50 micrograms / 5 micrograms per puff, 125 micrograms / 5 micrograms per puff, inhalation spray , suspension
fluticasone propionate / formoterol fumarate dihydrate

1. What Flutiform K ‑ haler is and what it is used for

Flutiform K ‑ haler is an inhaler (an inhalation spray, suspension ) that contains two active ingredients:

  • Fluticasone propionate belongs to a group of medicines called steroids. Steroids help reduce swelling and inflammation in the lungs.
  • Formoterol fumarate dihydrate belongs to a group of medications known as long-acting beta 2 – agonist you. Long-acting beta 2 – agonist s are long-acting bronchodilators (LABA) that help to keep the airways in the lungs open, making it easier for you to breathe.

Together, these two active ingredients help to improve your breathing. It is recommended that you use this medicine every day as directed by your doctor. The inhaler is inhalation driven, which means that it releases these two active ingredients when you inhale through the mouthpiece.

This medicine helps to prevent breathing problems like asthma and helps to stop shortness of breath and wheezing. However, it does not work if you already have an asthma attack, ie. if you are already wheezing and short of breath. You need to use a fast-acting bronchodilator for acute attacks such as salbutamol if this happens.

2. What you need to know before using Flutiform K ‑ tails

Do not use Flutiform K ‑ tails

  • if you are allergic to fluticasone propionate, formoterol fumarate, 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 this inhaler.

Before treatment with this inhaler  tell your doctor, pharmacist, or nurse if you have:

  • tuberculosis now or have had it before. Symptoms include a persistent cough, often with a bloody cough, fever, fatigue, loss of appetite, weight loss, and night sweats.
  • an infection of the lungs or chest
  • heart problems such as problems with blood flow to the heart or narrowing of one of the heart valves (aortic valve), heart failure that can cause shortness of breath or swollen ankles, a condition in which the heart muscle is enlarged ( hypertrophic obstructive cardiomyopathy ), irregular heartbeat or cardiac arrhythmia your heart rate ( ECG ) is abnormal (prolonged QTc interval)
  • an abnormal bulge of a blood vessel wall (an aneurysm )
  • diabetes
  • high blood pressure
  • an overactive thyroid gland that can cause increased appetite, weight loss, or sweating ( thyrotoxicosis )
  • low levels of potassium in the blood, which can cause muscle weakness, twitching, or abnormal heart rhythm ( hypokalaemia )
  • poor adrenal function (if your adrenal glands do not function properly you may get symptoms such as headache, weakness, fatigue, abdominal pain, loss of appetite, weight loss, dizziness, very low blood pressure, diarrhea, nausea, vomiting, or seizures) or a tumor in the adrenal glands ( pheochromocytoma )
  • liver problem.

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

Tell your doctor if you are going to have surgery or are very stressed, as you may need additional steroid treatment to control your asthma.

Other medicines and Flutiform K ‑ haler

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If you use this inhaler with other medicines, the effect of this inhaler or the other medicines may change.

Tell your doctor or pharmacist if you are taking:

  • drugs called beta-blockers (such as atenolol for the treatment of high blood pressure, sotalol for the treatment of irregular heartbeat, metoprolol for the treatment of fast heartbeat, or timolol eye drops for the treatment of glaucoma )
  • certain other medicines used to treat asthma or respiratory conditions (such as theophylline or aminophylline)
  • drugs containing epinephrine or like substances (including other beta agonist s such as salbutamol or beta antagonist s such as atenolol, metoprolol, timolol ) Further long-acting beta 2 – agonist s should not be added together with this inhaler. If your asthma worsens between doses of Flutiform K‑haler, use your fast-acting inhaler for immediate effect.
  • drugs for the treatment of allergic reactions ( antihistamines )
  • drugs for the treatment of high blood pressure or fluid retention, which increase the amount of urine produced ( diuretics )
  • medicines used to treat heart failure (such as digoxin )
  • drugs for the treatment of abnormal heart rhythms (such as quinidine, disopyramide, procainamide )
  • medicines for the treatment of depressive symptoms or mental disorders such as MAO inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), or if you have taken any of these medicines in the last two weeks
  • medicines used to treat mental or mental disorders (phenothiazines or antipsychotics)
  • medicines containing steroid s
  • antifungal drugs (such as ketoconazole or itraconazole)
  • some medicines may increase the effects of Flutiform K-tails and your doctor may want to check your asthma more closely if you use any of these medicines (for example, some medicines to treat HIV: ritonavir, atazanavir, indinavir, nelfinavir or saquinavir, or cobicistat)
  • antibiotics (such as clarithromycin, telithromycin, or furazolidone)
  • drugs for the treatment of Parkinson’s disease ( levodopa )
  • drugs for the treatment of hypothyroidism (levothyroxine)
  • drugs for the treatment of Hodgkin’s disease (procarbazine)
  • drugs used to induce labor ( oxytocin ).

If you are going to have surgery under anesthesia, tell your doctor at the hospital that you are using this inhaler.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using your inhaler. Your doctor will tell you if you should take this medicine.

Driving and using machines

This medicine 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 increased 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.

Flutiform K ‑ tails contain ethanol (alcohol) and sodium cromoglycate

This medicine contains very small amounts of ethanol (alcohol), 1 mg per dose (puff). It also contains a very small amount of sodium cromoglycate, but patients currently taking cromoglycate (for the treatment of asthma, allergic rhinitis, and allergic conjunctivitis ) should continue as usual.

3. How to use Flutiform K ‑ tails

Always use this inhaler as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure. You should use your inhaler regularly, ie two doses (puffs) in the morning and two doses (puffs) in the evening every day to get the most benefit from your inhaler, unless your doctor says otherwise or advises you to stop. Do not take more than the prescribed dose. Your doctor may have prescribed your inhaler for an indication other than asthma or a dose other than that normally prescribed and described in this leaflet. You should always use your inhaler exactly according to your doctor’s instructions. If you are not sure how much to take or how often to use your inhaler, talk to your doctor or pharmacist.

Adults and adolescents over 12 years of age

The usual dose is two inhalations twice a day, ie two puffs in the morning and two in the evening. Your doctor will prescribe the dose required to treat your asthma.

Flutiform  K ‑ tails should not be used in children under 12 years of age.

Instructions for use

Read this leaflet carefully before use and follow the instructions in the text and pictures below.

Your doctor or pharmacist will show you how to use the inhaler correctly. The inhaler is breath-driven, which means that it releases the two active ingredients when you inhale through the mouthpiece. The medicine is contained in an aerosol can, which is located inside a plastic casing. The plastic cover also has a counter that tells you how many puffs are left. This counter is color-coded. When there are less than 28 puffs left, it starts to change to red, and you should contact your doctor to get a new inhaler. Do not use the inhaler when the meter shows “0” or is completely red.

Inhaler picture

Before using your inhaler for the first time or if it has not been used for more than 3 days

If your inhaler is new or has not been used for more than 3 days, it must be activated to ensure that it works properly and gives you the right dose.

Activation
  • Always direct the nozzle away from you when activating
  • Follow the instructions to activate your inhaler
  • When the nozzle is closed, a puff is released.

If you drop the inhaler or leave the mouthpiece cap open for more than 10 minutes, the inhaler must be activated once by steps 1 and 2 above before using it.

If you expose the inhaler to cold, leave it at room temperature for 30 minutes and then activate it once according to steps 1 and 2 above.

The inhaler should always be shaken immediately before use.

Daily use

How to use the inhaler

If you feel short of breath or wheezing when using Flutiform K-Tails, continue to use Flutiform K-Tails, but consult a doctor as soon as possible, as you may need further treatment. Once your asthma is well controlled, your doctor may consider it appropriate to reduce the dose of one of Flutiform K’s.

  • The inhaler should be shaken immediately before each puff, to ensure that the contents of the inhaler are evenly distributed.
  • Sit upright or stand. Exhale as slowly and deeply as possible. See step 1.
  • Hold the inhaler upright, open the orange protective cap and place the mouthpiece in your mouth and close your lips around it. Do not bite into the nozzle.
  • Inhale slowly and deeply through the mouthpiece. This automatically releases a puff. Hold your breath and remove the inhaler from your mouth and close the protective cap. Keep holding your breath as long as it feels good. Do not exhale through the inhaler. See steps 2 and 3. If you see a “fog” when closing the protective cover, you have not inhaled properly and must repeat the steps above.
  • Before the second puff, hold the inhaler upright and repeat the steps above.

Always rinse your mouth, gargle with water or brush your teeth and spit out after using the inhaler. This can help prevent you from getting a sore mouth and throat or a hoarse voice.

If you use too much Flutiform K ‑ tails 

It is important that you take the dose indicated on the pharmacy label or prescribed by your doctor. You should not increase or decrease the dose without consulting a doctor.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

You may have severe chest pain (angina), high or low blood pressure, headache, muscle cramps, difficulty sleeping, nervousness, dry mouth, loss of appetite, seizures, epileptic seizures, or convulsions. You may feel shaky, dizzy, weak, tired, nauseous, or general illness. You may also notice changes in heart rate and you may have low levels of potassium or increased blood sugar. You may also experience symptoms such as abdominal pain, nausea, weight loss, decreased level of consciousness (which may make you feel drowsy or confused), or low blood sugar.

If you have taken more than the prescribed dose for a long time, consult your doctor or pharmacist. This is because large doses can reduce the number of steroid hormones normally produced by your adrenal glands (see section 4).

If you forget to use Flutiform K ‑ tails

If you forget to take a dose, take it as soon as you remember. If it is soon 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 Flutiform K ‑ haler

You must use this inhaler every day according to your doctor’s instructions even if you are feeling well, as it helps to control your asthma. If you want to stop using your inhaler, talk to your doctor first. Your doctor will tell you how to do this, usually by gradually reducing the dose so that you do not trigger an asthma attack.

4. Possible side effects

Like all medicines, this inhaler can cause side effects, although not everybody gets them. Your doctor will prescribe the lowest necessary dose to control your asthma which reduces the risk of side effects.

All medicines can cause allergic reactions, although severe allergic reactions are rare. Tell your doctor immediately if you suddenly have swelling in the eyelids, face, throat, tongue or lips, rash or itching, especially if it is all over the body, symptoms such as dizziness, headache, fainting, or sudden changes in breathing patterns such as increased wheezing or shortness of breath.

Like other inhalers, your breathing may deteriorate shortly after using your inhaler. You may notice increased wheezing or shortness of breath. If this happens, stop using your Flutiform K-Haler inhaler and instead use your fast-acting, anfallskuperande inhaler. Contact your doctor immediately. Your doctor will assess your asthma and, if necessary, change your treatment. You should always have your attack-inducing inhaler with you.

Uncommon (may affect up to 1 in 100 people)

  • Exacerbated asthma
  • Headache
  • Shaking
  • Irregular heartbeat or palpitations
  • Dizziness
  • Difficulty sleeping
  • Altered voice or hoarse voice
  • Dry mouth, sore throat, or irritated throat
  • Rash

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

  • An increase in the amount of sugar in the blood. If you have diabetes, you may need to check your blood sugar more often and adjust your usual diabetes treatment.
  • Cod or other fungal infections of the mouth and throat
  • Sinusitis ( sinusitis )
  • Fast heartbeat
  • Chest pain associated with heart disease
  • Muscle cramps
  • Cough or shortness of breath
  • Diarrhea
  • Indigestion
  • Changed taste
  • A feeling of dizziness or that it “spins”
  • Abnormal dreams
  • Agitation
  • Skin itching
  • High blood pressure
  • A feeling of abnormal weakness
  • Swollen hands, ankles, or feet

No known frequency (cannot be calculated from available data)

  • Dimsyn
  • Sleep problems, depression or anxiety, aggression, anxiety, restlessness, nervousness, excessive arousal, or irritability. These effects are more likely to occur in children.

The following side effects are associated with formoterol fumarate, but they have not been reported during clinical trials with this inhaler:

  • Low potassium levels in the blood, which can cause muscle weakness, twitching, or abnormal heart rhythm
  • An abnormal heart curve that potentially leads to an abnormal heart rhythm (prolonged QTc interval)
  • High levels of lactic acid in the blood
  • Nausea
  • Muscle pain

Inhaled steroids can affect the normal production of steroid hormones in the body, especially if you use high doses for a long time. These effects include:

  • altered bone density (thinning of skeletal bones)
  • cataracts (cloudiness of the lens of the eye)
  • glaucoma (increased pressure in the eye)
  • bruising or thinning of the skin
  • increased risk of getting an infection
  • slower growth in children and adolescents
  • a round (moon-shaped) face
  • an effect on the adrenal glands (small glands that sit next to the kidneys), which means you may have symptoms such as weakness, fatigue, poor stress resistance, abdominal pain, loss of appetite, weight loss, headache dizziness, very low blood pressure diarrhea, nausea or vomiting or seizures.

These effects are much less likely with inhaled steroids than with steroid tablets.

5. How to store Flutiform K ‑ tails

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

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

Do not store above 25 ° C. Store in a cold place. Do not freeze. If the inhaler is exposed to frost, it must reach room temperature for 30 minutes and then be prepared once before use (see section 3). Do not use the inhaler if it has been removed from the foil bag more than 3 months ago or if the dose indicator shows “0”.

Do not expose to temperatures above 50 ° C. The aerosol container contains a compressed liquid and therefore the container must not be punctured, broken, or burned, not even when it is apparently empty. 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.

6. Contents of the packaging and other information

Content declaration

The active substances are fluticasone propionate and formoterol fumarate dihydrate. There is an inhaler er with two different strengths. 

Flutiform K ‑ holds 50 micrograms / 5 micrograms per puff, inhalation spray, suspension – only

Each puff (measured dose ) contains 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate

Flutiform K ‑ holds  125 micrograms / 5 micrograms per puff, inhalation spray, suspension – only

Each puff (measured dose ) contains 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate

Other ingredients are:

  • Sodium cromoglycate
  • Ethanol
  • Apaflurane HFA 227 ( propellant )

What the medicine looks like and the contents of the pack

These inhalers are small aerosol containers sealed in a gray plastic casing with an orange mouthpiece cap. You cannot see the aerosol container inside the plastic cover. The aerosol container contains a white to off-white liquid suspension and is equipped with a metering valve. Each inhaler contains 120 puffs.

There are single packs with one inhaler and triple packs with three inhalers.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Mundipharma AB

Mölndalsvägen 30B

412 63 Gothenburg

info@mundipharma.se

Manufacturer

Mundipharma DC BV

Listening 16

3832 RC Leusden

Netherlands

Bard Pharmaceuticals Ltd.

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

UK

Muhammad Nadeem

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