Theraflu Max Grip

Leaflet attached to the packaging: information for the user

Theraflu MAX GRIP

(1000 mg + 70 mg + 10 mg), powder for oral solution preparation
Paracetamol + Ascorbic Acid + Phenylephrine Hydrochloride

Read the leaflet carefully 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, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the 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 contains three active substances: paracetamol, phenylephrine, and ascorbic acid (vitamin C):

• Paracetamol- has analgesic and antipyretic effects
• Vitamin C- a vitamin whose deficiency may occur in the first days of a cold or flu
• Phenylephrine- constricts blood vessels, clears nasal passages and sinuses, making it easier to breathe.

Theraflu MAX GRIP is indicated for short-term treatment of symptoms occurring during a cold or flu: fever, headache, sore throat, nasal congestion, and sinus pain.
If there is no improvement after 3 days or the patient feels worse, or if the symptoms are accompanied by high fever, rash, or persistent headache, they should consult a doctor.
Theraflu MAX GRIP is intended for use only in adults (including the elderly) with a body weight of 50 kg or more.

2. Important information before taking Theraflu MAX GRIP

When not to take Theraflu MAX GRIP:

• if the patient is allergicto paracetamol, phenylephrine, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6).
• in patients taking monoamine oxidase inhibitors (MAOIs)or within 2 weeks of stopping treatment with such medicines,
• in patients who have been diagnosed with angle-closure glaucoma, liver failure, severe kidney failure, hyperthyroidism, diabetes, cardiovascular diseases, including heart disease, high blood pressure, pheochromocytomaof the adrenal gland,
• in patients taking tricyclic antidepressants,
• in patients taking beta-adrenergic receptor blockers.

Do not give to children and adolescents under 18 years of age.

Warnings and precautions

The medicine contains paracetamol.

Overdose of paracetamol can lead to severe liver damage.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, used to treat cold and flu symptoms.
Do not take with other medicines containingsympathomimetics (such as nasal decongestants, appetite suppressants, and psychostimulants with an effect similar to amphetamine) or medicines used in colds and flu or sleep aids.
Read the leaflet before taking the medicine and follow the recommendations contained therein.
In case of taking a higher dose than recommended, contact a doctor immediately, even if the patient feels well.
Before taking the medicine, the patient should consult a doctor in case of:

• liver or kidney disease. General liver disease increases the risk of liver damage from paracetamol. In patients with liver disease, there is an increased risk of overdose.
• patients who are underweight or malnourished, suffering from anorexia,
• patients who regularly abuse alcohol.
• severe infection, which may increase the risk of metabolic acidosis, manifested by, among other things:
• deep, rapid, and difficult breathing,
• nausea, vomiting, and (or) loss of appetite,
• general poor condition. Contact a doctor immediately if the patient experiences the above symptoms simultaneously.
• high blood pressure, heart disease, vascular diseases such as Raynaud's syndrome (characterized by episodic pain in the fingers under the influence of cold or emotions),
• diabetes,
• hyperthyroidism,
• glaucoma (a disease characterized by progressive eye damage and consequent deterioration or loss of vision),
• pheochromocytoma of the adrenal gland,
• having difficulty urinating due to prostate enlargement,
• pregnancy, suspected pregnancy, or breastfeeding.
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase).

Consult a doctor if symptoms worsen, persist for more than 3 days, or are accompanied by high fever, rash, or persistent headache. These may be signs of a more serious condition.

Children and adolescents:

The medicinal product is not intended for children and adolescents under 18 years of age.

Theraflu MAX GRIP and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Consult a doctor when taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulant medicines (e.g., warfarin) in case of a need for long-term use of a pain medicine,
• sleeping pills, antiepileptic drugs, rifampicin (an antitubercular drug),
• MAO inhibitors(used, among other things, in depression) and other antidepressant medicines (from the group of tricyclic antidepressants, such as amitriptyline),
• nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid),
• ergot alkaloids (used, among other things, in migraine),
• certain medicines used in heart diseases or high blood pressure (i.e., digoxin, beta-adrenolytics, methyldopa),
• using appetite suppressants, nasal decongestants, and psychostimulants derived from amphetamine (e.g., used in attention deficit hyperactivity disorder), medicines used in migraine treatment (ergotamine, methysergide).

Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
Phenylephrine may enhance the blood pressure-increasing effect of medicines that accelerate childbirth.
Caffeine increases the analgesic effect of paracetamol.
Ascorbic acid increases iron absorption, increases aluminum absorption from preparations containing it.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

The medicine may cause dizziness. If you experience such symptoms, do not drive vehicles or operate machines.
Theraflu MAX GRIP contains sodium, sucrose, orange yellow, carmoisine, aspartame, and glucose:

• 1 sachet contains 5 g of sucrose. This should be taken into account in patients with diabetes. If intolerance to some sugars has been previously diagnosed in the patient, the patient should consult a doctor before taking the medicine.
• Due to the sucrose content, if intolerance to some sugars has been previously diagnosed in the patient, the patient should consult a doctor before taking the medicine.
• The medicine contains dyes: orange yellow(E110) and carmoisine(E122). These substances may cause allergic reactions.
• The medicine contains 80 mg of aspartame (E 951) in each sachet. Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disease in which phenylalanine accumulates in the body due to its improper excretion.

1 sachet contains 118 mg of sodium. (the main component of table salt in each sachet, corresponding to 6% of the maximum recommended daily intake of sodium in the diet for adults). This should be taken into account in patients controlling their sodium intake.

• The medicine contains glucose (a component of maltodextrin). If intolerance to some sugars has been previously diagnosed in the patient, the patient should consult a doctor before taking the medicine.

Store in a place not visible and inaccessible to children.

3. How to take Theraflu MAX GRIP

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

Administration in adults (including the elderly) with a body weight over 50 kg

One sachet of Theraflu MAX GRIP every 4 to 6 hours as needed.
Do not exceed 4 sachets per day.Do not exceed the recommended dose or frequency of administration.
Always use the lowest effective dose of the medicine for the shortest possible time.

Without a doctor's recommendation, the medicine should not be taken for more than 3 days.

Method of administration

For oral use only.
Before administration, the powder should be dissolved in hot, but not boiling, water. Pour the contents of one sachet into a glass, add half a glass of hot, but not boiling, water, mix well, and drink.
Do not give the medicine to children and adolescents under 18 years of age, adults, and the elderly with a body weight below 50 kg.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Taking a higher dose of Theraflu MAX GRIP than recommended

In case of taking more than 4 sachets of the medicine within 24 hours, immediately contact

a doctor, even if no adverse reactions occur, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death. Paracetamol overdose can cause, within a few or several hours, nausea, vomiting, excessive sweating, drowsiness, and general weakness. In each case of paracetamol overdose, vomiting can be provoked if it has not been more than an hour since ingestion, and contact a doctor immediately. Administer 60-100 g of activated charcoal orally, preferably mixed with water. The amount of medicine that can cause severe symptoms of phenylephrine or ascorbic acid overdose would cause severe liver damage due to paracetamol. Phenylephrine overdose may cause nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, irritability, restlessness, hypertension, and decreased heart rate. In severe cases, confusion, hallucinations, and arrhythmia may occur. High doses of ascorbic acid (above 3 g) may cause transient diarrhea and gastrointestinal symptoms, such as nausea and discomfort in the abdominal cavity.
In case of taking a higher dose than recommended, immediately consult a doctor, even if the patient feels well, due to the risk of delayed, severe liver damage.

Missing a dose of Theraflu MAX GRIP

Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

Stop taking the medicine and consult a doctor immediately if you experience:

• an allergic reaction (hypersensitivity) such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin rash or severe skin reaction characterized by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or large, bursting blisters under the skin, extensive erosions on the skin, and fever,
• breathing problems, if similar problems have occurred in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• bruises or bleeding of unknown cause,
• vision loss, which may be caused by excessively high intraocular pressure. This is very rare but possible in patients with glaucoma,
• abnormal heart rhythm or feeling of irregular heartbeat,
• difficulty urinating. This is more likely in men with prostate enlargement,
• liver function disorders (which may be indicated by yellowing of the skin and eyes, liver tenderness). The above reactions occur rarely (more often than 1 in 10,000 but less often than 1 in 1,000 patients) or very rarely (less often than 1 in 10,000 patients).

Theraflu MAX GRIP may also cause the following side effects:
very rarely (affecting less than 1 in 10,000 patients)

• headache,
• dizziness,
• insomnia,
• nervousness,
• increased blood pressure,
• nausea and vomiting.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell 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 gather more information on the safety of the medicine.

5. How to store Theraflu MAX GRIP

Store the medicine in a place not visible and inaccessible to children.

Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
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. Contents of the packaging and other information

What Theraflu MAX GRIP contains

The active substances of the medicine are: paracetamol, ascorbic acid (vitamin C), and phenylephrine hydrochloride. Each sachet contains 1000 mg of paracetamol, 70 mg of ascorbic acid, and 10 mg of phenylephrine hydrochloride.
The other ingredients are: sucrose, citric acid, sodium citrate, aspartame E951, menthol flavor, and fruit flavor Berry Fruits Flavorburst (contains 4-(parahydroxyphenyl)-2-butanone, acetic acid, vanillin, propionic acid, 1-menthol, d-limonene, menthone, 4-carvomenthol, aniseed oil, blackcurrant flower flavor, bucco oil, Cognac white flavor, sucrose, maltodextrin, modified starch E1450, sunflower oil), Euroblend Blackcurrant dye (contains carmoisine E122, green S E142, orange yellow E110, sodium chloride, sodium sulfate, volatile substances)

What Theraflu MAX GRIP looks like and what the packaging contains

The medicine is a pale pink powder with a characteristic fruity-menthol aroma.
The packaging contains 5, 8, or 10 sachets. Not all pack sizes may be available for sale.

Marketing authorization holder:

GlaxoSmithKline Consumer Healthcare Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. +48 22 576 96 00

Manufacturer:

SmithKline Beecham S.A.
Carretera de Ajalvir, km 2.500
28806 Alcala de Henares
Madrid
Spain

Date of last update of the leaflet:

Detailed information about this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.