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ALLEVIA 120 MG TABLETS - Patient leaflet, side effects, dosage

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Patient leaflet - ALLEVIA 120 MG TABLETS

Attevia

120mg tablets

fexofenadine hydrochloride

Package leaflet: Information for the user

(Referred to as Allevia in the remainder of the leaflet)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

  • – Keep this leaflet. You may need to read it again.

  • – Ask your pharmacist if you need more information or advice.

  • – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  • – You must talk to a doctor if you do not feel better or if you feel worse after taking Allevia.

What is in this leaflet

  • 1. What Allevia is and what it is used for

  • 2. What you need to know before you take Allevia

  • 3. How to take Allevia

  • 4. Possible side effects

  • 5. How to store Allevia

  • 6. Contents of the pack and other information

1. what allevia is and what it is used for

Allevia contains fexofenadine hydrochloride, which is an antihistamine.

Allevia is used in adults and adolescents over 12 years of age to relieve the symptoms of hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.

2. what you need to know before you take allevia

TO

Do not take Allevia

X if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)

^3 Warnings and precautions

Talk to your doctor or pharmacist before taking Allevia if: ▲ you have problems with your liver or kidneys ▲ you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat

  • ▲ you are elderly

If any of these apply to you, or if you are not sure, tell your doctor before taking Allevia.

SANOFI


Other medicines and Allevia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Indigestion remedies containing aluminium and magnesium may affect the action of Allevia, by lowering the amount of medicinal product absorbed. It is recommended that you leave about 2 hours between the time that you take Allevia and your indigestion remedy.

Pregnancy and breast-feeding

Allevia should not be taken during pregnancy and whilst breast-feeding unless advised by a doctor.

Driving and using machines

Allevia is unlikely to affect your ability to drive or operate machinery. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery.

3. how to take allevia

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

For adults and children aged 12 years and over

The recommended dose is one tablet (120 mg) daily. Take the tablet with water before a meal.

This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.

Allevia is not recommended for children under 12 years of age.

If you take more Allevia than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry mouth.

If you forget to take Allevia

Do not take double dose to make up for a forgotten tablet. Take the next dose at the usual time.

0If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Turn Over


4. possible side effects

6. Contents of the pack and other information

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Allevia 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
  • drowsiness
  • feeling sick (nausea)
  • dizziness.

Uncommon side effects (may affect up to 1 in 100 people):

  • tiredness/sle­epiness.

Additional side effects (frequency not known: cannot be estimated from the available data) which may occur are:

  • difficulty sleeping (insomnia)
  • sleeping disorders
  • bad dreams
  • nervousness
  • fast or irregular heart beat
  • diarrhoea
  • skin rash and itching
  • hives
  • serious allergic reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and difficulty breathing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store allevia

What Allevia contains

  • The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
  • The other ingredients are:

n Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate.

n Film coating: hypromellose, povidone K30, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, red iron oxide (E172) and yellow iron oxide (E172).

What Allevia looks like and contents of the pack

Allevia are peach coloured, capsule shaped tablets marked with “012” on one side and a scripted “e” on the other.

Allevia is presented in blister packs, available in pack sizes of 7, 10, 15, 20, 30 tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder:

Sanofi

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

UK

Tel: 0800 035 2525

email:

Manufacturers

Sanofi Winthrop industrie

30–36 Avenue Gustave Eiffel

37100 Tours

France

Or

Sanofi Winthrop industrie

56, route de Choisy

60200 Compiegne

FRANCE

This leaflet was last revised in 05/2021

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 expiry date refers to the last day of that month.

III


This medicine does not require any special storage condition. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

789315

SANOFI


Plant PM code : 789315


Local code :

Old PM code :

Name :


V3 – 11/MAY/2021

N.A.

CREATION

NT ALLEVIA 120MG

RL


Country :


GB


Plant :

Supplier code :


Tours TN

N.A.


Format :210 × 170 mm – Rouleau - Simple


Sens de deroulement :

Recto Interieur_4A (Portrait) – Verso Ext. : 4B



Plant barcode : 789315


Colors : 2

  • - Noir PMS BLACK U

  • - PMS 513 U



Assembly Card : Layout of Cutting


N.A.

TN_LCG_NTRL_13c


Technical Constraint : PLANTYPE-NTRL-2015_S-DB (CAB/Verxo ext.)


W ~ TOURS –

XWDUSTRJE/


Colours may note reproduce accurately on this proof.

You should refer to Pantone references for accurate colour match.

Nature du changement/Reason for change :

C – Marketing Change

Creation of a new pack/foil and leaflet for Allevia 120mg –

15 tabs

CHLOE_PCP15 : Changes linked to Chloe PCP



Frequently Asked Questions

What is Allevia 120 mg used for?

Allevia 120 mg is primarily used to relieve symptoms of seasonal allergies, such as sneezing, runny nose, and itchy or watery eyes.

How does Allevia work in the body?

Allevia works by blocking histamine, a substance in your body that causes allergic symptoms.

Can I take Allevia 120 mg with food?

Yes, Allevia can be taken with or without food. However, taking it with food may help reduce any potential stomach upset.

How long does it take for Allevia to start working?

You can expect Allevia to start working within 1 hour, providing relief from allergy symptoms.

Is Allevia suitable for children?

Allevia is generally safe for children aged 12 and older. For younger children, consult your healthcare provider.

What should I do if I miss a dose of Allevia?

If you miss a dose of Allevia, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

Can I drink alcohol while taking Allevia?

While moderate alcohol consumption may not cause serious issues with Allevia, it's best to avoid alcohol as it can increase drowsiness.

Are there any side effects of taking Allevia?

Common side effects may include drowsiness, dry mouth, fatigue, or headache. If you experience severe side effects, contact your healthcare provider.

Is Allevia safe during pregnancy?

Consult your doctor before taking Allevia if you are pregnant or breastfeeding to ensure it's safe for you.

Can I use Allevia for pet allergies?

Allevia is specifically designed for human use and should not be used to treat pet allergies. Consult your doctor for appropriate treatment options.

How should I store Allevia tablets?

Store Allevia tablets at room temperature in a cool, dry place away from direct sunlight and moisture.

Can I take other allergy medications with Allevia?

It's advisable to consult your healthcare provider before combining allergy medications to avoid potential interactions.

How long can I take Allevia without stopping?

You can typically take Allevia throughout the allergy season; however, consult your doctor if you need to use it long-term.

Does Allevia have any drug interactions I should know about?

Yes, certain medications may interact with Allevia. Always inform your healthcare provider about all medications you're currently taking.

What should I do if I overdose on Allevia?

If you suspect an overdose of Allevia, seek medical attention immediately or contact a poison control center.

Does Allevia cause weight gain or loss?

Weight changes are not commonly associated with Allevia; however, any unusual changes should be discussed with your doctor.

Can I drive after taking Allevia 120 mg?

Allevia may cause drowsiness in some individuals. Avoid driving or operating heavy machinery until you know how it affects you.

Are there any alternatives to Allevia for allergy relief?

Yes, there are several alternatives such as other antihistamines like cetirizine or loratadine. Consult your physician for recommendations based on your specific needs.

What is the recommended dosage of Allevia for adults?

The typical adult dosage of Allevia is one tablet (120 mg) once daily as needed for allergy relief.

How does seasonal allergy affect everyday life?

Seasonal allergies can lead to fatigue and irritability due to constant discomfort from sneezing and congestion affecting daily activities.