120 mg film-coated tablets
fexofenadine hydrochloride
What Fexofenadine ABECE is and what it is used for
Fexofenadine Abece contains fexofenadine hydrochloride which is an antihistamine.
Used in adults and adolescents from the age of 12 to relieve symptoms that occur with hay fever (seasonal allergic rhinitis ) such as sneezing, itching, runny or stuffy nose, and itching, red and watery eyes.
Fexofenadine hydrochloride contained in Fexofenadine Abece may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Fexofenadine ABECE
Do not use Fexofenadine ABECE
- if you are allergic to fexofenadine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist or nurse before taking Fexofenadine Abece if:
- you have liver or kidney problems
- you have or have had heart disease because this medicine may cause a fast or irregular heartbeat
- you are older
Children and young people
Fexofenadine Abece 120 mg is not recommended for use in children and adolescents below 12 years of age.
Other medicines and Fexofenadine ABECE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of Fexofenadine Abece may be impaired by reduced uptake if certain medicines for acidic stomachs containing aluminum and magnesium hydroxide are taken at the same time.
It is recommended that you allow 2 hours between the intake of Fexofenadine Abece and the medicine for an upset stomach.
Pregnancy and breastfeeding
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.
If you are pregnant, do not use Fexofenadine Abece unless your doctor tells you to.
Fexofenadine Abece is not recommended, for breastfeeding women.
Driving and using machines
Fexofenadine Abece is unlikely to affect your ability to drive or use machines. However, you should make sure that these tablets do not make you tired or dizzy before driving or handling machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Fexofenadine ABECE contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Fexofenadine 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.
For adults and young people from 12 years
The recommended dose is 1 tablet (120 mg) once a day for adults and children 12 years of age and older.
Take the tablet with water before a meal.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
Do not use Fexofenadine Abece for more than 3 months without consulting a doctor.
Use for children and adolescents
Fexofenadine Abece 120 mg is not recommended for use in children and adolescents below 12 years of age.
If you use more Fexofenadine ABECE then you should
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.
Symptoms of overdose include dizziness, drowsiness, tiredness, and dry mouth.
If you forget to use Fexofenadine ABECE
Do not take a double dose to make up for a forgotten tablet
Take the next dose at the usual time as prescribed by your doctor.
If you stop using Fexofenadine ABECE
Tell your doctor if you want to stop using Fexofenadine Abece before stopping treatment.
If treatment is stopped too early, symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Fexofenadine ABECE if you:
- swells up the face, lips, tongue, or throat and has difficulty breathing, as this may be a sign of a severe allergic reaction.
Common adverse s (occurring in more than 1 in 100):
- headache
- drowsiness
- nausea (nausea)
- dizziness.
Less common side effects are (by less than 1 in 100):
- fatigue
- somnolence.
Additional side effects that may occur :
- difficulty sleeping (insomnia)
- sleep disorders
- nightmares
- nervousness
- fast or irregular heartbeat
- diarrhea
- skin rash and itching
- hives
- severe allergic reactions that may cause swelling of the face, lips, tongue, or throat, hot flashes, chest tightness, and difficulty breathing.
5. How to store Fexofenadine ABECE
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. and blister after EXP: The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
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 fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
- Other ingredients are:
– Tablet core: microcrystalline cellulose, maize starch, croscarmellose sodium, povidone,
magnesium stearate.
– Film coating: hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron oxide (E172).
What the medicine looks like and the contents of the pack
Fexofenadine Abece is a peach-colored, elongated film-coated tablet that is smooth on both sides. Size: 15×6.5 mm.
PVC / PVDC / Al-blister packed in cartons. 7, 10, 15, 20 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
S&D Pharma CZ, spol. s ro, Theodor 28, 273 08 Pchery, Czech Republic
Cipla (EU) Limited
4th Floor, 20 Balderton Street, London, W1 6TL, UK
Cipla Europe NV
Uitbreidingstraat 80, 2600 Antwerp, Belgium
Evolan Pharma AB
Svärdvägen 19, 182 33 Danderyd