Spiolto Respimat 30 doses

1. What Spiolto Respimat is and what it is used for
What Spiolto Respimat is
Spiolto Respimat contains two active substances called tiotropium and olodaterol. They belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergic agents, and olodaterol belongs to the subgroup of long-acting beta2 agonists.

What Spiolto Respimat is used for
Spiolto Respimat helps patients with chronic obstructive pulmonary disease (COPD) to breathe easier. COPD is a chronic lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions of chronic bronchitis and emphysema.

Spiolto Respimat helps to open the airways and makes it easier to inhale and exhale air from the lungs. Regular use of Spiolto Respimat can also help you with shortness of breath associated with your disease and reduce the impact of your disease on your daily activities.
Because COPD is a chronic disease, you will need to take Spiolto Respimat every day, not just when you have breathing problems or other COPD symptoms.

2. What you need to know before you take Spiolto Respimat
Do not use Spiolto Respimat
if you are allergic to tiotropium, olodaterol or any of the other ingredients of this medicine (listed in section 6).
if you are allergic to atropine or similar medicines such as ipratropium or oxytropium.
Warnings and precautions
Talk to your doctor or pharmacist before using Spiolto Respimat
if you have asthma (you should not use Spiolto Respimat to treat asthma),
if you have heart disease,
if you have high blood pressure,
if you have epilepsy.
if you have a specific thyroid problem called thyrotoxicosis.
if you have an abnormal enlargement of an artery called an aneurysm.
if you have diabetes.
if you have severe liver disease.
if you have kidney disease.
in case of planned surgery.
if you have an eye problem called narrow-angle glaucoma.
if you have prostate problems or difficulty urinating.
During treatment with Spiolto Respimat
Stop using the medicine and tell your doctor immediately if you experience chest tightness, coughing, wheezing, or shortness of breath immediately after using the medicine. These may be signs of a condition called bronchospasm (see section 4).
If your breathing becomes worse or you get a rash, swelling or itching immediately after using the inhaler, stop using it and tell your doctor immediately (see section 4).
If you get side effects affecting the heart (rapid heart rate, increase in blood pressure and/or worsening of symptoms such as chest pain), tell your doctor immediately (see section 4).
If you experience muscle spasms, muscle weakness or an abnormal heart rhythm, consult your doctor as these symptoms may be due to low potassium levels in the blood (see section 4).
While taking Spiolto Respimat, be careful not to get the spray in the eyes. This can cause pain or discomfort in the eyes, blurred vision, seeing halos around lights or colored spots, accompanied by red eyes (ie, angle-closure glaucoma). Ocular symptoms may be accompanied by headache, nausea or vomiting. Rinse your eyes with warm water, stop using Spiolto Respimat and consult your doctor immediately for further instructions.

Spiolto Respimat is indicated for the maintenance treatment of your chronic obstructive pulmonary disease. It should not be used to treat sudden attacks of breathlessness or wheezing.

Do not use Spiolto Respimat with certain medicines containing long-acting β-adrenergic agonists, such as salmeterol or formoterol.

If you regularly take certain medicines called short-acting β-adrenergic agonists, such as salbutamol, continue to use them only to relieve acute symptoms such as shortness of breath.

During treatment with anticholinergic agents, dry mouth is observed, which may be associated with the formation of dental caries during longer treatment. Therefore, do not forget to pay special attention to your oral hygiene.

Do not take Spiolto Respimat more than once a day.

Children and adolescents
Spiolto Respimat should not be given to children or adolescents (under 18 years of age).

Other medicines and Spiolto Respimat
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

In particular, tell your doctor if you use:

medicines that are similar to Spiolto Respimat (containing similar active substances, such as anticholinergic medicines or B-adrenergic medicines). The risk of getting side effects is higher.
medicines called beta-blockers, which are used for high blood pressure or other heart problems (such as propranolol), or for an eye problem called glaucoma (such as timolol). They can neutralize the effect of Spiolto Respima
t.
medicines that lower the amount of potassium in the blood. These include:
steroids (eg prednisolone),
diuretics (tablets for dehydration),
medicines for breathing problems such as theophylline.
If you use these medicines together with Spiolto Respimat, you may experience symptoms such as muscle spasms, muscle weakness or an abnormal heart rhythm.

medicines called tricyclic antidepressants or monoamine oxidase (MAO) inhibitors (such as selegiline or moclobemide), which are used to treat neurological or mental disorders such as Parkinson's disease or depression; the use of these drugs will increase the risk of side effects affecting the heart.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

You should not use this medicine unless specifically recommended by your doctor.

Driving and using machines
No studies have been conducted to determine the effects on the ability to drive and use machines. If you feel dizzy or have blurred vision while taking Spiolto Respimat, do not drive or operate tools or machines.

Spiolto Respimat contains benzalkonium chloride
This medicine contains 0.0011 mg of benzalkonium chloride per injection.

Benzalkonium chloride can cause wheezing and difficulty breathing (bronchospasm), especially if you have asthma.
3. How to take Spiolto Respimat
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Spiolto Respimat is for inhalation use only.

Dose
The recommended dose is:

Spiolto Respimat is effective for 24 hours, so you will only need to use Spiolto Respimat ONCE A DAY, preferably at the same time of day. Each time you use it, do TWO SPRAYS.

Because COPD is a chronic disease, take Spiolto Respimat every day, not just when you have breathing problems. The recommended dose should not be exceeded.

Use in children and adolescents
There is no appropriate use of Spiolto Respimat in the pediatric population (under 18 years of age).

Make sure you know how to use Spiolto Respimat inhaler correctly. Instructions for use of the Spiolto Respimat inhaler are indicated on the back of the leaflet.

If you have taken more Spiolto Respimat than you should
You may be at higher risk of side effects such as dry mouth, constipation, difficulty urinating, blurred vision, chest pain, high or low blood pressure, fast or irregular heartbeat, dizziness, nervousness, sleep disturbances , restlessness, headache, tremors, muscle spasms, nausea, fatigue, feeling unwell, low levels of potassium in the blood (which can cause symptoms such as muscle spasms, muscle weakness or abnormal heart rhythm), high blood sugar or increased acidity of the blood (which can cause symptoms of nausea, vomiting, weakness, muscle spasms and rapid breathing).

If you forget to take Spiolto Respimat
If you miss a dose, inhale just one dose at the usual time the next day. Do not take a double dose to make up for a missed dose.

If you have stopped using Spiolto Respimat
Before you stop using Spiolto Respimat, talk to your doctor or pharmacist. If you stop taking Spiolto Respimat, the signs and symptoms of COPD may get worse.

If you have any further 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.

If any of the following side effects occur, stop using this medicine and contact your doctor immediately.

Sudden allergic reactions to Spiolto Respimat are rare (may affect up to 1 in 1,000 people). These reactions may occur alone or as part of a severe allergic reaction (anaphylactic reaction) after administration of Spiolto Respimat. These reactions include rash, hives (urticaria), swelling of the mouth and face, sudden difficulty in breathing (angioedema) or other hypersensitivity reactions (such as a sudden drop in blood pressure or fainting).
As with all inhaled medicines, chest tightness associated with coughing, wheezing or shortness of breath (paradoxical bronchospasm) may occur immediately after inhalation. Frequency cannot be estimated from the available data.
Seeing halos around lights or colored images, accompanied by red eyes (glaucoma). Frequency cannot be estimated from the available data.
Intestinal obstruction or lack of peristalsis (intestinal obstruction, including paralytic ileus). Frequency cannot be estimated from the available data.
Other adverse drug reactions:

Uncommon (may affect up to 1 in 100 people)
fast heart rate (tachycardia)
dizziness
headache
cough
hoarse voice (dysphonia)
dry mouth
Rare (may affect up to 1 in 1,000 people)
irregular heartbeat (fibrillation)
fast heartbeat (supraventricular tachycardia)
palpitations
high blood pressure (hypertension)
difficulty urinating (urinary retention)
urinary tract infection
painful urination (dysuria)
sore throat (pharyngitis)
inflammation of the larynx (laryngitis)
inflammation of the gums (gingivitis)
inflammation in the mouth (stomatitis)
fungal infections of the mouth and throat (oropharyngeal candidiasis)
nosebleeds (epistaxis)
sleep disorders (insomnia)
blurred vision
chest tightness associated with coughing, wheezing or shortness of breath immediately after inhalation (bronchospasm).
constipation
nausea
itching (pruritus)
joint pain (arthralgia)
swelling of the joints
back pain
Not known (frequency cannot be estimated from the available data)
increased when measuring eye pressure
nasopharyngitis
inflammation of the sinuses (sinusitis)
difficulty swallowing (dysphagia)
inflammation of the tongue (glossitis)
heartburn (gastroesophageal reflux disease)
dental caries
infections or skin ulceration
dryness of the skin
loss of fluids in the body (dehydration)
You may also get side effects known to occur with some medicines for breathing problems similar to Spiolto Respi
mat (beta-adrenergic agents). These may be irregular heartbeat, chest pain, low blood pressure, shaking, nervousness, muscle spasms, tiredness, feeling unwell, low levels of potassium in the blood (which can lead to symptoms such as muscle spasms, muscle weakness or an abnormal heart rhythm ), high blood sugar or increased acidity of the blood (which can cause symptoms of nausea, vomiting, weakness, muscle cramps and rapid breathing).
5. How to store Spiolto Respimat
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the inhaler label after EXP. The expiration date corresponds to the last day of the specified month.

Do not freeze.

Shelf life after first use:
Replace the filler no later than 3 months after insertion.
Do not use Respimat reusable inhaler for more than one year. Recommended use: 6 refills for one inhaler.

Note: the performance of the Respimat reusable inhaler has been proven in tests for 540 puffs (corresponding to 9 refills).

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Spiolto Respimat contains
The active substances are tiotropium and olodaterol. The delivered dose per injection is 2.5 micrograms of tiotropium (as bromide monohydrate) and 2.5 micrograms of olodaterol (as hydrochloride).

Delivered dose is the dose reaching the patient after passing through the mouthpiece.

The other ingredients are:

Benzalkonium chloride, disodium edetate, purified water and hydrochloric acid for pH adjustment.

What Spiolto Respimat looks like and contents of the pack
Spiolto Respimat consists of one inhalation solution refill and one Respimat inhaler. Before the first use, the refill must be placed in the inhaler.

Single pack: 1 Respimat reusable inhaler and 1 refill providing 60 puffs (30 medicinal doses)

Triple pack: 1 Respimat reusable inhaler and 3 refills, each providing 60 puffs (30 medicinal doses)

Single refill pack: 1 refill providing 60 sprays (30 medicinal doses)

Triple pack refill: 3 refills each providing 60 puffs (30 medication doses)

Not all types of packaging can be put on sale.

 

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