Package leaflet: Information for the patient

FluControl Symptom
300 mg + 100 mg + 50 mg, tablets
Acidum acetylsalicylicum + Ethoxybenzamidum + Coffeinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

What FluControl Symptom is and what it is used for
Important information before taking FluControl Symptom
How to take FluControl Symptom
Possible side effects
How to store FluControl Symptom
Contents of the pack and other information

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

FluControl Symptom is an analgesic, anti-inflammatory and antipyretic medicine.
The medicine contains three active substances: acetylsalicylic acid, o-ethoxybenzamide and caffeine.
Therapeutic indications

Temporarily for headaches and other mild to moderate pain.
Feverish conditions, symptomatic treatment of influenza 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 (NSAIDs);
if the patient has severe renal or (and) hepatic insufficiency;
if the patient has severe heart failure;
if the patient has gastrointestinal inflammatory conditions, peptic ulcer of the stomach and (or) duodenum;
if the patient has a bleeding tendency (blood clotting disorders);
if the patient has experienced bronchial asthma with nasal polyps after taking acetylsalicylic acid (e.g. aspirin), because FluControl Symptom may cause similar adverse reactions;
in children under 12 years of age (due to the presence of acetylsalicylic acid, as there is a risk of life-threatening Reye's syndrome—a disease causing liver and brain damage, manifesting with seizures and loss of consciousness);
if the patient is pregnant.

Warnings and precautions
Before starting treatment with FluControl Symptom, consult a doctor or
pharmacist:

if the patient suffers from allergic conditions (e.g. bronchial asthma, hay fever);
if the patient has impaired kidney and (or) liver function;
if the patient has hypertension;
if the patient has heart failure;
if the patient has anaemia (also known as anemia);
if the female patient experiences uterine bleeding or heavy menstrual bleeding;
if the patient has had or currently suffers from gout (a joint inflammatory condition with redness, swelling, and acute pain);
if the patient has had peptic ulcer disease of the stomach and (or) duodenum;
if the patient has experienced or is experiencing gastrointestinal bleeding;
if the female patient uses an intrauterine contraceptive device.

Patients with glucose-6-phosphate dehydrogenase deficiency should consult a doctor
before taking this medicine due to the risk of haemolytic anaemia.
Patients scheduled for surgery should consult a doctor before taking this
medicine (do 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 effect on fertility).
If headache persists for more than 2 days, medical advice should be sought.
Do not take this medicine for longer than 3 days due to the risk of dependence.
Taking medicines with the same composition as FluControl Symptom may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term
use of high doses. Therefore, do not use higher doses for 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, elevated cholesterol, smoking), discuss the treatment approach with a doctor or pharmacist.
Children
Do not give to children under 12 years of age.
FluControl Symptom and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently used, or planned to be taken.
If the patient is taking any of the following medicines, a dose adjustment or discontinuation of treatment may be necessary:

oral antidiabetic drugs (used in the treatment of diabetes, including sulfonylurea group drugs);
insulin (a medicine used in the treatment of diabetes);
anticoagulants (used to reduce blood coagulability, e.g. heparin);
antiplatelet drugs (used to prevent clot formation, e.g. ticlopidine, clopidogrel);
methotrexate (a medicine used in cancer treatment and certain rheumatic diseases);
spironolactone (a medicine that increases urine production);
non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain or reduce fever, e.g. indomethacin, ibuprofen);
medicines promoting uric acid excretion from the body;
sulfonamides (medicines used to treat certain bacterial infections);
muscle relaxants (e.g. used before surgical procedures);
sodium bicarbonate (also known as baking soda, used in the treatment of, among others, metabolic acidosis);
valproic acid (a medicine used in the treatment of epilepsy);
vancomycin (an antibiotic used in the treatment of certain bacterial infections);
digoxin (a medicine used in the treatment of heart failure and cardiac arrhythmias);
corticosteroids (steroids, used in the treatment of, among others, rheumatic disease);
sympathomimetic drugs (drugs stimulating the nervous system);
thyroid hormones;
oral contraceptives (used to prevent pregnancy);
cimetidine (a medicine used in the treatment of peptic ulcer disease of the stomach and (or) duodenum);
disulfiram (a medicine used in the treatment of alcoholism);
barbiturates (drugs used in the treatment of insomnia and epilepsy);
centrally acting sympathomimetics (drugs administered before surgical procedures);
theophylline (a medicine used in the treatment of asthma);
fluoroquinolone derivatives (medicines used in the treatment of certain bacterial infections, e.g. ciprofloxacin).
metamizole (a substance with analgesic and antipyretic properties) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when both medicines are used simultaneously. Therefore, caution is advised when using metamizole in patients receiving acetylsalicylic acid.

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should
contact a doctor or pharmacist.
Taking FluControl Symptom with food and drink

Take tablets after meals, with a large amount of fluid.
Do not consume alcohol while taking this medicine due to the risk of gastrointestinal bleeding.
The medicine contains caffeine; therefore, individuals who drink large amounts of coffee should use it cautiously.

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

This medicine may be harmful to the fetus, as it readily crosses the placenta. FluControl Symptom may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the child.
Do not use the medicine during the last three months of pregnancy, as complications in the child or during delivery may occur.
The medicine passes into breast milk; therefore, breastfeeding women should not take this medicine.
The medicine may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
No negative effects on the ability to drive or operate machinery have been observed.
However, if dizziness, difficulty concentrating, or irritability occur, do not drive
or operate machinery.

3. How to take FluControl Symptom

This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use FluControl Symptom for longer than 3 days continuously without consulting a doctor.
This medicine is for oral use.
Recommended dose:
Adults and adolescents over 12 years of age:
1 to 2 tablets at a time, up to 3 times daily, every 8 hours.
Do not take more than 6 tablets per day.
Method of administration
The tablets should be taken after meals, with a large amount of fluid.
Use in children
Do not use in children under 12 years of age.
Overdose of FluControl Symptom
If more medicine has been taken than recommended, contact a doctor.
The following symptoms of overdose may occur:

intolerance symptoms caused by irritation of the gastric mucosa;
exacerbation of gastric or duodenal ulcer disease;
gastrointestinal bleeding (see section 4: Possible side effects);
tinnitus, transient deafness;
dizziness;
nausea and vomiting.

Missed dose of FluControl Symptom
Do not take a double dose to make up for a missed dose.
Continue taking the medicine as prescribed, without increasing the next dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should contact your doctor immediately if the following occur:

gastrointestinal bleeding (vomiting blood or material resembling ground coffee, black stools or blood in the stool);
allergic reactions (rash, severe swelling of the face, lips or throat making breathing, speaking or swallowing difficult, low blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest or cardiac arrest).

The following adverse effects may occur:

abdominal pain, nausea, vomiting;
activation of gastric or duodenal ulcer disease;
gastrointestinal discomfort (feeling of pressure in the stomach, bloating, belching, heartburn, constipation);
dizziness;
insomnia;
difficulty concentrating;
irritability;
tinnitus;
transient deafness;
proteinuria (presence of protein in urine);
kidney damage (nephropathy);
acute liver failure;
thrombocytopenia – reduced number of blood platelets (increased risk of bleeding and bruising), reduced blood coagulability;
haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficiency (also known as anaemia);
urticaria (bright pink, itchy skin blisters);
erythema (localised redness of the skin);
induction of asthma symptoms (e.g. wheezing, difficulty breathing, shortness of breath, cough);
sweating;
cardiac arrhythmia.

Taking medicines such as FluControl Symptom may be associated with a small increased risk
of heart attack (myocardial infarction) or stroke (see section: Warnings and precautions).
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 be reported directly to the Department of Monitoring of 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
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store FluControl Symptom

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the blister and outer carton after EXP. The expiry date refers to the last day of the stated month.
Lot: means batch number
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What FluControl Symptom contains

The active substances in this medicine are: acetylsalicylic acid, o-ethoxyacetanilide, and caffeine.
Each tablet contains: 300 mg acetylsalicylic acid (Acidum acetylsalicylicum), 100 mg o-ethoxyacetanilide (Ethoxybenzamidum), 50 mg caffeine (Coffeinum).
Other ingredients are: potato starch, stearic acid, colloidal anhydrous silica.

What FluControl Symptom looks like and contents of the pack
The medicine is in the form of tablets.
The tablets are packed in blisters. The pack contains 6 or 10 tablets. Blisters are packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100