RUPAFIN 10 mg Coated Tablet

Зміст інструкції

1. Rupafin 10 mg tablets
   1. What is Rupafin and what is it used for
   2. What you need to know before taking Rupafin
2. Rupafin 10 mg tablets are not recommended in patients with impaired renal or hepatic function
   1. How to take Rupafin
   2. Possible side effects
   3. How to store Rupafin
   4. Contents of the pack and other information
3. Rupafin 1 mg/ml oral solution
   1. What is Rupafin 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. Package contents and other information

Rupafin 10 mg tablets

rupatadine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Rupafin and what is it used for

Rupatadine is an antihistamine.
Rupafin relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching of the eyes and nose.
Rupafin is also used to relieve the symptoms associated with chronic idiopathic urticaria (allergic skin rash) such as itching and wheals (redness and swelling of the skin localized).

2. What you need to know before taking 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 failure, ask your doctor for advice. Currently, the use of

Rupafin 10 mg tablets are not recommended in patients with impaired renal or hepatic function

compromised.
If you have low levels of potassium in your blood and/or have an abnormal heart rhythm
(known prolongation of the QTc interval on ECG) which may occur in some forms of
heart disease, ask your doctor for advice.
If you are over 65 years of age, consult your doctor or pharmacist.

Children
This medicine is not indicated for children under 12 years of age.

Other medicines and Rupafin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
If you are taking Rupafin do not take other medicines containing ketoconazole (medicine for
fungal infections) or erythromycin (medicine for bacterial infections).
If you are taking medicines with a depressive effect on the central nervous system, medicines based on
statins (medicines used to treat high cholesterol levels) or midazolam (medicine
used for short-term sedation), ask your doctor for advice before taking Rupafin.

Rupafin with food, drinks and alcohol
Rupafin should not be taken with grapefruit juice, as this may increase the
level of Rupafin in the body.
Rupafin, at the recommended dose (10 mg), does not increase the drowsiness induced by alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and operating machinery
At the recommended dosage, Rupafin is not expected to impair the ability to drive vehicles or
operate machinery. However, when you start treatment with Rupafin, be careful and
observe what effects the treatment has on you before driving or operating machinery.

Rupafin contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before
taking this medicine.

3. How to take Rupafin

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
Rupafin is indicated for adolescents (aged 12 years and over) and adults. The usual dose
is one tablet (10 mg of rupatadine) once a day with or without food.
Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water).
Your doctor will tell you how long to take Rupafin.

If you take more Rupafin than you should
Contact your doctor or pharmacist immediately if you have accidentally taken an excessive dose
of the medicine.

If you forget to take Rupafin
Take the dose as soon as possible and continue with the usual dosage. Do not take a double
dose to make up for missed 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) are drowsiness, headache, dizziness, dry
mouth, feeling of weakness and fatigue.
Uncommon side effects (may affect up to 1 in 100 people) are increased
appetite, irritability, attention disorders, nosebleeds, nasal dryness,
pharyngitis, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting,
constipation, skin rash, back pain, joint pain, muscle pain, thirst,
general feeling of discomfort, fever, alteration of liver function tests and weight gain.
Rare side effects (may affect up to 1 in 1000 people) are palpitations,
increased heart rate and allergic reactions (itching, hives and swelling of the face, lips, tongue or
mouth).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help to provide more information on the
safety of this medicine.

5. How to store Rupafin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister. The
expiry date refers to the last day of that month.
Store the blister in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rupafin contains

• The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other ingredients are pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magnesium stearate. See section 2 “Rupafin contains lactose”.

Description of the appearance of Rupafin and contents of the pack
Rupafin presents as round, light salmon-colored tablets, packaged in blisters
containing 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be
marketed.

Marketing authorization holder and manufacturer
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
E-08184 Palau-solità i Plegamans (Barcelona-Spain)

Distributor for sale: Recordati S.p.A. - Via M. Civitali, 1 - Milan

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Rupatall 10 mg tablets Belgium, Luxembourg
Rinialer 10 mg tablets Portugal, Malta
Rupafin 10 mg tablets Austria, Bulgaria, Croatia,
Cyprus, Denmark, Estonia,
Germany, Greece, Iceland,
Italy, Ireland, Latvia,
Liechtenstein, Lithuania, Netherlands,
Norway, Poland,
Slovenia, Slovak Republic,
Spain
Rupatadine 10 mg tablets United Kingdom
Wystamm 10 mg tablets France
Tamalis10 mg tablets Hungary, Czech Republic,
Romania
Pafinur 10 mg tablets Finland, Sweden

Rupafin 1 mg/ml oral solution

rupatadine

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What Rupafin is and what it is used for
• 8. What you need to know before you take Rupafin
• 9. How to take Rupafin
• 10. Possible side effects
• 11. How to store Rupafin
• 12. Contents of the pack and other information

1. What is Rupafin and what it is used for

Rupafin contains the active ingredient rupatadine which is an antihistamine.
Rupafin oral solution relieves the symptoms of allergic rhinitis such as sneezing, runny nose,
nasal congestion, itchy eyes and nose in children aged between 2 and 11 years.
Rupafin is also used to relieve the symptoms associated with urticaria (allergic skin rash)
such as itching and wheals (localized redness and swelling of the skin) in children aged between
2 and 11 years.

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 failure, ask your doctor for advice. Currently, the use of
Rupafin is not recommended in patients with impaired kidney or liver function.
If you have low levels of potassium in your blood and/or have an abnormal heart rhythm
(known prolongation of the QTc interval on ECG) which can occur in some forms of
heart disease, ask your doctor for advice.

Children
This medicine is contraindicated in children under 2 years of age or weighing less than
10 kg.

Other medicines and Rupafin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
If you are taking Rupafin do not take other medicines containing ketoconazole (medicine for
fungal infections) or erythromycin (medicine for bacterial infections).
If you are taking medicines with a depressant effect on the central nervous system, medicines based on
statins (medicines used to treat high cholesterol levels) or midazolam (medicine
used for short-term sedation), ask your doctor for advice before taking Rupafin.

Rupafin with food, drinks and alcohol
Rupafin can be taken with or without food.
Rupafin should not be taken with grapefruit juice, as this may increase the
level of Rupafin in the body.
Rupafin, at a dose of 10 mg, does not increase drowsiness induced by alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
At the recommended dosage, Rupafin is not expected to affect your ability to drive vehicles or
operate machines. However, when you start treatment with Rupafin, be careful and
observe what effects the treatment has on you before driving or using machines.

Rupafin contains sucrose, methyl parahydroxybenzoate and propylene glycol
This medicine contains sucrose, so it may be harmful to teeth. If your doctor has
diagnosed you with an intolerance to some sugars, contact them before taking this
medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including
delayed reactions).
This medicine contains 200 mg of propylene glycol per ml.
If the child is under 5 years of age, talk to your doctor or pharmacist before
giving this medicine, especially if the child is taking other medicines
containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e. essentially
“sodium-free”.

3. How to take Rupafin

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Rupafin oral solution is for oral use.

Dosage in children weighing 25 kg or more:5 ml (5 mg of rupatadine) of oral solution once
a day, with or without food.

Dosage in children weighing from 10 kg to less than 25 kg:2.5 ml (2.5 mg of rupatadine) of
oral solution once a day, with or without food.
Your doctor will tell you how long to take Rupafin.

Instructions for use:

• To open the bottle, press the cap and rotate counterclockwise.
• Take the syringe, insert it into the perforated cap and turn the bottle upside down.
• Fill the syringe with the prescribed dose.
• Administer directly from the dosing syringe.
• Wash the syringe after use.

If you take more Rupafin than you should
Contact your doctor or pharmacist immediately if you have accidentally taken an excessive
dose of the medicine.

If you forget to take Rupafin
Do not take a double dose to make up for missed 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) are headache and
drowsiness.
Uncommon side effects (may affect up to 1 in 100 people) are influenza,
nasopharyngitis, upper respiratory tract infections, eosinophilia, neutropenia, dizziness, nausea,
eczema, night sweats and fatigue.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the
safety of this medicine.

7. How to store Rupafin

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is reported on the bottle and on the package
after the EXP. The expiry date refers to the last day of that month. The validity after
first opening is the same as the expiry date indicated on the package and on the bottle.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rupafin contains

• The active ingredient is rupatadine. Each ml contains 1 mg of rupatadine (as fumarate).
• The other ingredients are propylene glycol (E-1520), anhydrous citric acid, anhydrous disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate (E-218), quinoline yellow (E-104), banana flavour, purified water. See section 2 “Rupafin contains sucrose, methyl parahydroxybenzoate and propylene glycol”.

Description of Rupafin and package contents
Rupafin is a light yellow-coloured oral solution.
Rupafin is packaged in an amber-coloured plastic bottle with a perforated cap with
child-resistant closure. Each bottle contains 120 ml of Rupafin solution. The package
contains a 5 ml oral syringe graduated at intervals of 0.25 ml.

Marketing Authorisation Holder
NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
E-08184 Palau-solità i Plegamans (Barcelona – Spain)

Distributor for sale: Recordati S.p.A. - Via M. Civitali, 1 - Milan

Manufacturer
Italfarmaco S.A.
San Rafael, 3
Pol. Ind. Alcobendas
E-28108 Alcobendas (Spain)
or
Recipharm Parets S.L.
Ramón y Cajal, 2
08150 Parets del Vallés (Spain)

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Rupatall 1mg/ml oral solution Belgium, Luxembourg
Rinialer 1mg/ml oral solution Portugal, Malta
Rupafin 1 mg/ml oral solution Austria, Bulgaria, Croatia, Cyprus, Denmark,
Estonia, Germany, Greece, Iceland, Italy,
Ireland, Latvia, Liechtenstein, Lithuania, Netherlands,
Norway, Poland, Slovenia, Slovak Republic, Spain
Rupatadine 1mg/ml oral solution United Kingdom
Wystamm 1mg/ml oral solution France
Tamalis 1mg/ml oral solution Hungary, Czech Republic, Romania
Pafinur 1 mg/ml oral solution Finland, Sweden