Arcapta 150 Mcg 30 inhaler Capsules

ARCAPTA 150 mcg Inhaler Capsule

It cannot be swallowed. It is used by mouth inhalation through the device out of the box (NEOHALER).

Active ingredient
Each capsule contains 194 micrograms of indacaterol maleate, equivalent to 150 micrograms of indacaterol. With each inhalation, 120 micrograms of indacaterol is dispensed from the mouthpiece.

Excipients
Capsule filling: Lactose monohydrate (bovine origin), Empty capsule shell: Gelatin (bovine origin), black printing ink, Printing ink: Shellac (E904), black iron oxide (E172), n-butyl alcohol, purified water, propylene glycol ( E1520), anhydrous ethanol, isopropyl alcohol, strong ammonia solution.

1. What ARCAPTA is and what it is used for

ARCAPTA is in the group of drugs that expand the airways (bronchodilator). It contains indacaterol as an active ingredient. When you inhale this substance, it relaxes the muscles in the walls of the small airways in your lungs. This opens your airways and makes it easier for air to come in and out.

ARCAPTA is used in adults who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD). The medicine makes you breathe easier and minimizes the effects of COPD.

ARCAPTA 150 microgram capsules are yellowish transparent and colorless. The product code “IDL 150” is printed in black on the upper part of the black line on the capsule body.

ARCAPTA is available in blister packs of 30 or 60 capsules.

Inside each box, there are a device (Neohaler) that allows you to inhale the drug, and capsules containing the drug as powder, which you can use by placing them in blisters into this device.

Use this medicine only with the NEOHALER device (inhaler) included in this package.

2. How to use ARCAPTA?

The usual dose is one inhalation of the contents of one capsule each day (1 capsule = 1 inhalation).

Your doctor will determine the appropriate dose for your treatment based on your condition and how you respond to the medication. Do not use more medicine than your doctor tells you.

Use the inhaler at the same time each day. This practice will ensure that enough medication is available in your body to help you breathe easier throughout the day and night. It will also help you remember to use the medicine.

In this box you will find an inhaler and capsules (in blisters) containing medicine in the form of inhalation powder. The inhaler Neohaler allows you to inhale (inhale) the medicine contained in the capsule.

Use capsules only with the inhaler contained in this box (Neohaler).

Do not use the Neohaler inhaler to take any other capsule medicine. The capsules must remain in the blister until they are used.

When you start a new box, use the Neohaler, the new inhaler included in the box. Since there is an inhaler in each new box, when the capsules in the box run out, throw the device out of that box. Do not swallow ARCAPTA capsules.

Always use ARCAPTA according to your doctor's instructions. If you are not sure how to use it, you should consult your doctor.
Application route and method

The 'Instructions for Use of ARCAPTA Inhaler Capsules' section of the leaflet explains how to use ARCAPTA and care for the inhaler. Please read carefully and follow this instruction.

If you have any questions, ask your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in ARCAPTA.

Side effects are listed as shown in the following categories:

Very common: may occur in at least 1 in 10 patients.

Common: less than 1 in 10 patients, but more than 1 in 100 patients.

Uncommon: less than 1 in 100 patients, but more than 1 in 1,000 patients

visible.

Rare

Very rare

: It can be seen in less than one of 1,000 patients.

It can be seen in less than 1 in 10000 patients.

Frequency not known: It can be seen in too few patients to be determined with the available data.
Very common:

Sore throat, runny nose, stuffy nose, sneezing, cough, one or more of the symptoms of headache with or without fever.
Widespread:

•  Headache,

• Dizziness,

• Feeling of pressure or pain in the cheeks or forehead (inflammation of the sinuses),

• runny nose,

•  Cough,

•  Throat ache,

• Pain in the muscles, bones or joints (musculoskeletal pain),

• Muscle spasm,

• Difficulty in breathing as in bronchitis,

• Swelling of the hands, ankles or feet (edema),

• Pressing chest pain (heart problems),

• Itching/rash,

• Palpitations,

• Excessive thirst, urinating more than normal, increased appetite with weight loss, fatigue, high blood sugar level (these are symptoms of diabetes).
Unusual: