LORATADINE TEVA-RATIOPHARM 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Loratadina Teva-ratiopharm 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Loratadina Teva-ratiopharm and what is it used for
2. What you need to know before you take Loratadina Teva-ratiopharm
3. How to take Loratadina Teva-ratiopharm
4. Possible side effects

5. Storage of Loratadina Teva-ratiopharm

1. Contents of the pack and other information

1. What is Loratadina Teva-ratiopharm and what is it used for

The full name of this medicine is Loratadina Teva-ratiopharm 10 mg Tablets.

What is Loratadina Teva-ratiopharm

Loratadina Teva-ratiopharm contains the active substance loratadine, which belongs to a class of medicines called “antihistamines”.

How Loratadina Teva-ratiopharm works

Loratadina Teva-ratiopharm helps to relieve your allergy symptoms by blocking the effects of a substance called histamine, which is produced by your body when you are allergic to something.

When to take Loratadina Teva-ratiopharm

Loratadina Teva-ratiopharm relieves the symptoms of allergic rhinitis (e.g. hay fever) such as sneezing, runny or itchy nose, and itchy or watery eyes in adults and children aged 6 years and older who weigh more than 30 kg.

Loratadina Teva-ratiopharm can also be used to help relieve the symptoms of urticaria (itching, redness of the skin) and the number and size of skin eruptions.

The effect of Loratadina Teva-ratiopharm lasts all day and will help you to continue with your normal activities and sleep.

You should consult your doctor if it worsens or does not improve.

2. What you need to know before you take Loratadina Teva-ratiopharm

Do not take Loratadina Teva-ratiopharm

• if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Loratadina Teva-ratiopharm if:

• you have liver disease
• you are going to have any skin allergy tests. Do not take Loratadina Teva-ratiopharm for 2 days before you have these tests, as this medicine may affect the results.

If you are in any of the above situations (or are unsure), please consult your doctor, pharmacist or nurse before taking Loratadina Teva-ratiopharm.

Children

Do not give Loratadina Teva-ratiopharm to children under 6 years of age or children who weigh 30 kg or less. There are other formulations more suitable for children under 6 years of age who weigh 30 kg or less.

Children under 2 years of age

The safety and efficacy of Loratadina Teva-ratiopharm have not been established. No data are available.

Taking Loratadina Teva-ratiopharm with other medicines

The side effects of loratadine may increase when taken with medicines that affect the performance of certain enzymes found in the liver, or if your liver is not working properly. In clinical studies, no increase in the side effects of loratadine was observed with medicines that affect the performance of these enzymes.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Taking Loratadina Teva-ratiopharm with alcohol

It has not been shown that loratadine increases the effects of alcoholic drinks.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As a precaution, it is recommended to avoid taking loratadine if you are pregnant.

Do not take Loratadina Teva-ratiopharm if you are breast-feeding. Loratadine is excreted in breast milk.

Driving and using machines

In clinical trials that evaluated driving ability, no reduced function was observed in patients who received loratadine. At the recommended dose, it is not expected that Loratadina Teva-ratiopharm will cause drowsiness or reduced alertness. However, very rarely some people may experience drowsiness, which may affect their ability to drive or use machines.

Loratadina Teva-ratiopharm contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Loratadina Teva-ratiopharm

Take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor, pharmacist or nurse.

The score line is only to help you break the tablet if you have difficulty swallowing it whole.

The recommended dose is:

Adults and children over 6 years of age with a body weight of more than 30 kg:

Take 1 tablet once a day with a glass of water, with or without food.

Body weight of 30 kg or less:

Do not give Loratadina Teva-ratiopharm. There are other formulations more suitable for children under 6 years of age who weigh 30 kg or less.

Children under 2 years of age:

Loratadina Teva-ratiopharm is not recommended for children under 2 years of age.

Adults and children with severe liver problems:

Adults and children who weigh more than 30 kg

Take 1 tablet once a day, every other day, with a glass of water, with or without food.

However, you should consult your doctor, pharmacist or nurse before taking this medicine.

If you take more Loratadina Teva-ratiopharm than you should

If you take more Loratadina Teva-ratiopharm than you should, talk to your doctor or pharmacist immediately. No serious problems are expected with accidental overdose. However, you may experience headache, palpitations or drowsiness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone (91) 562 04 20, stating the medicine and the amount taken.

If you forget to take Loratadina Teva-ratiopharm

• If you forget to take your dose, take it as soon as you remember, and then continue as before.
• Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Loratadina Teva-ratiopharm and contact your doctor immediately if you notice any of the following:

• Allergic reaction: swelling of the face, lips, tongue or throat, narrowing of the airways, causing difficulty breathing, shock, collapse, skin rash, itching.
• Fast or irregular heartbeat
• Changes in liver function (this can be seen in a blood test).

Other side effects:

Very common (may affect up to 1 in 10 people) in adults and children over 12 years of age are:

• Drowsiness
• Headache
• Increased appetite
• Difficulty sleeping.

Very common (may affect up to 1 in 10 people) in children aged 2 to 12 years are:

• Headache
• Nervousness
• Fatigue

Very rare (may affect up to 1 in 10,000 people) side effects were also observed during the marketing of loratadine:

• Dizziness
• Seizure
• Nausea (feeling sick)
• Dry mouth
• Upset stomach
• Hair loss
• Skin rash
• Fatigue.

Frequency not known (cannot be estimated from the available data):

• Weight gain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadina Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not transfer the tablets to another container. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

Composition of Loratadina Teva-ratiopharm 10 mg

• The active substance is loratadine. Each tablet contains 10 mg of loratadine.
• The other ingredients are lactose monohydrate, maize starch, pregelatinized starch and magnesium stearate. Contains lactose (see section 2 “Loratadina Teva contains lactose”).

Appearance of the product and pack size

Loratadina Teva-ratiopharm 10 mg Tablets are white, oval, scored on one side and flat on the other, marked “L” and “10” on either side of the score line.

They are available in packs of 5, 7, 10, 15, 20, 28, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11 Edificio Albatros, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Pharmaceutical Works Private Limited Company Pallagi ut 13

4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg, 5. P.O. Box 552 (Haarlem) -2003

Netherlands

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium Loratadine Teva 10 mg tablets

France LORATADINE TEVA 10 mg, tablet

Italy Loratadina Teva 10 mg tablets

Spain Loratadina Teva-ratiopharm 10 mg tablets EFG

United Kingdom (Northern Ireland) TEVA Loratadine 10 mg Tablets

Date of last revision of this leaflet:October 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66530/P_66530.html

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