Theraflu total grip

Patient Information Leaflet

Theraflu Total Grip, 1000 mg + 12.2 mg + 200 mg, effervescent powder for oral solution
For adults and adolescents aged 16 years and older
Paracetamolum + Phenylephrini hydrochloridum + Guaifenesinum
Please read this leaflet carefully before taking the medicine, as it contains important
information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, 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 your condition worsens, consult your doctor.

Table of contents

1. What Theraflu Total Grip is and what it is 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 pack and other information

1. What Theraflu Total Grip is and what it is used for
Theraflu Total Grip is indicated for the short-term treatment of symptoms of cold,
chills, and flu. These symptoms include mild to moderate pain, fever, nasal congestion
(blocked nose), and productive cough.
Theraflu Total Grip is indicated only for use in adults, elderly individuals, and adolescents aged 16 years and older.
Theraflu Total Grip should be taken ONLY when ALL of the following symptoms are present: pain and (or) fever, nasal congestion, and productive cough. If there is no improvement after 3 days, if your condition worsens, or if cough is accompanied by high fever, skin rash, or persistent headache, consult your doctor.
How Theraflu Total Grip works
Theraflu Total Grip contains three active substances:

• Paracetamol, a pain-relieving and antipyretic agent (reduces body temperature during fever).
• Phenylephrine hydrochloride, which reduces swelling and congestion of the nasal mucosa. It relieves nasal blockage and facilitates breathing by reducing nasal passage swelling.
• Guaifenesin is an expectorant that thins mucus (phlegm) and reduces the severity of productive cough.

2. Important information before taking Theraflu Total Grip

Do NOT take Theraflu Total Grip:

• if you are 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 you have heart disease or high blood pressure (hypertension),
• if you have diabetes,
• if you have hyperthyroidism,
• if you have closed-angle glaucoma (increased eye pressure),
• if you have a phaeochromocytoma (a type of adrenal gland tumor located near the kidneys),
• if you are currently taking or have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days (medicines used to treat depression or Parkinson's disease),
• if you are taking tricyclic antidepressants,
• if you are taking beta-blockers (medicines used to treat high blood pressure and heart conditions),
• if you are taking other sympathomimetic medicines, such as decongestants, appetite suppressants, or psychostimulants similar to amphetamines.

Warnings and precautions
It is important to take Theraflu Total Grip ONLY when ALL of the following symptoms are present: pain and (or) fever, nasal congestion, and productive cough.
This medicine contains paracetamol. DO NOT take this medicine together with other products containing paracetamol.
Do not exceed the recommended dose, as this may lead to severe liver damage.
Regular use of painkillers, especially combinations of multiple analgesic substances, may lead to permanent kidney damage and risk of kidney failure.
Do not consume alcoholic beverages while taking this medicine.
Do not take this medicine together with other medicines intended for the treatment of cough, cold, or nasal congestion.
Consult your doctor if symptoms worsen or do not improve within 3 days, or if cough is accompanied by high fever, skin rash, or persistent headache.
Before taking Theraflu Total Grip, consult your doctor or pharmacist if you have:

• liver function disorders
• kidney function disorders
• benign prostatic hyperplasia (enlarged prostate), as this may cause urinary retention or difficulty urinating
• circulatory problems (such as Raynaud's phenomenon)
• mild jaundice (Gilbert's syndrome)
• severe infection, severe malnutrition, significant underweight, or chronic excessive alcohol consumption
• chronic cough (e.g., due to smoking), asthma, chronic bronchitis, or emphysema (lung disease)

During treatment with Theraflu Total Grip, immediately inform your doctor if:

• you have severe illnesses, including severe kidney dysfunction or sepsis (bacteria and their toxins circulating in the blood leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). Cases of severe metabolic acidosis (a blood and fluid imbalance) have been reported in patients taking paracetamol regularly over a long period or when paracetamol is taken 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 and adolescents under 16 years of age, or in adolescents aged 16 to 18 years weighing less than 50 kg.
Theraflu Total Grip and other medicines
Do NOT take Theraflu Total Grip if you are taking:

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

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, especially the following:

• 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 seizures, 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 nasal decongestants used to treat colds and flu
• halogenated anaesthetic agents used for anaesthesia before surgery
• flucloxacillin (antibiotic), due to the serious risk of blood and fluid imbalance (metabolic acidosis), which requires urgent treatment (see section 2).
• inform your doctor about taking this medicine if undergoing urine tests.

Theraflu Total Grip with food, drink, and alcohol
Do not consume alcoholic beverages while taking this medicine. This medicine can be taken with or without food.
Pregnancy and breastfeeding
Do not take Theraflu Total Grip during pregnancy or breastfeeding.
Driving and operating machinery
This medicine may cause dizziness. If this occurs, do not drive or operate machinery.

Theraflu Total Grip contains:

• Sucrose: If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine. This medicine contains 2 g of sucrose per dose. This should be considered in patients with diabetes.
• Sodium: This medicine contains 5.10 mmol (i.e., 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 adult diet.
• Aspartame (E951): The 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 improper excretion.

3. How to take Theraflu Total Grip

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

Recommended dose:
For adults, elderly patients, and adolescents aged 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 (equivalent to 3000 mg paracetamol, 36.6 mg phenylephrine hydrochloride, and 600 mg guaifenesin).
• Leave at least 4 hours between doses. Use the lowest effective dose for the shortest possible duration.
• Do not use this medicine for longer than 3 days. Consult a doctor if symptoms persist beyond 3 days or worsen, or if cough is accompanied by high fever, skin rash, or persistent headache.

Theraflu Total Grip powder for oral solution should not be used in adults, elderly patients, or adolescents aged 16 years and older if their body weight is below 50 kg.
Do not exceed the recommended dose.

Use in children and adolescents
This medicine must not be used in children under 16 years of age. This medicine must not be used in adolescents aged 16 to 18 years with a body weight below 50 kg.

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

Patients with kidney impairment
In patients with impaired kidney function, the interval between doses should be extended.
Consult a doctor before using this medicine.
Other pharmaceutical forms more suitable for such patients are available on the market.

Instructions for preparation and administration:
Oral use.
Dissolve the contents of one sachet in a standard-sized cup of hot, but not boiling, water (250 ml). Stir until fully dissolved. Allow to cool to a drinkable temperature. The solution should be consumed while still warm.
After dissolution, the liquid forms a yellow, opalescent solution with a characteristic citrus-menthol odour, free from solid particles.

Accidental overdose of Theraflu Total Grip
If an overdose is taken, contact 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 the next scheduled dose is approaching. Then continue treatment as recommended. Always maintain at least a 4-hour interval between doses. 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.
DISCONTINUE use of Theraflu Total Grip and consult a doctor immediately if any of the following symptoms occur:

• 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, mouth ulcers
• blood-related disorders, including unusual bleeding or bruising
• yellowing of the skin or eyes (jaundice). These are signs of liver problems.
  The above adverse reactions occur rarely (may occur in 1 out of 1,000 people) or very rarely. In particular, serious skin reactions occur very rarely (may occur in 1 out of 10,000 people).

The following adverse reactions may occur rarely or very rarely (in up to 1 out of 1,000 or 1 out of 10,000 people). Tell your doctor if any of the following symptoms occur:

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

In very rare cases, liver problems may occur, including abnormal liver function test results.
Frequency of occurrence: "frequency not known" (cannot be estimated based on available data):
A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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.: 22 49-21-301, fax: 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 provide more information on the safety of the medicine.

5. How to store Theraflu Total Grip

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

6. Contents of the pack and other information

What Theraflu Total Grip contains
Active substances: paracetamol, phenylephrine hydrochloride, and guaifenesin.
One sachet contains 1000 mg of paracetamol, 12.2 mg of phenylephrine hydrochloride (equivalent to 10 mg of phenylephrine base), and 200 mg of guaifenesin.
Other ingredients: sucrose, sodium citrate, anhydrous citric acid, tartaric acid, lemon flavour 87A069, lemon flavour 875060 (containing butylated hydroxyanisole), mint flavour 876026, potassium acesulfame (E950), lemon flavour 501.476/AP05.04, aspartame (E951), lemon flavour 875928, quinoline yellow (E104).
Additional information on ingredients is provided at the end of section 2.

What Theraflu Total Grip looks like and contents of the pack
This medicine is a white, free-flowing powder without large lumps or solid impurities, packed into individual sachets.
Theraflu Total Grip is available in packs containing 10 sachets.

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

Importer
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

This medicine has been authorised in the European Union 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