Buscopresc Compositum 2500 mg/20 mg solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Buscopresc Compositum 2500 mg/20 mg injectable solution

Sodium metamizole / Butylscopolamine bromide

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What Buscopresc Compositum is and what it is used for
2. What you need to know before using Buscopresc Compositum
3. How to use Buscopresc Compositum
4. Possible adverse effects
5. How to store Buscopresc Compositum
6. Contents of the package and other information

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

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

Buscopresc Compositum is used for the treatment of severe postoperative or post-traumatic acute pain and severe colicky-type pain.

2. What you need to know before using Buscopresc Compositum

Do not take Buscopresc Compositum

• if you have previously experienced a significant decrease in a type of white blood cells called granulocytes, caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines
• if you have bone marrow problems or a disorder affecting the production or function of your blood cells
• if you have had impaired bone marrow function; for example, after receiving chemotherapy, or if you have had blood disorders
• if you are allergic (hypersensitive) to pyrazolone or pyrazolidines (e.g. metamizole, isopropylaminophenazone, propyphenazone, phenazone or phenylbutazone) or to scopolamine butylbromide or to any of the other components of this medicine (listed in section 6)
• if you have previously experienced symptoms of asthma, rhinitis or urticaria (red skin patches or hives that may cause itching) after taking acetylsalicylic acid, paracetamol or non-steroidal anti-inflammatory drugs, as cross-sensitivity may occur
• if you have a genetic deficiency of glucose-6-phosphate dehydrogenase
• if you have acute intermittent porphyria (a disorder in the metabolism of blood pigments that are part of hemoglobin)
• if you have increased eye pressure
• if you have an enlarged prostate 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 enlarged 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 variable degrees of muscle weakness)
• if you are in the last three months of pregnancy (see section Pregnancy, lactation and fertility)
• children under 12 months of age
• if you have low blood pressure or circulatory problems
• if you are being treated with medications intended for coagulation disorders and administered intramuscularly; such patients may use the intravenous route
• subcutaneous injection and intraarterial injection

Warnings and precautions

Lower than normal white blood cell count (agranulocytosis)

Buscopresc Compositum can 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 must stop taking metamizole 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 body surfaces), 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 levels.

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 may develop agranulocytosis even if you have previously used metamizole without problems.

Consult your doctor or pharmacist before using this medicine:

• if severe abdominal pain of unknown origin persists or worsens, or occurs with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain upon palpation, low blood pressure, fainting, or presence of blood in stools, you must consult your doctor immediately
• if you experience any signs or symptoms suggestive of agranulocytosis (reduction in white blood cells in blood) such as high fever, chills, sore throat, inflammation in mouth, nose or throat, lesions in oral or genital mucosa that could indicate a decrease in white blood cell count, or any other type of blood dyscrasia (alteration in blood components) such as general malaise, infection, persistent fever, bruising, bleeding or paleness. In such cases, you must discontinue treatment and consult your doctor immediately
• if you have analgesic-induced asthma syndrome or analgesic intolerance, bronchial asthma, chronic urticaria, or if you are intolerant to dyes and/or preservatives or to alcohol, as the risk of serious allergic reactions is higher
• if you experience any signs or symptoms suggestive of anaphylaxis/anaphylactic shock (dizziness, difficulty breathing, rhinitis, facial swelling (angioneurotic edema), low blood pressure, sudden appearance of red skin rashes). In such cases, discontinue treatment and consult your doctor immediately. The likelihood of anaphylactic shock is higher in certain predisposed patients, such as those with asthma or atopy
• if you have had an anaphylactic 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 metamizole, other pyrazolones and pyrazolidines, or other non-narcotic analgesics, you must not take any medicine containing them again
• if you have pre-existing low blood pressure, unstable circulation, high fever, or if intravenous injection is administered too rapidly, as in these cases the risk of a sudden drop in blood pressure is higher
• if skin or mucosal lesions appear, discontinue treatment with this medicine and consult your doctor immediately
• if you have impaired 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 condition in which eye pressure increases)
• if you have heart disorders or have had them in the past

Buscopresc Compositum must be administered only by intravenous or intramuscular route. Accidental intraarterial administration may cause tissue damage in the distal vascular area.

Liver problems

Liver inflammation has been reported in patients taking metamizole, with symptoms developing from 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 malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You must not take Buscopresc Compositum if you have previously taken a medicine containing metamizole and experienced liver problems.

Serious skin reactions

Serious 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 immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you have ever experienced serious skin reactions, you must never resume treatment with Buscopresc Compositum (see section 4).

Children and adolescents

Its use is not indicated in children and adolescents.

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

Other medicines and Buscopresc Compositum

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

If administered together with dopaminergic antagonists (e.g. metoclopramide, used to treat nausea/vomiting and/or gastric motility paralysis), the effect of both medicines may be reduced.

It may enhance the tachycardic effect of beta-adrenergic medicines (used to treat asthma) and alter the effect of other medicines such as digoxin (used to treat heart disorders).

If administered together with cyclosporine (a medicine that suppresses immune responses), it may reduce cyclosporine blood levels, and therefore these levels should be monitored regularly.

If administered together with methotrexate (a medicine used to treat cancer), it may increase methotrexate toxicity and therefore concomitant use should be avoided, especially in elderly patients.

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

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

Buscopresc Compositum should be administered with caution in patients taking:

• bupropion (a medicine used to treat depression and/or to help quit smoking), as metamizole may reduce bupropion blood levels
  • efavirenz, a medicine used to treat HIV/AIDS
  • methadone, a medicine used to treat dependence on illicit drugs (opioids)
  • 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 interfere with certain blood glucose monitoring tests (glucose oxidase method assay).

Pregnancy, lactation and fertility

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

Pregnancy

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 where no other treatment options are available, single doses of metamizole 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 metamizole. However, in general, the use of metamizole during the first and second trimesters is not recommended.

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

Lactation

Metamizole metabolites are excreted in breast milk in considerable amounts, and a risk to the infant cannot be excluded. Therefore, repeated use of metamizole during breastfeeding should be avoided. If a single dose of metamizole is administered, mothers are advised to express and discard breast milk for 48 hours after administration.

Fertility

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

Driving and using machines

Visual disturbances and dizziness may occur during treatment. It should also be noted that at higher doses, concentration and reaction abilities may be impaired; therefore, driving, operating machinery, and engaging in other hazardous activities should be avoided. This is especially important if alcohol has been consumed.

Buscopresc Compositum contains sodium

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

3. How to use Buscopresc Compositum

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

This medicine should only be administered in cases of spasm with severe pain, such as biliary or renal colic, whereas oral administration of Buscopresc Compositum tablets is recommended for milder pain.

The dose is determined according to the intensity of pain and individual sensitivity 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 diminished, your doctor may administer another dose up to the maximum daily dose.

Adults

A single parenteral dose of metamizole 500–1,000 mg may be administered up to 4 times daily at intervals of 6–8 hours, resulting in a maximum daily dose of 4,000 mg. However, if necessary, a single parenteral dose of 2,500 mg of metamizole and a maximum daily dose of 5,000 mg of metamizole may be administered.

Elderly persons and patients with poor general health/with renal impairment

Dosage should be reduced in elderly persons, in debilitated patients, and in those with impaired renal function, as elimination of metamizole degradation products may be delayed.

Patients with renal or hepatic impairment

Since elimination rate is reduced in cases of renal or hepatic impairment, repeated administration of high doses should be avoided. For short-term treatments, dose reduction may not be necessary. Experience with prolonged treatment is lacking.

Administration must be by slow intravenous injection. The injection should last at least 5 minutes. The patient must remain lying down. If intravenous injection is not possible, intramuscular injection may also be used, but never by subcutaneous route. Unintentional intraarterial administration may cause necrosis of the distal vascular area.

The solution must be warmed to body temperature before injection.

For intramuscular injection, the following technique must be carefully observed:

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

Direction: Sagittally, directed toward the iliac crest.

Depth: A sufficiently long needle must be used to ensure the injection reaches the muscle.

Precautions for parenteral administration

Appropriate equipment for the treatment of possible shock reactions must be available.

Parenteral administration may cause a drop in blood pressure, frequently due to too rapid injection. To minimize the risk of sudden hypotension and to allow interruption of the injection at the first sign of allergy, intravenous injection of Buscopresc Compositum must be administered slowly, with the patient lying down and under close medical supervision. Because non-allergic hypotension is likely dose-dependent, intravenous administration of a single dose exceeding 1 g of metamizole should be carefully considered.

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

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

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

Administration of the medicine depends on the occurrence of painful symptoms; as symptoms subside, the dose should be reduced and eventually discontinued.

Buscopresc Compositum must not be used for long periods or at higher doses without a prescription from a doctor or dentist.

If you use more Buscopresc Compositum than you should

Symptoms

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

Due to metamizole, nausea, vomiting, abdominal pain, impaired kidney function, and less commonly dizziness, drowsiness, coma, seizures, decreased blood pressure, or even shock and increased heart rate (tachycardia) may also occur. After administration of very high doses of metamizole, red discoloration of urine may occur, which disappears upon discontinuation of treatment.

If you have used more Buscopresc Compositum than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone 91 562 04 20.

Treatment

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

There is no known specific antidote for metamizole. After oral overdose, gastric lavage and induction of emesis may be possible. Forced diuresis or dialysis may be considered, as metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should also be applied, such as placing the patient in the lateral position, maintaining airway patency, or administering oxygen. Pharmacological emergency measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is advised, along with implementation of necessary general supportive 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 unwell (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites 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 medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Uncommon adverse effects (may affect up to 1 in 100 patients) are decreased number of white blood cells in the blood (leucopenia, agranulocytosis (including fatal cases)), drug eruptions and skin reactions, visual accommodation disorders, drastic drop in blood pressure (shock), injection site pain, and flushing.

Rare adverse effects (may affect up to 1 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 adverse effects (may affect up to 1 in 10,000 patients) are decreased number of platelets in the blood, skin reactions with blisters or bullae (toxic epidermal necrolysis, Stevens-Johnson syndrome), swelling of blood vessels (phlebitis), acute kidney failure, absence of urine, reduced kidney filtration capacity, decreased urine output, presence of protein in the urine, and kidney function impairment.

Adverse effects with unknown frequency (cannot be estimated from available data) are: liver inflammation, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes, systemic infection (sepsis, including fatal cases), inability of the bone marrow to produce new blood cells (aplastic anaemia), decreased levels in blood of red blood cells, white blood cells and platelets (pancytopenia, including fatal cases), drastic drop in blood pressure due to an allergic reaction (anaphylactic shock, including fatal cases), breathing difficulty, allergy, sweating disorders, increased heart rate, Kounis syndrome (a syndrome characterized by simultaneous occurrence of heart disorders and allergic reactions), injection site reaction, gastrointestinal bleeding, inability to urinate, abnormal urine coloration, pupil dilation, and increased intraocular pressure.

Severe skin reactions. Stop taking metamizole and seek immediate medical attention if you notice any of the following serious adverse effects:

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Buscopresc Compositum

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Buscopresc Compositum

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

Presentation of the product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

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 most recent review of this leaflet: November 2025

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

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

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/