Gexiro fc

Patient Information Leaflet

Gexiro FC, 500 mg + 150 mg, coated tablets
Paracetamolum + Ibuprofenum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.
• Do not take this medicine for longer than 3 days.

This medicine is available without a prescription. However, to achieve good treatment outcomes, please read this leaflet carefully.
Table of Contents

1. What Gexiro FC is and what it is 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. Contents of the pack and other information

1. What Gexiro FC is and what it is used for
Gexiro FC contains paracetamol and ibuprofen.
Paracetamol works by inhibiting the transmission of pain signals to the brain. It also reduces fever.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces inflammation (swelling, redness, or tenderness).
Gexiro FC is used to temporarily relieve:

• headaches
• migraine pain
• back pain
• menstrual pain
• toothache
• muscle pain
• pain associated with cold and flu symptoms
• sore throat
• fever

Consult your doctor or pharmacist if you have any questions about this medicine.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Gexiro FC

When not to take Gexiro FC:

• if you are allergic to the active substance or substances, or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have had in the past) bleeding from the rectum, pass black, tarry stools, or have bloody diarrhoea;
• if you have or have recently had a peptic ulcer (i.e. stomach or duodenal ulcer), or have had peptic ulcers in the past;
• with any other medicines containing paracetamol or ibuprofen;
• if you regularly consume large amounts of alcohol;
• if you have severe heart, liver, or kidney failure;
• if you have cerebral haemorrhage or any other active bleeding;
• if you have blood formation disorders;
• if you suffer from asthma, urticaria, or an allergic-type 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, discuss this with your doctor or pharmacist.
Inform your pharmacist or doctor if you have an infection – see section below titled “Infections”.
If you have severe illnesses while taking Gexiro FC, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic), please note that a serious condition called metabolic acidosis (a blood and fluid imbalance) has been reported in patients who take paracetamol regularly over a long period or who take paracetamol together with flucloxacillin.
Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Taking anti-inflammatory and/or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Skin reactions
Severe skin reactions have been reported with Gexiro FC treatment. Discontinue taking Gexiro FC and seek immediate medical advice if you develop a skin rash, mucosal lesions, blisters, or other allergic symptoms, as these may be early signs of a very serious skin reaction. See section 4.
Infections
Gexiro FC may mask symptoms of infection such as fever and pain. Therefore, Gexiro FC may delay appropriate treatment of an infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection and symptoms persist or worsen, consult your doctor immediately.
Before taking Gexiro FC, discuss treatment with your doctor or pharmacist if:

• you have heart conditions such as heart failure, angina (chest pain), a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or if you have had any stroke (including mini-stroke or transient ischaemic attack - TIA);
• you have high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if you smoke;
• you have liver disease, hepatitis, kidney disease, or have difficulty passing urine;
• you consume large amounts of alcohol or take narcotics;
• you are allergic to other medicines containing aspirin/acetylsalicylic acid or other NSAIDs, or to any other substances listed at the end of this leaflet;
• you are pregnant or planning to become pregnant;
• you are breastfeeding or planning to breastfeed;
• you currently have an infection;
• you are scheduled for surgery;
• you currently have or have had in the past other medical conditions, including:
  ➢ heartburn, indigestion, stomach ulcers, or other stomach problems;
  ➢ vomiting blood or rectal bleeding;
  ➢ asthma;
  ➢ vision disturbances;
  ➢ tendency to bleed or other blood-related problems;
  ➢ intestinal problems such as ulcerative colitis or Crohn’s disease;
  ➢ swelling of ankles or feet;
  ➢ diarrhoea;
  ➢ inherited, genetic, or acquired disorders of certain enzymes, manifesting as neurological complications or skin changes, or sometimes both, e.g. porphyria;
  ➢ chickenpox;
  ➢ autoimmune diseases, e.g. systemic lupus erythematosus.

Do not drink alcoholic beverages while taking this medicine. Combining alcohol with Gexiro FC may lead to liver damage.
This medicine belongs to a group of drugs (NSAIDs) which may cause reversible impairment of fertility in women. This effect reverses upon discontinuation of 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 several hours before and during urine sample collection.
Children and adolescents
Use of this medicine is not recommended in patients under 18 years of age.
Gexiro FC and other medicines
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:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine
• antiepileptic medicines such as phenytoin
• chloramphenicol, an antibiotic used to treat ear and eye infections
• probenecid, a medicine used to treat gout
• zidovudine, a medicine used to treat HIV infection (causing acquired immunodeficiency syndrome)
• medicines used to treat tuberculosis, e.g. isoniazid
• aspirin/acetylsalicylic acid, salicylates, or other NSAIDs
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan)
• medicines used for other heart conditions, such as digoxin
• diuretics (water tablets)
• 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
• some antibiotics (e.g. quinolones)
• flucloxacillin (antibiotic), due to a serious blood and fluid imbalance (called high anion gap metabolic acidosis), which requires urgent treatment (see section 2).

Gexiro FC may affect the above medicines, or these medicines may affect the efficacy of Gexiro FC. You may require different doses of these medicines or alternative treatments.
Also, some other medicines may be affected by Gexiro FC or may affect treatment with this medicine. Therefore, always consult your doctor or pharmacist before taking Gexiro FC with other medicines.
Further information about these and other medicines that should be used cautiously or avoided during treatment with this medicine can be obtained from your doctor or pharmacist.
Pregnancy, breastfeeding, and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Gexiro FC if you are in the last three 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 bleeding tendencies in both mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, do not take Gexiro FC unless absolutely necessary and recommended by your doctor. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. Gexiro FC taken for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, leading to reduced amniotic fluid volume surrounding the baby (oligohydramnios). Constriction of a blood vessel (ductus arteriosus) in the baby’s heart has also been observed. If treatment lasts longer than a few days, your doctor may recommend additional monitoring.
The medicine may reduce fertility in women; therefore, it is not recommended for women trying to conceive.
Driving and operating machinery
Exercise caution when driving or operating machinery until you know how Gexiro FC affects you.
Gexiro FC contains monohydrate lactose:
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Sodium content
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is considered "sodium-free".

3. How to take Gexiro FC

This medicine should always be taken as directed by a doctor or pharmacist. These instructions may differ from the information contained in this leaflet. If in doubt, consult your doctor or pharmacist. Do not take this medicine for longer than 3 days.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Recommended dose:
Adults: The usual dose is one or two tablets every six hours, as needed, up to a maximum of six tablets per day.
Use the lowest effective dose for the shortest possible time necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if treatment with the medicine is required for more than 3 days.
Do not take more than 6 tablets in 24 hours.
If your doctor prescribes a different dose, follow their instructions.
Swallow Gexiro FC tablets with a full glass of water. The break line on the tablet is intended only to facilitate swallowing by allowing the tablet to be split and does not ensure equal dosing.

Use in children under 18 years of age
Gexiro FC is not recommended for use in children under 18 years of age.

Taking more than the recommended dose of Gexiro FC
If a patient takes more than the recommended dose of Gexiro FC or if the medicine is accidentally ingested by children, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions. This recommendation applies even if no discomfort or poisoning symptoms are present.
Taking too many Gexiro FC tablets may lead to delayed, severe liver or kidney damage. Urgent medical attention may be required.
Symptoms of overdose may include: nausea, abdominal pain, vomiting (possibly containing blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. In individual cases, seizures may develop. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, and dizziness have been reported, as well as blood in urine, low blood potassium levels, feeling cold, and breathing difficulties. Additionally, prothrombin time/INR may be prolonged, likely due to impaired circulating coagulation factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms is possible. Furthermore, low blood pressure and reduced breathing rate may occur.

Missed dose of Gexiro FC
If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Otherwise, take the missed dose as soon as remembered, then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
If in doubt about whether to take a missed dose, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, inform your doctor or pharmacist.
If any of the serious adverse reactions listed below occur, stop taking Gexiro FC immediately and
contact your doctor right away or go to the nearest hospital emergency department:

• vomiting blood or material resembling coffee grounds;
• bleeding from the rectum, black tarry stools, or bloody diarrhoea;
• swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing;
• asthma, wheezing, or shortness of breath;
• very rare cases of serious skin reactions have been reported, such as sudden or severe itching, skin rash, urticaria;
• blisters and bleeding affecting the lips, eyes, mouth, nose, and genital organs (Stevens-Johnson syndrome);
• a severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS syndrome include, among others: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell);
• fever, general malaise, nausea, abdominal pain, headache, and neck stiffness.

Other adverse reactions:
Common (may occur in up to 1 in 10 people):

• fluid retention, oedema
• ringing in the ears (tinnitus)
• nausea or vomiting
• loss of appetite
• heartburn or pain in the upper abdomen
• diarrhoea
• skin rashes
• headaches
• disturbances in liver and kidney function (confirmed by blood tests)

Uncommon (may occur in up to 1 in 100 people):

• decreased number of red blood cells, episodes of bleeding such as nosebleeds, abnormal or prolonged menstrual bleeding, increased number of platelets
• eye disorders, e.g. blurred or double vision, disturbances in colour vision
• flatulence and constipation
• increased sensitivity to allergic reactions, angioedema (symptoms may include itching, eye pain, and redness)
• breast enlargement (in men)
• abnormally low blood sugar levels (hypoglycaemia)
• mood changes, such as depression, confusion, nervousness, increased emotional reactions
• changes in sleep patterns (drowsiness or insomnia)
• difficulty urinating
• thickening of respiratory secretions (mucus)

Rare (may occur in up to 1 in 1,000 people):

• hallucinations and increased occurrence of nightmares
• numbness or unusual skin sensations (e.g. burning, tingling, pricking) in the hands and feet

Very rare (may occur in up to 1 in 10,000 people):

• severe pain or tenderness in the abdomen
• signs of frequent or severe infections, such as fever, intense chills, sore throat, or mouth ulcers
• bleeding or bruising more easily than usual, red or purple spots under the skin
• symptoms of anaemia, such as feeling tired, headaches, shortness of breath, and pale skin
• dizziness
• yellowing of the skin and/or eyes (jaundice)
• unexplained weight gain, swelling of the ankles or legs, reduced urine output
• involuntary movements and/or muscle contractions, tremors or convulsions, slowed physical and emotional reactions
• temporary loss of vision, pain during eye movement
• symptoms of sunburn (such as redness, itching, swelling, blistering) that may appear more quickly than usual
• severe or persistent headaches
• rapid or irregular heartbeat (palpitations), increased sweating

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

• red, scaly, widespread rash with subcutaneous nodules and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue use of Gexiro FC immediately if these symptoms occur and seek medical advice without delay. See also section 2.
• a serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

The above list includes serious adverse reactions which may require medical intervention.
Serious adverse reactions rarely occur with low doses of this medicine and when used for short durations.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Gexiro FC

Keep this medicine out of sight and reach of children.
Store below 30°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister pack after the words: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Do not use the medicine if the packaging is damaged or if there are any signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Gexiro FC contains
The active substances are paracetamol and ibuprofen.
The other components are: maize starch, pregelatinized maize starch, microcrystalline cellulose,
sodium croscarmellose, magnesium stearate, talc and Opadry white coating (composition:
HMPC (hydroxypropylmethylcellulose/hypromellose (E464)), lactose monohydrate, titanium dioxide
(E171), macrogol/PEG 4000 and disodium citrate dihydrate (E331)).

What Gexiro FC looks like and contents of the pack
Gexiro FC coated tablets are white, capsule-shaped tablets, 19 mm in length, with a score line on one side and smooth on the other. The score line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing.
Each blister contains 8, 10, 16, 20, 24, 30 or 32 coated tablets. Not all pack sizes may be marketed.

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

Manufacturer / Importer
Alterno Labs d.o.o.
Brnčičeva ulica 29
Ljubljana-Črnuče, 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 authorised in the European Economic Area under the following names:
Bulgaria: Combogesic 500 mg/150mg film-coated
Комбoгесик 500 mg/150 mg филмирани таблетки
Estonia: Combogesic
Latvia: Combogesic 500 mg/150 mg apvalkotâ tabletes
Malta: Duomax 500 mg/150 mg film coated tablets
Poland: Gexiro FC
Czech Republic: Combogesic 500 mg/150mg potahované tablety
Romania: Combogesic 500 mg/150 mg comprimate filmate
Slovakia: Combogesic 500 mg/150 mg
Slovenia: Adobil 500 mg/150 mg film coated tablets
Hungary: Combogesic 500mg/150mg film tabletta