Coldrex complex grip

Coldrex Complex Grip
500 mg + 200 mg + 10 mg, powder for oral solution
Paracetamolum + Guaifenesinum + Phenylephrini hydrochloridum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet, so that you may read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Leaflet 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. Package contents and other information

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

This medicine contains :

• Paracetamol, a substance with analgesic and antipyretic properties, used to relieve pain and reduce fever.
• Guaifenesin, an expectorant that helps loosen mucus and facilitate its expulsion.
• Phenylephrine hydrochloride, a vasoconstrictor that reduces nasal congestion and helps clear nasal passages.

The sachets are intended for short-term, symptomatic relief of cold and flu symptoms such as pain, headache, nasal congestion, sore throat, chills, fever, and to aid expectoration in productive cough (wet cough).
This medicine should only be used when all of the following symptoms are present: pain and/or fever, nasal congestion, and productive cough.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important Information Before Using Coldrex Complex Grip

When not to use 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 conditions or cardiovascular disorders, or blood disorders such as hemolytic anemia (abnormal breakdown of red blood cells leading to weakness or pale skin)
• in patients with high blood pressure (hypertension)
• in patients with hyperthyroidism
• in patients with diabetes
• in patients with pheochromocytoma (a rare tumor of adrenal gland tissue)
• in patients with glaucoma, including angle-closure glaucoma (eye damage caused by sudden increase in intraocular pressure due to blocked fluid drainage)
• in patients experiencing difficulty urinating or inability to fully empty the bladder
• in patients taking antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), or who have taken them within the last 14 days – such medicines include phenelzine and isocarboxazid
• in patients taking tricyclic antidepressants (e.g. amitriptyline)
• in patients taking beta-blockers
• in patients taking other medicines containing paracetamol
• in patients currently taking other vasoconstrictor medicines (e.g. ephedrine, xylometazoline), or medicines suppressing or stimulating appetite (e.g. amphetamine-like drugs)
• in patients taking medicines for suppressing dry cough.

Warnings and Precautions
Before starting to use Coldrex Complex Grip, consult your doctor or
pharmacist if:

• the patient has a very strong cough or a cough accompanied by fever, rash, or persistent headache. Consult a doctor if the cough lasts longer than 3 days or recurs.
• the patient has asthma and is sensitive (allergic) to aspirin
• the patient has circulatory disorders such as Raynaud's phenomenon, which results from poor circulation in fingers and toes
• the patient has angina pectoris
• the patient has kidney disease
• the patient has an enlarged prostate gland, which may cause difficulty urinating
• the patient has serious stomach or intestinal problems
• the patient has a circulatory system disorder
• the patient suffers from chronic alcoholism, malnutrition, or dehydration
• the patient has Gilbert's syndrome (hereditary non-haemolytic jaundice)
• the patient has myasthenia gravis, an autoimmune disease
• the patient is elderly, an adult, or an adolescent weighing less than 50 kg
• the patient has glutathione deficiency (a disorder preventing glutathione production)
• the patient has glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency in red blood cells)
• the patient is concurrently taking medicinal products affecting liver function

During treatment with Coldrex Complex Grip, contact your doctor immediately if:
The patient has severe medical conditions, including severe kidney dysfunction or sepsis
(bacteria and their toxins circulating in the blood, leading to organ damage), malnutrition,
chronic alcoholism, or is also taking flucloxacillin (an antibiotic). In these
situations, severe adverse effects known as metabolic acidosis
(an abnormality in blood and body fluids) have been reported in patients taking paracetamol
regularly over a long period or in combination with flucloxacillin. Symptoms of metabolic
acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children
This medicine must not be given to children under 12 years of age.

Coldrex Complex Grip and Other Medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken, including those obtained without a prescription.
Coldrex Complex Grip may interact with certain medicines:

• medicines used to treat high cholesterol levels that reduce blood fats, such as cholestyramine
• medicines used to control nausea or vomiting, such as metoclopramide or domperidone
• anticoagulants (blood thinners), such as warfarin or other coumarins – occasional paracetamol doses may be taken, but regular use requires medical advice
• barbiturates (used in epilepsy treatment or to aid sleep), such as phenobarbitone
• tricyclic antidepressants, such as imipramine, amitriptyline
• monoamine oxidase inhibitors (including moclobemide)
• medicines used to treat heart or circulatory diseases, or those lowering blood pressure (e.g. cardiac glycosides such as digitalis glycosides, digoxin, debryzoquine, guanethidine, reserpine, methyldopa)
• beta-blockers (e.g. atenolol)
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)
• medicines used to treat migraine (e.g. ergotamine and methysergide)
• zidovudine, as it may cause blood disorders (low white blood cell count)
• phenothiazines used as tranquilizers (e.g. chlorpromazine, periciazine, fluphenazine)
• probenecid (a medicine used to treat gout and hyperuricemia)
• chloramphenicol (an antibiotic)
• sympathomimetic amines (e.g. phenylephrine)
• flucloxacillin (an antibiotic), due to serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Inform your doctor if:

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

Other Important Information:

• Do not use for longer 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 productive cough.
• Use only medicines intended for the symptoms actually present.
• Do not use together with other flu, cold, or decongestant medicines.
• Long-term use of any pain-relieving medicines for headaches may worsen them. If this occurs or is suspected, consult a doctor and discontinue treatment.
• Do not take with other medicines containing paracetamol.

Pregnancy, Breastfeeding, and Fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Coldrex Complex Grip must not be used during pregnancy or while breastfeeding.

Driving and Operating Machinery

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

Coldrex Complex Grip contains sucrose, aspartame, and sodium.

• Contains 2.1 g of sucrose (sugar) per sachet. If the patient has been previously diagnosed with an intolerance to certain sugars, consult a doctor before use. This should be considered in diabetic patients.
• Contains 12 mg of aspartame (E951) per sachet. Aspartame is a source of phenylalanine. This may be harmful for patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
• Contains 129.5 mg of sodium (the main component of table salt) per sachet. This corresponds to 6.5% of the recommended maximum daily dietary sodium intake for an adult.

3. How to use Coldrex Complex Grip

This medicine should always be used exactly as described in this patient information leaflet or
as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Empty the contents of 1 sachet into a standard-sized cup. Fill the cup with 250 ml of hot, but not
boiling, water. Stir until dissolved and allow to cool to a drinkable temperature. Drink the solution within 1½ hours.
Recommended dose
Adults, elderly patients, and adolescents aged 12 years and over:
1 sachet every 4 hours, if needed. Do not use more than 4 sachets (4 doses) in any 24-hour period.
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 more Coldrex Complex Grip than recommended
Coldrex Complex Grip contains paracetamol.
In case of overdose, seek immediate medical advice even if the patient feels well. This is because excessive amounts of paracetamol may cause delayed, serious liver damage. Go to the nearest hospital, taking the medicine and this leaflet with you.
If you forget to take Coldrex Complex Grip
Do not take a double dose to make up for a missed dose.
Do not exceed the recommended dose stated in the leaflet.
If you have any further doubts 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.

Serious adverse effects

• Allergic reactions, which may be sudden and severe, manifesting as difficulty breathing, swelling, dizziness, sweating, and loss of consciousness.
• Very rare cases of serious skin reactions have been reported, including life-threatening reactions with flu-like symptoms and blistering or painful rash on the skin, in the mouth, eyes, and genital organs. Sudden blisters over large areas of skin. Skin inflammation • shortness of breath
• Decrease in platelet count, increasing the risk of bleeding or bruising
• Significant decrease in white blood cell count, which may lead to serious infections
• Sudden inflammation of the pancreas causing severe abdominal and back pain
• Optic nerve damage due to rapid increase in intraocular pressure when fluid cannot drain properly

Other adverse effects
Rare: may occur in not more than 1 in 1,000 patients

• Abdominal pain and discomfort
• Diarrhea
• Rapid heartbeat
• Increased awareness of heartbeat (palpitations)
• Eye disorders such as constriction/dilation of pupils
• Problems with urination or inability to completely empty the bladder
• Malaise
• Vomiting
• Urticaria (hives)
• Rash

Very rare: may occur in not more than 1 in 10,000 patients

• Liver problems
• Itching
• Sweating
• Rash with raised red or purple spots resembling small bruises or blood spots
• Cloudy urine

Frequency not known: cannot be estimated based on available data

• Nervousness, irritability, anxiety, or agitation
• Sleep disturbances (insomnia)
• Headache
• High blood pressure
• Serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

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 at 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 to provide more information on the safety of the medicine.

5. How to store Coldrex Complex Grip

This medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date (EXP) stated on the carton and sachet. 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

• The active substances 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 flavour (powder), lemon flavour, lemon juice flavour, quinoline yellow (E 104).

What Coldrex Complex Grip looks like and contents of the pack
This medicine is a whiteish powder with a characteristic citrus-menthol odour,
packed into single sachets containing 4.4 g of powder.
The medicine is available in packs containing 5, 6 or 10 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warszawa
tel.: +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 authorised in the European Economic Area countries 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