Gripex Duo

Leaflet attached to the packaging: patient information

Gripex Duo, (500 mg + 6.1 mg), coated tablets

Paracetamol+ 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 or pharmacist.

• 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 side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 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 packaging and other information

1. What is Gripex Duo and what is it used for

Gripex Duo is a medicine intended for temporary use to treat symptoms of colds, flu, and flu-like conditions, such as: fever, headache, sore throat, muscle and joint pain, runny nose, and nasal congestion. Gripex Duo is a combination medicine. It contains two active substances: paracetamol and phenylephrine. Paracetamol has analgesic and antipyretic effects, while phenylephrine reduces swelling and congestion of the nasal mucosa and sinuses. Gripex Duo is intended for the treatment of adults and adolescents over 12 years of age.

2. Important information before taking Gripex Duo

When not to take Gripex Duo:

• if the patient is allergic to the active substances or other sympathomimetic amines or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has cardiovascular disorders,
• if the patient has heart rhythm disorders,
• if the patient has hypertension,
• if the patient has diabetes,
• if the patient has been diagnosed with a pheochromocytoma of the adrenal gland,
• if the patient has been diagnosed with angle-closure glaucoma,
• if the patient has hyperthyroidism,
• if the patient has been diagnosed with prostatic hyperplasia,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• in the case of taking MAO inhibitor drugs and within 14 days of stopping their use,
• in the case of taking tricyclic antidepressants or zidovudine,
• do not use in children under 12 years of age,
• do not use during pregnancy and breastfeeding,
• in the case of alcoholism.

Warnings and precautions

The medicine contains paracetamol.

Overdose of paracetamol can lead to life-threatening liver damage. Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms. Do not take with other medicines containing sympathomimetics (such as nasal decongestants, appetite suppressants, and psychostimulants with amphetamine-like effects) or medicines used for colds and flu. Do not drink alcohol while taking this medicine. Taking the medicine by people with liver failure, alcohol abusers, or fasting individuals poses a risk of toxic liver damage. In patients with liver disease, there is an increased risk of overdose. Before starting to take Gripex Duo, discuss the possibility of taking the medicine with a doctor or pharmacist if the patient:

• has liver or kidney failure (should monitor liver enzyme activity and kidney function),
• has arteriosclerosis,
• has Raynaud's syndrome,
• has stable coronary artery disease,
• has respiratory failure,
• has asthma,
• takes beta-adrenergic receptor antagonist drugs and other blood pressure-lowering drugs (debrisoquine, guanethidine, reserpine, methyldopa),
• takes anticoagulant drugs (may require dose adjustment based on blood coagulation tests).

While taking Gripex Duo, the patient should immediately inform their doctor if they experience severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting. Liver damage is possible in individuals who have ingested 10 g of paracetamol or more. Ingestion of 5 g of paracetamol may lead to liver damage in patients with the following risk factors:

• Patient 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 liver enzyme-inducing drugs.
• Patient regularly abusing alcohol.
• Patients who may have a glutathione deficiency, e.g., with eating disorders, cystic fibrosis, HIV infection, fasting, or malnourished.

Children and adolescents

The medicine should not be used in children under 12 years of age.

Patients with kidney or liver function disorders

Particular caution should be exercised in patients with kidney or liver disease. The medicine is contraindicated in patients with severe liver or kidney failure.

Elderly patients

Caution should be exercised when taking Gripex Duo.

Gripex Duo and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The interaction of Gripex Duo with other medicines results from the interaction of the active substances contained in the medicine:

Paracetamol:

• The medicine should not be taken simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol.
• Medicines that delay gastric emptying (e.g., propanteline) may delay the absorption of paracetamol.
• MAO inhibitor drugs (used in the treatment of, among others, depression and within 2 weeks of stopping treatment) may cause excitement and fever.
• Concomitant use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow.
• Paracetamol may enhance the effect of anticoagulant drugs (coumarin derivatives).
• Concomitant use of paracetamol and drugs that increase liver metabolism, such as certain sedatives or antiepileptic drugs, such as phenobarbital, phenytoin, carbamazepine, as well as rifampicin (used in the treatment of, among others, tuberculosis), may lead to liver damage, even when taking recommended doses of paracetamol. Therefore, before taking Gripex Duo, the patient should always consult a doctor.
  • Drinking alcohol while being treated with paracetamol leads to the formation of a toxic metabolite that causes liver cell necrosis, which can lead to 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 administration 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.
  • The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

  Phenylephrine:

  • MAO inhibitors may enhance the effect of phenylephrine. The patient should avoid taking them simultaneously with phenylephrine or take phenylephrine at least 14 days after stopping MAO inhibitors.
  • Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants.
  • Phenylephrine may weaken the hypotensive effect of guanethidine, mecamylamine, methyldopa, and reserpine.
  • Concomitant use of phenylephrine with indomethacin, beta-adrenergic receptor antagonists, or methyldopa may cause a hypertensive crisis.
  • Concomitant use of digoxin and cardiac glycosides increases the risk of heart rhythm disorders or myocardial infarction.
  • There is a risk of increased blood pressure in patients taking ergot alkaloids and phenylephrine concomitantly.

  Gripex Duo with food, drink, and alcohol

  Food slows down the absorption of paracetamol. The patient should not drink alcohol while taking this medicine.

  Pregnancy, breastfeeding, and fertility

  The medicine should not be used during pregnancy and breastfeeding.

  Driving and using machines

  While taking Gripex Duo, the patient should exercise caution when driving vehicles and operating machinery. Warnings regarding excipients. The medicine contains 184 mg of sorbitol (E420), 0.63 mg of tartrazine (E102), and 13.3 mg of glucose in each coated tablet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free". The 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 the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist. Gripex Duo should be taken orally. The dosage is as follows:

  Adults and adolescents with a body weight over 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 a body weight from 43 kg to 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 a body weight from 33 kg to 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

  The medicine should not be used in children under 12 years of age.

  The medicine should not be used for more than 3 days without consulting a doctor. The patient should use the lowest effective dose for the shortest possible time. Do not take a higher dose than recommended.

  The tablet can 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 water at room temperature. The solution should be drunk within 1 hour of preparation. The tablet can also be divided into two parts to facilitate swallowing. The dividing line on the tablet only allows the tablet to be broken in half to facilitate swallowing, not to divide the tablet into two equal smaller doses.

  Taking a higher dose of Gripex Duo than recommended

  Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, and difficulty urinating, as well as respiratory distress, within a few or several hours. There may be nystagmus, increased blood pressure, seizures, and difficulty urinating. These symptoms may subside the next day, despite the fact that life-threatening liver damage is developing, which will then manifest as abdominal distension, return of nausea, and jaundice. Therefore, in case of overdose, the patient should immediately call a doctor. Treatment should be carried out in a hospital and involves accelerating the elimination of the medicine's components from the body and maintaining vital functions. In the case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

  Missing a dose of Gripex Duo

  In case of missing a dose and persistence of symptoms, the patient should take the next dose of Gripex Duo. The patient should not take a double dose to make up for the missed dose.

  Stopping treatment with Gripex Duo

  In case of further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Gripex Duo can cause side effects, although not everybody gets them.

  If the following symptoms occur, the patient should not take the medicine and should immediately contact their doctor.

  These are life-threatening conditions that occur with an unknown frequency:

  • Anaphylactic shock (pallor, blood pressure drop, sweating, oliguria, laryngeal edema, tachypnea, weakness);
  • Severe skin reactions, which may include oral, pharyngeal, and nasal ulcers, and conjunctivitis (eye redness and swelling). These severe skin rashes are often preceded by symptoms such as fever, headache, and body aches (flu-like symptoms). The rash may spread, causing blisters on the skin and peeling (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, drug rash).

  Possible side effects of the medicine due to the presence of paracetamol.

  Side effects that occur 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 (decreased white blood cell count), neutropenia (decreased neutrophil count);
  • Edema;
  • Acute pancreatitis (severe pain in the middle and upper abdomen, vomiting, abdominal distension, often with gas and stool retention, high fever), chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting;
  • Itching, sweating, rash, urticaria; angioedema;
  • Kidney damage, manifested by fever, lumbar pain, skin rash, hematuria (blood in the urine), renal colic, urinary retention.

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

  • Bronchospasm, making breathing difficult in patients with hypersensitivity 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 whose frequency cannot be determined based on available data:
  • Polymorphic erythema;
  • Dizziness;
  • A serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2). The medicine rarely has a toxic effect on the kidneys, except in cases of chronic use of the medicine.

  Possible side effects of the medicine due to the presence of phenylephrine.

  Side effects that occur frequently (may affect less than 1 in 10 patients taking the medicine):

  • Nausea, vomiting, digestive disorders, anorexia. Side effects that occur rarely (may affect less than 1 in 1,000 patients taking the medicine):
  • Bronchospasm;
  • Allergic reactions (itching, urticaria);
  • Increased blood pressure, tachycardia (too rapid heart rate), heart rhythm disorders, palpitations, pallor. Side effects that occur very rarely (may affect less than 1 in 10,000 patients taking the medicine)
  • Anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness, and headaches, hallucinations. Side effects whose frequency cannot be determined based on available data:
  • Urinary retention.

  Reporting side effects

  If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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/. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

  5. How to store Gripex Duo

  Store in a temperature below 25°C. The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister packaging (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Gripex Duo contains

  • The active substances of the medicine are paracetamol and phenylephrine hydrochloride. The other ingredients are: povidone, citric acid; lemon flavor (lemon juice concentrate (contains sulfites), lemon oil, lime oil, natural flavoring substance - citral, anhydrous glucose syrup, sodium octenyl succinate starch (E1450)), crospovidone (type A); sucralose; sorbitol; microcrystalline cellulose; colloidal silica, anhydrous; talc; magnesium stearate; Opadry II: polyvinyl alcohol, E1203; talc, E553b; titanium dioxide, E171; Macrogol 3350; methacrylic acid and ethyl acrylate copolymer (1:1); quinoline yellow, E104; tartrazine, aluminum lake, E102; iron oxide, yellow E172; sodium bicarbonate, E500; indigo carmine, aluminum lake, E132.

  What Gripex Duo looks like and what the packaging contains

  Yellow, oval, biconvex coated tablets with the inscription "Gripex" on one side and a dividing line on the other side of the tablet. The dividing line on the tablet only allows the tablet to be broken in half to facilitate swallowing, not to divide the tablet into two equal smaller doses.

  Available packaging:

  OPA/Aluminum/PVC/Aluminum or Aclar/PVC/Aluminum blisters in a cardboard box. 10 pieces (1 blister of 10 pieces). 16 pieces (2 blisters of 8 pieces). 20 pieces (2 blisters of 10 pieces). Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer:

  US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław. For more detailed information on this medicine, please contact: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel.: +48 (22) 543 60 00.

  Date of last revision of the leaflet: