10 mg tablets
loratadine
What Loratadine Actavis is and what it is used for
Loratadine Actavis is used for allergic conditions such as sneezing, runny nose, itchy nose, itching, and burning in the eyes. Can also be prescribed by a doctor for hives.
Loratadine is an antihistamine, which counteracts the effect of histamine. Histamine is a substance in the body’s tissues that are released when you are exposed to the allergenic substance and which causes sneezing, runny nose, itching, and eye problems.
The allergic problems can be caused by, among other things, pollen, fur animals, mites, or dust. Pollen allergy is seasonal to the pollen periods. Allergy to fur animals, mites, or dust can, on the other hand, occur all year round and must be diagnosed by a doctor before starting treatment. This type of allergy can be treated temporarily if needed.
Ordinary runny nose, so-called “cold runny nose” is caused by a virus and then antihistamines have no effect. Loratadine Actavis should therefore not be used for colds other than allergic rhinitis.
Please note that your doctor may have prescribed Loratadine Actavis for use other than that indicated on the package leaflet. Always follow your doctor’s prescription.
Loratadine Actavis usually relieves symptoms within 1 hour and lasts for 24 hours.
Loratadine contained in Loratadine Actavis 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 use Loratadine Actavis
Do not use Loratadine Actavis
- If you are allergic (hypersensitive) to loratadine or any of the other ingredients of Loratadine Actavis (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Loratadine Actavis if:
- you have liver problems
- the patient is a child and has a kidney disease
- you must undergo a spot test ( allergy test ), the treatment should be stopped at least 48 hours before the test.
Children
Do not give Loratadine Actavis to children under 12 years of age or children weighing 30 kg or less. Other forms of medicine are more suitable for children with a bodyweight of 30 kg or less.
Other medicines and Loratadine Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Side effects of loratadine tablets may increase with concomitant use of other drugs that affect the function of certain liver enzymes responsible for the breakdown of drugs in the liver. However, in clinical trials, no increase in side effects of loratadine has been observed with drugs that affect the function of these enzymes.
Pregnancy, breastfeeding and fertility
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. The use of Loratadine Actavis is not recommended if you are pregnant or breastfeeding.
Driving and using machines
Loratadine Actavis does not normally cause drowsiness. However, it should be taken into account that drowsiness may occur in rare cases and that this may then affect the ability to perform precision work (such as driving a car). 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 Actavis 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 as it contains a type of sugar called lactose.
How to use Loratadine Actavis
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Swallow the tablets whole with a glass of water, with or without food.
Loratadine Actavis 10 mg tablets are over-the-counter for adults and children over 12 years (with bodyweight over 30 kg) for allergic disorders caused by pollen.
Dosage for adults and children over 12 years with body weight over 30 kg: 1 tablet once daily.
Contact a doctor or pharmacist if the improvement is not seen within 7 days.
Loratadine Actavis should not be given to children under 12 years of age without a doctor’s prescription.
The length of treatment may vary depending on your symptoms. 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 Loratadine Actavis for a maximum of 3 consecutive months unless your doctor prescribes otherwise.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Discontinue treatment with Loratadine Actavis and contact a physician immediately if you notice any signs of:
- an allergic reaction: swelling of the face, lips, tongue or throat, narrowing of the airways that causes difficulty breathing, shock , collapse, rash, itching .
Tell your doctor if you notice any of these side effects are or notice other side effects are not listed here:
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
- fatigue.
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
- fast or irregular heartbeat
- nausea
- dry mouth
- upset stomach
- liver problem
- hair loss
- fatigue.
The frequency of the following side effects is unknown
- weight gain
Reporting of side effects is
if you get side effects are, speak with your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
How to store Loratadine Actavis
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. 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 . Each tablet contains 10 mg of loratadine .
- The other ingredients are lactose monohydrate , microcrystalline cellulose (E460), corn starch and magnesium stearate.
What the medicine looks like and contents of the pack
Loratadine Actavis tablets are white, or almost white, 8 mm in diameter, round, flat tablets marked with the letter “L” on one side and with a notch on the other side.
Pack size: 7, 10, 14 and 28 tablets.
Marketing Authorization Holder and Manufacturer
Actavis Group PTC ehf., Reykjavikurvegur 76-78, IS-220 Hafnarfjordur, Iceland
Agent:
SanoSwiss UAB
Love 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com