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LORATADINE 10MG ORODISPERSIBLE TABLETS

Active substance(s): LORATADINE / LORATADINE / LORATADINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Loratadine 10 mg Orodispersible Tablets

Loratadine

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Loratadine 10 mg
Orodispersible Tablets carefully to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 10 days.
• 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.

In this leaflet:
1. What Loratadine 10 mg Orodispersible
Tablets are and what they are used for
2. Before you take Loratadine 10 mg
Orodispersible Tablets
3. How to take Loratadine 10 mg
Orodispersible Tablets
4. Possible side effects
5. How to store Loratadine 10 mg
Orodispersible Tablets
6. Further information

1

What Loratadine 10 mg
Orodispersible Tablets are and
what they are used for

Loratadine 10 mg Orodispersible Tablets belong
to a class of medicines known as antihistamines.
Antihistamines help to reduce allergic symptoms
by preventing the effects of a substance called
histamine, which is produced in the body.
The tablet relieves symptoms associated with
allergic rhinitis (for example, hayfever) such as
sneezing, runny or itchy nose and burning or
itchy eyes.
The tablet may also be used to help relieve
symptoms of urticaria (itching and redness),
which is often known as hives or nettle rash.

2

Before you take Loratadine
10 mg Orodispersible Tablets

Do not take Loratadine 10 mg Orodispersible
Tablets:
• if you are hypersensitive (allergic) to
loratadine, or any of the other ingredients of
Loratadine 10 mg Orodispersible Tablets (see
section 6. Further Information).
• if you are pregnant or breastfeeding
• if you have phenylketonuria (a metabolism
disorder)

Take special care with Loratadine 10 mg
Orodispersible Tablets:
Before taking these tablets, tell your doctor or
pharmacist
• if you have severe liver disease or
• if you have to undergo any skin tests ( it may
be necessary to stop taking this medicine at
least 2 days before the test to make sure the
result of the test is correct)

Taking other medicines
This medicine is not expected to affect any other
medicines that you may be taking. However,
some medicines may affect the way that the
active ingredient in this medicine is broken down
in the body.
If you are unsure about interactions with any
other medicines, talk to your pharmacist. This
includes medicines prescribed by your doctor
and medicines you have bought for yourself,
including herbal and homeopathic remedies.

Taking Loratadine 10 mg orodispersible
tablets with food and drink
The tablets can be taken with or without a meal.
The tablets will normally disintegrate in the
mouth in contact with saliva, therefore water or
other liquids are not normally needed.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Do not take Loratadine 10 mg Orodispersible
Tablets if you are pregnant or breastfeeding.

Driving and using machines
At the recommended dose, Loratadine 10 mg
Orodispersible 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.

Important information about some of the
ingredients of Loratadine 10 mg
Orodispersible Tablets
Loratadine 10 mg Orodispersible Tablets contain
0.5 mg aspartame/dose. Aspartame is a source
of phenylalanine which may be harmful for people with phenylketonuria a metabolism disorder.
Loratadine 10 mg Orodispersible Tablets contain
lactose and sorbitol. If you have intolerance to
some sugars, contact your doctor or pharmacist
before taking this medicine.

3

How to take Loratadine
10 mg Orodispersible Tablets

Loratadine 10 mg Orodispersible (“melt in the
mouth”) Tablets are intended to be put on the
tongue (see below) and for oral use.

Always take Loratadine 10 mg Orodispersible
Tablets exactly as recommended. You should
check with your doctor or pharmacist if you are
not sure.

Loratadine 10 mg Orodispersible Tablets break
easily, so you should handle the tablets carefully
and with dry hands only.
1. Tear one blister unit along the
perforations.

Continued on the next page >>

2. Peel open the backing in direction
of the arrow and take the tablet
out carefully. The tablet shouldnʼt
be pushed through the backing.

3. Put the tablet on your tongue as
soon as it is removed from the
packaging. It will melt in your
mouth directly. Water is not
required to swallow the tablet.

Loratadine 10 mg Orodispersible Tablets are
dispersed in your mouth in contact with saliva
and can be therefore taken without water. They
have a sweet orange taste.

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 30 kg (four and half stone).

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 less than 30 kg (four and half stone).
Age

Adults and children
over 12 years

How many How often
to take
to take
One tablet

Children of 2 to 12 One tablet
years who weigh
more than 30 kg
(four and half stone)
Children of 2 to 12
years who weigh
less than 30 kg
(four and half stone

Once a day
Once a day

Do not give this
medicine.
For children over 2 years
of age and who weigh
less than 30 kg a syrup
form of this medicine
may be more suitable.

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.

Duration of treatment:
You must contact a doctor if your symptoms do
not improve or even get worse after 10 days.

If you take more tablets than you should:
If you take more Loratadine 10 mg
Orodispersible Tablets than recommended,
contact your doctor or pharmacist. Taking more
tablets than recommended may cause
drowsiness, rapid heart beat and headache.

If you forget to take a tablet:
If you forget to take your dose on time, take it as
soon as possible, then go back to your regular
dosing schedule. Do not take a double dose to
make up for a forgotten tablet.

If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Loratadine 10 mg can cause
side effects, although not everybody gets them.

Patients have very rarely experienced
hypersensitive reactions, such as difficulty in
breathing, swelling of the face, neck, tongue or
throat after use of this product. If you experience
any of these side effects stop taking the tablets

and contact your pharmacist or doctor at once.

The most commonly reported side effects in
children aged 2 through 12 years include
headache, nervousness and tiredness.

The most commonly reported side effects in adults
and adolescents include drowsiness, headache,
increased appetite and difficulty sleeping.

Other side effects reported very rarely were
dizziness, irregular or rapid heart beat, nausea
(feeling sick), dry mouth, upset stomach, liver
problems, hair loss, rash and tiredness.

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.

5

How to store Loratadine
10 mg Orodispersible Tablets

Keep out of the reach and sight of children.

Do not use Loratadine 10 mg Orodispersible
Tablets after the expiry date which is stated on
the carton and blister after EXP. The expiry date
refers to the last day of that month.

Store the tablets in the original packaging in
order to protect from moisture.

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.

6

Further information

What Loratadine 10 mg Orodispersible
Tablets contains
• The active substance is loratadine.
• The other ingredients are sweet orange flavour,
aspartame (E951), citric acid anhydrous
(E330), silica colloidal anhydrous (E551),
maize starch dried, lactose anhydrous,
magnesium stearate (E470b), croscarmellose
sodium (E468), mannitol (E421), sorbitol
(E420), crospovidone, silica colloidal hydrated
(E551), polysorbate 80 (E433), povidone
(E1201), microcrystalline cellulose (E460).

What Loratadine 10 mg Orodispersible
Tablets looks like and contents of the pack
Loratadine 10 mg Orodispersible Tablets are
white, round and flat.

The packs may contain 7, 14, 21 or 30 tablets,
packed in aluminium/aluminium unit dose
perforated blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia.

This leaflet was last revised in 06/2013.
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Expand Transcript

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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