Loratadine Pensa 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Loratadine pensa 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could be harmful to them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What LORATADINE pensa 10 mg tablets are and what they are used for.
2. Before taking LORATADINE pensa 10 mg tablets.
3. How to take LORATADINE pensa 10 mg tablets.
4. Possible side effects.
5. How to store LORATADINE pensa 10 mg tablets.
6. Further information.

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

LORATADINE pensa belongs to a class of medicines known as antihistamines.

LORATADINE pensa relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose, and burning or itchy eyes).

LORATADINE pensa can also be used to help relieve symptoms of urticaria (such as itching, redness, and the number and size of skin wheals).

2. Before taking Loratadine pensa 10 mg tablets

Do not take LORATADINE pensa if:

• you are allergic (hypersensitive) to the active substance or to any of the other components of LORATADINE pensa.

Take special care with LORATADINE pensa if:

• you have severe liver disease (see section 3. How to take LORATADINE pensa 10 mg tablets).
• you are due to undergo any type of skin allergy testing. Do not take LORATADINE pensa during the 2 days prior to such tests, as this medicine may interfere with the test results.

Use with other medicines:

No interactions between LORATADINE pensa and other medicines are known. However, inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking LORATADINE pensa with food and drink

LORATADINE pensa may be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

It is not recommended that you take LORATADINE pensa if you are pregnant or breastfeeding.

Driving and using machines

At normal doses, LORATADINE pensa does not affect the ability to drive or operate machinery. If you experience symptoms of drowsiness, do not drive or use machines. However, avoid performing tasks requiring special attention until you know how you tolerate the medicine.

Important information about some of the components of LORATADINE pensa:

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

3. How to take Loratadine pensa 10 mg tablets

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

Remember to take your medicine

Your doctor will tell you how long to take LORATADINE pensa. Do not stop treatment early.

Adults and children over 2 years of age weighing more than 30 kg:

Take one tablet (10 mg) once daily.

Patients with severe liver problems weighing more than 30 kg:

Take one tablet (10 mg) once daily, on alternate days.

LORATADINE pensa 10 mg tablets are not suitable for:

• administering doses lower than 10 mg.
• administration in patients weighing less than 30 kg.
• patients who have difficulty swallowing.

LORATADINE pensa is not recommended for children under 2 years of age.

If you take more LORATADINE pensa than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20, stating the medication and the amount ingested.

If you forget to take LORATADINE pensa:

If you miss a dose, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, LORATADINE pensa may cause adverse effects, although not everyone experiences them.

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

Very rare adverse effects reported (less than 1 in 10,000 patients) have included cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, stomach discomfort, liver problems, hair loss, skin rash, and tiredness.

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

5. Storage of Loratadine pensa 10 mg tablets

Keep out of the reach and sight of children.

Expiry

Do not use LORATADINE pensa after the expiry date stated on the packaging and on the blister.

Do not use LORATADINE pensa if you notice any changes in the appearance of the tablet.

Storage conditions

No special storage conditions required.

6. Additional Information

Composition of Loratadina pensa

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

• The other components (excipients) are lactose, microcrystalline cellulose, corn starch, and magnesium stearate q.s.

Appearance of the medicinal product and contents of the pack

Loratadina pensa 10 mg is presented as tablets. Each pack contains 20 tablets in a blister.

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 leaflet was approved in September 2004

Latest revision: February 2010