Theraflu Zatoki

Leaflet attached to the packaging: patient information

Theraflu Zatoki, 650 mg + 10 mg, powder for oral solution

Paracetamol + Phenylephrine hydrochloride

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 this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4. If the fever persists after 3 days or the symptoms of the disease persist after 5 days, or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Theraflu Zatoki and what is it 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 packaging and other information

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

The medicine contains the active substances: paracetamol, which has analgesic and antipyretic effects, and phenylephrine hydrochloride, which reduces swelling and congestion of the nasal mucosa and sinuses.
Theraflu Zatoki clears the nose and sinuses. It reduces headache.
Indications for use:
Symptomatic treatment of sinusitis, such as headache, nasal and sinus congestion accompanied by pain and symptoms of congestion and swelling of the mucous membrane, has an antipyretic effect, relieves symptoms of colds and flu (chills, muscle and headache).
Do not use in children under 12 years of age.
If the fever persists after 3 days or the symptoms of the disease persist after 5 days, or if the patient feels worse, they should contact their doctor.

2. Important information before taking Theraflu Zatoki

When not to take Theraflu Zatoki

Do not take 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, medicines used to treat depression or Parkinson's disease) within the last 14 days; if the patient is unsure,

they should consult their doctor or pharmacist before taking the medicine described in the 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 disease with progressive damage to the optic nerve and at least partially related to increased intraocular pressure),
• the patient has a pheochromocytoma (a tumor located near the kidneys that causes increased blood pressure),
• the patient is hypersensitive to peanuts or soy,
• the patient is taking tricyclic antidepressants,
• the patient is taking beta-adrenergic blockers (medicines used to treat high blood pressure and heart disease),
• the patient is taking other sympathomimetic medicines orally, such as nasal decongestants, appetite suppressants, etc.,
• the patient is taking other medicines that relieve cold and flu symptoms or facilitate sleep,
• during pregnancy and breastfeeding,
• in children under 12 years of age.

Warnings and precautions

Before taking Theraflu Zatoki, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver or kidney disease,
• if the patient has hemolytic anemia,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a hereditary disorder),
• if the patient is dehydrated or malnourished for a long time,
• if the patient has a blood system disease,
• if the patient has diabetes,
• if the patient has an enlarged prostate (prostate), as this may be associated with urinary retention,
• if the patient suffers from rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (see section 6).

The medicine contains paracetamol. DO NOT take this medicine with other products containing paracetamol. If a higher dose than recommended is taken, the patient should contact their doctor immediately, even if no symptoms have occurred, as this may lead to severe liver damage.
The medicine should be taken according to the established dosage schedule. The patient should always take the lowest effective dose of the medicine for the shortest possible time.
The patient should consult their doctor:

• if they have lung disease, including asthma,
• if they have a fever that lasts longer than 3 days,
• if they have pain or nasal congestion that lasts longer than 5 days,
• if they have a skin rash or persistent headache. These situations may be symptoms of a serious disease.

If the patient has severe diseases, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic), in these situations, patients have reported a serious disease called metabolic acidosis (a blood and body fluid disorder) when taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
During treatment with the medicine, the patient should not drink alcoholic beverages due to the risk of toxic liver damage. There is a particular risk of liver damage in people who are starving and regularly drink alcohol. Paracetamol should be used with caution in people addicted to alcohol. Paracetamol should be used with caution in patients taking other medicines that affect the liver, such as barbiturates, antiepileptic drugs (e.g., phenytoin, phenobarbital, carbamazepine), rifampicin, and isoniazid (see below).

Theraflu Zatoki and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including:

• monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease: do not take Theraflu Zatoki if the patient is taking MAOIs or has taken them within the last 14 days,
• medicines used to treat depression, e.g., tricyclic antidepressants,
• medicines that lower high blood pressure, e.g., beta blockers, debryzochine, guanethidine, reserpine, and methyldopa,
• medicines used to treat heart failure and arrhythmias (digoxin and other cardiac glycosides),
• medicines that prevent blood clots, e.g., warfarin or other coumarin derivatives,
• medicines containing paracetamol or sympathomimetic medicines, e.g., nasal decongestants used to treat colds and flu,
• medicines used to treat nausea and vomiting, such as metoclopramide or domperidone,
• medicines used to treat tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol),
• barbiturates (sleeping pills),
• medicines used to treat seizure disorders, 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 migraines.

The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Effect on laboratory test results

The medicine may interfere with the results of uric acid measurements in the blood using the phosphotungstic method.
Phenylephrine may cause false-positive doping test results (information particularly important for athletes).

Taking Theraflu Zatoki with alcohol

The patient should not drink alcohol while taking Theraflu Zatoki.

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.
It is not recommended to take the medicine during pregnancy.
It is not recommended to take the medicine during breastfeeding.

Driving and using machines

The medicine may cause dizziness. If this occurs, the patient should not drive or operate machinery.

Children

Theraflu Zatoki should not be taken by children under 12 years of age.

Warnings about excipients:

Theraflu Zatoki contains:

• 12.6 g of sucrose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the 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 the diet for adults. This should be taken into account in patients controlling their sodium intake.
• orange yellow (E 110). May cause allergic reactions.
• glucose (as a component of maltodextrin). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
• sulfites. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Theraflu Zatoki

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Adults and adolescents over 12 years: the contents of one sachet should be dissolved in 1 glass of hot, but not boiling, water. Drink after cooling to a suitable temperature.
One sachet can be taken at a time. If further symptomatic treatment is needed, the dose can be repeated after 4-6 hours. Do not take more than 3-4 sachets in 24 hours.
Do not take for more than 5 days. The patient should contact their doctor if the symptoms persist or worsen after 5 days or if the fever persists for more than 3 days.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor. Do not take a higher dose than recommended. The patient should always take the lowest effective dose of the medicine for the shortest possible time.

Use in children

Do not give the medicine to children under 12 years of age.

Patient with liver disease

In the case of adults weighing less than 50 kg, patients with low or moderate liver failure, Gilbert's syndrome (familial hyperbilirubinemia), dehydration, chronic malnutrition, patients with alcoholic liver disease, the recommended daily dose of paracetamol should not exceed 60 mg/kg/day (up to 2 g/day, i.e., the contents of a maximum of 3 sachets per day).

Patient with renal impairment

In the case of patients with renal impairment, one sachet should be taken at a time. The intervals between doses should be:

Taking a higher dose of Theraflu Zatoki than recommended

If a higher dose than recommended is taken, the patient should contact their doctor immediately, even if no symptoms have occurred, as this may lead to life-threatening liver damage.

Missing a dose of Theraflu Zatoki

Theraflu Zatoki is taken as needed when symptoms occur.
If the doctor recommends regular intake of the medicine, the patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Theraflu Zatoki can cause side effects, although not everybody gets them.

The patient should STOP taking the medicine and consult their doctor immediately if they experience:

• allergic reactions (rare),
• angioedema, including wheezing, shortness of breath, swelling of the face, lips, tongue, or throat (rare),
• anaphylactic reaction (a severe allergic reaction, frequency not known),
• rash, hives, itching, redness (rare),
• severe skin reactions, including skin peeling, blisters, ulcers, and mouth ulcers (very rare),
• bleeding or bruising (blood clotting disorders caused by a low platelet count - thrombocytopenia) (very rare),
• difficulty urinating. This is more likely in men with an enlarged prostate,
• vision loss, which may be caused by excessively high intraocular pressure. This is very rare but possible in people with glaucoma,
• abnormal heart rhythm or irregular heartbeat.

Other side effects of the medicine:
Common(occurring in 1 to 10 out of 100 patients):

• nausea,
• vomiting.

Rare(occurring in 1 to 10 out of 10,000 patients):

• nervousness, insomnia,
• dizziness, headache,
• rapid heartbeat, palpitations, increased blood pressure,
• diarrhea. In rare cases, abnormal liver function test results may also be observed. Very rare(occurring less frequently than 1 in 10,000 patients):
• agranulocytosis (a decrease in the number of granulocytes in the blood),
• leukopenia (a decrease in the number of white blood cells in the blood), pancytopenia (a deficiency of blood cells), Frequency not known(cannot be estimated from available data)
• a serious condition that can cause acidification of the blood (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including those 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, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Theraflu Zatoki

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not take Theraflu Zatoki after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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 Theraflu Zatoki contains

• The active substances of the medicine in one sachet are: paracetamol 650 mg and phenylephrine hydrochloride 10 mg.
• The medicine also contains: sucrose, acesulfame potassium, quinoline yellow (E 104), orange yellow (E 110), maltodextrin M100 (contains glucose), colloidal silica, anhydrous, citric flavor PHS 163671 (contains maltodextrin - contains glucose, butylhydroxyanisole E320), citric acid, sodium citrate, calcium phosphate.

What Theraflu Zatoki looks like and what the packaging contains

The packaging contains 6, 10, or 14 sachets of PET/LDPE/Al./EMAA in a cardboard box. Each sachet has a child-resistant closure.
1 sachet contains 14.88 g of powder for oral solution with a citrus flavor.
The powder is soluble in hot water.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 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

Date of leaflet approval: