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Lorapaed Allergy Relief 5 Mg/5 Ml Oral Solution

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PATIENT INFORMATION LEAFLET Lorapaed Allergy Relief 5 mg/5 ml 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 or if you feel worse after a few days.

What is in this leaflet

What Lorapaed Allergy Relief is and what it is used for

What you need to know before you take Lorapaed Allergy Relief

How to take Lorapaed Allergy Relief

Possible side effects

How to store Lorapaed Allergy Relief

Contents of the pack and other information


1.


What Lorapaed Allergy Relief is and what it is used for

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.


What you need to know before you take Lorapaed Allergy Relief

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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.

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).

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

Age

How much to take

How often to take

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

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.

Do not take more than the label tells you to


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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.

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

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 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).

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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