TIOTROPIO 18 MICROGRAMS Inhalation powder, hard capsule

Зміст інструкції

1. TIOTROPIO EG 18 micrograms powder for inhalation, hard capsule
   1. What is TIOTROPIO EG and what it is used for
   2. How to use TIOTROPIO EG
   3. Possible side effects
   4. How to store TIOTROPIO EG
   5. Contents of the pack and other information

TIOTROPIO EG 18 micrograms powder for inhalation, hard capsule

Generic medicine

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is TIOTROPIO EG and what it is used for

TIOTROPIO EG contains the active substance tiotropium. It helps people affected by 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. Because COPD is a chronic disease, TIOTROPIO EG must be used every day and not only when difficulty breathing or other COPD symptoms occur.
TIOTROPIO EG is a long-acting bronchodilator that helps to dilate the airways and facilitates the entry and exit of air from the lungs. Regular use of TIOTROPIO EG can also be helpful when shortness of breath associated with the disease develops and will help to minimize the effects of the disease on your daily life. It also allows you to be active for longer. Daily use of TIOTROPIO EG also helps to prevent the sudden worsening of COPD symptoms in the short term, which can last for several days.

2. What you need to know before you use TIOTROPIO EG
Do not use TIOTROPIO EG

• if you are allergic to tiotropium or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to atropine or substances related to it, such as ipratropium or oxitropium.

Warnings and precautions
Talk to your doctor or pharmacist before using TIOTROPIO EG.

• Tell your doctor if you suffer from closed-angle glaucoma, prostate problems or if you have difficulty urinating.
• If you suffer from kidney problems, consult your doctor.
• TIOTROPIO EG is indicated for the maintenance therapy of chronic obstructive pulmonary disease, it should not be used to treat a sudden attack of shortness of breath or difficulty breathing.
• Immediate allergic reactions such as skin rash, edema (swelling, swelling), itching, wheezing or shortness of breath may occur after the administration of TIOTROPIO EG. If this happens, consult your doctor immediately.
• Medicines taken by inhalation such as TIOTROPIO EG can cause chest tightness, coughing, wheezing or shortness of breath immediately after administration. If this happens, consult your doctor immediately.
• Carefully avoid contact of the inhaled powder with the eyes as this may cause precipitation or worsening of closed-angle glaucoma, an eye disease. Pain or a feeling of discomfort in the eyes, blurred vision, seeing halos around lights or colored images in association with red eyes may be signs of an acute attack of closed-angle glaucoma. Eye symptoms may be accompanied by headache, nausea or vomiting. Stop taking TIOTROPIO EG and consult your doctor immediately, preferably an eye specialist, if signs and symptoms of closed-angle glaucoma appear.
• Dry mouth, which has been reported during treatment with anticholinergics, may be associated with dental caries in the long term. Therefore, careful dental hygiene is recommended.
• If you have had a myocardial infarction in the last 6 months or any form of unstable or life-threatening irregular heartbeat or severe heart failure in the previous year, tell your doctor. This information is important to establish whether TIOTROPIO EG is the right medicine for you.
• Do not use this medicine more frequently than once a day.

Children and adolescents
TIOTROPIO EG is not recommended in children and adolescents under 18 years of age.

Other medicines and TIOTROPIO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines.
Tell your doctor or pharmacist if you are using or have used similar medicines for your lung disease, such as ipratropium or oxitropium.
No specific adverse effects have been reported following the use of TIOTROPIO EG in combination with other medicines used for the treatment of COPD such as medicines taken by inhalation that relieve symptoms such as salbutamol, methylxanthines such as theophylline and/or steroids administered orally or by inhalation such as prednisolone.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you 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
The onset of dizziness, blurred vision or headache may affect your ability to drive and use machines.

TIOTROPIO EGcontains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this medicine. Lactose contains traces of milk proteins that can cause allergic reactions.

3. How to use TIOTROPIO EG

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts
consult your doctor or pharmacist.
The recommended dose is the inhalation of the contents of 1 capsule (18 micrograms of tiotropium) once a
day. You must inhale 2 times from the same capsule(see section "Instructions for handling and use")
Try to use the capsule every day at the same time. This is important because TIOTROPIO EG is effective
for 24 hours.

Use in children and adolescents
TIOTROPIO EG is not recommended for use in children and adolescents under 18 years of age.

Route of administration
The capsules are only for inhalation and not for oral administration. Do not swallow the capsules.
The capsule must be removed from the blister only immediately before using the inhaler!
The Vertical-Haler device, inside which the TIOTROPIO EG capsule must be placed, punctures the
capsule and allows inhalation of the powder.
Make sure you have a Vertical-Haler and know how to use it properly. Instructions for
If you feel that your breathing is getting worse, inform your doctor as soon as possible.

If you use more TIOTROPIO EG than you should
If you inhale the contents of more than one TIOTROPIO EG capsule in a day, you should seek medical attention
immediately. The risk of experiencing undesirable effects such as dry mouth, constipation, difficulty
urinating, increased heart rate or blurred vision may be greater.

If you forget to use TIOTROPIO EG
If you forget to take a dose, take it as soon as you remember, but do not take a double dose at the
same time or on the same day. Then use the next dose as usual. Do not use a double
dose to make up for a missed dose.

If you stop taking TIOTROPIO EG
Before stopping treatment with TIOTROPIO EG, you should consult your doctor or pharmacist. If
you stop treatment with this medicine, a worsening of the signs and symptoms of
COPD may occur.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects described below have been reported by people who have used this
medicine.

Serious side effectsinclude allergic reactionsthat cause swelling of the face or throat
(angioedema) or other hypersensitivity reactions(such as a sudden drop in blood pressure or
dizziness) may occur individually or as part of a serious allergic reaction (anaphylactic reaction) after the administration of TIOTROPIO EG. Additionally, some patients may experience an
unexpected feeling of tightness in the chest, cough, wheezing or shortness of breathimmediately after inhalation
(bronchospasm).

If this happens, seek immediate medical attention.
Other side effects
Common (may affect up to 1 in 10 people)

• dry mouth.

Uncommon (may affect up to 1 in 100 people)

• dizziness;
• headache;
• altered taste;
• blurred vision;
• irregular heartbeat (atrial fibrillation);
• sore throat (pharyngitis);
• hoarseness (dysphonia);
• cough;
• heartburn (gastroesophageal reflux disease);
• constipation;
• fungal infections of the mouth and throat (oral and pharyngeal candidiasis);
• skin rash;
• difficulty urinating (urinary retention);
• painful urination (dysuria).

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

• difficulty sleeping (insomnia);
• halos around lights or colored images associated with red eyes (glaucoma);
• increased eye pressure measured;
• irregular heartbeat (supraventricular tachycardia);
• fast heartbeat (tachycardia);
• awareness of heartbeat (palpitations);
• feeling of tightness in the chest associated with cough, wheezing or shortness of breath immediately after inhalation (bronchospasm);
• nosebleeds (epistaxis);
• inflammation of the larynx (laryngitis);
• inflammation of the sinuses (sinusitis);
• blockage of the intestine 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);
• allergic reactions (hypersensitivity), including immediate reactions;
• severe allergic reaction causing swelling of the face or throat (angioedema);
• urticaria;
• itching;
• urinary tract infections.

Not known (frequency cannot be estimated from available data)

• loss of body fluids (dehydration);
• tooth decay;
• severe allergic reaction (anaphylactic reaction);
• skin infections or ulcerations;
• dry skin;
• joint swelling.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store TIOTROPIO EG

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 package and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Dispose of the inhaler 90 days after first use.
Use the capsule immediately after removing it from the blister.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TIOTROPIO EG contains
The active ingredient is tiotropium.
Each capsule contains 22.5 micrograms of tiotropium bromide monohydrate, equivalent to 18 micrograms of
tiotropium. The delivered dose (dose that is released from the mouthpiece of the Vertical-Haler device) is 10
micrograms of tiotropium.
The other ingredient is lactose monohydrate (which may contain traces of milk proteins).
The capsule shell contains gelatin (E441), water, macrogol 4000 (E1521), titanium dioxide (E171),
yellow iron oxide (E172) and Brilliant Blue (E133).

Description of the appearance of TIOTROPIO EG and contents of the pack
TIOTROPIO EG is available in capsule form with dimensions of 16 mm x 5.8 mm, opaque green in colour,
containing the powder for inhalation.
Pressure-formed (push-through) blisters made of Al/Al containing 5 or 10 capsules.
TIOTROPIO EG is available in the following packs:

• Cardboard box containing the Vertical-Haler device and 10 capsules.
• Cardboard box containing the Vertical-Haler device and 15 capsules.
• Cardboard box containing the Vertical-Haler device and 30 capsules.
• Cardboard box containing the Vertical-Haler device and 60 capsules.
• Cardboard box containing the Vertical-Haler device and 90 capsules.
• Hospital pack: Cardboard box containing the Vertical-Haler device and 5x30 capsules (multipack).
• Cardboard box containing two Vertical-Haler devices and 60 capsules.
• Cardboard box containing three Vertical-Haler devices and 90 capsules.
• Hospital pack: Cardboard box containing 5x60 capsules (multipack).
• Cardboard box containing 30 capsules.
• Cardboard box containing 60 capsules.
• Cardboard box containing 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milano

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Stada Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna - Austria
Centrafarm Services B.V., Van De Reijtstraat 31 E Breda 4814 NE – Netherlands
Clonmel Healthcare Limited, 3 Waterford Road, Clonmel Co. Tipperary E91 D768 - Ireland
Pharmadox Healthcare Limited, Kw20a Kordin Industrial Park, Paola PLA 3000 - Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
DE Tiotropium AL 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation
AT Tiotropium STADA 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation
DK Tiotropium STADA
EL TIOTROPIUM/STADA
FI Tiotropium STADA 18 mikrog inhalaatiojauhe, kapseli, kova
FR TIOTROPIUM EG VERTICAL-HALER 18 microgrammes, poudre pour inhalation en gélule
IE Tiotropium Clonmel 18 microgram inhalation powder, hard capsule
IS Tiotropium STADA 18 míkrógrömm, innöndunarduft, hart hylki
IT TIOTROPIO EG
NL Tiotropium CF 18 microgram, inhalatiepoeder in harde capsules
NO Tiotropium STADA 18 mikrogram inhalasjonspulver, hard kapsel
PT Brometo de tiotrópio Stada
SE Tiotropium STADA 18 mikrogram, inhalationspulver, hård kapsel
SI Tiotropij STADA 18 mikrogramov prašek za inhaliranje, trde kapsule

Instructions for use and handling
Remember to carefully follow the instructions provided by your doctor for using TIOTROPIO EG. The
Vertical-Haler device has been specifically developed for TIOTROPIO EG. It should not be
used for taking other medicines. The Vertical-Haler device can be used for a maximum of 90 days for taking the medicine.

A g e n

Vertical-Haler – description of the different parts of the device 1 Closing cap 2 Mouthpiece 3 Base 4 Piercing button 5 Capsule housing compartment

	1. Removing the cap Hold the Vertical-Haler and remove the cap by pushing it upwards from the base to expose the mouthpiece as shown (Fig. 1). c a
	m
	r 2. Opening the device a To open the Vertical-Haler, hold it on the sides of the base. Press with the fingertip on the area marked with “˄” (as shown in the enlarged image). Open the inhaler by lifting the mouthpiece from the base as shown (Fig. 2). l
	e
	d 3. Inserting the capsule Hold the Vertical-Haler with the opening facing upwards. Insert a the capsule shell into the appropriate housing compartment (Fig. 3). n Note: The capsule should only be removed from the blister immediately before using the inhaler! a
a	i Make sure that the capsule shell is inserted correctly (Fig. 4). a t I
i
A g e n z	4. Closing the compartment Close the mouthpiece firmly against the base until you hear a “click” (Fig. 5).

	5. Piercing the capsule Hold the Vertical-Haler with the mouthpiece pointing upwards. Press firmly on the button once all the way down, until it is completely hidden (Fig. 6). Release the button. With this action, the capsule is pierced allowing the release of the medicine during inhalation. Caution: If it is necessary to repeat step 5, open the capsule housing compartment (Fig. 2) to make sure that the capsule shell is inserted correctly (Fig. 4).
	a
	F 6. Preparing for use Exhale completely while keeping the Vertical-Haler away from your mouth. (Fig. 7) l Do not blow into the Vertical-Haler. e d
	a 7. Inhalation n Hold your breath while keeping your head in an upright position and close your lips around the mouthpiece. Inhale slowly and deeply as much as possible (Fig. 8). You will feel the vibrating sound of the capsule rotating inside the housing compartment as the medicine is dispersed. Inhale until your lungs are full; then hold your breath as long as possible and at the same time remove the Vertical-Haler from your mouth. Resume normal breathing. Repeat steps 6 and 7 again once. You must inhale 2 times from the same capsule.
z i a	I Caution: When holding the inhaler during inhalation, make sure not to obstruct the airways on the sides of the mouthpiece. This may prevent air from flowing into the inhaler, reducing the movement of the capsule and the dispersion of the medicine. Do not push down on the mouthpiece during inhalation. This may block the movement of the capsule.
n
A g e	Cleaning the Vertical-Haler After use, open the mouthpiece. Hold the inhaler pointing downwards to remove the capsule from the housing compartment. Clean the mouthpiece and the housing with a dry, clean cloth. Alternatively, you can use a soft, clean brush to remove any residual powder inside the capsule housing compartment. Close the mouthpiece and place the cap. This will keep the dry powder inhaler clean and dry.

Please note:
The capsules of TIOTROPIO EG contain only a small amount of powder, so the capsule is filled only
partially.