Scopolan compositum

Package leaflet: Information for the patient

Scopolan compositum
Hyoscini butylbromidum + Metamizolum natricum monohydricum
10 mg + 250 mg, coated tablets
Scopolan compositum may cause a very low number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).
Treatment should be discontinued and medical advice sought immediately if any of the following symptoms occur: fever, chills, sore throat, painful ulcers in the nose, mouth or throat, or in the genital or anal area. If agranulocytosis has ever occurred in the patient during treatment with metamizole or similar medicines, this medicine must never be taken again in the future (see section 2).
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Contents of the leaflet

1. What Scopolan compositum is and what it is used for
2. What you need to know 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 Scopolan compositum is and what it is used for

Scopolan compositum contains two active substances: hyoscine butylbromide and monohydrate sodium metamizole.
Hyoscine butylbromide relieves spasms of smooth muscles in the abdominal cavity.
Monohydrate sodium metamizole has strong analgesic and antipyretic effects and additionally reduces smooth muscle tone. Scopolan compositum reduces painful spasms of the gastrointestinal tract, biliary ducts, and the urogenital system.
Indications
Scopolan compositum is indicated for short-term treatment of severe pain associated with spastic conditions:

• of the gastrointestinal tract (e.g. stomach spasms, intestinal colic, irritable bowel syndrome),
• of the biliary system (e.g. biliary colic),
• of the urogenital system (e.g. renal colic, spastic conditions associated with ureteric calculi, painful menstruation). Scopolan compositum is indicated when the use of other medicines is contraindicated or ineffective.

2. What you need to know before taking Scopolan compositum
When not to take Scopolan compositum

• if the patient has previously experienced a significant decrease in the number of white blood cells called granulocytes, caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines,
• if the patient has disorders of bone marrow function or a disease affecting the production or function of blood cells.
• Do not take Scopolan compositum if the patient is allergic to the active substances in the medicine (hyoscine butylbromide, monohydrate sodium metamizole) or to any of the other components (listed in section 6).

Do not take Scopolan compositum if the patient has:

• hypersensitivity to pyrazolones and other non-steroidal anti-inflammatory drugs (medicines with anti-inflammatory, analgesic and antipyretic properties),
• allergy to tropane alkaloids (e.g. atropine) and their derivatives,
• blood morphology abnormalities,
• congenital deficiency of glucose-6-phosphate dehydrogenase (an enzyme involved in red blood cell metabolism),
• acute hepatic porphyria (a disease with severe abdominal pain, vomiting, weakness, muscle pain and psychiatric disturbances),
• acute renal or hepatic failure,
• narrow-angle glaucoma (an eye disease characterised by increased intraocular pressure),
• prostate enlargement (enlargement of the prostate gland),
• paralytic ileus (a condition where intestinal contents do not move),
• atonic constipation,
• oesophageal, pyloric or gastric outlet stenosis,
• urethral stricture,
• tachycardia,
• myasthenia gravis (a disease characterised by impaired muscle function and significant muscle weakness),
• pathological dilation of the large intestine (megacolon),
• if the patient is in the last three months of pregnancy.

Do not use in children under 10 years of age.
Warnings and precautions
Very low number of white blood cells (agranulocytosis)
Scopolan compositum may cause agranulocytosis, i.e. a very low number of a type of white blood cells called granulocytes, which play an important role in fighting infections (see section 4). Treatment with metamizole should be discontinued and medical advice sought immediately if the following symptoms occur, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful ulcers of the mucous membranes, especially in the mouth, nose and throat or in the genital or anal area. The doctor will order laboratory tests to check the patient's blood cell count.
If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if the patient is receiving antibiotics.
Agranulocytosis may develop at any time during treatment with Scopolan compositum, and even shortly after stopping metamizole.
Agranulocytosis may occur even if metamizole was previously administered without complications.
The medicine should only be taken on an as-needed basis (when symptoms occur) and only for the recommended indications. The medicine should not be used for longer than 3 days without consulting a doctor.
If the patient experiences sudden abdominal pain of unknown cause, accompanied by fever, nausea, vomiting, changes in bowel habits (e.g. diarrhoea), pain on abdominal palpation, low blood pressure, fainting or blood in the stool, the patient should not take the medicine without first consulting a doctor. To determine the cause of the symptoms, the doctor will recommend appropriate diagnostic tests.
The use of Scopolan compositum should be discussed with a doctor if the patient suffers from:

• gastro-oesophageal reflux disease (reflux of stomach contents into the oesophagus),
• ulcerative colitis,
• peptic ulcer disease of the stomach and duodenum,
• ischaemic heart disease,
• mitral stenosis (narrowing of one of the heart valves),
• impaired kidney and/or liver function,
• hypersensitivity to analgesics manifesting as asthma, urticaria, angioedema of the tongue, face, lips and/or throat, especially when associated with sinusitis and nasal polyps,
• bronchial asthma or other allergic (hypersensitivity) diseases, including atopic, chronic urticaria, allergy to dyes (e.g. tartrazine) or preservatives (e.g. benzoates),
• alcohol intolerance manifesting as sneezing, lacrimation and severe facial flushing even after small amounts of alcohol; this may indicate previously undiagnosed analgesic-induced asthma.

Special caution is required in elderly patients.
Caution is also advised in patients with low blood pressure (systolic pressure below 100 mm Hg), dehydration, high fever, reduced blood volume, heart failure and circulatory disorders, as the medicine may cause a drop in blood pressure.
Treatment should be discontinued immediately and medical help sought due to the risk of life-threatening severe allergic reactions, anaphylactic shock (difficulty breathing, significant drop in blood pressure, sudden swelling, urticaria). The risk of these symptoms is higher in patients with intolerance to other analgesics, certain dyes (e.g. tartrazine) and preservatives (e.g. benzoates), asthma (especially when associated with nasal polyps and sinusitis), atopy, chronic urticaria and alcohol intolerance (manifesting as sneezing, lacrimation and severe facial flushing after even small amounts of alcohol). Particular caution is recommended when administering the medicine to such patients.
Treatment should be discontinued immediately and medical advice sought without delay if the following symptoms occur:

• agranulocytosis (very low number of white blood cells, see above),
• thrombocytopenia (low platelet count - decreased number of blood platelets, manifesting e.g. as petechiae on the skin and mucous membranes, recurrent bleeding from gums, nose, gastrointestinal tract),
• pancytopenia (significant decrease in all blood cells: red and white blood cells and platelets, characterised by worsening general condition, weakness, signs of infection, fever, petechiae and recurrent bleeding, pallor).

Severe skin reactions.
Severe skin reactions have been reported with metamizole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). If the patient experiences any of these symptoms related to severe skin reactions listed in section 4, treatment with metamizole should be discontinued and immediate medical help sought.
If the patient has ever experienced severe skin reactions, Scopolan compositum treatment must never be repeated in the future (see section 4).
Liver-related disorders.
Cases of hepatitis have been reported in patients taking metamizole, with symptoms appearing from several days to several months after starting treatment.
Treatment with Scopolan compositum should be discontinued and medical advice sought if the patient experiences liver-related symptoms such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, jaundice (yellowing of the skin or whites of the eyes), itching, rash or upper abdominal pain.
The doctor will check the patient's liver function.
The patient should not take Scopolan compositum if previously treated with any medicinal products containing metamizole and experienced liver-related disorders.
If any disturbances in visual acuity or eye pain due to increased intraocular pressure occur, treatment should be discontinued and medical advice sought.
Due to the possibility of reduced 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 aged 10 to 14 years, use only as directed by a doctor.
Scopolan compositum and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
This medicine should not be taken simultaneously with other medicines from the pyrazolone and pyrazolidine groups (propyphenazone, aminophenazone, phenylbutazone, oxyphenbutazone). These are medicines with analgesic, antipyretic and anti-inflammatory effects.
Before starting treatment with Scopolan compositum, consult a doctor if taking:

• tricyclic antidepressants, e.g. clomipramine, amitriptyline,
• monoamine oxidase inhibitors (MAO), 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 in smoking cessation),
• neuroleptics (antipsychotic medicines) from the phenothiazine derivatives group, e.g. chlorpromazine, as well as clozapine and olanzapine,
• barbiturates, e.g. phenobarbital (used, among others, in epilepsy) and glutethimide,
• phenytoin (an anticonvulsant medicine),
• certain antihistamines (antiallergic 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 heart rhythm),
• other cholinolytic medicines, such as ipratropium or tiotropium (medicines used to treat chronic obstructive pulmonary disease) or other substances similar to atropine,
• oral antidiabetic medicines,
• dopamine receptor-blocking medicines, e.g. metoclopramide (a medicine used for gastric motility disorders),
• beta-adrenergic medicines (used to treat breathlessness and asthma),
• sulfonamides (antibacterial medicines),
• non-steroidal anti-inflammatory drugs, e.g. ibuprofen, acetylsalicylic acid,
• pethidine (a medicine used for severe and prolonged pain),
• methotrexate (a medicine used in cancer and autoimmune diseases),
• allopurinol (a medicine reducing urate and/or uric acid production),
• cyclosporine (a medicine used to prevent transplant rejection),
• efavirenz (a medicine used to treat HIV infection (AIDS)),
• methadone (a medicine used to treat addiction to illegal opioids),
• valproate (a medicine used to treat epilepsy or bipolar affective disorder),
• tacrolimus (a medicine used to prevent organ rejection in transplant patients),
• sertraline (a medicine used to treat depression).

When using pyrazolone derivatives, including metamizole, changes in the effectiveness of antihypertensive and diuretic medicines (e.g. captopril, triamterene) and lithium may occur. It is not known whether metamizole causes similar interactions.
Taking Scopolan compositum with alcohol
Do not consume alcohol while taking this medicine. Alcohol taken concurrently with the medicine increases the risk of severe adverse effects.
Pregnancy, breastfeeding and fertility
This medicinal product 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 show significant embryotoxic or teratogenic risk.
Metamizole sodium
Available data on the use of metamizole during the first three months of pregnancy are limited, but do not indicate harmful effects on the embryo. In selected cases, if no other treatment options are available, after consultation with a doctor or pharmacist, the patient may take single doses of metamizole during the first and second trimesters, provided that the benefits and risks of taking the medicine are carefully considered. In principle, administration of metamizole during the first and second trimesters is not recommended.
Scopolan compositum must not be taken during the last three months of pregnancy due to increased risk of complications for mother and child (bleeding, premature closure of an important blood vessel, the so-called Botall's duct in the unborn child, which normally closes only after birth).
Breastfeeding
Hyoscine butylbromide
There are no data on the passage of hyoscine butylbromide into human breast milk.
Cholinolytics may inhibit milk secretion; therefore, use of Scopolan compositum during breastfeeding is not recommended.
Metamizole sodium
Metamizole metabolites pass into the breast milk of nursing women in significant amounts, and risk to the breastfed infant cannot be excluded. For this reason, repeated use of metamizole during breastfeeding should be particularly avoided.
After a single dose of metamizole, mothers should be advised to express and discard milk for 48 hours after administration of the medicinal product.
Fertility
No data available.
Driving and operating machinery
During treatment, do not drive or operate machinery, as the medicine may cause disturbances in psychomotor performance and visual disturbances.
Scopolan compositum contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use Scopolan compositum

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine should be used only on an as-needed basis (when symptoms occur).
The dose depends on the intensity of pain and individual response to Scopolan compositum. It is essential to use the lowest effective dose that controls the pain.

Recommended dose
Adults and adolescents over 14 years of age – orally, 1 to 2 film-coated tablets at a time.
In cases of severe pain, the dosage may be increased to 1 to 2 film-coated tablets up to 3 times daily.

Children aged 10 to 14 years – use only as directed by a physician.
Use of Scopolan compositum in children under 10 years of age is contraindicated.

A clear effect can be expected within 30 to 60 minutes after oral administration.

Elderly patients and patients in poor general health or with renal impairment
In elderly patients, weakened patients, and patients with impaired kidney function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.

Patients with impaired renal or hepatic function
Due to reduced elimination rate in patients with impaired renal or hepatic function, repeated administration of high doses should be avoided. In short-term use, dose reduction is not required. There is no experience with long-term use.

Do not use this medicine for longer than 3 days without consulting a doctor.
If symptoms worsen despite treatment, the patient should stop taking the medicine and consult a doctor.

Use of a higher than recommended dose of Scopolan compositum
If a higher than recommended dose of Scopolan compositum is taken, or if the medicine is ingested by a child, seek immediate medical advice.
Symptoms of overdose may result from both sodium metamizole monohydrate and hyoscine butylbromide.

Possible symptoms include: dizziness, tinnitus, hearing disturbances, psychomotor agitation, and after very large doses – disturbances of consciousness, coma, and convulsions.
In addition, the following may occur: dry mouth, visual disturbances, increased heart rate, drop in blood pressure, difficulty swallowing, painful urge to urinate, severe abdominal pain, nausea, and vomiting.

If symptoms of overdose occur, discontinue the medicine immediately and contact a doctor without delay.

Missed dose of Scopolan compositum
Do not take a double dose to make up for a missed dose.

Discontinuation of Scopolan compositum
Scopolan compositum should be taken only when necessary and should be discontinued once symptoms have resolved.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Scopolan compositum can cause adverse reactions, although not everyone will
experience them.
The treatment should be discontinued and immediate medical help sought if the patient
experiences any of the following serious adverse reactions:

• Reddish, flat spots on the trunk in the shape of a target or circular rash, often with blisters in the center, peeling of the skin, mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Extensive rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• General malaise (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark-colored urine, pale-colored 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".

Adverse reactions to the medicine are listed according to organ system and frequency of occurrence:
not uncommon (occur less frequently than in 1 in 100 patients, but more frequently than in 1 in 1,000
patients); rare (occur less frequently than in 1 in 1,000 patients, but more frequently than in 1 in 10,000
patients); very rare (occur less frequently than in 1 in 10,000 patients); unknown (cannot be
estimated based on available data).
During treatment with Scopolan compositum, the following may occur:
Skin and subcutaneous tissue disorders: erythema, burning sensation of the skin, pruritus, urticaria,
edema – not uncommon;
Severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis – very rare;
drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) – frequency unknown;
Gastrointestinal disorders: dry mouth, nausea, vomiting, constipation – not uncommon;
Cardiac disorders: tachycardia (accelerated heart rate) – not uncommon;
Vascular disorders: hypotension (low blood pressure) – not uncommon;
Renal and urinary disorders: kidney damage, anuria (retention of urine) – rare;
Eye disorders: visual disturbances – rare;
Blood and lymphatic system disorders – impairment of hematopoietic bone marrow function of
allergic origin – very rare, leading to:

• agranulocytosis (marked decrease in the number of white blood cells in blood; early signs may include symptoms of infection such as sudden fever, chills, muscle and joint pain, worsening general condition, inflammation and ulceration of the mucous membranes of the mouth, throat, genital organs),
• thrombocytopenia (low platelet count) – reduced number of platelets, manifesting as, e.g., petechiae on the skin and mucous membranes, recurrent bleeding from gums, nose, gastrointestinal tract,
• anemia – reduced number of red blood cells and hemoglobin levels, manifesting as pallor of the skin, weakness,
• pancytopenia (marked reduction in all blood cells: red and white blood cells and platelets), symptoms of which include worsening general condition, weakness, signs of infection, fever, petechiae and recurrent bleeding, pallor of the skin. These complications may result in death (see Warnings and precautions).
  Immune system disorders: anaphylactic (allergic) reactions, anaphylactoid reactions, asthma (recurrent episodes of wheezing, shortness of breath, chest tightness, and cough), anaphylactic shock (sudden and severe allergic reaction characterized by difficulty breathing, marked drop in blood pressure, swelling, rash) – frequency unknown;
  Hepatobiliary disorders: liver damage, hepatitis, jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme activity in blood – frequency unknown.

If any of the above symptoms occur, the medicine should be discontinued immediately and a
physician should be contacted.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a
physician or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Scopolan compositum

Store below 25°C.
Keep the medicine out of the 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

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

What Scopolan compositum looks like and contents of the packaging
Scopolan compositum is in the form of white coated tablets.
Packaging: Aluminium/PVC foil blister pack in a cardboard box.
Available pack sizes: 10 coated tablets in 1 blister; 20 coated tablets in 2 blisters.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50 – 951 Wrocław, ul. św. Mikołaja 65/68
tel.: +48 71 335 72 25
fax: +48 71 372 47 40
e-mail: [email protected]

For further information about this medicinal product, please contact the Marketing Authorisation Holder – tel. 71 321 86 04 ext. 123