10 mg tablet
loratadine
What Loratadine ABECE is and what it is used for
Loratadine Abece contains the active substance loratadine, which belongs to the group of antihistamines and is used by adults and children over 6 years (with bodyweight over 30 kg) for the treatment of allergic nose and eye problems. The allergic problems can be caused by e.g. pollen, mites, or dust.
Loratadine Abece works by relieving allergic symptoms due to the release of histamines, such as sneezing, nasal congestion, runny or itchy nose, and burning or itchy eyes.
Loratadine contained in Loratadine Abece may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 use Loratadine ABECE
Do not use Loratadine ABECE
- if you are allergic to loratadine or any of the other ingredients of Loratadine Abece (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Loratadine Abece
– If you have impaired liver function.
– If you are going to perform an allergy test, treatment with Loratadine Abece should be stopped at least 48 hours before the test as the test result may be affected.
Some users may become dry in the mouth from the treatment, which may involve the risk of tooth damage during long-term treatment. Therefore, the teeth should be thoroughly cleaned with fluoride toothpaste twice daily.
Other medicines and Loratadine ABECE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
If several drugs are used at the same time, they can affect each other’s effect. The breakdown of Loratadine Abece is dependent on some of the body’s enzymes. Other medicines that affect these enzymes may affect the effect of Loratadine Abece and increase the risk of side effects.
Loratadine ABECE with food, drink and alcohol
Loratadine Abece has not been shown to increase the effects of alcohol.
Pregnancy and breastfeeding
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.
Pregnancy
Loratadine Abece should not be used during pregnancy.
Breast-feeding
Loratadine Abece should not be used during breastfeeding, as Loratadine Abece is excreted in human milk.
Driving and using machines
Individuals may experience fatigue or dizziness with Loratadine Abece, 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 ABECE contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Loratadine ABECE
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The tablets should be taken with a glass of liquid, with or without food.
The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
Adults and children over 6 years with body weight over 30 kg: 1 tablet daily.
Loratadine Abece should not be given to children under 6 years of age without medical advice. Contact a doctor if symptoms worsen or if the improvement is not seen after 7 days of treatment.
Loratadine Abece should be used for a maximum of 3 consecutive months unless your doctor prescribes otherwise. Feel free to try to end the treatment, if you think that the pollen season for you is over or if there are very low levels of pollen in the air.
Use for children:
Loratadine Abece should not be given to children weighing less than 30 kg.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Loratadine Abece and contact your doctor immediately if you get any of the following symptoms:
- Swelling of the face, tongue or throat
- Difficulty swallowing
- Breathing difficulties
- Hives
This can be a sign of a severe allergic reaction and can occur in very rare cases (in up to 1 in 10,000 users).
The most commonly reported adverse reactions in adults and children over 12 years of age are:
drowsiness
– headache
– increased appetite
– sleeping problems.
The most commonly reported adverse reactions in children aged 2 to 12 years are:
– headache
– nervousness
– sleeping problems.
The following very rare side effects ( may affect up to 1 in 10,000 people ) have also been seen with the marketing of loratadine:
- dizziness
- cramps
- irregular or fast heartbeat
- nausea
- dry mouth
- upset stomach
- liver problem
- hair loss
- rash
- fatigue.
Has been reported (occurs in an unknown number of users) :- weight gain
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Loratadine ABECE
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified month.
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 10 mg
- The other ingredients are: corn starch, lactose monohydrate , sodium starch glycolate , magnesium stearate, sodium lauryl sulfate and colloidal anhydrous silica.
What the medicine looks like and contents of the pack
Loratadine Abece is a white to off-white tablet with a notch on one side and an “L” mark on the other side. The diameter of the tablet is 6 mm.
Pack sizes: 7, 10, 14, 28 and 30 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer
MEIJI PHARMA SPAIN SA
Avda de Madrid, 94
Alcala de Henares,
Madrid, 28802
Spain