Package Insert: Information for the User

Buscopresc Compositum 2500 mg/20 mg Injectable Solution

Metamizol Sodic/ Butilescopolamina Bromide

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert (see section 4).

This medication is an association of escopolamine, which has antispasmodic action on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts, and metamizol sodium,a pain reliever that reduces pain.

Buscopresc Compositum is used for the treatment of intense acute post-operative or post-traumatic pain and intense colicky pain.

Do not take Buscopresc Compositum

• if you have had a significant decrease in a type of white blood cells called granulocytes, caused by metamizol or other similar medications called pyrazolones or pyrazolidines
• if you have problems with your bone marrow or have a disorder that affects the way your blood cells are produced or function
• if you have had alterations in bone marrow function; for example, after receiving chemotherapy, or if you have had blood diseases
• if you are allergic (hypersensitive) to pyrazolone or pyrazolidines (e.g. metamizol, isopropylaminophenazone, propifenazone, phenazone, or phenylbutazone) or to butylbromide of scopolamine or to any of the other components of this medication (listed in section 6)
• if you have had symptoms of asthma, rhinitis, or urticaria (red spots or hives on the skin that can cause itching) after taking acetylsalicylic acid, paracetamol, or nonsteroidal anti-inflammatory drugs, as there may be cross-reactivity
• if you have glucose-6-phosphate dehydrogenase deficiency
• if you have intermittent acute porphyria (a disorder of the metabolism of blood pigments that form part of hemoglobin)
• if you have increased intraocular pressure
• if you have an enlarged prostate with difficulty urinating
• if you have gastrointestinal tract narrowing
• if you have paralytic or obstructive ileus (intestinal paralysis)
• if you have tachycardia (increased heart rate)
• if you have megacolon (abnormally large colon)
• if you have had severe allergic reactions such as severe skin reactions with this medication (see section 4)
• if you have myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness)
• if you are in the last three months of pregnancy(see Pregnancy, breastfeeding, and fertility)
• children under 12 months of age
• if you have low blood pressure or circulation problems
• if you are being treated with medications for coagulation problems and used intramuscularly; these patients may use the intravenous route
• subcutaneous injection and intraarterial injection

Warnings and precautions

Low white blood cell count (agranulocytosis)

Buscopresc Compositum may cause agranulocytosis, a very low level of a type of white blood cells called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizol and contact a doctor immediately if you experience the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (moist surfaces of the body), especially in the mouth, nose, and throat, or in the genital or anal area. Your doctor will perform laboratory tests to check your blood cell count.

If you take metamizol for fever, some symptoms of agranulocytosis may be masked. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Buscopresc Compositum and even after you have stopped taking metamizol.

You may develop agranulocytosis even if you have used metamizol without problems in the past.

Consult your doctor or pharmacist before starting to use this medication:

• if you have severe and unexplained abdominal pain that persists or worsens, or if you experience symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain with palpation, decreased blood pressure, dizziness, or presence of blood in stool, you should consult your doctor immediately
• if you have any signs or symptoms suggestive of agranulocytosis (low white blood cell count in the blood) such as high fever, chills, sore throat, inflammation in the mouth, nose, or throat, or lesions in the mucous membranes that may indicate a low white blood cell count in the blood or any other type of blood disorder such as general malaise, infection, persistent fever, bruises, bleeding, or pallor. In these cases, you should discontinue treatment and consult your doctor immediately
• if you have asthma caused by analgesics or intolerance to analgesics, bronchial asthma, chronic urticaria, or if you are intolerant to colorants and/or preservatives or to alcohol, as the risk of severe allergic reactions is higher
• if you have any signs or symptoms suggestive of anaphylaxis/shock anaphylactic (dizziness, difficulty breathing, rhinitis, facial swelling (angioneuritic edema), decreased blood pressure, sudden appearance of red spots on the skin). In these cases, you should discontinue treatment and consult your doctor immediately. The probability of anaphylactic shock is higher in certain patients with predisposition, such as patients with asthma or atopy
• if you have had an allergic reaction or immunological reaction (such as agranulocytosis) to Buscopresc Compositum, you also have a high risk of reacting similarly to other pyrazolones and pyrazolidines. If you have had an allergic reaction to metamizol, other pyrazolones and pyrazolidines, or other non-narcotic analgesics, you should not take a medication that contains them again
• if you have pre-existing low blood pressure, unstable circulation, high fever, or if the intravenous injection is administered too quickly, as the risk of a sudden drop in blood pressure is higher
• if you have skin or mucous membrane lesions, discontinue treatment with this medication and consult your doctor immediately
• if you have decreased liver or kidney function or if you are an elderly patient
• if after the injection of Buscopresc Compositum you experience eye pain and redness, with vision loss, inform your ophthalmologist immediately, as you may have undiagnosed narrow-angle glaucoma (a disease in which the pressure in the eyes increases)
• if you have or have had heart problems

Buscopresc Compositum should only be administered intravenously or intramuscularly. Unintentional intraarterial administration can cause damage to the distal vascular area.

Problems with the liver

Inflammation of the liver has been reported in patients taking metamizol with symptoms that develop within a few days to several months after starting treatment.

Stop using Buscopresc Compositum and contact a doctor if you experience symptoms of liver problems, such as nausea, vomiting, fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or white part of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should not take Buscopresc Compositum if you have previously taken a medication containing metamizol and had liver problems.

Severe skin reactions

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizol treatment. Stop taking metamizol and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

If you have ever had severe skin reactions, you should not restart treatment with Buscopresc Compositum at any time (see section 4).

Children and adolescents

This medication is not indicated for use in children and adolescents.

It should not be used in children under 12 months of age.

Other medications and Buscopresc Compositum

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

The simultaneous use of Buscopresc Compositum with other medications may potentiate the anticholinergic effect (such as dry mouth, constipation) of medications for the treatment of depression (tricyclic and tetracyclic antidepressants), medications for the treatment of allergies (antihistamines), medications for the treatment of some mental disorders (antipsychotics), medications for the treatment of cardiac arrhythmias (quinidine, disopyramide), medications for the treatment of viral infections and/or treatment of Parkinson's disease (amantadine), and other anticholinergic medications (such as tiotropium, ipratropium, and compounds similar to atropine).

If administered concurrently with dopamine antagonists (such as metoclopramide, used for the treatment of vomiting/nausea and/or paralysis of the stomach movements), it may decrease the effect of both medications.

It may potentiate the tachycardic effect of beta-adrenergic medications (medications used for the treatment of asthma) and alter the effect of other medications such as digoxin (medication used to treat heart rhythm disorders).

Concurrent administration with ciclosporin (medication that reduces the body's immune reactions) may reduce ciclosporin levels in the blood and therefore they should be measured regularly.

Concurrent administration with methotrexate (medication for cancer treatment) may increase methotrexate toxicity and therefore concurrent use should be avoided, especially in elderly patients.

Metamizol may affect the efficacy of antihypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).

Buscopresc Compositum should be administered with caution in patients taking low doses of acetylsalicylic acid (as a cardioprotective agent), as metamizol may reduce the antiplatelet effect of acetylsalicylic acid.

Buscopresc Compositum should be administered with caution in patients taking:

• bupropion (medication used for the treatment of depression and/or to help quit smoking), as metamizol may reduce bupropion levels in the blood
• • efavirenz, medication used for the treatment of HIV/AIDS
  • metadone, medication used to treat opioid dependence
  • valproate, medication used to treat epilepsy or bipolar disorder
  • tacrolimus, medication used to prevent organ rejection in transplant patients
  • sertraline, medication used to treat depression

In diabetic patients, metamizol may affect some blood sugar control tests (glucose-oxidase method).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The available data on the use of metamizol during the first three months of pregnancy are limited, but do not indicate any harm to the embryo. In selected cases where there are no other treatment options, single doses of metamizol during the first and second trimesters may be acceptable after consulting with your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizol. However, in general, the use of metamizol is not recommended during the first and second trimesters.

During the last three months of pregnancy, you should not take Buscopresc Compositum due to the increased risk of complications for the mother and baby (bleeding, premature closure of a major blood vessel for the fetus, called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Metamizol degradation products are excreted in breast milk in significant amounts and it cannot be ruled out that there is a risk to the infant. Therefore, repeated use of metamizol during breastfeeding should be avoided. If a single dose of metamizol is administered, mothers should express and discard breast milk for 48 hours after its administration.

Fertility

No studies have been conducted on the effects of Buscopresc Compositum on human fertility.

Driving and operating machines

It is possible that vision disturbances and dizziness may occur during treatment. You should also be aware that at higher doses, concentration and reaction abilities may be affected, so you should avoid driving, operating machinery, and performing other hazardous activities. This is especially applicable when alcohol has been consumed.

Buscopresc Compositum contains sodium

This medication contains 163.6 mg of sodium (main component of table salt/for cooking) in each 5 ml ampoule. This corresponds to 8.18% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication should only be administered in case of intense spasms with pain, such as in case of biliary or renal colic, while oral administration of Buscopresc Compositum tablets is recommended for less intense pain.

The dose is established according to the intensity of the pain and the sensitivity of each person to treatment with Buscopresc Compositum. Buscopresc Compositum will be administered via injection into a vein or muscle.

If the effect of a single dose is insufficient or later, when the analgesic effect has decreased, your doctor may administer another dose until the maximum daily dose is reached.

Adults

A single parenteral dose of metamizol 500-1,000 mg may be administered up to 4 times a day in intervals of 6-8 hours, which represents a maximum daily dose of 4,000 mg. However, if necessary, a single parenteral dose of 2,500 mg of metamizol and a maximum daily dose of 5,000 mg of metamizol may be administered.

Older adults and patients with poor general health/renal insufficiency

The dose should be reduced in older adults, in debilitated patients, and in those with decreased renal function, as the elimination of metamizol degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since in cases of renal or hepatic insufficiency the elimination rate decreases, repeated high doses should be avoided. Only in short-term treatments, a dose reduction is not necessary. No experience is available with prolonged treatments.

It should be administered via slow intravenous injection. The duration of the injection should be at least 5 minutes. The patient should be in a supine position. If intravenous injection is not possible, it may also be administered via intramuscular injection, but in no case via subcutaneous injection.

Unintentional intraarterial administration may cause necrosis of the distal vascular area.

The solution should be warmed to body temperature before injection.

With intramuscular injection, the following technique should be carefully observed:

Injection site:Only in the upper, outer quadrant of the buttock.

Direction:Sagittally and directed towards the iliac crest.

Depth:A needle long enough to ensure that the injection reaches the muscle.

Precautions in parenteral administration

Adequate equipment should be available for the treatment of cases of shock that may occur.

Parenteral administration may cause a decrease in blood pressure, which is often due to excessive injection speed. To minimize the risk of a sudden drop in blood pressure and to be able to interrupt the injection at the first sign of allergy, the intravenous injection of Buscopresc Compositum should be administeredslowlyandwith the patient lying down and under close medical supervision. Since it is likely that the decrease in blood pressure not due to an allergic reaction is dose-dependent, the administration via intravenous injection of a single dose of more than 1 g of metamizol should be carefully considered.

Buscopresc Compositum ampoules may be mixed or diluted with glucose 50 mg/ml (5%), sodium chloride 9 mg/ml (0.9%), or lactate Ringer solution and should be administered immediately after preparation.

No additives should be added to intravenous solutions of large volume pH correctors or parenteral nutrition (amino acids, lipids).

Due to the possibility of incompatibilities, Buscopresc Compositum should not be mixed with other medications in the same syringe.

The administration of the medication is subject to the appearance of painful symptoms and as these symptoms disappear, the dose should be reduced and then the medication discontinued.

Buscopresc Compositum should not be used for a long period of time or at higher doses without a doctor's or dentist's prescription.

If you use more Buscopresc Compositum than you should

Symptoms

Due to butylscopolamine bromide, anticholinergic symptoms (such as urinary retention, dry mouth, skin redness, tachycardia, inhibition of gastrointestinal motility, and visual disturbances) may appear.

Due to metamizol, nausea, vomiting, abdominal pain, renal function deterioration, and in some cases, dizziness, somnolence, coma, seizures, and a decrease in blood pressure or even shock, and an increase in heart rate (tachycardia) may also appear. After administration of very high doses of metamizol, a reddish discoloration of the urine may occur, which disappears when treatment is discontinued.

If you have used more Buscopresc Compositum than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20.

Treatment

Information for the doctor: if necessary, parasymptomatic mimetics may be administered. Patients should urgently consult an ophthalmologist in case of glaucoma. Cardiovascular complications should be treated according to standard therapeutic measures. If respiratory paralysis occurs, intubation and artificial respiration should be performed. Catheterize if urinary retention occurs.

No specific antidote is known for metamizol. After oral overdose, gastric lavage and forced vomiting may be performed. Forced diuresis or dialysis may be considered, as metamizol is dialyzable.

In case of severe allergic reactions, other emergency measures should also be applied, such as placing the patient on their side, maintaining airways free of obstruction, or administering oxygen. Emergency pharmacological measures include the administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions, as well as taking general necessary measures, is recommended.

Stop using Buscopresc Compositum and contact a doctor immediately if you experience any of the following symptoms:

Liver reactions: Feeling of illness (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or the white part of the eyes, itching, rash, or pain in the upper stomach area. These symptoms may be signs of liver damage. See also section 2 Warnings and precautions.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Common side effects (may affect up to one in 10 patients) are low blood pressure, dizziness, and dry mouth.

Uncommon side effects (may affect up to one in 100 patients) are a decrease in the number of white blood cells in the blood (leukopenia, agranulocytosis, including fatal cases), drug eruptions, and skin reactions, visual accommodation disorders, a drastic decrease in blood pressure (shock), pain at the injection site, and flushing.

Rare side effects (may affect up to one in 1,000 patients) are allergic reactions (anaphylactic reaction, anaphylactoid reaction), asthma (in patients with analgesic-induced asthma syndrome) and maculopapular skin rash.

Very rare side effects (may affect up to one in 10,000 patients) are a decrease in the number of platelets in the blood, skin reactions in which blisters or bubbles appear (toxic epidermal necrolysis, Stevens-Johnson syndrome), blood vessel swelling (phlebitis), acute kidney failure, absence of urine, decreased kidney filtration capacity, decreased urine output, presence of protein in the urine, and kidney function alteration.

Side effects of unknown frequency (cannot be estimated from available data) are: liver inflammation, yellow discoloration of the skin and the white part of the eyes, increased blood levels of liver enzymes, generalized infection (sepsis, including fatal cases), inability of the bone marrow to produce new blood cells (aplastic anemia), decrease in blood levels of red blood cells, white blood cells, and platelets (pancytopenia, including fatal cases), drastic decrease in blood pressure due to an allergic reaction (anaphylactic shock, including fatal cases), difficulty breathing, allergy, sweating disorders, increased heart rate, Kounis syndrome (syndrome characterized by the simultaneous appearance of heart disorders and allergic reactions), reaction at the injection site, gastrointestinal bleeding, inability to urinate, abnormal urine color, pupil dilation, and increased intraocular pressure.

Severe skin reactions. Stop taking metamizol and seek medical attention immediately if you observe any of the following severe side effects:

• Flat, red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Buscopresc Compositum

• The active principles are butylbromide of scopolamine and sodium metamizole. Each 5 ml ampoule contains 0.02 g of butylbromide of scopolamine and 2.5 g of sodium metamizole.
• The other components are tartaric acid (E-334) and water for injectable preparations.

Aspect of the product and content of the container

It is presented in containers that contain 3 ampoules with 5 ml of injectable solution.

Holder of the manufacturing authorization

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona, Spain

Sanofi Group

Responsible for manufacturing

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 San Cugat del Vallés (Barcelona)

Spain

or

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR)

Italy

Last review date of this prospectus: November 2024

You can access detailed information about this medication by scanning with your mobile phone (smartphone) the QR code included in the packaging and prospectus. You can also access this information on the following internet address:

https://cima.aemps.es/cima/dochtml/p/26791/P_26791.html

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/