Flucontrol hot

Package leaflet: information for the patient

FluControl Hot (1000 mg + 10 mg + 4 mg)/sachet, powder for oral solution
Paracetamolum + Phenylephrini hydrochloridum + Chlorphenamini maleas
Please read the entire leaflet carefully before taking this medicine, as it contains important
information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician 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 adverse reactions, 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, you should contact your doctor.

Table of contents

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

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

FluControl Hot is a combination of paracetamol – an antipyretic and analgesic substance,
chlorphenamine – an antihistamine substance which reduces nasal secretion, and
phenylephrine – which acts by reducing nasal mucosal swelling.
Indications
Symptomatic treatment of cold and flu associated with fever, mild to moderate pain, nasal mucosal swelling and nasal discharge.

2. Information before taking FluControl Hot

When not to take FluControl Hot

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, chlorpheniramine maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver failure or viral hepatitis;
• if the patient has hypertension;
• if the patient has hyperthyroidism;
• if the patient has severe heart or vascular diseases (e.g. coronary heart disease or angina pectoris);
• if the patient has tachycardia (excessively rapid heartbeat);
• if the patient is being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressants or drugs used in the treatment of Parkinson's disease or others), or within 2 weeks after discontinuation of such treatment;
• if the patient has glaucoma (a condition characterized by increased intraocular pressure);
• if the patient has severe renal failure;
• in children under 12 years of age;
• in pregnant and breastfeeding women.

Warnings and precautions
This medicine contains paracetamol. Due to the risk of overdose, check whether other medicines being taken also contain paracetamol. Concurrent use of FluControl Hot and paracetamol-containing medicines may lead to overdose.
Before starting treatment with FluControl Hot, consult a doctor or pharmacist if:

• the patient has kidney, heart, or lung diseases;
• the patient has anaemia;
• the patient has asthma or is allergic to acetylsalicylic acid;
• the patient is allergic to antihistamines or other medicines (such as chlorpheniramine);
• the patient is sensitive to the effects of sedative medicines;
• the patient has epilepsy;
• the patient suffers from: benign prostatic hyperplasia, diabetes, bronchial asthma, very slow heartbeat, hypotension (low blood pressure), cerebral atherosclerosis, pancreatitis, active peptic ulcer (gastric ulcer), pyloric or duodenal stenosis (narrowing at the junction between stomach and intestine), or thyroid disorders;
• if patients treated with tricyclic antidepressants or other medicines with similar effects develop gastrointestinal symptoms. These symptoms may be due to paralytic ileus (intestinal paralysis with cessation of peristaltic movements propelling food content);
• in alcoholics, caution is required and no more than 2 sachets of FluControl Hot (2 g paracetamol) should be taken per day, as paracetamol may cause liver damage;
• in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may lead to methemoglobinemia and hemolytic anaemia).

During treatment with FluControl Hot, inform the doctor immediately if:

• the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, severe metabolic acidosis (a disturbance in blood and body fluid balance) has been reported in patients taking paracetamol regularly over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children
Do not use in children under 12 years of age due to the dose of paracetamol and the presence of other active ingredients.

FluControl Hot and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, or those planned for future use.

Do not take FluControl Hot simultaneously with other medicines containing:

• paracetamol (the active ingredient found in many cold and flu remedies), because paracetamol overdose may occur;
• phenylephrine (sympathomimetic agents used in symptomatic treatment of nasal mucosal inflammation, i.e. rhinitis);
• monoamine oxidase inhibitors (MAOIs) (medicines used, among others, in the treatment of depression and Parkinson’s disease). FluControl Hot should not be taken until at least 15 days after stopping treatment with these medicines.

Due to paracetamol content
If the patient is taking any of the following medicines, a dose adjustment or discontinuation of treatment may be necessary:

• antibiotics (chloramphenicol);
• oral anticoagulants (acenocoumarol, warfarin);
• oral contraceptives and estrogen therapy;
• antiepileptic drugs (lamotrigine, phenytoin and other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine);
• antituberculosis drugs (isoniazid, rifampicin);
• barbiturates (used as general anaesthetics, sedatives, and anticonvulsants);
• activated charcoal (adsorbent);
• cholestyramine (used to reduce blood cholesterol levels);
• medicines used in the treatment of gout (probenecid and sulfinpyrazone);
• certain diuretics used to increase urine excretion (loop diuretics, e.g. furosemide);
• medicines used to relieve spasms or cramps of the stomach, intestines, and urinary bladder (anticholinergics such as glycopyrronium, propantheline);
• cardiac glycosides (digitalis glycosides);
• medicines used against nausea and vomiting (metoclopramide and domperidone);
• propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (arrhythmias);
• zidovudine (used in the treatment of HIV infections).

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Due to phenylephrine content
If the patient is taking any of the following medicines, treatment interruption may be necessary:

• alpha-adrenergic receptor blockers (medicines used in migraine treatment, labour induction, antihypertensives, or treatment of other diseases);
• beta-adrenergic receptor blockers (medicines that, among others, lower blood pressure);
• tricyclic or tetracyclic antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, maprotiline);
• inhaled anaesthetics;
• antihypertensive medicines acting via the sympathetic nervous system (e.g. methyldopa, guanethidine);
• medicines causing potassium loss (diuretics used for hypertension and others, e.g. furosemide);
• medicines affecting cardiac conduction (used in heart diseases), such as cardiac glycosides and antiarrhythmics;
• thyroid hormones;
• medicines blocking both alpha and beta adrenergic receptors, such as labetalol and carvedilol (used in heart and vascular diseases);
• atropine sulphate (used, among others, in heart and gastrointestinal diseases).

Due to chlorpheniramine content
Concomitant use of the following medicines may intensify the occurrence of adverse effects:

• medicines causing central nervous system depression (medicines used to treat insomnia or anxiety);
• ototoxic medicines (which may cause hearing damage as an adverse effect);
• photosensitising medicines (which may cause light allergy as an adverse effect).

FluControl Hot with food, drink, and alcohol
Paracetamol use in patients who regularly consume alcohol (three or more alcoholic drinks daily) may lead to liver damage.
Do not drink alcohol while taking FluControl Hot, as it may cause overdose symptoms such as enhanced sedative effects.

Use of FluControl Hot in elderly patients
Do not use in elderly patients without consulting a doctor.
Due to the presence of phenylephrine and chlorpheniramine, elderly patients may be particularly prone to adverse effects such as bradycardia (slow heartbeat) or reduced cardiac output.
Blood pressure should be monitored, especially in patients with heart disease.
In elderly patients, symptoms such as dizziness, sedation, confusion, hypotension (low blood pressure), agitation, dry mouth, and urinary retention are more likely.

Pregnancy and breastfeeding
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.

Pregnancy
FluControl Hot is contraindicated during pregnancy.

Breastfeeding
Paracetamol and chlorpheniramine pass into breast milk; therefore, women who are breastfeeding should not take this medicine. The medicine is contraindicated during breastfeeding.

Driving and operating machinery
This medicine may affect the ability to drive or operate machinery. If drowsiness or sedation occurs, do not drive or operate machinery.

FluControl Hot contains sucrose, sulphites, sodium, citral, citronellol, d-limonene, geraniol, linalool

Sucrose
Each sachet contains 3.994 g of sucrose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sulphites
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sodium
Each sachet contains 20.1 mg of sodium.
Four sachets contain 80.4 mg of sodium (main component of table salt), equivalent to 4.02% of the maximum recommended daily sodium intake in the adult diet.

Effect on laboratory test results
Before undergoing laboratory tests (blood, urine, skin tests using allergens, etc.), the patient should inform the doctor that they are taking FluControl Hot, as it may interfere with the results of certain tests (e.g. blood glucose or uric acid measurements).

3. How to take FluControl Hot

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Take orally.
Recommended dose
Adults and adolescents over 12 years of age: one sachet, no more frequently than every 6–8 hours
(3 or 4 times daily).
Do not take more than 4 sachets in 24 hours (corresponding to 4000 mg paracetamol, 40 mg
phenylephrine, and 16 mg chlorphenamine).
If pain or fever subsides, discontinue use of FluControl Hot.
Administration method
Dissolve the contents of the sachet in a small amount of liquid, preferably half a glass of water.
If fever persists for more than 3 days of treatment, pain or other symptoms last longer than 5 days,
or symptoms worsen or new symptoms appear, consult a doctor. This medicine should only be
taken when experiencing pain or fever symptoms. Discontinue use once symptoms resolve.
Use the lowest effective dose. Do not exceed the recommended dose.
Patients with renal or hepatic impairment
FluControl Hot should not be used in patients with liver disease or severe renal impairment.
Use in children
FluControl Hot should not be used in children under 12 years of age due to the paracetamol dose
and the presence of other active substances.
Taking more than the recommended dose of FluControl Hot
If a dose exceeding the recommended amount has been taken, seek immediate medical advice,
since symptoms may not appear until three days after ingestion, even in cases of severe poisoning.
Symptoms of overdose:
caused by paracetamol:
nausea, vomiting, loss of appetite, pallor, and abdominal pain usually occur within the first 24
hours.
Significant overdose may cause severe hepatotoxic effects, leading to liver failure, metabolic
acidosis, and encephalopathy, which may result in coma and death.
Overdose may also lead to coagulation disorders (impaired blood clotting and bleeding).
In case of overdose, seek immediate medical advice, even if no symptoms are present.
Treatment of paracetamol overdose is most effective if initiated within 4 hours of ingestion.
Patients treated with barbiturates or alcoholics may be more susceptible to paracetamol overdose.
caused by phenylephrine:
excessive stimulation of the nervous system with symptoms such as: restlessness, anxiety,
excitement, headache (possibly symptoms of hypertension), seizures, insomnia, confusion,
irritability, tremors, loss of appetite, nausea, vomiting, psychosis with hallucinations (more common
in children), hypertension (with cerebral hemorrhage, pulmonary edema), cardiac arrhythmias,
palpitations, vasoconstriction with possible reduction in blood flow to vital organs.
Severe symptoms are more likely in patients with reduced blood volume due to bleeding,
dehydration, etc., with slow, irregular, or rapid heartbeat, tachycardia, reduced urine output,
metabolic acidosis (excessive accumulation of acidic substances in the blood), and paresthesia
(sensation of tingling and burning in various parts of the body).
caused by chlorphenamine:
stiffness, instability, increased drowsiness, dryness of the mucous membranes of the mouth, nose,
or throat, facial flushing, dyspnea (difficulty breathing), cardiac arrhythmias (irregular or rapid
heartbeat), hallucinations, seizures, insomnia, hypotension (low blood pressure – feeling of
fainting) – may occur as a late effect.
In cases of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment
is administered.
In case of overdose or accidental ingestion, seek immediate medical advice.
Missed dose of FluControl Hot
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for a
missed 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 everyone will experience them.
The following adverse reactions may occur:

Common (occur in 1 to 10 out of 100 people):

• drowsiness, nausea, and muscle weakness (which may subside after 2–3 days of treatment);
• movement disorders affecting the face, stiffness, tremors, dizziness, tingling sensations, numbness of limbs (paresthesia), altered perception of sensations and sounds;
• dry mouth, loss of appetite, changes in taste and smell;
• gastrointestinal disturbances such as nausea, vomiting, diarrhea, constipation, epigastric pain (these may be reduced by taking the medicine with food);
• urinary retention;
• dryness and drying of nasal and pharyngeal mucous membranes;
• excessive sweating;
• blurred or double vision.

Uncommon (occur in 1 to 10 out of 1,000 people) or rare (occur in 1 to 10 out of 10,000 people):

• nervous system excitation (manifested by anxiety, insomnia, delirium, palpitations, nervousness, and seizures);
• chest tightness, shortness of breath;
• rapid or irregular heartbeat (usually in case of overdose);
• liver function disorders (which may present, among others, as epigastric or abdominal pain and dark urine);
• allergic reactions, severe allergic reactions (cough, difficulty swallowing, rapid heartbeat, itching, eyelid or periorbital swelling, facial, tongue or throat swelling, shortness of breath);
• photosensitivity;
• cross-allergy to drugs similar to chlorpheniramine;
• blood morphology changes (such as agranulocytosis, leukopenia, aplastic anemia, or thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue;
• low or high blood pressure;
• edema (swelling);
• tinnitus, acute labyrinthitis (part of the ear);
• impotence;
• intermenstrual bleeding.

Rare (occur in 1 to 10 out of 10,000 people):

• kidney function disorders, cloudy urine;
• allergic dermatitis (skin rashes);
• jaundice (yellowing of the skin);
• hypoglycemia (reduced blood sugar concentration);
• myocardial infarction;
• cardiac arrhythmias (ventricular);
• pulmonary edema;
• intracerebral hemorrhage;
• neutropenia, hemolytic anemia.
  Paracetamol may cause liver damage when large doses are taken or with prolonged treatment.

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

• anxiety, weakness, hypertension (elevated blood pressure), headache;
• irritability;
• pain or discomfort in the chest;
• severe bradycardia (very slow heart rate);
• vasoconstriction, increased myocardial workload (particularly affecting elderly patients or patients with cerebral or coronary circulation disorders). Induction or worsening of heart disease is possible;
• difficulty breathing;
• pallor;
• piloerection (hair standing on end);
• hyperglycemia (increased blood sugar concentration);
• decreased potassium concentration in blood;
• cold extremities (feet or hands);
• redness;
• liver failure;
• kidney failure;
• dyspnea;
• hypersensitivity reaction, hepatic encephalopathy;
• serious condition potentially causing blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

When high doses are used, the following may occur: vomiting, palpitations, psychotic states with hallucinations. With prolonged use, plasma volume deficiency may develop.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store FluControl Hot

Keep this medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the sachet and carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What FluControl Hot contains

• The active substances in FluControl Hot are: paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate.
• The other ingredients are: colloidal anhydrous silica, citric acid (E 330), sodium saccharin (E 954), sucrose, sodium cyclamate (E 952), orange flavour PHS-003270 (containing, among others, sulphites, citral, citronellol, d-limonene, geraniol, linalool).

What FluControl Hot looks like and contents of the pack
FluControl Hot is a powder for oral solution in sachets.
One pack contains 4, 8 or 10 sachets.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel: + 48 42 22-53-100