Coldrex MaxGrip flu cold lemon flavor 14 sachets

Producer:

OMEGA PHARMA POLAND SP Z OO

Coldrex MaxGrip

(1000 mg + 10 mg + 40 mg) / sachet, powder for oral solution

Paracetamolum + Phenylephrini hydrochloridum + Acidum ascorbicum

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

Coldrex MaxGrip is a drug with analgesic and antipyretic effects, constricting blood vessels of the nasal mucosa and reducing its congestion, and as a result unblocking the nose and sinuses. The drug contains vitamin C.

Coldrex MaxGrip is indicated for short-term, symptomatic treatment of influenza or cold, accompanied by fever, chills, headache, sore throat and rhinitis (runny nose).

If after 3 days there is no improvement or the patient feels worse, contact your doctor.

2. Important information before using Coldrex MaxGrip

When not to use Coldrex MaxGrip:

– if you are allergic to paracetamol, phenylephrine, ascorbic acid or any of the other ingredients of this medicine (listed in section 6).

– in people with liver failure or severe kidney failure,

– in people with alcoholism,

– in people taking zidovudine (used to treat HIV infection),

– in people taking monoamine oxidase inhibitors (MAO) and within 2 weeks after their last use.

Do not give to children under 12 years of age.

Warnings and precautions

Do not use with other medicinal products containing paracetamol and/or sympathomimetics (such as nasal decongestants, appetite suppressants and amphetamine-like psychostimulants) or medicinal products for colds and flu.

The medicine contains paracetamol.

Paracetamol overdose can lead to severe liver damage.

The medicine should not be used concomitantly with other medicines containing paracetamol, such as painkillers, antipyretics, medicines used to treat flu and cold symptoms.

Please read the leaflet before using the medicine and follow the instructions contained therein.

Before using the medicine, consult your doctor if:

– liver or kidney diseases,

– underweight or malnourished patients,

– patients who regularly consume alcohol.

In such cases, the drug may not be recommended or a dose reduction may be necessary.

– severe infection, which may increase the risk of metabolic acidosis, including:

– deep, rapid and difficult breathing,

– nausea, vomiting and/or loss of appetite,

– generally feeling unwell.

You should contact your doctor immediately if you experience the symptoms described above at the same time.

– high blood pressure, heart disease, vascular diseases such as

Raynaud’s disease (characterized by attacks of pain in the fingers caused by cold or emotion),

– diabetes,

– hyperthyroidism,

– glaucoma (a disease characterized by progressive damage to the eye and consequently deterioration or loss of vision),

– pheochromocytoma of the adrenal gland,

– prostate gland hyperplasia,

– deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase).

You should not drink alcohol while taking this medicine due to the increased risk of liver damage.

Liver damage is possible in people who have taken 10 g or more of paracetamol at one time. Ingestion of 5 g of paracetamol may lead to liver damage in patients with the following risk factors:

– Patients taking long-term carbamazepine, phenobarbital, phenytoin, primidone (drugs used, among others, in epilepsy), rifampicin (drugs used, among others, in tuberculosis), St. John’s wort (used, among others, in depression) or other drugs that induce liver enzymes.

– Patients who regularly abuse alcohol.

– Patients who may be glutathione deficient, e.g. with eating disorders, cystic fibrosis, HIV infection, starving or emaciated.

People with liver disease are at increased risk of overdose.

Kids

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

Coldrex MaxGrip and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.

You should consult your doctor if you are taking the following medications:

– metoclopramide, domperidone (used against nausea and vomiting),

– cholestyramine (used to reduce high levels of cholesterol in the blood),

– anticoagulant drugs (e.g. warfarin) if long-term use of pain medication is necessary,

– sleeping pills, antiepileptic drugs, rifampicin (antituberculosis drug),

– MAO inhibitors (used, among others, in depression) and other antidepressants (from the group of tricyclic antidepressants),

– non-steroidal anti-inflammatory drugs (including acetylsalicylic acid),

– ergot alkaloids (used, among others, for migraines),

– certain medicines used to treat heart disease or high blood pressure (e.g. digoxin, beta-blockers, methyldopa).

– use of appetite suppressants, nasal decongestants and psychostimulants derived from amphetamines (e.g. used in hyperactivity with attention disorders),

– flucloxacillin (antibiotic), due to a serious risk of a disorder affecting the blood and body fluids (high anion gap metabolic acidosis), which must be treated urgently and which may occur especially in patients with severe kidney problems, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to

organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

The use of paracetamol may cause false results in some laboratory tests (e.g. blood glucose testing).

Phenylephrine may enhance the blood pressure-increasing effects of labor-inducing drugs.

Caffeine enhances the analgesic effect of paracetamol.

Ascorbic acid increases the absorption of iron, increases the absorption of aluminum from antacid preparations containing it.

COLDREX MAXGRIP and pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine should not be used during pregnancy or breast-feeding without consulting your doctor. Phenylephrine hydrochloride given during pregnancy causes

congenital defects, and may also cause fetal hypoxia.

Phenylephrine may pass into breast milk.

There are no data on the effect of Coldrex MaxGip on fertility.

Driving and operating machinery

The medicine may cause dizziness. If you experience these symptoms, do not drive or operate machinery.

Important information about some of the ingredients of Coldrex MaxGrip:

– 1 sachet contains 129.15 mg of sodium, to be taken into account in patients with reduced renal function and in patients controlling the sodium content in the diet.

– 1 sachet contains 3.73 g of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to use Coldrex MaxGrip

Always use this medicine exactly as described in the package leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor, pharmacist or nurse.

Use in adults and adolescents over 12 years of age:

One sachet of Coldrex MaxGrip every 4 to 6 hours. Do not take the medicine more often than every 4 hours or use more than 4 sachets in 24 hours. Do not use more than the recommended dose.

Always use the lowest possible effective dose of the medication.

Method of administration

Before administration, the powder should be dissolved in warm water.

Pour the contents of one sachet into a glass, fill halfway with warm water, mix well and drink. If necessary, add cold water or sweeten.

The medicine should not be used regularly for longer than 3 days without consulting a doctor.

If symptoms persist, consult a doctor.

If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.

Taking more than the recommended dose of Coldrex MaxGrip

If you take more than 4 sachets in 24 hours, you should seek immediate medical attention, even if you do not experience any side effects, because of the risk of delayed, serious liver damage.

Failure to take Coldrex MaxGrip

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 using the medicine immediately and consult a doctor if you experience:

– an allergic reaction such as skin rash or itching, sometimes with difficulty breathing or swelling of the lips, tongue, throat or face,

– severe skin reaction (acute generalized exanthematous pustulosis, bullous erythema multiforme (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell’s syndrome)), manifested by a rash with pustules all over the body, erosions in the mouth, eyes, genitals and skin, red spots on the trunk often with central blisters, giant blisters bursting, large flakes of skin peeling, weakness, fever and joint pain,

– breathing problems if you have experienced similar problems in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,

– bruising or bleeding of unknown cause,

– vision loss, which may be caused by excessively high intraocular pressure. This is very rare but is likely to happen in people with glaucoma,

– unusually fast heart rate or feeling of an irregular heartbeat,

– difficulty urinating. This is more likely in men with an enlarged prostate gland,

– liver function disorders.

The above reactions occur rarely (more than 1 in 10,000 but less than 1 in 1,000 patients) or very rarely (less than 1 in 10,000 patients).

Coldrex MaxGrip may also cause the following side effects: very rare (affecting less than 1 in 10,000 patients)

– headache,

– dizziness,

– insomnia,

– nervousness,

– increased blood pressure,

– nausea and vomiting.

Some people may experience other side effects while taking Coldrex MaxGrip. If you experience any other side effects not listed in this leaflet, please inform your doctor.

Reporting adverse reactions

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Adverse reactions 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

You can also report side effects to the responsible entity. By reporting side effects you can help gather more information on the safety of the medicine.

5. How to store Coldrex MaxGrip

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging.

Store at a temperature below 25oC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These actions will help protect the environment.

6. Package contents and other information

What does Coldrex MaxGrip contain?

The active substances of the drug are: paracetamol, phenylephrine hydrochloride and ascorbic acid (vitamin C). Each sachet contains 1000 mg of paracetamol, 10 mg of phenylephrine hydrochloride and 40 mg of ascorbic acid.

The other ingredients are: sucrose, anhydrous citric acid, sodium citrate, corn starch, sodium cyclamate, sodium saccharin, anhydrous colloidal silica, lemon flavour, curcumin (E100).

What does Coldrex MaxGrip look like and what does the package contain?

The medicine is a light yellow powder in sachets.

Before use, read the leaflet, which contains indications, contraindications, data on adverse effects and dosage, and information on the use of the medicinal product, or consult a doctor or pharmacist, as any drug used improperly may threaten your life or health.