Package leaflet: Information for the user

Loratadine Teva 10 mg tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If any side effects occur, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.
Talk to your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What Loratadine Teva tablets are and what they are used for
What you need to know before taking Loratadine Teva tablets
How to take Loratadine Teva tablets
Possible side effects
How to store Loratadine Teva tablets
Contents of the pack and other information

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

The full name of this medicine is Loratadine Teva 10 mg tablets.
What Loratadine Teva tablets are
Loratadine Teva tablets contain the active substance loratadine and belong to a class of medicines known as "antihistamines".
What Loratadine Teva tablets are used for
Loratadine Teva helps reduce allergic symptoms by counteracting the effects of a substance called "histamine", which is produced by the human body when someone is allergic to something.
When Loratadine Teva should be taken
Loratadine Teva relieves symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny nose and nasal itching, burning or itchy eyes, in adults and children over 2 years of age who weigh more than 30 kg.
Loratadine Teva is also used to relieve symptoms associated with urticaria (itching and redness).
The effect of Loratadine Teva lasts for a full day and helps restore normal daily activities and sleep.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before taking Loratadine Teva

Do not take Loratadine Teva:

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Loratadine Teva:

If you have liver problems.
If you are scheduled to undergo skin allergy tests. You must not take Loratadine Teva within the two days prior to such tests, as it may interfere with test results.

If any of the above conditions apply to you (or if you are unsure), consult your doctor, pharmacist or nurse before taking Loratadine Teva.
Children
Do not give Loratadine Teva to children under 2 years of age or to children between 2 and 12 years of age who weigh less than 30 kg.
Other formulations are more suitable for children aged 2 to 12 years weighing less than 30 kg.
Other medicines and Loratadine Teva
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines not requiring a prescription.

Loratadine Teva and alcohol
Loratadine Teva has not been shown to enhance the effects of alcoholic beverages.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take Loratadine Teva during pregnancy.
Do not take Loratadine Teva if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and using machines
At the recommended dose, Loratadine Teva is not expected to cause drowsiness or impair attention. However, drowsiness has very rarely occurred in some individuals, which may affect the ability to drive or operate machinery.
Loratadine Teva contains lactose
Loratadine Teva contains lactose; therefore, if your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Loratadine Teva

Take this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Use in children
Loratadine syrup is preferred for children. It is important to know your child's weight to ensure the correct dose is given. For example, a 9-year-old child weighs approximately 30 kg. If in doubt, weigh the child and follow the instructions in the table.
Do not administer to children under 2 years of age or weighing less than 30 kg.
The recommended dose is:

Age	How much to take	For how long
Children aged 2 to 12 years weighing more than 30 kg	1 tablet	Once daily
Adults and children over 12 years of age	1 tablet	Once daily
If you have severe liver problems, your doctor or pharmacist may advise you to take the recommended dose on alternate days. If this applies to you, follow their instructions.

The score line is only intended to facilitate breaking the tablet if you have
difficulty swallowing it whole.
If you take more Loratadine Teva than you should
If you take more Loratadine Teva than recommended, contact your doctor or pharmacist immediately.
Serious problems are not expected, but you may experience headache, rapid heartbeat, or drowsiness.
If you forget to take Loratadine Teva

If you forget to take your dose at the scheduled time, take it as soon as possible; then continue taking the medicine as usual.
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult 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 Loratadine Teva tablets and contact your doctor immediately
if you notice the following symptoms:

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

Other side effects:
Very common in adults and children over 12 years of age (may affect more than 1 in 10 people):

Drowsiness,
Headache,
Increased appetite,
Difficulty sleeping.

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

Headache,
Nervousness,
Fatigue.

Very rare (may affect 1 in 10,000 people); very rare cases have been reported during post-marketing surveillance of Loratadine:

Dizziness
Seizures or epileptic fits
Nausea (feeling unwell)
Dry mouth
Stomach discomfort
Hair loss
Skin rash
Tiredness

Not known (frequency 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 side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loratadine Teva

Keep this medicine out of the sight and reach of children.
Do not place the tablets in another container.
Do not use this medicine after the expiry date stated on the blister after Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any changes in the appearance of the tablet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Loratadina Teva contains

The active substance is loratadine.
The other components are monohydrate lactose, maize starch, pregelatinized starch and magnesium stearate.

Description of the appearance of Loratadina Teva and package contents
Loratadina Teva 10 mg tablets are white, oval, scored on one side and smooth on the other,
with "L" and "10" printed on both sides separated by the break line.
The medicine is available in packages containing 5, 7, 10, 15, 20, 28, 30, 50 and 100
tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturers

Teva Pharmaceutical Works Co. Ltd. - Pallagi ùt 13 - 4042 Debrecen (Hungary)
Teva UK Ltd. - Brampton Road, Hampden Park - BN 22 9AG Eastbourne - East Sussex (England)
PHARMACHEMIE B.V. - Swensweg, 5 - 2003 RN Haarlem (Netherlands)