Alergoliber 10 mg comprimidos

Package Insert: Information for the User

Alergoliber 10 mg Tablets

Rupatadina

Read this entire package insert carefully before taking this medication, as it contains

important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may 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 package insert. See section 4.

Rupatadine is an antihistamine.

Alergoliber is indicated for the relief of symptoms of allergic rhinitis such as: sneezing, runny nose, itchy eyes and nose.

Alergoliber 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 Alergoliber:

• 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 Alergoliber

If you have kidney or liver insufficiency. In this case, consult your doctor. The use of Alergoliber 10 mg tablets is not currently recommended for 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 Alergoliber

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

If you are taking Alergoliber, 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 Alergoliber.

Taking Alergoliber with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

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

Driving and operating machinery

No significant effect on your ability to drive vehicles or operate machinery is expected from the recommended dose of Alergoliber. However, when you first use Alergoliber, you should exercise caution to see how the treatment affects you before driving or operating machinery.

Alergoliber contains 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.

Alergoliber is administered to 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 inform you of the duration of your treatment with Alergoliber.

If you take more Alergoliber 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 forgot to take Alergoliber

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 less frequent 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.

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

If you notice adverse effects not mentioned in this leaflet or if you experience one of the described adverse effects severely, inform your doctor or pharmacist.

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 the leaflet. 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 the blister pack in the outer packaging to protect it from light.

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

Composition of Alergoliber

• The active ingredient is rupatadine. Each tablet contains 10 mg 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 “Alergoliber contains lactose”.

Appearance of the product and content of the container

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Urquima, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Paseo Club Deportivo 1, Edif 4

28223 Pozuelo de Alarcón

Madrid, Spain

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

Alergoliber 10 mg TabletsSpain,

Pafinur 10 mg TabletsItaly

Urtimed 10 mg TabletsGermany

Last review date of this leaflet 08/2020

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