Rupafin

Package leaflet: Information for the user

Rupafin 10 mg tablets

rupatadine
Please 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 symptoms of allergic rhinitis such as sneezing, runny nose, and itching of the eyes and nose.
Rupafin is also used to relieve symptoms associated with chronic idiopathic urticaria (allergic skin rash), such as itching and wheals (localized redness and swelling of the skin).

2. What you need to know before taking Rupafin

Do not take Rupafin

• if you are allergic to rupatadine or to 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 have renal or hepatic impairment, consult your doctor. Currently, the use of
Rupafin 10 mg tablets is not recommended in patients with impaired renal or hepatic function.
If you have low potassium levels in the blood and/or an abnormal heart rhythm pattern (known QTc prolongation on ECG), which may occur in certain forms of heart disease, consult your doctor.
If you are over 65 years old, consult your doctor or pharmacist.

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

Other medicines and Rupafin
Inform 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 (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).
If you are taking medicines with central nervous system depressant effects, statin-based medicines (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Rupafin.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
At the recommended dose, Rupafin is not expected to affect the ability to drive or operate machinery. However, when starting treatment with Rupafin, exercise caution and observe how the treatment affects you before driving or using machinery.

Rupafin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Rupafin

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
Rupafin is indicated for adolescents (aged 12 years and older) and adults. The usual dose is
one tablet (10 mg of rupatadine) once daily, 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 missed dose as soon as possible and then continue with your regular dosing schedule. 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) are drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
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, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general feeling of discomfort, fever, changes in liver function tests and weight gain.
Rare side effects (may affect up to 1 in 1,000 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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.

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 stated on the carton and 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 medicines via 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 substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other components are pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), monohydrate lactose and magnesium stearate. See section 2 “Rupafin contains lactose”.

Description of the appearance of Rupafin and the contents of the pack
Rupafin is presented as round, light salmon-coloured tablets, packed in blisters
containing 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be
commercialized.

Marketing Authorization Holder and Manufacturer
NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
E-08184 Palau-solità i Plegamans (Barcelona-Spain)
Sales concessionaire: Recordati S.p.A. - Via M. Civitali, 1 - Milan

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
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, Slovakia,
Spain
Rupatadine 10 mg tablets United Kingdom
Wystamm 10 mg tablets France
Tamalis 10 mg tablets Hungary, Czech Republic,
Romania
Pafinur 10 mg tablets Finland, Sweden

Package leaflet: Information for the user

Rupafin 1 mg/ml oral solution

rupatadine
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Rupafin is and what it is used for

Rupafin contains the active substance rupatadine, which is an antihistamine.
Rupafin oral solution relieves the symptoms of allergic rhinitis such as sneezing, runny nose,
nasal congestion, and itching of the eyes and nose in children aged between 2 and 11 years.
Rupafin is also used to relieve 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 taking Rupafin

Do not take Rupafin

• if you are allergic to rupatadine or to 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 renal or hepatic impairment, consult your doctor. Currently, the use of Rupafin is not recommended in patients with impaired renal or hepatic function.
If you have low potassium levels in the blood and/or have an abnormal heart rhythm pattern (known QTc prolongation on ECG), which may occur in certain forms of heart disease, consult your doctor.

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

Other medicines and Rupafin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take other medicines containing ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections) while taking Rupafin.
If you are taking medicines with central nervous system depressant effects, statin-based medicines (used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Rupafin.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
At the recommended dose, Rupafin is not expected to affect your ability to drive or operate machinery. However, when starting treatment with Rupafin, take care and observe how the treatment affects you before driving or operating machinery.

Rupafin contains sucrose, methyl parahydroxybenzoate and propylene glycol
This medicine contains sucrose and therefore may be harmful to teeth. If your doctor has diagnosed you with intolerance to certain sugars, contact him/her 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 administering 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. Your doctor may perform additional monitoring during treatment.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
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 exactly as directed by your doctor. 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 daily, 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 daily, with or without food.
Your doctor will tell you how long to take Rupafin.

Instructions for use:

• To open the bottle, press down on the cap and turn it counterclockwise.
• Take the oral syringe, insert it into the pierced cap, and turn the bottle upside down.
• Draw up the prescribed dose into the syringe.
• 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 accidentally take an overdose of this medicine.
If you forget to take Rupafin
Do not take a double dose to make up for forgotten individual doses.

4. Possible side effects

Like all medicines, this medicine may 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website:
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 stated on the bottle and on the carton after EXP. The expiry date refers to the last day of that month. The shelf life after first opening is the same as the expiry date indicated on the carton and bottle.
Do not dispose of any medicine via 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 substance is rupatadine. Each ml contains 1 mg of rupatadine (as fumarate).
• The other components are propylene glycol (E-1520), anhydrous citric acid, anhydrous disodium phosphate, sodium saccharin, sucrose, methyl 4-hydroxybenzoate (E-218), quinoline yellow (E-104), banana flavour, purified water. See section 2 “Rupafin contains sucrose, methyl 4-hydroxybenzoate and propylene glycol”.

Description of the appearance of Rupafin and package contents
Rupafin is a light yellow oral solution.
Rupafin is supplied in an amber-coloured plastic bottle with a perforated cap and child-resistant closure. Each bottle contains 120 ml of Rupafin solution. The package includes a 5 ml oral syringe graduated in 0.25 ml increments.
Marketing Authorization Holder
NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
E-08184 Palau-solità i Plegamans (Barcelona – Spain)
Marketing authorisation holder 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 European Economic Area countries under the
following names:
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, Slovakia, 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