LORATIN EXPRESS TBL 10MG N10

ATC code: R06AX13 

Active substances: Loratadinum

Vendor, principal: Hexal Ag/salutas Pharma Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

LORATIN EXPRESS 10MG N10

Package leaflet: Information for the user

Loratin express, 10 mg tablets

Loratadine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-   Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet

1.   What Loratin express is and what it is used for
2.   What you need to know before you use Loratin express
3.   How to take Loratin express
4.   Possible side effects
5.   How to store Loratin express
6.   Contents of the pack and other information

1. What Loratin express is and what it is used for

Loratin express contains the active substance loratadine. It belongs to a class of medicines called antihistamines and its anti-allergic effect is obtained by blocking histamine receptors and inhibiting the release of inflammatory agents .
Loratin express is used for symptomatic treatment of allergic rhinitis, eye infections (conjunctivitis) and nettle rash (urticaria).

2. What you need to know before you use Loratin express Do not take Loratin express:

- if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
This medicine is not recommended for children younger than 2 years of age.

Warnings and precautions

- if you have severe liver impairment
Treatment with Loratin express should be discontinued at least 48 hours before taking skin tests, as the anti-allergy medicines may interfere with or hinder the positive reaction of skin tests.

Other medicines and Loratin express

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines bought without a prescription.
Concomitant use of Loratin express with cimetidine (a medicine for curing gastric ulcers), erythromycin (an antibiotic), or ketoconazole (an anti-fungal medicine) may increase the effect (including side effects) of loratidine. Therefore special care must be taken if using loratidine simultaneously with these medicines.

Loratin express with food, drink and alcohol

Taking Loratin express with food and drink may slow absorption of the medicine, but it does not influence its efficacy.
Loratin express does not strengthen the effects of alcohol.

Pregnancy, breast-feeding and fertility

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.
Pregnancy
Although the data concerning pregnant women does not show any malformations or adverse effects on the foetus/newborn, as a precautionary measure it is recommended to avoid loratadine use during pregnancy.
Breast-Feeding
Loratidine is excreted in breast milk. Therefore, if treatment is needed while breast-feeding, a decision must be made whether to discontinue breast-feeding or to abstain from therapy.

Driving and using machines

Loratin express has no known effects on the ability to drive, e.g. on reaction time, visual acuity, vigilance, or driving behaviour. In isolated cases loratadine has caused drowsiness, which may influence the ability to drive or use machines. Sensitive persons who may have unusual reactions to medicines should therefore determine how they react to the effects of to the medicine before driving a vehicle, using machines, or carrying out other activities that require concentration.

Loratin express contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Loratin express

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents above 12 years of age
The recommended dose is 1 tablet (10 mg) once daily.
Children aged 2 to 12 years Children with a body weight over 30 kg:
1 tablet (10 mg) once daily.
Children with a body weight of 30 kg or less:
Half a tablet (5 mg) once daily.
For patients with severe liver disease the recommended initial dose is half a tablet (corresponds to 5 mg of loratidine) daily or 1 tablet (corresponds to 10 mg of loratidine) every other day. Thereafter the dose may be increased.
The tablet should be swallowed whole with a small amount of liquid.
Treatment duration is determined by your doctor. It depends on the course of the disease and does not exceed 6 months.
According to available data, treatment of urticaria may take up to 4 weeks.
The permitted duration of treatment for children between 2 and 12 years of age is up to 2 weeks.
Sensitivity towards the medicine varies between individuals. If the medicine does not show any effect within 3 days of treatment, it will most probably fail to have an effect altogether.
If you feel that the effect of Loratin express is too strong or too weak, talk to your doctor or pharmacist.

If you take more Loratin express than you should

Accidental overdose probably has no serious consequences. In the case of overdose, you may develop sleepiness, increased heart rate or headache. If you have taken more tablets than you should, contact your doctor.

If you forget to take Loratin express

Do not take a double dose to make up for a forgotten tablet. Continue treatment on a regular basis.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects of this medicine reported in adults and children aged 12 and over are:
•   drowsiness
•   headache
•   increased appetite
•   sleep disorders.
The most common side effects of this medicine reported in children aged 2-12 are:
•   headache
•   nervousness
•   fatigue.
During the time that Loratin Express has been marketed, the following side effects have been reported very rarely (may affect up to 1 person in 10,000):
•   acute allergic reactions (incl. swelling)
•   dizziness
•   convulsions
•   irregular or rapid heartrate
•   nausea (malaise)
•   dry mouth
•   digestive disorders
•   liver function disorders
•   hair loss
•   rash
•   fatigue.
The following side effect has been reported with unknown frequency (cannot be evaluated from 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 www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Loratin express

5.

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and on the blister pack after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Loratin express contains

-   The active substance is loratidine. Each tablet contains 10 mg of loratidine.
-   The other excipients are lactose, magnesium stearate, corn starch, silicon dioxide.

What Loratin express looks like and contents of the pack

Loratin express is a white, ellipsoidal tablet with a scoring line, 7.5 to 7.9 mm in length and about 5 mm in width. Tablets are packaged in blister packs, 30 tablets in a pack.
Marketing Authorisation Holder HEXAL AG Industriestraße 25 D-83607 Holzkirchen Germany

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Germany
or
Lek Spolka Akcyjna 50 C Domaniewska 02-672 Warsaw Poland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz d.d. Estonian Branch Pämu mnt 105 EE-11312 Tallinn Tel: +372 6652400 Fax: +372 6652410

This leaflet was last revised in August 2018.

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