Loratadine Almus 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadine Almus 10 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Loratadine Almus is and what it is used for
2. What you need to know before taking Loratadine Almus
3. How to take Loratadine Almus
4. Possible side effects
5. How to store Loratadine Almus
6. Contents of the pack and other information

1. What Loratadina Almus is and what it is used for

Loratadine belongs to a class of medicines known as antihistamines.

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

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

2. What you need to know before starting to take Loratadine Almus

Do not take Loratadine Almus:

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Loratadine Almus.

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

Taking Loratadine Almus with other medicines:

No interactions between loratadine and other medicines are known.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Loratadine Almus with food and drink:

Loratadine may be taken with or without food.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

It is preferable to avoid using this medicine if you are pregnant.

Do not take this medicine if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and using machines:

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

Loratadine Almus 10 mg tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Loratadine Almus

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long you should take this medicine. 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 Almus 10 mg tablets are not suitable for:

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

This medicine is not recommended for children under 2 years of age.

If you take more Loratadine Almus than you should:

If you take more loratadine than you should, contact your doctor, pharmacist, or nearest hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91562 04 20, indicating the medicine and the amount ingested.

If you forget to take Loratadine Almus:

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The most frequently reported adverse effects (affecting 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 reported (affecting less than 1 in 10,000 patients) have included cases of serious allergic reactions, dizziness, seizures, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, stomach discomfort, liver problems, hair loss, skin rash, and fatigue.

Adverse effects with frequency not known (cannot be estimated from available data) have included cases of weight gain.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadine Almus

Keep out of sight and reach of children.

Store in the original container.

Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any changes in the appearance of the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadine Almus

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

The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, maize starch and magnesium stearate.

Appearance of the product and contents of the pack

Loratadine Almus 10 mg tablets are presented as white, round, scored tablets on one side. Each pack contains 20 tablets in blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4

50016 Zaragoza, Spain.

Date of the most recent revision of this leaflet: November 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.