Scopolan compositum

Package Leaflet: Information for the Patient

Scopolan Compositum

Hyoscine Butylbromide + Metamizole Sodium Monohydrate

10 mg + 250 mg, Chewable Tablets

Scopolan Compositum may cause a severely decreased number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4). You should stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth ulcers, or ulcers in the genital or anal area. If you have ever had agranulocytosis while taking metamizole or similar medicines, you should never take this medicine again (see section 2).

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet to be able to read it again if needed.
• If you need advice or additional information, you should consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not improve or feel worse after 3 days, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Scopolan Compositum and what is it used for

Scopolan Compositum contains two active substances: hyoscine butylbromide and metamizole sodium monohydrate.
Hyoscine butylbromide relieves smooth muscle spasms in the abdominal cavity.
Metamizole sodium monohydrate has strong analgesic and antipyretic effects and also reduces smooth muscle tension. Scopolan Compositum reduces painful spasms of the digestive tract, bile ducts, and the urogenital system.

Indications for Use

Scopolan Compositum is used for short-term treatment of severe pain in spasmodic conditions:

• of the digestive tract (e.g., stomach cramps, intestinal colic, irritable bowel syndrome),
• of the bile ducts (e.g., biliary colic),
• of the urogenital system (e.g., renal colic, spasmodic conditions associated with ureteral stones, painful menstruation). Scopolan Compositum is indicated when the use of other medicines is contraindicated or ineffective.

2. Important Information Before Taking Scopolan Compositum

When Not to Take Scopolan Compositum

• if you have had a significant decrease in the number of white blood cells (granulocytes) caused by metamizole or other similar medicines called pyrazolones or pyrazolidines,
• if you have disorders of bone marrow function or a disease that affects the production or function of blood cells.
• You should not take Scopolan Compositum if you are allergic to the active substances (hyoscine butylbromide, metamizole sodium monohydrate) or any of the other ingredients (listed in section 6).

Do Not Take Scopolan Compositum if You Have:

• hypersensitivity to pyrazolones and other nonsteroidal anti-inflammatory drugs (NSAIDs),
• allergy to tropane alkaloids (e.g., atropine) and their derivatives,
• changes in blood morphology,
• congenital glucose-6-phosphate dehydrogenase deficiency (an enzyme involved in red blood cell metabolism),
• acute porphyria (a disease with severe abdominal pain, vomiting, weakness, and muscle pain, as well as psychiatric disorders),
• acute renal or hepatic failure,
• glaucoma with a narrow angle of filtration (an eye disease with increased intraocular pressure),
• prostate enlargement (prostatic hyperplasia),
• paralytic ileus (obstruction of the intestinal contents),
• atomic constipation,
• esophageal, gastric, or duodenal stenosis,
• urethral stricture,
• tachycardia,
• myasthenia gravis (a disease with muscle weakness and fatigue),
• toxic megacolon (a condition with a very enlarged colon),
• if you are in the last three months of pregnancy.

Do not use in children under 10 years of age.

Warnings and Precautions

Agranulocytosis (severely decreased number of white blood cells)
Scopolan Compositum may cause agranulocytosis, a severely decreased number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). You should stop taking metamizole and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful mouth ulcers, especially in the mouth, nose, and throat or in the genital or anal area. Your doctor will order a laboratory test to check your blood cell count.
If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if you are taking antibiotics.
Agranulocytosis can develop at any time during Scopolan Compositum treatment, even after a short period of treatment. Agranulocytosis can occur even if metamizole was previously taken without complications.
The medicine should only be taken as needed (when symptoms occur) in the recommended indications. Do not take the medicine for more than 3 days without consulting your doctor.
If you experience sudden abdominal pain with unknown cause and also have: fever, nausea, vomiting, changes in bowel movements (e.g., diarrhea), abdominal tenderness, decreased blood pressure, fainting, or blood in the stool, you should not take the medicine without consulting your doctor. To investigate the cause of the symptoms, your doctor will order appropriate diagnostic tests.
You should discuss the use of Scopolan Compositum with your doctor if you have:

• gastroesophageal reflux disease (stomach contents flowing back into the esophagus),
• ulcerative colitis,
• gastric or duodenal ulcer disease,
• ischemic heart disease,
• mitral stenosis (narrowing of a heart valve),
• renal or hepatic impairment,
• hypersensitivity to painkillers, manifested by shortness of breath, hives, swelling of the tongue, face, lips, and/or throat, especially with concurrent sinusitis and nasal polyps,
• asthma or other allergic diseases (including atopic diseases, chronic urticaria, hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates)),
• alcohol intolerance, manifested by sneezing, tearing, and severe facial flushing in response to even small amounts of alcohol; this may indicate previously undiagnosed analgesic asthma.

You should exercise particular caution in elderly patients.
You should also exercise caution when taking the medicine in patients with low blood pressure (systolic blood pressure below 100 mmHg), dehydration, high fever, decreased blood volume, heart failure, and circulatory disorders, as the medicine may cause a decrease in blood pressure.
You should stop taking the medicine immediately and seek medical help due to the risk of life-threatening reactions in case of sudden symptoms of a severe allergic reaction, anaphylactic shock (difficulty breathing, significant drop in blood pressure, sudden swelling, hives). The risk of these symptoms is higher in patients with intolerance to other painkillers, certain dyes (e.g., tartrazine), and preservatives (e.g., benzoates), asthma (especially if accompanied by nasal polypoid sinusitis), atopy, chronic urticaria, and alcohol intolerance (manifested by sneezing, tearing, and severe facial flushing after consuming even small amounts of alcohol). When taking the medicine in these patients, particular caution is recommended.
You should stop taking the medicine immediately and consult your doctor if you experience:

• agranulocytosis (severely decreased number of white blood cells, see above),
• thrombocytopenia (decreased platelet count, manifested by, e.g., bruising on the skin and mucous membranes, recurrent bleeding from the gums, nose, gastrointestinal tract),
• pancytopenia (severely decreased number of all blood cells: red and white blood cells and platelets, manifested by worsening general condition, weakness, signs of infection, fever, bruising, and recurrent bleeding, pallor).
  Severe skin reactions.
  Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with metamizole treatment. If you experience any of these symptoms, you should stop taking metamizole and seek medical help immediately.
  If you have ever experienced severe skin reactions, you should never take Scopolan Compositum again (see section 4).
  Liver disorders.
  Metamizole has been associated with cases of liver inflammation, with symptoms appearing within a few days to several months after starting treatment.
  You should stop taking Scopolan Compositum and consult your doctor if you experience liver disorders, such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen.
  Your doctor will check your liver function.
  You should not take Scopolan Compositum if you have previously taken metamizole-containing products and experienced liver disorders.
  If you experience any vision disturbances or eye pain due to increased intraocular pressure, you should stop taking the medicine and consult your doctor.
  Due to the possibility of decreased sweating, the medicine should be used with caution in patients with fever.

  Children

  Do not use in children under 10 years of age.
  In children between 10 and 14 years of age, use only under medical supervision.

  Scopolan Compositum and Other Medicines

  Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
  Do not take Scopolan Compositum with other pyrazolone or pyrazolidine derivatives (e.g., propyphenazone, aminophenazone, phenylbutazone, oxyphenbutazone). These are painkillers, antipyretics, and anti-inflammatory medicines.
  Before taking Scopolan Compositum, consult your doctor if you are taking:

  • tricyclic antidepressants, e.g., clomipramine, amitriptyline,
  • monoamine oxidase inhibitors (MAOIs), e.g., selegiline, moclobemide (some medicines used to treat depression and Parkinson's disease),
  • bupropion (a medicine used to treat depression or as an aid to smoking cessation),
  • neuroleptics (antipsychotic medicines) from the phenothiazine group, e.g., chlorpromazine, as well as clozapine and olanzapine,
  • barbiturates, e.g., phenobarbital (used in epilepsy) and glutethimide,
  • phenytoin (an antiepileptic medicine),
  • certain antihistamines (anti-allergic medicines), e.g., dimenhydrinate, clemastine,
  • amantadine (a medicine used to treat Parkinson's disease),
  • anticoagulants (e.g., warfarin, acenocoumarol),
  • disopyramide (an antiarrhythmic medicine used to treat irregular heartbeat),
  • other cholinolytic medicines, such as ipratropium or tiotropium (medicines used to treat chronic obstructive pulmonary disease) or other atropine-like medicines,
  • oral antidiabetic medicines,
  • dopamine receptor blockers, e.g., metoclopramide (a medicine used to treat gastric disorders),
  • beta-adrenergic medicines (used to treat breathlessness and asthma),
  • sulfonamides (antibacterial medicines),
  • nonsteroidal anti-inflammatory medicines, e.g., ibuprofen, acetylsalicylic acid,
  • pethidine (a medicine used to treat severe and prolonged pain),
  • methotrexate (a medicine used to treat cancer and autoimmune diseases),
  • allopurinol (a medicine that reduces uric acid production),
  • cyclosporine (a medicine that prevents transplant rejection),
  • efavirenz (a medicine used to treat HIV infection/AIDS),
  • methadone (a medicine used to treat opioid addiction),
  • valproate (a medicine used to treat epilepsy or bipolar disorder),
  • tacrolimus (a medicine used to prevent transplant rejection),
  • sertraline (a medicine used to treat depression).

  When taking pyrazolone derivatives, to which metamizole belongs, there may be changes in the effectiveness of blood pressure-lowering and diuretic medicines (e.g., captopril, triamterene) and lithium. It is not known if metamizole also causes such interactions.

  Taking Scopolan Compositum with Alcohol

  Do not consume alcohol while taking the medicine. Alcohol taken with the medicine increases the risk of severe side effects.

  Pregnancy, Breastfeeding, and Fertility

  The medicine is not recommended during pregnancy and breastfeeding.
  Pregnancy
  Hyoscine Butylbromide
  Data on the use of hyoscine butylbromide in pregnant women are limited. Preclinical studies did not reveal any significant risk of embryotoxic or teratogenic effects.
  Metamizole Sodium
  Available data on the use of metamizole during the first 3 months of pregnancy are limited but do not indicate any harmful effects on the fetus. In selected cases, if there are no other treatment options, after consulting a doctor or pharmacist, a patient may take single doses of metamizole in the first and second trimester, provided that the benefits and risks of taking the medicine are carefully weighed. As a rule, administering metamizole in the first and second trimester is not recommended.
  Do not take Scopolan Compositum during the last three months of pregnancy due to the increased risk of complications in the mother and child (bleeding, premature closure of the ductus arteriosus in the unborn child, which normally closes after birth).
  Breastfeeding
  Hyoscine Butylbromide
  There are no data on the passage of hyoscine butylbromide into breast milk.
  Cholinolytics may inhibit milk production, so Scopolan Compositum is not recommended during breastfeeding.
  Metamizole Sodium
  Metamizole metabolites pass into breast milk in significant amounts, and it cannot be ruled out that there is a risk to the breastfed infant. Therefore, metamizole should be avoided during breastfeeding.
  In the case of single-dose administration of metamizole, it is recommended that mothers discard breast milk for 48 hours after taking the medicine.
  Fertility
  No data available.

  Driving and Using Machines

  Do not drive or operate machinery while taking the medicine, as it may cause impaired physical and mental performance and vision disturbances.

  Scopolan Compositum Contains Sucrose

  If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

  3. How to Take Scopolan Compositum

  This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
  The medicine should only be taken as needed (when symptoms occur).
  The dose depends on the severity of the pain and individual response to Scopolan Compositum. The key is to choose the smallest dose that relieves the pain.
  Recommended dose
  Adults and adolescents over 14 years: orally, 1 to 2 chewable tablets at a time.
  If the pain is severe, the dose can be increased to 1 to 2 chewable tablets up to 3 times a day.
  Children between 10 and 14 years: use only under medical supervision.
  Scopolan Compositum is contraindicated in children under 10 years of age.
  A noticeable effect can be expected within 30 to 60 minutes after oral administration.
  Elderly Patients and Patients with Impaired Renal Function or Poor General Health
  In elderly patients, weakened patients, and patients with impaired renal function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.
  Patients with Renal or Hepatic Impairment
  Due to reduced elimination in patients with renal or hepatic impairment, multiple administration of high doses should be avoided. In the case of short-term use, dose reduction is not required. There is no experience with long-term use.
  Do not take the medicine for more than 3 days without consulting your doctor.
  If symptoms worsen despite taking the medicine, you should stop taking it and consult your doctor.

  Overdose of Scopolan Compositum

  In case of overdose or accidental ingestion of the medicine by a child, you should immediately consult your doctor.
  Overdose symptoms may result from both metamizole sodium and hyoscine butylbromide.
  The following symptoms may occur: dizziness, ringing in the ears, hearing disturbances, psychomotor agitation, and in the case of very high doses, impaired consciousness, coma, and convulsions. Additionally, the following may occur: dry mouth, vision disturbances, rapid heartbeat, decreased blood pressure, difficulty swallowing, painful urination, severe abdominal pain, nausea, and vomiting.
  In case of overdose symptoms, you should stop taking the medicine and immediately consult your doctor.

  Missed Dose of Scopolan Compositum

  Do not take a double dose to make up for a missed dose.

  Stopping Scopolan Compositum Treatment

  Scopolan Compositum should only be taken when needed and should be stopped after symptoms resolve.
  If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

  4. Possible Side Effects

  Like all medicines, Scopolan Compositum can cause side effects, although not everybody gets them.
  You should stop taking the medicine and seek medical help immediately if you experience any of the following severe side effects:

  • red, flat spots on the torso, target-like or round, often with blisters in the center, peeling skin, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
  • widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome);
  • malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. These may be symptoms of liver damage. See also section 2 "Warnings and Precautions".

  Side effects are presented according to the classification of organs and systems and frequency of occurrence: uncommon (occurring in less than 1 in 100 patients but more than 1 in 1,000 patients); rare (occurring in less than 1 in 1,000 patients but more than 1 in 10,000 patients); very rare (occurring in less than 1 in 10,000 patients); unknown (cannot be estimated from available data).
  During Scopolan Compositum treatment, the following may occur:

  • skin and subcutaneous tissue disorders: flushing, burning sensation, itching, hives, swelling - uncommon;
  • severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis - very rare; drug rash with eosinophilia and systemic symptoms (DRESS syndrome) - frequency unknown;
  • gastrointestinal disorders: dry mouth, nausea, vomiting, constipation - uncommon;
  • cardiac disorders: tachycardia (rapid heartbeat) - uncommon;
  • vascular disorders: hypotension (low blood pressure) - uncommon;
  • renal and urinary disorders: kidney damage, anuria (urine retention) - rare;
  • eye disorders: vision disturbances - rare;
  • blood and lymphatic system disorders: allergic damage to bone marrow function, leading to:

  In case of any of the above symptoms, you should stop taking the medicine and consult your doctor immediately.

  Reporting Side Effects

  If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
  Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
  Jerozolimskie Avenue 181 C, 02-222 Warsaw
  Phone: +48 22 49 21 301
  Fax: +48 22 49 21 309
  Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects will help gather more information on the safety of the medicine.

  5. How to Store Scopolan Compositum

  Store in a temperature below 25°C.
  Keep the medicine out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the packaging. 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 Scopolan Compositum Contains

  Active substances:
  One chewable tablet contains:
  10 mg hyoscine butylbromide (Hyoscini butylbromidum)
  250 mg metamizole sodium monohydrate (Metamizolum natricum monohydricum)
  Excipients: sucrose, talc, potato starch, gum arabic, pig gelatin, glycerol, magnesium stearate, titanium dioxide (E 171).

  What Scopolan Compositum Looks Like and Contents of the Pack

  Scopolan Compositum is a white, chewable tablet.
  Packaging: aluminum/PVC blister pack in a cardboard box.
  Available packs: 10 chewable tablets in 1 blister pack; 20 chewable tablets in 2 blister packs.
  Marketing Authorization Holder and Manufacturer
  Wrocławskie Zakłady Zielarskie "Herbapol" SA

  • 50-951 Wrocław, ul. Świętego Mikołaja 65/68, phone: +48 71 335 72 25, fax: +48 71 372 47 40, e-mail: [email protected]

  For more detailed information on this medicine, please contact the marketing authorization holder - phone: 71 321 86 04, ext. 123

  Date of Last Revision of the Leaflet: