Budesonide and formoterol Cipla

Patient Information Leaflet

Budesonide and Formoterol Cipla 160 micrograms/4.5 micrograms/dose, pressurised suspension for inhalation

budesonide/formoterol fumarate dihydrate
Equivalent medicinal product
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Budesonide and Formoterol Cipla is and what it is used for
2. What you need to know before using Budesonide and Formoterol Cipla
3. How to use Budesonide and Formoterol Cipla
4. Possible side effects
5. How to store Budesonide and Formoterol Cipla
6. Contents of the pack and other information

1. What Budesonide and Formoterolo Cipla is and what it is used for

Budesonide and Formoterolo Cipla is an inhaler used to treat the symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older.
COPD is a long-term disease of the airways, often caused by cigarette smoking. Budesonide and Formoterolo Cipla contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called "corticosteroids". It works by reducing and preventing swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting beta(_2)-adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways, thereby making breathing easier.

This medicine must not be used as a "rescue" inhaler.

2. What you need to know before using Budesonide and Formoterolo Cipla

Do not use Budesonide and Formoterolo Cipla:

• If you are allergic to budesonide, formoterol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Budesonide and Formoterolo Cipla if:

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have previously had heart problems (e.g. irregular heartbeat,

very rapid pulse, narrowed arteries, or heart failure).

• You have thyroid or adrenal gland problems.
• You have low levels of potassium in your blood.
• You have severe liver problems. Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Budesonide and Formoterolo Cipla is not recommended for children and adolescents under 18 years of age.
Other medicines and Budesonide and Formoterolo Cipla
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma).
• Medicines for rapid or irregular heartbeat (such as quinidine).
• Medicines such as digoxin, often used to treat heart failure.
• Diuretics, also known as 'water tablets' (such as furosemide), used to treat high blood pressure.
• Oral steroids (such as prednisolone).
• Xanthines (such as theophylline or aminophylline), often used to treat COPD or asthma.
• Other bronchodilators (such as salbutamol).
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines called “HIV protease inhibitors” (such as ritonavir) used to treat HIV infection.
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin).
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines for thyroid problems (such as levothyroxine).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist before
using this medicine.
Also inform your doctor or pharmacist if you are due to undergo general anaesthesia for a surgical or
dental procedure.
Pregnancy, breastfeeding and fertility

• If you are pregnant or planning to become pregnant, consult your doctor before taking Budesonide and Formoterolo Cipla – do not use Budesonide and Formoterolo Cipla unless advised by your doctor.
• If you become pregnant while being treated with Budesonide and Formoterolo Cipla, do not stop using Budesonide and Formoterolo Cipla but consult your doctor immediately.
• If you are breastfeeding, inform your doctor before using this medicine.

Driving and using machines
Budesonide and Formoterolo Cipla has no effect or negligible effects on the ability to drive
vehicles or operate tools or machinery.

3. How to use Budesonide and Formoterol Cipla

• Always use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
• It is important to use Budesonide and Formoterol Cipla every day, even if you currently have no symptoms of COPD.

The usual dose is 2 inhalations twice daily. Budesonide and Formoterol Cipla is not recommended for children and adolescents under 18 years of age.
If you are taking steroid tablets for COPD, your doctor may reduce the number of tablets you are taking once you have started using Budesonide and Formoterol Cipla. If you have been taking oral steroids for a long time, your doctor may require you to have periodic blood tests. When reducing the amount of oral steroids, you may feel generally unwell even though your breathing symptoms may improve. You may experience symptoms such as nasal congestion and rhinorrhea, weakness or muscle or joint pain, and skin rash (eczema). If any of these symptoms concern you, or if you experience symptoms such as headache, fatigue, nausea (feeling unwell), or vomiting (being sick), contact your doctor immediately. You may need to take another medicine if you develop allergic or arthritic symptoms. Ask your doctor if you have any doubts about continuing or stopping treatment with Budesonide and Formoterol Cipla.
Your doctor may consider adding oral steroids to your usual treatment during periods of stress (for example, when you have a respiratory infection or before undergoing surgery).

Important information about COPD symptoms
If you notice that you are becoming breathless or wheezy while using Budesonide and Formoterol Cipla, you should continue using it but consult your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:

• Your breathing worsens or you wake up frequently at night due to breathlessness.
• You begin to experience chest tightness in the morning or if chest tightness lasts longer than usual.

These signs may mean that your COPD is not adequately controlled and that different or additional treatment may be urgently required.

Your doctor may also prescribe other bronchodilators, such as anticholinergics (e.g., tiotropium or ipratropium bromide), for COPD.

Information about Budesonide and Formoterol Cipla

• Before starting to use Budesonide and Formoterol Cipla, remove it from the aluminium foil pouch. Discard the pouch and the desiccant (drying agent) inside the pouch. Do not use the inhaler if the desiccant has escaped from its packaging.
• After removing the inhaler from the aluminium foil pouch, it must be used within 3 months. Record the date (3 months from opening the pouch) on the label of the inhaler to remind yourself when to stop using it.
• The components of the inhaler are shown in the image. The inhaler will already be assembled when you first receive it. Do not disassemble it. If the canister becomes loose, reinsert it into the inhaler and continue using the inhaler.

Preparing Budesonide and Formoterol Cipla
You need to prepare the inhaler for use in the following situations:

• When using a new Budesonide and Formoterol Cipla inhaler for the first time.
• If you have not used it for more than 7 days.
• If it has been dropped.

To prepare the inhaler for use, follow the instructions below:

1. Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
2. Remove the mouthpiece cap.
3. Hold the inhaler upright. Then press down on the canister (at the top of the inhaler) to release one puff into the air. You may use one or both hands, as shown in the images.

4. Lift your finger off the canister.
5. Wait 10 seconds, shake the inhaler well again, then repeat steps 3 and 4.
6. The inhaler is now ready for use.

How to take an inhalation
Each time you need to take an inhalation, follow the instructions below:

• Shake the inhaler well for at least 5 seconds to mix the contents of the aerosol canister.
• Remove the mouthpiece cap by pressing. Check that the mouthpiece is not blocked.
• Hold the inhaler upright (using one or both hands). Breathe out slowly.

• Gently place the mouthpiece between your teeth. Close your lips around it.
• Begin to inhale slowly and deeply through your mouth. At the same time, press firmly on the canister (at the top of the inhaler) to release one puff. Continue inhaling for a few seconds after pressing the canister. Inhaling at the same time as activating the inhaler ensures that the medicine reaches your lungs.
• Hold your breath for 10 seconds or as long as is comfortable.
• Before exhaling, lift your finger off the canister and remove the mouthpiece from your mouth. Keep the inhaler upright.
• Then breathe out slowly. To take a second inhalation, shake the inhaler well for at least 5 seconds and repeat steps 3 to 7.
• Replace the mouthpiece cap.
• Rinse your mouth with water after the morning and evening doses and spit it out.

Use of a spacer device
Your doctor, nurse, or pharmacist may recommend using a spacer device (e.g., AeroChamber Plus Flow-Vu or AeroChamber Plus). Follow the instructions provided in the leaflet accompanying the spacer device.

How to clean Budesonide and Formoterol Cipla

• Clean the inside and outside of the mouthpiece at least once a week with a dry cloth.
• Do not use water or any other liquids, and do not remove the canister from the inhaler.

How do I know when to replace Budesonide and Formoterol Cipla?

• The dose counter, located on the front of the inhaler, shows the number of sprays (actuations) remaining in Budesonide and Formoterol Cipla. It reads 120 sprays when full.

• With each inhalation or puff released into the air, the arrow moves downward towards zero (‘0’).
• When the arrow first enters the red zone, approximately 20 sprays remain.

• When the arrow reaches ‘0’, you must stop using Budesonide and Formoterol Cipla and obtain a new inhaler. Your inhaler may appear not to be empty and may still seem to work. However, if you continue to use it, the device will not deliver the correct amount of medicine.

If you use more Budesonide and Formoterol Cipla than you should
If you use more Budesonide and Formoterol Cipla than prescribed, contact your doctor or pharmacist.
The following symptoms may occur: tremor, headache, or rapid heartbeat.

If you forget to use Budesonide and Formoterol Cipla

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you stop using Budesonide and Formoterol Cipla
You must consult your doctor or pharmacist before stopping treatment with Budesonide and Formoterol Cipla. If you discontinue treatment with Budesonide and Formoterol Cipla, your COPD signs and symptoms may worsen.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If any of the following occur, stop using Budesonide and Formoterolo Cipla immediately and
contact your doctor straight away:

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing), skin rash or hives accompanied by difficulty breathing (angioedema) and/or sudden feeling of fainting. This could indicate that you are having an allergic reaction. This side effect is rare and affects fewer than 1 in 1,000 people.
• Sudden acute wheezing or shortness of breath immediately after using the inhaler. If you experience any of these symptoms, stop using Budesonide and Formoterolo Cipla immediately and use your "reliever" inhaler. Contact your doctor immediately, as you may need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 people.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Palpitations (awareness of heartbeat), tremor or restlessness. If these effects occur, they are usually mild and disappear with continued use of Budesonide and Formoterolo Cipla.
• Oral candidiasis (a fungal infection in the mouth). This is less likely if you rinse your mouth with water after using Budesonide and Formoterolo Cipla.
• Mild sore throat, cough, and hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you experience any of the following symptoms while taking Budesonide and Formoterolo Cipla, as they may be signs of a lung infection:

• Fever or chills.
• Increased mucus production, change in mucus colour.
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• Feeling restless, nervousness, or agitation.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling unwell).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Skin rash, itching.
• Bronchospasm (narrowing of the muscles in the airways, causing wheezing). If sudden wheezing occurs after using Budesonide and Formoterolo Cipla, stop using the medicine and contact your doctor immediately.
• Low levels of potassium in the blood.
• Irregular heartbeat.

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

• Depression.
• Changes in behaviour, particularly in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, for example unpleasant taste in the mouth.
• Changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, particularly if high doses are used for prolonged periods. These effects include:

• Changes in bone mineral density (thinning of the bones).
• Cataract (clouding of the lens in the eye).
• Glaucoma (increased pressure in the eye).
• Reduced growth rate in children and adolescents.
• Effects on the adrenal gland (a small gland near the kidney).

These effects are much less likely with inhaled corticosteroids than with corticosteroid tablets.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Budesonide and Formoterol Cipla

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label, carton, or aluminium pouch after Exp. The expiry date refers to the last day of that month.
• Before first opening: Store in the original packaging to protect from light. Do not refrigerate or freeze.
• After first opening: Do not store above 25°C. Store in the original packaging to protect from light. Do not refrigerate or freeze.
• After removing the inhaler from the aluminium pouch, it must be used within 3 months. Record the date (3 months from opening the pouch) on the inhaler label to remind yourself when to stop using the inhaler.
• After each use of the inhaler, always securely replace the mouthpiece cap.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Warning: The canister contains a pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce the canister. Do not break, pierce, or burn the canister, even when it appears empty.

6. Package contents and other information

What Budesonide and Formoterol Cipla contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each spray (actuation) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
• The other components are apaflurane (HFA 227), povidone and macrogol.
• This inhaler contains fluorinated greenhouse gases. Each inhaler contains 11.1 g of apaflurane (HFC-227ea), equivalent to 0.0035 tonnes of CO₂ (global warming potential GWP = 3,220).

Description of the appearance of Budesonide and Formoterol Cipla and contents of the pack
Budesonide and Formoterol Cipla consists of an inhaler containing the medicinal product.
The pressurised canister, equipped with a dose counter, contains a white inhalation suspension.
The canister is inserted into a white polypropylene actuator incorporating a dose counter and a brown plastic protective cap. Each inhaler contains 120 sprays (actuations) after it has been prepared for use. Each inhaler is individually packaged in an aluminium foil pouch containing a desiccant.
Budesonide and Formoterol Cipla is available in packs containing one inhaler.

Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium

Responsible manufacturers for batch release
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium
S&D Pharma CZ, spol. s.r.o.
Theodor 28
273 08 Pchery
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden Budesonide/Formoterol Cipla
Bulgaria Foracort 160 micrograms/4.5 micrograms per actuation pressurised inhalation, suspension
Форакорт 160 микрограма/4,5 микрограма на задействане инхалация под налягане, суспензия
Czech Republic Budesonide/Formoterol Cipla
Denmark Budesonid/Formoterolfumaratdihydrat Cipla 160 mikrogram/4.5 mikrogram/dosis inhalationsspray, suspension
Spain Foracort 160 microgramos/4,5 microgramos/pulsación suspensión para inhalación en envase a presión
France Budésonide/Formotérol Cipla 200 microgrammes/6 microgrammes par dose, suspension pour inhalation en flacon pressurisé
Italy Budesonide e Formoterolo Cipla
Netherlands Budesonide/Formoterolfumaraatdihydraat Cipla 200 microgram/6 microgram per dosis, aërosol, suspensie
Norway Budesonid/Formoterolfumaratdihydrat Cipla
Poland Budesonide + Formoterol Cipla