Prospecto: Information for the User

Rupafin 10mg Tablets

Rupatadina

Read this entire prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Rupafin is and for what it is used

2.What you need to know before starting to take Rupafin

3.How to take Rupafin

4.Possible adverse effects

5.Storage of Rupafin

6.Contents of the package and additional information

Rupatadine is an antihistamine.

Rupafin is indicated for the relief of symptoms of allergic rhinitis such as: sneezing, runny nose, eye and nasal itching.

Rupafin is indicated for the relief of symptoms associated with urticaria (allergic skin eruption) such as itching and skin hives (redness and swelling of the skin).

Do not take Rupafin

- If you are allergic to rupatadine or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rupafin.

If you have kidney or liver insufficiency, consult your doctor. The use of Rupafin is not currently recommended in patients with kidney or liver insufficiency.

If you have low potassium levels in the blood and/or if you have a certain abnormal heart rhythm pattern (prolongation of the QTc interval in the ECG) that may occur in certain heart diseases, consult your doctor.

If you are over 65 years old, consult your doctor or pharmacist.

Children

This medication should not be used in children under 12 years of age.

Other medications and Rupafin

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

If you are taking Rupafin, do not take medications that contain ketoconazole (fungal infection medication) or erythromycin (bacterial infection medication).

If you are taking central nervous system depressants, statin medications (used to treat high cholesterol levels) or midazolam (sedation medication for short duration), consult your doctor before taking Rupafin.

Taking Rupafin with food, drinks, and alcohol

Do not take Rupafin in combination with grapefruit juice as it may increase the level of rupatadine in your body.

Rupafin, at the recommended dose of 10 mg, does not increase the drowsiness caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

It is not expected that at the recommended dose, Rupafin will affect your ability to drive vehicles or operate machinery. However, when you first use Rupafin, you should be cautious and see how the treatment affects you before driving or operating machinery.

Rupafincontains lactose.

If your doctor has informed you that you have an intolerance to some sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Rupafin is administered in adolescents (12 years of age and older) and adults. The recommended 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 indicate the duration of your treatment with Rupafin.

If you take more Rupafin than you should

In case of accidental ingestion of high doses of the medication, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 915 620 420.

If you forget to take Rupafin

Take your dose as soon as possible and continue with your tablets at the usual times. Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequent adverse effects (may affect up to 1 in 10 patients) are drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

The infrequent adverse effects (may affect up to 1 in 100 patients) are increased appetite, irritability, difficulty concentrating, nasal bleeding, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, discomfort, fever, abnormal liver function tests, and weight gain.

The rare adverse effects (may affect up to 1 in 1,000 patients) are palpitations and increased heart rate and allergic reactions (itching, urticaria, and swelling of the face, lips, tongue, or throat).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and the blister pack. The expiration date is the last day of the month indicated.

Store in the outer carton to preserve the tablets from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rupafin

–The active ingredient is rupatadine. Each tablet contains 10mg of rupatadine (as fumarate).

–The other components are: pregelatinized cornstarch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, and magnesium stearate. See section 2 “Rupafin contains lactose”.

Appearance of the product and content of the container

Rupafin are salmon-colored round tablets and are presented in unit dose blisters containing 3, 7, 10, 15, 20, 30, 50, or 100tablets. Not all containers are marketed.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona

Spain

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

This medicine is authorized in the member states of the European Economic Area with the following names:

Rupatall 10 mg TabletsBelgium, Luxembourg

Rinialer 10 mg TabletsPortugal, Malta

Rupafin 10 mg TabletsAustria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Germany, Greece, Iceland, Italy, Ireland, Latvia, Liechtenstein, Lithuania, Netherlands, Norway, Poland, Slovenia, Slovak Republic, Spain

Rupatadine 10 mg TabletsUnited Kingdom

Wystamm 10 mg TabletsFrance

Tamalis 10 mg TabletsHungary, Czech Republic, Romania

Pafinur 10 mg tabletsFinland, Sweden

Last review date of this leaflet: 08/2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es