COLDREX 500 mg + 100 Mg + 6.1 Mg Capsules

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. Do not take this medicine if you:
   2. Warnings and precautions
   3. Children and adolescents
   4. Coldrex Complex Grip and other medicines
   5. Coldrex Complex Grip with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to take Coldrex Complex Grip
   1. Adults and adolescents over 16 years old with a body weight over 50 kg
   2. Use in elderly patients and patients with liver or kidney disease
   3. Use in children and adolescents
   4. Overdose of Coldrex Complex Grip
   5. Missed dose of Coldrex Complex Grip
6. Possible side effects
   1. Reporting side effects
7. How to store Coldrex Complex Grip
8. Contents of the pack and other information
   1. What Coldrex Complex Grip contains
   2. What Coldrex Complex Grip looks like and contents of the pack
   3. Marketing authorization holder and importer
   4. Marketing authorization holder
   5. Importer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: January 2025

PATIENT INFORMATION LEAFLET: USER INFORMATION

Coldrex Complex Grip

500 mg + 100 mg + 6.1 mg, hard capsules
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 information leaflet or as advised by
your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, 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 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. Contents of the pack and other information

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

Coldrex Complex Grip contains the following active substances:

• Paracetamol, which acts as a pain reliever (analgesic) for pain, including headache and sore throat, and also helps to lower fever (antipyretic action).
• Guaifenesin, which is an expectorant, helping to thin out mucus (phlegm) during a wet cough.
• Phenylephrine hydrochloride, which is a vasoconstrictor, used to reduce nasal congestion to make breathing easier.

This medicine is intended for short-term relief of symptoms of cold and flu, such as pain (mild to moderate), headache, runny nose, sore throat, chills, and fever, as well as to facilitate expectoration in productive cough. Coldrex Complex Grip should only be taken when symptoms such as pain or fever, runny nose, and wet cough occur simultaneously.
This medicine can be taken by adults, elderly, and adolescents over 16 years old.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Coldrex Complex Grip

Do not take this medicine if you:

• are allergic (hypersensitive) to paracetamol, guaifenesin, phenylephrine, or any of the other ingredients of this medicine (listed in section 6),
• are taking antidepressant medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, isocarboxazid, and tranylcypromine, or have taken them in the last 14 days,
• have high blood pressure (hypertension),
• have heart disease or blood vessel disorders (cardiovascular disorders),
• have hyperthyroidism (an overactive thyroid gland),
• have diabetes,
• have a rare adrenal gland tumor (pheochromocytoma),
• are taking tricyclic antidepressants, such as imipramine and amitriptyline,
• are taking beta-adrenergic blockers or other medicines used to treat high blood pressure,
• have glaucoma (high pressure in the eye),
• have severe liver impairment,
• are pregnant,
• are taking other vasoconstrictor medicines containing sympathomimetic amines (e.g., phenylephrine).

Warnings and precautions

Consult your doctor:

• if symptoms persist for more than 3 days,
• if symptoms worsen,
• if a high fever or other symptoms occur.

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

• if you have circulation problems, such as Raynaud's syndrome, which results from poor circulation in the fingers and toes,
• if you are taking medicines that affect liver function,
• if you have enzyme deficiencies or metabolic disorders (glucose-6-phosphate dehydrogenase deficiency, glutathione deficiency, or non-hemolytic familial jaundice),
• if you have a condition that causes faster destruction of red blood cells than their production (hemolytic anemia),
• if you are dehydrated,
• if you have difficulty urinating or an enlarged prostate,
• if you have chronic cough, asthma, or chronic obstructive pulmonary disease (COPD),
• if you experience frequent or daily headaches,
• if you have asthma and are sensitive to acetylsalicylic acid.

Before taking this medicine, consult your doctor if you have liver or kidney problems, are underweight (<50 kg), are malnourished, or regularly drink alcohol, as this may increase the risk of liver damage. it be necessary to reduce amount paracetamol taken completely avoid taking product.
During treatment with Coldrex Complex Grip, immediately inform your doctor if you have severe illnesses, including severe kidney or liver disorders, 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 taking paracetamol have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), especially when taking paracetamol regularly over a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
This product contains paracetamol. Do not take this product at the same time as other products containing paracetamol.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years old.

Coldrex Complex Grip and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take Coldrex Complex Grip at the same time as any of the following medicines (see "When not to take Coldrex Complex Grip"):

• Tricyclic antidepressants, such as imipramine, amitriptyline.
• Monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, isocarboxazid, and tranylcypromine, used to treat depression.
• Medicines known as beta-blockers, such as metoprolol and atenolol.
• Other products containing sympathomimetic amines, such as phenylephrine.
• Medicines used to lower blood pressure, such as guanethidine, reserpine, and methyldopa.

If you are taking any of the following medicines, consult your doctor before taking Coldrex Complex Grip:

• Probenecid, which is commonly used to treat gout.
• Medicines used to lower high cholesterol levels, which reduce the amount of fat in the blood, such as cholestyramine.
• Medicines that control nausea or vomiting, such as metoclopramide or domperidone.
• Medicines called anticoagulants, used to thin the blood, such as warfarin or other coumarins. You can take occasional doses of paracetamol, but consult your doctor if you need to take it regularly.
• The antibiotic chloramphenicol.
• Medicines used to treat heart conditions, such as digoxin.
• Medicines used to treat migraines, such as ergotamine and methysergide.
• Other cough medicines.
• Other cold and flu medicines.
• 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).
• 2).

Consult your doctor if you plan to have a urine test, as this medicine may affect the test results.

Coldrex Complex Grip with alcohol

Avoid drinking alcohol while taking Coldrex Complex Grip.

Pregnancy and breastfeeding

Pregnancy
Do not take this medicine if you are pregnant or think you may be pregnant.
If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Based on human experience, phenylephrine hydrochloride given during pregnancy has been reported to cause congenital malformations.
Breastfeeding
Do not take this medicine while breastfeeding without consulting your doctor first.

Driving and using machines

This medicinal product may cause dizziness. Do not drive or operate machinery if you experience dizziness after taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose (2 capsules), and is therefore considered to be sodium-free.

3. How to take Coldrex Complex Grip

Take this medicine exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults and adolescents over 16 years old with a body weight over 50 kg

The recommended dose is 2 capsules every 4 to 6 hours, as needed, up to a maximum of 3 doses in 24 hours. Do not exceed the recommended dose. Do not take more than 6 capsules (3 g paracetamol) in 24 hours.
Coldrex Complex Grip should not be taken by adults, elderly, and adolescents over 16 years old with a body weight below 50 kg.
Do not take more than 4 capsules per day in the following situations, unless advised by your doctor:

• chronic alcoholism
• dehydration
• malnutrition

Use in elderly patients and patients with liver or kidney disease

Before taking this medicine, talk to your doctor or pharmacist if you are elderly or have kidney or liver disease, as you may need to take a lower dose or have longer intervals between doses.

Use in children and adolescents

Do not give to children and adolescents under 16 years old.
For oral use. Swallow the capsules whole with water. Do not chew.
Consult your doctor if symptoms persist for more than 3 days, worsen, or if other symptoms occur.

Overdose of Coldrex Complex Grip

If you have taken too much of this medicine, immediately consult your doctor, even if you feel well. This is because too much paracetamol may cause delayed, irreversible liver damage. Initial symptoms of overdose may include pallor, nausea, vomiting, and abdominal pain. Go to the nearest hospital emergency department. Take the medicine and this leaflet with you.

Missed dose of Coldrex Complex Grip

Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most people do not experience any side effects when taking this medicine. However, if you experience any of the following side effects or if anything unusual happens, stop taking the medicine immediatelyand consult your doctor or pharmacist.

• Serious skin reactions.
• Allergic reactions, which can be severe, such as skin rash, itching, swollen, red patches on the skin, which may be accompanied by difficulty breathing or swelling of the lips, face, throat, or tongue.
• Blood disorders, which can increase the risk of bleeding, bruising, fever, and infection, such as sore throat and mouth ulcers.
• Problems or pain when urinating.
• Increased pressure in the eye (angle-closure glaucoma).
• Dilated pupils.
• Breathing problems, which are more likely if you have experienced them before when taking other painkillers, such as acetylsalicylic acid or ibuprofen.
• High blood pressure.
• Faster, slower, or irregular heart rate at rest.
• Liver problems.

The above side effects are rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people). The frequency of pain and problems with urination is unknown.
Other side effects of this medicine are listed below by frequency of occurrence.

• Difficulty sleeping (insomnia)
• Nervousness
• Headache
• Dizziness
• Feeling of tingling or coolness on the skin
• A serious condition that can cause acidification of the blood (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2)

The frequency of the following side effects is unknown (cannot be estimated from the available data):

• Abdominal pain or discomfort
• Diarrhea
• Nausea
• Vomiting

The frequency of the following side effects is rare (may affect up to 1 in 1,000 patients):

• Cloudy urine (due to increased white blood cell count in the urine)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coldrex Complex Grip

Keep this medicine out of the sight and reach of children.
Do not take the medicine after the expiry date (EXP) stated on the carton and blister. The expiry date refers to the last day of that 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Coldrex Complex Grip contains

Each capsule contains the following active substances: paracetamol (500 mg), guaifenesin (100 mg), and phenylephrine hydrochloride (6.1 mg, equivalent to 5 mg phenylephrine).
The other ingredients of the medicine are: corn starch, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, talc; capsule shell: gelatin, sodium lauryl sulfate, quinoline yellow (E104), indigo carmine (E132), erythrosine (E127), titanium dioxide (E171), purified water.

What Coldrex Complex Grip looks like and contents of the pack

Hard gelatin capsules with a transparent green body and an opaque blue cap, containing a white to off-white powder. The capsules are packed in plastic blisters with a paper/aluminum closure.
The medicine is available in packs of 8, 16, 24, and 32 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

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

Importer

Omega Pharma International NV
Venecoweg 26
9810 Nazareth
Belgium
Perrigo Supply Chain International DAC
The Sharp Building
10-12 Hogan Place
Dublin 2, Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Колдрекс Макс Плюс Кашлица (Coldrex Max Plus Cough)
Croatia
Coldrex ComboGrip
Cyprus
Solpadeine Cold & Flu
Czech Republic
Estonia
Coldrex MaxGrip
Greece
BronchoGrip
Hungary
Coldrex Plus köhögés elleni kemény kapszula
(Coldrex Plus against cough hard capsule)
Ireland
Paracetamol 500mg, Guaifenesin 100mg, Phenylephrine hydrochloride 6.1mg capsules, hard

• Latvia ColCaps 500 mg/100 mg/6,1 mg cietās kapsulas Lithuania Coldrex Complex Grip Portugal Antigrippine Maxeffect Tosse Cápsulas Romania Coldrex Max Răceală și Tuse capsule (Coldrex Max Cold and Cough capsule) Slovakia Coldrex Grip plus kašel Slovenia Combocoldrex 500 mg/100 mg/6,1 mg trde kapsule

For more detailed information on this medicine, contact the marketing authorization holder:
Perrigo Poland Sp. z o.o.
Domaniewska 48
02-672 Warsaw

Date of last revision of the leaflet: January 2025