Tobramycin Sun 300 mg/5 ml solution for inhalation by nebulizer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tobramycin SUN 300 mg/5 ml solution for inhalation by nebulizer
tobramycin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Tobramycin SUN is and what it is used for
- What you need to know before using Tobramycin SUN
- How to use Tobramycin SUN
- Possible adverse effects
- How to store Tobramycin SUN
- Contents of the pack and other information
1. What Tobramycin SUN is and what it is used for
Tobramycin SUN contains an antibiotic medicine called tobramycin. This belongs to a class of antibiotic medicines known as aminoglycosides.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.
It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.
Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in household waste.
Tobramycin SUN is used in patients aged 6 years and older who have cystic fibrosis, for the treatment of lung infections caused by a bacterium called Pseudomonas aeruginosa.
Tobramycin SUN fights the infection caused by Pseudomonas bacteria in your lungs and helps improve your breathing.
When you inhale Tobramycin SUN, the antibiotic goes directly to your lungs to fight the bacteria causing the infection. For the best effect from this medicine, follow the instructions in this leaflet.
What is Pseudomonas aeruginosa?
Pseudomonas aeruginosa is a very common bacterium that infects almost all patients with cystic fibrosis at some point in their lives. Some individuals do not acquire this infection until later in life, while others are affected at a young age.
This bacterium is one of the most harmful to people with cystic fibrosis. If the infection is not adequately controlled, it may continue to damage your lungs, causing further breathing problems.
Tobramycin SUN kills the bacteria causing lung infections. This infection can be successfully controlled if treated early.
2. What you need to know before using Tobramicina SUN
Do not use Tobramicina SUN:
- if you are allergic to tobramycin, to any aminoglycoside antibiotic, or to any of the other components of this medicine (listed in section 6).
If any of the above cases apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor before using Tobramicina SUN if you have or have ever had any of the following conditions:
- hearing problems (including ringing in the ears and dizziness)
- kidney problems
- unusual difficulty breathing with wheezing or coughing, chest tightness
- blood in your sputum (the substance you cough up)
- muscle weakness that lasts or worsens over time, for example, symptoms related to myasthenia (muscle weakness) or Parkinson's disease
- if you or your family members have a mitochondrial mutation disorder (a condition caused by variants in the mitochondrial genome, the parts of your cells that help produce energy) or hearing loss due to taking antibiotic medicines; certain mitochondrial mutations may increase the risk of hearing loss when taking this medicine.
If any of these situations apply to you, inform your doctor before using Tobramicina SUN.
Inhaling medication may cause chest tightness and wheezing, and this may occur with Tobramicina SUN. Your doctor will supervise your first dose of Tobramicina SUN and monitor your lung function before and after the dose. If you are not already doing so, your doctor may ask you to use a bronchodilator (e.g., salbutamol) before using Tobramicina SUN.
While using Tobramicina SUN, Pseudomonas strains may over time become resistant to treatment. This means that over time, the medicine may not work as well as expected. Speak with your doctor if you are concerned about this.
If tobramycin is administered by injection, it may occasionally cause hearing loss, dizziness, and kidney damage, and may harm the fetus.
Children and adolescents
Tobramicina SUN can be administered to children and adolescents aged 6 years and older. Tobramicina SUN must not be given to children under 6 years of age.
Elderly
If you are 65 years old or older, your doctor may carry out additional tests to determine whether Tobramicina SUN is an appropriate treatment for you.
Other medicines and Tobramicina SUN
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
DO NOT take the following medicines while using Tobramicina SUN:
- furosemide or ethacrynic acid, diuretics (medicines for fluid retention)
- other medicines that may affect kidney function, such as intravenous urea or mannitol
- other medicines that may damage your nervous system, kidneys, or ears.
The following medicines may increase the risk of harmful effects if administered while you are receiving injections of tobramycin:
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- amphotericin B, cephalothin, cyclosporine, polymyxins (used to treat microbial infections), tacrolimus (used to reduce immune system activity). These medicines may damage your kidneys
- platinum compounds such as carboplatin and cisplatin (used to treat certain types of cancer). These medicines may damage your kidneys or ears
- medicines with anticholinesterase activity, such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines may cause the onset or worsening of muscle weakness.
If you are taking one or more of the medicines listed above, discuss this with your doctor before using Tobramicina SUN.
Do not mix or dilute Tobramicina SUN with any other medicine in your nebulizer.
If you are taking several different treatments for cystic fibrosis, you should take them in the following order:
- bronchodilator treatment, such as salbutamol
- chest physiotherapy
- other inhaled medicines
- Tobramicina SUN last
Confirm this order with your doctor as well.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether inhaling this medicine during pregnancy causes adverse effects. When administered by injection, tobramycin and other aminoglycoside antibiotics may cause harm to the fetus, such as deafness.
Breastfeeding
If you are breastfeeding, consult your doctor before using any medicine.
Driving and using machines
Tobramicina SUN is not expected to affect your ability to drive or use machines.
3. How to use Tobramycin SUN
Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor again.
The recommended dose is two vials each day (one in the morning and one in the evening) for 28 days.
- The recommended dose is the same for all individuals aged 6 years and above.
- Inhale through the mouth the complete contents of one vial in the morning and another in the evening using the nebulizer.
- It is best if the interval between doses is as close as possible to 12 hours, but this interval must be at least 6 hours.
- After taking your medicine for 28 days, there will be a 28-day break during which you must not inhale any dose of Tobramycin SUN. Then another cycle will begin after the break (as illustrated).
- It is important that you continue using the product twice daily throughout your 28-day treatment period and that you follow the cycles of 28 days on, 28 days off.
With Tobramycin SUN | Without Tobramycin SUN |
Take Tobramycin SUN twice daily, every day for 28 days | Do not take Tobramycin SUN for the next 28 days |
Repeat the cycle
Continue using Tobramycin SUN according to this cyclic regimen for as long as your doctor instructs you. If you have any doubts about the duration of treatment with Tobramycin SUN, consult your doctor or pharmacist.
Instructions for using Tobramycin SUN
This section of the leaflet explains how to use, care for, and handle Tobramycin SUN. Please read and follow these instructions carefully.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Equipment needed to inhale Tobramycin SUN
Tobramycin SUN must be used with a clean, dry, reusable nebulizer.
The LC PLUS nebulizer (manufactured by PARI GmbH) is suitable for use with Tobramycin SUN.
Your doctor or physiotherapist can advise you on the correct use of Tobramycin SUN and the equipment you need. You may require different nebulizers for your other inhaled medications for cystic fibrosis.
Preparing Tobramycin SUN for inhalation
- Wash your hands thoroughly with soap and water.
- Each aluminum foil pouch contains 4 ampoules. Cut or tear open the pouch. Remove one ampoule of Tobramycin SUN from the aluminum pouch. Store the remaining ampoules refrigerated in the original packaging.
- Lay out the parts of your nebulizer on a clean, dry paper or cloth towel.
- Make sure you have the correct compressor and tubing to connect the nebulizer to the compressor.
- Carefully follow the instructions for your specific nebulizer model. You must read the instruction manual provided by the manufacturer with the nebulizer. Check that your nebulizer and compressor are working properly according to the manufacturer's instructions before starting to use your medication.
Using Tobramycin SUN with LC PLUS (PARI GmbH)
For more detailed instructions on the use and care of the nebulizer, refer to the leaflet provided with the PARI LC PLUS.
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Remove the top part of the nebulizer by turning it counterclockwise and lifting it off. Place this top part on the towel and stand the nebulizer chamber upright on the towel.
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Connect one end of the tubing to the air outlet of the compressor. Ensure the tubing fits securely. Connect one end of the tubing to the air outlet of the compressor.
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Open the Tobramycin SUN ampoule by holding the lower tab with one hand and twisting and pulling off the top tip with the other hand. Empty the entire contents of the ampoule into the nebulizer chamber.
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Replace the top part of the nebulizer, attach the mouthpiece, and place the inspiratory valve cap onto the nebulizer. Then connect the compressor as described in the instruction manual for your PARI LC PLUS nebulizer.
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Turn on the compressor. Check that a constant mist is coming from the mouthpiece. If no mist is visible, check all tubing connections and ensure the compressor is functioning properly.
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Sit or stand in a position that allows you to breathe normally.
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Place the mouthpiece between your teeth and over the tip of your tongue. Breathe normally, but only through your mouth (if your doctor considers it appropriate, you may use a nose clip). Try not to block the airflow with your tongue.
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Continue until all the Tobramycin SUN has been used and no more mist is produced. The complete inhalation should take approximately 15 minutes. You may hear a gurgling sound when the nebulizer chamber is empty.
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Remember to clean and disinfect your nebulizer after treatment according to the manufacturer's instruction manual. Never use a dirty or clogged nebulizer. Do not share your nebulizer with other people.
If you are interrupted, or need to cough or rest during administration, turn off the compressor to avoid wasting the medication.
Turn the compressor back on when you are ready to resume treatment. Skip this dose if your next dose is due in less than 6 hours.
If you use more Tobramycin SUN than you should
If you inhale too much Tobramycin SUN, your voice may become very hoarse. Be sure to inform your doctor as soon as possible. If you swallow Tobramycin SUN, inform your doctor as soon as possible.
If you forget to use Tobramycin SUN
If you forget to use Tobramycin SUN and there are at least 6 hours until your next dose, take the missed dose as soon as possible. Otherwise, wait until your next scheduled dose. Do not take a double dose to make up for a missed dose.
If you stop using Tobramycin SUN
Do not stop using Tobramycin SUN unless your doctor tells you to, as the lung infection may not be adequately controlled and could worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects
Stop using Tobramycin SUN and contact your doctor immediately if you experience any of the following:
- unusual difficulty breathing with wheezing or coughing and chest tightness
- allergic reactions, including hives and itching
Contact your doctor immediately if you experience any of the following adverse effects:
- hearing loss (ringing in the ears is a potential warning sign of hearing loss), noises (such as whistling) in the ears
Your underlying lung disease may worsen while using Tobramycin SUN. This may be due to lack of effectiveness. Inform your doctor immediately if this occurs.
Other adverse effects
Inform your doctor as soon as possible if you experience any of the following adverse effects:
Very common (may affect more than 1 in 10 people)
- runny or stuffy nose, sneezing
- voice changes (hoarseness)
- discoloration of the substance you cough up (sputum)
- worsening of pulmonary function test results
Common (may affect up to 1 in 10 people)
- general feeling of malaise
- muscle pain
- voice changes with sore throat and difficulty swallowing (laryngitis)
Other adverse effects
- itching
- itchy skin rash
- skin rash
- loss of voice
- altered sense of taste
- sore throat
Frequency not known (cannot be estimated from available data)
- increased amount of substance coughed up (sputum)
- chest pain
- reduced appetite
If you have received Tobramycin SUN at the same time as, or following, repeated courses of injected tobramycin or other aminoglycoside antibiotics, hearing loss has been reported as a side effect.
Injections of tobramycin or other aminoglycosides may cause allergic reactions, hearing problems, and kidney problems.
Patients with cystic fibrosis have various symptoms specific to the disease. These may occur even while taking Tobramycin SUN, but should not become more frequent or appear worse than before treatment.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tobramycin SUN
Keep this medicine out of the sight and reach of children.
Do not use Tobramycin SUN after the expiry date stated on the pack, on the pouch, or printed on the vial after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). If a refrigerator is not available (for example, during transport of the medicine), the aluminium pouches (opened or unopened) may be kept at room temperature (not above 25°C) for a maximum of 28 days. Do not use Tobramycin SUN vials if they have been stored at room temperature for more than 28 days.
Keep the vials in the original packaging to protect them from light. This medicine is usually colourless to pale yellow, but the colour may vary and sometimes it may be dark yellow. This does not affect the activity of the medicine, provided storage instructions are followed.
Do not use this medicine if you notice it has become cloudy or if there are particles in the solution.
Never store an opened vial. Once a vial has been opened, it must be used immediately and any unused portion must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Tobramycin SUN
- The active substance is tobramycin. Each 5 ml vial contains 300 mg of tobramycin, corresponding to 60 mg/ml.
- The other components are sodium chloride, water for injections, sulfuric acid (E513) (to adjust pH) and/or sodium hydroxide (E524) (to adjust pH).
Appearance of the product and contents of the container
Tobramycin SUN solution for inhalation by nebulizer is a clear, colourless to pale yellow solution, free from visible particles.
Tobramycin SUN is supplied as a ready-to-use vial. The vials are packed in aluminium foil pouches; each aluminium pouch contains 4 vials, corresponding to 2 days of treatment.
Tobramycin SUN is available in pack sizes of 56, 112 or 168 vials, which are sufficient for one, two or three treatment cycles, respectively.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia SA
Str. Fabricii Nr. 124
400632, Cluj-Napoca
Romania
For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:
Local Representative
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 Barcelona
Spain
Tel: +34 93 342 78 90
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany: Tobramycin SUN 300 mg Lösung für einen Vernebler
Denmark: Tobramycin SUN 300 mg/5 ml inhalationsvæske til nebulisator, opløsning
Spain: Tobramicina SUN 300 mg/5 ml solución para inhalación por nebulizador
France: Tobramycine SUN 300 mg/5 ml solution pour inhalation par nébuliseur
Italy: Tobramicina SUN 300 mg/5 ml soluzione per nebulizzatore
The Netherlands: Tobramycine SUN 300 mg/5 ml verneveloplossing
Poland: Tobramycyna SUN 300 mg/5 ml roztwór do nebulizacji
Romania: Tobramicina SUN 300 mg/5 ml solutie pentru nebulizator
United Kingdom (Northern Ireland): Tobramycin 300 mg/5 ml nebuliser solution
Date of the latest revision of this leaflet: September 2021