20 mg / ml injection solution 
hyoscinbutylbromid

1. What Buscopan is and what it is used for

Buscopan counteracts cramps that can occur in smooth muscles (non-will-controlled muscles in internal organs).

Buscopan can be used as an antispasmodic for X-rays or in acute spasms of the gastrointestinal tract, bile ducts, pancreas, urinary tract, or genitals.

2. What you need to know before you take Buscopan

Do not use Buscopan

  • if you are allergic to hyosquinbutyl bromide or any of the other ingredients of this medicine (listed in section 6).
  • if you have any of the following problems:
    • Prostate enlargement with difficulty emptying the bladder
    • Narrowing of the gastrointestinal tract ( stenosis )
    • Enlarged colon (megacolon)
    • Myasthenia gravis (a disease with muscle weakness)
    • Untreated narrow-angle glaucoma (eye disease due to the eye’s fluid not flowing away as quickly as it is formed, which means that the pressure in the eye becomes too high).

Warnings and cautions

Talk to your doctor or nurse before using Buscopan.

Buscopan can contribute to increased pressure in the eye if you have a hidden eye disease ( narrow-angle glaucoma ).

Contact an ophthalmologist immediately if you experience pain in one or both eyes, rapid visual impairment, and red-eye after receiving an injection of Buscopan.

Contact a doctor or nurse immediately if you suddenly experience itching and swelling around the eyes, mouth, and lips, as well as a feeling of warmth in the face and difficulty breathing or swallowing. This may be a sign of an allergic shock.

Contact a doctor immediately if severe unexplained abdominal pain persists or worsens and symptoms such as fever, nausea, vomiting, altered bowel movements, tenderness over the stomach, falling blood pressure, fainting or blood in the stool are added. In that case, the cause of the symptoms needs to be investigated.

If you have cardiovascular disease, treatment should be given under supervision to check that your cardiovascular disease is not getting worse.

If you are being treated with blood thinners, Buscopan should not be injected into muscle tissue as there is a risk of bleeding in the muscle. Buscopan is instead injected under the skin ( subcutaneous injection ) or slowly directly into a blood vessel (slow intravenous injection ).

Other medicines and Buscopan

Buscopan may potentiate the anticholinergic effect of other medicines. Examples of anticholinergic effects are dilated pupils, increased heart rate, decreased saliva production, and decreased activity in the intestines. This applies, for example:

  • antidepressants (tri- and tetracyclic antidepressants)
  • anti-allergy drugs ( antihistamines )
  • drugs against psychosis s
  • disopyramide (medicine for heart rhythm disorders)
  • drugs for chronic obstructive pulmonary disease (COPD) such as tiotropium, ipratropium.
  • atropine

If you are taking metoclopramide (a medicine used to treat nausea) at the same time, the effect of both medicines on the gastrointestinal tract may be reduced.

If you are being treated with a higher heart rate at the same time, it can be further boosted by Buscopan.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

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.

There is insufficient experience from use in pregnant women to assess whether Buscopan is suitable for use in pregnancy. Animal studies have not shown any direct or indirect harm. As a precautionary measure, Buscopan is not recommended during pregnancy.

There is no information on whether the active substance or its degradation products are transferred to breast milk. As a precautionary measure, Buscopan is not recommended during breast-feeding.

It is not known if fertility is affected when using Buscopan.

Driving and using machines

No studies have been performed to see if Buscopan affects your ability to drive or use machines. Buscopan treatment can affect your ability to adjust visual acuity and can also cause dizziness. Refrain from driving or performing work that requires increased attention if you become dizzy or if your vision is affected.

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.

3. How to use Buscopan

Dose one is given by a doctor or nurse. Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

The recommended dose is 1-2 ampoules that are injected into a muscle or under the skin or alternatively as a slow injection directly into the bloodstream. The maximum daily dose is five ampoules.

Buscopan should not be used daily for long periods without examination of the cause of the abdominal pain.

4. Possible side effects

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

Many of these side effects are due to Buscopan’s anticholinergic effects (effects on smooth muscle ) and are usually mild and transient.

Contact a doctor immediately if you get signs of allergic shock, allergy-like reactions, or hypersensitivity, for example:

  • itching, redness, and swelling of the skin and mucous membranes
  • difficult to breathe and swallow cough
  • dizziness, fainting
  • nausea, vomiting, or diarrhea

These side effects have been reported with the use of Buscopan, but it is not possible to say how common they are (they occur in an unknown number of users). Prompt treatment of allergic shock is important as it can be life-threatening.

Common (may affect up to 1 in 10 people): increased heart rate, difficulty adjusting visual acuity at different distances (accommodation disorders), dizziness, dry mouth.

Has been reported (occurs in an unknown number of users): dilated pupils, increased pressure in the eye, swelling, drop in blood pressure, shortness of breath, skin reactions (rash, eczema, reddening of the skin, itching ), hypohidrosis (absence or abnormally slight sweating), fluid retention in the body.

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 Buscopan

No special storage instructions. 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 after EXP. The expiration date is the last day of the specified month.

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 hyoscine butyl bromide.
  • The other ingredients are sodium chloride and water for injections.

What the medicine looks like and the contents of the pack

Each pack contains 5 glass ampoules of 1 ml each.

Marketing Authorization Holder and Manufacturer

Sanofi AB

Box 30052

104 25 Stockholm

Manufacturer

BOEHRINGER INGELHEIM ESPAÑA, SA

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

or

Sanofi SpAb

VIa Valcanello 4, 03012 Anagni (FR), Italy

Muhammad Nadeem

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