COLDREX 500 mg + 200 Mg + 10 Mg Powder

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. Coldrex Complex Grip
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet
3. What is Coldrex Complex Grip and what is it used for
4. Important information before taking Coldrex Complex Grip
   1. When not to take Coldrex Complex Grip:
   2. Warnings and precautions
   3. Before taking Coldrex Complex Grip, discuss with your doctor or pharmacist:
   4. Children
   5. Coldrex Complex Grip and other medicines
   6. Other important information:
   7. Pregnancy, breastfeeding, and fertility
   8. Coldrex Complex Grip should not be taken during pregnancy and breastfeeding.
   9. Driving and using machines
   10. Coldrex Complex Grip contains sucrose, aspartame, and sodium.
   11. Coldrex Complex Grip:
5. How to take Coldrex Complex Grip
   1. This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
   2. Recommended dose
   3. Do not give to children under 12 years of age.
   4. Taking a higher dose of Coldrex Complex Grip than recommended
   5. Coldrex Complex Grip contains paracetamol.
   6. In case of overdose, immediately consult a doctor, even if the patient feels well. This is because too much paracetamol can
   7. Missing a dose of Coldrex Complex Grip
6. Possible side effects
   1. Severe side effects
   2. Other side effects
   3. Rare: may occur in up to 1 in 1000 patients
   4. Very rare: may occur in up to 1 in 10,000 patients
   5. Frequency not known: cannot be estimated from available data
   6. Reporting side effects
7. How to store Coldrex Complex Grip
   1. This medicine should be stored out of sight and reach of children.
   2. Do not store above 25°C.
8. Package contents and other information
   1. What Coldrex Complex Grip contains
   2. What Coldrex Complex Grip looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer / Importer

PATIENT INFORMATION LEAFLET: USER INFORMATION

Coldrex Complex Grip

500 mg + 200 mg + 10 mg, powder for oral solution preparation
Paracetamol + Guaifenesin + 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 advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if needed.
• 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 this 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 Coldrex Complex Grip and what is it used for
• 2. Important information before taking Coldrex Complex Grip
• 3. How to take Coldrex Complex Grip
• 4. Possible side effects
• 5. How to store Coldrex Complex Grip
• 6. Package contents and other information

1. What is Coldrex Complex Grip and what is it used for

This medicine contains:

• Paracetamol, which is a pain reliever and reduces body temperature in case of fever.
• Guaifenesin, which is an expectorant, helping to loosen secretions
• Phenylephrine, which is a vasoconstrictor, reducing nasal congestion and facilitating its clearance.

The sachets are intended for short-term, occasional relief of symptoms associated with colds and flu, such as pain, headache, runny nose, sore throat, chills, and fever, as well as facilitating expectoration in productive cough (wet cough).
This medicine should only be recommended when all symptoms are present: (pain and (or) fever, nasal congestion, wet cough).
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Coldrex Complex Grip

When not to take Coldrex Complex Grip:

• if the patient is allergic (hypersensitive)to paracetamol, guaifenesin, phenylephrine, or any of the other ingredients of this medicine (listed in section 6)
• if the patient is pregnant or breastfeeding
• in patients with liver disease or severe kidney disease, including alcoholic liver disease
• in patients with serious heart disease or cardiovascular disorders or blood disorders, such as hemolytic anemia (abnormal breakdown of red blood cells, which can cause weakness or pale skin)
• in patients with high blood pressure
• in patients with hyperthyroidism
• in patients with diabetes
• in patients with a pheochromocytoma (a rare tumor of the adrenal gland tissue)
• in patients with glaucoma, including angle-closure glaucoma (nerve damage in the eye caused by a sudden increase in pressure inside the eye, as fluid cannot drain)
• in patients with difficulty urinating or when the bladder cannot be completely emptied
• in patients taking antidepressant medications called monoamine oxidase inhibitors (MAOIs) or who have taken them in the last 14 days - these are medications such as phenelzine and isocarboxazid
• in patients taking tricyclic antidepressants (e.g., amitriptyline)
• in patients taking beta-blockers
• in patients taking other medications containing paracetamol
• in patients currently taking other vasoconstrictor medications (e.g., ephedrine, xylometazoline), appetite suppressants (e.g., amphetamine-like medications)
• in patients taking cough suppressants

Warnings and precautions

Before taking Coldrex Complex Grip, discuss with your doctor or pharmacist:

• if the patient has a very severe cough or cough accompanied by fever, rash, or persistent headache. Consult a doctor if the cough persists for more than 3 days or recurs.
• if the patient has asthma and is sensitive (allergic) to aspirin
• if the patient has circulation disorders such as Raynaud's phenomenon, which results from poor circulation in the fingers and toes
• if the patient has angina pectoris
• if the patient has kidney disease
• if the patient has an enlarged prostate gland, which can cause difficulty urinating
• if the patient has severe stomach or intestinal problems
• if the patient has cardiovascular disease
• if the patient suffers from chronic alcoholism, malnutrition, or dehydration
• if the patient has Gilbert's syndrome (familial non-hemolytic jaundice)
• if the patient has myasthenia gravis (an autoimmune disease)
• if the patient is elderly, an adult, or an adolescent weighing less than 50 kg
• if the patient has a glutathione deficiency (a disorder that prevents the production of glutathione)
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (an enzyme deficiency occurring in red blood cells)
• if the patient is taking medications that affect liver function

While taking Coldrex Complex Grip, immediately inform your doctor if:
the patient has severe diseases, including severe kidney function disorders 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 in regular doses for a longer period or taking paracetamol with flucloxacillin have reported a severe disease called metabolic acidosis (a blood and body fluid disorder). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children

Do not give this medicine to children under 12 years of age.

Coldrex Complex Grip and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those available without a prescription.
Coldrex Complex Grip may interact with some medicines:

• used to treat high cholesterol levels, which reduce the amount of fat in the blood, such as cholestyramine
• used to control nausea or vomiting, such as metoclopramide or domperidone
• called anticoagulants, used to thin the blood, such as warfarin or other coumarins - paracetamol doses can be taken occasionally, but if regular use is necessary, consult a doctor
• barbiturates (used to treat epilepsy or facilitate sleep), such as phenobarbital
• tricyclic antidepressants, such as imipramine, amitriptyline
• monoamine oxidase inhibitors (including moclobemide)
• medicines used to treat heart disease or cardiovascular disorders, or to lower blood pressure (e.g., cardiac glycosides, such as digitalis, digoxin, debryzoxine, guanethidine, reserpine, methyldopa)
• beta-blocker medications (e.g., atenolol)
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)
• medicines used to treat migraines (e.g., ergotamine and methysergide)
• zidovudine, as it may cause blood disorders (low white blood cell count)
• phenothiazines used as sedatives (e.g., chlorpromazine, pericyazine, and fluphenazine)
• probenecid (a medicine used to treat gout and hyperuricemia)
• chloramphenicol (an antibiotic)
• sympathomimetic amines (e.g., phenylephrine)
• 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).

Tell your doctor if:

• the patient will have blood or urine tests, as taking this medicine may affect the results of these tests
• the patient will undergo general anesthesia, as this medicine may cause changes in heart rhythm.

Other important information:

• Do not take for more than 3 days, unless advised by a doctor.
• This medicine should only be used when all listed symptoms are present - pain and (or) fever, nasal congestion, and wet cough.
• Only use medicines intended to treat the actual symptoms.
• Do not take with other flu, cold, or decongestant medicines.
• Long-term use of any pain relievers for headaches may worsen them. If this occurs or is suspected, consult a doctor and stop treatment.
• Do not take with other medicines containing paracetamol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Coldrex Complex Grip should not be taken during pregnancy and breastfeeding.

Driving and using machines

• This medicine may cause dizziness. If this occurs, do not drive or operate machinery.

Coldrex Complex Grip contains sucrose, aspartame, and sodium.

Coldrex Complex Grip:

• contains 2.1 g of sucrose (sugar) per sachet. If the doctor has previously informed the patient about an intolerance to some sugars, they should consult their doctor before taking the medicine. This should be considered in patients with diabetes.
• contains 12 mg of aspartame (E951) per sachet. Aspartame is a source of phenylalanine. This may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
• contains 129.5 mg of sodium (the main component of common salt) per sachet. This corresponds to 6.5% of the recommended maximum daily sodium intake in the diet for an adult.

3. How to take Coldrex Complex Grip

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Pour the contents of 1 sachet into a standard cup. Fill the cup with 250 ml of hot, but not boiling, water. Stir until dissolved and let it cool to a temperature that allows drinking. Drink the solution within 1½ hours.

Recommended dose

Adults, elderly patients, and adolescents 12 years and older:
1 sachet every 4 hours, as needed. Do not take more than 4 sachets (4 doses) in 24 hours.
Do not take more frequently than every 4 hours.
If symptoms persist for more than 3 days or worsen, consult a doctor or pharmacist.

Do not give to children under 12 years of age.

Taking a higher dose of Coldrex Complex Grip than recommended

Coldrex Complex Grip contains paracetamol.

In case of overdose, immediately consult a doctor, even if the patient feels well. This is because too much paracetamol can

cause delayed, serious liver damage.Go to the nearest hospital, taking the medicine and this leaflet with you.

Missing a dose of Coldrex Complex Grip

Do not take a dose higher than recommended in the leaflet.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

• allergic reactions, which can be sudden and severe, with symptoms such as difficulty breathing, swelling, dizziness, sweating, and loss of consciousness.
• very rare cases of serious skin reactions have been reported, such as life-threatening reactions with flu-like symptoms and blistering or painful rashes on the skin, mouth, eyes, and genitals. Sudden blisters on large areas of skin. Skin inflammation • shortness of breath
• decreased platelet count, which increases the risk of bleeding or bruising
• significant decrease in white blood cell count, which can lead to serious infections
• Sudden pancreatitis causing severe abdominal and back pain
• nerve damage in the eye caused by a rapid increase in pressure inside the eye, as fluid cannot drain

Other side effects

Rare: may occur in up to 1 in 1000 patients

• abdominal pain and discomfort
• diarrhea
• rapid heartbeat
• increased sensitivity of the heartbeat (palpitations)
• eye disorders such as constriction/dilation of the pupils
• urination problems or inability to completely empty the bladder
• malaise
• vomiting
• hives
• rash

Very rare: may occur in up to 1 in 10,000 patients

• liver problems
• itching
• sweating
• rash with raised red or purple spots, which look like small bruises or blood spots
• cloudy urine

Frequency not known: cannot be estimated from available data

• nervousness, irritability, restlessness, or excitement
• sleep problems (insomnia)
• headache
• high blood pressure
• a serious condition that can cause blood acidification (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 gather more information on the safety of this medicine.

5. How to store Coldrex Complex Grip

This medicine should be stored out of sight and reach of children.

Do not take the medicine after the expiration date (EXP) stated on the carton and sachet. The expiration date is the last day of the given month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Package contents and other information

What Coldrex Complex Grip contains

• The active substances of the medicine in one sachet are: paracetamol 500 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 10 mg.
• Other ingredients are: sucrose, anhydrous citric acid (E 330), tartaric acid (E 334), sodium cyclamate (E 952), sodium citrate (E 331), acesulfame potassium (E 950), aspartame (E 951), menthol aroma (powder), lemon aroma, lemon juice aroma, quinoline yellow (E 104).

What Coldrex Complex Grip looks like and what the package contains

This medicine is a white, powdery substance with a characteristic citrus-menthol aroma, packaged in single sachets containing 4.4 g of powder.
The medicine is available in packages containing 5, 6, or 10 sachets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
phone: +48 (22) 852 55 51

Manufacturer / Importer

Omega Pharma International NV
Venecoweg 26
Nazareth, 9810
Belgium
Perrigo Supply Chain International DAC
The Sharp Building, Hogan Place,
Dublin 2, Dublin,
D02 TY74, Ireland
This medicine is authorized in the Member States of the European Economic Area under the following names:
United Kingdom: Perrigo Paracetamol/Guaifenesin/Phenylephrine Hydrochloride
(500mg/200mg/10mg) powder for oral solution.
Italy:
Bronchenolo Tosse, Influenza e Raffreddore
Poland:
Coldrex Complex Grip
Date of last update of the leaflet: January 2025