Package Leaflet: Information for the User

Loratadine Teva-ratiopharm 10mg Tablets EFG

Read this 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 yourdoctor or pharmacist.
• This medicine has been prescribed for you only.Do not pass it on to others even if theirsymptoms are the same as yours,as it may harm them.
• If you experience any side effects,talk to your doctor or pharmacist. See section 4.

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

2.What you need to know beforestarting on Loratadine Teva-ratiopharm

3.How to take Loratadine Teva-ratiopharm

4.Possible side effects

5Storage of Loratadine Teva-ratiopharm

6.Contents of the pack and additional information

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

What is Loratadina Teva-ratiopharm

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

How Loratadina Teva-ratiopharm works

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

When to take Loratadina Teva-ratiopharm

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

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

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

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

Do not take Loratadina Teva-ratiopharm

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Loratadina Teva-ratiopharm if

• you have liver disease
• you are to undergo any type of skin allergy test. Do not take Loratadina Teva-ratiopharm during the 2 days prior to the test, as this medication may alter 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 Loratadina Teva-ratiopharm.

Children

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

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

Inform your doctor, pharmacist, or nurse if you aretaking, havetakenrecentlyor may need to take any other medication, including non-prescription medications.

Taking Loratadina Teva-ratiopharm with alcohol

No increase in the effects of alcoholic beverages has been demonstrated with loratadine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

In clinical studies evaluating driving ability, noreduced function was observed in patients who received loratadine. At the recommended dose, Loratadina Teva-ratiopharm is not expected to produce drowsiness or decreased alertness. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or operate machinery.

Loratadina Teva-ratiopharm contains lactose

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The groove 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 over 30 kg:

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

Body weight of30 kgor less:

Do not give Loratadina Teva-ratiopharm. There are other more suitable presentations for children under 6 years of age who weigh30 kgor less.

Children under 2 years:

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

Adults and children with severe liver problems:

Adults and children weighing over 30 kg

Take 1 tablet once a day and on alternate days with a glass of water, with or without food.

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

If you take more Loratadina Teva-ratiopharm than you should

If you take more Loratadina Teva than you should, consult your doctor or pharmacist immediately. No serious problems are expected with an accidental overdose. However, you may experience a headache, palpitations, or feel drowsy.

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

If you forgot to take Loratadina Teva-ratiopharm

• If you forgot 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 compensate for the missed doses.

If you have any other questions about the use of thismedication, consult with your doctor,pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

• 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 observed 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 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) were also observed during the marketing of loratadine:

• Dizziness
• Convulsion
• Nausea (urge to vomit)
• Dry mouth
• Upset stomach
• Hair loss
• Skin rash
• Fatigue.

Unknown frequency (frequency cannot be estimated from available data):

• Weight gain.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not transfer the tablets to another container. Do not usethis medicationafter the expiration date that appears onthe container and on the blisterafter CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any change in the appearance of the tablet.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

This medication does not require special conservation conditions.

Loratadine Teva-ratiopharm 10 mg Composition

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other components are lactose monohydrate, cornstarch, pregelatinized starch, and magnesium stearate. Contains lactose (see section 2 “Loratadine Teva contains lactose”).

Appearance of the product and contents of the package

Loratadine 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.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11 Edificio Albatros, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible 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 Areaand in the United Kingdom (Northern Ireland)with the following names:

BelgiumLoratadine Teva 10 mg tablets

FranceLORATADINE TEVA 10 mg, tablet

ItalyLoratadina Teva 10 mg tablets

SpainLoratadina Teva-ratiopharm 10 mg tablets EFG

United Kingdom (Northern Ireland)TEVA Loratadine 10 mg Tablets

Last review date of this leaflet:October 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your 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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