Flucontrol Simptom

Leaflet accompanying the packaging: patient information

FluControl Symptom

300 mg + 100 mg + 50 mg, tablets
Acetylsalicylic acid + Ethoxybenzamide + Caffeine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects 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.

Table of contents of the leaflet

• 1. What is FluControl Symptom and what is it used for
• 2. Important information before taking FluControl Symptom
• 3. How to take FluControl Symptom
• 4. Possible side effects
• 5. How to store FluControl Symptom
• 6. Contents of the packaging and other information

1. What is FluControl Symptom and what is it used for

FluControl Symptom is a pain-relieving, anti-inflammatory, and antipyretic medicine.
The medicine contains 3 active substances: acetylsalicylic acid, ethoxybenzamide, and caffeine.

Indications for use

• For temporary relief of headaches and other pains of moderate or mild intensity.
• For feverish conditions, symptomatic treatment of flu and colds.

2. Important information before taking FluControl Symptom

When not to take FluControl Symptom:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to salicylates or other non-steroidal anti-inflammatory drugs;
• if the patient has severe kidney and/or liver failure;
• if the patient has severe heart failure;
• if the patient has inflammatory diseases of the digestive tract, stomach ulcers, and/or duodenal ulcers;
• if the patient has bleeding disorders (blood clotting disorders);
• if the patient has had asthma with nasal polyps after taking acetylsalicylic acid (e.g., aspirin), as FluControl Symptom may cause similar side effects;
• in children under 12 years of age (due to the content of acetylsalicylic acid, as there is a risk of life-threatening Reye's syndrome - a disease in which there is liver and brain damage, manifested by seizures and loss of consciousness);
• if the patient is pregnant.

Warnings and precautions

Before starting to take FluControl Symptom, the patient should discuss it with their doctor or pharmacist:

• if the patient has allergic diseases (e.g., asthma, hay fever);
• if the patient has kidney and/or liver function disorders;
• if the patient has high blood pressure;
• if the patient has heart failure;
• if the patient has anemia (also called anemia);
• if the patient has menstrual bleeding or heavy menstrual bleeding;
• if the patient has had gout (inflammatory joint disease with redness, swelling, and severe pain);
• if the patient has had stomach ulcers and/or duodenal ulcers;
• if the patient has had gastrointestinal bleeding;
• if the patient is using an intrauterine contraceptive device.

Patient with glucose-6-phosphate dehydrogenase deficiency should consult their doctor before taking this medicine due to the risk of hemolytic anemia (anemia).
Patient before surgical procedures should consult their doctor before taking this medicine (should not take acetylsalicylic acid for at least 5 days before the planned procedure).
FluControl Symptom may adversely affect female fertility (see section: Pregnancy, breastfeeding, and fertility).
In case of persistent headache, the patient should consult their doctor.
The medicine should not be taken for more than 3 days due to the risk of dependence.
Taking medicines with a similar composition to FluControl Symptom may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Therefore, higher doses should not be used for a period longer than the recommended 3 days.
If the patient has heart disease, has had a stroke, or is at risk of stroke (e.g., high blood pressure, diabetes, high cholesterol, smoking), they should discuss the treatment with their doctor or pharmacist.

Children

Do not give to children under 12 years of age.

FluControl Symptom and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking any of the following medicines, it may be necessary to change the dose or stop the treatment:

• oral anti-diabetic medicines(used to treat diabetes, including sulfonylurea medicines);
• insulin(a medicine used to treat diabetes);
• anticoagulant medicines(used to reduce blood clotting, e.g., heparin);
• antiplatelet medicines(used to prevent blood clots, e.g., ticlopidine, clopidogrel);
• methotrexate(a medicine used to treat cancer and some rheumatic diseases);
• spironolactone(a medicine that increases urine production);
• non-steroidal anti-inflammatory medicines- NSAIDs (medicines used to relieve pain or reduce fever, e.g., indomethacin, ibuprofen);
• medicines that increase the excretion of uric acidfrom the body;
• sulfonamides(medicines used to treat certain bacterial infections);
• muscle relaxants(used, e.g., before surgery);
• sodium bicarbonate(also known as baking soda, a medicine used to treat, e.g., metabolic acidosis);
• valproic acid(a medicine used to treat epilepsy);
• vancomycin(an antibiotic used to treat certain bacterial infections);
• digoxin(a medicine used to treat heart failure and heart rhythm disorders);
• corticosteroids(also known as steroids, used to treat, e.g., rheumatic disease);
• sympathomimetic medicines(medicines that stimulate the nervous system);
• thyroid hormones;
• oral contraceptives(used to prevent pregnancy);
• cimetidine(a medicine used to treat stomach ulcers and/or duodenal ulcers);
• disulfiram(a medicine used to treat alcoholism);
• barbiturates(medicines used to treat insomnia and epilepsy);
• centrally acting sympathomimetics(medicines given before surgery);
• theophylline(a medicine used to treat asthma);
• fluoroquinolone derivatives(medicines used to treat certain bacterial infections, e.g., ciprofloxacin).
• Metamizole(a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells and formation of a clot), if these medicines are taken at the same time. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

If the patient is unsure whether they are taking any of the above medicines, they should consult their doctor or pharmacist.

Taking FluControl Symptom with food and drink

• Tablets should be taken after meals, with a large amount of fluid.
• During treatment with this medicine, the patient should not drink alcohol due to the risk of gastrointestinal bleeding.
• The medicine contains caffeine, so people who drink large amounts of coffee should use it with caution.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• This medicine may be harmful to the fetus, as it easily passes through the placenta. FluControl Symptom should only be used during pregnancy if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the child.
• The medicine should not be taken during the last three months of pregnancy, as complications may occur in the child or during delivery.
• The medicine passes into breast milk, so breastfeeding women should not take this medicine.
• The medicine may adversely affect female fertility. This effect is temporary and disappears after the end of treatment.

Driving and operating machinery

No negative effect on the ability to drive and operate machinery has been observed.
If dizziness, inability to focus, and irritability occur, the patient should not drive or operate machinery.

3. How to take FluControl Symptom

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Without consulting a doctor, the patient should not take FluControl Symptom for more than 3 days (without interruption).
The medicine is for oral use.

Recommended dose:

Adults and adolescents over 12 years of age:
1 to 2 tablets at a time, take up to 3 times a day, every 8 hours.
Do not take more than 6 tablets per day.
Method of administration
Tablets should be taken after meals, with a large amount of fluid.

Use in children

Do not give to children under 12 years of age.

Taking a higher dose of FluControl Symptom than recommended

In case of taking a higher dose than recommended, the patient should contact their doctor.
The following overdose symptoms may occur:

• symptoms of intolerance caused by irritation of the stomach lining;
• exacerbation of stomach ulcers and/or duodenal ulcers;
• gastrointestinal bleeding (see section 4: Possible side effects);
• ringing in the ears, temporary hearing loss;
• dizziness;
• nausea and vomiting.

Missing a dose of FluControl Symptom

The patient should not take a double dose to make up for a missed dose.
The patient should continue taking the medicine, without increasing the next dose.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, FluControl Symptom can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience:

• gastrointestinal bleeding (vomiting blood or coffee grounds-like material, black stools, or blood in the stool);
• allergic reactions (rash, severe swelling of the face, lips, or throat, making it difficult to breathe, speak, or swallow, low blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness, loss of consciousness, and cardiac arrest).

The following side effects may occur:

• abdominal pain, nausea, vomiting;
• exacerbation of stomach ulcers and/or duodenal ulcers;
• gastrointestinal disorders (feeling of bloating in the stomach, bloating, belching, heartburn, constipation);
• dizziness;
• insomnia;
• inability to focus;
• irritability;
• ringing in the ears;
• temporary hearing loss;
• proteinuria (presence of protein in the urine);
• kidney damage (nephropathy);
• acute liver failure;
• thrombocytopenia - decreased platelet count (increased risk of bleeding and bruising), decreased blood clotting;
• hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency (also called anemia);
• urticaria (light red, itchy blisters on the skin);
• erythema (local redness of the skin);
• asthma symptoms (e.g., wheezing, difficulty breathing, shortness of breath, cough);
• sweating;
• arrhythmia .

Taking medicines with a similar composition to FluControl Symptom may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke (see section: Warnings and precautions).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store FluControl Symptom

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
Batch: means batch number
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What FluControl Symptom contains

• The active substances of the medicine are: acetylsalicylic acid, ethoxybenzamide, and caffeine.
• -Each tablet contains: 300 mg of acetylsalicylic acid (Acidum acetylsalicylicum),100 mg of

ethoxybenzamide (Ethoxybenzamidum),50 mg of caffeine (Coffeinum).

• Other ingredients are: potato starch, stearic acid, anhydrous colloidal silica.

What FluControl Symptom looks like and what the pack contains

The medicine is in the form of tablets.
Tablets are packaged in blisters. The packaging contains 6 or 10 tablets. Blisters are packaged in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Date of last revision of the leaflet: