Coldrex Maxgrip C

Leaflet attached to the packaging: information for the user

COLDREX MAXGRIP C, tablets

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Coldrex MaxGrip C and what is it used for
• 2. Important information before taking Coldrex MaxGrip C
• 3. How to take Coldrex MaxGrip C
• 4. Possible side effects
• 5. How to store Coldrex MaxGrip C
• 6. Contents of the pack and other information

1. What is Coldrex MaxGrip C and what is it used for

Coldrex MaxGrip C tablets contain the following active substances: paracetamol, phenylephrine hydrochloride, caffeine, terpine hydrate, and vitamin C.

• Paracetamol- has analgesic and antipyretic effects
• Phenylephrine- constricts blood vessels and decongests nasal passages
• Caffeine- enhances the analgesic effect of paracetamol
• Terpine hydrate- has an expectorant effect
• Vitamin C- a vitamin whose deficiency may occur in the first days of a cold or flu.

Indications for use

Treatment of cold and flu symptoms, such as: fever, chills, headache, sore throat, bone and muscle pain, runny nose.

2. Important information before taking Coldrex MaxGrip C

When not to take Coldrex MaxGrip C:

• if the patient is allergic to paracetamol, caffeine, phenylephrine, terpine hydrate, vitamin C, or any of the other ingredients of this medicine (listed in section 6).
• in patients with liver or severe kidney failure,
• in patients with alcoholism,
• in patients taking zidovudine (used to treat HIV infections),
• in patients taking monoamine oxidase inhibitors (MAOIs) and within 2 weeks of their last use. Do not give to children under 12 years of age.

Warnings and precautions

Do not take with other medicines containing paracetamol

and/or sympathomimetics (such as decongestants, appetite suppressants, and psychostimulants similar to amphetamine) or medicines used to treat colds and flu.

The medicine contains paracetamol.

Overdose of paracetamol can lead to severe liver damage.
The medicine should not be taken at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms or to aid sleep.
One should read the leaflet before taking the medicine and follow the recommendations contained therein.
Before taking the medicine, one should consult a doctor in case of:

• liver or kidney disease, as liver disease increases the risk of liver damage from paracetamol.
• patients who are underweight or malnourished,
• patients who regularly consume alcohol; in such cases, taking the medicine may be contraindicated or the dose may need to be reduced.
• high blood pressure, heart disease, vascular disease such as Raynaud's syndrome (characterized by episodic finger pain caused by cold or emotion),
• diabetes,
• hyperthyroidism,
• glaucoma (a disease characterized by progressive eye damage and consequent vision impairment or loss),
• chromaffin tumor of the adrenal gland,
• prostate enlargement,
• use of beta-blockers and other blood pressure-lowering medications (debrisoquine, guanethidine, reserpine, methyldopa),
• respiratory function disorders (pulmonary emphysema, chronic bronchitis),
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• severe infection, which may increase the risk of metabolic acidosis characterized by, among other things:
• deep, rapid, and labored breathing,
• nausea, vomiting, and/or loss of appetite,
• general poor condition. One should immediately consult a doctor if the patient experiences the above symptoms simultaneously.

During treatment with Coldrex MaxGrip C, one should immediately inform their doctor if they have severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they 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, feeling of nausea (nausea) and vomiting.
During treatment with the medicine, one should not drink alcohol due to the increased risk of liver damage. Liver damage is possible in individuals who have consumed more than 10 g of paracetamol at once or more. Consuming 5 g of paracetamol may lead to liver damage in patients with the following risk factors:

• Patient taking carbamazepine, phenobarbital, phenytoin, primidone (medicines used, among other things, in epilepsy), rifampicin (a medicine used, among other things, in tuberculosis), St. John's Wort (used, among other things, in depression), or other medicines that induce liver enzymes.
• Patient regularly abusing alcohol.
• Patient who may have a glutathione deficiency, e.g., with appetite disorders, cystic fibrosis, HIV infection, starvation, or exhaustion. In patients with liver disease, there is an increased risk of overdose.

The medicine contains caffeine. One should avoid excessive consumption of coffee, tea, or caffeine-containing beverages while taking the medicine.

Children

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

Coldrex MaxGrip C and other medicines

One should inform their doctor about all medicines taken recently, even those that are available without a prescription.
One should consult a doctor when taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulant medicines (e.g., warfarin) in case of a need for long-term use of a pain medicine,
• sleeping pills, antiepileptic drugs, rifampicin (an antitubercular medicine),
• MAOIs (used, among other things, in depression) and other antidepressant medicines (from the group of tricyclic antidepressants),
• estrogens and progesterone (sex hormones),
• lithium salts (used, among other things, in depression, mania),
• disulfiram (used, among other things, in the treatment of alcoholism),
• non-steroidal anti-inflammatory medicines (e.g., acetylsalicylic acid),
• ergot alkaloids (used, among other things, in migraine),
• certain medicines used in heart disease or high blood pressure (i.e., digoxin, beta-adrenolytics, methyldopa),
• use of appetite suppressants, nasal decongestants, and psychostimulants similar to amphetamine (e.g., used in hyperactivity with attention disorders),
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).

Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
Phenylephrine may enhance the blood pressure-increasing effect of medicines that accelerate childbirth.
Vitamin C increases the absorption of iron and aluminum from medicines that neutralize them.

Coldrex MaxGrip C with food, drink, and alcohol

Excessive consumption of coffee or tea while taking the medicine may cause a feeling of tension and irritability. During treatment with the medicine, one should not drink alcohol - see "Warnings and precautions" above.

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.
This medicine should not be taken during pregnancy or breastfeeding without consulting a doctor. Taking phenylephrine hydrochloride during pregnancy may cause congenital malformations and may also cause fetal hypoxia. Phenylephrine may pass into breast milk.
There is no data on the effect of Coldrex MaxGrip C on fertility.

Driving and using machines

The medicine may cause dizziness. If such symptoms occur, one should not drive vehicles or operate machines.
The medicine contains Eurocol Sunset Yellow(a mixture of Eurocol Sunset Yellow E110 + sodium chloride)
It may cause allergic reactions.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Coldrex MaxGrip C

This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor, pharmacist, or nurse. In case of doubt, one should consult a doctor, pharmacist, or nurse.

Use in adults and children over 12 years of age

Orally 2 tablets, to be taken up to 4 times a day. The medicine should not be taken more frequently than every 4 hours, and no more than 8 tablets should be taken in 24 hours.
Do not take a higher dose than recommended.
One should always use the smallest effective dose of the medicine.
The medicine should not be taken for more than 3 days without consulting a doctor.
If the symptoms of the disease persist, one should consult a doctor.
If one feels that the effect of the medicine is too strong or too weak, they should consult a doctor.

Taking a higher dose of Coldrex MaxGrip C than recommended

In case of taking a higher dose than recommended, one should immediately consult a doctor, even if no side effects occur, due to the risk of delayed, severe liver damage.

Missing a dose of Coldrex MaxGrip C

One should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
One should stop taking the medicine and consult a doctor immediately if they experience:

• an allergic reaction (hypersensitivity), such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin rash or severe skin reaction characterized by acute generalized pustular rash or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or large blisters under the skin, extensive erosions on the skin, and fever,
• breathing difficulties, in case of similar problems in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines,
• bruises or bleeding of unknown cause,
• vision loss, which may be caused by excessively high intraocular pressure. This is very rare but possible in patients with glaucoma,
• abnormal rapid heartbeat or feeling of irregular heartbeat,
• difficulty urinating, urinary retention. This is more likely in men with prostate enlargement,
• liver function disorders.

The above reactions occur rarely (more often than 1 in 10,000 patients but less often than 1 in 1,000 patients) or very rarely (less often than 1 in 10,000 patients).
Coldrex MaxGrip C may also cause the following side effects:
very rarely (affecting less than 1 in 10,000 patients)

• headache,
• dizziness,
• insomnia,
• nervousness,
• increased blood pressure,
• nausea and vomiting.

frequency not known (cannot be estimated from the available data)

• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Excessive consumption of coffee or tea while taking the medicine may cause a feeling of tension, irritability, insomnia, anxiety, headaches, stomach and intestinal disorders, abnormal rapid heartbeat, or feeling of irregular heartbeat.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, one should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181c, 02-222 Warsaw, tel.: +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 the medicine.

5. How to store Coldrex MaxGrip C

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.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. One should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Coldrex MaxGrip C contains

• The active substances of the medicine are: paracetamol, caffeine, phenylephrine hydrochloride, terpine hydrate, and vitamin C. Each tablet contains 500 mg of paracetamol, 25 mg of caffeine, 5 mg of phenylephrine hydrochloride, 20 mg of terpine hydrate, and 30 mg of vitamin C.
• The other ingredients are: cornstarch, soluble starch, talc, stearic acid, povidone, potassium sorbate, sodium lauryl sulfate, Eurocol Sunset Yellow: a mixture (Eurocol Sunset Yellow E110) + sodium chloride).

What Coldrex MaxGrip C looks like and what the pack contains

Coldrex MaxGrip C is in the form of oval, two-layer tablets.
The packaging contains 12 or 24 tablets.

Marketing authorization 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
Nazareth, 9810
Belgium
Perrigo Supply Chain International Designated Activity Company
The Sharp Building
Hogan Place
Dublin 2
Dublin, D02 TY74, Ireland

Date of last revision of the leaflet:

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.