Theraflu for cold

Package leaflet: Information for the user

Theraflu Zatoki, 650 mg + 10 mg, effervescent powder for oral solution
Paracetamolum + Phenylephrini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4. If fever persists after 3 days or symptoms last longer than 5 days, or if you feel worse, consult your doctor.

Leaflet contents:

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

1. What Theraflu Zatoki is and what it is used for

This medicine contains as active substances: paracetamol, which has analgesic and antipyretic properties, and phenylephrine hydrochloride, which reduces swelling and congestion of the nasal and sinus mucosa.
Theraflu Zatoki helps clear the nose and sinuses and reduces headache.
Indications:
Symptomatic treatment of sinus-related conditions such as headache, nasal and sinus congestion with pain, and symptoms of mucosal congestion and swelling. It has antipyretic effects and relieves symptoms of cold and flu (chills, muscle and headache).
Do not use in children under 12 years of age.
If fever persists after 3 days or symptoms last longer than 5 days, or if you feel worse, consult your doctor.

2. Important information before using Theraflu Zatoki

When not to use Theraflu Zatoki
Do not use Theraflu Zatoki if:

• the patient is allergic to paracetamol, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6),
• the patient is taking or has taken monoamine oxidase inhibitors (MAOIs) within the last 14 days (MAOIs are medicines used to treat depression or Parkinson's disease); if the patient is unsure whether their prescribed medicines contain MAOIs, they should consult a doctor or pharmacist before taking the medicine described in this leaflet,
• the patient has severe heart disease or very high blood pressure (hypertension),
• the patient has hyperthyroidism,
• the patient has narrow-angle glaucoma (an eye condition involving progressive damage to the optic nerve, at least partially related to increased intraocular pressure),
• the patient has a pheochromocytoma (a tumour near the kidneys that causes high blood pressure),
• the patient has hypersensitivity to peanuts or soya,
• the patient is taking tricyclic antidepressants,
• the patient is taking beta-blockers (medicines used to treat high blood pressure and heart conditions),
• the patient is taking other oral sympathomimetic medicines, such as nasal decongestants, appetite suppressants, etc.,
• the patient is taking other cold and flu symptom relievers or medicines that help with sleep,
• during pregnancy or breastfeeding,
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Theraflu Zatoki, consult a doctor or pharmacist if:

• the patient has liver or kidney disease,
• the patient has haemolytic anaemia,
• the patient has glucose-6-phosphate dehydrogenase deficiency (an inherited disorder),
• the patient is dehydrated or chronically undernourished,
• the patient has a blood disorder,
• the patient has diabetes,
• the patient has an enlarged prostate gland, as this may lead to difficulty in passing urine,
• the patient has rare inherited disorders such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency (see section 6).

This medicine contains paracetamol. Do not take this medicine together with other products containing paracetamol. If a higher than recommended dose is taken, contact a doctor immediately, even if no symptoms occur, as serious liver damage may result.
Take the medicine exactly as directed. Always use the lowest effective dose for the shortest possible duration.
Consult a doctor if:

• the patient has lung disease, including asthma,
• fever persists for more than 3 days,
• nasal pain or congestion lasts longer than 5 days,
• a skin rash or persistent headache develops. These may be signs of a serious illness.

If the patient has severe medical conditions, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is also taking flucloxacillin (an antibiotic), there have been reports of a serious condition called metabolic acidosis (an imbalance in blood and body fluids) in patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Do not consume alcoholic beverages while taking this medicine due to the risk of toxic liver damage. The risk of liver damage is particularly high in fasting individuals and those who regularly consume alcohol. Paracetamol should be used with caution in patients who are alcohol-dependent.
Paracetamol should also be used cautiously in patients taking other medicines that affect the liver, such as barbiturates, antiepileptic medicines (e.g. phenytoin, phenobarbital, carbamazepine), rifampicin, and isoniazid (see below).

Theraflu Zatoki and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take, particularly the following:

• monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease: do not take Theraflu Zatoki if you are taking MAOIs or have taken them within the last 14 days,
• medicines used to treat depression, such as tricyclic antidepressants,
• medicines used to lower high blood pressure, e.g. beta-blockers, debrisoquine, guanethidine, reserpine, and methyldopa,
• medicines used to treat heart failure and heart rhythm disorders (digoxin and other cardiac glycosides),
• medicines used to prevent blood clots, such as warfarin or other coumarin derivatives,
• medicines containing paracetamol or sympathomimetics, e.g. nasal decongestants used to treat colds and flu,
• medicines for nausea and vomiting, such as metoclopramide or domperidone,
• medicines used to treat tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol),
• barbiturates (sleeping medicines),
• medicines used to treat seizures, such as phenytoin, phenobarbital, carbamazepine, and lamotrigine,
• cholestyramine, used to lower cholesterol levels,
• zidovudine (AZT), used to treat HIV infection,
• probenecid, used to treat gout,
• ergotamine and methysergide, used to treat migraine.

Inform your doctor or pharmacist if you are taking:

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

Effect on laboratory test results
This medicine may interfere with blood uric acid measurements using the phosphotungstic acid method.
Phenylephrine may cause false positive results in doping tests (particularly important for competitive athletes).

Alcohol and Theraflu Zatoki
Do not drink alcohol while taking Theraflu Zatoki.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine is not recommended during pregnancy.
Use of this medicine is not recommended during breastfeeding.

Driving and operating machinery
This medicine may cause dizziness. If this occurs, do not drive or operate machinery.

Children
Theraflu Zatoki should not be used in children under 12 years of age.

Warnings about excipients:
Theraflu Zatoki contains per sachet:

• 12.6 g of sucrose. This should be taken into account in patients with diabetes. If a patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
• 42.5 mg of sodium, the main component of table salt. This corresponds to 2.1% of the maximum recommended daily sodium intake in adults. This should be taken into account in patients who are monitoring their dietary sodium intake.
• sunset yellow (E 110). May cause allergic reactions.
• glucose (as a component of maltodextrin). If a patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
• sulphites. This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Theraflu Zatoki

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years of age: dissolve the contents of one sachet in a glass of hot, but not boiling, water. Drink after cooling to a suitable temperature.
One sachet may be taken at a time. If further symptomatic treatment is needed, this dose may be repeated after 4–6 hours. Do not use more than 3–4 sachets per day.
Do not use for longer than 5 days. Consult a doctor if symptoms persist or worsen after 5 days, or if fever persists for more than 3 days.
If you feel the effect of the medicine is too strong or too weak, consult a doctor. Do not use more than the recommended dose. Always use the lowest effective dose for the shortest possible time.
Use in children
Do not give this medicine to children under 12 years of age.
Patients with liver disease
In adults weighing less than 50 kg, patients with mild or moderate liver impairment, Gilbert's syndrome (familial hyperbilirubinemia), dehydrated patients, chronically undernourished individuals, and those with alcohol-related liver disease, the daily effective dose of paracetamol should not exceed 60 mg/kg/day (up to 2 g/day, i.e., a maximum of 3 sachets per day).
Patients with renal impairment
In patients with renal impairment, take the contents of one sachet at a time. The intervals between doses should be:

Use of a higher than recommended dose of Theraflu Zatoki
If a higher than recommended dose is used, contact a doctor immediately,
even if no symptoms have occurred, as it may lead to life-threatening liver damage.
Missed dose of Theraflu Zatoki
Theraflu Zatoki is used on an as-needed basis when symptoms occur.
However, if a doctor recommends regular use of the medicine, do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Theraflu Zatoki may cause adverse reactions, although not everyone will experience them.
You should STOP taking the medicine and consult a doctor immediately if any of the following symptoms occur:

• allergic reactions (uncommon),
• angioedema, including wheezing, shortness of breath, swelling of the face, lips, tongue or throat (uncommon),
• anaphylactic reaction (severe allergic reaction, frequency not known),
• rash, urticaria, itching, redness of the skin (uncommon),
• severe skin reactions, including skin peeling, blisters, ulcers, erosions in the oral cavity (very rare),
• bleeding or bruising (blood coagulation disorders due to low platelet count - thrombocytopenia) (very rare),
• difficulty in urinating. This is more likely in men with benign prostatic hyperplasia,
• loss of vision, which may be caused by abnormally high intraocular pressure. This is very rare, but there is a possibility of such an event in individuals with glaucoma,
• unusually rapid heartbeat or sensation of irregular heart rhythm.

Other adverse reactions of the medicine:
Common (occur in 1 to 10 out of 100 patients):

• nausea,
• vomiting.

Uncommon (occur in 1 to 10 out of 10,000 patients):

• nervousness, insomnia,
• dizziness, headache,
• increased heart rate, palpitations, elevated blood pressure,
• diarrhoea. In rare cases, abnormal laboratory liver function test results may also be observed.
  Very rare (occur in fewer than 1 out of 10,000 patients):
• agranulocytosis (decrease in granulocyte count in blood),
• leukopenia (decrease in leukocyte count in blood), pancytopenia (deficiency of formed blood elements).
  Frequency not known (cannot be estimated from available data):
• serious condition that may cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorization holder. Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Theraflu Zatoki

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use Theraflu Zatoki after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Theraflu Zatoki contains

• The active substances in one sachet are: paracetamol 650 mg and phenylephrine hydrochloride 10 mg.
• Other ingredients include: sucrose, potassium acesulfame, quinoline yellow (E 104), sunset yellow (E 110), maltodextrin M100 (contains glucose), colloidal anhydrous silica, lemon flavour PHS 163671 (contains maltodextrin – contains glucose, butylated hydroxyanisole E320), citric acid, sodium citrate, calcium phosphate.

What Theraflu Zatoki looks like and contents of the pack
The pack contains 6, 10 or 14 PET/LDPE/Al./EMAA sachets in a cardboard box. Each
sachet has child-resistant closure.
1 sachet contains 14.88 g of effervescent powder for oral solution with lemon flavour.
The powder is soluble in hot water.
Marketing Authorisation Holder:
Haleon Poland Sp. z o.o.
Rzymowskiego Street 53
02-697 Warsaw
Tel. 800 702 849
Manufacturer:
Haleon Alcala, S.A.
Ctra. De Ajalvir, Km. 2,500,
Alcalá de Henares, Madrid
28806, Spain
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany