Salmeterol / Fluticasone Cipla - Fluticasone propionat uses, dose and side effects

Salmeterol is a long-acting tracheal dilator. Tracheal dilators act on the airways in the lungs to keep them open. This makes it easier to breathe. 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. Salmeterol / Fluticasone Cipla must be taken every day according to the doctor’s instructions for it to work in the best way and give control of your asthma.
Salmeterol / Fluticasone Cipla prevents breathing problems and wheezing. However, Salmeterol / Fluticasone Cipla should not be used to relieve a sudden onset of shortness of breath or wheezing. Then you should use a fast-acting tracheal dilator ‘on demand’ inhaler, such as salbutamol. You should always have your fast-acting ‘if needed’ inhaler with you.
Salmeterol and fluticasone propionate contained in Salmeterol / Fluticasone Cipla may also be approved for the treatment of other conditions not included in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Salmeterol / Fluticasone Cipla

Do not take Salmeterol / Fluticasone Cipla:

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Salmeterol / Fluticasone Cipla. Your treatment will be followed up more often if you have

heart disease, including irregular or rapid heartbeat
overactive thyroid gland
high blood pressure
diabetes (Salmeterol / Fluticasone Cipla may increase blood sugar)
conditions with low potassium in the blood
ongoing or previously had tuberculosis (TB), or other lung infections.

Contact a doctor if you experience blurred vision or other visual disturbances.

Other medicines and Salmeterol / Fluticasone Cipla

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines for asthma and over-the-counter medicines. This is important because it may not be appropriate to take Salmeterol / Fluticasone Cipla with certain other medicines.

Tell your doctor if you are taking any of the following medicines before starting treatment with Salmeterol / Fluticasone Cipla.

Beta-blockers (eg atenolol, propranolol, and sotalol). Beta-blockers are often used to treat high blood pressure or other heart conditions.
Medicines for infection (eg ketoconazole, erythromycin, and itraconazole). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase the risk of side effects of Salmeterol / Fluticasone Cipla, including irregular heartbeat, or aggravate side effects.
Cortisone (taken orally or by injection ). If you have recently been treated with these drugs, it may increase the risk of affecting the function of the adrenal glands.
Diuretics, also known as diuretics, are used to treat high blood pressure.
Other bronchodilators (eg salbutamol ).
Xanthines. These are often used to treat asthma.
Antiviral drugs (eg some anti-HIV drugs: ritonavir, cobicistat). Your doctor may want to monitor you closely if you are taking these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Salmeterol / Fluticasone Cipla is unlikely to affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Salmeterol / Fluticasone Cipla

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Use your Salmeterol / Fluticasone Cipla every day until your doctor tells you to stop. Do not take more than the recommended dose. Ask your doctor or pharmacist if you are unsure.
Do not stop taking Salmeterol / Fluticasone Cipla and do not reduce the dose of Salmeterol / Fluticasone Cipla without talking to your doctor first.
Salmeterol / Fluticasone Cipla should be inhaled through the mouth and into the lungs.

Adults and adolescents aged 12 years and older

Salmeterol / Fluticasone Cipla 25 micrograms / 125 micrograms / dose – 2 puffs twice daily
Salmeterol / Fluticasone Cipla 25 micrograms / 250 micrograms / dose – 2 puffs twice daily

Use for children and adolescents

Salmeterol / Fluticasone Cipla 25 micrograms / 125 micrograms and 25 micrograms / 250 micrograms are not recommended for children under 12 years of age.

Dose one should be adjusted so that you are on the lowest dose that keeps your ailments under control.

If your problems are kept under good control with the lowest strength of Salmeterol / Fluticasone Cipla (25/125 micrograms), the next step may be a switch to another inhalation drug-containing salmeterol/fluticasone, but with a lower strength (25/50 micrograms).

If your symptoms are well controlled when you take Salmeterol / Fluticasone Cipla twice a day, your doctor may decide to reduce your dose once or once a day. Dose one can be changed to:

once in the evening – if you have problems at night
once in the morning – if you have problems during the day.

It is very important to follow your doctor’s instructions on how many inhalations you should take and how often you should take your medicine.

If you are using Salmeterol / Fluticasone Cipla for asthma, your doctor may want to follow up on your symptoms more often.

Contact a doctor immediately if your asthma or breathing worsens. You may feel that your breathing becomes more wheezy, the feeling of tightness in your chest comes more often, or you need to use more of your fast-acting bronchodilator medication. If any of these occur, continue to take Salmeterol / Fluticasone Cipla, but do not increase the number of doses. Your breathing problems may worsen and you may become seriously ill. Contact your doctor as you may need additional asthma treatment.

Instructions for use

Doctors, nurses, or pharmacists should
The medicine is stored under pressure in a container that sits in a plastic housing with a nozzle
A dose counter on the front of the indicator shows how many doses you have left. When using the inhaler, the dose counter rotates to a lower number after every 5 to 7 puffs.
Be careful not to drop the inhaler as this may cause the meter to count down a dose.

To check that the inhaler is working

Before using the inhaler for the first time, check that it works. Remove the nozzle by tapping both sides of it with your thumb and forefinger and pulling it apart.
To check that the inhaler works, shake it well, point the nozzle away from you, push the container down and spray four puffs into the air. The dose counter shows the number ‘120’ which indicates the number of puffs in the inhaler. If you have not used the inhaler for a week or more, shake well and spray two puffs in the air.

How to use the inhaler

It is important to breathe as slowly as possible just before using the inhaler.

Stand or sit upright when using the inhaler.
Remove the cover on the nozzle. Check that the nozzle is clean and free of loose objects both inside and outside (picture A).
Shake the inhaler 4 or 5 times so that any loose objects are removed and the contents of the inhaler are mixed well (picture B).
Hold the inhaler upright with your thumb on the bottom, under the mouthpiece. Exhale as far as it feels comfortable (picture C).
Place the mouthpiece in your mouth between your teeth. Close your lips around the nozzle. Do not bite (picture D).
Inhale through the mouth slowly and deeply. Just as you begin to inhale, firmly press down on the top of the container to spray a dose. Continue to inhale calmly and deeply (picture D).
Hold your breath, remove the inhaler from your mouth and release your finger from the top of the inhaler. Continue to hold your breath for a few seconds, or as long as possible without it starting to feel uncomfortable (Figure E).
If another dose is to be taken, wait about half a minute between each dose and then repeat steps 3 to 7.
Rinse mouth with water and spit out, and/or brush teeth after use. This will help you reduce the risk of getting fungal infections and getting hoarse.
Always put the protective cap back on as a dust cover after using the inhaler. A snap is heard when the protective hood is pressed into place. If it cannot be pushed into place, check that it is facing in the right direction and try again. Do not press too hard.

Do not rush through steps 4, 5, 6, and 7. You must inhale as slowly as possible just before using your inhaler. You should stand in front of a mirror the first few times you use the inhaler. If you see a “shower” coming from the top of the inhaler or the sides of your mouth, start again from step 3.

As with all inhalers, caregivers should ensure that adolescents who have been prescribed this medication use the correct inhalation technique, as described above.

If you find it difficult to use the inhaler, a breathing container, e.g. Use Volumatic or AeroChamber Plus or other respirators (depending on national guidelines). Before using a respirator for the first time or if you need to change to a respirator of a different model, talk to your doctor, nurse or pharmacist.

You should get a new inhaler when the dose counter shows ’40’ and the color of the dose counter changes from green to red. Stop using the inhaler when the dose counter shows ‘0’ as the remaining amount in the inhaler may not give a full dose. Never try to change the numbers in the dose counter or remove the dose counter from the shutter button. The dose counter cannot be reset and is attached to the trigger.

How to clean the inhaler

To prevent the inhaler from clogging, it is important to clean it at least once a week.

To clean the inhaler:

Remove the cover on the nozzle.
Never remove the metal container from the plastic cover.
Wipe the inside and outside of the nozzle and plastic wrap with a dry cloth or paper towel.
Replace the cover on the nozzle. A click is heard when pressed in place. If it cannot be pushed into place, check that it is facing in the right direction and try again. Do not use excessive force.

Do not place the metal container in water.

If you use more Salmeterol / Fluticasone Cipla than you should

You must use the inhaler according to the instructions. If you accidentally ingest a larger amount than recommended, contact your doctor or pharmacist. You may feel that your heart is beating faster than usual and that you are shaking. You may also experience dizziness, headache, muscle weakness, and joint pain.

If you have taken larger amounts for a long time or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Larger amounts of Salmeterol / Fluticasone Cipla may reduce the amount of cortisone produced in the adrenal glands.

If you forget to use Salmeterol / Fluticasone Cipla

If you forget to use your inhaler, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Salmeterol / Fluticasone Cipla

You must take Salmeterol / Fluticasone Cipla every day as prescribed. Keep taking this medicine until your doctor tells you to stop. Do not stop taking or reduce the dose of Salmeterol / Fluticasone Cipla suddenly. This can make your breathing worse.

In addition, if you suddenly stop taking Salmeterol / Fluticasone Cipla or reduce the dose of one of Salmeterol / Fluticasone Cipla, this can (in very rare cases) cause problems with the adrenal glands (adrenal insufficiency) which sometimes causes side effects.

Side effects may include any of the following:

Stomach ache
Fatigue, loss of appetite, and malaise
Nausea and diarrhea
Weight loss
Headache or drowsiness
Low blood sugar
Low blood pressure and seizures (seizures).When your body is exposed to stress, e.g. In the form of fever, trauma (eg after a car accident), infection, or surgery, adrenal cortex weight may worsen and you may experience any of the side effects listed above.

If you get any side effects, talk to your doctor or nurse

pharmacy staff. To prevent these symptoms from happening, your doctor may prescribe extra corticosteroid supplements in tablet form (eg prednisolone ).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the risk of side effects, your doctor will prescribe the lowest dose of Salmeterol / Fluticasone Cipla needed to control your asthma.

Allergic reactions: You may notice that you suddenly find it harder to breathe immediately after taking Salmeterol / Fluticasone Cipla. You may have wheezing and coughing or feel short of breath. You may also experience itching, rash (hives), and swelling (usually on the face, lips, tongue, or throat), or you may suddenly feel your heart beating very fast or feel dizzy and dizzy (which may lead to collapse or that you lose consciousness). Stop taking Salmeterol / Fluticasone Cipla and contact a doctor immediately if any of these occur or if they occur suddenly after taking Salmeterol / Fluticasone Cipla. Allergic reactions to Salmeterol / Fluticasone Cipla are uncommon (may affect up to 1 in 100 people).

Other side effects are listed below:

Very common (may affect more than 1 user in 10)

Headache – usually disappears after continued use.
More colds have been reported in patients with COPD.

Common (may affect up to 1 in 10 people)

Fungal infection (sore, light yellowish raised spots) in mouth and throat. Also sore tongue and hoarseness as well as irritation in the throat. This can be prevented by rinsing your mouth with water and spitting it out immediately and/or brushing your teeth after each inhalation. Your doctor may prescribe a fungicide to treat the fungal infection.
Painful, swollen joints, and muscle aches.
Muscle cramps.

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

Pneumonia in COPD patients tell your doctor if you have any of the following symptoms while taking Salmeterol / Fluticasone Cipla as they may be symptoms of pneumonia:• fever or chills• increased mucus production, changed the color of the mucus• increased cough or increased difficulty breathing
Irritation in the throat. This can be prevented by rinsing the mouth with water and spitting it out immediately after each inhalation.
Bruises and broken bones.
Sinusitis (a feeling of pressure or swelling in the nose, cheeks, and behind the eyes, sometimes with a throbbing pain).
Decreased potassium content in the blood (which can cause irregular heartbeat, muscle weakness, and cramps).

Uncommon (may affect up to 1 in 100 people)

Elevated blood sugar ( glucose ) (hyperglycemia). If you have diabetes, you may need to do more frequent blood sugar checks and possibly change your usual diabetes treatment.
Cloudy eye lens ( cataract ).
Very fast heartbeat ( tachycardia ).
Feeling shaky ( tremor ) and fast or irregular heartbeat ( palpitation ). This is usually harmless and disappears after a period of use.
Chest pain.
Feeling of anxiety (this occurs mainly in children).
Difficulty sleeping.
Allergic skin rash.

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

Difficulty breathing or wheezing that worsens immediately after taking Salmeterol / Fluticasone Cipla. If this happens, stop taking Salmeterol / Fluticasone Cipla. Use the inhaler with the fast-acting bronchodilator medicine and contact a doctor immediately.
Salmeterol / Fluticasone Cipla can affect the normal production of cortisone in the body, especially if you have been taking high doses for a long time. Effects of this can give:
- delayed height growth in children and adolescents
- reduced bone density
- damage to the optic nerve of the eye ( glaucoma )
- weight gain
- rounded face (full moon face) (Cushing’s syndrome).

Your doctor will monitor your treatment regularly to make sure you are on the lowest dose that keeps your asthma under control to reduce the risk of these side effects.

Behavioral disorders, e.g. becoming overactive and irritable (seen mainly in children).
Irregular heartbeat or that the heart beats an extra beat ( arrhythmia ). Tell your doctor but do not stop taking Salmeterol / Fluticasone Cipla until your doctor tells you to stop.
A fungal infection of the esophagus (esophagus), can cause difficulty swallowing.

Has been reported (occurs in an unknown number of users)

Depression or aggression. These side effects are more likely to occur in children. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Dim sum

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

www.läkemedelsverket.se

How to store Salmeterol / Fluticasone Cipla

Keep this medicine out of the sight and reach of children.

Replace the protective cap immediately after use with a push until you hear a click. Do not use extra force.

Do not store above 25 ° C. Do not expose to temperatures above 50 ° C. Salmeterol / Fluticasone Cipla should not be stored cold as the effect of the medicine may be impaired.

Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiration date is the last day of the specified month.

The container contains a liquid under pressure. The container must not be punctured.

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 to protect the environment.

Contents of the packaging and other information

Content declaration

Each metered dose of Salmeterol / Fluticasone Cipla contains:25 micrograms of salmeterol (as salmeterol xinafoate) and 125 or 250 micrograms of fluticasone propionate (the dose leaving the valve). This corresponds to a given dose (the dose leaving the inhaler) of 21 micrograms of salmeterol and 110 or 220 micrograms of fluticasone propionate.
The other ingredients are norflurane (HFA 134a).

What the medicine looks like and the contents of the pack

Aluminum container with a suitable dosing valve, a polypropylene trigger with a protective cap, and a dose counter in a sealed bag containing desiccant.
Each container contains 120 doses.

Pack sizes:

1, 2 (2×1) or 3 (3×1) containers containing 120 doses .

10 (10×1) containers containing 120 dose er – hospital packaging only.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp,

Belgium

Manufacturer

S&D Pharma CZ, spol. s ro,

Theodor 28, 273 08

Archery (Pharmos as a facility),

Czech Republic