10 mg tablets
loratadine
What Loratadine Apofri is and what it is used for
Loratadine Apofri 10 mg tablets are available without a prescription for 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. The symptoms can be sneezing, runny and itchy nose as well as itching and burning in the eyes. Loratadine Apofri can also be prescribed by a doctor to treat the symptoms of prolonged hives.
Loratadine Apofri works by relieving allergic symptoms, which are due to the release of histamines, such as sneezing, runny or itchy nose, and burning or itchy eyes.
Loratadine contained in Loratadine Apofri may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Loratadine Apofri
Do not use Loratadine Apofri
– if you are allergic to loratadine or any of the other ingredients of Loratadine Apofri (see section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Loratadine on April
– If you have severe hepatic impairment.
– If you are going to perform an allergy test, treatment with Loratadine Apofri should be stopped at least 48 hours before the test as the test result may be affected.
Some patients may become dry in the mouth from the treatment, which may involve a risk of tooth damage during long-term treatment. Therefore, the teeth should be thoroughly cleaned with fluoride toothpaste twice daily.
Other medicines and Loratadine Apofri
Tell your doctor or pharmacist if you are taking or have recently taken 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 Apofri depends on some of the body’s enzymes. Other medicines that affect these enzymes may affect the effect of Loratadine Apofri and increase the risk of side effects.
Loratadine Apofri with food, drink and alcohol
Loratadine Apofri can be taken with or without food.
Pregnancy, breastfeeding and fertility
Loratadine Apofri should not be taken during pregnancy. Loratadine Apofri should not be used during breastfeeding, as Loratadine Apofri is excreted in human milk.
Driving and using machines
Individuals may experience side effects from Loratadine Apofri, which may affect their ability to drive and 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 Apofri contains lactose monohydrate 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 Apofri
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.
The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
The tablets can be taken independently of meals.
Adults and children over 6 years with body weight over 30 kg: 1 tablet daily.
Loratadine Apofri should not be given to children under 6 years of age without consulting a doctor. Contact a doctor if the improvement is not seen after 7 days of treatment.
Loratadine Apofri 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.
Hepatic impairment:
Follow your doctor’s instructions. A starting dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg.
Use for children and adolescents
Loratadine Apofri 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 Apofri and contact your doctor immediately if you get any of the following symptoms ( angioedema ):
– Swelling of the face, tongue, or throat
– Difficulty swallowing
– Hives and difficulty breathing
Common side effects (affects 1 to 10 users in 100):
• Headache
• Sleepiness
• Fatigue
• Nervousness
Uncommon (affects 1 to 10 users in 1,000):
• Increased appetite
• Insomnia
Very rare (affects less than 1 in 10,000 people):
• Severe allergic reaction (anaphylactic reactions). Stop taking the medicine and contact a doctor or hospital
• Dizziness
• Rapid heartbeat, palpitations, nausea, dry mouth, and gastritis
Rash, hair loss
• Abnormal liver function
Has been reported (occurs in an unknown number of users):
• Weight gain
How to store Loratadine Apofri
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.
6. 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 Apofri is a white to off-white round tablet with a notch on one side and marked “L” 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
Apofri AB
Box 120
182 12 Danderyd
Manufacturer
MEIJI PHARMA SPAIN SA
Avda de Madrid, 94
Alcala de Henares,
Madrid, 28802
Spain