Gripex duo

Package leaflet: information for the patient

Gripex Duo, (500 mg + 6.1 mg), coated tablets
Paracetamolum + Phenylephrini hydrochloridum
Please read the entire 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, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, contact your doctor.

Leaflet contents:

1. What is Gripex Duo and what is it used for
2. Important information before taking Gripex Duo
3. How to take Gripex Duo
4. Possible side effects
5. How to store Gripex Duo
6. Contents of the pack and other information

1. What is Gripex Duo and what is it used for
Gripex Duo is a medicine intended for short-term use in the treatment of symptoms of cold, influenza, and flu-like conditions, such as fever, headache, sore throat, muscle and joint pain, nasal congestion, and sinus congestion.
Gripex Duo is a combination medicine. It contains two active substances: paracetamol and phenylephrine.
Paracetamol has antipyretic and analgesic effects, while phenylephrine reduces swelling and congestion of the nasal and sinus mucosa.
Gripex Duo is intended for use in adults and adolescents over 12 years of age.

2. Important information before taking Gripex Duo
When not to use Gripex Duo:

• if you are allergic to the active substances, other sympathomimetic amines, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver or kidney failure,
• if you have cardiovascular disorders,
• if you have cardiac arrhythmias,
• if you have hypertension,
• if you have diabetes,
• if you have been diagnosed with pheochromocytoma,
• if you have closed-angle glaucoma,
• if you have hyperthyroidism,
• if you have benign prostatic hyperplasia,
• if you have congenital glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency,
• during treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuation of such treatment,
• during treatment with tricyclic antidepressants or zidovudine,
• do not use in children under 12 years of age,
• do not use during pregnancy or breastfeeding,
• in case of alcohol-related disease.

Warnings and precautions
The medicine contains paracetamol.
Paracetamol overdose may lead to life-threatening liver damage.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as analgesics, antipyretics, or medicines used to treat flu and cold symptoms.
Do not take with other medicines containing sympathomimetics (such as nasal decongestants, appetite suppressants, or psychostimulants with amphetamine-like effects) or medicines used for cold and flu.
Alcohol must not be consumed while taking this medicine. Use in patients with liver impairment, alcohol abuse, or fasting increases the risk of hepatotoxic liver damage.
Patients with liver disease have an increased risk of overdose.
Before starting treatment with Gripex Duo, discuss with your doctor or pharmacist if you:

• have liver or kidney impairment (liver enzyme activity and kidney function should be monitored),
• have arteriosclerosis,
• have Raynaud's syndrome,
• have stable coronary artery disease,
• have respiratory insufficiency,
• have bronchial asthma,
• are taking beta-adrenergic receptor antagonists or other antihypertensive medicines (debrisoquine, guanethidine, reserpine, methyldopa),
• are taking anticoagulants (dose adjustment may be required based on coagulation tests).

During treatment with Gripex Duo, immediately inform your doctor if you have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (abnormality in blood and body fluids) when taking paracetamol regularly in therapeutic doses over a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Liver damage is possible in individuals who have ingested 10 g or more of paracetamol at once.
Ingestion of 5 g of paracetamol may lead to liver damage in patients with the following risk factors:

• Patients taking long-term carbamazepine, phenobarbital, phenytoin, primidone (medicines used, among others, in epilepsy), rifampicin (medicines used, among others, in tuberculosis), St. John's wort (used, among others, in depression), or other medicines inducing liver enzymes.
• Patients who regularly abuse alcohol.
• Patients who may have glutathione deficiency, e.g., due to eating disorders, cystic fibrosis, HIV infection, fasting, or cachexia.

Children and adolescents
Do not use in children under 12 years of age.

Patients with kidney and/or liver impairment
Exercise particular caution in patients with kidney or liver disease.
This medicine is contraindicated in patients with severe liver or kidney failure.

Elderly patients
Exercise caution when using Gripex Duo.

Gripex Duo and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The interaction of Gripex Duo with other medicines results from the effects of its active ingredients:

Paracetamol:

• Do not take this medicine simultaneously with other medicines containing paracetamol.

• Medicines that accelerate gastric emptying (e.g., metoclopramide) increase the absorption rate of paracetamol.

• Medicines that delay gastric emptying (e.g., propantheline) may delay the absorption of paracetamol.

• Monoamine oxidase inhibitors (MAOIs) (used, among others, in depression and within 2 weeks after discontinuation of treatment) may cause excitation and fever.

• Concurrent use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the myelotoxic effect of zidovudine.

• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).

• Concurrent use of paracetamol with medicines increasing hepatic metabolism, such as certain sedatives or antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine), or rifampicin (used, among others, in tuberculosis) may lead to liver damage, even when recommended doses of paracetamol are used. Therefore, always consult your doctor before using Gripex Duo.

• Consuming alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing necrosis of liver cells, which may subsequently result in liver failure.

• Cholestyramine reduces the absorption of paracetamol and should not be taken within the first hour after paracetamol administration.

• Probenecid prolongs the half-life of paracetamol.

• Concomitant use of paracetamol and nonsteroidal anti-inflammatory drugs increases the risk of kidney function disorders.

• Caffeine enhances the analgesic effect of paracetamol.

• Salicylamide prolongs the elimination time of paracetamol.

• Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Phenylephrine:

• Monoamine oxidase inhibitors (MAOIs) may enhance the effect of phenylephrine. Avoid concomitant use of MAOIs with phenylephrine or administer phenylephrine at least 14 days after discontinuation of MAOIs.
• Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants.
• Phenylephrine may reduce the antihypertensive effect of guanethidine, mecamylamine, methyldopa, and reserpine.
• Concurrent use of phenylephrine with indomethacin, beta-adrenergic receptor antagonists, or methyldopa may cause hypertensive crisis.
• Concomitant use of digoxin and cardiac glycosides increases the risk of cardiac arrhythmias or myocardial infarction.
• Risk of increased blood pressure exists in patients taking ergot alkaloids and phenylephrine simultaneously.

Gripex Duo with food, drink, and alcohol
Food slows down the absorption of paracetamol.
Do not consume alcohol during treatment with this medicine.

Pregnancy, breastfeeding, and fertility
Do not use during pregnancy or by breastfeeding women.

Driving and operating machinery
Exercise caution when driving vehicles or operating machinery while taking Gripex Duo.

Warnings regarding excipients
This medicine contains 184 mg sorbitol (E420), 0.63 mg tartrazine (E102), and 13.3 mg glucose per coated tablet.
Sorbitol is a source of fructose. If fructose intolerance has been previously diagnosed in you (or your child) or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking the medicine or giving it to your child.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."
This medicine may cause allergic reactions.
Due to the presence of sulfites, the medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Gripex Duo
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Gripex Duo should be taken orally.
Dosage recommendations are as follows:

Adults and adolescents with body weight above 65 kg
The usual dose is 500 mg to 1000 mg (1 to 2 tablets) of paracetamol every 4 hours if necessary. The maximum daily dose is 4 g of paracetamol (8 tablets of Gripex Duo).
Do not take more than 8 tablets per day.

Adults and adolescents with body weight between 43 kg and 65 kg
The usual dose of paracetamol is 500 mg (1 tablet) every 4 hours if necessary. The maximum daily dose is 3 g of paracetamol (6 tablets of Gripex Duo).

Adults and adolescents with body weight between 33 kg and 43 kg
The usual dose of paracetamol is 500 mg (1 tablet of Gripex Duo) every 6 hours if necessary. The maximum daily dose is 2 g of paracetamol (4 tablets of Gripex Duo).

Children and adolescents
Do not use in children under 12 years of age.

Do not use this medicine for longer than 3 days without consulting a doctor. Use the lowest effective dose for the shortest possible time. Do not exceed the recommended dose.
The tablet may be swallowed whole with a glass of water or dissolved in a glass of hot water (boiled water left to stand for 5 minutes) or room temperature water. The solution should be consumed within one hour of preparation. The tablet may also be divided into two parts to facilitate swallowing. The score line on the tablet is only intended to assist in breaking the tablet for easier swallowing and does not serve to divide the tablet into two equal smaller doses.

Overdose of Gripex Duo
Accidental or intentional overdose may cause symptoms within several to several dozen hours, such as nausea, vomiting, excessive sweating, drowsiness, general weakness, restlessness, and tremor. Nystagmus, increased blood pressure, seizures, difficulty urinating, and shortness of breath may also occur. These symptoms may subside the next day, although life-threatening liver damage may have started to develop, which later manifests as upper abdominal discomfort, recurrence of nausea, and jaundice. Therefore, despite temporary symptom relief, seek immediate medical attention in case of overdose. Treatment should be conducted in a hospital and involves accelerating the elimination of the medicine's components and maintaining vital functions. In case of paracetamol overdose, an antidote such as N-acetylcysteine and/or methionine may be required.

Missed dose of Gripex Duo
If you miss a dose and symptoms persist, take the next dose of Gripex Duo. Do not take a double dose to make up for a missed dose.

Stopping treatment with Gripex Duo
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gripex Duo may cause side effects, although not everyone experiences them.
If any of the following symptoms occur, stop taking the medicine and contact your doctor immediately.
These are life-threatening conditions occurring with unknown frequency:

• anaphylactic shock (pale skin, low blood pressure, sweating, reduced urine output, laryngeal edema, rapid breathing, weakness);
• severe skin reactions, which may include ulceration of the mouth, throat, nose, or genital organs, and conjunctivitis (redness and swelling of the eyes). These severe skin rashes are often preceded by fever, headache, and body aches (flu-like symptoms). The rash may spread, leading to blistering and skin peeling (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, drug rash).

Possible side effects due to the presence of paracetamol.
Side effects occurring rarely (may affect less than 1 in 1,000 patients taking the medicine):

• anemia, bone marrow suppression, thrombocytopenia, agranulocytosis (lack of granulocytes in the blood), leukopenia (reduced white blood cell count), neutropenia (reduced number of neutrophils);
• edema;
• acute pancreatitis (severe pain in the middle and upper abdomen, vomiting, abdominal distension, often with gas and stool retention, high fever), chronic pancreatitis, hemorrhage, abdominal pain, diarrhea, nausea, vomiting;
• itching, sweating, purpura, urticaria; angioedema;
• kidney damage manifested by fever, pain in the lumbar region, skin rash, red discoloration of urine (hematuria), renal colic, urinary retention.

Side effects occurring very rarely (may affect less than 1 in 10,000 patients taking the medicine):

• bronchospasm causing breathing difficulties in patients hypersensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs;
• liver failure, liver necrosis, jaundice, manifested by yellowing of the eyes and skin, abdominal pain, loss of appetite.

Side effects for which frequency cannot be determined from available data:

• erythema multiforme;
• dizziness;
• serious illness that may cause blood acidification (so-called metabolic acidosis) in severely ill patients taking paracetamol (see section 2). The medicine rarely has toxic effects on the kidneys; otherwise, no association with therapeutic doses has been reported, except in cases of chronic use.

Possible side effects due to the presence of phenylephrine.
Side effects occurring frequently (may affect less than 1 in 10 patients taking the medicine):

• nausea, vomiting, digestive disturbances, anorexia.

Side effects occurring rarely (may affect less than 1 in 1,000 patients taking the medicine):

• bronchospasm;
• allergic reactions (itching, urticaria);
• increased blood pressure, tachycardia (rapid heartbeat), cardiac arrhythmias, palpitations, pallor.

Side effects occurring very rarely (may affect less than 1 in 10,000 patients taking the medicine):

• anxiety, restlessness, tremor, nervousness, insomnia, irritability, dizziness, and headache, hallucinations.

Side effects for which frequency cannot be determined from available data:

• kidney and urinary tract disorders in the form of urinary retention.

Reporting of side effects
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 (22) 492-13-01, fax: +48 (22) 492-13-09
Website: https://smz.ezdrowie.gov.pl/
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps increase the knowledge on the safety of the medicine.

5. How to store Gripex Duo
Store below 25°C. Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the immediate packaging (month/year).
The blister packaging is labeled as follows: EXP - expiry date, Lot - batch number.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the packaging and other information

What Gripex Duo contains

• The active substances are: paracetamol and phenylephrine hydrochloride.
  Other ingredients include: povidone, citric acid; lemon flavouring (lemon juice concentrate (containing sulphites), lemon oil, lemongrass oil, natural flavouring substance – citral, anhydrous glucose-corn syrup, sodium octenyl succinate starch (E1450)), silicon dioxide (E551)); crospovidone (type A); sucralose; sorbitol; microcrystalline cellulose; colloidal anhydrous silica; talc; magnesium stearate; Opadry II: polyvinyl alcohol, E1203; talc, E553b; titanium dioxide, E171; macrogol 3350; methacrylic acid-ethyl acrylate copolymer (1:1); quinoline yellow, E104; tartrazine, aluminium lake, E102; iron oxide yellow, E172; sodium hydrogen carbonate, E500; indigo carmine, aluminium lake, E132.

What Gripex Duo looks like and contents of the pack
Yellow, oval, biconvex film-coated tablets with the inscription "Gripex" on one side and a breakline on the other side.
The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not serve to divide the tablet into two equal smaller doses.
Available pack sizes:
Blister packs OPA/Aluminium/PVC/Aluminium or Aclar/PVC/Aluminium in cardboard packaging.
10 tablets (1 blister with 10 tablets)
16 tablets (2 blisters with 8 tablets each)
20 tablets (2 blisters with 10 tablets each)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
US Pharmacia Sp. z o.o.
Ziębicka 40 Street
50-507 Wrocław, Poland

For further information regarding this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02-822 Warsaw, Poland
Tel.: +48 (22) 543 60 00