BUSCOPRESC COMPOSITUM 2500 mg/20 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Buscopresc Compositum 2500 mg/20 mg Solution for Injection

Metamizole Sodium/ Butylscopolamine Bromide

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, ask your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Buscopresc Compositum and what is it used for
2. What you need to know before taking Buscopresc Compositum
3. How to take Buscopresc Compositum
4. Possible side effects
5. Storage of Buscopresc Compositum
6. Contents of the pack and further information

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

This medicine is a combination of scopolamine, which has an antispasmodic effect on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts, and metamizole sodium, an analgesic that reduces pain.

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

2. What you need to know before taking Buscopresc Compositum

Do not take Buscopresc Compositum

• if you have previously had a significant decrease in a type of white blood cell called granulocytes, which was caused by metamizole or other similar medicines called pyrazolones or pyrazolidines
• if you have bone marrow problems or have a disorder that affects the way your blood cells are produced or function
• if you have had bone marrow disorders, such as after receiving chemotherapy, or if you have had blood diseases
• if you are allergic (hypersensitive) to pyrazolone or pyrazolidines (e.g., metamizole, isopropylaminophenazone, propyphenazone, phenazone, or phenylbutazone) or to butylscopolamine bromide or to any of the other components of this medicine (listed in section 6)
• if you have had symptoms of asthma, rhinitis, or urticaria (red patches or hives on the skin that can cause itching) after taking acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, as there may be cross-sensitivity
• if you have a genetic deficiency of glucose-6-phosphate dehydrogenase
• if you have acute intermittent porphyria (a disorder of the metabolism of blood pigments that are part of hemoglobin)
• if you have increased eye pressure
• if you have prostate enlargement with difficulty urinating
• if you have narrowing of the gastrointestinal tract
• if you have paralytic or obstructive ileus (intestinal paralysis)
• if you have an increased heart rate
• if you have megacolon (abnormally large colon)
• if you have ever experienced allergic reactions such as severe skin reactions with this medicine (see section 4)
• if you have myasthenia gravis (a chronic disease characterized by varying degrees of muscle weakness)
• if you are in the last three months of pregnancy (see section 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 medicines for blood coagulation problems and are using the intramuscular route; these patients can 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 cell called granulocytes, which are important for 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 sores in the mucous membranes (wet 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 metamizole for fever, some symptoms of agranulocytosis may go unnoticed. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Buscopresc Compositum and even shortly after stopping metamizole.

You can develop agranulocytosis even if you have used metamizole without problems in the past.

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

• if you have severe abdominal pain of unknown origin that persists or worsens, or if you experience symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain on palpation, decreased blood pressure, fainting, or blood in the stool, you should consult your doctor immediately
• if you have any signs or symptoms suggestive of agranulocytosis (decrease in white blood cells in the blood), such as high fever, chills, sore throat, inflammation in the mouth, nose, or throat, lesions in the oral or genital mucosa that could indicate a decrease in the number of white blood cells in the blood or any other type of blood disorder (alteration of blood components) such as general malaise, infection, persistent fever, bruising, bleeding, or pallor. In these cases, you should stop treatment and consult your doctor immediately
• if you have asthma-analgesic syndrome or analgesic intolerance, bronchial asthma, chronic urticaria, or if you are intolerant to colorants and/or preservatives or alcohol, as the risk of severe allergic reactions is higher
• if you have any signs or symptoms suggestive of anaphylaxis/anaphylactic shock (dizziness, difficulty breathing, rhinitis, facial swelling (angioneurotic edema), decreased blood pressure, red patches on the skin that appear suddenly). In these cases, you should stop 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 anaphylactic or immunological reaction (such as agranulocytosis) to Buscopresc Compositum, you are also at high risk of reacting similarly to other pyrazolones and pyrazolidines. If you have had an allergic reaction to metamizole, other pyrazolones, and pyrazolidines, or other non-narcotic analgesics, you should not take a medicine that contains it again
• if you have pre-existing low blood pressure problems, if you have unstable circulation, if you have high fever, or if the intravenous injection is given too quickly, as the risk of a sudden drop in blood pressure is higher
• if skin or mucous membrane lesions appear, stop treatment with this medicine and consult your doctor immediately
• if you have reduced kidney or liver function or if you are an elderly patient
• if after 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 that increases eye pressure)
• if you have had heart disorders

Buscopresc Compositum should be administered only by the intravenous or intramuscular route. Inadvertent intraarterial administration can cause tissue damage in the distal vascular area.

Liver problems

Liver inflammation has been reported in patients taking metamizole with symptoms developing within a few days to a few months after starting treatment.

Stop using Buscopresc Compositum and contact your doctor if you experience symptoms of liver problems, such as discomfort (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, pale stools, yellowing of the skin or the 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 medicine containing metamizole 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 metamizole treatment. Stop taking metamizole and seek medical attention immediately if you notice 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

It is not indicated for use in children and adolescents.

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

Other medicines and Buscopresc Compositum

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

Concomitant use with Buscopresc Compositum may enhance the anticholinergic effect (such as dry mouth, constipation) of medicines for the treatment of depression (tricyclic and tetracyclic antidepressants), medicines for the treatment of allergies (antihistamines), medicines for the treatment of certain mental disorders (antipsychotics), medicines for the treatment of cardiac arrhythmias (quinidine, disopyramide), medicines for the treatment of viral infections and/or Parkinson's disease (amantadine), and other anticholinergic medicines (such as tiotropium, ipratropium, and atropine-like compounds).

If administered concomitantly with dopaminergic antagonists (such as metoclopramide, used for the treatment of nausea/vomiting and/or stomach movement paralysis), it may decrease the effect of both medicines.

It may enhance the heart rate-increasing effect of beta-adrenergic medicines (medicines used for the treatment of asthma) and alter the effect of other medicines such as digoxin (a medicine used to treat heart disorders).

If administered concomitantly with cyclosporine (a medicine that reduces the body's immune reactions), it may reduce cyclosporine blood levels, and these should be measured regularly.

If administered concomitantly with methotrexate (a medicine for the treatment of cancer), it may increase methotrexate toxicity, and concomitant use of both medicines should be avoided, especially in elderly patients.

Metamizole may affect the efficacy of antihypertensive medicines (medicines that reduce blood pressure) and diuretics (medicines that increase fluid elimination).

Buscopresc Compositum should be administered with caution in patients who are taking low-dose acetylsalicylic acid (such as for cardiac protection), as metamizole may decrease the antiplatelet effect of acetylsalicylic acid.

Buscopresc Compositum should be administered with caution in patients who are taking:

• bupropion (a medicine used for the treatment of depression and/or to help stop smoking), as metamizole may decrease bupropion blood levels
• • efavirenz, a medicine used for the treatment of HIV/AIDS
  • methadone, a medicine used to treat opioid dependence
  • valproate, a medicine used to treat epilepsy or bipolar disorder
  • tacrolimus, a medicine used to prevent organ rejection in transplant patients
  • sertraline, a medicine used to treat depression

In diabetic patients, metamizole may affect some tests for controlling blood sugar levels (glucose-oxidase method).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Available data on the use of metamizole during the first three months of pregnancy are limited, but they do not indicate harmful effects on the embryo. In selected cases when there are no other treatment options, single doses of metamizole during the first and second trimester may be acceptable after consulting your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizole. However, in general, the use of metamizole during the first and second trimester is not recommended.

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

Breastfeeding

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

Fertility

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

Driving and using machines

Visual disturbances and dizziness may occur during treatment. Additionally, 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 if you have consumed alcohol.

Buscopresc Compositum contains sodium

This medicine contains 163.6 mg of sodium (a major component of cooking/table salt) in each 5 ml ampoule. This is equivalent to 8.18% of the maximum recommended daily intake of sodium for an adult.

3. How to use Buscopresc Compositum

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

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

The dose is established based on the intensity of the pain and the sensitivity of each person to treatment with Buscopresc Compositum. Buscopresc Compositum will be administered to you by injection into a vein or into a 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 of 500-1,000 mg may be administered up to 4 times a day at intervals of 6-8 hours, which corresponds to 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.

Elderly people and patients with poor general health/renal insufficiency

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

Patients with renal or hepatic insufficiency

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

It should be administered by slow intravenous injection. The duration of the injection should be at least 5 minutes. The patient should be in a lying position. If intravenous injection is not possible, it can also be injected intramuscularly, but never subcutaneously. Inadvertent intra-arterial administration can 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.

Precautionary measures in parenteral administration

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

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

The ampoules of Buscopresc Compositum can be mixed or diluted with glucose 50 mg/ml (5%), saline solution 9 mg/ml (0.9%), or Ringer's lactate solution and should be administered immediately after preparation.

The contents of the ampoule should not be added to large-volume intravenous solutions for pH correction or parenteral nutrition (amino acids, lipids).

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

The administration of the medication is subject to the appearance of painful symptoms and as they disappear, the dose should be decreased and the medication subsequently suspended.

Buscopresc Compositum should not be used for a long period 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, flushing, tachycardia, inhibition of gastrointestinal motility, and vision disorders) may appear.

Due to metamizol, nausea, vomiting, abdominal pain, impairment of renal function, and less frequently dizziness, somnolence, coma, convulsions, and a drop in blood pressure or even shock and increased heart rate (tachycardia) may also appear. After administration of very high doses of metamizol, a red coloration 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 Toxicology Information Service, phone 91 562 04 20.

Treatment

Information for the doctor: if necessary, parasymphathomimetics can be administered. Patients should urgently consult an ophthalmologist in case of glaucoma. Cardiovascular complications should be treated according to usual therapeutic measures. If respiratory paralysis occurs, intubation and artificial respiration will be performed. Catheterization should be performed if urinary retention occurs.

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

In case of severe allergic reactions, other usual emergency measures should be applied, such as placing the patient on their side, keeping the airways clear of obstruction, or administering oxygen. Pharmacological emergency measures include the administration of adrenaline, fluid therapy, and glucocorticoids.

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

4. Possible adverse effects

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

Hepatic reactions: Feeling of illness (nausea or vomiting), fever, feeling of tiredness, loss of appetite, dark urine, light-colored stools, yellowing 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 can cause side effects, although not all people experience them.

Common side effects (may affect up to 1 in 10 patients) are low blood pressure, dizziness, and dry mouth.

Uncommon side effects (may affect up to 1 in 100 patients) are decreased white blood cell count in blood (leukopenia, agranulocytosis (including fatal cases)), drug eruptions and skin reactions, disorders of visual accommodation, drastic decrease in blood pressure (shock), pain at the injection site, and flushing.

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

Very rare side effects (may affect up to 1 in 10,000 patients) are decreased platelet count in blood, skin reactions with blisters or vesicles (toxic epidermal necrolysis, Stevens-Johnson syndrome), swelling of blood vessels (phlebitis), acute kidney failure, absence of urine, decreased kidney filtration capacity, decreased urine output, presence of protein in urine, and altered kidney function.

Side effects of unknown frequency (cannot be estimated from available data) are: liver inflammation, yellowing 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 pressure inside the eye.

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

• Red patches that are not raised, 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 erythemas can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Reporting of side effects

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

5. Conservation of Buscopresc Compositum

Keep this medication out of 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.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofBuscopresc Compositum

• The active ingredients are butylscopolamine bromide and sodium metamizol. Each 5 ml ampoule contains 0.02 g of butylscopolamine bromide and 2.5 g of sodium metamizol.
• The other ingredients are tartaric acid (E-334) and water for injectable preparations.

Appearance of the product and package contents

It is presented in packages containing 3 ampoules with 5 ml of injectable solution.

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona, Spain

Sanofi Group

Manufacturer

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

Date of the last revision of this leaflet: November 2024

You can access detailed information about this medication by scanning the QR code included in the packaging and leaflet with your mobile phone (smartphone). You can also access this information at 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 Health Products (AEMPS) http://www.aemps.gob.es/