Gripex Control Duo

Leaflet attached to the packaging: patient information

Gripex Control Duo, 500 mg + 65 mg, coated tablets

Paracetamol+ Caffeine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

Gripex Control Duo is a combination medicine. It contains two active substances with a combined effect: paracetamol and caffeine.
Paracetamol has an antipyretic and analgesic effect, while caffeine has a stimulating effect on the central nervous system, enhances the analgesic effect of paracetamol, and accelerates its absorption into the blood.
Gripex Control Duo is a medicine intended for use in adults and adolescents over 12 years of age.

Indications for use

Relief of symptoms of colds and flu, such as: fever, sore throat, muscle and joint pain, malaise, fatigue, weakness.
Pain of various origins: headache, including migraine, muscle, tooth, neuralgia, menstrual, joint, post-operative, and post-traumatic.

2. Important information before taking Gripex Control Duo

When not to take Gripex Control Duo:

• if you are allergic to paracetamol or caffeine or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver or kidney failure,
• if you have heart rhythm disorders,
• if you have a congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• do not use in children under 12 years of age,
• do not use during pregnancy and breastfeeding,

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• in case of alcoholism,
• while taking MAO inhibitors and for 2 weeks after their withdrawal.

Warnings and precautions

The medicine contains paracetamol.

Overdose of paracetamol can lead to severe, life-threatening liver damage.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as some painkillers, antipyretics, used to treat flu and cold symptoms.
During the period of taking this medicine, you must not drink alcohol. Taking the medicine by people with liver failure, alcohol abusers, or fasting individuals creates a risk of toxic liver damage.
In people with liver disease, there is an increased risk of overdose.
Before starting to take Gripex Control Duo, you should discuss the possibility of using the medicine with your doctor or pharmacist, especially if you have:

• liver or kidney failure (you should monitor liver enzyme activity and kidney function),
• respiratory failure,
• asthma,
• hereditary fructose intolerance,
• dehydration,
• malnutrition.

In the course of taking Gripex Control Duo, you should immediately inform your doctor if you experience severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.
Taking paracetamol may lead to liver damage in patients with the following risk factors:

• patients taking long-term sedatives, antiepileptics, St. John's wort, tuberculosis medications,
• patients who regularly abuse alcohol.

In case of skin rash, often with blisters or changes in the mucous membranes, you should immediately stop taking Gripex Control Duo and immediately consult a doctor.

Children and adolescents

The medicine should not be taken by children under 12 years of age.

Patients with kidney and/or liver dysfunction

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 Control Duo.

Gripex Control Duo and other medicines

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You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The interaction of Gripex Control Duo with other medicines results from the interaction of the active substances contained in the medicine. The medicine should not be taken simultaneously with other medicines containing paracetamol or caffeine.

Before taking Gripex Control Duo, you should consult a doctor if you are taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• oral antidiabetic drugs,
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulant drugs,
• probenecid (used to treat gout),
• sedatives and antiepileptics,
• rifampicin (an antitubercular drug),
• drugs that delay gastric emptying (e.g., propanteline), as they may delay the absorption of paracetamol,
• 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),
• lithium salts (used, among others, in depression, mania),
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid),
• disulfiram (used, among others, in the treatment of alcoholism),
• sympathomimetic drugs (used, among others, in respiratory tract inflammation, orthostatic circulation disorders, and low blood pressure),
• theophylline (used in the treatment of asthma and COPD),
• clozapine (an antipsychotic drug),
• oral contraceptives,
• St. John's wort,
• MAO inhibitors (used in the treatment of atypical depression and Parkinson's disease),
• cimetidine (used in hyperacidity and stomach and duodenal ulcers),
• quinolones (used in the treatment of bacterial infections),
• verapamil (used in hypertension and heart disease).

Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite that causes liver cell necrosis, which can subsequently lead to liver failure.
The medicine contains caffeine. During the treatment, you should avoid excessive caffeine consumption (e.g., in coffee, tea, or some drinks). Excessive caffeine consumption can cause difficulty falling asleep, tremors, and unpleasant feelings in the chest due to heart palpitations. Nicotine (used in the treatment of nicotine addiction), phenytoin (used in epilepsy), and phenylpropanolamine (used in bronchitis and hypotension) accelerate the elimination of caffeine from the body.
In case of taking a higher dose than recommended, you should immediately contact a doctor, even if you feel well.
Taking paracetamol may be the cause of false results in some laboratory tests (e.g., blood glucose measurement).

Gripex Control Duo with food, drink, and alcohol

Food slows down the absorption of paracetamol. During the treatment with Gripex Control Duo, you should avoid excessive caffeine consumption (e.g., coffee, tea, and some drinks in cans), as excessive caffeine can cause feelings of anxiety, irritability, insomnia, and sometimes rapid heartbeat.
During the treatment, you must not drink alcohol.
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Pregnancy, breastfeeding, and fertility

Do not take during pregnancy and breastfeeding.

Driving and using machines

Gripex Control Duo does not affect the ability to drive and use machines.

Gripex Control Duo contains sorbitol, glucose (from dried corn syrup), sodium, tartrazine (E 102).

The medicine contains 180.1 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which your body does not break down fructose, you should consult a doctor before taking the medicine or giving it to your child.
If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
The medicine contains the dye tartrazine (E 102), which may cause allergic reactions.

3. How to take Gripex Control Duo

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
Gripex Control Duo should be taken orally.
The tablet can be swallowed with a glass of water or dissolved to take the medicine in liquid form.
Then, you should throw the tablet (whole or broken) into about 1/2 glass of warm water (temperature around 30-40°C) and stir until it dissolves.
A slightly cloudy, light yellow liquid should be drunk within an hour of preparation.

Persons having difficulty swallowing the tablet whole (including persons under 18 years of age and the elderly)

can divide the tablet into two parts.

Recommended dose

Adults and adolescents with a body weight over 65 kg
Usually, the dose is 1-2 tablets every 4 hours, if necessary.

Do not take more than 8 tablets per day (4 g of paracetamol and 520 mg of caffeine)

Adults and adolescents with a body weight from 43 kg to 65 kg
Usually, the dose is 1 tablet every 4 hours, if necessary.

Do not take more than 6 tablets per day (3 g of paracetamol and 390 mg of caffeine).

Adults and adolescents with a body weight from 33 kg to 43 kg
Usually, the dose of paracetamol is 1 tablet every 6 hours, if necessary.

Do not take more than 4 tablets per day (2 g of paracetamol and 260 mg of caffeine).

Children under 12 years of age
Do not take the medicine in children under 12 years of age.
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Gripex Control Duo should not be taken for more than 3 days without consulting a doctor.

Kidney failure:
In patients with reduced kidney function, the dosage of the medicine should be modified.
In case of moderate kidney failure (creatinine clearance 10-50 ml/min), the minimum interval between consecutive doses of the medicine should be 6 hours. In case of severe kidney failure (creatinine clearance <10 ml min), the minimum interval between consecutive doses of medicine should be 8 hours.
Liver failure:
In case of stable, chronic liver failure, the use of paracetamol, according to the above dosage regimen, usually does not cause liver damage. However, it is recommended not to administer the maximum doses and to maintain an interval of at least 6 hours between consecutive doses.
The daily dose of paracetamol should not exceed 2 g/day (4 tablets of Gripex Control Duo), unless your doctor has prescribed otherwise.

Taking a higher dose of Gripex Control Duo than recommended

Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, within a few or several hours. There may be nystagmus, increased blood pressure, convulsions, difficulty urinating, and shortness of breath. 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, despite the temporary subsidence of symptoms in case of overdose, you 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.

Missing a dose of Gripex Control Duo

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

Stopping the treatment with Gripex Control Duo

In case of any further doubts regarding the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

• If you experience the following symptoms, do not take the medicine and immediately contact your 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, nasal, genital, and ocular mucosa ulceration, and conjunctivitis (redness and swelling of the eyes). 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).
• Rare side effects (occurring in 1 to 10 in 10,000 patients taking the medicine):
• allergic reactions, such as urticaria, rash, itching, facial, lip, tongue, throat swelling (angioedema), bronchospasm, which makes breathing difficult, Page 5 7
• bleeding,
• liver failure, liver necrosis, jaundice, manifested by yellowing of the eyes and skin, abdominal pain, loss of appetite,
• acute pancreatitis (severe pain in the middle and upper abdomen, vomiting, abdominal distension, often with gas and stool retention, high fever),
• kidney damage, manifested by fever, pain in the lumbar region, rash on the skin, red urine (hematuria), renal colic, urinary retention.
• Very rare side effects (occurring less frequently than in 1 in 10,000 patients taking the medicine):
• severe skin reactions, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome (pustular polymorphic erythema), toxic epidermal necrolysis, which are characterized by: initially red spots on the torso, often with blisters in the center, pustular rash all over the body or erosions in the mouth, eyes, genitals, and skin, or bursting large blisters, peeling off large flakes of epidermis, accompanied by weakness, fever, and joint pain.

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

• Rare side effects (occurring in 1 to 10 in 10,000 patients taking the medicine):
• anemia, bone marrow suppression, thrombocytopenia, agranulocytosis (lack of granulocytes in the blood), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count),
• edema,
• chronic pancreatitis, abdominal pain, diarrhea, nausea,
• sweating, rash.
• Side effects whose frequency cannot be determined based on available data:
• erythema multiforme,
• dizziness,
• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

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

• Side effects whose frequency cannot be determined based on available data:
• dizziness and headaches,
• palpitations,
• insomnia, restlessness, anxiety, irritability, nervousness,
• gastrointestinal disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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, you can help gather more information on the safety of the medicine.
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5. How to store Gripex Control Duo

Store at a temperature below 25°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste.
You should 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 Gripex Control Duo contains

• The active substances of the medicine are paracetamol and caffeine. One coated tablet contains: 500 mg of paracetamol and 65 mg of caffeine.
• The other ingredients are: citric acid, crospovidone (type A), povidone K29/32, sucralose, sorbitol, microcrystalline cellulose, anhydrous colloidal silica, talc, magnesium stearate, Opadry II 200F220052 (polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, methacrylic acid, and ethyl acrylate copolymer (1:1), type A, quinoline yellow (E 104), tartrazine (E 102), yellow iron oxide (E 172), sodium bicarbonate (E 500), indigo carmine (E 132)), lemon flavor 87.A069 (contains: lemon oil, dried corn syrup).

What Gripex Control Duo looks like and what the packaging contains

Yellow, oval, approximately 20 mm x 9 mm, biconvex tablets with the inscription "G" on one side and a score line on the other side.
The score line on the tablet allows only for breaking the tablet to facilitate swallowing; it does not allow for dividing the tablet into two equal smaller doses.
The packaging contains:4, 6, 8, 16, or 24 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:

USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel.: +48 (22) 543 60 00

Date of the last update of the leaflet:

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