Theraflu max grip

Patient Information Leaflet

Theraflu MAX GRIP
1000 mg + 10 mg + 70 mg, effervescent powder for oral solution
Paracetamolum + Phenylephrini hydrochloridum + Acidum ascorbicum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet. 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, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Leaflet Contents

1. What Theraflu MAX GRIP is and what it is used for
2. What you need to know 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 pack and other information

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

Theraflu MAX GRIP is used to relieve symptoms of cold and flu when nasal mucosal 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 elderly individuals, with a body weight of 50 kg or more.
Theraflu MAX GRIP should only be used when all of the following symptoms are present: nasal mucosal congestion accompanied by fever and/or mild to moderate pain.
If there is no improvement after 3 days or if you feel worse, consult your doctor.
Theraflu MAX GRIP contains three active substances:

• paracetamol – provides analgesic and antipyretic effects.
• phenylephrine hydrochloride – constricts blood vessels in the nose, clears a stuffy nose and sinuses, and facilitates breathing by reducing swelling in the nasal passages.
• ascorbic acid (vitamin C) – an essential dietary component that supplements vitamin C intake. This is particularly beneficial in the early stages of cold and flu, when vitamin C reserves may be low and appetite poor.

2. Important information before using Theraflu MAX GRIP

When not to use Theraflu MAX GRIP:

• if the patient is allergic to paracetamol, hydrochloride phenylephrine, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking or has taken within the last 14 days monoamine oxidase inhibitors (MAOI inhibitors, medicines used to treat depression or Parkinson's disease),
• in patients diagnosed with angle-closure glaucoma (increased pressure in the eye),
• in patients diagnosed with hyperthyroidism,
• in patients diagnosed with diabetes (high blood glucose levels),
• in patients diagnosed with high blood pressure or heart disease,
• in patients diagnosed with pheochromocytoma (a rare adrenal gland tumour),
• 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 medicines reducing nasal congestion, suppressing appetite, or certain central nervous system stimulants),
• in patients diagnosed with severe liver impairment.

Warnings and precautions
Theraflu MAX GRIP contains paracetamol. Do not take this medicine together with other medicines
containing paracetamol, whether prescribed or available without a prescription, used for pain relief, fever reduction, or for treating cold and flu symptoms.
Overdosing on paracetamol may lead to severe liver damage.
Do not take together with other medicines used to treat cough and cold, nasal mucosal congestion, or nasal congestion.
Before starting Theraflu MAX GRIP, consult your doctor or
pharmacist if the patient has:

• liver or kidney problems,
• is suffering from a severe infection, is severely malnourished, has significant underweight, or regularly abuses alcohol, as this may increase the risk of developing metabolic acidosis, which may manifest as: deep, rapid, and laboured breathing, nausea, vomiting, and loss of appetite. Contact a doctor immediately if the patient experiences the above symptoms simultaneously.
• difficulty urinating due to an enlarged prostate gland,
• suffers from a blood vessel disorder such as Raynaud's phenomenon (which may cause numbness, tingling, and colour changes (white, blue, then red) in fingers and toes triggered by cold).

Theraflu MAX GRIP and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take Theraflu MAX GRIP with:

• monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression or Parkinson's disease), if the patient is currently taking or has taken them within the last 14 days,
• medicines used to treat depression, such as tricyclic antidepressants (e.g. amitryptyline),
• blood pressure-lowering medicines, such as beta-blockers and other antihypertensive medicines,
• sympathomimetic medicines (such as medicines reducing nasal congestion, suppressing appetite, and certain central nervous system stimulants),
• medicines containing paracetamol or medicines reducing nasal mucosal congestion used to treat cold and flu.

Consult a doctor before taking Theraflu MAX GRIP if the patient is 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 blood cholesterol levels),
• sedatives, 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 for heart conditions (e.g. digoxin),
• appetite-suppressing or appetite-stimulating medicines,
• medicines used to treat acute migraine headache (e.g. ergotamine, methysergide).

Paracetamol use may cause false results in certain laboratory tests
(e.g. blood glucose measurements).
Theraflu MAX GRIP and alcohol
Do not drink alcohol while taking this medicine.
Pregnancy, breastfeeding, and fertility
Do not use this medicine during pregnancy or if the patient suspects she may be pregnant, or during breastfeeding, unless advised by a doctor.
If the patient plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
This medicine may cause dizziness. If such symptoms occur, do not drive or operate machinery.
Theraflu MAX GRIP contains:

• Sucrose. If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult their 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 (the main component of table/food salt) per sachet. This corresponds to 5.9% of the recommended maximum daily sodium intake for an adult.
• Sunset Yellow FCF (E 110) and Carmoisine (E 122), which may cause allergic reactions. Each sachet contains 0.1 mg of Sunset Yellow FCF and 3.91 mg of Carmoisine.
• Aspartame (E 951). This medicine contains 80 mg of aspartame per sachet. Aspartame is a source of phenylalanine. This may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to use Theraflu MAX GRIP

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

Recommended dose:
Adults and elderly patients weighing 50 kg or more:

• One sachet of Theraflu MAX GRIP every 4 to 6 hours as needed, not exceeding 4 sachets per day. Always leave at least a 4-hour interval between doses.
• Do not exceed 4 sachets within 24 hours (corresponding to 4000 mg of paracetamol, 40 mg of phenylephrine hydrochloride, and 280 mg of ascorbic acid).
• Do not use for longer than 3 days. Inform your doctor if symptoms persist beyond 3 days or are accompanied by high fever, rash, or persistent headache.

Theraflu MAX GRIP is not intended for use in adults and elderly patients weighing less than 50 kg.
Do not exceed the recommended dose.
Use the lowest possible number of sachets daily and for the shortest possible 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
Consult a doctor before using this medicine. Do not take this medicine if the patient has severe liver function impairment.

Patients with kidney disease
Consult a doctor before using this medicine.

Method of administration and instructions for use
Dissolve the contents of one sachet in a glass of hot, but not boiling, water. Drink after cooling to a comfortable temperature.

Overdose of Theraflu MAX GRIP
If the patient has accidentally taken too many sachets, contact a doctor immediately, even if the patient feels well, due to the risk of delayed, severe liver damage.

Missed dose of Theraflu MAX GRIP
If a dose is missed, take it as soon as remembered. Do not take a double dose to make up for a missed dose. Always maintain at least a 4-hour interval between consecutive doses.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop using Theraflu MAX GRIP and immediately contact a doctor if:

• an allergic reaction occurs, such as skin rash or skin itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face.
• a skin rash, skin peeling, or oral mucosal ulceration occurs.
• you previously experienced breathing problems after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs, and similar reactions occur with this medicine.
• unexplained bruising or bleeding appears.
• rapid heartbeat or a sensation of unusual, fast, or irregular heartbeat occurs.
• vision loss occurs, which may be caused by abnormally high intraocular pressure. This is very rare, but there is a possibility of such an event in individuals with glaucoma.
• difficulty urinating occurs. This is more likely in men with enlarged prostate gland.

The frequency of these events is unknown (frequency cannot be estimated from available data), but they are considered rare or very rare.
Other common adverse reactions (may affect up to 1 in 10 people) include: headache, dizziness, high blood pressure, sleep disturbances, nervousness, nausea, vomiting. You should inform your doctor or pharmacist if any of these symptoms occur.

Reporting of adverse reactions
If any adverse symptoms occur, including those not listed in this leaflet, you should 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, tel.: +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 the medicine.

5. How to store Theraflu MAX 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 the cardboard
package after EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Do not use this medicine if the sachet is damaged.
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 packaging and other information

What Theraflu MAX GRIP contains
Active substances: paracetamol 1000 mg, phenylephrine hydrochloride 10 mg, and ascorbic acid 70 mg in each sachet.
Other ingredients: sucrose, tartaric acid, anhydrous sodium citrate, aspartame (E 951), forest fruit flavour, and colouring mixture "Euroblend Blackcurrant" (containing sunset yellow (E 110), brilliant 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 ranging in colour from light pink to peach, with a characteristic aroma of menthol and berry fruits.
Theraflu MAX GRIP is available in packs containing 5 or 10 sachets.
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
SmithKline Beecham, S.A.
Ctra. de Ajalvir, Km. 2,500
28806 Alcalá de Henares
Madrid
Spain

This medicinal product is authorised in the European Economic Area countries 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