Gexiro

Leaflet accompanying the packaging: patient information

Gexiro, (10 mg + 3 mg)/mL, solution for infusion

Paracetamol + Ibuprofen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including all side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• The medicine should not be used for more than 2 days.

Table of contents of the leaflet

• 1. What is Gexiro and what is it used for
• 2. Important information before using Gexiro
• 3. How to use Gexiro
• 4. Possible side effects
• 5. How to store Gexiro
• 6. Package contents and other information

1. What is Gexiro and what is it used for

Gexiro contains the active substances paracetamol and ibuprofen. Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (or NSAIDs). Paracetamol works in a different way than ibuprofen, but both substances together reduce pain. Gexiro is used in adults for short-term symptomatic treatment of moderate acute pain when intravenous administration is necessary and (or) administration by other routes is not possible.

2. Important information before using Gexiro

When not to use Gexiro:

• if the patient is allergic to the active substances, other NSAIDs, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe heart, liver, or kidney failure;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has asthma, has had hives, or allergic reactions after taking acetylsalicylic acid or other NSAIDs;
• if the patient has had gastrointestinal bleeding or perforation related to NSAID treatment in the past;
• if the patient has or has had active or recurrent peptic ulcer (e.g., stomach or duodenal ulcer) or bleeding (two or more clear episodes of confirmed ulceration or bleeding);
• if the patient has cerebral bleeding (cerebral vascular bleeding) or other active bleeding;
• if the patient has blood coagulation disorders or an increased tendency to bleed;
• if the patient is severely dehydrated (due to vomiting, diarrhea, or insufficient fluid intake);
• in the third trimester of pregnancy;
• if the patient is under 18 years old.

Warnings and precautions

To avoid the risk of overdose, you should:

• check if other medicines you are taking contain paracetamol;
• not exceed the maximum recommended doses (see section 3).

Side effects can be minimized by using the smallest effective dose for the shortest necessary time to control symptoms. Do not use Gexiro for more than 2 days. If the patient develops severe illnesses during treatment with Gexiro, including severe kidney or liver disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, alcoholism in the chronic phase, or when the patient is also taking flucloxacillin (an antibiotic). There have been reports of a severe condition called metabolic acidosis (blood and fluid disorder) in patients who have taken paracetamol regularly for a long time or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Children and adolescents

Gexiro is not indicated for use in children and adolescents under 18 years old.

Gexiro and other medicines

Tell your doctor or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Always tell your doctor if you are taking other medicines containing paracetamol, ibuprofen, or other pain-relieving NSAIDs, including those available without a prescription. This is to avoid the risk of overdose. Gexiro may affect other medicines or other medicines may affect Gexiro. For example:

• acetylsalicylic acid, salicylates, or other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib);
• medicines used to treat heart conditions (e.g., digoxin or beta-blockers);
• corticosteroids, such as prednisone, cortisone;
• anticoagulant medicines (i.e., blood thinners/preventing blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower high blood pressure (angiotensin-converting enzyme inhibitors, such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
• medicines used to treat epilepsy or seizures (e.g., phenytoin, phenobarbital, carbamazepine);
• medicines used to treat mania (e.g., lithium);
• medicines used to treat depression, e.g., selective serotonin reuptake inhibitors;
• probenecid, a medicine used to treat gout;
• diuretics, used to increase urine production;
• methotrexate, a medicine used to treat arthritis and certain types of cancer;
• tacrolimus or cyclosporin, immunosuppressive medicines used after organ transplantation;
• zidovudine, a medicine used to treat HIV infection (the virus that causes AIDS);
• sulfonylurea derivatives, medicines used to treat diabetes;
• certain antibiotics known as quinolone antibiotics (e.g., ciprofloxacin);
• certain antibiotics known as aminoglycosides (e.g., gentamicin, streptomycin);
• chloramphenicol, an antibiotic used to treat ear and eye infections;
• antifungal medicines, such as voriconazole or fluconazole;
• medicines used to treat tuberculosis, such as isoniazid and rifampicin;
• mifepristone, a medicine used for medical termination of pregnancy;
• certain herbal medicines, such as Ginkgo biloba (sometimes used to treat dementia) or St. John's Wort (Hypericum perforatum, sometimes used to treat mild depression);
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis with a large anion gap), which requires emergency treatment (see section 2).

Some other medicines may also affect the action of Gexiro or Gexiro may affect their action. Therefore, before taking any other medicine, you should always consult a doctor, nurse, or pharmacist. If a blood or urine test is to be taken, you should inform your doctor that you are taking Gexiro, as it may affect the test results.

Gexiro with alcohol

You should not drink alcoholic beverages while being treated with this medicine. Consuming alcohol while taking Gexiro may cause liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult a doctor or nurse before taking this medicine. PregnancyDo not take this medicine if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn baby. It may affect the mother's and baby's tendency to bleed and may cause prolonged or difficult delivery. In the first 6 months of pregnancy, do not take this medicine unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. Gexiro taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn baby, leading to reduced amniotic fluid (oligohydramnios) and narrowing of the arterial duct in the baby's heart. In case of longer treatment, the doctor may recommend additional monitoring. BreastfeedingOnly small amounts of paracetamol and ibuprofen pass into breast milk. This medicine can be used during breastfeeding if used in the recommended dose and for as short a time as possible. FertilityThis medicine may affect fertility in women and is not recommended for women trying to conceive. This effect is reversible after stopping the medicine.

Driving and using machines

After taking NSAIDs, side effects such as dizziness, drowsiness, fatigue, and vision disturbances may occur. If such symptoms occur, do not drive vehicles or operate machines.

Gexiro contains sodium

Gexiro contains 35 mg (1.52 mmol) of sodium (the main component of common salt) per 100 mL of solution (0.35 mg [0.0152 mmol] per 1 mL). This corresponds to 1.75% of the maximum recommended daily intake of sodium for an adult.

3. How to use Gexiro

Gexiro will be administered to you by a healthcare professional as an infusion into one of your veins. The medicine should be administered over 15 minutes. This medicine is intended for short-term use only, for a maximum of 2 days.

Recommended dose:

For adult patients weighing over 50 kg:if necessary, one vial (100 mL) every 6 hours. The maximum daily dose of the medicine is 4 vials (400 mL), which corresponds to 4000 mg of paracetamol and 1200 mg of ibuprofen. In the case of a patient weighing 50 kg or less, elderly patients, or those with liver or kidney function disorders:the doctor may decide to reduce the dose or extend the time between doses due to the increased risk of side effects. A dose higher than recommended does not increase the analgesic effect; it may, however, lead to serious risks (see also the section " Taking a higher dose of Gexiro than recommended"). You should use the smallest effective dose for the shortest time necessary to relieve symptoms. If the patient has an infection, they should consult a doctor immediately if the symptoms (such as fever and pain) persist or worsen (see section 2).

Taking a higher dose of Gexiro than recommended

If you suspect that you have accidentally been given too much Gexiro, you should immediatelycontact a doctor or nurse. You should do this even if you feel well. This is because too much paracetamol can cause delayed, severe liver damage, which can be fatal. Even if you do not have symptoms of discomfort or poisoning, you may need emergency medical attention. To avoid liver damage, treatment should be started as soon as possible. The sooner the treatment is started (the shorter the time, i.e., the fewer hours, between taking the medicine and starting the antidote), the greater the likelihood that liver damage can be prevented. Other symptoms of overdose that may occur include nausea, abdominal pain, vomiting (which may be bloody), headache, ringing in the ears, and confusion. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been observed, as well as blood in the urine, low potassium levels in the blood, and respiratory disorders.

4. Possible side effects

Like all medicines, Gexiro can cause side effects, although not everybody gets them. You should stop usingGexiro and immediatelytell your doctor or go to the nearest hospital emergency department if you experience any of the following side effects: Uncommon

• vomiting blood or coffee grounds-like material;
• bleeding from the anus, black, tarry stools, or bloody diarrhea;
• swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing.

Very rare

• asthma, wheezing, shortness of breath;
• sudden or severe itching, rash, hives;
• severe rash with blisters and bleeding in the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome). Very rare cases of severe skin reactions have been reported;
• exacerbation of existing severe skin infections (may cause rash, blisters, and discoloration of the skin, fever, drowsiness, diarrhea, and nausea) or exacerbation of other infections, including chickenpox or shingles or severe infection with tissue necrosis and muscle damage, blistering, and peeling of the skin;
• fever, general malaise, nausea, abdominal pain, headache, and stiffness of the neck (symptoms of aseptic meningitis, i.e., inflammation of the protective membrane surrounding the brain).

Frequency not known(frequency cannot be estimated from the available data):

• a severe skin reaction known as DRESS (drug reaction with eosinophilia and systemic symptoms), whose symptoms include skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell);
• a red, scaly, widespread rash with nodules under the skin and blisters, mainly on the skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). See also section 2.

Other side effects that may occur

Common side effects(may occur in less than 1 in 10 people):

• nausea or vomiting;
• loss of appetite;
• heartburn or upper abdominal pain;
• abdominal cramps, gas, constipation, or diarrhea, minor gastrointestinal bleeding;
• skin rashes, itching;
• headache;
• dizziness;
• feeling agitated;
• ringing or buzzing in the ears;
• unusual weight gain, swelling, and fluid retention, swelling of the ankles or feet.

Uncommon side effects(may occur in less than 1 in 100 people):

• decreased red blood cell count, nosebleeds, and heavy menstrual bleeding (menstrual bleeding);
• allergic reactions - skin rash, fatigue, joint pain (e.g., rheumatoid arthritis, lupus, Henoch-Schönlein purpura, angioedema);
• breast enlargement in men;
• low blood sugar levels;
• insomnia;
• mood changes, such as depression, disorientation, nervousness;
• eye problems, such as blurred vision (reversible), eye pain, and redness;
• thickened mucus;
• severe abdominal pain or tenderness; stomach ulcers and (or) gastrointestinal ulcers;
• inflammation of the intestines and worsening of inflammatory bowel disease (inflammatory bowel disease) and gastrointestinal tract (Crohn's disease) and complications of diverticulitis (perforation or fistula);
• inability to fully empty the bladder (urinary retention);
• abnormal laboratory test results (related to blood, liver, and kidney enzymes).

Rare side effects(may occur in less than 1 in 1,000 people):

• tingling in hands and feet;
• unusual dreams, seeing things that do not exist (hallucinations);
• kidney tissue damage (especially with long-term use of the medicine);
• high levels of uric acid in the blood (hyperuricemia).

Very rareside effects(may occur in less than 1 in 10,000 people):

• low potassium levels - weakness, fatigue, muscle cramps (hypokalemia);
• symptoms of anemia, such as fatigue, headaches, shortness of breath, and pale skin;
• easier than usual bleeding or bruising, red or purple spots under the skin;
• severe or persistent headache;
• feeling of spinning (vertigo);
• fast or irregular heartbeat, also known as palpitations;
• increased blood pressure and possible heart problems;
• esophageal inflammation;
• yellowing of the skin and (or) eyes, also known as jaundice;
• liver damage (especially with long-term use);
• hair loss;
• increased sweating;
• symptoms of frequent or worrying infections, such as fever, severe chills, sore throat, or mouth ulcers;
• various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome, and acute and chronic kidney failure.

Frequency not known(frequency cannot be estimated from the available data):
A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

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

5. How to store Gexiro

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not store in the refrigerator or freeze. Store the vial in the outer packaging to protect from light. Do not use this medicine after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of the month stated. Do not use this medicine if the packaging is damaged or shows signs of tampering. Do not use this medicine if you can see any particles or discoloration. Gexiro is intended for single use only. Use the medicine immediately after opening. Any unused solution should be disposed of. Unused solution should be disposed of in accordance with local regulations.

6. Package contents and other information

What Gexiro contains

The active substances of Gexiro are paracetamol 10 mg/mL and ibuprofen, in the form of ibuprofen sodium dihydrate 3 mg/mL. The other ingredients are cysteine hydrochloride monohydrate, disodium phosphate dihydrate, mannitol (E 421), hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and water for injections.

What Gexiro looks like and contents of the pack

Gexiro is a clear, colorless solution for infusion, free from visible particles. It is available in 100 mL vials made of colorless glass type II, closed with a gray rubber stopper and an aluminum flip-off cap. The medicine is available in packs of 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer

S.M. Farmaceutici S.r.l.
Zona Industriale Tito Scalo Snc
85050 Tito
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Greece
Combogesic
Ireland
Combogesic 10mg/ml Paracetamol + 3mg/ml Ibuprofen solution for infusion
Poland
Gexiro
Portugal Combogesic IV
Sweden
Duofen
Date of last revision of the leaflet:01/2025
The following information is intended for healthcare professionals only:
Gexiro,(10 mg + 3 mg)/mL, solution for infusion
Paracetamolum + Ibuprofenum
Gexiro should be inspected visually before administration to ensure that the solution does not contain particles or discoloration, as far as the solution and container permit. The solution should not be used if it is cloudy or discolored or if it contains particles or other foreign particles. Due to the lack of compatibility studies, this medicine should not be mixed with diluents. If less than a full vial is needed to administer a single dose, the appropriate amount should be administered, and any unused solution should be discarded. Gexiro should be used in one patient only once. This medicine does not contain antimicrobial preservatives. Any unused solution should be discarded. Method of administration Gexiro should be administered by intravenous infusion over 15 minutes. To withdraw the solution from the 100 mL vial, a 0.8 mm (21G) needle should be used to puncture the stopper vertically at the marked point. In patients weighing less than 50 kg, where a full vial (100 mL) is not required, the appropriate amount should be administered, and any unused solution should be discarded. As with all solutions for infusion in glass vials, careful monitoring is necessary, especially at the end of the infusion, regardless of the route of administration. This monitoring at the end of the perfusion is especially important for central venous infusion to avoid air embolism.