Fullhale Ciphaler

Leaflet accompanying the packaging: patient information

Fullhale Ciphaler, (50 micrograms + 250 micrograms)/dose, inhalation powder,

divided

Fullhale Ciphaler, (50 micrograms + 500 micrograms/dose, inhalation powder, divided

Salmeterol + Fluticasone propionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fullhale Ciphaler and what is it used for
• 2. Important information before using Fullhale Ciphaler
• 3. How to use Fullhale Ciphaler
• 4. Possible side effects
• 5. How to store Fullhale Ciphaler
• 6. Contents of the packaging and other information

1. What is Fullhale Ciphaler and what is it used for

Fullhale Ciphaler contains two medicines – salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help to maintain the patency of the airways in the lungs. This makes it easier for air to flow in and out of the lungs. The effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and inflammation in the lungs.

The doctor has prescribed this medicine to the patient to prevent breathing disorders such as:

• asthma
• chronic obstructive pulmonary disease (COPD). Salmeterol with fluticasone propionate, in a dose of 50 micrograms + 500 micrograms, reduces the number of exacerbations of COPD symptoms.

Fullhale Ciphaler should be used daily as recommended by the doctor. This will ensure proper control of asthma or COPD.

Fullhale Ciphaler prevents the occurrence of shortness of breath and wheezing. However, it should not be used to control sudden attacks of shortness of breath or wheezing.

In the event of such an attack, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always carry such a medicine with them.

2. Important information before using Fullhale Ciphaler

When not to use Fullhale Ciphaler:

• if the patient is allergic to salmeterol, fluticasone propionate, or any other ingredient, lactose monohydrate.

Warnings and precautions

Before starting to use Fullhale Ciphaler, the patient should discuss with their doctor if they have:

• heart disease, including irregular or rapid heartbeat
• hyperthyroidism
• high blood pressure
• diabetes (Fullhale Ciphaler may increase blood glucose levels)
• low potassium levels in the blood
• tuberculosis currently being treated or a history of tuberculosis or other lung infections

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children and adolescents

Fullhale Ciphaler should not be used in children under 12 years of age.

Fullhale Ciphaler and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including asthma medicines and any medicines available without a prescription. Fullhale Ciphaler should not be used with certain other medicines.

Before starting to use Fullhale Ciphaler, the patient should inform their doctor about taking the following medicines:

• beta-blockers (e.g., atenolol, propranolol, and sotalol). Beta-blockers are most commonly used to treat high blood pressure or other heart diseases.
• medicines used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV infections (e.g., ritonavir, cobicistat-containing medicines). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects of Fullhale Ciphaler, including irregular heartbeat, or may worsen existing side effects. The doctor may want to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (orally or by injection). If the patient has recently taken such medicines, it may increase the risk of adrenal gland disorders caused by Fullhale Ciphaler.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives. They are often used to treat asthma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Fullhale Ciphaler will affect the ability to drive or use machines, unless side effects such as blurred vision occur.

Fullhale Ciphaler contains lactose

Each delivered dose of Fullhale Ciphaler contains 12 mg of lactose monohydrate. This amount usually does not cause problems in people with lactose intolerance. The excipient lactose monohydrate contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Fullhale Ciphaler

This medicine should always be used as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

• Fullhale Ciphaler should be used daily, unless the doctor recommends stopping its use. The patient should not take a higher dose than recommended. In case of doubts, they should consult their doctor or pharmacist.
• The patient should not stop using Fullhale Ciphaler or reduce the dose without consulting their doctor.
• Fullhale Ciphaler should be inhaled into the lungs through the mouth.
• The patient may not be able to feel the taste or sensation of the powder on the tongue, even if the inhaler is used correctly.

Asthma

Adults and adolescents aged 12 and over

• Fullhale Ciphaler 50 micrograms + 250 micrograms - one inhalation twice a day
• Fullhale Ciphaler 50 micrograms + 500 micrograms - one inhalation twice a day

Use in children

It is not recommendedto use Fullhale Ciphaler in children under 12 years of age.

Adults with chronic obstructive pulmonary disease (COPD)

• Fullhale Ciphaler 50 micrograms + 500 micrograms - one inhalation twice a day

If asthma symptoms are well-controlled while using Fullhale Ciphaler twice a day, the doctor may recommend reducing the frequency of use to once a day. The dose may be changed to:

• once a day, in the evening - if the patient's symptoms occur at night,
• once a day, in the morning - if the patient's symptoms occur during the day.

It is very important that the doctor instructs the patient on how many inhalations and how often to use.

If the patient is using Fullhale Ciphaler for asthma, the doctor will regularly check the patient's symptoms.

In the event of worsening asthma symptoms or breathing difficulties, the patient should

contact their doctor immediately. There may be an increase in wheezing, more frequent chest tightness, or a need for a higher dose of a fast-acting bronchodilator. In any of these situations, the patient should continue using Fullhale Ciphaler, but not increase the number of inhalations. The symptoms of the disease may worsen, and the patient's condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for use

Housing
Dose counter
Thumb grip
Mouthpiece
Lever

• The doctor, nurse, or pharmacist should train the patient in using the inhaler. They should also periodically check how the patient uses the inhaler. Using Fullhale Ciphaler incorrectly or not as recommended by the doctor may cause the medicine to not produce the expected improvement in asthma or COPD.
• The inhaler contains blisters with Fullhale Ciphaler powder.
• In the upper part of the inhaler, there is a dose counter that indicates how many doses of the medicine are left. See Fig. A. The counter counts down to 0. The numbers from 5 to 0 appear in red to warn that there are only a few doses of the medicine left in the inhaler. If the counter shows 0, it means that the inhaler is empty.

Fig. A

Using the inhaler

• 1. To open the Fullhale Ciphaler inhaler, hold the housing with one hand and place your thumb on the thumb grip. Push your thumb as far as possible - until it stops. See Fig. B. You will hear a click. A small opening will appear in the mouthpiece.

Fig. B

• 2. Hold the inhaler with the mouthpiece facing you. You can hold it in your right or left hand. Slide the lever as far as possible - until it stops. See Fig. C. You will hear a click. A dose of the medicine will be placed in the mouthpiece. Each time you move the lever, a blister opens inside, and a dose of powder is prepared for inhalation. Do not unnecessarily use the lever, as this will cause the opening of subsequent blisters and waste of the medicine.

Fig. C

• 3. Hold the inhaler at a distance from your mouth and exhale without causing discomfort. Do not exhale into the inhaler. See Fig. D.

Fig. D

• 4. Put the mouthpiece in your mouth. Take a slow and deep breath in through the inhaler, not through your nose. See Fig. E.

Remove the inhaler from your mouth.
Hold your breath for about 10 seconds or as long as it is comfortable.
Exhale slowly.

Fig. E

• 5. After inhaling the medicine, rinse your mouth with water and spit it out and (or) brush your teeth. This may help prevent thrush and hoarseness.
• 6. To close the inhaler, slide the thumb grip back - until it stops and you hear a click.

The lever will now return to its original position and will be reset. See Fig. F.
The inhaler is now ready for reuse.

Fig. F
As with all inhalers, caregivers should ensure that children prescribed Fullhale Ciphaler use the correct inhalation technique, as described above.

Cleaning the inhaler

Wipe the Fullhale Ciphaler mouthpiece with a dry cloth or tissue.

Using a higher dose of Fullhale Ciphaler than recommended

It is important to use the inhaler as instructed. If a higher dose than recommended is used accidentally, the patient should tell their doctor or pharmacist. The following may occur: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
In the event of using higher doses for a long period, the patient should contact their doctor or pharmacist for advice, as high doses of Fullhale Ciphaler may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Fullhale Ciphaler

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping the use of Fullhale Ciphaler

It is very important to take Fullhale Ciphaler daily as recommended by the doctor. The medicine should be taken until the doctor recommends stopping it. The patient should not suddenly stop taking Fullhale Ciphaler or reduce the dose, as the symptoms of the disease may worsen.

Additionally, sudden stopping of Fullhale Ciphaler or reducing the dose may (very rarely) cause adrenal gland disorders (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• abdominal pain
• fatigue and loss of appetite, nausea
• vomiting and diarrhea
• weight loss
• headache or drowsiness
• low blood sugar
• low blood pressure and seizures

When the body is under stress, such as due to fever, injury (e.g., a car accident), infection, or surgery, adrenal insufficiency may worsen, and any of the above side effects may occur.

If the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in the form of tablets (e.g., prednisolone).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To minimize the risk of side effects, the doctor will recommend the smallest dose of Fullhale Ciphaler that controls asthma or COPD.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after using

Fullhale Ciphaler. There may be an increase in wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). There may also be a sudden feeling of a very fast heartbeat, weakness, or dizziness (which can lead to falls or loss of consciousness). If any of these symptoms occur, including if they occur suddenly after using Fullhale Ciphaler, the patient should stop using Fullhale Ciphaler and contact their doctor immediately. Allergic reactions to Fullhale Ciphaler are uncommon (they may occur less often than in 1 in 100 people).

Pneumonia (lung infection) in patients with chronic obstructive pulmonary disease (COPD) (common side effect)

The patient should tell their doctorif they experience any of the following symptoms while using Fullhale Ciphaler - they may be symptoms of a lung infection:

• fever or chills
• increased production of sputum or a change in its color
• worsening cough or increased breathing difficulties

Other side effects are listed below:

Very common (may occur more often than in 1 in 10 people)

• Headache - usually decreases as treatment continues.
• There have been reports of an increased incidence of colds in patients with chronic obstructive pulmonary disease (COPD).

Common (may occur less often than in 1 in 10 people)

• Thrush (painful, creamy-white patches) in the mouth and throat, as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and (or) brushing the teeth after each inhalation may be helpful. The doctor may recommend an antifungal medicine to treat thrush.
• Pain, swelling of the joints, and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

• Bruising and fractures.
• Sinusitis (feeling of tension and fullness in the nose, cheeks, and behind the eyes, sometimes with a throbbing headache).
• Low potassium levels in the blood (the patient may experience irregular heartbeat, muscle weakness, or cramps).

Uncommon (may occur less often than in 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of diabetes medicines.
• Cataract (clouding of the lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease as treatment continues.
• Chest pain.
• Restlessness (this symptom occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may occur less often than in 1 in 1000 people)

Frequency not known (cannot be estimated from the available data):

• Depression or aggression. The occurrence of these side effects is more likely in children.
• Blurred vision

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Fullhale Ciphaler

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and inhaler label after: EXP. The expiry date refers to the last day of the month stated.
• Do not store in the refrigerator or freeze.
• Shelf life after opening the foil bag: 2 months. Store the opened inhaler at a temperature below 25°C.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fullhale Ciphaler contains

• The active substances of the medicine are salmeterol and fluticasone propionate. Each single inhalation provides a dose (dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 231 or 460 micrograms of fluticasone propionate. This is equivalent to a divided dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 or 500 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate (which contains milk proteins). See section 2.

What Fullhale Ciphaler looks like and contents of the pack

• Fullhale Ciphaler is provided in a ruby-red and white plastic inhaler for single use, containing a strip with 60 evenly spaced blisters filled with white or off-white powder. The inhaler is packed in a foil bag, which is placed in a cardboard box.
• Each dose is divided.

Fullhale Ciphaler is available in a pack containing 1 inhaler. Each inhaler contains 60 inhalations.

Marketing authorization holder and importer

Marketing authorization holder

ELC Group s.r.o.
Pobřežní 394/12,
Karlín, Prague 8,
186 00
Czech Republic
tel: +420 22 491 0000

Importer

Cipla Europe NV
De Keyserlei
58-60 box 19
2018 Antwerp
Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:12.2024