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LORAPAED ALLERGY RELIEF 5 MG/5 ML ORAL SOLUTION

Active substance(s): LORATADINE

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PATIENT INFORMATION LEAFLET
Loratadine 5mg/5ml Oral Solution
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, if you feel worse after a few days.

What is in this leaflet
1.
What Loratadine is and what it is used for
2.
What you need to know before you take Loratadine
3.
How to take Loratadine
4.
Possible side effects
5.
How to store Loratadine
6.
Contents of the pack and other information
1.

What Loratadine is and what it is used for

Loratadine 5mg/5ml Oral Solution (ʻLoratadine') belongs to a group of medicines called
antihistamines. It works by counteracting the effects of histamine which is produced naturally
by your body's defence system, but may be over-produced in allergic reactions.
Loratadine is used to relieve the symptoms of hayfever (allergic rhinitis) in adults and children
over the age of 2 years, which include:

sneezing

irritated, runny or blocked nose

itchy, red and watering eyes
It is also used to relieve the symptoms of skin allergies in adults and children (over the age
of 2 years), which include:

rash, itching and urticaria (hives).
2.

What you need to know before you take Loratadine

Do not take Loratadine if you are:

allergic to loratadine, or any of the other ingredients of Loratadine 5mg/5ml Oral
Solution (see Section 6 and end of Section 2).

pregnant or planning to become pregnant.

breast-feeding, as loratadine can pass into breast milk.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Loratadine:
you have severe liver problems

you have an hereditary intolerance to some sugars.


Loratadine should not be taken for 48 hours before a skin test, since it may affect the
results.
Children
Do not give Loratadine to children younger than 2 years old.
Other medicines and Loratadine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription. There are some
medicines which may increase the risk of side-effects.
Especially, tell your doctor if you are taking any of the following:

cimetidine (for stomach problems)

erythromycin (an antibiotic)

ketoconazole or fluconazole (for fungal infections)

quinidine (for heart problems)

fluoxetine (for depression).
Loratadine with alcohol
You must avoid excessive alcohol consumption while you are taking this medicine, as
with all antihistamine medicines.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or if you are breastfeeding.
Driving and using machines
Loratadine does not usually cause drowsiness at the recommended dose. However,
individuals react differently, so do not drive or operate machinery until you know how it
affects you.
Loratadine contains
sucrose: It contains 3.0g of sucrose per 5 ml dose which may be harmful to the
teeth. Tell your doctor before taking this medicine if you have an intolerance to
some sugars or diabetes mellitus.

This medicinal product contains small amounts of ethanol (alcohol), less than
100mg per 10 ml.


3.

How to take Loratadine

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. 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 is to be taken only by mouth, and is not to be taken by children aged under 2
years.
The spoon provided holds 5ml of your medicine.
Shake the bottle well before use. The usual dose is:
Age
Children of 2 to 12 years who
weigh 30kg (4st 7lb) or less

How much to take
1 x 5ml spoonful

How often to take
Once daily

Children of 2 to 12 years who
weigh more than 30kg (4st
7lb)
Adults and children over 12
years

2 x 5ml spoonfuls

Once daily

2 x 5ml spoonfuls

Once daily

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.
Do not exceed the stated dose
If you take more Loratadine than you should:
If you or your child may have taken too much of this medicine, talk to a doctor or pharmacist
immediately. You or the child may feel drowsy, have a headache or rapid heartbeat.
If you forget to take Loratadine
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 the 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, this medicine can cause side effects, although not everybody gets them.
Swelling of the face, mouth, lips or throat can be signs of an allergic reaction. If this
happens to you, STOP taking Loratadine and tell your doctor immediately, or go to your
nearest hospital. Take the bottle with you if you can.
The most commonly reported side effects in adults and children over 12 years of age are:
 drowsiness
 headache
 increased appetite
 difficulty sleeping
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

dizziness

fast or irregular heartbeat

nausea (feeling sick)

dry mouth

upset stomach

liver problems

hair loss

rash

tiredness

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.
5.

How to store Loratadine

Keep out of the sight and reach of children, and do not store above 25˚C.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month. Use within 6 months after opening.
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 protect the
environment.
6.

Contents of the pack and other information

What Loratadine contains
The active ingredient is loratadine: 5mg in each 5ml of oral solution.

The other ingredients are: sucrose, glycerol (E422), propylene glycol, sodium
benzoate (E211), citric acid monohydrate, peach flavour and purified water (see end
of Section 2 for further information).


What Loratadine looks like and contents of the pack
Loratadine is a colourless solution, with the taste of peach. It is available in a pack size of
60ml amber glass bottles, and includes a 5ml spoon.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0141
This leaflet was last updated in 11/2015

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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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