LORANOPRO

LORANOPRO 5 mg film-coated tablets

Important notes (mandatory information)

Lorano Pro 5 mg film-coated tablets. Active ingredient: Desloratadine. Areas of application: improves symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy); for improving symptoms of urticaria (a skin condition caused by an allergy).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lorano Pro 5 mg film-coated tablets for adults and adolescents aged 12 years and over
Active ingredient: Desloratadine

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 10 days, contact your doctor.

What this leaflet contains

1. WHAT IS LORANOPRO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LORANOPRO?
3. HOW TO TAKE LORANOPRO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LORANOPRO?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LORANOPRO AND WHAT IS IT USED FOR?

What is LoranoPro?
LoranoPro contains desloratadine, which belongs to the antihistamines.

How does LoranoPro work?
LoranoPro is an anti-allergic medicine that does not make you drowsy. It helps to control your allergic reaction and your symptoms.

When should LoranoPro be used?
LoranoPro improves symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy) in adults and adolescents aged 12 years and over. These symptoms include sneezing, runny or itchy nose, itchy palate and itchy, red or watery eyes. LoranoPro is also used to improve symptoms of urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. The improvement of these symptoms lasts for a whole day and helps you to resume your normal daily activities and regain your sleep. If you do not feel better or if you feel worse after 10 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LORANOPRO?

LoranoPro must not be taken if you are allergic to desloratadine or any of the other ingredients of this medicine listed in section 6 or to loratadine.

Warnings and precautions

Please talk to your doctor or pharmacist before taking LoranoPro:

• if you have a history of seizures or a family history of seizures.
• if you have impaired kidney function.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Taking LoranoPro with other medicines

Interactions of LoranoPro with other medicines are not known. Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking LoranoPro with food, drink and alcohol

LoranoPro can be taken with or without food. You should only drink alcohol with caution during treatment with LoranoPro.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. LoranoPro is not recommended during pregnancy and breastfeeding.

Fertility

Data on male fertility/female reproductive capacity are not available.

Driving and using machines

At the recommended dosage, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended that you refrain from activities that require mental alertness such as driving or operating machinery until you have established your personal response to the medicine.

3. HOW TO TAKE LORANOPRO?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents (12 years and over)

The recommended dose is 1 film-coated tablet once a day with water, with or without food.

This medicine is for oral use. Swallow the film-coated tablet whole (unchewed). Your doctor will determine the duration of treatment based on the type of allergic rhinitis you have and will then determine how long you should take LoranoPro. If your allergic rhinitis is intermittent (symptoms occur less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment regimen that depends on the evaluation of your previous medical history. If your allergic rhinitis is persistent (symptoms occur on 4 or more days a week and for more than 4 weeks), your doctor may recommend longer-term treatment. For urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's instructions.

If you have taken more LoranoPro than you should

Take LoranoPro only as prescribed or as recommended. No serious problems are expected in the event of an accidental overdose. If you have taken more LoranoPro than you should, contact your doctor or pharmacist immediately.

If you forget to take LoranoPro

If you forget to take your dose on time, take it as soon as possible and then continue with your normal dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. After LoranoPro was marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) were reported. If you notice any of these serious side effects, stop taking the medicine immediately and seek medical attention immediately. In clinical studies in adults, side effects were similar to those with placebo. However, fatigue, dry mouth and headache were reported more often than with placebo. In adolescents, headache was the most commonly reported side effect.

The following side effects have been reported in clinical studies with desloratadine

Common (may affect up to 1 in 10 people):

• chronic fatigue
• dry mouth
• headache

The following side effects have been reported during the marketing of desloratadine - adults

Very rare (may affect up to 1 in 10,000 people):

• severe allergic reactions
• rash
• palpitations or irregular heartbeat
• racing heart
• abdominal pain
• nausea
• vomiting
• upset stomach
• diarrhoea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with increased physical movement
• liver inflammation
• abnormal liver function tests

Not known (frequency cannot be estimated from the available data):

• abnormal behaviour
• aggression
• unusual fatigue
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even in hazy sunlight, and to UV (ultraviolet) light, e.g. from UV lamps in a solarium
• altered heartbeat
• weight gain
• increased appetite

The following side effects have been reported during the marketing of desloratadine - children

Not known (frequency cannot be estimated from the available data):

• abnormal behaviour
• aggression
• slow heart rate
• altered heartbeat
• weight gain
• increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LORANOPRO?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "use by" or "exp. date". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not use this medicine if you notice any change in the appearance of the film-coated tablets. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What LoranoPro contains: The active ingredient is desloratadine. Each film-coated tablet contains 5 mg desloratadine.

The other ingredients are:

• Tablet core: maize starch, microcrystalline cellulose, hypromellose, highly dispersed silicon dioxide, hydrogenated vegetable oil (type 1).
• Film coating: hypromellose, titanium dioxide, macrogol 400, indigo carmine aluminium salt.

What LoranoPro looks like and contents of the pack

LoranoPro are light blue, round, biconvex film-coated tablets with the imprint "5" on one side. Diameter 6.50 ± 0.10 mm. LoranoPro is available in OPA/ALU/PVC/ALU blister packs.

Pack sizes

6, 7, 18, 20, 50 and 100 film-coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Telefax: (08024) 908-1290
E-mail: service@hexal.com

Manufacturer

Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

This leaflet was last revised in September 2019.

Source: Package leaflet information
Status: 09/2021
Active ingredient: Desloratadine. Areas of application: improves symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy); for improving symptoms of urticaria (a skin condition caused by an allergy).