Loratadine Teva-Ratiopharm 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadine Teva-ratiopharm 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as 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; do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

What Loratadina Teva-ratiopharm is

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 reduce your allergy symptoms by blocking the effects of a substance called histamine, which is released in the body when you are allergic to something.

When Loratadina Teva-ratiopharm should be taken

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

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

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

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

2. What you need to know before taking Loratadine Teva-ratiopharm

Do not take Loratadine Teva-ratiopharm

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Loratadine Teva-ratiopharm if

• you have liver disease
• you are scheduled to undergo any type of skin allergy testing. Do not take Loratadine Teva-ratiopharm during the 2 days prior to such tests, as this medicine may interfere with the test results.

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

Children

Do not administer Loratadine Teva-ratiopharm to children under 6 years of age or to children weighing 30 kg or less. Other formulations are 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 Loratadine Teva-ratiopharm have not been established. No data are available.

Taking Loratadine Teva-ratiopharm with other medicines

The side effects of loratadine may increase when used together with medicines that affect the function of certain liver enzymes, or if your liver is not functioning properly. In clinical studies, no increase in loratadine side effects was observed with medicines affecting these enzymes.

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including medicines not requiring a prescription.

Taking Loratadine Teva-ratiopharm with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid taking loratadine during pregnancy.

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

Driving and using machines

In clinical trials assessing driving ability, no impairment of function was observed in patients receiving loratadine. At the recommended dose, Loratadine Teva-ratiopharm is not expected to cause drowsiness or reduced alertness. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Loratadine Teva-ratiopharm contains lactose

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

3. How to take Loratadine Teva-ratiopharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

The score line is only intended to facilitate splitting the tablet if you have difficulty swallowing it whole.

Recommended dose:

Adults and children over 6 years of age weighing more than 30 kg:

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

Body weight of 30 kg or less:

Do not administer Loratadine Teva-ratiopharm. Other formulations more suitable for children under 6 years of age weighing 30 kg or less are available.

Children under 2 years of age:

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

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg

Take 1 tablet once daily on alternate days 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 Loratadine Teva-ratiopharm than you should

If you take more Loratadine Teva than you should, consult your doctor or pharmacist immediately. Serious problems are not expected with accidental overdose. However, you may experience headache, palpitations, or drowsiness.

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

If you forget to take Loratadine Teva-ratiopharm

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

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

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

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

Other adverse effects:

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

• Drowsiness
• Headache
• Increased appetite
• Difficulty sleeping.

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

• Headache
• Nervousness
• Fatigue

Very rare (may affect up to 1 in 10,000 people) have also been observed during post-marketing surveillance of loratadine:

• Dizziness
• Seizure
• Nausea (feeling sick)
• Dry mouth
• Stomach discomfort
• Hair loss
• Skin rash
• Fatigue

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

• Weight gain

Reporting of adverse effects:

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

5. Storage of Loratadine 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 stated on the packaging and on the blister after EXP. 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. Return unused medicines and their packaging to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

Composition of Loratadine Teva-ratiopharm 10 mg

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

Appearance of the medicine and contents of the pack

Loratadine Teva-ratiopharm 10 mg tablets are white, oval, biconvex tablets, scored on one side and flat on the other, marked “L” and “10” on each side of the score.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros, 1st floor

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 authorized 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 tabletten

France LORATADINE TEVA 10 mg, comprimé

Italy Loratadina Teva 10 mg compresse

Spain Loratadina Teva-ratiopharm 10 mg comprimidos EFG

United Kingdom (Northern Ireland) TEVA Loratadine 10 mg Tablets

Date of the most recent review of this leaflet: October 2022

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. 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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