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ULTARIN 10 MG TABLETS

Active substance(s): LORATADINE

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Ultarin 10 mg
Tablets

Try to get into the habit of taking it at the same
time every day. This will make it easier for you to
remember.

Take special care with Ultarin 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 Ultarin 10 mg
tablets carefully to get the best results from it.
- 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.
- 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.

-

if you have severe liver problems

-

if you have been told that you have an
intolerance to some sugars.

-

if you are due to have skin tests since
loratdine could affect the results.

The usual dose is
Age

10 mg once daily
(swallow one tablet
daily with water)

Children aged 2 to 12
years and weighing
over 30 kg

10 mg once daily
(swallow one tablet
daily with water)

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

Children who are aged
over 2 years old but do
not weigh more than
30 kg

Should not take this
medicine

Laboratory tests:

Children under 2 years
of age

Should not take this
medicine

Patients with severe
liver problems

Your doctor may
prescribe a different
dose for patients with
severe liver problems

Taking other medicines

Antihistamines may prevent response to allergens
in skin allergy testing, therefore this medicine
should be stopped two days prior to such testing.

1. What Ultarin 10 mg Tablets are and what
they are used for
2. Before you take Ultarin Tablets

Taking Ultarin Tablets with food and drink

3. How to take Ultarin Tablets

This medicine may be taken with or without food.

4. Possible side effects
5. How to store Ultarin Tablets

If you take more Ultarin Tablets than you
should

Pregnancy and breast-feeding

6. Further information

Ask your doctor or pharmacist for advice before
taking any medicine.

1. WHAT ULTARIN 10 MG TABLETS
ARE AND WHAT THEY ARE USED FOR

Pregnancy: the safe use of loratadine during
pregnancy has not been established. The use of
loratadine during pregnancy is therefore not
recommended.

The name of your medicine is Ultarin 10 mg
Tablets. It will be referred to as Ultarin Tablets
throughout this leaflet.

Breast feeding: loratadine, the active substance in
this medicine is excreted in breast milk; therefore
the use of Ultarin Tablets is not recommended in
breast-feeding women.

Ultarin 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.

Driving and using machines
At the recommended dose, Ultarin Tablets are not
expected to cause you to be drowsy or less alert.
However, very rarely some patients
experience drowsiness, which may affect their
ability to drive or use machines. Please make sure
you are not drowsy before performing these
activities.

Ultarin Tablets relieve symptoms associated with
allergic rhinitis (for example, hay fever),
such as sneezing, runny or itchy nose, and burning
or itchy eyes.
Ultarin tablets may also be used to help relieve
symptoms of urticaria (itching, redness and
number and size of hives).

Ultarin Tablets contain lactose (milk sugar). If
you have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before taking this medicinal product.

2. BEFORE YOU TAKE ULTARIN
TABLETS
DO NOT TAKE Ultarin Tablets
if you are allergic (hypersensitive) to
loratadine or any of the other ingredients of
Ultarin Tablets. An allergic reaction can
include skin rash, itching, swelling or
breathing difficulties.

XXXXX

However, check with your doctor if they
continue or are bothersome:
- nausea (feeling sick)
- fatigue
- headache
- nervousness
- dryness of the mouth, nose and throat
- hair loss
In addition, other side effects that have been
reported when taking Ultarin Tablets are:
- dizziness
- rapid heartbeat
- palpitation (awareness of heartbeat/racing)
- irritation of the stomach lining (gastritis)
- increased appetite
- insomnia
- skin rashes
- abnormal liver function.
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 ULTARIN TABLETS
Keep your tablets out of the reach and sight of
children.
- Do not take Ultarin Tablets after the expiry
date which is stated on the carton after “Exp”.
The expiry date refers to the last day of that
month.
- Store in the original package.
- 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.

If you forget to take Ultarin Tablets
If you have forgotten to take your tablet, take it as
soon as you remember and continue as usual. Do
not take a double dose to make up for a forgotten
dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

You must stop taking Ultarin Tablets
immediately and consult your doctor if you
develop any allergic reaction to this medicine.
This can consist of
- skin rash or eruptions (including inside the mouth)
- itching
- swelling of the face, tongue, lips, hands, feet
- breathing difficulties
Other side effects
The following side effects have been reported
rarely with loratadine use. They are generally
non serious and may go away on their own.

6. FURTHER INFORMATION
What Ultarin Tablets contain
- The active substance is Loratadine 10 mg.
- The other ingredients are lactose monohydrate,
colloidal anhydrous silica, croscarmellose
sodium, talc and magnesium stearate .
What Ultarin Tablets look like and contents of
the pack
Ultarin Tablets are white coloured, circular, flat
beveled uncoated tablets, with central breakline on
one side and ‘L’ on other side.
Ultarin Tablets are available in blister strips in
pack size of 7 and 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
APTIL Pharma Limited,
9th floor, C.P.House,97-107 Uxbridge Road,
Ealing,London W5 5TL
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th floor, C.P. House, 97-107 Uxbridge Road,
Ealing, London , W5 5TL
This leaflet was last revised in 01/2013.

Ultarin

Loratadine

10 mg Tablets

Check Code

if you are breast-feeding currently.
Loratadine

-

Ultarin

if you are pregnant or planning to become
pregnant

10 mg Tablets

-

If you may have taken more Ultarin than you
should, talk to your doctor or pharmacist
immediately. Overdose may cause sleepiness or a
faster heart beat. Immediate medical attention
should be sought in the event of an overdose;
take your tablets along to show to your doctor, if
possible.

Like all medicines, Ultarin Tablets can cause side
effects, although not everybody gets them.

Important information about some of the
ingredients of Ultarin tablets

Relief of these symptoms lasts a full day and helps
you to resume your normal daily activities and sleep.

-

Dose

Adults and children
over 12 years of age

If any of the above applies to you, please tell your
doctor or pharmacist.

In this leaflet:

3. HOW TO TAKE ULTARIN TABLETS

XXXXX

Children under 2 years of age and/or under 30 kg
of weight should not take this medicine.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

APTIL Ultarin PIL V1(2C) First Proof 15.10.12
Size 160 x 310 (text area 132 x 273 mm)
Font size 9pt, Font used Times Roman Regular and Bold as placed
Minimum document line spacing 3.8 mm

GSL

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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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