CLARITINE TBL 10MG N10

ATC code: R06AX13 

Active substances: Loratadinum

Vendor, principal: Schering-Plough Europe. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

CLARITINE 10MG N30

Claritine 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, pharmacist, or nurse has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If any side effects occur, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
-   You must talk to a doctor if you do not feel better or if you feel worse. See section 4.

What is in this leaflet

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

1. What Claritine is and what it is used for

The name of this medicine is Claritine tablets.

What Claritine is

Claritine tablets contain the active substance loratadine, an antihistamine medication.

How Claritine works

Claritine helps reduce the activity of histamine by inhibiting allergic symptoms. Histamine is a natural compound triggering allergic reactions.

When to use Claritine

Claritine reduces the symptoms of allergic rhinitis (e.g. hay fever), such as sneezing, runny nose, itchy nose, itchy eyes and redness in adults and children over 2 years of age weighing more than 30 kg.
Claritine tablets are also used for reducing the occurrence and size of symptoms of urticaria, such as itchiness, redness, or wheals.
The effect of Claritine lasts all day and enables you to return to normal daily activities and undisturbed sleep.
You must talk to your doctor if you do not feel any better or if you feel worse.

2. What you need to know before you use Claritine Do not use Claritine:

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

Warnings and precautions

Talk to a doctor, pharmacist or a nurse before using Claritine:
-   if you have a liver disease;
-   if skin tests are planned for determining the cause of your allergy. Do not take Claritine for two days before such tests. This is necessary because Claritine can affect the test results.
If any of the above applies to you (or if you are uncertain), ask your doctor, pharmacist, or a nurse for advice before using Claritine.

Children

Do not administer Claritine to children under 2 years of age or children aged 2-12 weighing less than 30 kg. Other more suitable dosage forms are available for children aged 2-12 weighing less than 30 kg.

Other medicines and Claritine

The side effects of Claritine can increase if it is used concomitantly with medicines modifying the activity of liver enzymes participating in the metabolism of medicines. Despite of this, clinical studies showed no increase in the side effects of loratadine when used concomitantly with medicines affecting such enzymes. Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Claritine with alcohol

Claritine does not increase the effects of alcohol.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As a preventive measure, it is recommended to avoid using Claritine during pregnancy.
Do not use Claritine while breastfeeding. Loratadine is absorbed into breast milk.

Driving and using machines

No reduction in driving ability was noted in patients receiving loratadine in clinical trials. When used in recommended doses, Claritine causes no sleepiness or impaired attention. In very rare cases, some people still feel sleepy, in which case driving or using machines should be avoided.

Claritine contains lactose.

Claritine tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

3. How to use Claritine

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure.
The score line is only there to help you break the tablet if you have difficulties swallowing it whole.

Adults and children aged 12 and above

Take one tablet per day with a glass of water, independent of meals.

Children aged 2-12 years

Body weight over 30 kg
One tablet per day with a glass of water, independent of meals.
Body weight 30 kg or less
Do not give Claritine to children aged 2-12 weighing less than 30 kg; there are other more suitable dosage forms available for them.
Loratadine 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 one tablet every other day with a glass of water, independent of meals. Talk to your doctor, pharmacist, or nurse before using this medicine.

If you take more Claritine than you should

If you have taken an overdose, talk to your doctor or pharmacist immediately. Severe problems are unlikely to occur, but you may get a headache, your heart rate may increase, and you may feel sleepy.

If you forget to take Claritine

•   If you forgot to take the medicine, do it as soon as you remember and then return to your normal dosage regimen.
•   Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4.   Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects of using this medicine in adults and children over 12 years of age are:
•   sleepiness;
•   headache;
•   increased appetite;
•   sleep problems.
The most common side effects of using this medicine in children aged 2-12 are:
•   headache;
•   anxiety;
•   fatigue.
The following post-marketing side effects have been reported in very rare cases (can occur in up to 1 person in 10,000):
•   severe allergic reactions (incl. swelling);
•   dizziness;
•   cramps;
•   irregular or accelerated heart rate;
•   nausea (feeling sick);
•   dry mouth;
•   indigestion;
•   abnormal hepatic function;
•   hair loss;
•   rash;
•   fatigue.
Side effects with unknown incidence (cannot be estimated based on existing data):
• increased body weight
Reporting of side effects
If any side effects occur, talk to a doctor, pharmacist, or nurse. 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 Claritine

5.

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not use this medicine if you observe any changes in the tablet’s appearance.
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 Claritine contains

-   The active substance is loratadine. One tablet contains 10 mg of loratadine.
-   The excipients are lactose monohydrate, corn starch, and magnesium stearate.

What Claritine looks like and contents of the pack

Claritine tablets are white to off-white oval tablets with a score line one side and the other side empty. Claritine 10 mg tablets are packaged in single-dose blister packages of 10 or 30 tablets per package.

Marketing Authorisation Holder:

UAB Bayer Sporto 18 LT-09238 Vilnius Lithuania

Manufacturer:

Bayer Bitterfeld GmbH OT Greppin Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bayer OÜ Löötsa 2 11415 Tallinn Phone: +372 655 8565

This leaflet was last revised in April 2018.