Package Insert: Information for the Patient

Loratadine ratiopharm 10 mg Tablets EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

- Keep this package insert, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3.How to take Loratadine ratiopharm

4.Possible adverse effects

5.Storage of Loratadine ratiopharm

6.Contents of the package and additional information

What is loratadina

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

How loratadina works

Loratadina 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 use loratadina

Loratadina relieves symptoms of allergic rhinitis (e.g. hay fever) such as sneezing, runny or itchy nose and itchy or watery eyes in adults and children over 6 years old, weighing more than 30 kg.

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

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

Consult your doctor if you do not notice improvement or if it worsens.

Do not take Loratadinaratiopharm

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Loratadina ratiopharm 10 mg

• if you have liver disease
• You are to undergo any type of skin allergy tests. Do not take loratadine during the 2 days prior to the performance of these tests. This is because this medication may alter the results of the same.

If any of the above conditions affect you (or you are unsure), consult your doctor, pharmacist, or nurse before taking Loratadina ratiopharm.

Children

This medication should not be administered to children under 2 years of age or with a weight of less than30 Kg. There are other formulations more suitable for children under 6 years old or weighing 30 kg or less.

Children under 2 years of age

The safety and efficacy of loratadine have not been established. No data are available.

Taking Loratadina ratiopharm with other medications

The side effects of loratadine may increase when used with medications that alter the performance of certain enzymes responsible for metabolism in the liver. However, in clinical studies, no increase in the side effects of loratadine was observed with medications that altered the performance of these enzymes.

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including non-prescription medications.

Taking Loratadina 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 loratadine if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and operating machinery

Loratadine may cause drowsiness or dizziness. If you feel affected, do not drive or operate machinery.

Loratadina ratiopharm contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 6 years old 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 ratiopharm. There are other more suitable presentations for children under 6 years old who weigh30 kgor less.

Children under 2 years old:

Loratadina is not recommended for children under 2 years old.

Adults and children with severe liver problems:

Adults and children who weigh more than 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 Loratadinaratiopharmthan you should

If you take more loratadina 10 mg than you should, consult your doctor or pharmacist immediately. No serious problems are expected, however, you may experience headaches, palpitations, or feel drowsy.

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In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Loratadinaratiopharm

If you forgotto take your dose, take it as soon as you remember, 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 this medication, consult your doctor or pharmacist.

Like all medications,this medicationmay have adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop treatmentimmediatelyand consult your doctor or visit the nearest hospital:

• cases of allergic reactions such as swelling of the lips, tongue, or face (Quincke's edema),
• difficulty breathing and allergic reactions (pinching, burning, itching on the skin with inflammation),
• angioedema (swelling of the skin and mucous membranes).

These are severe adverse effects. If you experience them, you may have had a severe allergic reaction. You may need urgent medical attention or hospitalization.

Frequent(may affect up to 1 in 10 people) in adults and children over 12 years old

• drowsiness

Additional adverse effects in children aged 2 to 12 years

• headache,
• anxiety,
• fatigue.

Rare(may affect up to 1 in 100 people) in adults and children over 12 years old

• headache
• increased appetite
• difficulty sleeping

Very rare(may affect up to 1 in 10,000 people)

• dizziness,
• seizures,
• irregular or rapid heartbeats,
• nausea (urge to vomit),
• dry mouth,
• stomach discomfort,
• liver problems,
• hair loss,
• skin rash,
• fatigue.

Unknown 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website: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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Loratadina ratiopharm

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

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

Appearance of the product and content of the packaging

The tablets are white, round, and biconvex with a curved notch on one side. The tablets can be divided into two equal halves.

Each package contains 2, 7, 10, 14, 20, 20x1, 21, 28, 30, 50, 100 or 100x1 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Last review date of this leaflet:September 2023

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