Theraflu Total Grip

Leaflet attached to the packaging: patient information

Theraflu Total Grip, 1000 mg + 12.2 mg + 200 mg, powder for oral solution preparation

Oral
For adults and adolescents 16 years and older
Paracetamol + Phenylephrine hydrochloride + Guaifenesin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell 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 Theraflu Total Grip and what is it used for
• 2. Important information before taking Theraflu Total Grip
• 3. How to take Theraflu Total Grip
• 4. Possible side effects
• 5. How to store Theraflu Total Grip
• 6. Contents of the packaging and other information

1. What is Theraflu Total Grip and what is it used for

Theraflu Total Grip is indicated for the short-term treatment of cold, chills, and flu symptoms. These symptoms include mild and moderate pain, fever, stuffy nose, and wet cough.

Theraflu Total Grip is indicated for use only in adults, the elderly, and adolescents 16 years and older.
Theraflu Total Grip should be taken ONLY when ALL of the following symptoms are present: pain and/or fever, stuffy nose, and cough with expectoration. If after 3 days there is no improvement, the patient feels worse, or the cough is accompanied by high fever, skin rash, or persistent headache, they should contact their doctor.

How Theraflu Total Grip works

Theraflu Total Grip contains three active substances:

• Paracetamol, which is a pain reliever and antipyretic (lowers body temperature in case of fever).
• Phenylephrine hydrochloride, which reduces swelling and congestion of the nasal mucosa. It unblocks the stuffy nose and facilitates breathing by reducing swelling in the nasal passages.
• Guaifenesin is an expectorant that thins mucus (phlegm) and reduces the severity of wet cough.

2. Important information before taking Theraflu Total Grip

When NOT to take Theraflu Total Grip:

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, guaifenesin, or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2),
• if the patient has heart disease or high blood pressure (hypertension),
• if the patient has diabetes,
• if the patient has hyperthyroidism,
• if the patient has glaucoma with closed-angle glaucoma (increased pressure in the eye),
• if the patient has a pheochromocytoma (a type of adrenal gland tumor),
• if the patient is currently taking or has taken within the last 14 days monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease,
• if the patient is taking tricyclic antidepressants,
• if the patient is taking beta-adrenergic blockers (used to treat high blood pressure and heart disease),
• if the patient is taking other sympathomimetic medicines, such as decongestants, appetite suppressants, and psychostimulants similar to amphetamine

Warnings and precautions

It is important to take Theraflu Total Grip ONLY when ALL of the following symptoms are present: pain and/or fever, stuffy nose, and wet cough.
The medicine contains paracetamol. DO NOT take the medicine at the same time as other products containing paracetamol.
Do not take a higher dose than recommended due to the risk of severe liver damage.
Do not drink alcoholic beverages while taking this medicine.
Do not take the medicine at the same time as other medicines for cough, cold, or flu.
Consult a doctor if symptoms worsen or do not improve within 3 days or if the cough is accompanied by high fever, skin rash, or persistent headache.

Before taking Theraflu Total Grip, consult a doctor or pharmacist if:

• you have liver function disorders
• you have kidney function disorders
• you have prostate enlargement (prostate), as urinary retention or difficulty urinating may occur
• you have blood circulation problems (such as Raynaud's phenomenon)
• you have mild jaundice (Gilbert's syndrome)
• you have severe infection, severe malnutrition, significant underweight, or long-term excessive alcohol consumption
• you have chronic cough (e.g., during smoking), asthma, chronic bronchitis, or chronic obstructive pulmonary disease (COPD)

While taking Theraflu Total Grip, immediately inform your doctor if:

• you have severe illnesses, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, alcoholism in the chronic phase, or if you are also taking flucloxacillin (an antibiotic). There have been reports of a severe condition called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a longer period or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents

Do not use this medicine in children under 16 years of age or in adolescents between 16 and 18 years of age with a body weight below 50 kg.

Theraflu Total Grip and other medicines

Do not use Theraflu Total Grip if you are taking:

• or have taken within the last 14 days monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease
• tricyclic antidepressants used to treat depression
• medicines used to treat high blood pressure, such as beta-adrenergic blockers
• medicines containing sympathomimetic agents, such as decongestants, appetite suppressants, and psychostimulants similar to amphetamine

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, especially:

• medicines used to treat heart failure and irregular heartbeat (digoxin and other cardiac glycosides)
• blood-thinning medicines (anticoagulants), such as warfarin or other coumarin derivatives
• medicines used to treat nausea and vomiting, such as metoclopramide or domperidone
• medicines used to treat tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol)
• medicines used to treat epilepsy, such as lamotrigine, phenytoin, phenobarbital, and carbamazepine
• cholestyramine used to lower cholesterol levels
• zidovudine (AZT) used to treat HIV infection (AIDS)
• probenecid used to treat gout
• ergotamine and methysergide used to treat migraine
• medicines used to treat fever or mild pain (salicylates, salicylamide)
• medicines containing paracetamol or decongestants used to treat colds and flu
• halogenated anesthetics used for anesthesia before surgery
• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis), which requires urgent treatment (see section 2).
• you should inform your doctor about taking this medicine if you are undergoing urine tests.

Theraflu Total Grip with food, drink, and alcohol

Do not drink alcoholic beverages while taking this medicine.
This medicine can be taken with or without food.

Pregnancy and breastfeeding

Do not use Theraflu Total Grip during pregnancy and breastfeeding.

Driving and using machines

This medicine may cause dizziness. If you experience such symptoms, do not drive or operate machinery.

Theraflu Total Grip contains:

• Sucrose:If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine. This medicine contains 2 g of sucrose per dose. This should be taken into account in patients with diabetes.
• Sodium:This medicine contains 5.10 mmol (or 117 mg) of sodium (the main component of table salt) per sachet. This corresponds to 6% of the maximum recommended daily intake of sodium in the diet for adults. Aspartame (E951). This medicine contains 30 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Theraflu Total Grip

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dose:

For adults, the elderly, and adolescents 16 years and older with a body weight of 50 kg or more:

• Take one sachet every 4 to 6 hours, as needed.
• Do not take more than 3 sachets (3 doses) per day (which corresponds to 3000 mg of paracetamol, 36.6 mg of phenylephrine hydrochloride, and 600 mg of guaifenesin).
• Maintain an interval of at least 4 hours between doses. Use the smallest effective dose and use the medicine for the shortest possible time.
• Do not use the medicine for more than 3 days. Consult a doctor if symptoms persist for more than 3 days or worsen, or if the cough is accompanied by high fever, skin rash, or persistent headache.

Theraflu Total Grip powder for oral solution preparation should not be used in adults, the elderly, and adolescents 16 years and older if their body weight is below 50 kg.

Do not exceed the recommended dose.

Use in children and adolescents

Do not use this medicine in children under 16 years of age. Do not use this medicine in adolescents between 16 and 18 years of age with a body weight below 50 kg.

Patients with liver disease

In patients with liver function disorders, the dose should be reduced or the interval between doses prolonged.
Consult a doctor before taking this medicine.
The total daily dose should not exceed 2 sachets per day (with an interval of at least 8 hours between sachets).

Patients with kidney function disorders

In patients with kidney function disorders, the interval between doses should be prolonged.
Consult a doctor before taking this medicine.
There are pharmaceutical forms more suitable for such patients available on the market.

Method of preparation and administration:

Oral administration.

The contents of one sachet should be dissolved in a standard-sized cup of hot, but not boiling, water (250 ml). Stir until dissolved. Let it cool to a temperature that allows drinking. The solution should be drunk when it is warm.
After dissolution, the liquid has the form of an opalescent solution with a yellow color, a characteristic citrus-menthol smell, and no solid particles.

Overdose of Theraflu Total Grip

In case of accidental ingestion of a higher dose than recommended, consult a doctor immediately, even if you feel well, due to the risk of delayed, severe liver damage.

Missed dose of Theraflu Total Grip

If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Then continue treatment as recommended.
Always maintain an interval of at least 4 hours between doses. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Theraflu Total Grip and consult a doctor immediately if you experience any of the following symptoms:

• allergic reactions, including wheezing, shortness of breath, swelling of the face or lips
• skin rash (including hives, itching), redness of the skin
• skin peeling, blisters, ulcers, ulcers in the mouth
• blood disorders, including unusual bleeding or bruising
• yellowing of the skin or eyes (jaundice). These are signs of liver problems The above side effects are rare (may affect up to 1 in 1000 people) or very rare. In particular, severe skin reactions are very rare (may affect up to 1 in 10,000 people).

The following side effects may occur rarely or very rarely(in up to 1 in 1000 people or 1 in 10,000 people). Tell your doctor if you experience any of the following symptoms:

• abdominal pain or discomfort (diarrhea, nausea, vomiting)
• headache, dizziness
• increased blood pressure, palpitations, rapid heartbeat
• sleep disorders, anxiety, restlessness, nervousness, irritability, or disorientation
• breathing problems
• pupil dilation, increased eye pressure
• painful urination, difficulty urinating

In very rare cases, liver problems, including abnormal liver function test results, may occur.

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

A serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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, you can help provide more information on the safety of this medicine.

5. How to store Theraflu Total Grip

Keep this medicine out of the sight and reach of children.
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 month.
Store in a temperature below 25°C.
Medicines should 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 packaging and other information

What Theraflu Total Grip contains

Active substancesof the medicine are paracetamol, phenylephrine hydrochloride, and guaifenesin. One sachet contains 1000 mg of paracetamol, 12.2 mg of phenylephrine hydrochloride (which corresponds to 10 mg of phenylephrine base) and 200 mg of guaifenesin.
Other ingredientsare: sucrose, sodium citrate, anhydrous citric acid, tartaric acid, lemon flavor 87A069, lemon flavor 875060 (contains butylhydroxyanisole), menthol flavor 876026, acesulfame potassium (E950), lemon flavor 501.476/AP05.04, aspartame (E951), lemon flavor 875928, quinoline yellow (E104).
Additional information about the ingredients is presented at the end of section 2.

What Theraflu Total Grip looks like and what the pack contains

This medicine is a white, powdery powder, without large agglomerates and solid impurities, packaged in single sachets.
Theraflu Total Grip is available in packs containing 10 sachets.

Marketing authorization holder

Haleon Poland Sp. z o.o.
Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

This medicine has been authorized in EU member states under the following trade names:

Bulgaria
Терафлу Макс Простуда и Кашлица 1000 mg/12,2 mg/200 mg прах за перорален разтвор
Croatia
Theraflu Max 1000 mg/12,2 mg/200 mg prašak za oralnu otopinu
Cyprus
Panadol Cold & Flu & Cough
Czech Republic
Panadol Forte chřipka a kašel horký nápoj citron
Estonia
Theraflu
Germany
OtriComplex forte Erkältungsgetränk 1000 mg / 12.2 mg / 200 mg Pulver zur Herstellung einer Lösung zum Einnehmen
Greece
Panadol Cold & Flu & Cough
Hungary
Neo Citran Max köptetővel por belsőleges oldathoz
Latvia
Theraflu 1000mg/ 200mg/ 12,2mg pulveris iekšķīgi lietojama šķīduma pagatavošanai
Lithuania
Theraflu 1000mg/ 200mg/ 12,2mg milteliai geriamajam tirpalui
Poland
Theraflu Total Grip
Romania
THERAFLU MAX RĂCEALĂ ŞI TUSE 1000 mg/ 12,2 mg/ 200 mg pulbere pentru soluţie orală
Slovakia
Theraflu Forte chrípka a kašeľ horúci nápoj
Slovenia
Theraflu 1000 mg/200 mg/12,2 mg prašek za peroralno raztopino
Date of last revision of the leaflet:February 2025