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Active substance(s): RUPATADINE

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Package Leaflet: Information for the user

Rupafin® 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 Rupafin is and what it is used for
2. What you need to know before you take Rupafin
3. How to take Rupafin
4. Possible side effects
5. How to store Rupafin
6. Contents of the pack and other information

1. What Rupafin is and what it is used for
Rupatadine is an antihistamine.
Rupafin relieves the symptoms of allergic rhinitis such
as sneezing, runny nose, itching in the eyes and nose.
Rupafin 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 Rupafin
Do not take Rupafin
• 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 Rupafin.
If you suffer from kidney or liver insufficiency, ask your
doctor for advice. The use of Rupafin 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 heart beat
(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 Rupafin
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.
If you are taking Rupafin 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 Rupafin.
Rupafin with food, drink and alcohol
Rupafin should not be taken in combination with
grapefruit juice, as this may increase the level of
Rupafin in your body.
Rupafin, 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, Rupafin is not expected
to influence your ability to drive or use machinery.
However, when you first start taking Rupafin you
should take care to see how the treatment affects you
before driving or using machines.
Rupafin 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 Rupafin
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure. Rupafin 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
Rupafin will last.

If you take more Rupafin than you should
If you have accidentally taken a high dose of your
medicine, talk to your doctor or pharmacist

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.

If you forget to take Rupafin
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.

6. Contents of the pack and other

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.

What Rupafin contains
• The active substance is rupatadine. Each tablet
contains 10mg of rupatadine (as fumarate).
• other ingredients are pregelatinised maize
starch, microcrystalline cellulose, red iron oxide
(E-172), yellow iron oxide (E-172), lactose
monohydrate and magnesium stearate.
What Rupafin looks like and contents of the pack
Rupafin 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
Bellamy House
Winton Road, Petersfield
Hampshire, GU32 3HA
United Kingdom
This leaflet was last revised in July 2016

5. How to store Rupafin
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.
Keep the blisters in the outer carton in order to
protect from light.

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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.