Ewofex 180 mg. 10 capsules

1. What Evofex is and what it is used for
Evofex contains fexofenadine hydrochloride, which is an antihistamine.

Evofex 120 mg film-coated tablets are used in adults and adolescents aged 12 years and over to relieve symptoms such as sneezing, itchy nose, runny or blocked nose and itchy, red and watery eyes that occur with hay fever (seasonal allergic rhinitis).

Evofex 180 mg film-coated tablets are used in adults and adolescents aged 12 years and over to relieve symptoms such as itching, swelling and hives that occur with long-term allergic skin reactions (chronic idiopathic urticaria).

2. What you need to know before you take Evofex
Do not take Evofex
if you are allergic to fexofenadine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Evofex;

if you have liver or kidney problems.

if you have or have had heart disease, as this medicine may cause a fast or irregular heartbeat.

if you are elderly.

This medicine contains less than 1 mmol sodium (23 mg) per Evofex 120/180 mg film-coated tablet, i.e. essentially sodium-free.

If any of the above applies to you, or you are not sure, talk to your doctor before taking Evofex.

Other medicines and Evofex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking apalutamide (a medicine to treat prostate cancer), the effect of fexofenadine may be reduced.

Indigestion medicines containing aluminium or magnesium may affect the effect of Evofex by reducing the amount of the medicinal product absorbed. It is therefore recommended that you allow about 2 hours between the time you take Evofex and the indigestion medicine.

If you take fexofenadine with erythromycin or ketoconazole, or with a single dose of the combination lopinavir/ritonavir, the level of fexofenadine in the plasma may increase. Side effects may be increased.

Pregnancy and breast-feeding
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 take Evofex unless clearly necessary.

If you are breast-feeding, taking Evofex is not recommended.

Driving and using machines
Evofex is unlikely to affect your ability to drive or use machines. However, you should make sure that taking the tablets does not make you feel sleepy or dizzy before driving or using machines.

3. How to take Evofex
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults and children 12 years of age and older:

Evofex 120 mg film-coated tablets: The recommended dose is one tablet (120 mg) once a day. Take the tablet with water before a meal.

Evofex 180 mg film-coated tablets: The recommended dose is one tablet (180 mg) once a day. Take the tablet with water before a meal.

If you take more Evofex than you should
If you have taken more tablets, contact your doctor or the nearest emergency department immediately.
Symptoms of overdose in adults include dizziness, drowsiness, tiredness and dry mouth.

If you forget to take Evofex
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 taking Evofex
Tell your doctor if you want to stop taking Evofex before you have finished your course of treatment.

If you stop taking Evofex earlier than planned, your symptoms may return.

If you have any further questions on the use of this medicine, 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 Evofex if you experience:
swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.
Common side effects (may affect up to 1 in 10 people):
headache
sleepiness
nausea
dizziness
Uncommon side effects (may affect up to 1 in 100 people):
tiredness/drowsiness
Additional side effects that may occur with an unknown frequency (frequency cannot be estimated from the available data):
difficulty falling asleep (insomnia)
sleep disturbances
nightmares
nervousness
fast or irregular heartbeat
diarrhoea
skin rash and itching
hives
serious allergic reactions which may cause swelling of the face, lips, tongue or throat, flushing, tightness in the chest
and difficulty breathing
blurred vision
5. How to store Evofex
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Evofex contains
The active substance is fexofenadine hydrochloride.
Each Evofex 120 mg film-coated tablet contains 120 mg fexofenadine hydrochloride.

The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, maize starch, povidone, magnesium stearate.
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, macrogol 4000, iron oxide yellow (E172) and iron oxide red (E172).
Each Evofex 180 mg film-coated tablet contains 180 mg of fexofenadine hydrochloride.

The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, maize starch, povidone, magnesium stearate.
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, macrogol 4000 and iron oxide yellow (E172).
What Evofex looks like and contents of the pack
Evofex 120 mg film-coated tablets are peach-coloured, oblong, film-coated tablets, plain on both sides.

Evofex 180 mg film-coated tablets are oblong, yellow film-coated tablets, plain on one side and scored on the other side.

Evofex is available in packs of 2, 7, 10, 15, 20, 30, 50, 100 or 200 tablets.

Not all pack sizes may be marketed.

 

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