0.5 mg / ml injection / concentrate for infusion solution 
terbutaline sulphate

1. What Bricanyl is and what it is used for

Bricanyl contains the active substance terbutaline sulphate, which dilates the trachea and makes it easier to breathe by relieving the cramps in the muscles of the trachea. Bricanyl also has a relaxing effect on the uterine muscles. Bricanyl is used for quick relief in acute ailments.

Bricanyl is used for:

  • asthma
  • chronic obstructive pulmonary disease (COPD).

Bricanyl is also used in women who have had premature labor (premature labor) between the 22nd and 37th week of pregnancy to prevent or delay premature birth. You will receive Bricanyl for a maximum of 48 hours. It gives the doctor or midwife time to take extra measures that improve your baby’s health.

2. What you need to know before you are given Bricanyl

Do not use Bricanyl

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

In the case of premature labor, Bricanyl should not be used:

  • if you are not yet 22 weeks pregnant
  • if you have or have a known risk of getting, ischemic heart disease (a disease characterized by the decreased blood supply to the heart muscle, which causes symptoms such as chest pain (angina)
  • if you have had severe bleeding (impending miscarriage) during the first six months of pregnancy
  • if you are pregnant and you or your baby have certain conditions where prolongation of pregnancy can be dangerous (such as very high blood pressure, infection in the womb, bleeding, the placenta covers the birth canal or the placenta is coming off, or your baby has died inside the womb )
  • if you have a heart condition with palpitations (for example, heart valve disorder) or long-term lung disease (for example, chronic bronchitis, emphysema ) that causes increased blood pressure in the lungs (pulmonary hypertension).

Warnings and cautions

Before receiving treatment with Bricanyl, it is important that you tell your doctor or nurse:

  • if you have had a problem with your pregnancy
  • if the water has passed during pregnancy
  • if you have too much fluid in your lungs, which causes shortness of breath ( pulmonary edema )
  • if you have high blood pressure
  • if you have diabetes. In that case, you may need to do some additional blood sugar testing before you receive Bricanyl
  • if you have an overactive thyroid gland ( hyperthyroidism )
  • if you have had a heart condition characterized by shortness of breath, palpitations, or angina (see Do not use Bricanyl ).

For temporary postponement of premature labor

You will receive Bricanyl after careful consideration of the balance between the benefits of Bricanyl for your child and the possible adverse effects the treatment may have on you. Your and your child’s health will be continuously monitored throughout the treatment.

The following measurements will be made:

  • Blood pressure and heart rate. Your doctor will consider lowering your dose or stopping Bricanyl treatment if your heart rate exceeds 120 beats per minute.
  • Electrocardiogram ( ECG, the electrical activity of the heart). Tell your doctor immediately if you experience chest pain during treatment. If there are changes in your ECG record and you have chest pain, your doctor will discontinue treatment with Bricanyl. See section 4.
  • Water and salt balance in the body. Tell your doctor immediately if you experience a cough or shortness of breath during treatment. If any signs (such as coughing or shortness of breath) indicate that fluid has accumulated in your lungs (also known as pulmonary edema ), your doctor may stop taking Bricanyl. See section 4.
  • Blood sugar level and the presence of low pH in the body with an accumulation of lactate in the blood (also called lactic acidosis)
  • Potassium levels in the blood (low potassium levels may be associated with the risk of irregular heartbeat)

Other drugs and Bricanyl

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. Bricanyl may affect the way some medicines work and some medicines may affect how Bricanyl works eg:

  • drugs for irregular or fast heartbeat (such as digoxin )
  • beta-blockers for the treatment of high blood pressure, irregular heartbeat (such as atenolol or propranolol), including eye drops for the treatment of certain eye diseases (such as timolol )
  • certain bronchodilators, so-called xanthine medicines (such as theophylline or aminophylline), or medicines containing ipratropium
  • medicines containing cortisone (such as prednisolone )
  • diuretic tablets also called diuretics (such as furosemide )
  • diabetes drugs that lower blood sugar levels (such as insulin, metformin, glibenclamide).

If you are going to have anesthesia surgery, your doctor will stop giving Bricanyl 6 hours before surgery, if possible, to protect you from side effects (such as irregular heartbeats or uterine bleeding).

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, pharmacist, or nurse for advice before taking this medicine.

Pregnancy

When treating asthma and COPD: No known risks of using Bricanyl during pregnancy. However, caution is recommended during the first trimester.

In the case of premature labor: Bricanyl should not be used for premature labor before week 22 of pregnancy.

Breast-feeding

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

Driving and using machines

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

How to take Bricanyl

Dose one is determined by the doctor and is tailored specifically for you.

The medicine will be given to you by trained healthcare professionals.

If you take more Bricanyl than you should

The symptoms you may feel if you have received too large a dose include nausea, vomiting, headache, anxiety, irritability, tremors, fatigue, dizziness, sewing, muscle cramps, and palpitations.

Contact your doctor immediately if you think you have been given too much Bricanyl.

4. Possible side effects

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

Serious side effects are

Uncommon (may affect up to 1 in 100 people):

  • Fluid buildup in the lungs ( pulmonary edema ), which may cause difficulty breathing. If this happens to you, tell your doctor or nurse immediately.

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

  • Chest pain (due to heart problems such as angina). If this happens to you, tell your doctor or nurse immediately.

Other side effects ar

Very common (may affect up to 1 in 10 people):

  • Palpitation
  • Tremors
  • Headache
  • Nausea

Common (may affect up to 1 in 10 people):

  • Muscle cramps
  • Palpitation er (awareness of your heartbeat)
  • Low blood pressure, which can cause dizziness
  • Low potassium levels in the blood, which can cause muscle weakness or fatigue, thirst, or “tingling”

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

  • Irregular heartbeat
  • Blush

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

  • Restlessness, overactivity, agitation
  • Sleep disorders
  • Itching, rash
  • Increased tendency to bleed from the uterus in connection with a cesarean section.
  • High levels of sugar ( glucose ) and/or lactic acid in the blood
  • Lactic acidosis (caused by an elevated amount of lactic acid in the blood. Symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing)

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

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the ampoule or carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater. 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, 0.5 mg/ml.
  • The other ingredients are sodium chloride, hydrochloric acid, and water.

What the medicine looks like and the contents of the pack

Bricanyl is available in glass ampoules in packs of 10 x 1 ml and 10 x 5 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

AstraZeneca AB, Södertälje

Manufacturer:

Cenexi

94120 Fontenay sous Bois

France

Muhammad Nadeem

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