Scinorus
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: information for the user
Scinorus 7 micrograms, inhalation powder, hard capsule
Tiotropium
Equivalent 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 or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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
- What Scinorus is and what it is used for
- What you need to know before using Scinorus
- How to use Scinorus
- Possible side effects
- How to store Scinorus
- Contents of the pack and other information
1. What Scinorus is and what it is used for
Scinorus helps adults with chronic obstructive pulmonary disease (COPD) to breathe more easily.
COPD is a chronic lung disease that causes shortness of breath and cough. The term COPD is associated with
chronic conditions of bronchitis and emphysema. Since COPD is a chronic disease, Scinorus must be
used every day, not only when breathing problems or other COPD symptoms occur.
Scinorus is a long-acting bronchodilator that helps widen the airways and makes it easier for air to move in and
out of the lungs. Regular use of Scinorus can also help when you experience disease-related shortness of breath,
and will help minimize the impact of the disease on your daily life.
It also allows you to stay active for longer. Daily use of Scinorus also helps prevent sudden short-term worsening
of COPD symptoms, which may last for several days.
The effect of this medicine lasts 24 hours; therefore, it should be used once daily. For the correct dosage of Scinorus,
see section 3. How to use Scinorus and the instructions for use provided on the back of the package leaflet.
2. What you need to know before using Scinorus
Do not use Scinorus:
- if you are allergic to tiotropium or to any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to atropine or to substances related to it, such as ipratropium or oxitropium.
Warnings and precautions
Talk to your doctor or pharmacist before using Scinorus
- Inform your doctor if you have narrow-angle glaucoma, prostate problems, or if you have difficulty urinating.
- If you have kidney problems, consult your doctor.
- This medicine is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD); it must not be used to treat sudden episodes of shortness of breath or wheezing.
- Immediate allergic reactions such as skin rash, swelling, itching, shortness of breath or wheezing may occur after administration of this medicine. If this happens, consult your doctor immediately.
- Inhaled medicines such as Scinorus may cause chest tightness, cough, shortness of breath or wheezing immediately after inhalation. If this occurs, consult your doctor immediately.
- Carefully avoid letting the inhaled powder come into contact with your eyes, as this may trigger or worsen narrow-angle glaucoma, an eye disease. Pain or discomfort in the eyes, blurred vision, seeing halos around lights or colored images associated with red eyes may be signs of an acute attack of narrow-angle glaucoma. Eye symptoms may be accompanied by headache, nausea, or vomiting. Discontinue use of tiotropium bromide and consult your doctor immediately, preferably an eye specialist, if signs or symptoms of narrow-angle glaucoma occur.
- Dry mouth, which has been observed with long-term anticholinergic treatment, may be associated with dental caries. Therefore, good dental hygiene is recommended.
- If you have suffered a myocardial infarction within the last 6 months, or have any unstable or life-threatening irregular heart rhythm, or severe heart failure within the past year, inform your doctor. This information is important to determine whether Scinorus is the right medicine for you.
Do not use Scinorus more than once a day.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and Scinorus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Inform your doctor or pharmacist if you are using or have recently used similar medicines for your lung condition, such as ipratropium or oxitropium.
No specific adverse effects have been reported following the use of Scinorus in combination with other medicines used to treat COPD, such as inhaled symptom-relieving medicines (e.g. salbutamol), methylxanthines such as theophylline, and/or steroids administered orally or by inhalation, such as prednisolone.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Do not use this medicine unless specifically recommended by your doctor.
Driving and using machines
Dizziness, blurred vision, or headache may affect your ability to drive or operate machinery.
Scinorus contains lactose
Each capsule delivers up to 22 mg of lactose when the medicine is used according to the recommended dosage of one capsule once daily. If your doctor has diagnosed you with an intolerance to certain sugars or an allergy to milk proteins (which may be present in small amounts in lactose), contact your doctor before taking this medicine.
3. How to use Scinorus
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is inhalation of the contents of 1 capsule (delivered dose of 7 micrograms of tiotropium) once daily. Do not use a higher dose than recommended.
Try to use the capsule at the same time each day. This is important because Scinorus is effective for 24 hours.
The capsules are for inhalation only and must not be taken orally.
Do not swallow the capsules.
The Vertical-Haler device, into which the Scinorus capsule must be placed, pierces the capsule and allows inhalation of the powder.
Make sure you have a Vertical-Haler device and that you use it correctly. Instructions for use are provided on the reverse of this leaflet.
Ensure that you do not blow into the device.
If you have any difficulty using the Vertical-Haler, ask your doctor, nurse, or pharmacist to show you how it works.
You must clean the inhaler once a month. Cleaning instructions are provided on the reverse of this leaflet.
When taking Scinorus, take care to avoid the powder entering your eyes. If this happens, you may experience blurred vision, eye pain and/or redness. In such a case, immediately rinse your eyes with lukewarm water and then contact your doctor immediately for further advice.
If you notice that your breathing worsens, inform your doctor as soon as possible.
If you use more Scinorus than you should
If you inhale the contents of more than 1 Scinorus capsule in one day, contact your doctor immediately. You may be at increased risk of experiencing side effects such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision.
If you forget to use Scinorus
If you forget to inhale a dose, take it as soon as you remember, but do not inhale a double dose at the same time or on the same day. Then take the next dose at your usual time.
If you stop using Scinorus
Before stopping treatment with Scinorus, consult your doctor or pharmacist.
If you stop treatment with Scinorus, the signs and symptoms of COPD may 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.
After administration of Scinorus, serious side effects may occur, including allergic reactions causing swelling of the face or throat (angioedema), or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), either alone or as part of a severe allergic reaction (anaphylactic reaction). In addition, as with other inhaled medicines, some patients may experience unexpected chest tightness, cough, breathlessness or shortness of breath immediately after inhalation (bronchospasm). If any of these effects occur, consult your doctor immediately.
The side effects described below have been reported in people who have used this medicine and are listed by frequency, categorized as common, uncommon, rare, or not known.
Common (may affect up to 1 in 10 people):
- Dry mouth: usually mild
Uncommon (may affect up to 1 in 100 people):
- Dizziness
- Headache
- Taste disturbances
- Blurred vision
- Irregular heartbeat (atrial fibrillation)
- Inflammation of the throat (pharyngitis)
- Hoarseness (dysphonia)
- Cough
- Heartburn (gastroesophageal reflux disease)
- Constipation
- Fungal infections of the mouth and throat (oropharyngeal candidiasis)
- Rash
- Difficulty urinating (urinary retention)
- Pain during urination (dysuria)
Rare (may affect up to 1 in 1,000 people):
- Difficulty sleeping (insomnia)
- Halos around lights or colored images together with red eyes (glaucoma)
- Increased measured eye pressure
- Irregular heartbeat (supraventricular tachycardia)
- Fast heartbeat (tachycardia)
- Awareness of heartbeat (palpitations)
- Chest tightness, cough, breathlessness or shortness of breath (bronchospasm)
- Nosebleeds (epistaxis)
- Inflammation of the larynx (laryngitis)
- Inflammation of the paranasal sinuses (sinusitis)
- Bowel obstruction or absence of bowel movements (intestinal obstruction including paralytic ileus)
- Inflammation of the gums (gingivitis)
- Inflammation of the tongue (glossitis)
- Difficulty swallowing (dysphagia)
- Inflammation of the mouth (stomatitis)
- Feeling unwell (nausea)
- Hypersensitivity, including immediate reactions
- Hives (urticaria)
- Itching (pruritus)
- Swelling of the face or throat (angioedema)
- Urinary tract infections
Frequency not known (frequency cannot be estimated from the available data):
- Loss of body fluids (dehydration)
- Dental caries
- Skin infections or ulcerations
- Dry skin
- Swelling of joints
- Severe allergic reaction (anaphylactic reaction)
Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at the following website: http://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 Scinorus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the label of the bottle.
The expiry date refers to the last day of that month.
Dispose of the Vertical-Haler device 6 months after first use.
Store in the original packaging (bottle in the aluminium foil pouch) to protect the medicine from moisture and light.
After opening the pouch, keep the bottle tightly closed to protect the medicine from moisture and light.
Use the capsules within 60 days of opening the pouch.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Scinorus contains
The active substance is tiotropium. Each capsule contains 8.8 micrograms of tiotropium. During inhalation,
7.0 micrograms are delivered from the mouthpiece of the Vertical-Haler device.
The other ingredients are lactose and monohydrate lactose (which may contain small amounts of milk proteins). The capsule shell contains hypromellose.
Description of the appearance of Scinorus and contents of the pack
Scinorus inhalation powder, hard capsule, is a transparent hard capsule containing a white to off-white powder.
The product is available in the following pack sizes:
One pack containing 30 capsules (one bottle packaged in an aluminum pouch) and 1 Vertical-Haler.
One pack containing 60 capsules (two bottles individually packaged in aluminum pouches) and 1 Vertical-Haler.
One pack containing 90 capsules (three bottles individually packaged in aluminum pouches) and 1 Vertical-Haler.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratoires S.M.B. S.A.
Rue de la Pastorale, 26-28
1080 Brussels
Belgium
Manufacturer:
S.M.B. Technology S.A.
Rue du Parc Industriel 39
6900 Marche-en-Famenne
Belgium
This medicinal product is authorized in the European Economic Area countries under the following trade names:
Belgium, Greece, Luxembourg: Tiotraxa
Denmark, Portugal, Sweden: Tiolair
Italy, Netherlands: Scinorus
Further information
More detailed information on this medicinal product is available on the website
https://medicinali.aifa.gov.it/it/#/it/
Instructions for use:
Dear Patient,
The Vertical-Haler device allows you to inhale the medicine contained in the Scinorus capsule – which your doctor has prescribed for your respiratory condition.
- Hold the Vertical-Haler and remove the outer cap
by pushing upwards to expose the mouthpiece.
-
Hold the base of the inhaler and open the mouthpiece
by pushing it upwards (press upwards on the area
marked with “ ˄ ”). -
Take one Scinorus capsule from the bottle immediately
before use and close the bottle tightly. Insert one capsule into
the central chamber as illustrated.
Make sure the capsule is correctly placed in the compartment.
Firmly close the mouthpiece until you hear a "click".
-
Hold the inhaler with the mouthpiece facing upwards and
press the piercing button fully down just once. Then release
the button. This action will pierce the capsule and allow the
medicine to be released during inhalation. -
Hold the Vertical-Haler away from your mouth and
breathe out fully to empty your lungs.
Do not blow into the inhaler.
- Place the mouthpiece in your mouth and keep your head
upright. Close your lips firmly around the mouthpiece.
Do not press the side button. Breathe in as quickly and
deeply as possible until your lungs are full. During
inhalation, you will hear or feel the capsule vibrating.
Hold your breath for as long as possible, while at the same
time removing the Vertical-Haler from your mouth.
Resume normal breathing. Repeat steps 6 and 7 once to
ensure the capsule is completely emptied.
- After use, open the mouthpiece and hold the inhaler
downwards to remove the capsule from the chamber.
Close the mouthpiece and replace the outer cap. This will
keep it clean and dry.
Dispose of the Vertical-Haler 6 months after first use.
Cleaning instructions
Clean the Vertical-Haler once a month. Remove the outer cap and open the mouthpiece.
Rinse the entire inhaler with lukewarm water to remove any powder residue. Dry it thoroughly by inverting it over a paper towel to drain excess water, and leave it to air-dry with the outer cap and mouthpiece open.
Air-drying takes 24 hours; therefore, the device should be cleaned immediately after use so that it is ready for the next inhalation. If necessary, the outer surface of the mouthpiece may be wiped with a damp (not wet) cloth.