 kg (4st 7lbs) or less
5ml (5mg) of the oral solution once daily (1 x 5ml spoonful)
If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day.
If this applies to you follow their instructions.

Pack size: 100 ml
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd, , County Oak Way , Crawley, West Sussex, RH11 7XA, United Kingdom
This leaflet was last amended 06/2017

8063333-7803

Loratadine 5 mg/5 ml

PRODUCT NAME

:

COUNTRY : UK

LOCATION : -

ITEM / PACK

:

PIL

NO. OF COLORS: 1

REMARK :

DESIGN STYLE

:

Front/Back

PANTONE SHADE NOS.:

SUBSTRATE :

CODE

:

8063333-7803

Black

Activities

Department

DIMENSIONS (MM)

:

180 x 240

Prepared By Pkg.Dev

ART WORK SIZE

:

S/S

Reviewed By Pkg.Dev

DATE

:

20-06-2017

Front Size 8.5 pt

Supersedes A/W No.:

Name

Signature

Approved By Quality

This colour proof is not colour binding. Follow Pantone shade reference for actual colour matching.

Date

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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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