Theraflu Total Grip

Leaflet attached to the packaging: patient information

Theraflu Total Grip, 500 mg + 6.1 mg + 100 mg, hard capsules

For adults and adolescents aged 16 and over
Paracetamol + Phenylephrine hydrochloride + Guaifenesin

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

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

• You should keep this leaflet so that 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 there is no improvement after 3 days or if 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. Package contents 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 symptoms of the common cold, chills, and flu. These symptoms include mild and moderate pain, fever, stuffy nose (blocked nose), and wet cough.

Theraflu Total Grip is indicated for use only in adults, elderly patients, and adolescents aged 16 and over.
Theraflu Total Grip should only be taken when ALL of the following symptoms are present: pain and/or fever, blocked nose, and cough with expectoration. If there is no improvement after 3 days, or if the patient feels worse, or if 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 blocked nose and makes breathing easier 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 used to treat depression,
• if the patient is taking beta blockers used to treat high blood pressure,
• if the patient is taking other sympathomimetic drugs, 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, nasal congestion, 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.
Regular use of painkillers, especially combinations of several pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure.
Do not consume 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
• kidney function disorders
• prostate enlargement (prostate), as urinary retention or difficulty urinating may occur
• blood circulation problems (such as Raynaud's phenomenon)
• mild jaundice (Gilbert's syndrome)
• severe infection, severe malnutrition, significant underweight, or long-term excessive alcohol consumption
• chronic cough (e.g., occurring during smoking), asthma, chronic bronchitis, or chronic obstructive pulmonary disease (COPD)

During treatment with 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 long time 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 and adolescents under 16 years of age, or in adolescents aged 16 to 18 years with a body weight below 50 kg.

Theraflu Total Grip and other medicines

Do not take 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 blockers
• medicines containing sympathomimetic drugs, 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 serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2)
• 2).
• inform your doctor about taking this medicine if you are 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 and breastfeeding.

Driving and using machines

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

3. How to take Theraflu Total Grip

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Recommended dose:

For adults, elderly patients, and adolescents aged 16 and over with a body weight of 50 kg or more:

• Take 2 capsules with water every 4 to 6 hours as needed.
• Do not take more than 6 capsules (3 doses of 2 capsules) 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 take 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 should not be taken by adults, elderly patients, and adolescents aged 16 and over 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 aged 16 to 18 years 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 4 capsules per day (with an interval of at least 8 hours between taking the next capsules).

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.
Other pharmaceutical forms more suitable for such patients are available on the market.

Method of preparation and administration:

Oral administration.

Swallow the capsules with water. Do not chew.

Taking a higher dose of Theraflu Total Grip than recommended

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

Missing a 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 taking 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:

• allergic reactions, including wheezing, shortness of breath, swelling of the face or lips
• skin rash (including hives, itching), redness of the skin
• peeling of the skin, 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, agitation, nervousness, or confusion
• 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 (called 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, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Theraflu Total Grip

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Theraflu Total Grip contains

The active substancesof Theraflu Total Grip are paracetamol, phenylephrine hydrochloride, and guaifenesin. One capsule contains 500 mg of paracetamol, 6.1 mg of phenylephrine hydrochloride (which corresponds to 5 mg of phenylephrine base), and 100 mg of guaifenesin.
Other ingredientsare: croscarmellose sodium, cornstarch, sodium lauryl sulfate, talc, and magnesium stearate.
The capsule shellcontains: gelatin, indigo carmine (E132), titanium dioxide (E171), quinoline yellow (E104), and erythrosine (E127).

What Theraflu Total Grip looks like and what the pack contains

Theraflu Total Grip is a hard gelatin capsule with a semi-transparent green body and a non-transparent blue cap, size 0, filled with a white powder, free from large particles and solid impurities.
Available packs:8 and 16 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

Manufacturer

Smithkline Beecham S.A.
Ctra. de Ajalvir, Km. 2,500
Alcalá de Henares
28806 Madrid
Spain
This medicine has been authorized in EU member states under the following trade names:
Bulgaria
Терафлу Форте Простуда и Кашлица 500 mg/6,1 mg/100 mg твърди капсули
Croatia
Theraflu 500 mg/6,1 mg/100mg tvrde kapsule
Cyprus
Panadol Cold & Flu & Cough
Czech Republic
Panadol chřipka a kašel
Estonia
Theraflu
Germany
OtriComplex Erkältungskapseln
500 mg / 6,1 mg / 100 mg Hartkapseln
Greece
Panadol Cold & Flu & Cough
Hungary
Neo Citran megfázásra és köhögésre kemény kapszula
Latvia
Theraflu 500mg/ 100mg/ 6,1mg cietās kapsulas
Lithuania
Theraflu 500mg/ 100mg/ 6,1mg kietosios kapsulės
Poland
Theraflu Total Grip
Portugal
Panadol Gripus
Romania
THERAFLU RĂCEALĂ ŞI TUSE 500 mg/ 6,1 mg/ 100 mg capsule
Slovenia
Theraflu 500 mg/100 mg/6,1 mg trde kapsule
Date of last revision of the leaflet:February 2025