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Active substance(s): RUPATADINE

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Package Leaflet: Information for the user

Rupatadine 10mg Tablets
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your
doctor or your pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Rupatadine is and what it is used for
2. What you need to know before you take Rupatadine
3. How to take Rupatadine
4. Possible side effects
5. How to store Rupatadine
6. Contents of the pack and other information

1. What Rupatadine is and
what it is used for
Rupatadine is an antihistamine.
Rupatadine relieves the symptoms of allergic rhinitis
such as sneezing, runny nose, itching in the eyes and
Rupatadine is also used to relieve the symptoms
associated with urticaria (an allergic skin rash) such as
itching and hives (localised skin redness and swelling).

2. What you need to know before you
take Rupatadine
Do not take Rupatadine
• If you are allergic to rupatadine or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
If you suffer from kidney or liver insufficiency, ask your
doctor for advice. The use of Rupatadine 10mg tablets
is at present not recommended in patients with
impaired kidney or liver functions.
If you have low blood levels of potassium and/or if you
have a certain abnormal pattern to your heartbeat

(known prolongation of the QT interval on the ECG)
which can occur in some forms of heart disease, ask
your doctor for advice.
If you are older than 65, ask your doctor or your
This medicine is not for use in children under 12 years
of age.
Other medicines and Rupatadine
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.
If you are taking Rupatadine do not take medicines
containing ketoconazole or erythromycin.
If you are taking central nervous system depressant
medicines or statin medicines, ask your doctor for
advice before taking Rupatadine.
Rupatadine with food, drink and alcohol
Rupatadine should not be taken in combination
with grapefruit juice, as this may increase the level
of Rupatadine in your body.
Rupatadine, at recommended dose (10mg), does not
increase the drowsiness produced by alcohol.
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.
Driving and using machines
At the recommended dosage, Rupatadine is not
expected to influence your ability to drive or use
machinery. However, when you first start taking
Rupatadine you should take care to see how the
treatment affects you before driving or using
Rupatadine contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. How to take Rupatadine
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure. Rupatadine is for adolescents (from 12
years and older) and adults. The usual dose is one
tablet (10mg of rupatadine) once daily with or without
food. Swallow the tablet with a sufficient quantity of
liquid (e. g. one glass of water).

Your doctor will tell you how long your treatment with
Rupatadine will last.
If you take more Rupatadine than you should
If you have accidentally taken a high dose of your
medicine, talk to your doctor or pharmacist
If you forget to take Rupatadine
Take your dose as soon as possible and then continue
with your tablets at the usual times. Do not take a
double dose to make up for forgotten individual doses.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Common side effects (may affect up to
1 in 10 people):
Sleepiness, headache, dizziness, dry mouth, sensation
of weakness and fatigue.
Uncommon side effects (may affect up to
1 in 100 people):
Increased appetite, irritability, difficulty
concentrating, nosebleed, nasal dryness, sore throat,
cough, dry throat, rhinitis, nausea, abdominal pain,
diarrhoea, indigestion, vomiting, constipation, rash,
back pain, joint pain, muscle pain, thirst, general
discomfort, fever, abnormal liver function test and
increased weight.
Rare side effects (may affect up to
1 in 1,000 people):
palpitations, increased heart rate , and allergic
reactions (itching, hives and swelling of the face, lips,
tongue or throat).
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
By reporting side effects you can help provide more
information on the safety of this medicine.

Keep the blisters in the outer carton in order to
protect from light.
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
What Rupatadine contains
• The active substance is rupatadine. Each tablet
contains 10mg of rupatadine (as fumarate).
• The other ingredients are pregelatinised maize
starch, microcrystalline cellulose, red iron oxide
(E-172), yellow iron oxide (E-172), lactose
monohydrate and magnesium stearate.
What Rupatadine looks like and contents of the
Rupatadine are round, light salmon coloured tablets
packed in unit blister doses of 3, 7, 10, 15, 20, 30, 50
and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
J. Uriach & Compañia, S.A.
Av. Camí Reial, 51-57
E-08184 Palau-solità i Plegamans
(Barcelona - Spain)
Distributed by:
Aspire Pharma Limited
Unit 4, Rotherbrook Court,
Bedford Road, Petersfield,
Hampshire, GU32 3QG,United Kingdom
This leaflet was last revised in December 2016

5. How to store Rupatadine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister. The expiry date refers
to the last day of that month.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.