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LORATADINE 10MG TABLETS

Active substance(s): LORATADINE

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Haylief Hayfever and Allergy 10mg tablets
[Loratadine]

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefullybefore 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 you feel worse or if your
symptoms change. See section 4.
What is in this Leaflet :
1. What are Haylief Hayfever and
Allergy 10mg tablets and what
are they used for
2. What you need to know before
you take Haylief Hayfever and
Allergy 10mg tablets
3. How to take Haylief Hayfever
and Allergy 10mg tablets
4. Possible side effects
5. How to store Haylief Hayfever
and Allergy 10mg tablets
6. Contents of the pack and other
information
1. What are Haylief Hayfever and
Allergy 10mg tablets and what
are they used for
This medicine contains Loratadine which
belongs to a group of medicines called
antihistamines, which act to relieve the
symptoms of allergies in adults and
children over the age of 2 years who
weigh more than 30kg.
It can be used to relieve the symptoms of
sneezing, runny and itchy nose and eye
irritation and other allergies such as pet
and dust allergies.
It can also be used to treat raised
symptoms of urticaria which is often
known as hives and nettle rash.
The effect of Haylief Hayfever and
Allergy 10mg tablets will last a whole day
and should help you to continue your
normal daily activities and sleep.
You must talk to a doctor if you do not
feel better or if you feel worse.
2. What you need to know before
you take Haylief Hayfever and
Allergy 10mg tablets
Do not take Haylief Hayfever and
Allergy 10mg tablets
•If you are allergic (hypersensitive) to
Loratadine or any of the other ingredients in
these tablets (listed in section 6).
•You are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse
before you take Haylief Hayfever & Allergy
10mg Tablets if you:
•Have severe liver problems (you may
need to take the medine less often, see
("How to take Haylief Hayfever and Allergy
10mg tablets")
•Are having allergy tests, stop taking this
medicine 48 hours before the test. This is
because it may affect the test results.
If any of the above applies to you (or you are
not sure), talk to your doctor, pharmacist or
nurse before taking Haylief Hayfever &
Allergy 10mg Tablets.
Children
Do not give Haylief Hayfever & Allergy 10mg
Tablets to children younger than 2 years or to
children 2 to 12 years old who weigh less
than 30kg. There are other formulations more
suitable for children 2 to 12 years old who
weigh less than 30kg.
Other medicines and Haylief
Hayfever & Allergy 10mg Tablets
The side effects of Haylief Hayfever and
Allergy 10mg Tablets may increase when
used together with medicines that alter the
performance of some enzymes responsible
for drug-metabolism in the liver. However in
the clinical studies, no increase in side effects
of loratadine was seen with products that
altered the performance of these enzymes.
Talk to your doctor, pharmacist or nurse if you
are taking, have recently taken or might take
any other medicines. This includes medicines
taken without a prescription.
Haylief Hayfever and Allergy 10mg
Tablets with Alcohol
Haylief Hayfever and Allergy 10mg Tablets
have not been shown to add the effects of an
alcoholic drink.
Pregnancy and Breastfeeding
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.
As a precautionary measure, it is preferable
to avoid the use of Haylief Hayfever and
Allergy 10mg Tablets during pregnancy.
Do not take Haylief Hayfever and Allergy
10mg Tablets if you are breast-feeding.
Loratadine is excreted in breast milk.
Driving and using machines
In clinical trials that assessed driving ability,
no impairment was observed in patients
receiving loratadine. At the recommended
dose, Haylief Hayfever and Allergy Tablets
are not expected to cause you to be drowsy
or less alert. However, very rarely some
people experience drowsiness, which may
affect their ability to drive or use machines.
Haylief Hayfever & Allergy 10mg
Tablets contain lactose
If you have been told by your doctor that you
have an intolerance to some sugars talk to
your doctor before taking this medicines.

3. How to take Haylief Hayfever
and Allergy 10mg tablets
The following section contains instructions on
how many tablets to take and when. Always
take this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse
has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The score line of the tablet is only there to
help you break the tablet if you have difficulty
swallowing it whole
Giving this medicine to children
A syrup may be preferable for 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.
Do not give to children under 2 years or who
weigh 30kg (4st 7lb) or less.
Age
Children
of 2 to 12
years who
weigh more
than 30kg
(4 st 7lb)

How much
to take
1 x tablet

Adults and
1 x tablet
children over
12 years

How often
to take
Once daily

• 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 (including swelling)
• Dizziness
• Fast or irregular heartbeat
• Nausea (feeling sick)
• Dry mouth
• Upset stomach
• Liver problems
• Hair loss
• Rash
• Tiredness
• Convulsion
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 haylief Hayfever & Allergy 10mg Tablets

Once daily

If you have severe liver problems your doctor
or pharmacist may advice you to take the
recommended amount every other day. If this
applies to you follow their instructions.
•Swallow the tablet with a drink of water
•Do not take more than the amount recommended above
•If symptoms do not go away talk to your
pharmacist or doctor
If you forget to take Haylief
Hayfever and Allergy Tablets
•If you forget to take your dose, take it as
soon as you remember, then continue to take
it as usual.
•Do not take a double dose to make up for a
forgotten dose.
If you take more Haylief Hayfever
and Allergy 10mg tablets than
you should
If you take too many tablets by mistake
contact your nearest hospital casualty department or tell your doctor immediately. Take
your tablet pack with you.
Symptoms of an overdose may include
sleepiness, rapid heart beat and headache.
If you have any further questions on the use
of this product ask your doctor, pharmacist or
nurse.
4.Possible side effects
Like all medicines, this medicine can cause
side effects, although not everyone gets
them.
If you get any of these serious side effects,
stop taking the tablets. See a doctor at once.
•Difficulty in breathing •Swelling of the face,
neck, tongue or throat (these are severe
allergic reactions)
The most commonly reported side effects in
adults and children over 12 years of age are:
• Drowsiness • Increased appetite
• Headache
• Difficulty sleeping
The most commonly reported side effects in
children aged 2 to 12 years are:

Check the expiry date printed on the label or
side of the box. Do not use after the expiry
date stated on the label. The expiry date
refers to the last day of the month.
There are no special storage recommendations for Loratadine. However, do not store
your medicine in a very damp or very hot
place, such as the bathroom or kitchen.
In case of any visible signs of deterioration,
you should discard the package.
Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures help to
protect the environment.
Keep out of the sight and reach of
children
6. Contents of the pack and
other information
What Haylief Hayfever and Allergy
10mg tablets contains
Each Haylief Hayfever and Allergy 10mg
tablet contains 10mg of Loratadine.
The other ingredients are : Lactose Monohydrate, Microcystalline cellulose, Maize starch,
Magnesium stearate.
What Haylief Hayfever and Allergy
10mg tablets look like and
contents of the pack :
Each tablet is white, round and flat with a
break line. Packs are 60 in blister pack
cartons.
Marketing Authorisation Holder and manufacturer
Relonchem Limited
Cheshire House, Gorsey Lane
Widnes, Cheshire, WA8 ORR UK
PL 20395/ 0072
Tel : 0044 207419 5043
Email : info@relonchem.com

Distributor:
Leansave Limited
35 Greenhey Place, Skelmersdale Lancashire,
WN8 9SA, UK

This Leaflet was last revised in Sept’ 2016.

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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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