500 mg film-coated tablets
paracetamol
What Paracetamol NET is and what it is used for
Paracetamol Net contains paracetamol which belongs to a group of medicines called analgesics (painkillers).
Paracetamol Net is used to treat temporary fever and pain conditions of a mild nature, such as fever in the common cold, headache, toothache, menstrual pain, and muscle and joint pain.
Paracetamol Net can be used by people with sensitive stomachs or ulcers and people with an increased tendency to bleed. You must talk to a doctor if you do not feel better or if you feel worse after 3 days with fever and 5 days with pain.
Paracetamol contained in Paracetamol Net may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Paracetamol NET
Do not use Paracetamol NET
– if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
– if you have severe hepatic impairment.
Warnings and cautions
– Do not use Paracetamol Net without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Paracetamol Net with alcohol. The intoxicating effect of alcohol does not increase with the addition of Paracetamol Net.
Ask your doctor for advice before using Paracetamol Net:
– if you have kidney or liver disease (including Gilbert’s syndrome or hepatitis)
– if you have alcohol problems, do not use Paracetamol Net without a doctor’s prescription.
– if you are dehydrated or malnourished, for example, due to alcohol abuse, anorexia, or incorrect diet
– if you have anemia ( red blood cell breakdown )
– if you are deficient in an enzyme called glucose -6-phosphate dehydrogenase – if you are taking other medicines that affect the liver
– if you use painkillers often and for a long time, long-term use can cause severe or recurrent headaches. You should then avoid increasing the dose of one of the painkillers and instead contact your doctor for advice
– if you have asthma and at the same time are hypersensitive to acetylsalicylic acid.
If you are taking other painkillers that contain paracetamol, do not use Paracetamol Net without talking to your doctor or pharmacist first.
Warning: Never take more Paracetamol Net than stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but instead carry the risk of very serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose.
Children and young people
Children under 40 kg (under 12 years):
Contact a doctor before using Paracetamol Net if:
– the child is difficult to carry or has abdominal pain, neck stiffness, or back pain.
– the child has severe problems with the ears, throat,t, or trachea.
If the child has a fever, contact a doctor if:
the child has not drunk any fluid or lost a large amount of fluid due to persistent vomiting or diarrhea.
– the treatment has not had any effect on the pain or fever after the first 24 hours.
– new symptoms appear or stomach pain/stomach upset worsens or lasts a long time.
Other medicines and Paracetamol NET
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Paracetamol Net may affect or be affected by certain medicines / traditional herbal medicines:
Chloramphenicol for injection (medicine for bacterial infections. However, chloramphenicol against infection in your eye can be used.
– Metoclopramide or domperidone (for nausea and vomiting), may enhance the effect of paracetamol.
– Cholestyramine (to lower cholesterol) and medicines that delay stomach emptying, as these may weaken the effect of paracetamol.
– Warfarin (blood thinner). Contact your doctor if you take more than 4 tablets of Paracetamol Net (500 mg) per day for more than 3 consecutive days. There is a risk that the effect of warfarin will be affected.
– Probenecid (treatment of eg gout ), dose one of Paracetamol Net may need to be reduced.
Medicines that may damage the liver, such as:
phenobarbital or carbamazepine (treatment of mental illness and epilepsy ).
– rifampicin (against bacterial infections)
– isoniazid (treatment of tuberculosis )
– phenytoin (treatment of epilepsy )
St. Joh’s wort (Hypericum perforatum) (treatment of depression).
Therefore, consult your pharmacist or treating physician before using Paracetamol Net with any of these medicines.
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Paracetamol can affect uric acid tests and blood sugar tests.
Paracetamol NET with alcohol
Concomitant use of Paracetamol Net and alcohol consumption should be avoided. The intoxicating effect of alcohol is not increased by the addition of paracetamol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If necessary, Paracetamol Net can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain and/or fever do not decrease or if you need to take the medicine more often.
No effects on the ability to drive or perform precision work have been observed. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are not sure. Going into breast milk, but not likely to affect breastfed infants. However, consult a physician if more than temporary use of Paracetamol Net during breast-feeding
Driving and using machines
No effects on the ability to drive or perform precision work have been observed. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Paracetamol NET
Note! Higher doses than those recommended carry a risk of very serious liver damage.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The tablet should be swallowed with a glass of water.
The tablet can be divided into two equal doses.
The recommended dose is:
Adults and adolescents over 40 kg (over 12 years): 1-2 tablets every 4-6 hours, maximum 8 tablets per day. Contact a doctor if the symptoms worsen or do not improve within 3 days in case of fever and 5 days in case of pain.
Children under 40 kg (under 12 years): For children, a dose should be given based on the child’s weight (age indication is approximate). Children 15-25 kg (approx. 3-7 years): ½ tablet every 4-6 hours, maximum 2 tablets per day. Children 25-40 kg (approx. 7-12 years): ½-1 tablet every 4-6 hours, maximum 4 tablets per day.
Do not use Paracetamol Net in children under 12 years of age for more than 2 days unless your doctor prescribes otherwise.
Patients with impaired renal or hepatic function
The dose should be reduced or the time between doses extended in patients with impaired renal or hepatic function and patients with Gilbert’s syndrome. In patients with severe renal impairment, at least 8 hours should elapse between two doses. Consult your doctor or pharmacist.
Older
A normal adult dose is usually appropriate. However, in some debilitated elderly patients, a lower dose or a longer period between doses may be appropriate.
Patients with chronic alcoholism
Chronic alcohol abuse can increase the risk of paracetamol poisoning. The time between two doses should be at least 8 hours. Do not exceed 2 g paracetamol per day.
Paracetamol Net film-coated tablets are provided with a film coating that becomes slippery upon contact with the saliva and thus it is easier to swallow the tablet, while the characteristic taste of paracetamol is hidden.
If you use more Paracetamol NET than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
Seek immediate contact with healthcare in case of overdose. There is a risk of liver damage even if you feel well, as symptoms of liver damage usually do not appear until after a few days.
To prevent possible liver damage, an antidote must be used as early as possible. Symptoms of overdose include nausea, vomiting, anorexia (no appetite) pallor, and abdominal pain. These symptoms usually appear within 24 hours after ingestion.
If you forget to use Paracetamol NET
Do not take a double dose to make up for a forgotten tablet.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Paracetamol Net and contact your doctor immediately or see your nearest hospital if you get any of the following serious side effects:
– swelling of the face, tongue, or throat, difficulty swallowing; hives, and difficulty breathing ( angioedema ) (a rare side effect )
– severe allergic reaction or hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure (anaphylactic shock, occurring in an unknown number of users)
– severe skin reactions (a very rare side effect )
Rare side effects (affects less than 1 user in 1,000):
Disorders of platelets (affects the ability of the blood to clot), disorders of stem cell function (disorders of cells formed in the spinal cord)
– Allergic reactions
– Depression, confusion, hallucinations
Shaking, headache
– Visual disturbances
Edema ( abnormal accumulation of fluid under the skin)
– Stomach pain, bleeding in the stomach or intestines, diarrhea, nausea, vomiting
– Disrupted liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver necrosis (liver cells die)
– Skin rash, itching, sweating, hives, red spots on the skin
– Dizziness, malaise, fever, fatigue, interaction with other medicines
– Overdose and poisoning
Very rare side effects (affects less than 1 user in 10,000):
– Breathing difficulties with shortness of breath – Changes in the blood picture (decreased number of platelets, decreased number of white and red blood cells )
– Low levels of glucose in the blood
– Poisoning of the liver (damage to the liver caused by chemical substances)
Turbid urine and kidney disease
Has been reported (occurs in an unknown number of users):
Accumulation of fluid in the larynx
– Anemia (decreased number of red blood cells )
– Hepatic changes and hepatitis (inflammation of the liver)
Renal changes (severe renal impairment, blood in the urine, difficulty in urinating)
A disease of the stomach or intestines
– Fraud
How to store Paracetamol NET
Keep this medicine out of the sight and reach of children and adolescents.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. data. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is paracetamol. One film-coated tablet contains 500 mg of paracetamol.
The other ingredients are the Core of the tablet: Pregelatinized starch, magnesium stearate; film-coating: Hypromellose, macrogol, propylene glycol, titanium dioxide (E171), and talc.
What the medicine looks like and the contents of the pack
White to off-white capsule-shaped tablets with a scoreline on one side.
Packaging:
Blister: 1, 10, and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Evolan Pharma AB
Box 120
182 12 Danderyd
Tel.:08-544 960 30