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Sanofi Tilade CFC-Free - User Manual

Sanofi Tilade CFC-Free
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Tilade
®
1
Tilade
®
CFC-Free Inhaler (TIE-laid)
nedocromil sodium (ned-oh-crow-mill so-dee-u m)
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common
questions about Tilade CFC-Free
Inhaler.
It does not contain all the information
that is known about Tilade CFC-
Free. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Tilade CFC-
Free against the benefits they expect
it will have for you.
If you have any concerns about
using this medicine ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Tilade CFC-Free
is used for
Tilade CFC-Free is inhaled into the
lungs for the preventive treatment of
mild to moderate asthma.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to an
allergy to house dust mites, pollens,
smoke, air-borne pollution or other
irritants.
Tilade CFC-Free is used to prevent
bronchial asthma due to allergy,
exercise, cold air or irritants, in both
adults and children over two years of
age.
Tilade CFC-Free works by reducing
the inflammation of the airways
which occurs in asthma.
With regular use, Tilade CFC-Free
will help prevent asthma symptoms
from occurring.
Tilade CFC-Free will not relieve the
symptoms of an asthma attack once
the attack has started.
You should follow your doctor's
advice and prescribed treatment to
get relief from a sudden asthma
attack.
Your doctor may have prescribed
Tilade CFC-Free for another reason.
Ask your doctor if you have any
questions about why Tilade CFC-
Free has been prescribed for you.
This medicine is only available with
a doctor's prescription.
There is no evidence that Tilade
CFC-Free is addictive.
This product contains HFA-227, a
non-ozone depleting propellant gas,
which has been introduced as a
replacement for the environmentally
damaging chlorofluorocarbons
(CFC's). This product contains no
CFC's.
Before you use Tilade
CFC-Free
When you must not use it
Do not use Tilade CFC-Free if you
have an allergy to Tilade CFC-
Free or any of the ingredients
listed at the end of this leaflet.
If you have an allergic reaction you
may get a skin rash, have difficulty in
breathing, get symptoms of hayfever
or feel faint.
Do not use Tilade CFC-Free after
the expiry date (EXP) printed on
the pack.
If you use this medicine after the
expiry date has passed, it may not
work as well.
Do not use Tilade CFC-Free if the
packaging is torn or shows signs of
tampering.
If you are not sure whether you
should start using Tilade CFC-
Free, contact your doctor or
pharmacist.
Before you use it
Ask your doctor to write an
asthma management plan for you
before you begin to use Tilade
CFC-Free.
Tilade CFC-Free is only one part of a
general plan to help you manage your
asthma.
You should discuss this plan
regularly with your doctor to
check your treatment.
As part of your asthma management
plan you will probably need to take
another sort of medicine called a
"reliever" to relieve the symptoms of
an asthma attack which has started.
If you need treatment for a sudden
asthma attack, use the "reliever"
medicine your doctor has
prescribed for you.
Tell your doctor or pharmacist if
you have allergies to:
Question and Answer IconNeed help?

Do you have a question about the Sanofi Tilade CFC-Free and is the answer not in the manual?

Summary

What Tilade CFC-Free is used for

Mechanism of Action

Tilade CFC-Free reduces inflammation of the airways occurring in asthma, helping to prevent symptoms.

Therapeutic Use

Used for the preventive treatment of mild to moderate asthma in adults and children over two years.

Before You Use Tilade CFC-Free

When Not to Use

Do not use if allergic, expired, or if packaging is torn or shows signs of tampering.

Asthma Management Plan

Consult your doctor for an asthma management plan and discuss regular check-ups.

How to Use Tilade CFC-Free

Dosage Instructions

Your doctor will specify the number of puffs; the usual dose is two puffs, two to four times daily.

Correct Inhalation Technique

Step-by-step guide on priming, shaking, breathing out, inhaling, and holding breath for effective delivery.

Continuous Use

Continue taking Tilade CFC-Free even when feeling well to achieve the best results.

Missed Dose

If a dose is missed, take the next one when due. Do not double the dose.

Usage Duration and Precautions

Duration of Treatment

Continue using the medicine for as long as your doctor or pharmacist advises, even if you feel better.

Things You Must Not Do

Do not take other breathing medicines without consultation, share the inhaler, or use for acute attacks.

Side Effects

Common side effects include cough, sore throat, unpleasant taste, or breathing difficulties. Contact doctor if unwell.

Cleaning Instructions

Daily cleaning and drying of the mouthpiece is crucial to prevent blockage from propellant residue.

Storage and Disposal

Storage Guidelines

Keep the inhaler in a cool, dry place below 30°C, protected from light and out of reach of children.

Disposal Advice

Consult your pharmacist for disposal of unused or expired Tilade CFC-Free. Do not puncture or burn.

Product Information

Product Description

Tilade CFC-Free Inhaler contains 112 puffs and an additional mouthpiece; it is CFC-free.

Ingredients List

Lists the active ingredient (nedocromil sodium) and inactive ingredients like HFA-227 propellant.

Overview

The Tilade® CFC-Free Inhaler is a device designed for the preventive treatment of mild to moderate asthma. It delivers nedocromil sodium, an active ingredient that works by reducing inflammation in the airways, which is a key characteristic of asthma. This inhaler is intended for regular use to prevent asthma symptoms from occurring, rather than for relieving sudden asthma attacks. It is suitable for both adults and children over two years of age and can be used to prevent bronchial asthma triggered by allergies, exercise, cold air, or other irritants.

Function Description:

The Tilade CFC-Free Inhaler delivers a measured dose of nedocromil sodium into the lungs. The active ingredient, nedocromil sodium, helps to reduce the inflammation of the lung lining, which is often swollen and red in individuals with asthma, making breathing difficult. By reducing this inflammation, the inhaler helps to prevent the onset of asthma symptoms. It is important to note that this device is a preventive treatment and will not alleviate the symptoms of an asthma attack once it has started. For sudden asthma attacks, a separate "reliever" medicine, as prescribed by a doctor, should be used. The inhaler uses 1,1,1,2,3,3,3-heptafluoropropane as a non-ozone depleting propellant gas, replacing environmentally damaging chlorofluorocarbons (CFCs). Each canister contains 112 puffs, and an additional mouthpiece is provided.

Usage Features:

To ensure effective delivery of the medicine, proper inhalation technique is crucial. Before initial use, or if the inhaler has not been used for more than three days, it needs to be "primed." For a new inhaler, this involves pressing the inhaler four times. If it hasn't been used for more than three days, it should be primed with two puffs.

The general steps for using the inhaler are as follows:

  1. Preparation: Remove the cap from the plastic mouthpiece.
  2. Shake: Shake the inhaler well to ensure the medicine is properly mixed.
  3. Exhale: Hold the inhaler away from your mouth and breathe out slowly and completely. It is crucial not to breathe out through the inhaler, as this can clog the valve.
  4. Inhale and Actuate: Place the inhaler in your mouth, closing your lips tightly around it. Begin to breathe in slowly and deeply, then firmly press the metal canister to release a puff of medicine while continuing to breathe in.
  5. Hold Breath: Remove the inhaler from your mouth and hold your breath for 10 seconds, or for as long as is comfortable, then breathe out slowly.
  6. Repeat (if necessary): If another puff is required, wait 1 minute before repeating steps 2 to 5.
  7. After Use: Replace the cap on the mouthpiece.

The usual dosage is two puffs, two to four times daily, as prescribed by a doctor. It is essential to follow the doctor's instructions carefully and not to exceed the prescribed dosage. Children should only use the inhaler under medical advice and with adult supervision. Regular checks of inhaler technique by a doctor or pharmacist are recommended to ensure optimal effectiveness. An asthma management plan, developed with a doctor, is an important part of managing asthma with this device.

Maintenance Features:

Regular cleaning of the mouthpiece is vital to prevent the build-up of excess powder, which can lead to blockages and hinder proper medicine delivery. The manufacturer emphasizes that the mouthpiece must be regularly cleaned and dried, ideally every night.

The cleaning instructions are as follows:

  1. Disassembly: Remove the cap and the metal canister from the mouthpiece.
  2. Wash Top: Wash the plastic mouthpiece in hand-hot water through the top for one minute.
  3. Wash Bottom: Wash through the bottom of the mouthpiece for one minute.
  4. Remove Excess Water: Shake out any excess water from inside the mouthpiece by tapping it on a hard surface.
  5. Dry: Leave the mouthpiece overnight, or for as long as possible, to dry thoroughly. In humid conditions, a longer drying period may be necessary.
  6. Reassembly Check: Before replacing the canister, ensure that the white rubber cap is firmly seated onto the metal canister.
  7. Reassembly: Once the mouthpiece is completely dry, replace the metal canister.

Important Maintenance Notes:

  • Never attempt to unblock the mouthpiece with a pin or any sharp object, as this can damage the inhaler.
  • The metal canister should never be washed.
  • If the inhaler becomes blocked, an additional step of soaking the mouthpiece in hot water for 20 minutes (after removing the canister) can be performed before following the regular cleaning steps.

Storage:

The inhaler should be stored in a cool, dry place below 30°C, protected from light, and should not be frozen. It should not be left in a car on hot days or on window sills, as heat, light, and dampness can degrade the medicine. It should also be kept out of reach of young children, ideally in a locked cupboard at least one-and-a-half meters above ground.

Disposal:

Once the inhaler has passed its expiry date or if a doctor advises to stop using it, consult a pharmacist for proper disposal instructions. The container should not be punctured or thrown into a fire.

Sanofi Tilade CFC-Free Specifications

General IconGeneral
Generic NameNedocromil Sodium
Delivery MethodInhalation
CFC-FreeYes
Active IngredientNedocromil Sodium
ManufacturerSanofi
Dosage FormInhaler
IndicationAsthma prevention