12 micrograms/dose inhaled powder
formoterol fumarate dihydrate

1. What Formatris Novolizer is and what it is used for

Formatris Novolizer belongs to a group of medicines called long-acting beta-agonists you or bronchodilators. The active substance in Formatris Novolizer has a dilating (relaxing and dilating) effect on the smooth muscles of the airways, increasing airflow and facilitating breathing.

Formatris Novolizer is used as a regular adjunct to maintenance treatment with inhaled corticosteroids for asthma and, if necessary, to prevent exertional asthma symptoms such as wheezing, shortness of breath, and cough. The effect sets in within 1-3 minutes and lasts up to 12 hours.

Formatris Novolizer is also used to relieve symptoms such as shortness of breath and cough in adults with chronic obstructive pulmonary disease (COPD). This is a chronic lung disease that is often caused by cigarette smoking.

Formoterol fumarate dihydrate contained in Formatris Novolizer may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Formatris Novolizer

Do not use Formatris Novolizer

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

Warnings and cautions

Talk to your doctor or pharmacist before using Formatris Novolizer if you have:

  • cardiovascular disease
  • diabetes
  • disturbed thyroid function
  • pheochromocytoma (a hormone-producing tumor in the adrenal medulla)
  • very high blood pressure
  • aneurysm (carotid artery hernia)
  • liver cirrhosis (severe liver disease)
  • low potassium in the blood

If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Formatris Novolizer.

If you get tracheal cramps, stop treatment immediately and contact a doctor.

In the event of an acute severe asthma attack, you should use short-acting asthma medication.

If you have difficulty breathing or wheezing, continue to take Formatris Novolizer, but contact your doctor as soon as possible as you may need further treatment. When your asthma is under control, your doctor may decide to gradually reduce the dose of Formatris Novolizer. Do not increase the dose without talking to a doctor.

Children

Children under 6 years of age should not use Formatris Novolizer.

Other medicines and Formatris Novolizer

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of Formatris Novolizer may be increased with concomitant use of medicines for:

  • treatment of i.a. obstructive pulmonary disease, inflammatory diseases ( cortisone )
  • treatment with diuretics for high blood pressure ( diuretics ) and cardiac glycosides for heart failure ( digoxin ), especially if the potassium level in the blood is already low
  • treatment of depression and mental conditions ( tricyclic antidepressants, MAO inhibitors, and phenothiazines)
  • treatment of allergies is with antihistamines (eg terfenadine, astemizole, mizolastine)
  • treatment with certain types of antibiotics (erythromycin)
  • treatment with bronchodilator anticholinergics (eg ipratropium)
  • treatment of Parkinson’s disease ( L-dopa )
  • treatment of reduced production of thyroid hormone (levothyroxine)
  • treatment with drugs for heart rate disorders (such as quinidine, disopyramide, procainamide )
  • treatment with xanthine-containing drugs (such as theophylline or aminophylline) used to treat asthma
  • treatment with other medicines that work in the same way as Formatris Novolizer, such as other beta-agonists (eg salbutamol )
  • treatment with ephedrine (used to treat asthma or as a decongestant of mucous membranes)

Also, tell your doctor or dentist that you are using Formatris Novolizer if you are going to receive anesthetics in connection with surgery or dental procedures.

The effect of Formatris Novolizer can reduce the concomitant use of beta-blockers (such as atenolol and propranolol for high blood pressure ), including eye drops (such as timolol against glaucoma ).

Formatris Novolizer with alcohol

Concomitant use of alcohol can affect the risk of heart side effects.

Pregnancy and breastfeeding

Experience of treatment during pregnancy is limited.

It is not known if formoterol passes into breast milk.

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 taking this medicine.

Driving and using machines

Formatris Novolizer is unlikely to affect your ability to drive or use machines. However, some side effects, such as dizziness, can occur in very rare cases.

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.

Formatris Novolizer contains lactose

Formatris Novolizer 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. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.

Lactose contains smaller amounts of milk protein which can cause allergic reactions.

3. How to use Formatris Novolizer

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

Dosage

Dose one is determined by the doctor, who adjusts it individually for you.

Asthma

Formatris Novolizer 12 micrograms/dose can be used both as regular maintenance treatment with an inhaled corticosteroid and as a temporary preventative treatment for exercise-induced asthma. If you use Formatris Novolizer regularly as a maintenance treatment, you should continue to do so even if you do not feel any symptoms.

The recommended dose for adults, from 18 years

Preventive maintenance medication

1 inhalation once or twice a day, in the morning and/or at night.

Extensive dosing

In addition to the maintenance dose, additional inhalations can be taken to relieve the symptoms up to a total daily dose of 6 inhalations per day (maintenance and, if necessary, dosing in total). You should not take more than a maximum of 3 inhalations at the same time.

If you need to inhale more than 2 times a day and/or 2 days a week in addition to the maintenance dose, it may be a sign that your asthma is unstable. You should then contact your doctor.

Prevention of exercise-induced asthma

1 inhalation before exertion.

The recommended dose for children and adolescents over 6 years

Preventive maintenance medication

1 inhalation once or twice a day, in the morning and/or at night.

Prevention of exercise-induced asthma

1 inhalation before exertion.

COPD ( chronic obstructive pulmonary disease )

The recommended dose for adults, from 18 years

The usual dose is 1 inhalation in the morning and 1 inhalation in the evening. Some patients may take the full daily dose at one time, ie. 2 inhalation is only in the morning. Your doctor will decide what is best for you. You should not take more than 2 inhalations at the same time. The total dose should not exceed 2 inhalations per day. In addition to your maintenance dose, your doctor may prescribe a dose if needed.

Information on how to use the Novolizer inhaler can be found at the end of this leaflet.

If you use more Formatris Novolizer then you should

The most common symptoms that can be felt if you take too much dose are tremors, headaches, and palpitations.

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.

If you forget to use Formatris Novolizer

If you forget to take your dose at one time, take it as soon as you remember or wait until the next time. Do not take a double dose to make up for a forgotten dose.

If you stop using Formatris Novolizer

Do not stop or end treatment or change the dose without consulting a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people): Headache, tremors, and palpitations.

Uncommon (may affect up to 1 in 100 people): Anxiety, restlessness, sleep disturbances, muscle cramps, increased heart rate.

Rare (may affect up to 1 in 1,000 people ): Heartbeat changes, hypersensitivity reactions such as bronchospasm (spasm of the trachea), skin rash, hives ( urticaria ) and itching, nausea, decreased / elevated potassium levels in the blood.

Very rare (may affect up to 1 in 10,000 people): Variations in blood pressure, taste changes, dizziness, angina (chest pain), high blood sugar, prolonged heart rate interval. Treatment with drugs such as Formatris Novolizer may result in elevated levels of insulin, free fatty acids, glycerol, and ketone bodies (a by-product of the breakdown of fatty acids) in the blood.

5. How to store Formatris Novolizer

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

Store in the box. Moisture sensitive.

Broken packaging: No special storage instructions.

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

The cassette must be replaced every 6 months.

Drug residues may remain in the empty packages. 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 substance is formoterol fumarate dihydrate. A measured dose contains 12 micrograms of formoterol fumarate dihydrate. Each dose delivered (the dose leaving the mouthpiece) from Formatris Novolizer contains 10.2 micrograms of formoterol fumarate dihydrate.
  • The other ingredient is lactose monohydrate (which contains small amounts of milk protein).

What the medicine looks like and the contents of the pack

1 powder inhaler and 1 cartridge with at least 60 doses.

1 powder inhaler and 3 cassettes with at least 60 doses in each.

Hospital packaging:

10 x (1 powder inhaler and 1 cartridge with at least 60 doses ).

Packaging for refilling:

Pack of 1, 2, or 3 cassettes with at least 60 doses in each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Tel: 08-630 19 00

Email: info@meda.se

Muhammad Nadeem

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