Theraflu Extragrip

Leaflet attached to the packaging: patient information

Theraflu ExtraGRIP, 650 mg + 10 mg + 20 mg, powder for oral solution

Paracetamol + Phenylephrine hydrochloride + Pheniramine maleate

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in the patient leaflet or as advised by
a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days the fever persists or after 5 days the symptoms of the disease persist or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

• 1. What is Theraflu ExtraGRIP and what is it used for
• 2. Important information before using Theraflu ExtraGRIP
• 3. How to use Theraflu ExtraGRIP
• 4. Possible side effects
• 5. How to store Theraflu ExtraGRIP
• 6. Package contents and other information

1. What is Theraflu ExtraGRIP and what is it used for

The medicine contains as active substances: paracetamol with analgesic and antipyretic effects,
phenylephrine hydrochloride which reduces nasal congestion and swelling, and pheniramine maleate,
an antihistamine that alleviates allergic symptoms such as sneezing, itching or nasal congestion and sinusitis.
Indications for use:
Treatment of flu and cold symptoms, such as: fever, chills, muscle aches, bone and joint pain, headache,
nasal congestion and runny nose, sneezing.

2. Important information before using Theraflu ExtraGRIP

When not to use Theraflu ExtraGRIP

Theraflu ExtraGRIP should not be used in case of:

• hypersensitivity (allergy) to paracetamol, phenylephrine hydrochloride, and pheniramine maleate or other components of this medicine listed in section 6,
• if the patient is taking or has taken within the last 14 days monoamine oxidase inhibitors (IMAO inhibitors, drugs used to treat depression or Parkinson's disease); if the patient is unsure whether the prescribed drugs contain IMAO inhibitors, they should consult a doctor or pharmacist before taking the medicine described in the leaflet,
• if the patient has severe heart disease or very high blood pressure (hypertension),
• if the patient has hyperthyroidism,
• if the patient has narrow-angle glaucoma (eye disease with progressive damage to the optic nerve and at least partially related to increased pressure in the eyeball),
• if the patient has a pheochromocytoma (a tumor located near the kidneys that causes increased blood pressure),
• if the patient is taking tricyclic antidepressants (e.g., amitriptyline),
• if the patient is taking beta-adrenergic blockers (drugs used to treat high blood pressure and heart disease),
• if the patient is taking sympathomimetic drugs, such as nasal decongestants, appetite suppressants, or psychostimulants with an effect similar to amphetamine, etc.,
• if the patient has a hypersensitivity to peanuts or soy,
• in children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol. THIS MEDICINE SHOULD NOT BE USED SIMULTANEOUSLY WITH OTHER MEDICINES CONTAINING PARACETAMOL (PAIN RELIEVERS, ANTIPYRETICS, MEDICINES USED TO TREAT FLU AND COLD SYMPTOMS AND SLEEP AIDS). In case of taking a higher dose than recommended, you should immediately contact a doctor, even if no symptoms have occurred, as this may lead to severe liver damage.
Before using Theraflu ExtraGRIP, you should consult a doctor or pharmacist:

• if the patient has liver disease,
• if the patient has kidney disease,
• if the patient is chronically malnourished, underweight (very low body mass),
• if the patient regularly consumes (abuses) alcohol, if the patient has a reduced glutathione level - a protein that plays an important role, among others, in the functioning of the immune system,
• if the patient has a blood system disease, if the patient has diabetes (high blood sugar level),
• if the patient has an enlarged prostate gland (prostate), as this may be associated with difficulty urinating and urinary retention, if the patient has a vascular disease such as Raynaud's syndrome, which is accompanied by numbness, tingling, and color change (white, blue, and then red) of the fingers and toes exposed to cold
• if the patient has epilepsy,
• if the patient suffers from rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (see Warnings regarding excipients)
• if the patient is pregnant, plans to become pregnant, or is breastfeeding

During the use of Theraflu ExtraGRIP, the doctor should be informed immediately if:

• the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). In these situations, patients taking paracetamol for a longer period or taking paracetamol with flucloxacillin have been reported to have a severe disease called metabolic acidosis (a blood and body fluid disorder), which requires emergency treatment. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

You should contact a doctor immediately if you experience a combination of these symptoms.
You should consult a doctor if:

• the patient has breathing difficulties, such as asthma, chronic obstructive pulmonary disease, or chronic bronchitis,
• if the fever increases or persists for more than 3 days,
• if the pain or nasal congestion worsens or lasts more than 5 days or is accompanied by high fever, skin rash, or persistent headache. These may be symptoms of a serious disease.

Paracetamol should be used with caution in patients taking antihypertensive drugs other than beta-blockers, digoxin, and cardiac glycosides, ergot alkaloids (e.g., ergotamine and methysergide), and other liver-acting drugs such as barbiturates, antiepileptic drugs (e.g., phenytoin, phenobarbital, carbamazepine), rifampicin, and isoniazid (see below).
Elderly patients should use the medicine with caution, as they are more likely to experience side effects. The medicine should be avoided in elderly patients with symptoms of consciousness disorders.

Children

Theraflu ExtraGRIP should not be used in children under 12 years of age.

Theraflu ExtraGRIP and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken,
as well as any medicines that the patient plans to take, in particular those listed below:

• monoamine oxidase inhibitors (IMAO inhibitors) used to treat depression and Parkinson's disease: Theraflu ExtraGRIP should not be used if the patient is taking IMAO inhibitors or has taken them within the last 14 days,
• drugs used to treat depression, e.g., tricyclic antidepressants,
• drugs used to lower high blood pressure, e.g., beta-blockers, debryzoxine, guanethidine, reserpine, and methyldopa,
• drugs used to lower high blood pressure other than beta-blockers,
• drugs used to treat heart failure and arrhythmias (digoxin and other cardiac glycosides),
• drugs that prevent blood clots, e.g., warfarin or other coumarin derivatives,
• drugs containing paracetamol or sympathomimetic drugs, e.g., nasal decongestants used to treat colds and flu, etc.,
• drugs used to treat nausea and vomiting, such as metoclopramide or domperidone,
• drugs used to treat tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol),
• barbiturates (sleeping pills),
• drugs used to treat seizure disorders, such as phenytoin, phenobarbital, carbamazepine, and lamotrigine,
• cholestyramine used to lower cholesterol levels,
• zidovudine (AZT) used to treat HIV infection,
• probenecid used to treat gout,
• ergotamine and methysergide used to treat migraines,
• drugs used to treat Parkinson's disease,
• opioid drugs (narcotics),
• antiallergic drugs,
• drugs containing alcohol,
• flucloxacillin (an antibiotic) due to a serious blood and body fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

Effect on laboratory test results:

Paracetamol may affect the results of uric acid tests using phosphotungstates.

Using Theraflu ExtraGRIP with alcohol

Alcohol should not be consumed while taking Theraflu ExtraGRIP.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child,
she should consult a doctor or pharmacist before using this medicine.
The use of the medicine is not recommended during pregnancy.
The use of the medicine is not recommended during breastfeeding.

Driving and using machines

Theraflu ExtraGRIP may cause drowsiness, dizziness, blurred vision, coordination disorders, and concentration disorders in some patients, which may significantly affect the ability to drive vehicles and operate machines. Alcohol and other sedatives may enhance this effect. Therefore, the patient should exercise caution when driving vehicles, operating machines, or performing other tasks that require psychophysical fitness.

Warnings regarding excipients:

Theraflu ExtraGRIP contains:

• 12.6 g of sucrose in 1 sachet. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine,
• orange yellow E110. The medicine may cause allergic reactions,
• 42.6 mg of sodium (the main component of table salt) in each sachet. This corresponds to 2.1% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients controlling their sodium intake,
• glucose (as a component of maltodextrin). If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine,
• soybean oil. Do not use in case of known hypersensitivity to peanuts or soy,
• sulfites. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Theraflu ExtraGRIP

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

Recommended dose

Adults (including elderly patients) and adolescents over 12 years of age:
One sachet can be taken at a time.
The contents of one sachet should be dissolved in 1 glass of hot, but not boiling, water. Drink after
cooling to a suitable temperature.
If further symptomatic treatment is necessary, the dose can be repeated, but not more often than
every 4-6 hours. Do not take more than 3-4 sachets in 24 hours.
Do not exceed the recommended dose. Use the lowest effective dose for the shortest possible time.
Contact a doctor if the symptoms persist or worsen after 5 days or if the fever persists for more than 3 days.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Use in children

Theraflu ExtraGRIP should not be used in children under 12 years of age.

Patients with liver disease:

In the case of adults weighing less than 50 kg, patients with low or moderate liver failure, Gilbert's syndrome (familial hyperbilirubinemia), dehydration, chronic malnutrition, patients with alcoholic liver disease, the recommended daily dose of paracetamol should not exceed 60 mg/kg/day (up to 2 g/day, i.e., the contents of 3 sachets per day).

Patients with renal impairment:

In the case of patients with renal impairment, the contents of one sachet should be taken at a time.
The intervals between doses should be:

Using a higher dose of Theraflu ExtraGRIP than recommended:

In case of taking a higher dose than recommended, you should immediately contact a doctor, even if no symptoms have occurred, as this may lead to life-threatening liver damage.
Medical advice should be sought immediately, even if the patient's condition is good, due to delayed severe liver damage.
Overdose may lead to disorders of consciousness or coma. In children, seizures may occur.
Additional symptoms may include irritability, restlessness, hypertension, and probable reflex bradycardia. In severe cases, confusion, hallucinations, seizures, and arrhythmias may occur.

Missing a dose of Theraflu ExtraGRIP:

Theraflu ExtraGRIP is used as needed when symptoms occur.
However, if a doctor recommends regular use of the medicine, a double dose should not be taken to make up for a missed dose.
The medicine should be taken according to the established dosing schedule.

4. Possible side effects

Like all medicines, Theraflu ExtraGRIP can cause side effects, although not everybody gets them.

STOP taking the medicine and consult a doctor immediately if you experience any of the following symptoms:

• allergic reactions (rare),
• angioedema, including wheezing, shortness of breath, swelling of the face, lips, tongue, or throat (rare),

• anaphylactic reaction (severe allergic reaction, rare),
• rash, urticaria (itchy, lumpy rash), itching, redness of the skin (rare),
• severe skin reactions, including skin exfoliation, blisters, ulcers, and mucosal lesions (very rare),
• bleeding or bruising (blood coagulation disorders due to a low platelet count) (very rare),
• breathing difficulties, if similar problems have occurred in the past when using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (very rare)
• dark urine color along with pale skin, dizziness, and fatigue,
• hallucinations (seeing or hearing things that are not really there)
• extremely rapid heartbeat or feeling of an extremely rapid or irregular heartbeat
• vision loss, which may be caused by abnormally high blood pressure in the eye. This reaction is very rare, more common in people with glaucoma
• difficulty urinating, more common in men with an enlarged prostate gland. These reactions are rare or very rare.

Other side effects of the medicine:

Related to paracetamol

Rare(occurring in 1 to 10 out of 10,000 patients)

• liver function disorders, discomfort in the abdominal cavity

Very rare(occurring in less than 1 in 10,000 patients)

• thrombocytopenia (decreased platelet count)

Related to pheniramine

Common(occurring in 1 to 10 out of 100 patients)

• drowsiness

Rare(occurring in 1 to 10 out of 10,000 patients)

• hypersensitivity, urticaria, as well as acute allergic reactions (angioedema, anaphylactic shock),
• restlessness, nervousness, insomnia,
• dizziness,
• dry mouth,
• palpitations,
• eczema, rash, redness, itching,
• constipation.

Very rare(occurring in less than 1 in 10,000 patients)

• leukopenia (decreased white blood cell count),
• thrombocytopenia (decreased platelet count).

Frequency not known(cannot be estimated from available data)

• hallucinations, confusion (disorders of consciousness),
• anticholinergic symptoms, such as dilated pupils, accommodation disorders, dry mucous membranes, urinary retention,
• coordination disorders, tremors, memory loss or concentration disorders, balance disorders, sedation,
• hemolytic anemia (reduced red blood cell count due to their abnormal breakdown),
• orthostatic hypotension (excessive decrease in blood pressure when standing up),
• a serious condition that can cause acidosis of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Related to phenylephrine

Common(occurring in 1 to 10 out of 100 patients)

• nervousness,
• dizziness, headaches,
• increased blood pressure,
• insomnia,
• nausea,
• vomiting.

Rare(occurring in 1 to 10 out of 10,000 patients)

• hypersensitivity, allergic skin inflammation, urticaria,
• rash,
• acute glaucoma (a disease that damages the optic nerve), dilated pupils,
• rapid heart rate, palpitations,
• urinary retention (most common in people with an enlarged prostate gland), dysuria (difficulty urinating).

Frequency not known(cannot be estimated from available data)

• hemolytic anemia (reduced red blood cell count due to their abnormal breakdown),
• hallucinations, confusion (disorders of consciousness).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine.

5. How to store Theraflu ExtraGRIP

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use Theraflu ExtraGRIP after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Theraflu ExtraGRIP contains

One sachet contains 14.85 g of powder for oral solution with a natural lemon flavor. The powder is soluble in hot water.

• The active substances of the medicine in one sachet are: paracetamol 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg.
• The medicine also contains: sucrose, acesulfame potassium (E 950), quinoline yellow (E 104), orange yellow (E 110), maltodextrin M100 (contains glucose), colloidal silica anhydrous, lemon flavor PHS 163671 (maltodextrin - contains glucose, butylhydroxyanisole (E320)), citric acid, sodium citrate, calcium phosphate.

What Theraflu ExtraGRIP looks like and what the package contains

The package contains 1, 3, 6, 10, or 14 sachets in a cardboard box. Each package has a child-resistant closure.

Marketing authorization holder:

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

Manufacturer:

Haleon Germany GmbH
Barthstraße 4
80339 München
Germany
Haleon Alcala, S.A.
Ctra. De Ajalvir, Km. 2,500,
Alcalá de Henares, Madrid
28806, Spain

Date of leaflet approval: