Tiotropium Eg: detailed information

Package leaflet: Information for the user

TIOTROPIUM EG 18 micrograms inhalation powder, hard capsule

Generic medicine
Please read all of this leaflet carefully before you start 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What TIOTROPIUM EG is and what it is used for
What you need to know before using TIOTROPIUM EG
How to use TIOTROPIUM EG
Possible side effects
How to store TIOTROPIUM EG
Contents of the pack and other information

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

TIOTROPIO EG contains the active substance tiotropium. It helps people 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 refers to chronic conditions such as bronchitis and emphysema. Since COPD is a chronic disease, TIOTROPIO EG must be used every day, not only when breathing difficulties or other COPD symptoms occur.
TIOTROPIO EG is a long-acting bronchodilator that helps to widen the airways and facilitates airflow into and out of the lungs. Regular use of TIOTROPIO EG may also help when shortness of breath associated with the disease develops, 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 TIOTROPIO EG also helps prevent sudden short-term worsening of COPD symptoms, which may last for several days.

2. What you need to know before using TIOTROPIO EG

Do not use TIOTROPIO EG

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 substances related to it, such as ipratropium or oxitropium.

Warnings and precautions

Talk to your doctor or pharmacist before using TIOTROPIO EG.

Inform your doctor if you have narrow-angle glaucoma, prostate problems, or difficulty urinating.
If you have kidney problems, consult your doctor.
TIOTROPIO EG is indicated for maintenance treatment of chronic obstructive pulmonary disease and must not be used to treat sudden attacks of shortness of breath or wheezing.
Immediate allergic reactions such as rash, oedema (swelling), itching, wheezing or shortness of breath may occur after administration of TIOTROPIO EG. If this happens, contact your doctor immediately.
Inhaled medicines such as TIOTROPIO EG may cause chest tightness, cough, wheezing or shortness of breath immediately after administration. If this occurs, contact your doctor immediately.
Avoid carefully that the inhaled powder comes into contact with the 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 TIOTROPIO EG and contact your doctor immediately, preferably an eye specialist, if signs and symptoms of narrow-angle glaucoma occur.
Dry mouth, which has been reported during treatment with anticholinergics, may over time be associated with dental caries. Therefore, careful dental hygiene is recommended.
If you have suffered a myocardial infarction within the last 6 months, or any form of unstable or life-threatening irregular heartbeat, or severe heart failure in the past year, inform your doctor. This information is important to determine whether TIOTROPIO EG is the appropriate medicine for you.
Do not use this medicine more than once a day.

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

Other medicines and TIOTROPIO EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Inform 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 to treat COPD, such as inhaled medicines that relieve symptoms like salbutamol, methylxanthines such as theophylline, and/or oral or inhaled steroids such as prednisolone.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist 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 vehicles or operate machinery.

TIOTROPIO EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. Lactose contains traces of milk proteins which may cause allergic reactions.

3. How to use TIOTROPIUM EG

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 inhaling the contents of 1 capsule (18 micrograms of tiotropium) once daily. You must inhale twice from the same capsule (see section "Instructions for handling and use" at the end of this leaflet). Do not use a higher dose than recommended.
Try to use the capsule at the same time every day. This is important because TIOTROPIUM EG is effective for 24 hours.

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

Method of administration
The capsules are for inhalation only and must not be taken orally. Do not swallow the capsules.
The capsule must be removed from the blister immediately before using the inhaler!
The Vertical-Haler device, into which the TIOTROPIUM EG capsule must be placed, pierces the capsule and allows the powder to be inhaled.
Make sure you have a Vertical-Haler and know how to use it correctly. Instructions for using the Vertical-Haler are provided at the end of this leaflet.
If you feel your breathing is getting worse, inform your doctor as soon as possible.

If you use more TIOTROPIUM EG than you should
If you inhale the contents of more than one TIOTROPIUM EG capsule in one day, you must contact your doctor immediately. The risk of side effects such as dry mouth, constipation, difficulty urinating, increased heart rate, or blurred vision may be higher.

If you forget to use TIOTROPIUM 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 take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using TIOTROPIUM EG
Before stopping treatment with TIOTROPIUM EG, you must consult your doctor or pharmacist. If you stop treatment with this medicine, your signs and symptoms of COPD may worsen.
If you have any questions about how to use 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 listed below have been reported by people using this medicine.
Serious side effects include allergic reactions causing swelling of the face or throat
(angioedema) or other hypersensitivity reactions (such as sudden drop in blood pressure or dizziness), which may occur individually or as part of a severe allergic reaction (anaphylactic reaction) after administration of TIOTROPIUM EG. In addition, some patients may experience unexpected chest tightness, cough, wheezing or shortness of breath immediately after inhalation (bronchospasm).
If this happens, consult your doctor immediately.
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);
throat inflammation (pharyngitis);
hoarseness (dysphonia);
cough;
heartburn (gastro-oesophageal reflux disease);
constipation;
fungal infections of the mouth and throat (oropharyngeal candidiasis);
skin rash;
difficulty in urination (urinary retention);
pain during urination (dysuria).

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

difficulty sleeping (insomnia);
visual halos around lights or coloured images associated with red eyes (glaucoma);
increased measured intraocular pressure;
irregular heartbeat (supraventricular tachycardia);
fast heartbeat (tachycardia);
awareness of heartbeat (palpitations);
chest tightness associated with cough, wheezing or shortness of breath immediately after inhalation (bronchospasm);
nosebleeds (epistaxis);
inflammation of the larynx (laryngitis);
inflammation of the sinuses (sinusitis);
intestinal blockage or absence of bowel movements (intestinal obstruction including paralytic ileus);
gum inflammation (gingivitis);
inflammation of the tongue (glossitis);
difficulty in 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);
hives (urticaria);
itching (pruritus);
urinary tract infections.

Not known (frequency cannot be estimated from the available data)

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

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 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 TIOTROPIUM 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 carton and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Discard the inhaler 90 days after first use.
Use the capsule immediately after removing it from the blister.
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 TIOTROPIO EG contains
The active substance is tiotropium.
Each capsule contains 22.5 micrograms of tiotropium bromide monohydrate, equivalent to 18 micrograms of
tiotropium. The delivered dose (the dose released from the mouthpiece of the Vertical-Haler device) is 10
micrograms of tiotropium.
The other component is lactose monohydrate (which may contain traces of milk proteins).
The capsule shell contains gelatin (E441), water, macrogol 4000 (E1521), titanium dioxide (E171),
iron oxide yellow (E172) and Brilliant Blue (E133).

Description of the appearance of TIOTROPIO EG and contents of the pack
TIOTROPIO EG is available as a 16 mm x 5.8 mm opaque green capsule containing powder for inhalation.
Al/Al push-through blisters containing 5 or 10 capsules.
TIOTROPIO EG is available in the following pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area (EEA) Member States under the following names:
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 designed for TIOTROPIO EG. It must not be used to take other medicines. The Vertical-Haler device can be used for up to 90 days to administer the medicine.

	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. Removal of the cap Hold the Vertical-Haler and remove the cap by pushing it upward from the base to expose the mouthpiece as shown (Fig. 1).

	2. Opening the device To open the Vertical-Haler, hold it by 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 away from the base as shown (Fig. 2).

	3. Inserting the capsule Hold the Vertical-Haler with the opening facing upward. Insert the capsule into the designated capsule housing compartment (Fig. 3). Note: The capsule must be removed from the blister pack only immediately before using the inhaler!
	Ensure that the capsule is correctly inserted (Fig. 4).

	4. Closing the compartment Close the mouthpiece firmly against the base until a "click" is heard (Fig. 5).

	5. Piercing the capsule Hold the Vertical-Haler with the mouthpiece facing upward. Press the button firmly once all the way down until it is completely hidden (Fig. 6). Release the button. This action pierces the capsule, allowing the medication to be released during inhalation. Caution: If it is necessary to repeat step 5, open the capsule housing compartment (Fig. 2) to ensure that the capsule is correctly inserted (Fig. 4).

	6. Preparation for use Breathe out fully, keeping the Vertical-Haler away from the mouth (Fig. 7). Do not blow into the Vertical-Haler.

	7. Inhalation Hold your breath with your head in an upright position and close your lips around the mouthpiece. Breathe in slowly and deeply as much as possible (Fig. 8). You will hear the vibrating sound of the capsule rotating inside the housing compartment as the medication disperses. Breathe in until your lungs are full; then hold your breath as long as possible while simultaneously removing the Vertical-Haler from your mouth. Resume normal breathing. Repeat steps 6 and 7 once again. You must inhale twice from the same capsule.
	Caution: When holding the inhaler during inhalation, make sure not to block the airways on the sides of the mouthpiece. This may prevent air from flowing into the inhaler, reducing capsule movement and medication dispersion. Do not press down on the mouthpiece during inhalation, as this may block capsule movement.

	Cleaning the Vertical-Haler After use, open the mouthpiece. Hold the inhaler downward to remove the capsule from the housing compartment. Clean the mouthpiece and housing with a clean, dry cloth. Alternatively, a clean, soft brush may be used to remove any residual powder inside the capsule compartment. Close the mouthpiece and replace the cap. This will keep the dry powder inhaler clean and dry.
	If necessary, clean the outer part of the mouthpiece with a damp cloth.

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