5 mg and 7.5 mg prolonged-release tablets are 
terbutaline sulphate

Read all of this leaflet carefully before you start taking 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 or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bricanyl Depot is and what it is used for 
2. What you need to know before taking Bricanyl Depot 
3. How to take Bricanyl Depot 
4. Possible side effects 
5. How to store Bricanyl Depot 
6. Package contents and other information 

1. What Bricanyl Depot is and what it is used for

Bricanyl Depot makes it easier to breathe by dilating the trachea and relieving the cramp in the tracheal muscles. Dehydration of viscous mucus is facilitated.

Bricanyl Depot is a special kind of tablet, which slowly releases the active substance. The effect of the tablet lasts for 12 hours.

The prolonged-release tablets may be emptied of active substance without the tablet skeleton breaking down. A seemingly whole prolonged-release tablet can then come out with the stool. This does not matter, as the prolonged-release tablet has nevertheless given the intended effect.

Bricanyl Depot is used for:

  • cramps in the muscles of the airways that are not controlled by the will ( smooth muscles )
  • asthma
  • tracheal catarrh ( chronic bronchitis )
  • damage to the alveoli ( emphysema )
  • other lung diseases that cause a contraction of the airways

What you need to know before taking Bricanyl Depot

Do not take Bricanyl Depot:

  • if you are allergic to terbutaline sulphate or any of the other ingredients of this medicine (listed in section 6)

Warnings and cautions

Talk to your doctor before using Bricanyl Depot if you have any of the following conditions:

  • increased thyroid function ( hyperthyroidism )
  • too low potassium levels in the blood
  • diabetes (diabetes)
  • heart disease, irregular heartbeat, or angina pectoris (angina)
  • glaucoma with narrow ventricular angle

If you are using a cortisone preparation, it is important that you continue with this when you start using Bricanyl Depot, even when your symptoms decrease.

If you notice that the effect of Bricanyl Depot is getting worse and you need to take a higher dose than usual, contact your doctor.

Your treatment may need to be reviewed. Do not increase your dose of Bricanyl Depot without talking to your doctor.

Other medicines and Bricanyl Depot

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may affect or be affected by treatment with Bricanyl Depot, for example:

  • certain medicines including eye drop that contain e.g. sotalol, atenolol, metoprolol, or timolol (so-called beta-blockers ) for the treatment of high blood pressure, irregular heartbeat, and certain eye diseases
  • diuretics
  • certain other bronchodilators, so-called xanthine derivatives, or medicines containing salbutamol or ipratropium
  • medicines containing cortisone
  • certain drugs under anesthesia (anesthesia)

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.

Pregnancy

No teratogenic effects have been observed with the use of Bricanyl Depot during pregnancy. However, use Bricanyl Depot with caution during the first trimester and at the end of pregnancy.

Breast-feeding

Terbutaline sulphate passes into breast milk but is unlikely to affect breastfed infants.

Driving and using machines

Bricanyl Depot does not affect your ability to drive or use machines.

3. How to take Bricanyl Depot

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

The recommended dose for adults and children over 8 years is 1 prolonged-release tablet of 5 mg morning and evening.

The prolonged-release tablets must not be divided or chewed but must be swallowed whole with liquid.

4. Possible side effects

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

Most of the side effects that Bricanyl Depot can cause usually occur at the beginning of treatment and usually disappear within 1-2 weeks.

If side effects persist or are bothersome or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Serious side effects are

No known frequency (cannot be calculated from the available data):

Chest pain (due to heart problems such as angina ( angina pectoris ). If this happens, tell your doctor or nurse immediately. However, do not stop using the medicine unless your doctor tells you to.

Other side effects ar

Very common (affects more than 1 user in 10): Tremors, headache.

Common (affects more than 1 user in 100): Low blood potassium, palpitations, muscle cramps.

No known frequency (can not be calculated from the available data): Restlessness, overactivity, agitation and sleep disorders, irregular heartbeat, nausea, itching, rash.

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 Bricanyl Depot

Do not use this medicine after the expiry date which is stated on the carton after EXP.

Keep this medicine out of the sight and reach of children.

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 terbutaline sulphate 5 and 7.5 mg per tablet respectively
  • The other ingredients are stearyl alcohol, tartaric acid, colloidal anhydrous silica, polyvinyl chloride, ethylcellulose

Other ingredients are included so that the prolonged-release tablet can be manufactured.

What the medicine looks like and the contents of the pack

Bricanyl Depot 5 mg are white with engraving A / TS, diameter 7.0 mm.

Bricanyl Depot 7.5 mg are white with engraving A / BD, diameter 7.0 mm.

The prolonged-release tablets are packed in a plastic jar containing 100 tablets.

Marketing Authorization Holder and Manufacturer

AstraZeneca AB, 151 85 Södertälje

Muhammad Nadeem

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