ParacetaMax Grip 12 sachets

What is Influenza ParacetaMax 500 mg / 12,2 mg powder for oral solution is and what it is used
Influenza ParacetaMax 500 mg / 12,2 mg powder for oral solution contains acetaminophen analgesic that relieves pain and reduces body temperature and decongestant (tool that shrinks swollen nasal) phenylephrine, which unblocks the nose.
Influenza ParacetaMax 500 mg / 12,2 mg powder for oral solution is used in adults and adolescents over 16 years to relieve symptoms of colds and flu, including relieving pain, headaches, nasal congestion and lowering the temperature.
If after three days you do not feel better or your condition deteriorates, you should seek medical attention.

2. What you need to know before taking ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution
Do not take ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution:
if you are allergic to paracetamol and to fenilefrinov hydrochloride or any of the other ingredients of this medicine (listed in section 6);
if you have serious heart disease;
if you have high blood pressure;
if you have glaucoma (eye disease is often associated with an increase of the fluid pressure in the eye);
if you have overactive thyroid gland (hyperthyroidism);
if you are taking monoamine oxidase inhibitors (used to treat depression);
if you are taking tricyclic antidepressants (for depression) or have taken them within the last 14 days;
if you have severe liver disease (hepatic insufficiency);
if you suffer from acute inflammation of the liver (acute hepatitis);
if you suffer from alcohol abuse.
Warnings and Precautions
Talk to your doctor before taking ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution:
if you have Raynaud's syndrome - a condition caused by poor circulation in the fingers and toes;
if you have diabetes - a condition associated with high blood sugar;
If you suffer from moderate and severe renal insufficiency;
If you suffer from mild to moderate liver disease or being treated with drugs that affect liver function;
suffer from hemolytic anemia (decreased numbers of red blood cells which can lead to a pallor or yellowing of the skin, weakness or dyspnea);
if you suffer from dehydration;
If you suffer from chronic malnutrition;
if you have an enlarged prostate;
if you have a tumor of the adrenal glands (pheochromocytoma);
if you have low levels of glutathione;
if you have asthma and hypersensitivity to acetylsalicylic acid (a drug for pain relief or to thin the blood) is also possible you are hypersensitive to ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution.
important:
This product contains acetaminophen. Do not take concomitantly with other acetaminophen-containing products. Never take more ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution than recommended. Higher doses than those recommended not enhance analgesic effect, but can cause severe liver damage. Symptoms of liver damage are not usually occur within a few days. After an overdose is very important to seek medical help as quickly as possible, even if you feel well. Do not take with other products against flu, colds or decongestants.
Do not take any other products to unblock the nose simultaneously ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution.
Please contact your doctor if your symptoms do not ease or even worsen after treatment with ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution for 3 days.

Children and adolescents
Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution is indicated for use in adults and adolescents over 16 years of age.

Other medicines and ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution
Do not use ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution if you are taking monoamine oxidase inhibitors (MAOIs such as moclobemide or tranylcypromine) or tricyclic antidepressants (such as amitriptyline, amoxapine, clomipramine, desipramine and doxepin), used to treat depression or if you have taken them within the last 14 days.
Since both active substances ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution, phenylephrine hydrochloride and acetaminophen, may have adverse interactions with other drugs, please make sure that you tell your doctor about all other medicines you are taking currently and in particular:
Drugs that can interact with phenylephrine, such as drugs used to treat high blood pressure and heart problems or blood circulation, such as:
ephedrine, noradrenaline, dopamine;
drugs, such as hydralazine and minoxidil, which lowers blood pressure by widening the blood vessels;
beta blockers or other drugs to treat high blood pressure.
Drugs that may enhance the effects of phenylephrine on the blood vessels, such as:
digoxin (for the treatment of diseases of the heart);
tetracyclic antidepressants (for treating depression), such as maprotiline;
antidepressants such as phenelzine, izokarboksilna acid, nialamide;
drugs for Parkinson's disease, such as selegiline;
furazolidone (for bacterial infections).
Drugs that can interfere with the hepatic metabolism of the active substances of Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution, and may increase the toxic effects of paracetamol on the liver, such as:
alcohol;
barbiturates (sedatives);
anticonvulsants (for epilepsy), such as phenytoin, phenobarbital, primidone and phenobarbital methyl;
rifampicin (to treat tuberculosis);
probenecid (for gout).
Drugs that have an impact on the amount of acetaminophen in the body, such as:
anticholinergic drugs (eg. glikopironium, propantheline);
metoclopramide and domperidone (anti-nausea or vomiting);
cholestyramine (to reduce fat in the blood);
isoniazid (used to treat tuberculosis);
propranolol (used to treat high blood pressure);
warfarin and other coumarin (blood thinning) as their anticoagulant effect may increase the risk of bleeding to increase by prolonged regular daily use of paracetamol; Influenza doses ParatsetaMaks 500 mg / 12,2 mg powder for oral solution to be adopted from time to time have a real impact.
Regular use of acetaminophen may increase the toxic effects of zidovudine (AZT) (to treat HIV infection).
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

Influenza ParacetaMax 500 mg / 12,2 mg powder for oral solution with food, drinks and alcohol
Do not drink alcohol (eg wine, beer, spirits) while taking ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution.
The effect of alcohol will be enhanced with the addition of paracetamol, but alcohol may increase toxic effects of paracetamol on the liver.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution is not recommended for use during pregnancy or breastfeeding.

Driving and using machines
There are currently no reports of negative impact of Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution on ability to drive and use machines.

Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution contains sucrose, aspartame, sorbitol, and carbohydrates
This medicine contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria (an inherited metabolic disease).
This medicine contains sorbitol (E420) and sucrose.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
Each sachet contains approximately 1,9 g carbohydrates. This should be taken into account in patients with diabetes mellitus.

3. How to take ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution
Always take this medicine exactly as described in this leaflet or as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.

The recommended daily dose is:
Age Amount How often
Adults and adolescents over the age of 16. One sachet dose may be considered again after an interval of 4 to 6 hours.
Do not take more than 4 sachets for 24 hours.
It should be noted that the use of higher than recommended doses, can lead to risk of serious damage to the liver.

Method of administration
After dissolving in water taken orally.
Dissolve the contents of the sachet in half a glass of warm water (about 125 ml), but not boiling water. Stir slightly to dissolve and drink colorless solution.

Use in children and adolescents
Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution is not recommended for use in children below 16 years of age.

Elderly
There is no evidence to suggest that the dose needed to be changed in the elderly.

Patients with impaired hepatic or renal function
In patients with impaired renal or hepatic function and patients with Gilbert's syndrome, the interval between two doses should be extended. In patients with severely impaired renal function, the interval between two doses of Influenza ParatsetaMaks 500 mg / 12,2 mg powder for oral solution should be at least 8 hours. Consult your doctor or pharmacist.

If you take more than the amount ParatsetaMaks Influenza 500 mg / 12,2 mg powder for oral solution
Consult your doctor if you take too high quantity of this medication even if you feel well. This is necessary because very high amounts of acetaminophen can lead to later, severe liver damage.

If you forget to take ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution
Do not take a double dose to make up the missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most people have no problems, but some may occur.

Adverse effects of paracetamol and phenylephrine are summarized as follows:
paracetamol
Following administration of therapeutic doses, side effects of paracetamol are rare and clinically are mild.
Rare (may affect up to 1 in 1000 patients):
Blood and lymphatic system, diseases of the blood, which can occur with bruising, pallor or poor resistance to infection, blood disorders, including platelet disorders, reduction of certain blood cells (agranulocytosis, leukopenia, thrombocytopenia), hemolytic anemia , pancytopenia;
Hepatobiliary disorders: hepatic dysfunction (elevations in liver enzymes), liver failure, jaundice (yellowing of the skin or eyes);
Skin and subcutaneous tissue disorders: hypersensitivity reactions, including skin rash and hives, itching, sweating, purpura (minor bleeding), angioedema (sudden swelling of the skin and mucous membranes);
Immune system disorders: allergic reactions or hypersensitivity reactions, including skin rashes, hives, anaphylaxis (severe allergic reaction which causes difficulty in breathing or dizziness).
Very rare (may affect up to 1 in 10,000 patients):
Respiratory, thoracic and mediastinal disorders: bronchospasm (difficulty breathing or wheezing);
Renal and urinary: After prolonged use of high doses of paracetamol may occur sterile pyuria (urine that contains white blood cells, cloudy urine) and renal side effects;
Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen or back).
There have been rare cases of serious skin reactions.
Not known (from the available data can not be estimated):
Red skin rash, possibly with blisters, swelling of the throat, anaphylactic shock, anemia, changes in liver function and hepatitis, changes in kidney function (renal failure, blood in urine, difficulty urinating), gastrointestinal problems and dizziness.
phenylephrine
Common (may affect up to 1 in 10 patients):
Gastrointestinal disorders: loss of appetite, nausea and vomiting.
Rare (may affect up to 1 in 1000 patients):
Cardiac disorders: tachycardia (rapid heart rate), palpitations (sensation of rapid heart beat);
Vascular disorders: high blood pressure;
Immune system disorders: allergic reactions or hypersensitivity reactions, including skin rashes, hives, anaphylaxis (severe allergic reaction which causes difficulty in breathing or dizziness) and bronchospasm (difficulty breathing or wheezing).
Very rare (may affect up to 1 in 10,000 patients):
Nervous system disorders: insomnia (trouble sleeping), nervousness, tremor (shaking), can be observed anxiety, restlessness, confusion, irritability, dizziness and headache.

5. How to store ParacetaMax Influenza 500 mg / 12,2 mg powder for oral solution
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of that month.