PROSPECTO : INFORMATION FOR THE USER

Loratadine 10 mg tablets EFG

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

LORATADINA pensabelongs to a class of medicines known as antihistamines.

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

LORATADINA pensacan also be used to help relieve symptoms of urticaria (such as itching, redness and the number and size of skin hives).

Do not take LORATADINAif:

• You are allergic (hypersensitive) to the active ingredient or to any of the other components ofLORATADINA.

Be especially careful with LORATADINAif:

• You have severe liver disease (See section 3. How to takeLORATADINA10 mg tablets).
• You are to undergo any type of skin test for allergy. Do not takeLORATADINAfor the 2 days prior to the performance of such tests, because this medication may alter the results of the same.

Use of other medications:

No interactions ofLORATADINAwith 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 LORATADINAwith food and beverages

LORATADINAcan be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication.

It is not recommended that you takeLORATADINAif you are pregnant or breastfeeding.

Driving and operating machines

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

Important information about some of the components of LORATADINA:

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

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication

Your doctor will tell you the duration of treatment withLORATADINApensaDo not stop 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.

LORATADINApensa10 mg tablets are 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.

It is not recommended to takeLORATADINApensain children under 2 years of age.

If you take more LORATADINApensathan you should:

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

If you forgot to take LORATADINApensa:

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 make up for the missed doses.

Like all medications,LORATADINAmayproduce 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.

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 prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Expiration Date

Do not useLORATADINAtabletsafter the expiration date indicated on the carton and in the blister pack.

Do not useLORATADINAtabletsif you observe any change in the appearance of the tablet.

Storage Conditions

No special storage conditions are required.

Loratadine pensa Composition

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.

• The other components (excipients) are lactose, microcrystalline cellulose, cornstarch, and magnesium stearate.

Product Appearance and Packaging Contents

Loratadine pensa 10 mg is presented in the form of tablets. Each package contains 20 tablets in a blister.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Responsible for Manufacturing

PHARMEX ADVANCED LABORATORIES S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Spain

or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A

Laguna, 66-68-70. Poligono Industrial Urtinsa II

Alcorcón (Madrid) - 28923 – Spain

This leaflet was approved in September 2004

Last review: February 2010