Loratadine Kern Pharma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine Kern Pharma 10 mg tablets EFG

Loratadine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Loratadine Kern Pharma is and what it is used for
2. What you need to know before taking Loratadine Kern Pharma
3. How to take Loratadine Kern Pharma
4. Possible side effects
5. How to store Loratadine Kern Pharma
6. Contents of the pack and other information

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

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

Loratadine Kern Pharma relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose, and burning or itchy eyes).

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

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

Do not take Loratadina Kern Pharma:

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

Take special care 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 due to undergo any type of skin allergy testing. Do not take Loratadina Kern Pharma within the 2 days prior to such tests, as this medicine may interfere with the test results.

Use with other medicines:

No interactions between Loratadina Kern Pharma and other medicines are known. However, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Loratadina Kern Pharma with food and drinks:

Loratadina Kern Pharma may be taken with or without food.

Pregnancy and breast-feeding:

Consult your doctor or pharmacist before taking any medicine.

Loratadina Kern Pharma is not recommended if you are pregnant or breast-feeding.

Driving and using machines:

At normal doses, Loratadina Kern Pharma does not affect the ability to drive or operate machinery. If you experience symptoms of drowsiness, do not drive or use machinery. Nevertheless, avoid performing tasks requiring special attention until you know how you tolerate the medicine.

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

Loratadina Kern Pharma contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Loratadine Kern Pharma 10 mg tablets

Follow exactly the administration instructions for Loratadine Kern Pharma provided by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will indicate how long you should take Loratadine Kern Pharma. Do not stop treatment prematurely.

Adults and children over 2 years of age weighing more than 30 kg:

Take one tablet (10 mg) once daily.

Patients with severe liver problems weighing more than 30 kg:

Take one tablet (10 mg) once daily, on alternate days.

Loratadine Kern Pharma 10 mg tablets are not suitable for:

• administration of doses lower than 10 mg
• administration in patients weighing less than 30 kg
• patients who have difficulty swallowing.

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

If you take more Loratadine Kern Pharma than you should:

If you take more Loratadine Kern Pharma than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service; Telephone 91562 04 20.

If you forget to take Loratadine Kern Pharma:

If you forget to take your dose on time, take it as soon as possible, then return to your usual dosing schedule.

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Loratadine Kern Pharma may have adverse effects, although not everyone experiences them.

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

Very rarely reported adverse effects (less than 1 in 10,000 patients) have included cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, stomach discomfort, liver problems, hair loss, skin rash, and fatigue.

Adverse effects reported with unknown frequency have included weight gain.

If you experience these adverse effects or any others not described in this leaflet, inform your doctor or pharmacist.

5. Storage of Loratadine Kern Pharma 10 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Loratadine Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not use Loratadine Kern Pharma if you notice any changes in the appearance of the tablet.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Loratadine Kern Pharma

• The active substance in Loratadine Kern Pharma is loratadine. Each tablet contains 10 mg of loratadine.
• The other components (excipients) are: lactose, corn starch, povidone, and magnesium stearate.

Appearance of the product and contents of the pack:

Loratadine Kern Pharma is presented as tablets. Each pack contains 20 tablets in a blister.

Marketing Authorization Holder and Manufacturer:

Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

Date of the most recent review of this leaflet: December 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/