Fullhale ciphaler

Package leaflet: Information for the patient

Fullhale Ciphaler, (50 micrograms + 250 micrograms/dose), powder for inhalation,
divided
Fullhale Ciphaler, (50 micrograms + 500 micrograms/dose), powder for inhalation,
divided
Salmeterolum + Fluticasoni propionas
Please read this leaflet carefully before using the medicine, as it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Fullhale Ciphaler is and what it is 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 pack and other information

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

Fullhale Ciphaler contains two medicines – salmeterol and fluticasone propionate:

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

Your doctor has prescribed this medicine to prevent breathing problems such as:

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

Fullhale Ciphaler should be used every day as directed by your doctor. This will help ensure proper control of asthma or COPD.
Fullhale Ciphaler helps prevent breathlessness and wheezing. However, it should not be used to treat sudden attacks of breathlessness or wheezing.
If such an attack occurs, a fast-acting bronchodilator such as salbutamol should be used immediately. The patient should always have such a medicine available.

2. Important information before using Fullhale Ciphaler

When not to use Fullhale Ciphaler:

• if the patient is allergic to salmeterol, fluticasone propionate, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Fullhale Ciphaler, discuss with the doctor if the patient has:

• heart disease, including irregular or rapid heartbeat
• hyperthyroidism
• high blood pressure
• diabetes (Fullhale Ciphaler may increase blood glucose levels)
• low blood potassium levels
• active or previously treated tuberculosis or other lung infections

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Children and adolescents
Fullhale Ciphaler must not be used in children under 12 years of age.
Fullhale Ciphaler and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including asthma medicines and any medicines available without a prescription. Fullhale Ciphaler must not be used with certain other medicines.
Before starting Fullhale Ciphaler, inform the doctor if the patient is taking any of the following medicines:

• beta-blockers (e.g. atenolol, propranolol, sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions.
• medicines used to treat infections (e.g. ketoconazole, itraconazole, erythromycin), including some medicines used to treat HIV infection (e.g. ritonavir, drugs containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects of Fullhale Ciphaler, including irregular heartbeat, or may worsen existing side effects. The doctor may wish to closely monitor the patient taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal suppression with Fullhale Ciphaler.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives. These are often used in the treatment of asthma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
It is unlikely that Fullhale Ciphaler will affect the ability to drive or operate machinery, unless side effects such as blurred vision occur.
Fullhale Ciphaler contains lactose
Each delivered dose of Fullhale Ciphaler contains 12 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine. 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 exactly as instructed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.

• Fullhale Ciphaler should be used daily, unless your doctor advises you to stop. Do not take a higher dose than recommended. If in doubt, consult your doctor or pharmacist.
• Do not stop using Fullhale Ciphaler or reduce the dose without first consulting your doctor.
• Fullhale Ciphaler should be inhaled into the lungs through the mouth.
• You may not taste or feel the powder on your tongue, even if the inhaler has been used correctly.

Asthma
Adults and adolescents aged 12 years and older

• Fullhale Ciphaler 50 micrograms + 250 micrograms – one inhalation twice daily
• Fullhale Ciphaler 50 micrograms + 500 micrograms – one inhalation twice daily

Use in children
Not recommended for children under 12 years of age.
Adults with chronic obstructive pulmonary disease (COPD)

• Fullhale Ciphaler 50 micrograms + 500 micrograms – one inhalation twice daily

If asthma symptoms are well controlled while using Fullhale Ciphaler twice daily, your doctor may recommend reducing the frequency to once daily. The dose may be changed to:

• once daily in the evening – if symptoms occur at night,
• once daily in the morning – if symptoms occur during the day.

It is very important that your doctor instructs you how many inhalations to take and how often.
If you are using Fullhale Ciphaler for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or breathing becomes more difficult, contact your doctor immediately.
Symptoms may include increased wheezing, more frequent chest tightness, or the need to use a higher dose of a fast-acting medicine to help breathing. In any of these situations, continue using Fullhale Ciphaler, but do not increase the number of inhalations. Your condition may worsen. Contact your doctor, as you may require additional treatment.

Instructions for use

Casing
Dose counter
Thumb grip
Mouthpiece
Lever

• Your doctor, nurse, or pharmacist should train you in how to use the inhaler and should periodically check your inhaler technique. Incorrect or inappropriate use of Fullhale Ciphaler may result in inadequate control of asthma or COPD.
• The inhaler contains blisters with Fullhale Ciphaler in powder form.
• The dose counter located at the top of the inhaler shows how many doses remain. See Fig. A. The counter counts down to 0. Numbers from 5 to 0 appear in red as a warning that only a few doses remain. When the counter shows 0, the inhaler is empty.

Fig. A
Using the inhaler

1. To open the Fullhale Ciphaler, hold the casing in one hand and place the thumb of the other hand on the thumb grip. Push the thumb grip away from you as far as it will go. See Fig. B. You will hear a click. A small opening in the mouthpiece will appear.

Fig. B

2. Hold the inhaler with the mouthpiece facing you. You may hold it in either your right or left hand. Slide the lever away from you as far as it will go. See Fig. C. You will hear a click. A dose of medicine will be loaded into the mouthpiece. Each time the lever is pulled, a blister opens and a dose of powder is prepared for inhalation. Do not operate the lever unnecessarily, as this opens additional blisters and wastes medicine.

Fig. C

3. Hold the inhaler away from your mouth and breathe out gently, without forcing. Do not breathe out into the inhaler. See Fig. D.

Fig. D

4. Place the mouthpiece in your mouth. Breathe in slowly and deeply through your mouth (not through your nose) from the inhaler. See Fig. E.

Remove the inhaler from your mouth.
Hold your breath for about 10 seconds, or as long as is comfortable.
Then breathe out slowly.

Fig. E

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

The lever will now return to its original position and reset. See Fig. F.
The inhaler is now ready for the next use.

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

Accidentally inhaling more than the recommended dose of Fullhale Ciphaler
It is important to use the inhaler as instructed. If you accidentally inhale more than the recommended dose, inform your doctor or pharmacist. Symptoms may include faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If higher doses have been used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Fullhale Ciphaler may reduce the production of steroid hormones by the adrenal glands.

If you forget to take Fullhale Ciphaler
Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.

Stopping Fullhale Ciphaler
It is very important to take Fullhale Ciphaler every day as directed. You should continue taking the medicine until your doctor advises you to stop. Do not suddenly stop taking Fullhale Ciphaler or reduce the dose, as your symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Fullhale Ciphaler may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to adverse effects.

These adverse effects may include any of the following:

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

Under stress conditions such as fever, injury (e.g. a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.
If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
To reduce the risk of adverse reactions, your doctor will prescribe the lowest dose of Fullhale Ciphaler that controls your asthma or COPD.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after using Fullhale Ciphaler.
Wheezing, coughing, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). There may also be a sudden sensation of very rapid heartbeat, weakness, or dizziness (which may lead to falling or loss of consciousness). If any of these symptoms occur, including sudden onset after using Fullhale Ciphaler, stop using Fullhale Ciphaler immediately and contact your doctor without delay. Allergic reactions to Fullhale Ciphaler occur uncommonly (may occur in fewer than 1 in 100 people).

Lung infection (pneumonia) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse reaction)

Tell your doctor if any of the following symptoms occur while using Fullhale Ciphaler – these may be signs of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• worsening cough or increased breathing difficulties

Other adverse reactions listed below:
Very common (may affect more than 1 in 10 people)

• Headache – usually decreases with continued treatment.
• Increased incidence of colds reported in patients with chronic obstructive pulmonary disease (COPD).

Common (may affect up to 1 in 10 people)

• Oral thrush (painful, creamy-white lesions in the mouth and throat), tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat oral thrush.
• Joint pain, swelling, and muscle pain.
• Muscle cramps.

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

• Bruising and fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of the dose of currently used antidiabetic medicines may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and tend to decrease with continued treatment.
• Chest pain.
• Restlessness (this reaction occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare (may affect up to 1 in 1000 people)

• Breathing difficulties or worsening wheezing occurring immediately after taking Fullhale Ciphaler. If such symptoms occur, stop using Fullhale Ciphaler immediately, use a fast-acting inhaled medicine to relieve breathing, and contact your doctor without delay.
• Fullhale Ciphaler may interfere with the body's normal production of steroid hormones, especially when high doses are used for long periods. These effects include:
  • Slowed growth in children and adolescents
  • Reduced bone mass
  • Glaucoma
  • Increased body weight
  • Rounded (moon-shaped) face (Cushing's syndrome)

Your doctor will regularly check whether you are experiencing such adverse reactions and ensure that you are using the lowest dose of Fullhale Ciphaler that controls your asthma.

• Behavioral changes such as excessive excitability and irritability (these reactions occur mainly in children).
• Irregular, uneven heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Fullhale Ciphaler unless advised by your doctor.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

• Depression or aggression. These reactions are more likely in children.
• Blurred vision

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fullhale Ciphaler

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label of the inhaler following EXP. The expiry date refers to the last day of the stated month.
• Do not store in a refrigerator or freeze.
• Shelf life after first opening of the foil pouch: 2 months. Store the opened inhalator below 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Fullhale Ciphaler contains

• The active substances in the medicine are salmeterol and fluticasone propionate. Each single inhalation delivers a dose (dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 231 or 460 micrograms of fluticasone propionate. This corresponds to a delivered 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 supplied as a ruby-white single-use plastic inhaler containing a strip of 60 evenly spaced blisters filled with white or off-white powder. Each blister consists of a foil tray (OPA/ALU/PVC) and a foil seal (PAPER/PET/ALU/HSL). The inhaler is packed in a laminated aluminium foil pouch (PET/PE/aluminium foil/PE), with a cardboard outer pack.
• Each dose is metered.

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

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
ELC Group s.r.o.
Pobřežní 394/12,
Karlín, Prague 8,
186 00
Czech Republic
Tel: +420 22 491 0000

Importers
Cipla Europe NV
De Keyserlei,
60C, Bus-1301,
2018 Antwerp
Belgium

G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria

S&D Pharma CZ, spol. s.r.o.
Theodor 28, 273 08,
Pchery (Pharmos a.s. facility),
Czech Republic

This medicinal product is authorised in the European Economic Area member countries under the following names: