Buscolisin

Package Leaflet: Information for the Patient

Buscolysin

20 mg/ml solution for injection,

(Hyoscini butylbromidum)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Buscolysin and what is it used for
• 2. Important information before using Buscolysin
• 3. How to use Buscolysin
• 4. Possible side effects
• 5. How to store Buscolysin
• 6. Contents of the pack and other information

1. What is Buscolysin and what is it used for

Buscolysin exhibits similar parasympatholytic activity to atropine, but acts peripherally without central nervous system effects. Compared to atropine, it acts faster but shorter.
Buscolysin blocks muscarinic receptors, resulting in decreased smooth muscle tension, weakened gastrointestinal motility and gastric secretion, and also relieves spasms of the biliary and urinary tracts.
Buscolysin is used in the following cases:

• acute spastic conditions of the gastrointestinal tract: esophageal spasms, cardiospasm and pylorospasm, spasmodic constipation, biliary dyskinesia,
• gastritis and duodenitis, as well as gastric and duodenal ulcers,
• biliary colic,
• acute spastic conditions of the urinary tract, especially in the course of kidney stones, renal colic, painful urination,
• as an aid in radiological diagnostics of the gastrointestinal and urinary tracts, in endoscopic examinations and accompanying procedures, as well as after surgical procedures,
• in obstetrics and gynecology: spasms of the birth canal during childbirth, postpartum endometritis, placenta removal, painful menstrual cramps, as an aid during abortion (in the initial stage).

2. Important information before using Buscolysin

When not to use Buscolysin

• if the patient is allergic to hyoscine or any of the other ingredients of the medicine (listed in section 6).
• if the patient has:
• hypersensitivity to butylbromide hyoscine, atropine or any ingredient of the medicine;
• glaucoma;
• prostatic hyperplasia with urinary retention;
• gastrointestinal obstruction;
• heart rhythm disorders (tachycardia);
• angina pectoris;
• heart failure;
• colonic dilation.

Warnings and precautions

Consult a doctor before using Buscolysin.
Butylbromide hyoscine may cause urinary retention or worsen the clinical condition, especially in the elderly with the following diseases: prostatic hyperplasia without obstruction, uropathy (impaired urine flow) with urinary tract obstruction, such as obstruction of the bladder neck caused by prostatic hyperplasia. In such cases, special caution should be exercised when using the medicine.
Caution is advised when using the medicine in patients with mechanical gastrointestinal obstruction of various origins, pyloric stenosis, colonic dilation, as administration of the medicine may lead to stagnation of gastrointestinal contents, bloating and intoxication, which can exacerbate the course of these diseases.
Special caution should be exercised when using the medicine in patients with heart diseases, especially cardiac arrhythmias (tachycardia, tachyarrhythmia).
The medicine should not be administered to patients with closed-angle glaucoma and those with high fever, as butylbromide hyoscine has an inhibitory effect on sweat glands, and its use may cause overheating of the body with all its consequences.
In patients with symptoms of dry mouth, drying of the nasal mucosa, hypertension (increased muscle tension), and hyperthyroidism, special caution should be exercised when using the medicine.
In case of any symptoms of hypersensitivity, the medicine should be discontinued.
It is not recommended to administer the medicine 24 hours before gastric acid secretion testing.

Children

The use of Buscolysin in children under 6 years of age is not recommended.

Buscolysin and other medicines

Inform your doctor or pharmacist about all medicines you have taken recently or plan to take.
Cholinomimetic preparations (pilocarpine - a medicine used to treat glaucoma) and anticholinesterase medicines (galantamine, physostigmine, pyridostigmine - medicines that increase neurotransmission) antagonize (inhibit) the action of butylbromide hyoscine,

Using Buscolysin with food, drink, and alcohol

Not applicable.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Experimental studies in animals have not shown any direct or indirect harmful effects of the medicine on pregnancy, embryonic/fetal development, childbirth, or postpartum development.
The medicine may be used during pregnancy only if medically justified, under the supervision of a doctor, and if the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding

The active substance of the medicine partially passes into breast milk. Therefore, its use is not recommended during breastfeeding. If the use of the medicine is necessary, breastfeeding should be discontinued. Butylbromide hyoscine may also reduce milk secretion due to impaired function of exocrine glands.

Fertility

There is no information on any adverse effects of the product on fertility in animals.

Driving and using machines

Prolonged use of the medicine may lead to accommodation disorders. During treatment with Buscolysin, you should not drive vehicles or operate machinery until full visual acuity is regained.
Buscolysin contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicinal product is considered sodium-free.

3. How to use Buscolysin

Dosage and duration of treatment will be determined by your doctor.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor. In case of any doubts, consult your doctor or nurse.
The attending physician determines the daily dose of Buscolysin based on the severity of clinical symptoms and any accompanying diseases.
Adults:
One ampoule (20 mg) intramuscularly or intravenously, if necessary, subsequent doses can be administered every 30 minutes. Intravenous injection should be performed "slowly" (may cause significant lowering of blood pressure and even shock caused by the administration of butylbromide hyoscine).
Maximum daily dose in adults is 100 mg.
Children over 6 years:
Buscolysin should be administered intramuscularly or slowly intravenously in a dose of 5-10 mg, 2 to 4 times a day.
Method of administration
Buscolysin should be administered intramuscularly or slowly intravenously, as well as by intravenous drip infusion.
Intramuscular administration in children over 6 years of age should be performed slowly, over at least 1 minute.

Using a higher dose of Buscolysin than recommended

Consult your doctor as soon as possible.
Overdose of the medicine, depending on the degree of poisoning, is characterized by the following symptoms:
redness and dryness of the skin, dryness of mucous membranes, dilation of pupils, heart rhythm disorders, difficulty swallowing, neuropsychiatric disorders (delirium, visual hallucinations, agitation and anxiety, ataxia) up to loss of consciousness, high fever, urinary retention, collapse and coma.
In case of overdose, the patient should be hospitalized and treated symptomatically.
Symptoms of overdose can be reduced by administering parasympathomimetic medicines, such as galantamine or physostigmine.
In severe cases of poisoning, the patient should be given barbiturates and benzodiazepines, and if necessary, resuscitated.

4. Possible side effects

Like all medicines, Buscolysin can cause side effects, although not everybody gets them.
The following side effects are listed according to the system organ classes.
Common (may affect up to 1 in 10 people):

• accommodation disorders of the eye
• tachycardia (heart beats faster than usual)
• dizziness
• dry mouth, constipation

Unknown * (cannot be estimated from the available data)

• anaphylactic shock, including fatal cases, anaphylactic reactions (severe allergic reaction causing facial or throat swelling), dyspnea (difficulty breathing), skin reactions (e.g., hives, rash, erythema, itching) and other hypersensitivity reactions,
• pupil dilation, increased intraocular pressure,
• blood pressure decrease, skin redness,
• urinary retention,
• decreased sweat secretion.

Pain at the injection site may occur, especially after intramuscular administration .
Butylbromide hyoscine, the active substance of Buscolysin, due to its chemical structure (quaternary ammonium compound), should not penetrate the central nervous system. Butylbromide hyoscine does not cross the blood-brain barrier. However, it cannot be entirely ruled out that after administration of Buscolysin, psychiatric disorders (e.g., disorientation) may occur.
*This side effect was observed after the medicinal product was placed on the market. With a probability of 95%, it can be stated that the frequency of occurrence is not higher than in the category "common", but may be lower. Accurate estimation of the frequency of occurrence is impossible, as this side effect did not occur in the group of 185 patients during clinical trials.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49-21-301, fax (22) 49-21-309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Buscolysin

Store in the original packaging at a temperature below 25°C. Do not freeze.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Buscolysin contains

• The active substance of the medicine is butylbromide hyoscine. One 1 ml ampoule of solution for injection contains 20 mg of butylbromide hyoscine (Hyoscini butylbromidum).
• The other ingredients of the medicine are sodium chloride and water for injections.

What Buscolysin looks like and contents of the pack

Ampoules made of orange type I glass in a soft blister pack with a PVC foil, placed in a cardboard box with a patient leaflet.

Package size:

1 blister pack of 10 ampoules in a box
10 blister packs of 10 ampoules in a box

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136
02-305 Warsaw

Manufacturer:

SOPHARMA AD
16 Iliensko Shosse str.
1220 Sofia, Bulgaria

Date of approval of the leaflet: