LORATADINE KERN PHARMA 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadina Kern Pharma 10 mg tablets EFG

Loratadine

Read the package leaflet carefully before starting to take the medicine, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Loratadina Kern Pharma and what is it used for
2. What you need to know before taking Loratadina Kern Pharma
3. How to take Loratadina Kern Pharma
4. Possible side effects
5. Storage of Loratadina Kern Pharma
6. Package contents and additional information

1. What is Loratadina Kern Pharma and what is it used for

Loratadina Kern Pharma belongs to a class of medicines known as antihistamines.

Loratadina Kern Pharma relieves the symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and itching or redness of the eyes).

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

2. What you need to know before taking Loratadina Kern Pharma 10 mg tablets

Do not take Loratadina Kern Pharma:

• If you are allergic (hypersensitive) to loratadine or any of the other ingredients of Loratadina Kern Pharma.

Be cautious with Loratadina Kern Pharma:

• If you have severe liver disease (see section 3. How to take Loratadina Kern Pharma 10 mg tablets).
• If you are going to undergo any type of skin allergy test. Do not take Loratadina Kern Pharma during the 2 days prior to the test, as this medicine may alter the results.

Use of other medicines:

No interactions of Loratadina Kern Pharma with other medicines are known. However, inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Taking Loratadina Kern Pharma with food and drinks:

Loratadina Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using a medicine.

Loratadina Kern Pharma is not recommended if you are pregnant or breastfeeding.

Driving and using machines:

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

Important information about some of the ingredients of Loratadina Kern Pharma:

Loratadina Kern Pharma contains lactose; if your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Loratadina Kern Pharma 10 mg tablets

Follow the administration instructions of Loratadina Kern Pharma exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Loratadina Kern Pharma. 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.

Patients with severe liver problems with a weight over 30 kg:

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

Loratadina Kern Pharma 10 mg tablets are not suitable for:

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

Loratadina Kern Pharma is not recommended for children under 2 years of age.

If you take more Loratadina Kern Pharma than you should:

If you take more Loratadina Kern Pharma 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.

If you forget to take Loratadina Kern Pharma:

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 have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Loratadina Kern Pharma can have side effects, although not everyone 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 rare 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, upset stomach, liver problems, hair loss, skin rash, and fatigue.

Side effects with unknown frequency have been cases of weight gain.

If you notice these side effects or others not described in this package leaflet, inform your doctor or pharmacist.

5. Storage of Loratadina Kern Pharma 10 mg tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Loratadina Kern Pharma after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

Do not use Loratadina Kern Pharma if you notice any change in the appearance of the tablet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Loratadina Kern Pharma

• The active ingredient of Loratadina Kern Pharma is loratadine. Each tablet contains 10 mg of loratadine.
• The other ingredients (excipients) are: lactose, cornstarch, povidone, and magnesium stearate.

Appearance of the product and package contents:

Loratadina Kern Pharma is presented in tablet form. Each package contains 20 tablets in blister packs.

Marketing authorization holder and manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this package leaflet:December 2017

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