Gexiro

Leaflet accompanying the packaging: patient information

Gexiro FC, 500 mg + 150 mg, coated tablets

Paracetamol + Ibuprofen

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

This medicine should always be taken according to the description in the patient leaflet or with the doctor's or pharmacist's recommendations.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.
• This medicine should not be taken for more than 3 days.

The medicine is available without a prescription. However, to achieve good treatment results, you should carefully read this leaflet.

Table of contents of the leaflet

1.

What is Gexiro FC and what is it used for

2.

Important information before taking Gexiro FC

3.

How to take Gexiro FC

4.

Possible side effects

5.

How to store Gexiro FC

6.

Package contents and other information

1. What is Gexiro FC and what is it used for

Gexiro FC contains paracetamol and ibuprofen.
Paracetamol works by blocking the transmission of pain messages to the brain. It also reduces fever.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
It relieves pain and reduces inflammation (swelling, redness, or tenderness).
Gexiro FC is used for the short-term treatment of:

• headaches
• migraines
• back pain
• menstrual cramps
• toothaches
• muscle aches
• pains associated with cold and flu symptoms
• sore throat
• fever

You should consult a doctor or pharmacist if you have any questions about the medicine.
If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Gexiro FC

When not to take Gexiro FC:

• if the patient is allergic to the active substance or active substances, or any of the other ingredients of this medicine (listed in section 6).
• if the patient currently has (or has had in the past) bleeding from the anus, black, tarry stools, or bloody diarrhea;
• if the patient has or has recently had a stomach ulcer (i.e., a stomach or duodenal ulcer) or has had stomach ulcers in the past;
• with any other medicines containing paracetamol or ibuprofen;
• if the patient regularly consumes large amounts of alcohol;
• if the patient has severe heart, liver, or kidney failure;
• if the patient has bleeding from the blood vessels or other active bleeding;
• if the patient has blood disorders;
• if the patient has asthma, has had hives, or an allergic reaction after taking aspirin/acetylsalicylic acid or other NSAIDs
• in women during the last three months of pregnancy

Warnings and precautions

Before starting to take Gexiro FC, you should consult a doctor or pharmacist.
You should inform the pharmacist or doctor if:
The patient has an infection - see below, the section entitled "Infections".
If during treatment with Gexiro FC, the patient experiences severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a long time or take paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Taking anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when these medicines are taken in high doses. Do not exceed the recommended dose and duration of treatment.
Severe skin reactions have been reported with Gexiro FC treatment. You should stop taking Gexiro FC and seek medical attention immediately if you experience a skin rash, mucosal lesions, blisters, or other signs of an allergic reaction, as these may be the first signs of a very serious skin reaction. See section 4.
Infections
Gexiro FC may mask the objective signs of infection, such as fever and pain. As a result, Gexiro FC may delay the application of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine while an infection is present, and the infection symptoms persist or worsen, they should consult their doctor immediately.
Before taking Gexiro FC, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had a stroke (including a mini-stroke or transient ischemic attack — TIA);

the patient has high blood pressure, diabetes, high cholesterol levels, or has a family history of heart disease or stroke, or smokes tobacco;

• the patient has liver disease, hepatitis, kidney disease, or has difficulty urinating;
• the patient consumes large amounts of alcohol or uses drugs;
• the patient is allergic to other medicines containing aspirin/acetylsalicylic acid or other NSAIDs or to any other substances listed at the end of the leaflet;
• the patient is pregnant or plans to become pregnant;
• the patient is breastfeeding or plans to breastfeed;
• the patient currently has an infection;
• the patient is scheduled for surgery;
• the patient has other diseases, including: heartburn, indigestion, stomach ulcers, or other stomach problems; bleeding vomit or bleeding from the anus; severe skin reactions, including Stevens-Johnson syndrome; asthma; vision disturbances; bleeding tendencies or other blood-related problems; bowel problems, such as ulcerative colitis or Crohn's disease; swelling of the ankles or feet; diarrhea; inherited, genetic, or acquired disorders of certain enzymes, manifesting as neurological complications or skin changes, and sometimes both types of disorders, e.g., porphyria; chickenpox; autoimmune disease, e.g., lupus. During treatment with this medicine, you should not drink alcoholic beverages. Combining alcohol with Gexiro FC may lead to liver damage.

The medicine belongs to a group of medicines (NSAIDs) that may cause fertility problems in women. They are reversible after stopping the medicine.
Taking Gexiro FC may affect the results of the 5-hydroxyindoleacetic acid (5HIAA) test in urine, leading to false-positive results. False test results can be avoided by not taking paracetamol for a few hours before and during urine collection

Children and adolescents

It is not recommended to use the medicine in patients under 18 years of age.

Gexiro FC and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Gexiro FC may affect the action of other medicines or other medicines may affect the action of Gexiro FC. For example:

• blood-thinning medicines (i.e., blood thinners/preventing blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• anti-epileptic medicines, such as phenytoin
• chloramphenicol, an antibiotic used to treat ear and eye infections
• probenecid, a medicine used to treat gout
• zydovudine, a medicine used to treat HIV infections (causing acquired immune deficiency syndrome)
• medicines used to treat tuberculosis, such as isoniazid
• aspirin/acetylsalicylic acid, salicylates, or other NSAIDs
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)
• medicines used in other heart diseases, such as digoxin
• diuretics (diuretics)
• lithium, a medicine used to treat certain types of depression
• methotrexate, a medicine used to treat arthritis and certain types of cancer
• corticosteroids, such as prednisone, cortisone
• metoclopramide, propantheline
• tacrolimus or cyclosporine, immunosuppressive medicines used after organ transplantation
• sulfonylurea derivatives, medicines used to treat diabetes
• certain antibiotics (e.g., quinolones)
• 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).

Gexiro FC may affect the above medicines or these medicines may affect the effectiveness of Gexiro FC. The patient may need to use different doses of these medicines or other medicines.
Also, some other medicines may be affected by Gexiro FC or may affect treatment with this medicine.
Therefore, before taking Gexiro FC with other medicines, you should always consult a doctor or pharmacist.
More information about these and other medicines that should be used with caution or avoided during treatment with this medicine can be obtained from a doctor and pharmacist.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, you should consult a doctor or pharmacist before taking this medicine.
Gexiro FC should not be used if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may affect the mother's and child's tendency to bleed and cause prolonged or difficult delivery.
In the first 6 months of pregnancy, the medicine should not be used unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. Gexiro FC taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios), and narrowing of the blood vessel (ductus arteriosus) in the child's heart has also been observed. In the case of longer treatment, the doctor may recommend additional monitoring.
The medicine may reduce fertility in women, so it is not recommended for women trying to conceive.

Driving and using machines

The patient should exercise caution when driving vehicles and operating machines until they know how Gexiro FC affects them.

Gexiro FC contains lactose monohydrate:

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium content

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "sodium-free".

3. How to take Gexiro FC

This medicine should always be taken according to the doctor's or pharmacist's recommendations. These recommendations may differ from the information contained in this leaflet. In case of doubts, you should consult a doctor or pharmacist. The medicine should not be taken for more than 3 days.
The smallest effective dose should be used for the shortest duration necessary to relieve the symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).
The recommended dose is:
Adults:the usual dose is one or two tablets every six hours, as needed, up to a maximum of six tablets per day.
The smallest effective dose of the medicine should be used for the shortest possible time necessary to relieve the symptoms. The patient should consult a doctor if the symptoms persist or worsen or if the medicine needs to be taken for more than 3 days.

Do not take more than 6 tablets in 24 hours.

If the doctor recommends a different dose, you should follow these recommendations.
Swallow the Gexiro FC tablets with a full glass of water. The dividing line has only a helping function to facilitate breaking the tablets for easier swallowing – it does not serve to divide the tablet into two equal parts.

Use in children under 18 years of age

Gexiro FC should not be used in children under 18 years of age.

Overdose of Gexiro FC

If the patient takes more than the recommended dose of Gexiro FC or if the medicine is accidentally ingested by children, they should always consult a doctor or the nearest hospital to obtain an opinion on the risk and advice on the actions to be taken.
This recommendation also applies if no discomfort or poisoning symptoms appear.
Taking too many Gexiro FC tablets may lead to delayed, severe liver or kidney damage. Emergency medical attention may be necessary.
Overdose symptoms may include: nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and eye tremors. It may also cause agitation, drowsiness, disorientation, or coma. In individual cases, the patient may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to disorders of circulating blood clotting factors. Acute kidney failure and liver damage may occur. In people with asthma, asthma may worsen. Furthermore, low blood pressure and decreased respiratory rate may occur.

Missed dose of Gexiro FC

If it is almost time for the next dose, you should skip the missed dose and take the next dose according to the plan. Otherwise, take the medicine as soon as possible, and then return to taking the tablets at the usual times.
You should not take a double dose to make up for the missed dose.
In case of doubts about whether to skip the missed dose, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, you should tell your doctor or pharmacist.

If you experience any of the following serious side effects, you should stop taking Gexiro FC and immediately inform your doctor or go to the emergency department of the nearest hospital:

• vomiting blood or coffee-ground-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;
• asthma, wheezing, shortness of breath;
• very rare cases of severe skin reactions, such as sudden or severe itching, rash, hives;
• blisters and bleeding in the mouth, eyes, lips, nose, and genitals (Stevens-Johnson syndrome);
• a severe skin reaction called DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• fever, general malaise, nausea, abdominal pain, headache, and neck stiffness.

Other side effects:
Common( ≥ 1/100 to <1>:

• fluid retention, edema
• ringing in the ears (tinnitus)
• nausea or vomiting
• loss of appetite
• heartburn or upper abdominal pain
• diarrhea
• skin rashes
• headaches
• dizziness
• insomnia
• liver and kidney function disorders (confirmed by blood test results) Uncommon( ≥ 1/1,000 to <1>
• decreased red blood cell count, bleeding episodes, such as nosebleeds, atypical or prolonged menstrual bleeding, increased platelet count
• eye problems, such as blurred or unclear vision, color vision disturbances
• gas and constipation
• increased sensitivity to allergic reactions, angioedema (including symptoms such as itching, painful red eyes)
• breast enlargement (in men)
• abnormally low blood sugar levels (hypoglycemia)
• mood changes, such as depression, confusion, nervousness, increased emotional reactions
• changes in sleep needs (drowsiness or insomnia)
• difficulty urinating
• thickening of respiratory tract secretions (mucus) Rare( ≥ 1/10,000 to <1>
• hallucinations and increased occurrence of nightmares
• numbness or abnormal skin sensations (e.g., burning, tingling, prickling) in the hands and feet

Very rare(<1>

• severe abdominal pain or tenderness
• symptoms of frequent or worrying infections, such as fever, chills, sore throat, or mouth ulcers
• bleeding or bruising more easily than usual, red or purple spots under the skin
• symptoms of anemia, such as fatigue, headaches, shortness of breath, and pale skin
• dizziness
• yellowing of the skin and/or eyes (jaundice)
• unexplained weight gain, swelling of the ankles or feet, decreased urine output
• involuntary muscle contractions/spasms, seizures, or convulsions, slowed physical and emotional reactions
• temporary loss of vision, pain when moving the eyes
• symptoms of sunburn (such as redness, itching, swelling, blistering), which may appear more quickly than usual
• severe or persistent headaches
• rapid or irregular heartbeat (palpitations)
• increased sweating

Frequency "unknown":

• A red, scaly, widespread rash with bumps under the skin and blisters, mainly in skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). You should stop using Gexiro FC if these symptoms occur and seek medical attention immediately. See also section 2.
• A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

The above list includes serious side effects that may require medical intervention.
Serious side effects rarely occur with low doses of this medicine and when it is used for a short period.

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 also be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Gexiro FC

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after the words: Expiry date (EXP). The expiry date refers to the last day of the month stated.
Do not use the medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Gexiro FC contains

The active substances are paracetamol and ibuprofen.
Other ingredients are: corn starch, corn starch paste, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, and Opadry white coating (ingredients: hydroxypropyl methylcellulose/hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol/PE-4000, and sodium citrate dihydrate (E331))

What Gexiro FC looks like and contents of the pack

Gexiro FC coated tablets are white, capsule-shaped tablets, 19 mm long, with a dividing line on one side and a smooth surface on the other. The dividing line is only to facilitate breaking the tablets to make them easier to swallow, and not to divide the tablet into two equal doses.
Each blister pack contains 8, 10, 16, 20, 24, 30, or 32 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

ALTERNO LABS d.o.o.,
Brnciceva ulica 29,
Ljubljana-Crnuce,
1231, Slovenia
Medochemie Ltd.
Factory AZ
2 Michael Erakleous street, Agios Athanassios, Industrial Area
4101 Agios Athanassios, Limassol
Cyprus
Santa SA
Str. Panselelor, Nr. 25, 27, 29
Municipiul Brasov, Judet
Brasov 500419
Romania

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

United Kingdom:

Combogesic 500mg/150 mg film-coated tablets

Czech Republic:

Combogesic 500 mg/150mg potahované tablety

Estonia:

Combogesic

Hungary:

Combogesic 500mg/150mg film tabletta

Latvia:

Combogesic 500 mg/150 mg apvalkotâ tabletes

Poland:

Gexiro FC

Bulgaria:

Combogesic 500 mg/150mg film-coated;
Комбoгесик 500 mg/150 mg филмирани таблетки

Slovakia:

Combogesic 500 mg/150 mg

Slovenia:

Adobil 500 mg/150 mg film coated tablets

Romania:

Combogesic 500 mg/150 mg comprimate filmate

Date of last revision of the leaflet:06/2025