TOBRAMYCIN TEVA

Package leaflet: Information for the user

Tobramycin Teva 300 mg/5 ml Nebuliser solution

Tobramycin
Generic medicine
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because 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 Tobramycin Teva is and what it is used for
2. What you need to know before using Tobramycin Teva
3. How to use Tobramycin Teva
4. Possible side effects
5. How to store Tobramycin Teva
6. Contents of the pack and other information

1. What Tobramycin Teva is and what it is used for

Tobramycin Teva contains the active substance tobramycin, which is an aminoglycoside antibiotic.
Tobramycin Teva is used in patients aged six years and older.
Tobramycin Teva is used to treat chest infections in patients with Cystic Fibrosis (CF) caused by a common bacterium, Pseudomonas aeruginosa. This antibiotic is able to kill the bacterium and helps improve breathing. Because tobramycin is inhaled and not taken as a pill, a higher concentration of the antibiotic reaches the lungs.
Contact your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using Tobramycin Teva

Do not use Tobramycin Teva

• if you are allergic to tobramycin or to any of the other ingredients of this medicine (listed in section 6) or to any other aminoglycoside antibiotic.

Warnings and precautions
Tell your doctor or pharmacist before using Tobramycin Teva if any of the following conditions apply to you:

• if you have hearing problems, have ever experienced ringing in the ears (tinnitus), or have had dizziness; your doctor may need to check your hearing and balance before starting treatment with tobramycin and at any time during therapy;
• if you are coughing up blood; your doctor may ask you to stop using tobramycin until blood in the sputum decreases or disappears;
• if you have kidney problems; your doctor may need to monitor your kidney function;
• if you have experienced muscle weakness – a symptom mainly associated with conditions such as myasthenia gravis or Parkinson’s disease;
• if you have antibiotic resistance; you should discuss this with your doctor.

Take special care with Tobramycin Teva
Inhalation of medicines, including tobramycin, may cause chest tightness. Your doctor will supervise your first dose of Tobramycin Teva and will assess your lung function before and after dosing.
Your doctor may ask you to use a bronchodilator (e.g. salbutamol), if you are not already using one, before taking Tobramycin Teva.

Children
Do not administer this medicine to children under 6 years of age, as sufficient data are not available in this population.

Other medicines and Tobramycin Teva
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
You must not use Tobramycin Teva if you are taking any of the following medicines:

• Diuretics (water tablets) containing furosemide;
• Urea or mannitol used in hospitals to treat serious conditions;
• Medicines that may cause potential kidney or hearing damage may increase their adverse effects when used together with Tobramycin Teva.

You may receive treatment with injections of tobramycin or other aminoglycosides while taking inhaled tobramycin. These injections, which increase the very low levels of aminoglycosides absorbed from inhaled tobramycin, are not recommended if you are concurrently taking any of the following medicines:

• Amphotericin B, cephalothin, cyclosporine, tacrolimus, polymyxin
• Platinum-containing compounds (e.g. carboplatin and cisplatin)
• Anticholinesterases (e.g. neostigmine and pyridostigmine), botulinum toxin.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The potential adverse effects of inhaled tobramycin in pregnant women are unknown. However, high blood levels of tobramycin and similar medicines, which occur when administered by injection, may cause harm to the fetus (e.g. deafness).

Breastfeeding
It is not known whether inhaled tobramycin at the recommended dose passes into breast milk.

Fertility
Effects on fertility are unlikely but cannot be ruled out.

Driving and using machines
Tobramycin Teva has no influence on the ability to drive or operate machinery.

3. How to use Tobramycin Teva

For inhalation use only.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is one vial twice daily for 28 days. The recommended dose is the same for all individuals aged 6 years and older. Inhale the contents of one vial in the morning and the contents of the second vial in the evening. An interval of 12 hours must be maintained between doses.

This will be followed by a 28-day period during which you will not take the medicine, after which you will start another 28-day treatment cycle.

It is important that you continue using the product twice daily for the full 28 days of treatment and that you follow the 28-day cycle of medicine use followed by a 28-day break from using the medicine.

Tobramycin Teva must be used with a reusable PARI LC PLUS nebulizer, clean and dry, and a suitable compressor. Ask your doctor or physiotherapist for advice on which compressor to use.

Your doctor and physiotherapist can advise you on the appropriate method of using the medicine and the necessary equipment. You may need separate nebulizers for using other inhaled medicines such as dornase alfa, which may be used to improve sputum clearance in cystic fibrosis.

Before starting to use Tobramycin Teva, ensure you have the following equipment components:

• Tobramycin vial
• Reusable PARI LC PLUS nebulizer
• Suitable compressor
• Tubing to connect the nebulizer to the compressor
• Clean paper or towel
• Nose clips (if needed)

You must check that the nebulizer and compressor are functioning properly according to the manufacturer's instructions before using the medicine.

Preparation of the medicine for inhalation

1. Wash your hands thoroughly with soap and water.

2. Each aluminum pouch contains 4 vials. Cut or tear open the pouch, take one vial, and store the remaining pouch in the refrigerator.

3. Place the individual components of the PARI LC PLUS nebulizer on a clean, dry sheet of paper or on a towel. You should have the following parts available:
   a. Nebulizer top part
   b. Nebulizer base
   c. Inspiratory valve cap
   d. Mouthpiece with valve
   e. Tubing

4. Separate the upper part of the nebulizer from the lower part: rotate the upper part counterclockwise and then lift it off. Place the upper part on the towel and keep the nebulizer base upright on the towel.
5. Connect one end of the tubing to the air outlet of the compressor. Ensure the tubing is securely attached, and plug the compressor into an electrical outlet.

6. Open the vial by holding the bottom part with one hand and breaking off the top with the other hand. Be careful not to spill the contents of the vial before emptying it into the nebulizer base.

7. When ready, squeeze the entire contents of the vial into the nebulizer base.

8. Reassemble the nebulizer by screwing the upper part onto the base clockwise until it is securely attached.
9. Attach the mouthpiece to the nebulizer. Firmly push the inspiratory valve cap into place on the top of the nebulizer. The inspiratory valve cap must be securely fixed (refer to the instructions for use of the PARI LC PLUS nebulizer).
10. Connect the free end of the tubing to the air inlet on the nebulizer base, making sure to keep the nebulizer in an upright position. Press the tubing firmly onto the air inlet.

Administration of the medicine

1. Turn on the compressor.

2. Make sure a constant mist is coming from the mouthpiece. If no mist is visible, check all connections and ensure the compressor is working properly.

3. Sit or stand in a comfortable position to breathe normally.

4. Place the mouthpiece between your teeth and the upper surface of your tongue. Breathe through your mouth (nose clips may be helpful for this purpose). Try not to block the airflow with your tongue.
5. Continue until all the Tobramycin Teva solution has been used and no more mist is produced.
6. Remember to clean and disinfect the nebulizer after treatment. Never use a nebulizer that appears dirty or blocked. The nebulizer must never be shared with other people.

Approximately 15 minutes are needed to inhale the full dose. When the nebulizer chamber is empty, you will hear a gurgling sound. If treatment is interrupted, or if you need to cough or take a break, turn off the compressor to avoid wasting the medicine. When you are ready to resume treatment, turn the compressor back on.

If you are following several treatments for cystic fibrosis, take the medicines in the following order:

• Bronchodilator (e.g., salbutamol)
• Respiratory physiotherapy
• Other inhaled medicines
• Then Tobramycin Teva

If you have any doubts, check the order of administration with your doctor.

If you use more Tobramycin Teva than you should
If you inhale too much tobramycin, your voice may become very hoarse. Inform your doctor as soon as possible.
If you accidentally swallow Tobramycin Teva, do not worry, but still inform your doctor as soon as possible.

If you forget to use Tobramycin Teva
Do not take a double dose to make up for a forgotten dose.
You must not take two doses within six hours. Take the missed dose immediately if at least six hours remain before the next dose, or skip the missed dose if less than six hours remain before the next dose.

If you stop using Tobramycin Teva
Do not stop using Tobramycin Teva until you have completed the full treatment cycle or your doctor tells you it is safe to do so.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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)
• Allergic reactions and hypersensitivity reactions, including hives and itching (very rare)

If you experience any of these side effects, stop taking Tobramycin Teva and inform your doctor immediately.
The following side effects have been reported at the approximate frequencies listed below:

Uncommon (may affect up to 1 in 100 people):

• Voice changes (hoarseness)
• Increased cough
• Shortness of breath
• Sore throat

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

• Chest pain
• General pain
• Laryngitis (voice changes with sore throat and difficulty swallowing)
• Ringing in the ears
• Mouth ulcers
• Skin rash
• Weakness
• Fever
• Headache
• Feeling of discomfort (nausea)
• Malaise (vomiting)
• Loss of appetite
• Dizziness
• Increased sputum production
• Coughing up blood
• Loss of voice
• Nosebleeds
• Runny nose
• Taste disturbances
• Asthma
• Back pain
• Patients who have received Tobramycin Teva concomitantly with, or following repeated doses of intravenous tobramycin or related medicines, may develop hearing loss.

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

• Abdominal pain
• Ear pain
• Diarrhoea
• Fungal infections (e.g. candidiasis)
• Swelling of the lymph glands
• Somnolence
• Hyperventilation
• Sinusitis
• Feeling of general malaise or feeling unwell

Patients with cystic fibrosis have many symptoms of the disease. These symptoms may still occur during treatment with Tobramycin Teva, but should not become more frequent or worse than before.
Patients have commonly experienced symptoms such as change in sputum colour, chest infection, muscle pain, nasal polyps, and ear infections.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tobramycin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging, on the sachet, and on the
vial after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 – 8°C). Do not freeze. The sachets (opened or unopened) may be stored at room
temperature (not exceeding 25°C) for a maximum period of 28 days. Keep in the original packaging to
protect from light. Never store an opened vial. Once the vial has been opened, it must be used immediately.
Do not use this medicine if you notice any visible signs of deterioration (cloudy appearance or presence of
particles in the solution). Tobramycin solution is pale yellow in colour, but some variation in colour may be
observed; this does not indicate loss of activity of the product provided the solution has been stored as
recommended.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tobramycin Teva contains:

• The active substance is Tobramycin. Each 5 ml single-dose vial contains 300 mg of tobramycin.
• The other components are: sodium chloride, water for injections, sulfuric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Description of the appearance of Tobramycin Teva and contents of the pack
Tobramycin Teva is a clear, slightly yellow solution.
Tobramycin Teva is supplied in 5 ml single-dose vials.
Each sealed aluminum pouch contains four vials.
Each carton contains 14 (56 vials), 28 (112 vials), or 42 (168 vials) pouches, sufficient for one, two, or three treatment cycles, respectively.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturers:
Norton Healthcare Limited
T/A Ivax Pharmaceuticals UK,
Preston Brook,
Runcorn,
Cheshire,
WA7 3FA,
United Kingdom
Pharmachemie B.V.
Swensweg 5 – 2031 GA
Haarlem - The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Tobramycin TEVA
Germany Tobramycin Teva® 300 mg/5 ml Steri-Neb® Lösung für einen Vernebler
Ireland Tymbrineb 300 mg/5 ml Nebuliser Solution
Italy Tobramicina Teva 300 mg/5 ml solution for nebuliser
Portugal Tobramicina Teva
Spain Tobramicina Teva 300 mg/5 ml solución para inhalador
The Netherlands Tobramycine Steri-Neb 300 mg/5 ml, vernevelossing
United Kingdom Tymbrineb 300 mg/5 ml Nebuliser Solution