Gardette Forte

Package leaflet - Information for the user

Gardette forte320 micrograms/9 micrograms/inhalation, Inhalation Powder

Budesonide/Formoterol fumarate dihydrate

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

What is in this leaflet:

What Gardette forte is and what it is used for

What you need to know before you use Gardette forte

How to use Gardette forte

Possible side effects

How to store Gardette forte

Contents of the pack and other information

1. What Gardette forte is and what it is used for

Gardette forte is an inhaler that is used to treat asthma in adults and adolescents aged 12-17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate.


For asthma, your doctor will prescribe two asthma inhalers: Gardette forte and a separate ‘reliever inhaler’.

Do not use Gardette forte as a reliever inhaler.

Chronic obstructive pulmonary disease (COPD)

Gardette forte can also be used to treat the symptoms of COPD in adults. COPD is a long‑term disease of the airways in the lungs, which is often caused by cigarette smoking.

2. What you need to know before you use Gardette forte

Do not use Gardette forte:

if you are allergic to budesonide, formoterol or the other ingredient of this medicine (listed in section 6), which is lactose (which contains small amounts of milk protein).

Warnings and precautions

Talk to your doctor or pharmacist before using Gardette forte if:

Other medicines and Gardette forte

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are using any of the following medicines:

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Gardette forte.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.

Pregnancy, breast-feeding and fertility

Driving and using machines

Gardette forte has no or negligible effect on your ability to drive or to use tools or machines.

Gardette forte contains lactose

Gardette forte contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Gardette forte

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Gardette forte. If you have been taking oral steroid tablets for a long time, your doctor may want you to have blood tests from time to time. When reducing oral steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medication if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use Gardette forte.

Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Gardette forte, you should continue to use Gardette forte but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.


Use your Gardette forte every day. This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

Adolescents (12 to 17 years)

A lower strength of Gardette is available for children aged from 6 to 11 years.

Gardette forte is not recommended to be used in children who are younger than 6 years.

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Gardette forte to treat asthma symptoms - use your separate reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as tiotropium or ipratropium bromide) for your COPD disease.

Preparing your new Gardette forte Inhaler

Before using your new Gardette forte Inhaler for the first time, you need to prepare it for use as follows:

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

Unscrew the cover and lift it off. You may hear a rattling sound.

old your Gardette forte Inhaler upright
with the red grip at the bottom.

Do not hold the mouthpiece when you load your Gardette forte Inhaler. To load your Gardette forte Inhaler with a dose, turn the red grip as far as it will go in one direction.

Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. Your Gardette forte Inhaler is now loaded and ready to use. Only load your Gardette forte Inhaler when you need to use it.

Hold your Gardette forte Inhaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Gardette forte Inhaler.

Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

Remove your Gardette forte Inhaler from your mouth. Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.

If you are to take a second inhalation, repeat steps 2 to 6.

Replace the cover tightly after use.

Rinse your mouth with water after your daily morning and/or evening doses, and spit it out.

Do not try to remove or twist the mouthpiece. It is fixed to your Gardette forte Inhaler and must not be taken off. Do not use your Gardette forte Inhaler if it has been damaged or if the mouthpiece has come apart from your Gardette forte Inhaler.

As with all inhalers, caregivers should ensure that children prescribed Gardette forte use correct inhalation technique, as described above.

Cleaning your Gardette forte Inhaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new inhaler

The dose indicator tells you how many doses (inhalations) are left in your Gardette forte Inhaler, starting with 60 doses when it is full.


If you use more Gardette forte than you should

It is important thatyou take your dose as stated on the pharmacist’s label or as advised by your doctor. You should not exceed your prescribed dose without seeking medicaladvice.

The most common symptoms that may occur after if you use more Gardette forte than you should are trembling, headache or a rapid heart beat.

If you forget to use Gardette forte

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.

If either of the following happens to you, stop using Gardette forte and talk to your doctor immediately:

Other possible side effects:

Common (may affect up to 1 in 10 people)

Tell your doctor if you have any of the following while taking Gardette forte, they could be symptoms of a lung infection:

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:

These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gardette forte

6. Contents of the pack and other information

What Gardette forte contains

The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.

The other ingredient is lactose monohydrate (which contains milk proteins).

What Gardette forte looks like and contents of the pack

Gardette forte is an inhaler containing your medicine. The inhalation powder is white in colour. Each inhaler contains 60 doses and has a white body with a red turning grip. The turning grip contains a Braille code with the number 6 for identification, to differ from other AstraZeneca inhaled products.

Gardette forte is available in packs of 1, 2, 3, 10 or 18 inhaler(s) containing 60 doses.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:


Trade name and strength


Assieme 320 μg/9 μg/inhalation


Assieme Turbohaler 320 μg/9 μg/inhalation


Rilast forte Turbuhaler 320 μg/9 μg/inhalation


Gardette forte 320 μg/9 μg/inhalation

This leaflet was last revised in 2016-10-26

[To be completed nationally]