Nefoxef 120mg film-coated tablets fexofenadine hydrochloride
WHAT NEFOXEF IS AND WHAT IT IS USED FOR
The active substance in your medicine fexofenadine hydrochloride belongs to a group of medicines called antihistamines.
Nefoxef 120 mg film-coated tablets are approved for relieving symptoms such as sneezing, runny nose, and eyes, itching of the nose and eyes, and redness which are typical symptoms of hay fever (allergic rhinitis ).
Fexofenadine hydrochloride contained in Nefoxef may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
BEFORE YOU TAKE NEFOXEF
Do not take Nefoxef
– if you are allergic (hypersensitive) to fexofenadine hydrochloride or any of the other ingredients of Nefoxef.
Take special care with Nefoxef
– if you are older.
– If you have or have had heart problems.
– if you have kidney or liver problems.
Ask your doctor for advice before taking this medicine.
Taking other medicines
If you are taking an acidic stomach medicine that contains aluminum and magnesium hydroxide, it is recommended that you allow 2 hours to elapse between taking an acidic stomach medicine and Nefoxef. The remedy for an acidic stomach can cause a smaller amount to be absorbed and affect the effect of Nefoxef.
If you take Nefoxef together with erythromycin (an antibiotic ) or ketoconazole (antifungal), the amount of fexofenadine in your blood may increase.
Allergy tests: If you are going to do an allergy test, stop taking the medicine 3 days before the test.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Intake of Nefoxef with food and drink
Nefoxef should be taken with water before a meal.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy: Only take Nefoxef according to your doctor’s instructions.
Breast-feeding: If you are breastfeeding, try to avoid taking Nefoxef. Consult your doctor.
Driving and using machines:
Clinical studies have shown that Nefoxef does not cause fatigue and therefore your ability to drive should not be affected when you are treated with Nefoxef. However, there may be exceptions so make sure you are alert before driving or performing tasks that require full attention.
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.
HOW TO TAKE NEFOXEF
Dosage instructions
Always take Nefoxef exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Nefoxef 120 mg film-coated tablets: For the relief of symptoms of hay fever (allergic rhinitis ): The usual dose is one tablet daily for adults and children 12 years of age and older.
Use for children
Nefoxef 120 mg film-coated tablets should not be used by children under 12 years of age.
The tablets are taken orally with water before a meal.
If you have the impression that the effect of Nefoxef is too strong or too weak, talk to your doctor or pharmacist.
If you take more Nefoxef than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Symptoms of overdose may include dizziness, drowsiness, tiredness, and dry mouth.
If you forget to take Nefoxef
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Nefoxef can cause side effects, although not everybody gets them. The side effects listed below have been experienced by people who have taken Nefoxef.
Contact a doctor immediately if you experience swelling of the face, lips, tongue, or throat and difficulty breathing, as this may be a sign of a severe allergic reaction.
Common (experienced in between 1 in 10 and 1 in 100 patients): Headache, drowsiness, nausea, dizziness.
Uncommon (experienced in between 1 in 100 and 1 in 1000 patients): Fatigue or drowsiness.
Additional side effects (unknown frequency) that may occur are difficulty sleeping (insomnia), sleep disturbances, nightmares, nervousness, fast or irregular heartbeat, diarrhea, rash and itching, hives, severe allergic reaction that may cause swelling of the face or lips, tongue, tongue pharynx, redness, pressure over the chest and difficulty breathing.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE NEFOXEF
Keep out of sight and reach of children.
Use Nefoxef before the expiry date which is stated on the carton. The expiration date is the last day of the specified month. No special storage instructions.
The medicine 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.
FURTHER INFORMATION
Content declaration for Nefoxef
The active substance is fexofenadine hydrochloride.
Each Nefoxef 120 mg film-coated tablet contains 120 mg fexofenadine hydrochloride, equivalent to 112 mg fexofenadine. The other ingredients are microcrystalline cellulose, croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000, yellow iron oxide (E172), and red iron oxide (E172).
What the medicine looks like and the contents of the pack
Nefoxef 120 mg film-coated tablets are peach-colored, oblong, biconvex, and film-coated, smooth on both sides.
Nefoxef is supplied in pack sizes of 7, 10, 15, 20, 30, 50, 100, 200 or 250 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer:
Chanelle Medical
IDA Industrial Estate
Loughrea, Co. Galway
Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan UTC 1
Hungary
McDermott Laboratories to Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland