LORATADINE PENSA 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine pensa 10 mg tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What Loratadina pensa 10 mg tablets are and what they are used for.
2. Before taking Loratadina pensa 10 mg tablets.
3. How to take Loratadina pensa 10 mg tablets.
4. Possible side effects
5. Storage of Loratadina pensa 10 mg tablets.
6. Additional information

1. What Loratadina pensa 10 mg tablets are and what they are used for

LORATADINA pensabelongs to a class of medications known as antihistamines.

LORATADINA pensarelieves the symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and itchy or red eyes).

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

2. Before taking Loratadina pensa 10 mg tablets

Do not take LORATADINApensa if:

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

Be particularly careful with LORATADINApensa if:

• You have severe liver disease (See section 3. How to take LORATADINApensa 10 mg tablets).
• You are going to undergo any type of skin allergy test. Do not take LORATADINApensa during the 2 days prior to the test, as this medication may alter the results.

Use of other medications:

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

Taking LORATADINApensa with food and drinks

LORATADINApensa can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication.

It is not recommended to take LORATADINApensa if you are pregnant or breastfeeding.

Driving and using machines

At normal doses, LORATADINApensa does not affect the ability to drive or use machines. If you notice symptoms of drowsiness, do not drive or use machines, but rather avoid performing tasks that require special attention until you know how you tolerate the medication.

Important information about some of the components of LORATADINApensa :

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

3. How to take Loratadina pensa 10 mg tablets

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

Remember to take your medication

Your doctor will indicate the duration of treatment with LORATADINApensa. Do not stop treatment before.

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

Take one tablet (10 mg) once a day.

Patients with severe liver problems with a weight over 30 kg:

Take one tablet (10 mg) once a day, every other day.

LORATADINApensa 10 mg tablets are not suitable for:

• administering doses less than 10 mg.
• administering to patients with a weight less than 30 kg.
• those patients who have difficulty swallowing.

It is not recommended to take LORATADINApensa in children under 2 years of age.

If you take more LORATADINApensa than you should:

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

If you forget to take LORATADINApensa :

If you forgot to take your dose on time, take it as soon as possible, and then return to your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, LORATADINApensa can cause side effects, although not everyone experiences them.

The most frequently reported side 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 side effects (less than 1 in 10,000 patients) have been cases of severe allergic reaction, dizziness, irregular or rapid heartbeats, nausea (vomiting), dry mouth, upset stomach, liver problems, hair loss, skin rash, and fatigue.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Loratadina pensa 10 mg tablets

Keep out of the reach and sight of children.

Expiration date

Do not use LORATADINApensa after the expiration date indicated on the packaging and blister.

Do not use LORATADINApensa if you notice any change in the appearance of the tablet.

Storage conditions

No special storage conditions are required.

6. Additional information

Composition of Loratadina pensa

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

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

Appearance of the product and packaging content

Loratadina pensa 10 mg is presented in tablet form. Each package contains 20 tablets in a blister pack.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Manufacturer

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 package leaflet was approved in September 2004

Last revision: February 2010