Theraflu total grip

Patient Information Leaflet

Theraflu Total Grip, 500 mg + 6.1 mg + 100 mg, hard capsules
For adults and adolescents aged 16 years and older
Paracetamolum + Phenylephrini hydrochloridum + Guaifenesinum
Please read this leaflet carefully before using 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 for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if symptoms worsen, contact a 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 relief of symptoms of colds,
chills, and influenza. 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 patients, 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, blocked nose, and productive cough. If there is no improvement after 3 days, if symptoms worsen, or if the cough is accompanied by high fever, skin rash, or persistent headache, contact a doctor.

How Theraflu Total Grip works
Theraflu Total Grip contains three active substances:

• Paracetamol, which is an analgesic and antipyretic (reduces body temperature in case of fever).
• Phenylephrine hydrochloride, which reduces swelling and congestion of the nasal mucosa. It helps relieve nasal congestion and facilitates breathing by reducing swelling in the nasal passages.
• Guaifenesin is an expectorant that helps thin mucus (phlegm) and reduces the severity of productive cough.

2. Important information before using 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 closed-angle glaucoma (increased pressure in the eye),
• if the patient has a phaeochromocytoma (a type of tumour of the adrenal glands, located near the kidneys),
• if the patient is currently taking or has taken within the last 14 days monoamine oxidase inhibitors (MAOIs, medicines used to treat depression or Parkinson's disease),
• if the patient is taking tricyclic antidepressants,
• if the patient is taking beta-blockers (medicines used to treat high blood pressure and heart conditions),
• if the patient is taking other sympathomimetic medicines, such as decongestants, appetite suppressants, or amphetamine-like psychostimulants.

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 mucosal congestion, and productive cough.
The 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 pain-relieving medicines, especially combinations of several pain-relieving substances, may lead to permanent kidney damage with a 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, colds, or flu.
Contact a 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 using Theraflu Total Grip, consult a doctor or pharmacist if any of the following apply:

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

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

• the patient has serious medical conditions, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly over a long period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age, nor in adolescents aged 16 to 18 years with body weight below 50 kg.
Theraflu Total Grip and other medicines
Do not take Theraflu Total Grip if the patient is taking:

• or has 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, e.g. beta-blockers
• medicines containing sympathomimetic agents, such as nasal decongestants, appetite suppressants, or amphetamine-like psychostimulants

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, particularly:

• medicines used to treat heart failure and irregular heartbeat (digoxin and other cardiac glycosides)
• anticoagulant medicines (blood thinners), 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 (an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (called 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 use Theraflu Total Grip during pregnancy or breastfeeding.
Driving and operating machinery
This medicine may cause dizziness. If such symptoms occur, 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 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 body weight of 50 kg or more:

• Take 2 capsules with water every 4 to 6 hours as needed.
• Do not exceed 6 capsules (3 doses of 2 capsules) per day (corresponding to 3000 mg paracetamol, 36.6 mg phenylephrine hydrochloride, and 600 mg guaifenesin).
• Maintain an interval of at least 4 hours between doses. Use the lowest effective dose for the shortest possible duration.
• Do not use the medicine for longer than 3 days. Contact 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 should not be used in adults, elderly patients, or adolescents aged 16 years and older with body weight below 50 kg.
Do not exceed the recommended dose.

Use in children and adolescents
This medicine should not be used in children under 16 years of age. This medicine should not be used in adolescents aged 16 to 18 years with 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 4 capsules per day (maintaining an interval of at least 8 hours between doses).

Patients with renal 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.

Method of preparation and administration:
Oral use.
Swallow the capsules whole with water. Do not chew.

Overdose of Theraflu Total Grip
In case of accidental overdose, seek immediate medical advice even if feeling 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 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 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.
You should STOP using Theraflu Total Grip and consult a doctor immediately if any of the following symptoms occur:

• allergic reactions, including wheezing, difficulty breathing, 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). You should inform 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, anxiety, psychomotor agitation, nervousness, irritability, or disorientation
• breathing difficulties
• pupil dilation, increased eye pressure
• painful urination, problems with urination

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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 provide more information on the safety of this 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 blister and the 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 required. 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.
Each capsule contains 500 mg of paracetamol, 6.1 mg of phenylephrine hydrochloride (equivalent to 5 mg of phenylephrine base), and 100 mg of guaifenesin.
Other ingredients: Sodium croscarmellose, corn starch, sodium lauryl sulfate, talc, and magnesium stearate.
Capsule shell contains: Gelatin, indigo carmine (E132), titanium dioxide (E171), quinoline yellow (E104), erythrosine (E127).

What Theraflu Total Grip looks like and contents of the pack
Theraflu Total Grip is a hard gelatin capsule with a translucent green body and an opaque blue cap, size 0, filled with a whitish powder free from large particles and solid impurities.
Available pack sizes: 8 and 16 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. 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 medicinal product has been authorised in the Member States of the European Union 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/100 mg 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 500 mg/100 mg/6.1 mg cietās kapsulas
Lithuania Theraflu 500 mg/100 mg/6.1 mg 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