Coldrex complex grip

Coldrex Complex Grip
500 mg + 100 mg + 6.1 mg, hard capsules
Paracetamolum + Guaifenesinum + Phenylephrini hydrochloridum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult a pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Table of contents

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

Coldrex Complex Grip contains the following active substances:

• Paracetamol, which has analgesic (pain-relieving) properties, relieving pain including headache and sore throat, and also helps reduce fever (antipyretic effect).
• Guaifenesin, an expectorant that helps thin mucus (phlegm) during productive cough.
• Phenylephrine hydrochloride, a vasoconstrictor used to reduce nasal congestion by shrinking swollen nasal passages, thus facilitating breathing.

This medicine is intended for short-term relief of cold and flu symptoms such as pain (mild to moderate), headache, nasal congestion, sore throat, chills, fever, and to aid expectoration in productive cough. Coldrex Complex Grip should only be used when symptoms such as pain or fever, nasal congestion, and productive cough occur simultaneously.
This medicine may be used by adults, elderly patients, and adolescents aged 16 years and above.
If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

2. Important information before using Coldrex Complex Grip

Do not use this medicine if the patient:

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

Warnings and precautions
Consult a doctor:

• if symptoms last longer than 3 days,
• if symptoms worsen,
• if high fever or other symptoms develop.

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

• if the patient has circulatory problems, such as Raynaud's syndrome, which results from poor circulation in fingers and toes,
• if the patient is taking medicines that affect liver function,
• if the patient suffers from enzyme deficiencies or metabolic disorders (glucose-6-phosphate dehydrogenase deficiency, glutathione deficiency, or familial non-haemolytic jaundice),
• if the patient suffers from a condition causing faster destruction of red blood cells than their production (haemolytic anaemia),
• if the patient is dehydrated,
• if the patient has difficulty passing urine or has an enlarged prostate,
• if the patient suffers from chronic cough, asthma, or emphysema,
• if the patient experiences frequent or daily headaches,
• if the patient has asthma and is sensitive to acetylsalicylic acid.

Consult a doctor before use if the patient has liver or kidney problems, is underweight (<50 kg), is malnourished, or regularly consumes alcohol, as this may increase the risk of liver damage. It may be necessary to reduce the dose of paracetamol or avoid this product completely.
During treatment with Coldrex Complex Grip, inform your doctor immediately if:
The patient has serious conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is 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 over a long 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.
This product contains paracetamol. Do not take this product simultaneously with other products containing paracetamol.
Children and adolescents
This medicine must not be given to children and adolescents under 16 years of age.
Coldrex Complex Grip and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Coldrex Complex Grip at the same time as any of the following medicines (see "When not to use Coldrex Complex Grip"):

• Tricyclic antidepressants, such as imipramine, amitriptyline.
• Monoamine oxidase inhibitors (MAOIs), such as moklobemide, 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 the patient is taking any of the following medicines, consult a doctor before taking Coldrex Complex Grip:

• Probenecid, commonly used in the treatment of gout.
• Medicines used to treat high cholesterol levels, which reduce fat in the blood, such as cholestyramine.
• Medicines used to control nausea or vomiting, such as metoclopramide or domperidone.
• Medicines called anticoagulants, used to thin the blood, such as warfarin or other coumarins. Occasional doses of paracetamol may be taken, but consult a doctor if regular use is needed.
• The antibiotic chloramphenicol.
• Medicines used for heart conditions, such as digoxin.
• Medicines used to treat migraine, such as ergotamine and methysergide.
• Other cough medicines.
• Other cold and flu remedies.
• Flucloxacillin (antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Consult a doctor if the patient plans to undergo a urine test, as this medicine may affect test results.
Coldrex Complex Grip and alcohol
Avoid consuming alcohol while taking Coldrex Complex Grip.
Pregnancy and breastfeeding
Pregnancy
Do not use this medicine if the patient is pregnant or suspects she may be pregnant.
If the patient plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Based on human experience, phenylephrine hydrochloride administered during pregnancy has been associated with congenital malformations.
Breastfeeding
Do not use this medicine during breastfeeding without prior consultation with a doctor.
Driving and operating machinery
This medicinal product may cause dizziness. Do not drive or operate machinery if dizziness occurs after taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose (2 capsules), and is therefore considered sodium-free.

3. How to take Coldrex Complex Grip

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents aged 16 years and older with body weight above 50 kg
The recommended dose is 2 capsules every 4 to 6 hours, as needed, up to a maximum of 3 doses within 24 hours. Do not exceed the recommended dose. Do not take more than 6 capsules (3 g of paracetamol) in 24 hours.
Coldrex Complex Grip should not be used in adults, elderly individuals, or adolescents aged 16 years and older with body weight below 50 kg.
Do not take more than 4 capsules per day in the following situations, unless otherwise directed by a doctor:

• chronic alcoholism
• dehydration
• malnutrition

Use in elderly patients and patients with liver or kidney disease
Consult a doctor or pharmacist before using this medicine if the patient is elderly or suffers from kidney or liver disease, as a lower dose or longer intervals between doses may be required.
Use in children and adolescents
Do not give to children and adolescents under 16 years of age.
For oral use. Swallow the capsules whole with water. Do not chew.
Consult a doctor if symptoms persist for more than 3 days, worsen, or new symptoms occur.
Taking more Coldrex Complex Grip than recommended
If an excessive amount of this medicine has been taken, seek immediate medical advice, even if the patient feels well. This is because an overdose of paracetamol may cause delayed, irreversible liver damage. Initial symptoms of overdose may include pale skin, nausea, vomiting, and abdominal pain. Go to the nearest hospital emergency department. Take the medicine and this leaflet with you.
If you miss a dose of Coldrex Complex Grip
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Most people do not experience any side effects while taking this medicine. However, if any of the
following adverse effects occur, or if anything unusual happens, you should IMMEDIATELY STOP taking the medicine and contact your doctor or
pharmacist.

• Serious skin reactions.
• Allergic reactions, which may be severe, such as skin rash, itching, swollen red patches on the skin, sometimes accompanied by shortness of breath or swelling of the lips, tongue, throat or face.
• Blood disorders, which may increase the tendency to bleed or bruise, fever and infections such as sore throat and mouth ulcers.
• Problems or pain when passing urine.
• Increased pressure inside the eye (closed-angle glaucoma).
• Dilated pupils.
• Breathing difficulties, which are more likely if the patient has previously experienced them while taking other painkillers such as acetylsalicylic acid or ibuprofen.
• Increased blood pressure.
• Faster, slower or irregular heartbeat at rest.
• Liver problems.

The above adverse effects are rare (may occur in no more than 1 in 1,000 people) or very rare (may occur in no more than 1 in 10,000 people). The frequency of occurrence of pain and problems when passing urine is unknown.
Other adverse effects of this medicine are listed below according to their frequency of occurrence.
The frequency of occurrence of the following adverse effects is unknown (cannot be estimated from the available data):

• Difficulty sleeping (insomnia)
• Nervousness
• Headache
• Dizziness
• Tingling or cold sensation on the skin
• Serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2)

The frequency of occurrence of the following adverse effects is rare (may occur in no more than 1 in 1,000 patients):

• Abdominal pain or discomfort
• Diarrhoea
• Nausea
• Vomiting

The frequency of occurrence of the following adverse effects is very rare (may occur in no more than 1 in 10,000 patients):

• Cloudy urine (due to increased number of white blood cells in the urine)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Coldrex Complex Grip

Keep this medicine out of sight and reach of children.
Do not use the medicine after the expiry date (EXP) stated on the carton and blister. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must 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 of phenylephrine).
Other components of the medicine are: maize starch, sodium croscarmellose, sodium lauryl sulfate,
magnesium stearate, talc; gelatin 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 sealed with paper/aluminium foil.
The medicine is available in packs containing 8, 16, 24 or 32 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +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 authorised 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 hard capsules
Lithuania
Poland 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 hard capsules

For further information about this medicine, please contact the Marketing Authorisation Holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw