Vantobra

Patient Information Leaflet

Vantobra 170 mg solution for nebuliser

Tobramycin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vantobra is and what it is used for
2. What you need to know before using Vantobra
3. How to use Vantobra
4. Possible side effects
5. How to store Vantobra
6. Contents of the pack and other information

1. What Vantobra is and what it is used for

What Vantobra is
Vantobra contains a medicine called tobramycin. It belongs to a group of antibiotics called aminoglycosides.
What Vantobra is used for
Vantobra is used in patients with cystic fibrosis who are at least 6 years of age, for the treatment of lung infections caused by bacteria called Pseudomonas aeruginosa.
Pseudomonas aeruginosa is a bacterium that frequently infects the lungs of patients with cystic fibrosis during their lifetime. If the infection is not properly treated, it continues to damage the lungs, leading to further breathing problems.
How Vantobra works
When Vantobra is inhaled, the antibiotic is able to penetrate directly into the lungs and fight the bacteria causing the infection. The antibiotic works by interfering with the production of proteins that bacteria need to build their cell walls. This damages the bacteria, ultimately killing them.

2. What you need to know before using Vantobra

Do not use Vantobra

• if you are allergic to tobramycin, to any type of aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before using Vantobra.

Warnings and precautions
Talk to your doctor if you have ever had any of the following conditions:

• hearing problems (including ringing in the ears and dizziness)
• kidney problems
• chest tightness
• presence of blood in the sputum (the substance produced by coughing)
• prolonged or worsening muscle weakness – a symptom mainly associated with conditions such as myasthenia (muscle weakness) or Parkinson’s disease. If you are in any of these situations, inform your doctor before using Vantobra.

If you have hearing or kidney function problems, your doctor may take blood samples to monitor the amount of Vantobra in your body.
If you or your maternal relatives have a mitochondrial mutation disease (a genetic disorder) or hearing loss caused by antibiotics, we recommend that you inform your doctor or pharmacist before taking this medicine; certain mitochondrial mutations may increase the risk of hearing loss with this medicine. Your doctor may recommend genetic testing before administering Vantobra.
Inhalation of medicines can cause a sensation of chest tightness due to narrowing of the airways, and this may occur with Vantobra. Your doctor may ask you to use other appropriate medicines to dilate the airways before using Vantobra.
Over time, some strains of Pseudomonas may become resistant to treatment with an antibiotic. This means that, in the long term, the effectiveness of Vantobra may decrease. Inform your doctor if you are concerned about this.
If you are also taking tobramycin or another aminoglycoside antibiotic by injection, this may increase the risk of side effects, and your doctor will perform appropriate monitoring.

Children
This medicine is not intended for use in children under 6 years of age.

Other medicines and Vantobra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Do not take the following medicines while using Vantobra:

• furosemide, a diuretic
• other potentially diuretic medicines, such as urea or mannitol
• other medicines that may damage the kidneys or hearing:
  o amphotericin B, cephalothin, polymyxins (for the treatment of microbial infections), cyclosporine, tacrolimus (to reduce the activity of the immune system). These medicines can damage the kidneys.
  o platinum compounds, such as carboplatin and cisplatin (for the treatment of certain types of cancer). These medicines can damage the kidneys or hearing.

The following medicines may increase the risk of side effects if administered while you are also taking tobramycin or another aminoglycoside antibiotic by injection:

• anticholinesterases, such as neostigmine and pyridostigmine (for the treatment of muscle weakness), or botulinum toxin. These medicines may cause muscle weakness or worsening of existing muscle weakness. If you are taking one or more of these medicines, inform your doctor before using Vantobra.

Do not mix or dilute Vantobra with other medicines in the nebulizer mouthpiece Tolero provided with Vantobra.
If you are following various treatments for cystic fibrosis, take them in the following order:

1. Bronchodilator therapy, such as salbutamol
2. Chest physiotherapy
3. Other inhaled medicines
4. Vantobra
   Confirm this order with your doctor as well.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before using this medicine.
It is not known whether inhaling this medicine during pregnancy may cause adverse effects.
When administered by injection, tobramycin and other aminoglycoside antibiotics can harm the fetus, for example by causing deafness and kidney problems.
If you are breastfeeding, talk to your doctor before using this medicine.

Driving and using machines
Vantobra is not expected to affect your ability to drive or use machinery.

3. How to use Vantobra

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The recommended dose is two vials per day (one in the morning and one in the evening) for 28 days.

• The dose is the same for all individuals aged 6 years and older.
• Inhale the entire contents of one vial in the morning and one vial in the evening through the mouth, using the Tolero nebulizer mouthpiece.
• It is recommended that 12 hours elapse between doses, but the interval must be at least 6 hours.
• After using the medicine for 28 days, you will stop taking it for another 28 days and will not inhale Vantobra during this period. Afterwards, you will start another cycle after the rest period (as shown below).
• It is important that you continue to use the medicine twice daily during the 28-day treatment period and that you follow the 28-day treatment / 28-day no-treatment regimen.

IN TREATMENT with Vantobra  NOT IN TREATMENT with Vantobra
Use Vantobra twice daily for 28 days  Do not use Vantobra for the next 28 days
Repeat the cycle
Continue using Vantobra in this cyclic manner until your doctor tells you otherwise.
If you have any questions about how long to use Vantobra, consult your doctor or pharmacist.

How to prepare Vantobra for inhalation

• Use Vantobra only with the Tolero nebulizer mouthpiece shown in the illustration below to ensure you inhale the correct dose. Do not use the Tolero nebulizer mouthpiece for any other medicine.
• Read the instructions for use provided with the nebulizer mouthpiece before using it.

• Check that you have an eTrack unit or eBase Controller to which the Tolero nebulizer mouthpiece can be connected. The respective control unit may be prescribed by your doctor or purchased separately.
• Wash your hands thoroughly with soap and water.
• Remove one vial of Vantobra from the aluminum pouch just before inhalation.
• Store the remaining medicine in the refrigerator, in the original packaging.
• Place all components of the Tolero nebulizer mouthpiece on clean, dry paper towels or a clean, dry cloth. Ensure the nebulizer mouthpiece is placed on a flat, stable surface.
• Assemble the Tolero nebulizer mouthpiece as illustrated in the device’s instructions for use.
• Hold the vial upright and gently tap it before breaking the top to avoid spillage. Pour the contents of one vial into the medication chamber of the Tolero nebulizer mouthpiece.
• Begin treatment by sitting upright in a well-ventilated room. Hold the nebulizer mouthpiece horizontally and breathe normally through your mouth. Avoid breathing through your nose. Continue to inhale and exhale gently until the treatment is complete. When all the medicine has been delivered, you will hear an audible signal confirming that the treatment is finished.
• If you need to interrupt the treatment for any reason, press and hold the On/Off button for one full second. To resume treatment, press and hold the On/Off button again for one full second.
• The Tolero nebulizer mouthpiece must be cleaned and disinfected as described in the device’s instructions for use.
• Use a new Tolero nebulizer mouthpiece for each treatment cycle (28 days of treatment), as supplied with the medicine.

Do not use other untested nebulization systems, as they may alter the amount of medicine reaching the lungs. This, in turn, may affect the medicine’s efficacy and safety.

If you use more Vantobra than you should
If you inhale too much Vantobra, your voice may become very hoarse. Inform your doctor as soon as possible. If Vantobra is swallowed, it is unlikely to cause serious problems, as tobramycin is poorly absorbed from the stomach. However, you should still inform your doctor as soon as possible.

If you forget to use Vantobra
If you forget to use Vantobra and there are at least 6 hours remaining before your next dose, take your missed dose as soon as possible. Otherwise, wait until your next scheduled dose. Do not use a double dose to make up for the missed dose.

If you stop treatment with Vantobra
Do not stop using Vantobra unless your doctor tells you to do so, as your lung infection may not be adequately controlled and could worsen.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• chest tightness with difficulty breathing (rare, affects up to 1 in 1,000 people)
• allergic reactions, including hives and itching (very rare, affects up to 1 in 10,000 people). If you experience any of these conditions, stop using Vantobra and contact your doctor immediately.

People with cystic fibrosis may have many symptoms related to their disease. These symptoms may also occur during treatment with Vantobra, but they should not become more frequent or worse than before.
If your underlying lung condition appears to worsen during treatment with Vantobra, inform your doctor immediately.

Other possible side effects include:
Uncommon (may affect up to 1 in 100 people)

• shortness of breath
• voice changes (hoarseness)
• increased coughing
• sore throat

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

• laryngitis (inflammation of the larynx which may cause voice changes, sore throat, and difficulty swallowing)
• loss of voice
• headache, weakness
• nosebleeds, runny nose
• ringing in the ears (usually temporary), hearing loss, dizziness
• bloody cough, increased sputum production, chest discomfort, asthma, fever
• taste disturbances, nausea, mouth ulcers, vomiting, loss of appetite
• skin rash
• chest pain or generalised pain
• worsening of lung function test results

Very rare (may affect up to 1 in 10,000 people)

• fungal infections of the mouth or throat, such as thrush
• swollen lymph glands
• drowsiness
• earache, ear problems
• hyperventilation, low blood oxygen levels, sinusitis
• diarrhoea, pain inside and around the stomach
• appearance of red pustules, skin papules
• hives, itching
• back pain
• feeling of general malaise

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vantobra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial, sachet, or carton after "Exp." The expiry date refers to the last day of that month.
Store in the refrigerator (2°C – 8°C). If you do not have access to a refrigerator (for example, when transporting the medicine), the carton containing the medicine (even if the sachets are opened) may be stored at a temperature below 25°C for up to 4 weeks. If the medicine has been stored at room temperature for more than 4 weeks, it must be disposed of according to local regulations.
Do not use this medicine if you notice it has become cloudy or if the solution contains particles.
Never store an opened vial. After opening, the vial must be used immediately and any remaining product must be discarded.
Do not dispose of any medicine via household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Vantobra contains

• The active substance is tobramycin. Each vial contains 170 mg of tobramycin as a single dose.
• The other components are: sodium chloride, calcium chloride, magnesium sulfate, water for injections, sulfuric acid, and sodium hydroxide for pH adjustment.

Description of the appearance of Vantobra and contents of the pack
Vantobra solution for nebuliser is supplied in a ready-to-use vial.
Vantobra is a solution ranging from colourless to slightly yellow, and its colour may vary to a darker yellow.
This does not affect how Vantobra works, provided that storage instructions have been followed.
Eight vials are packed in a sachet, corresponding to four days of treatment.
Vantobra is available together with the Tolero nebuliser mouthpiece. It is supplied in a carton containing two inner boxes: one with the medicinal product (56 vials of solution for nebuliser, in 7 sachets) and one with the nebuliser mouthpiece. One pack is sufficient for one treatment cycle of 28 days.

Marketing Authorisation Holder and Manufacturer
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany
Tel.: +49 (0) 89 – 74 28 46 - 10
Fax: +49 (0) 89 – 74 28 46 30
E-Mail: [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.