PRODUCT INFORMATION FOR THE USER

Loratadine Kern Pharma 10 mg Tablets EFG

Loratadine

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

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

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

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

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

Do not take Loratadina Kern Pharma:

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

Be especially careful 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 to undergo any type of skin test for allergy. Do not take Loratadina Kern Pharma during the 2 days prior to the performance of these tests, as this medication may alter the results of the same.

Use of other medications:

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

Taking Loratadina Kern Pharma with food and beverages:

Loratadina Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using a medication.

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

Driving and operating machinery:

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 operate machinery, however, try not to perform tasks that may require special attention until you know how you tolerate the medication.

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

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

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

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Loratadina Kern Pharma. Do not discontinue treatment before.

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

Take one tablet (10 mg) once a day.

Patients with severe liver problems with a weight of more than 30 kg:

Take one tablet (10 mg), once a day and on alternate days.

Loratadina Kern Pharma 10 mg tablets is not suitable for:

• administration of doses less than 10 mg
• administration in patients with a weight of 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 Toxicological Information Service; Telephone 91562 04 20.

If you forgot to take Loratadina Kern Pharma:

If you forgot 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 compensate for missed doses.

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

Like all medications, Loratadina Kern Pharma may have adverse effects, although not all people may experience them.

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

The very rarely reported adverse effects (less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeats, nausea (urge to vomit), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

The frequency of adverse effects is unknown, but cases of weight gain have been reported.

If you observe these adverse effects or other effects not described in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Loratadina Kern Pharma after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Loratadina Kern Pharma

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

Appearance of the product and content of the packaging:

Loratadina Kern Pharma is presented in the form of tablets. Each package contains 20 tablets in a blister.

Holder of the marketing authorization and responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last review of this leaflet:December 2017

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/