Coldrex Maxgrip

Leaflet accompanying 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.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a 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 and flu.

Indications for use

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

2. Important information before taking Coldrex MaxGrip C

When not to take Coldrex MaxGrip C:

• if you are 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 alcoholic disease,
• 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.

Paracetamol overdose may lead to severe liver damage.
Do not take this medicine 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.
Read the leaflet before taking the medicine and follow the instructions in it.
Consult your doctor before taking the medicine if you have:

• liver or kidney disease, as liver disease increases the risk of liver damage from paracetamol.
• you are underweight or malnourished,
• you regularly consume alcohol, in which case 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),
• phaeochromocytoma (a tumor of the adrenal gland),
• prostatic hyperplasia,
• taking beta-blockers and other blood pressure lowering medicines (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. You should immediately consult a doctor if you experience the above symptoms simultaneously.

While taking Coldrex MaxGrip C, you should immediately inform your doctor if you have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you 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.
Do not drink alcohol while taking the medicine due to the increased risk of liver damage. Liver damage is possible in people who have consumed more than 10g of paracetamol at once or more. Consuming 5g 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 liver enzyme-inducing medicines.
• Patient regularly abusing alcohol.
• Patient who may have a glutathione deficiency, e.g., with appetite disorders, cystic fibrosis, HIV infection, starvation, or exhaustion. In people with liver disease, there is an increased risk of overdose.

The medicine contains caffeine. You 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

Tell your doctor about all the medicines you have taken recently, even those that are available without a prescription.
Consult your doctor if you are 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 painkillers,
• sleeping pills, antiepileptics, rifampicin (an antitubercular medicine),
• MAOIs (used, among other things, in depression) and other antidepressants (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),
• nonsteroidal anti-inflammatory medicines (e.g., acetylsalicylic acid),
• ergot alkaloids (used, among other things, in migraines),
• certain medicines used in heart diseases or hypertension (e.g., digoxin, beta-adrenergic blockers, methyldopa),
• 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 treated urgently (see section 2).

Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
Phenylephrine may enhance the blood pressure-raising 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. Do not drink alcohol while taking the medicine - see "Warnings and precautions" above.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy or breastfeeding without consulting a doctor. The use of 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 you experience such symptoms, do not drive or operate machinery.
The medicine contains Eurocol Sunset Yellow(a mixture of Eurocol Sunset Yellow E110 + sodium chloride)
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
your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse.

Use in adults and children over 12 years of age

Orally, 2 tablets, up to 4 times a day. Do not take the medicine more frequently than every 4 hours or take more than 8 tablets in 24 hours.
Do not exceed the recommended dose.
Always use the lowest effective dose of the medicine.
Do not take the medicine for more than 3 days without consulting a doctor.
If the symptoms of the disease persist, consult a doctor.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Taking a higher dose of Coldrex MaxGrip C than recommended

If you have taken a higher dose than recommended, seek medical advice immediately, even if you do not experience any side effects, due to the risk of delayed, severe liver damage.

Missing a dose of Coldrex MaxGrip C

Do 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.
Stop taking the medicine and consult your doctor if you 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, mouth, eyes, and genitals, fever, and joint pain or large blisters under the skin, extensive erosions on the skin, and fever,
• breathing difficulties, if you have experienced such problems in the past when taking acetylsalicylic acid or other nonsteroidal 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 people with glaucoma,
• abnormal heart rhythm or feeling of irregular heartbeat,
• difficulty urinating, urinary retention. This is more likely in men with prostatic hyperplasia,
• 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, gastrointestinal disorders, or abnormal heart rhythm.

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 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 to gather more information on the safety of the medicine.

5. How to store Coldrex MaxGrip C

Keep the medicine out of the 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. 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 MaxGrip C contains

• The active substances of the medicine are: paracetamol, caffeine, phenylephrine hydrochloride, terpine hydrate, and ascorbic acid (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 ascorbic acid (vitamin C).
• The other ingredients are: corn starch, 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 contents of the pack

Coldrex MaxGrip C is in the form of oval, two-layer tablets.
The pack 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.