Alerprof

Package Leaflet: Information for the Patient

Alerprof, 10 mg, Tablets

Rupatadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Alerprof and what is it used for
• 2. Important information before taking Alerprof
• 3. How to take Alerprof
• 4. Possible side effects
• 5. How to store Alerprof
• 6. Contents of the pack and other information

1. What is Alerprof and what is it used for

Rupatadine, the active substance of Alerprof, is an antihistamine.
Alerprof relieves the symptoms of allergic rhinitis, such as sneezing, runny nose, itchy eyes and nose.
Alerprof is also used to relieve the symptoms of urticaria (allergic skin rash), such as itching and rash (local redness and swelling of the skin).

2. Important information before taking Alerprof

When not to take Alerprof

If you are allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Alerprof, discuss it with your doctor or pharmacist.
If you have kidney or liver problems, consult your doctor. Currently, it is not recommended to take Alerprof 10 mg tablets if you have kidney or liver problems.
If you have low potassium levels in your blood and/or an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart diseases, consult your doctor.
If you are over 65 years old, consult your doctor or pharmacist.

Children and adolescents

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

Alerprof and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription.
If you are taking Alerprof, do not take medicines containing ketokonazole or erythromycin.
If you are taking medicines that affect the central nervous system or statins, consult your doctor before taking Alerprof.

Taking Alerprof with food and drink

Do not take Alerprof with grapefruit juice, as it may increase the level of Alerprof in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Alerprof during pregnancy and breastfeeding, unless your doctor advises you to do so.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Alerprof is not expected to affect your ability to drive or use machines. However, if you are taking Alerprof for the first time, be cautious and observe your reaction to the medicine before driving or using machines.

Alerprof contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Alerprof

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Alerprof is intended for use in adolescents (12 years and older) and adults. The usual dose is one tablet (10 mg 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 Alerprof.

If you take more Alerprof than you should

If you have taken too much of this medicine, contact your doctor or pharmacist immediately.

If you forget to take Alerprof

Take the dose as soon as you remember, and then continue taking the tablets as prescribed. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Alerprof can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people) include:
drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
Uncommon side effects(may affect up to 1 in 100 people) include: increased appetite, irritability, difficulty concentrating, nosebleeds, dry nose, sore throat, cough, dry throat, nasal congestion, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, increased thirst, general feeling of being unwell, fever, abnormal liver function tests and weight gain.
Rare side effects(may affect up to 1 in 1,000 people) include: palpitations, increased heart rate and hypersensitivity reactions (including anaphylactic reactions, angioedema and urticaria).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
You can also report side effects to the representative of the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alerprof

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 carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Alerprof contains

The active substance is rupatadine. Each tablet contains 10 mg rupatadine (as rupatadine fumarate).
The other ingredients are: lactose monohydrate, microcrystalline cellulose PH 102, maize starch, magnesium stearate, yellow iron oxide (E172) and red iron oxide (E172).

What Alerprof looks like and contents of the pack

Alerprof, 10 mg, tablets are light orange, round tablets with a diameter of 6.35 mm, packaged in blisters of 10, 20, 30, 50 or 100 tablets and in single-dose blisters of 10x1, 20x1, 30x1, 50x1 or 100x1 tablet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw

Manufacturer/Importer:

Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
31-546 Krakow
Poland
MEIJI PHARMA SPAIN S.A
Avda de Madrid, 94 28802 Alcala de Henares
Madrid
Spain
MARTIN DOW PHARMACEUTICALS
Goualle Le Puy, Champ de Lachaud
Meymac 19250
France

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel. (22) 345 93 00
Date of last revision of the leaflet:May 2021