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YOSQIERO 5MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Yosqiero 5 mg Film-coated Tablets

Desloratadine

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 any further questions, ask your doctor or 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.

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

1

What Yosqiero is and what it is
used for

Yosqiero is an anti-allergy medicine that does not
make you drowsy. It helps control your allergic
reaction and its symptoms.

Yosqiero relieves symptoms associated with
allergic rhinitis (inflammation of the nasal
passages caused by an allergy, for example, hay
fever or allergy to dust mites). These symptoms
include sneezing, runny or itchy nose, itchy
palate, and itchy, red or watery eyes.

Yosqiero is also used to relieve the symptoms
associated with urticaria (a skin condition caused
by an allergy). These symptoms include itching
and hives.

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

Yosqiero is indicated for adults and adolescents
(12 years of age and older).

2

What you need to know before you
take Yosqiero

Do not take Yosqiero
• if you are allergic (hypersensitive) to
desloratadine, to any of the other ingredients of
Yosqiero or to loratadine.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Yosqiero:
• if you have poor kidney function.

If this applies to you, or if you are not sure, please
check with your doctor before taking Yosqiero.

Other medicines and Yosqiero
There are no known interactions of Yosqiero with
other medicines.

Yosqiero with food and drink
Yosqiero may be taken with or without a meal.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy and
breastfeeding.
If you are pregnant or nursing a baby, taking
Yosqiero is not recommended.

Driving and using machines
At the recommended dose, Yosqiero is 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.

3

How to take Yosqiero

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

The usual dose is:
Adults and adolescents (12 years of age and
older): take one tablet once a day.
Swallow the tablet with or without food.

Regarding the duration of treatment, your
physician will determine the type of allergic rhinitis
you are suffering from and will determine for how
long you should take Yosqiero.
• If your allergic rhinitis is intermittent
(presence of symptoms for less than 4 days per
week or for less than 4 weeks), your physician
will recommend you a treatment schedule that
will depend on the evaluation of the history of
your disease.
• If your allergic rhinitis is persistent (presence
of symptoms for 4 days or more per week and
for more than 4 weeks), your physician may
recommend you a longer term treatment.
Continued on the next page >>

• For urticaria, the duration of treatment may be
variable from patient to patient and therefore
you should follow the instructions of your
physician.

If you take more Yosqiero than you should
Take Yosqiero only as it is prescribed for you. No
serious problems are expected with accidental
overdose. However, if you take more Yosqiero
than you were told to, contact your doctor or
pharmacist.

If you forget to take Yosqiero
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 dose.

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

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• In adults, side effects were about the same as
with a dummy tablet. However, fatigue, dry
mouth and headache were reported more often
than with a dummy tablet.
• In adolescents, headache was the most
commonly reported side effect.

During the marketing of Yosqiero, following side
effects have been reported very rarely (may affect
up to 1 in 10,000 people):
• Severe allergic reactions (difficulty in
breathing, wheezing, itching, hives and
swelling) and rash. Stop taking the medicine
and seek medical help immediately if you
experience any of these symptoms.
• Palpitations, rapid heartbeat,
• Stomach pain, nausea (feeling sick), vomiting,
upset stomach, diarrhoea,
• Dizziness, drowsiness, inability to sleep,
• Muscle pain, hallucinations, seizures,
restlessness with increased body movement,
• Liver inflammation and abnormal liver function
tests.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.

5

How to store Yosqiero

Keep this medicine out of the sight and reach of
children.

Do not use Yosqiero 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.

throw away medicines you no longer use. These
measures will help to protect the environment.

6

Contents of the pack and other
information

What Yosqiero contains
• The active substance is desloratadine. Each
film-coated tablet contains 5 mg desloratadine.
• The other ingredients are:
Film-coated tablet core: Maize starch,
Cellulose, microcrystalline, Hypromellose, Silica
Colloidal anhydrous, Hydrogenated vegetable
oil (Type 1).
Film-coated tablet coating: Opadry Blue
03B50689 (Hypromellose E464, Titanium
dioxide E171, Macrogol 400 E1521, Indigo
Carmine Aluminum Lake E132)

What Yosqiero looks like and contents of the
pack
Yosqiero is a Light blue, round shaped, biconvex
film coated tablets, with “5” debossed on one
side. Diameter 6.50 ± 0.10 mm.

Yosqiero is supplied in blister pack comprising of
OPA/ ALU/ PVC/ ALU and in blister pack
comprising of PVC/ Aclar/ ALU)

Pack sizes (unit dose):
1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 and
100 film coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia
or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
or

LEK S.A.,
ul. Domaniewska 50 C,
02-672 Warszawa,
Poland.

This leaflet was last approved in 03/2012 (to be
amended upon approval).

This medicinal product does not require any
special storage conditions

Do not use this medicine if you notice any change
in the appearance of the tablets.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to

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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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