10 micrograms / dose inhalation powder, hard capsule 
tiotropium

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Braltus is and what it is used for 
2. What you need to know before you use Braltus 
3. How to use Braltus 
4. Possible side effects 
5. How to store Braltus 
6. Contents of the packaging and other information 

1. What Braltus is and what it is used for

Braltus contains the active substance tiotropium. Tiotropium helps people with chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a chronic lung disease that can cause shortness of breath and cough. The diagnosis of COPD is also associated with chronic bronchitis and emphysema . Because COPD is a chronic disease, you should use this medicine every day, not just when you have breathing problems or other symptoms of COPD.

Braltus is a long-acting bronchodilator that helps open your airways and makes it easier to get air in and out of your lungs. Regular use of this medicine can also help when you have a period of shortness of breath due to your illness and help minimize the effects of the illness in your daily life. It also helps you to be active for a longer period of time. Daily use of this drug will also help prevent sudden, short-term worsening of COPD symptoms, which can last for several days. The effect of the drug lasts for 24 hours, so you only need to use it once a day.

This medicine should not be used as an acute treatment for sudden pressure over the chest, coughing or sudden attacks of shortness of breath or wheezing or wheezing. Instead, use a fast-acting “on-demand” ( emergency ) inhaler with e.g. salbutamol . You should always have your fast-acting “if needed” inhaler with you.

Tiotropium contained in Braltus may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Braltus

Do not use Braltus:

  • if you are allergic (hypersensitive) to tiotropium or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to atropine or similar substances such as ipratropium or oxitropium.
  • if you are allergic (hypersensitive) to lactose or other sugars.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Braltus.

  • if you are taking any other medicine that contains ipratropium or oxitropium
  • If you suffer from glaucoma ( angle-closure glaucoma ), prostate problems or have difficulty passing urine
  • if you have kidney problems
  • if you have had a heart attack in the last 6 months, or suffered from unstable or life-threatening heart rhythm disorders or severe heart failure in the last year

Braltus is intended for the maintenance treatment of your COPD. It should not be used for the treatment of sudden attacks of shortness of breath, wheezing or wheezing.

Immediate hypersensitivity reactions such as rash, swelling, itching , wheezing or shortness of breath or shortness of breath may occur after taking Braltus. If this happens, you should contact your doctor immediately (see section 4).

Inhaled medicines such as Braltus may cause chest tightness, coughing, wheezing or wheezing or shortness of breath ( bronchospasm ) immediately after inhalation . If this occurs, you should immediately use a fast-acting “on-demand” inhaler , such as salbutamol . If these symptoms occur, stop using Braltus and contact your doctor immediately .

Be careful that the inhalation powder does not get into the eyes as this may lead to increased tear flow or cause narrow-angle glaucoma to be triggered or worsened. Narrow-angle glaucoma is an eye disease. Pain or discomfort in the eyes, blurred vision, visual phenomena such as rainbow-colored circles around light or colored images in connection with red eyes can be signs of an acute attack of narrow-angle glaucoma . Eye symptoms may be accompanied by headache, nausea or vomiting. Stop using this medicine and contact a doctor immediately , preferably an ophthalmologist, if symptoms of narrow-angle glaucoma occur.

The medicine in your inhaler can lower the normal saliva secretion in your mouth and make your mouth feel dry. This can lead to caries in long-term treatment. Therefore, be careful with oral hygiene, rinse your mouth and brush your teeth regularly.

Tell your doctor if you have had a heart attack in the last 6 months, or suffered from unstable or life-threatening heart rhythm disorders or severe heart failure in the past year. It is important for your doctor to determine if Braltus is the right treatment for you.

Do not use Braltus more than once a day (see section 3).

Children and young people

Braltus should not be used by children or adolescents under 18 years of age.

Other drugs and Braltus

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including other inhalers and medicines obtained without a prescription.

Tell your doctor or pharmacist if you are taking / have been taking similar medicines for your lung disease such as ipratropium or oxitropium.

No specific side effects have been reported when this medicine has been used with other medicines used to treat COPD, such as bronchodilators for inhalation such as salbutamol , methylxanthines such as theophylline and / or oral and inhaled steroidssuch as prednisolone .

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine unless your doctor specifically recommends it.

Driving and using machines

If dizziness, blurred vision or headache occur, it may affect the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Braltus contains lactose

Lactose is a type of sugar found in milk. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this inhaler . Lactose can contain very small amounts of milk proteins, which can cause reactions in those who have severe hypersensitivity or allergy to milk proteins. When this medicine is used according to the dosing recommendation, 1 capsule per day, each dose provides up to 18 mg of lactose monohydrate .

3. How to use Braltus

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. 

The recommended dose is inhalation of the contents of 1 capsule once daily with the Zonda inhaler. One capsule gives the daily dose of one of tiotropium (an added dose of 10 micrograms of tiotropium). Do not use more than the recommended dose .

You should try to use this medicine at the same time each day. This is important because the medicine has an effect for 24 hours.

The capsules are for inhalation use only and should not be swallowed.

Do not swallow the capsules.

The Zonda inhaler, in which you place the Braltus capsule, makes a hole in the capsule so that the powder becomes available for inhalation. The capsule may only be inhaled with a Zonda inhaler . Do not use another inhaler to administer Braltus capsules.

Make sure you can use the Zonda inhaler correctly. Instructions for use of the Zonda inhaler can be found in the instructions for use at the end of this leaflet. Remember to carefully follow these instructions for use. Pictures showing how to place the capsule in the inhaler correctly can also be found on the inside of the carton lid. To avoid the risk of suffocation,  NEVER place a capsule directly in the nozzle. If you have any problems using the Zonda inhaler, ask your doctor, nurse or pharmacist to show you how it works.

If necessary, you can clean the mouthpiece of the Zonda inhaler after use with a dry cloth or handkerchief.

Avoid blowing into the Zonda inhaler. When using Braltus, be careful not to get any powder in your eyes. If you get powder in your eyes, you may get blurred vision, eye pain and / or red eyes. In this case, rinse your eyes immediately with lukewarm water. Then talk to your doctor immediately for further advice.

If your breathing deteriorates, contact your doctor as soon as possible.

Use for children and adolescents

Braltus should not be used by children and adolescents under 18 years of age.

If you forget to use Braltus

If you forget to administer a dose , do so as soon as you remember, but do notadminister  two doses at the same time or day. Then administer the next dose as usual. Do not administer  double dose to compensate for missed dose .

If you stop using Braltus

Before stopping using Braltus, talk to your doctor or pharmacist.

If you stop using Braltus, your COPD symptoms may get worse.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects including allergic reactions leading to swelling of the face or throat ( angioedema ) or other hypersensitivity reactions (such as a sudden drop in blood pressure or dizziness) or increased wheezing or wheezing and shortness of breath may occur as a single reaction or as part of a severe allergic reaction. ( anaphylactic reaction ) after using this medicine. Such serious side effects are rare. In addition, like other inhaled medicines, some patients may experience unexpected chest tightness, coughing, wheezing and wheezing or shortness of breath immediately after inhalation (so-calledbronchospasm ).

Contact a doctor immediately if you experience any of these side effects .

Do not use your Zonda inhaler again until you have seen or at least talked to your doctor. If you have wheezing and gasping for breath and shortness of breath, you should use your fast-acting “on-demand” ( emergency ) inhaler  immediately.

Other side effects described below have been reported by people taking the medicine and are listed by frequency below.

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 changes
  • dimsyn
  • irregular heartbeat ( atrial fibrillation )
  • inflammation of the pharynx ( pharyngitis )
  • hoarseness ( dysphonia )
  • cough
  • heartburn ( gastroesophageal reflux )
  • constipation
  • fungal infection of the mouth and throat ( oropharyngeal candidiasis)
  • rash
  • difficulty emptying the bladder ( urinary retention )
  • pain when emptying the bladder ( dysuria )

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

  • insomnia (insomnia)
  • visual phenomena such as rainbow-colored rings around light or colored images in connection with red eyes ( glaucoma )
  • increased measured pressure in the eye
  • irregular heartbeat ( supraventricular tachycardia )
  • faster heartbeat ( tachycardia )
  • palpitation
  • pressure over the chest in connection with coughing, wheezing or wheezing or shortness of breath immediately after inhalation ( bronchospasm )
  • nosebleeds (rhinorrhagia)
  • inflammation of the larynx ( laryngitis )
  • inflammation of the sinuses ( sinusitis )
  • bowel obstruction or absent bowel movements (bowel obstruction including paralytic bowel)
  • inflammation of the gums ( gingivitis )
  • inflammation of the tongue ( glossitis )
  • difficulty swallowing ( dysphagia )
  • inflammation of the oral mucosa ( stomatitis )
  • nausea
  • hives ( urticaria )
  • itching ( pruritus )
  • infection you in the urinary tract

Has been reported (occurs in an unknown number of users) :

  • dehydration ( dehydration )
  • caries
  • infection and sores on the skin
  • dry skin
  • swollen joints

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Braltus

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 jar after EXP. dat./EXP. The expiration date is the last day of the specified month.

Store in a cold place. Do not freeze.

Close the jar tightly. Store in the original package. Moisture sensitive. Use the product within 30 days (15 capsules per can) or 60 days (30 capsules per can) after the first opening of the can.

The Zonda inhaler should only be used with the enclosed can of capsules. provided either in the same package as the inhaler or in a package connected to the inhaler package. Do not reuse the inhaler with another can of capsules.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is tiotropium. Each capsule contains 13 micrograms of the active substance tiotropium (as bromide). Upon inhalation, 10 micrograms of tiotropium is delivered from each capsule from the mouthpiece of the Zonda inhaler and inhaled into the lungs.
  • The other ingredients are lactose monohydrate (capsule content) and hypromellose (capsule shell).

What the medicine looks like and the contents of the pack

Braltus 10 micrograms / dose hard inhalation powder is a colorless, clear, hard capsule containing a white powder.

The medicine is supplied in jars with screw caps. The jar is supplied in a carton with a Zonda inhaler . The Zonda inhaler has a green body and a lid with a white push-button.

Braltus is available in packages of either 15 or 30 capsules and a Zonda- inhaler and in multipacks containing either 60 capsules (2 packs of 30) and 2 Zonda- inhaler s or 90 capsules (3 packs of 30) and 3 Zonda- inhaler s .

Multi-pack: 30 capsules (can) in a pack that is connected to a separate pack with Zonda inhaler .

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Manufacturer:

Laboratories LICONSA SA

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Teva Pharma BV

Swensweg 5, 2031 GA Haarlem, The Netherlands

Netherlands

Teva Operations Poland Sp. Zoo

ul. Mogilska 80, 31-546

Poland

Actavis Ltd

BLB015, BLB016, Bulebel Industrial Estate,

Zejtun, ZTN3000,

Malta

Muhammad Nadeem

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