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LORAPAED ALLERGY RELIEF 5 MG/5 ML ORAL SOLUTION

Active substance(s): LORATADINE

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DUMMY

DUMMY

PATIENT INFORMATION LEAFLET
Lorapaed Allergy Relief 5 mg/5 ml Oral Solution
loratadine

The spoon provided holds 5 ml of your medicine. Shake the bottle well before use. The usual dose is:

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

How often to take

1 x 5 ml spoonful

Once daily

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

2 x 5 ml spoonfuls

Once daily

Adults and children over 12 years

2 x 5 ml 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.

If you take more Lorapaed Allergy Relief 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 your child may feel drowsy, have a headache
or rapid heartbeat.

What Lorapaed Allergy Relief is and what it is used for

If you forget to take Lorapaed Allergy Relief
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 Lorapaed Allergy Relief 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

What you need to know before you take Lorapaed Allergy Relief

Do not take Lorapaed Allergy Relief if you are:

allergic to loratadine, or any of the other ingredients of this medicine (see Section 6 and end of Section 2).

pregnant or planning to become pregnant.

breast-feeding, as loratadine can pass into breast milk.

The most commonly reported side effects in children aged 2 through 12 years are:

headache

nervousness

tiredness

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lorapaed Allergy Relief if:

you have severe liver problems

you have a hereditary intolerance to some sugars.
Lorapaed Allergy Relief should not be taken for 48 hours before a skin test, since it may affect the results.
Children
Do not give Lorapaed Allergy Relief to children younger than 2 years old.
Other medicines and Lorapaed Allergy Relief
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).

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.

Lorapaed Allergy Relief with alcohol
You must avoid excessive alcohol consumption while you are taking this medicine, as with all antihistamine medicines.

5.

Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or if you are breast-feeding.
Driving and using machines
Lorapaed Allergy Relief 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.
Lorapaed Allergy Relief contains

sucrose: It contains 3g 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.

ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 10 ml.
3.

How much to take

Children of 2 to 12 years who weigh 30 kg (4st 7lb) or less

Do not take more than the label tells you to

Lorapaed Allergy Relief 5 mg/5 ml Oral Solution (’Lorapaed Allergy Relief') 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. Lorapaed Allergy Relief 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.

Age

How to store Lorapaed Allergy Relief

Keep out of the sight and reach of children. This medicinal product does not require any special storage conditions.
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 Lorapaed Allergy Relief contains

The active ingredient is loratadine: 5 mg in each 5 ml 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).

How to take Lorapaed Allergy Relief

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.
Lorapaed Allergy Relief is to be taken only by mouth, and is not to be taken by children aged under 2 years.
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What Lorapaed Allergy Relief looks like and contents of the pack
Lorapaed Allergy Relief is a colourless solution, with the taste of peach. It is available in pack sizes of 60 ml & 70 ml amber glass bottles, and includes a 5 ml
spoon. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
This leaflet was last updated in 06/2016

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PL 04917/0141

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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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