Package Insert: Information for the Patient

Loratadine Normon 1 mg/ml Syrup EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Contents of the package and additional information.

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

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

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 1 mg/ml syrup EFG:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loratadina Normon 1 mg/ml syrup EFG

• If you have severe liver disease (see section 3).
• 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 such tests, as this medication may alter the results of the same.

Interaction of Loratadina Normron 1 mg/ml syrup EFG with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

No interactions of Loratadina Normon with other medications are known.

Loratadina Normon 1 mg/ml syrup EFG with food and beverages:

Loratadina Normon may be taken with or without food.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

It is not recommended that you take this medication 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 saccharose, sodium benzoate (E-211), sodium and propylene glycol (E-1520)

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

Patients with diabetes mellitus should note that this medication contains 6 g of saccharose per dose of 10 ml.

It may cause caries.

This medication containscontains 0.56 mg of sodium benzoate (E-211) per milliliter.

This medication contains less than 23 mg of sodium (1 mmol) per milliliter; it is essentially "sodium-free".

This medication contains 100.03 mg of propylene glycol (E-1520) per milliliter.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will inform you of the duration of treatment with Loratadina Normon. Do not discontinue treatment before.

Adults and children over 12 years of age:

Take 10 ml of Loratadina Normon 1 mg/ml syrup once a day.

Children from 2 to 12 years of age:

Weight over 30 kg:

Take 10 ml of Loratadina Normon 1 mg/ml syrup once a day.

Weight equal to or less than 30 kg:

Administer 5 ml of Loratadina Normon 1 mg/ml syrup once a day.

Patients with severe liver problems:

Adults and children with a weight over 30 kg:

Take 10 ml of Loratadina Normon 1 mg/ml syrup, once a day, on alternate days.

Children with a weight equal to or less than 30 kg:

Administer 5 ml of Loratadina Normon 1 mg/ml syrup, once a day, on alternate days.

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

If you take more Loratadina Normon than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Loratadina Normon:

If you forgot to take your dose on time, take it as soon as you remember, and then return to your usual dosing schedule. Do not take a double dose to compensate for the missed doses.

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

Like all medications, Loratadina Normon 1 mg/ml syrup EFG may produce adverse effects, although not all people will 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 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.

Adverse effects of unknown frequency: Weight gain.If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this leaflet.

Keep out of the sight and reach of children.

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

Do not use this medicine after the expiration date that appears on the container after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medicine if you observe any change in the appearance of the syrup.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Loratadina Normon

• The active ingredient is loratadine.
• The other components are sodium benzoate (E-211), sucrose, glycerol (E-422), propylene glycol (E-1520), anhydrous citric acid, peach essence (contains propylene glycol E-1520) and purified water.

Appearance of the product and content of the packaging

Loratadina Normon is presented in the form of a syrup. Each package contains 120 ml. The syrup is a slightly viscous, transparent, colorless liquid with a peach odor. A dosifier is included.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Other presentations

Loratadina Normon 10 mg EFG tablets

Last review of this leaflet was in: January 2018

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

You can access detailed and updated information on 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/64243/P_64243.html