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What Duaklir Genuair is and what it is used for What is Duaklir Genuair
This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medicines called bronchodilators. Bronchodilators relax the muscles of the airways, which opens the airways more widely and helps you breathe more easily. The Genuair Inhaler delivers the active ingredients directly into your lungs when inhaled.
What Duaklir Genuair is used for
Duaklir Genuair is used in adult patients who have difficulty breathing due to a pulmonary disease called chronic obstructive pulmonary disease (COPD), where the airways and alveoli in the lungs are damaged or blocked. By opening the airways, the medicine helps relieve symptoms such as shortness of breath. Regular administration of Duaklir Genuair will help minimize the effects of COPD in your daily routine.
2. What you need to know before using Duaklir Genuair
Do not use Duaklir Genuair:
If you are allergic to aclidinium, formoterol fumarate dihydrate or the other ingredient of this medicine, lactose (see section 2 in "Duaklir Genuair contains lactose").
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Duaklir Genuair if you have any of the following symptoms / symptoms:
If you have asthma. This medicine should not be used to treat asthma.
If you have heart problems.
If you have epilepsy.
If you have thyroid problems (thyrotoxicosis).
If you have a tumor in one of the adrenal glands (pheochromocytoma).
If you have difficulty in passing urine or problems due to enlarged prostate.
If you have eye disease called narrow-angle glaucoma, which results in higher eye pressure.
Stop taking Duaklir Genuair and get immediate medical attention if you get any of the following:
If you have a sudden difficulty in breathing or swallowing, if you have swollen tongue, throat, lips or face, or skin rash and / or itching. These may be signs of an allergic reaction.
If you experience sudden chest tightness, coughing, wheezing or shortness of breath immediately after using the medicine. These may be signs of a condition called "paroxysmal bronchospasm", which is an excessive and prolonged contraction of the respiratory muscles immediately after administration of bronchodilator therapy.
Duaklir Genuair is used for maintenance (long-term) treatment of COPD. You should not use this medicine to treat a sudden onset of shortness of breath or wheezing.
If your usual symptoms of COPD (shortness of breath, wheezing, coughing) do not improve or worsen when using Duaklir Genuair, you should continue to use it, but consult a doctor as soon as you may need another medicine.
If you see a halo around a light source or color images, have pain or discomfort in the eyes or temporarily blur vision, talk to your doctor immediately.
Dry mouth is seen in medicines such as Duaklir Genuair. After prolonged use, dry mouth can be associated with tooth decay, so it is important to take care of your oral hygiene.
Children and adolescents
Duaklir Genuair should not be used in children and adolescents under the age of 18 years.
Other Drugs and Duaklir Genuair
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you use Duaklir Genuair with any other medicines, the effect of Duaklir Genuair or other medicines may change.
Tell your doctor or pharmacist if you are taking:
Any medicines that may be similar to Duaklir Genuair for the treatment of difficult breathing.
Medicines that lower the level of potassium in the blood. They include:
Corticosteroids that you can take orally (such as prednisolone);
Diuretics (such as furosemide or hydrochlorothiazide);
Certain medicines used to treat breathing conditions (such as theophylline).
Medicines called beta blockers that can be used to treat high blood pressure and other heart problems (such as atenolol and propranolol) or to treat glaucoma (such as timolol).
Medicines that can cause a change in electrical activity of the heart, known as QT prolongation (observed in electrocardiogram). Here are included medicines for the treatment of:
Depression (such as monoamine oxidase inhibitors or tricyclic antidepressants);
Bacterial infections (such as erythromycin, clarithromycin, telithromycin);
Allergic reactions (antihistamines).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor, nurse or pharmacist for advice before taking this medicine. You should not use Duaklir Genuair if you are pregnant or breast-feeding
Duaklir Genuair contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Duaklir Genuair
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one inhalation twice a day in the morning and in the evening.
The effect of Duaklir Genuair lasts for 12 hours; Therefore you should try to use Duaklir Genuair at the same time in the morning and evening, as this always provides a sufficient amount of the medicine in your body to help you breathe easier during the day and night. It will also help you to remember to use it.
Instructions for use: See section 7 at the end of the leaflet for instructions on how to use the Genuair inhaler. If you are not sure how to use Duaklir Genuair, ask your doctor or pharmacist.
You can use Duaklir Genuair at any time before or after eating and drinking.
COPD is a chronic disease, so Duaklir Genuair should be used every day, twice a day, and not just when you have respiratory problems or other COPD symptoms.
The recommended dose may be used in the elderly and in patients with kidney or liver problems. No dose adjustment is required in such patients.
If you use more Duaklir Genuair than you should
If you think you may have taken more Duaklir Genuair than you should, you may have any of the following side effects, such as blurred vision, dry mouth, nausea, trembling / tremor, headache, palpitations or You should contact your doctor immediately or visit the nearest emergency department. Show Duaklir Genuair. Medical treatment may be necessary.
If you forget to use Duaklir Genuair
If you miss a dose of Duaklir Genuair, just take it as soon as possible and take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
If you stop using Duaklir Genuair
This medicine is for long-term use. If you want to stop treatment, talk to your doctor first as the symptoms may get worse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious: if you get any of them, tell your doctor immediately.
Uncommon: may affect up to 1 in 100 people:
Muscle weakness, muscle twitching and / or impaired heart rhythm, as these may be signs of lowering potassium levels in the blood;
Fatigue, increased thirst and / or need for more frequent urination than usual, as this may be an increase in the amount of sugar in the blood;
Palpitations, as this may be unusually rapid heartbeat or abnormal heart rhythm.
Rare: may affect up to 1 in 1,000 people:
Chest tightness, cough, wheezing or shortness of breath immediately after using the medicine;
Sudden difficulty in breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and / or itching may be an allergic reaction.
Not known: can not be estimated from the available data:
Swelling of the face, throat, lips or tongue (with or without difficulty in breathing or swallowing), a severe itchy skin rash (urticaria), as these may be symptoms of an allergic reaction.
While you are taking Duaklir Genuair, other side effects may occur:
Common: may affect up to 1 in 10 people:
A combination of sore throat and runny nose - these may be nasopharyngitis;
Painful and / or frequent urination - these may be signs of urinary tract infection;
Clogged, nasal secretion and / or pain or pressure sensation in the cheek or forehead - these may be sinusitis;
Swelling of the hands, ankles or feet;
Abscess (infection) of the tissues in and / or around the root of the tooth;
Elevated blood levels of protein found in the muscle called creatine phosphokinase;
Tremor / tremor;
Accelerated cardiac activity (tachycardia);
Voice changes (dysphonia);
Difficulty urinating or feeling that the bladder is not completely emptied (urinary retention);
Change in electrocardiogram (QT prolongation) potentially leading to impaired heart rhythm;
Changed taste (dysgeusia);
Inflammation of the lining of the mouth (stomatitis);
Increased blood pressure;
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Duaklir Genuair
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label of the inhaler, the carton and the inhaler bag after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Keep the Genuair inhaler protected in the sealed pouch until the application starts.
Use within 60 days of opening the bag.
Do not use Duaklir Genuair if you notice that the pack is damaged or is visible to be open.
After taking the last dose, the inhaler should be discarded. Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Duaklir Genuair contains
The active substances are: aclidinium bromide and formoterol fumarate dihydrate. Each dose delivered contains 396 micrograms of aclidinium bromide, equivalent to 340 micrograms of aclidinium, and 11.8 micrograms of formoterol fumarate dihydrate.
The other ingredient is lactose monohydrate.
What Duaklir Genuair looks like and contents of the pack
Duaklir Genuair is a white or almost white powder.
The Genuair inhaler is a white product with a built-in dose indicator and an orange dye button. The mouthpiece is covered with a removable protective cap in orange. Supplied in a sealed protective aluminum bag containing a sachet with a desiccant.
Suggested types of packaging:
Carton containing 1 inhaler with 30 doses.
Cardboard pack containing 1 inhaler with 60 doses.
Cardboard packaging containing 3 inhalers, each with 60 doses.
Not all pack sizes may be marketed.
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