200 micrograms/dose inhaled powder
budesonide
What Novopulmon Novolizer is and what it is used for
The active substance in Novopulmon Novolizer, budesonide, is a glucocorticoid ( corticosteroid ) intended for inhalation.
Novopulmon Novolizer is used for the long-term treatment of chronic asthma.
NOTE:
Novopulmon Novolizer should not be used for the treatment of sudden attacks of shortness of breath (acute asthma attack or status asthmaticus (very frequent asthma attacks and/or asthma attacks lasting several days)).
What you need to know before you use Novopulmon Novolizer
Do not use Novopulmon Novolizer
- if you are allergic to budesonide or to milk protein, which is present in small amounts in the excipient lactose monohydrate (see section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Novopulmon Novolizer.
Contact a doctor if you experience blurred vision or other visual disturbances.
Take special care with Novopulmon Novolizer
- if you have pulmonary tuberculosis, a fungal infection of the respiratory tract or any other respiratory infection. This also applies if you have had these permits before. Consult your doctor.
It is not advisable to treat sudden shortness of breath or persistent, sharp contraction of the trachea ( status asthmaticus ) with budesonide. To remedy your acute symptoms, your doctor will advise you to use a fast-acting bronchodilator inhalation medicine.
If you have severe liver disease, the breakdown of budesonide may be impaired. This in turn can lead to elevated levels of budesonide in the blood.
All inhaled glucocorticoids can cause side effects, especially if high doses are used for a long time. However, these side effects are much less likely with inhalation therapy than with the use of glucocorticoid tablets. Possible side effects include impaired adrenal function, Cushing’s syndrome, Cushing’s-like symptoms (a hormonal disorder caused by high levels of cortisol in the blood with obesity, ‘moon face’, thinning of the skin, high blood pressure, etc.), osteoporosis, growth disorders in children and adolescents and eye diseases. (gray and green cataracts), and more rarely a range of psychological or behavioral disorders including psychomotor hyperactivity (restlessness with increased activity), sleep disorders, anxiety, depression, or aggression (especially in children). Therefore, you must use the lowest possible dose needed to keep your asthma under control.
If stressful or acute situations (eg severe infections, injuries, or operations) occur during the first months after the transition from tablets to inhalation therapy, treatment with tablets or intravenous drip may need to be resumed. The same applies to patients who have already been treated for a long time with high doses of inhaled glucocorticoids. These patients may also have adrenal insufficiency and may need treatment with glucocorticoids in tablet form or as an intravenous drip during periods of stress and/or before a scheduled surgery.
After the transition to inhalation therapy, symptoms may occur that have been prevented during the previous treatment with glucocorticoids in tablet form or intravenous drip, e.g. allergic rhinitis, an allergic rash, or rheumatic symptoms. These symptoms should be treated with appropriate medication. Some patients may experience general malaise for some time after switching to inhalation therapy, even if lung function is unchanged or even improved. In these cases, consult a doctor. The doctor will assess whether your treatment can continue unchanged or whether you should end the treatment, e.g. if you have symptoms of insufficient adrenal function.
Other medicines and Novopulmon Novolizer
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effect of Novopulmon Novolizer and your doctor may want to monitor you closely if you are taking these medicines (eg some HIV medicines: nelfinavir, ritonavir, cobicistat, and medicines to treat fungal diseases: ketoconazole, itraconazole).
Therefore, this combination should be avoided. If this is not possible, the time interval between taking these medicines and budesonide should be as long as possible.
Elevated plasma concentrations and increased efficacy of corticosteroids (which is a steroid hormone) have been observed in women treated concomitantly with estrogen (another steroid hormone) or steroid-containing contraceptives but no effect has been observed with budesonide and concomitant use with combined low-dose oral contraceptives.
Because adrenal function may be impaired, ACTH stimulation tests performed to check pituitary function may give incorrect results (low values).
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.
Pregnancy
Most results from post-marketing studies and information worldwide have not been able to demonstrate an increased risk of side effects for the fetus and the newborn baby when using inhaled budesonide during pregnancy. Both the fetus and the mother need to maintain adequate asthma treatment during pregnancy. Like other medicines given during pregnancy, the benefits of budesonide to the mother should be weighed against the risks to the fetus.
Breast-feeding
Budesonide passes into breast milk. However, no effects on the breast-fed infant are expected at doses used during treatment. Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in breastfeeding women with asthma shows negligible amounts of budesonide in the breast-fed infant.
Novopulmon Novolizer can therefore be used during breastfeeding.
Driving and using machines
Budesonide does not influence the ability to drive and use machines.
Novopulmon Novolizer contains milk sugar (lactose)
Novopulmon Novolizer contains milk sugar ( lactose ), 10.7 mg lactose monohydrate/dose given. The lactose content of a dose usually does not cause any problems in patients with lactose intolerance. Talk to your doctor if you are worried about not being able to tolerate lactose. Milk sugar ( lactose ) contains small amounts of milk protein.
How to use Novopulmon Novolizer
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Patients who have not previously been treated with glucocorticoids and patients who have previously used inhaled steroids
Unless your doctor prescribes otherwise, this dosage is recommended for:
Adults (and older) and children / young people over 12 years:
| Recommended starting dose | 1-2 doses (200-400 micrograms) 1 or 2 times daily |
| Highest recommended dose | 4 doses (800 micrograms) twice daily (daily dose: 1,600 micrograms) |
Children aged 6-12 years:
| Recommended starting dose | 1 dose (200 micrograms) twice daily or 1-2 doses (200-400 micrograms) once daily |
| Highest recommended dose | 2 doses (400 micrograms) twice daily (daily dose: 800 micrograms) |
If you use 1 dose daily, it is recommended that you take this dose in the evening.
Children under 6 years:
Novopulmon Novolizer is not recommended for use in children below 6 years due to insufficient data on safety and efficacy.
Help your child use the Novolizer inhaler correctly.
Children
Regular monitoring of growth in children receiving long-term treatment with high-dose inhaled glucocorticoids is recommended.
Older
Usually, no special dose adjustment is needed. In general, the lowest effective dose for adequate asthma control should be used.
If the symptoms worsen (which you notice, for example, persistent shortness of breath and increased need for other bronchodilators), you should see a doctor as soon as possible. If you have so far taken one inhalation a day, in this case you may need two inhalations daily (in the morning and the evening). Your doctor will decide if your usual dose of Novopulmon Novolizer needs to be increased.
If you have the impression that the effect of Novopulmon Novolizer is too weak or too strong, tell your doctor or pharmacist.
For the treatment of acute asthma symptoms, always take short-acting bronchodilators (beta-2- agonist, eg salbutamol ) with you.
Your doctor may adjust your asthma treatment as you switch from using another inhaled budesonide to Novopulmon Novolizer.
Method of administration
For inhalation.
Perform inhalation according to the instructions in the instructions for use.
Important information about the use
To reduce the risk of fungal infections in the oral cavity and throat as well as hoarseness, it is recommended that you perform inhalation one before a meal and/or that you rinse your mouth with water or brush your teeth after each inhalation.
Duration of treatment
Novopulmon Novolizer is intended for long-term treatment. You should use the medicine regularly as prescribed also during periods when you have no symptoms at all.
If you have not used glucocorticoids before or have been temporarily treated with glucocorticoids for only a short period, regular use of Novopulmon Novolizer as directed will lead to improved breathing after approximately 10 days. However, large accumulations of mucus and inflammatory processes can prevent the passage of airways to such an extent that budesonide can not exert its full effect on the lungs. In these cases, treatment should initially be supplemented with cortisone drugs (systemic glucocorticoids ) in tablet form. After a while, the tablet dose should be gradually reduced while the inhalation treatment is continued.
If you have been taking cortisone for a long time, switch to Novopulmon Novolizer at a time when your symptoms are under control. Usually, the function is then impaired in the adrenal cortex, and intake of cortisone tablets ( systemic intake of glucocorticoid ) should therefore be gradually reduced and must not be stopped abruptly. At the beginning of the transition period, Novopulmon Novolizer should be given as a supplement for approximately 10 days. Depending on how you react to the treatment, then the daily dose of one of the cortisone tablets can be gradually reduced in intervals of one to two weeks.
If you use more Novopulmon Novolizer than you should
You must take a dose as stated on the label on the package or as your doctor has informed you. Do 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 ingested the medicine by mistake, contact a doctor, hospital for risk assessment and advice.
If you forget to use Novopulmon Novolizer
Do not take a double dose to make up for a forgotten dose.
If you stop using Novopulmon Novolizer
Do not stop taking Novopulmon Novolizer without talking to your doctor beforehand, as sudden discontinuation of the medication may make the disease worse.
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.
The main side effects
Mucosal irritation (throat irritation) with accompanying swallowing difficulties, hoarseness, and cough may be common.
Treatment with inhaled budesonide may cause fungal infections of the mouth and throat. Experience has shown that this fungal infection occurs less frequently if inhaled before a meal and/or if the mouth is rinsed or the teeth are brushed after inhalation. In most cases, this condition responds to local antifungal treatment without the need to discontinue treatment with Novopulmon Novolizer.
As is the case with other inhalation treatments, in rare cases of tracheal spasm (paradoxical bronchospasm ) may occur. This is characterized by a transient worsening of shortness of breath and an immediate increase in wheezing after dosing. Only in this case should you discontinue treatment with Novopulmon Novolizer on your own and contact your doctor immediately.
Inhalation of high doses for a long time can increase the tendency for infection. The ability to adapt to stress can be impaired.
Other side effects ar
Uncommon (may affect up to 1 in 100 people):
Depression, anxiety or worry, cataracts, muscle cramps, tremors (tremors), blurred vision.
Rare (may affect up to 1 in 1,000 people):
Allergic reactions (hypersensitivity) and swelling of the face, eyes, lips, mouth, and throat ( angioneurotic edema ), anaphylactic reaction, impaired adrenal insufficiency (adrenal suppression); stunted growth in children and adolescents, restlessness, anxiety, abnormal behavior, feeling of being very hurried and/or irritable (these side effects are more likely to occur in children); skin reactions, i.a. hives, eczema, dermatitis ( dermatitis ), pruritus, redness of the blood vessels due to blood vessels ( erythema ), bruising, alteration of voice and hoarseness (in children).
Very rare (may affect up to 1 in 10,000 people):
Osteoporosis
Has been reported (occurs in the unknown number of users):
Sleep problems, aggression, a strong drive to be physically active with concomitant mental anxiety ( psychomotor hyperactivity); glaucoma. Lactose monohydrate contains small amounts of milk protein and can therefore cause allergic reactions.
How to store Novopulmon Novolizer
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, carton, and cassette container. The expiration date is the last day of the specified month.
Storage instructions
Store the cassette in its original packaging. No special temperature instructions.
Storage during use: Close the Novolizer inhaler tightly. Moisture sensitive.
Information regarding the shelf life of opened packaging
Replace the cartridge six months after opening.
Do not use the powder inhaler for more than 1 year.
Note: The Novolizer inhaler has been shown to work for at least 2,000 separate doses. Therefore, a maximum of 10 cassettes with 200 doses each and/or 20 cassettes with 100 doses each can be used for the inhaler before it is replaced (within one year).
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 pack and other information
Content declaration
- The active substance is budesonide.Each inhalation contains 200 micrograms of budesonide.
- The other ingredient is lactose monohydrate .
What the medicine looks like and contents of the pack
Novopulmon Novolizer, inhalation powder, contains white powder (1.09 g or 2.18 g) in a cassette with 100 or 200 delivered doses packaged in a container sealed with aluminum foil and a Novolizer powder inhaler.
All components are made of plastic material.
Pack sizes:
Original packaging:
1 cartridge with 100/200 doses and 1 Novolizer powder inhaler.
2 cassettes with 200 doses each and 1 Novolizer powder inhaler.
Refill packaging:
1 cassette with 200 dos is.
2 cassettes with 200 doses 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
Manufacturer:
McDermott Laboratories T / A Mylan Dublin
Respiratory
Unit 25 Baldoyle Industrial Estate
Grange Road, Baldoyle
Dublin 13
Ireland