LORATADINE COMBIX 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Loratadina Combix 10 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Loratadina Combix and what is it used for
2. What you need to know before you take Loratadina Combix
3. How to take Loratadina Combix
4. Possible side effects
5. Storage of Loratadina Combix
6. Contents of the pack and other information

1. What is Loratadina Combix and what is it used for

Loratadina Combix belongs to a class of medicines known as antihistamines.

Loratadina Combix relieves the symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and scratchy or itchy eyes).

Loratadina Combix can also be used to help relieve the symptoms of urticaria (such as itching, redness, and the number and size of skin wheals).

2. What you need to know before you take Loratadina Combix

Do not take Loratadina Combix

• If you are allergic (hypersensitive) to the active substance loratadine or any of the other ingredients of this medicine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Loratadina Combix:

• If you have severe liver disease (see section 3. How to take Loratadina Combix).
• If you are going to have any skin tests for allergies. Do not take Loratadina Combix for 2 days before these tests, as this medicine may affect the results.

Interaction of Loratadina Combix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

No interactions of Loratadina Combix with other medicines are known. However, tell your doctor or pharmacist if you are using or have recently used other medicines.

Loratadina Combix with food, drink, and alcohol

Loratadina Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medicine.

It is not recommended to take Loratadina Combix if you are pregnant or breastfeeding.

Driving and using machines

At normal doses, Loratadina Combix does not affect the ability to drive or use machines. If you notice symptoms of drowsiness, do not drive or use machines, however, try not to perform tasks that require special attention until you know how you tolerate the medicine.

Important information about some of the ingredients of Loratadina Combix

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Loratadina Combix

Follow these instructions for taking Loratadina Combix as indicated by your doctor.

Remember to take your medicine. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment with Loratadina Combix. Do not stop treatment before.

Adults and children over 2 years of age with a weight over 30 kg

Take one tablet (10 mg) once a day.

Patient with severe liver problems with a weight over 30 kg

Take one tablet (10 mg) once a day, every other day.

Loratadina Combix is not suitable for:

• administration of doses less than 10 mg.
• administration in patients with a weight less than 30 kg.
• those patients who have swallowing problems.

Use in children and adolescents

Loratadina Combix is not recommended in children under 2 years of age.

If you take more Loratadina Combix than you should

If you take more Loratadina Combix than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service; Telephone 91562 04 20 indicating the medicine and the amount ingested.

If you forget to take Loratadina Combix

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

If you stop taking Loratadina Combix

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Loratadina Combix can cause side effects, although not everybody gets them.

The most frequently reported side effects (less than 1 in 10 patients but more than 1 in 100 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

Very rarely reported side effects (less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (vomiting), dry mouth, stomach pain or heartburn, liver problems, hair loss, skin rash, and fatigue.

A side effect with a frequency of "unknown" is weight gain.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadina Combix

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 packaging after "EXP". The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging or medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadina Combix

The active substance is Loratadine. Each Loratadina Combix tablet contains 10 mg of loratadine.

The other ingredients are lactose monohydrate, corn starch, and magnesium stearate.

Appearance of the product and contents of the pack

Loratadina Combix tablets are white, round, and flat with a score line on one side and smooth on the other.

The tablet can be divided into two equal halves.

Loratadina Combix is available in packs containing 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Manufacturer

Zydus France

25, parc d’activités des Peupliers, Bâtiment L

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

ZAC du Suzot

35 rue de la Chapelle

63450 St Amant Tallende

France

This package leaflet was last revised in January 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/