Desloratadine Apofri 5 mg Film Coated Tablets
What Is Desloratadine Apofri And What It Is Used For
Desloratadine Apofri relieves the symptoms of allergic rhinitis ( inflammation of the nasal mucosa caused by allergies, such as hay fever or allergies to dust mites) in adults and adolescents 12 years of age and older. These symptoms include
- Sneezing
- Runny or itchy nose
- Palate itching
- Itchy, red, or watery eyes
Relieving these symptoms lasts all day and helps you maintain normal daily activities and normal sleep.
Desloratadine Apofri can also be prescribed to relieve symptoms associated with urticaria (a skin condition caused by allergies ). These symptoms include
- Itching
- Hives
Desloratadine contained in Desloratadine Apofri 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.
Desloratadine Apofri contains desloratadine which is an antihistamine. Desloratadine Apofri is an antiallergic medicine that does not make you drowsy. It helps keep your allergic reactions and their symptoms under control.
What You Need To Know Before You Use Desloratadine Apofri
Do Not Use Desloratadine Apofri
- If you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Warnings And Cautions
Talk to your doctor or pharmacist before taking Desloratadine Apofri
- If you have impaired kidney function
- If you or someone in your family has had seizures.
Children And Young People
Do not give this medicine to children under 12 years of age.
Other Medicines And Desloratadine Apofri
There is no known interaction between Desloratadine Apofri and other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Desloratadine Apofri With Food, Drink, And Alcohol
Desloratadine Apofri can be taken with or without food.
Pregnancy, Breastfeeding, And Fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking Desloratadine Apofri is not recommended if you are pregnant or breast-feeding.
Fertility
There are no fertility data for men and women.
Driving And Using Machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not feel drowsy, it is recommended that you do not perform activities that require sharp attention, such as driving a vehicle or using machinery until you know how you react to the medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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
How To Use Desloratadine Apofri
Desloratadine Apofri uses
- 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.
- Adults and adolescents (12 years and older):
- The recommended dose is one tablet once a day.
- The tablet is swallowed whole with water. Can be taken with or without food.
- Contact a doctor if the improvement is not seen after 7 days of treatment.
- Desloratadine Apofri should be used for a maximum of 3 consecutive months unless your doctor prescribes otherwise.
If You Use More Desloratadine Apofri Than You Should
Take Desloratadine Apofri as prescribed for you. No serious problems are to be expected in case of accidental overdose.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If You Forget To Use Desloratadine Apofri
If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If You Stop Using Desloratadine Apofri
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible Desloratadine Apofri Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of Desloratadine Apofri, cases of severe allergic reactions
- Difficulty breathing
- Wheezing
- Itching
- Hives
- Swelling
Have been reported in very rare cases. If you experience any of these side effects are, stop taking the drug and seek immediate emergency medical attention.
In clinical trials in adults, the side effects were about the same as with an inactive tablet.
However, were reported more often than with an inactive tablet. In adolescents, headache was the most commonly reported side effect.
- Fatigue
- Dry mouth
- Headache
In clinical trials with desloratadine, the following side effects have been reported:
Common Desloratadine apofri side effects (the following may affect up to 1 in 10 people)
- Fatigue
- Dry mouth
- Headache
During the marketing of desloratadine, the following side effects have been reported:
Very rare (may affect up to 1 in 10,000 people)
- Severe allergic reactions
- Fast heartbeat
- Vomiting
- Dizziness
- Muscle pain
- Restlessness with increased body movement
- Rash
- Stomach ache
- Upset stomach
- Drowsiness
- Hallucinations
- Hepatitis
- Throbbing or irregular heartbeat
- Nausea
- Diarrhea
- Difficulty sleeping
- Seizures
- Abnormal liver function tests
Has been reported (occurs in an unknown number of users):
- Unusual weakness
- Yellowing of the skin and/or eyes
- Increased sensitivity of the skin to sunlight, even in sunlight and to UV light, for example for UV light in solarium
- Changes in how the heartbeats
- Abnormal behavior
- Aggression
- Weight gain
- Increased appetite
Children
Has been reported (occurs in an unknown number of users):
- Slow heartbeat
- Changes in how the heartbeats
- Abnormal behavior
- Aggression
5. How To Store Desloratadine Apofri
- Keep this medicine out of the sight and reach of children.
- Store in the original package. Sensitive to light.
- 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.
6. Contents Of The Packaging And Other Information
Content Declaration
- The active substance is desloratadine 5 mg.
- The other ingredients are
- Microcrystalline cellulose
- Partially pregelatinized maize starch
- Magnesium stearate
- Colloidal anhydrous silica
- Hypromellose
- Titanium dioxide (E171)
- Stearic acid
- Indigo carmine (E132)
What The Medicine Looks Like And The Contents Of The Pack
Blue, round, biconvex, film-coated tablet 6.5 mm in diameter, smooth on both sides.
Marketing Authorization Holder And Manufacturer
Marketing Authorization Holder
Apofri AB
Box 120
182 12 Danderyd
Manufacturer
Genepharm SA
18 hm Marathon Avenue
153 51 Pallini Attikis
Greece
Carton containing blister (PVC / PCTFE (ACLAR) aluminum foil or PVC / PE / PVDC aluminum foil) with 5, 10, 20 and 30 tablets.
Not all pack sizes may be marketed.