Package Leaflet: Information for the user

Loratadine Normon 10 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Loratadina Normon belongs to a class of medications known as antihistamines.

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

Loratadina Normon 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 Normon:

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

• Be especially careful with Loratadina Normon:

• If you have severe liver disease (See section 3. How to take Loratadina Normon).
• If you are to undergo any type of skin test for allergy. Do not take Loratadina Normon 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:

Inform your doctor or pharmacist if you are taking, or have recently taken any other medication, including those acquired without a prescription.

No interactions of Loratadina Normon with other medications are known. However, inform your doctor or pharmacist if you are using or have recently used other medications.

• Taking Loratadina Normon with food and beverages:

This medication may be taken with or without food.

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking a medication.

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

• Driving and operating machines:

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

This medication contains lactose . If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow the administration instructions for this medication as indicated by your doctor.

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

Your doctor will indicate the duration of treatment with Loratadina Normon. 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 Normon 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.

Use in children

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

• If you take more Loratadina Normon than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service Telephone: 91 562 04 20.

• If you forgot to take Loratadina Normon

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 the missed doses.

• If you interrupt treatment with Loratadina Normon

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

Like all medications, Loratadina Normon 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.

Very rare adverse effects (less than 1 in 10,000 patients) have been reported, including severe allergic reactions, dizziness, irregular or rapid heartbeats, nausea (urge to vomit), dry mouth, stomach upset, liver problems, hair loss, skin rash, and fatigue.

Adverse effects of unknown frequency: weight gain.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medication 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 Normon if you observe any change in the appearance of the tablet.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Loratadine Normon Composition

• The active ingredient is loratadine.
• The other components are: pregelatinized cornstarch, lactose monohydrate, and magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

• Loratadine Normon is presented in the form of tablets. Each package contains 20 tablets. The tablets are white, round, scored on one side, and printed on the other.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Loratadine Normon 1 mg/ml syrup EFG.

Last review date of this leaflet: January 2018

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63784/P_63784.html