10 mg tablets loratadine
What Loratadine Hexal is and what it is used for
Loratadine Hexal belongs to a group of medicines called antihistamines.
Loratadine Hexal is used to treat the symptoms of
- allergic inflammation of the nose , e.g. hay fever
- chronic hives of unknown origin.
Loratadine contained in Loratadine Hexal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Loratadine Hexal
Do not take Loratadine Hexal
- if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Loratadine Hexal if you:
- suffers from severe hepatic impairmentSee dosing instructions in section 3 under “Patients with severe hepatic impairment”.
- shall undergo a spot testTreatment of Loratadine Hexal should be discontinued at least 48 hours before the test because the drug can affect the outcome.
Children
Loratadine Hexal is not recommended for use in children below 2 years of age as efficacy and safety have not been established. Do not give Loratadine Hexal to children weighing less than 30 kg. There are other, more appropriate formulations.
Other medicines and Loratadine Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No significant effect of Loratadine Hexal on other drugs, or vice versa, has been observed.
Loratadine Hexal with food, drink and alcohol
Food does not affect the effect of Loratadine Hexal. Loratadine Hexal has not been shown to increase the effects of alcohol.
Pregnancy, breastfeeding and fertility
The use of Loratadine Hexal is not recommended during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
At the recommended dose, Loratadine Hexal is not expected to make you drowsy or less alert. In very rare cases, some people may experience drowsiness, which may affect their ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Loratadine Hexal contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Loratadine Hexal
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults and children over 12 years
- 1 tablet once daily.
No dose adjustment is required for patients over 65 years of age or patients with renal impairment.
Children between 2 and 12 years
- weighing more than 30 kg: 1 tablet once daily
Patients with severe hepatic impairment
- adults and children weighing more than 30 kg:starting dose: 1 tablet every other day
Method of use
The tablet can be taken without regard to meals. Swallow the tablet with a glass of water.
Duration of treatment
Take Loratadine Hexal for as long as you have symptoms or as directed by your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported adverse reactions were of adults and children over 12 years:
- drowsiness
- headache
- increased appetite
- sleeping problems.
The most commonly reported adverse reactions in children aged 2 to 12 years are:
- headache
- nervousness
- fatigue.
The following very rare side effects are (may affect up to 1 in 10 000 people) have also been seen for the marketing of loratadine:
- severe allergic reaction (including swelling)
- dizziness
- seizures
- irregular or fast heartbeat
- nausea
- dry mouth
- upset stomach
- liver problem
- hair loss
- rash
- fatigue.
The frequency of the following side effects is unknown (can not be calculated from the available data):
- weight gain.
How to store Loratadine Hexal
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is loratadine.
One tablet contains 10 mg loratadine .
Other ingredients are:
lactose monohydrate, magnesium stearate, corn starch, anhydrous colloidal silica.
What the medicine looks like and contents of the pack
Loratadine Hexal is a white, oval tablet with a score, marked “LT10” on one side
The tablets are packaged in polyvinyl chloride/aluminum blister cards of 7, 10, 20, 21, 30, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany