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SELARIZ 10 MG TABLETS

Active substance(s): LORATADINE / LORATADINE / LORATADINE

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Package leaflet:
Information for the user

Selariz 10 mg
tablets
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, if you feel worse or if your symptoms
change. See section 4.
What is in this leaflet:
1. What Selariz Tablets are and what they are
used for
2. What you need to know before you take
Selariz Tablets
3. How to take Selariz Tablets
4. Possible side effects
5. How to store Selariz Tablets
6. Contents of the pack and other information
1. What Selariz Tablets are and what they
are used for
The full name of your medicine is Selariz
10 mg Tablets.
What Selariz Tablets are
This medicine contains the active substance
loratadine which belongs to a class of medicines
called “antihistamines”.
How Selariz Tablets work
Selariz Tablets help to reduce your allergy
symptoms by stopping the effects of a substance
called “histamine”, which is produced in the
body when you are allergic to something.
When Selariz Tablets should be taken
Selariz Tablets relieve symptoms associated
with allergic rhinitis (for example, hay fever),
such as sneezing, runny or itchy nose, and
burning or itchy eyes in adults and children over
the age of 2 years who weigh more than 30 kg.
Selariz tablets may also be used to help relieve
symptoms of urticaria (itching and redness)
which is often known as hives or nettle rash.
The effect of Selariz 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
Selariz Tablets
Do not take Selariz Tablets
- if you are allergic to loratadine or any of the
other ingredients of this medicine (listed in
section 6)
- if you are pregnant or planning to become
pregnant
- if you are breast-feeding currently.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Selariz Tablets
- if you have severe liver problems
- if you are scheduled to have any skin tests
for allergies. Do not take Selariz tablets for
two days before having these tests. This is
because it may affect test results.
If any of the above applies to you (or you are
not sure), please tell your doctor, pharmacist or
nurse before taking Selariz Tablets.
Children
Do not give Selariz Tablets to children younger
than 2 years old or to children 2 to 12 years old
who weigh less than 30 kg. There are other
formulations more suitable for children 2 to 12
years old who weigh less than 30 kg.
Other medicines and Selariz Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines taken
without a prescription.
This is particularly important if you are taking
- Cimetidine (for stomach problems)
- Erythromycin (an antibiotic)
- Ketoconazole or fluconazole (for fungal
infections)
The side effects of Selariz Tablets may increase
when used together with medicines that alter the
performance of some enzymes responsible for
drug-metabolism in the liver. However, in
clinical studies, no increase in side effects of
loratadine was seen with products that altered
the performance of these enzymes.
Selariz Tablets with alcohol
Selariz Tablets have not been shown to add to
the effects of an alcoholic drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy: Do not take Selariz Tablets if you
are pregnant.
Breast feeding: Do not take Selariz 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, Selariz
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. Please
make sure you are not drowsy before
performing these activities.
Selariz Tablets contains lactose
Selariz Tablets contain lactose; thus if you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take Selariz Tablets
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.
Try to get into the habit of taking it at the same
time every day. This will make it easier for you
to remember.
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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
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 which cause
difficulty in breathing or dizziness.
- convulsion
- rapid heartbeat
- palpitation (awareness of heartbeat/racing)

-

gastritis (abdominal pain, burning feeling in
the stomach between meals or at night and
nausea (with or without vomiting)
- feeling tired
- skin rashes
- hair loss
- fainting,
- nausea (feeling sick)
- dry mouth
- liver problems
- serious allergic reaction which causes
swelling of the face or throat
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 Selariz Tablets
-

-

This medicinal product does not require any
special storage conditions.
Keep this medicine out of the sight and
reach of children.
Do not take Selariz Tablets after the expiry
date which is stated on the carton after
“EXP”. The expiry date refers to the last day
of that month.
Do not use this medicine if you notice any
change in the appearance of the tablet.
Store in the original package.
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
to protect the environment.
6. Contents of the pack and other
information

What Selariz Tablet contains
- The active substance is loratadine. Each
tablet contains 10 mg loratadine.
- The other ingredients are lactose
monohydrate, maize starch, colloidal
anhydrous silica, croscarmellose sodium,
talc and magnesium stearate.
What Selariz Tablets look like and contents
of the pack
Selariz Tablets are white coloured, circular, flat
beveled uncoated tablets, with central breakline
on one side and ‘L’ on other side.
Selariz Tablets are available in blister strips in
pack size of 7, 10, 14, 20 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited,
Dixcart House, Addlestone Road, Bourne
Business Park, Addlestone, Surrey, KT15 2LE,
United Kingdom.
Manufacturer:
Cipla (EU) Limited,
Dixcart House, Addlestone Road, Bourne
Bussiness Park, Addlestone, Surrey, KT15 2LE,
United Kingdom
Cipla Europe NV
De Keyserlei 58-60 bus 19, Antwerpen, 2018,
Belgium.
This leaflet was last revised in 08/2017
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The Central breakline of the tablet is only there
to help you the break the tablet if you have
difficulty swallowing it whole.
Giving this medicine to children:
A loratadine syrup formulation may be
preferable for children. It is important to know
how much your child weights to make sure that
you give the correct amount of the medicine.
For example, a 9 year old child weight about
30 kg (4st 7lbs). 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 30 kg (4st 7lb) or less.
The recommended dose is
Age
Dose
Adults and children
10 mg once daily
over 12 years of age
(swallow one tablet
daily with water)
Children aged 2 to
10 mg once daily
12 years and
(swallow one tablet
weighing over 30 kg
daily with water)
Children who are
Should not take this
aged over 2 years
medicine
old but do not weigh
more than 30 kg
Children under 2 years Should not take this
of age
medicine
Patients with severe
Your doctor may
liver problems
prescribe a different
dose for patients with
severe liver problems
If you take more Selariz Tablets than you
should
If you may have taken more Loratadine Tablets
than you should, talk to your doctor or
pharmacist immediately. Overdose may cause
headache, 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.
If you forget to take Selariz 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 medicine, ask your doctor, pharmacist or
nurse.

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1B Variation
PACKAGING DEVELOPMENT
Product Name: Loratadine Selariz 10mg Tablets GSL
(1B Variation) Cipla (EU) Own Ltd PIL
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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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