Theraflu Max Grip

Leaflet accompanying the packaging: patient information

Theraflu MAX GRIP

1000 mg + 10 mg + 70 mg, powder for oral solution preparation
Paracetamol + Phenylephrine hydrochloride + Ascorbic acid

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 your doctor, pharmacist, or nurse.

• 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 this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Theraflu MAX GRIP and what is it used for
• 2. Important information before taking Theraflu MAX GRIP
• 3. How to take Theraflu MAX GRIP
• 4. Possible side effects
• 5. How to store Theraflu MAX GRIP
• 6. Contents of the packaging and other information

1. What is Theraflu MAX GRIP and what is it used for

Theraflu MAX GRIP is used to relieve the symptoms of colds and flu, if nasal congestion (stuffy nose) is accompanied by fever and/or mild to moderate pain, such as sore throat, headache, muscle pain, and sinus pain. Theraflu MAX GRIP is intended for use only in adults, including the elderly, with a body weight of 50 kg and above.
Theraflu MAX GRIP should only be used if all of the following symptoms are present: nasal congestion with fever and/or mild to moderate pain.
If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.
Theraflu MAX GRIP contains three active substances:

• Paracetamol- has analgesic and antipyretic effects.
• Phenylephrine hydrochloride- constricts nasal blood vessels, clears a stuffy nose and sinuses, making it easier to breathe by reducing swelling in the nasal passages.
• Ascorbic acid(Vitamin C) - is an essential component of the human diet and supplements the diet with vitamin C. This is particularly valuable in the early stages of colds and flu, as vitamin C stores may be low and appetite may be poor.

2. Important information before taking Theraflu MAX GRIP

When not to take Theraflu MAX GRIP:

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, medicines used to treat depression or Parkinson's disease) in the last 14 days,
• in patients with narrow-angle glaucoma (excessive pressure in the eyes),
• in patients with hyperthyroidism,
• in patients with diabetes (high blood glucose levels),
• in patients with high blood pressure or heart disease,
• in patients with a pheochromocytoma (a rare tumor of the adrenal gland),
• in patients taking antidepressant medicines, such as tricyclic antidepressants (e.g., amitriptyline),
• in patients taking medicines to control blood pressure,
• if the patient is taking other sympathomimetic medicines (such as decongestants, appetite suppressants, and certain stimulants),
• in patients with severe liver impairment.

Warnings and precautions

Theraflu MAX GRIP contains paracetamol.This medicine should not be takenwith other medicines containing paracetamol, prescribed or available without a prescription, with analgesic, antipyretic, or cold and flu symptom-relieving effects.
Paracetamol overdose can lead to severe liver damage.
Do not take with other medicines used to treat cough and cold, nasal congestion, or stuffy nose.
Before taking Theraflu MAX GRIP, you should discuss it with your doctor or pharmacist if you have:

• liver or kidney problems,
• you are undergoing a severe infection, are seriously malnourished, have significant weight loss, or regularly abuse alcohol, as this may increase the risk of metabolic acidosis, which may manifest as: deep, rapid, and labored breathing, nausea, vomiting, loss of appetite. You should contact your doctor immediately if you experience any of these symptoms.
• difficulty urinating due to an enlarged prostate,
• you have a history of vascular disease, such as Raynaud's phenomenon (which may cause numbness, tingling, and color changes (white, blue, then red) of the fingers and toes in response to cold).

Theraflu MAX GRIP and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take Theraflu MAX GRIPwith:

• monoamine oxidase inhibitors (MAOIs, medicines used to treat depression or Parkinson's disease) if you have taken them in the last 14 days,
• medicines used to treat depression, such as tricyclic antidepressants (e.g., amitriptyline),
• medicines used to control blood pressure, known as beta-blockers and other medicines used to treat hypertension,
• sympathomimetic medicines (such as decongestants, appetite suppressants, and certain stimulants),
• medicines containing paracetamol or decongestants used to treat colds and flu.

You should consult your doctor before taking Theraflu MAX GRIP if you are taking any of the following medicines:

• warfarin or similar medicines (anticoagulants) used to thin the blood
• medicines used to treat nausea and vomiting, such as metoclopramide or domperidone
• cholestyramine (used to lower high cholesterol levels in the blood)
• sleeping pills, antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine)
• rifampicin and isoniazid (medicines used to treat tuberculosis)
• salicylamide (a medicine used to treat fever and pain)
• medicines used to treat heart conditions (e.g., digoxin)
• appetite suppressants or stimulants
• medicines used to treat acute migraine headaches (e.g., ergotamine, methysergide)

Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Theraflu MAX GRIP and alcohol

You should not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

Do not take this medicine during pregnancy or if you think you may be pregnant, and during breastfeeding, without consulting your doctor.
If you are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Theraflu MAX GRIP contains:

• Sucrose.If you have been told by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking this medicine. Each sachet contains 5210 mg of sucrose. This should be taken into account in patients with diabetes.
• Sodium. This medicine contains 118 mg of sodium (a major component of common salt/salt) in each sachet. This corresponds to 5.9% of the recommended maximum daily intake of sodium for an adult.
• Orange yellow (E 110) and carmoisine (E 122),which may cause allergic reactions. Each sachet contains 0.1 mg of orange yellow and 3.91 mg of carmoisine.
• Aspartame (E 951).This medicine contains 80 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. This may be harmful if you have phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly).

3. How to take Theraflu MAX GRIP

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

Recommended dose:

Adults and the elderly, with a body weight of 50 kg and above:

• One sachet of Theraflu MAX GRIP every 4 to 6 hours as needed, but no more than 4 sachets in 24 hours. You should always maintain at least a 4-hour interval between doses.
• Do not take more than 4 sachets in 24 hours (which corresponds to 4000 mg of paracetamol, 40 mg of phenylephrine hydrochloride, and 280 mg of ascorbic acid).
• Do not take for more than 3 days. You should inform your doctor if symptoms persist after 3 days or are accompanied by high fever, rash, or persistent headache.

Theraflu MAX GRIP is not intended for use in adults and the elderly with a body weight below 50 kg.
Do not exceed the recommended dose.
You should use the minimum number of sachets per day and for the shortest duration necessary to relieve symptoms.
Use in children and adolescents:Theraflu MAX GRIP is not intended for use in children and adolescents under 18 years of age.

Patients with liver disease

You should consult your doctor before taking this medicine. Do not take this medicine if you have severe liver impairment.

Patients with kidney disease

You should consult your doctor before taking this medicine.

Method of administration and instructions for use

The contents of the sachet should be dissolved in a glass of hot, but not boiling, water. You should drink it after it has cooled to an acceptable temperature.

Taking a higher dose of Theraflu MAX GRIP than recommended

If you accidentally take too many sachets, you should contact your doctor immediately, even if you feel well, due to the risk of delayed, severe liver damage.

Missing a dose of Theraflu MAX GRIP

If you miss a dose, you should take it as soon as you remember. Do not take a double dose to make up for a missed dose. You should always maintain at least a 4-hour interval between doses.

4. Possible side effects

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

You should stop taking Theraflu MAX GRIP and contact your doctor immediately if you experience:

• an allergic reaction such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face.
• skin rash or peeling, or mouth ulcers.
• previously experienced breathing problems after taking acetylsalicylic acid or nonsteroidal anti-inflammatory medicines and experienced similar reactions with this medicine.
• bruising or bleeding of unknown cause.
• abnormal heart rhythm or palpitations.
• vision loss, which may be caused by excessively high eye pressure. This is very rare but can occur in people with glaucoma.
• difficulty urinating. This is more likely in men with an enlarged prostate.

The frequency of these events is not known (the frequency cannot be estimated from the available data), but they are considered rare or very rare.

Other common side effects (may affect up to 1 in 10 people) that may occur are:

headache, dizziness, high blood pressure, sleep disturbances, nervousness, nausea, vomiting.You should inform your doctor or pharmacist if you experience any of these symptoms.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Theraflu MAX GRIP

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the sachet and carton after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Do not take this medicine if you notice that the sachet is damaged.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 MAX GRIP contains

Active substancesare: paracetamol 1000 mg, phenylephrine hydrochloride 10 mg, and ascorbic acid 70 mg in each sachet.
Other ingredientsare: sucrose, citric acid, sodium citrate, aspartame (E 951), fruit flavor, and colorant mixture "Euroblend Blackcurrant" (containing orange yellow (E 110), green S (E 142), and carmoisine (E 122)).

What Theraflu MAX GRIP looks like and contents of the pack

Each sachet of Theraflu MAX GRIP contains a powder that is pink to peach in color with a characteristic menthol and fruit flavor.
Theraflu MAX GRIP is available in packs containing 5 or 10 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

SmithKline Beecham, S.A.
Ctra. de Ajalvir, Km. 2,500
28806 Alcalá de Henares
Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
ТЕРАФЛУ МАКС ГРИП 1000 mg/10mg/70mg прах за перорален разтвор
Czech Republic
Theraflu Forte s vitaminem C lesní ovoce
Hungary
Neo Citran Max C-vitaminnal por belsőleges oldathoz
Romania
Theraflu Max Răceală și Gripă 1000 mg/10 mg/70 mg pulbere pentru soluție orală
Slovakia
Theraflu Forte s vitamínom C s príchuťou lesného ovocia

Date of last revision of the leaflet: