Paracetamol Evolan 1 g Film Coated Tablets
What Is Paracetamol Evolan And What Paracetamol Evolan Used For
Paracetamol Evolan contains paracetamol which belongs to a group of medicines called analgesics (painkillers). Paracetamol Evolan is used for aches and pains of various kinds (eg headache, toothache, menstrual pain, muscle, and joint pain, and rheumatic pain) and fever (eg colds).
Paracetamol Evolan can be used by people with sensitive stomachs or stomach ulcers and people with an increased tendency to bleed.
Paracetamol contained in Paracetamol Evolan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What You Need To Know Before You Use Paracetamol Evolan
Do Not Use Paracetamol Evolan
- If you are allergic to paracetamol or any of the other ingredients of paracetamol evolan (listed in section 6).
- If you have severe hepatic impairment.
Warnings And Cautions
- Do not use Paracetamol Evolan without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Paracetamol Evolan with alcohol. The intoxicating effect of alcohol is not increased by the addition of Paracetamol Evolan.
Ask your doctor for advice before using Paracetamol Evolan:
- If you have kidney or liver disease (including Gilbert’s syndrome or hepatitis)
- If you have alcohol problems, do not use Paracetamol Evolan 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, as 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 Evolan without first talking to your doctor or pharmacist.
Warning: Never take Paracetamol Evolan more than what is stated in the dosing instructions or what your doctor has prescribed. 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
Paracetamol Evolan 1 g film-coated tablets are not recommended for children under 12 years of age.
Other Medicines And Paracetamol Evolan
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Paracetamol Evolan 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 the emptying of the stomach, as can weaken the effect of paracetamol.
- Warfarin (a blood thinner). Contact your treating physician if you take more than 2 tablets of Paracetamol Evolan (1 g) 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. John’s wort ( Hypericum perforatum) (treatment of depression).
Therefore, consult your pharmacist or treating physician before using Paracetamol Evolan 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 Evolan With Alcohol
Concomitant use of Paracetamol Evolan 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 paracetamol evolan.
If necessary, Paracetamol Evolan 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.
Transfers to breast milk, but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Paracetamol Evolan during breastfeeding.
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 Evolan
Note! Do not exceed the prescribed dose. Higher doses than those recommended carry a risk of very serious liver damage.
- Always use paracetamol evolan 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):
- ½ – 1 tablet every 4 – 6 hours, maximum 4 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.
- 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 Evolan film-coated tablets are provided with a film coating that becomes slippery on contact with the saliva and thus makes it easier to swallow the tablet, while at the same time hiding the characteristic taste of paracetamol.
If You Use More Paracetamol Evolan 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
- Abdominal pain
These symptoms usually appear within 24 hours after ingestion.
If You Forget To Use Paracetamol Evolan
Do not take a double dose to make up for a forgotten tablet.
Possible Paracetamol Evolan Side Effects
Like all medicines, paracetamol evolan can cause side effects, although not everybody gets them.
Stop taking Paracetamol Evolan 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
- Difficulty breathing (angioedema ) (a rare side effect )
- Severe allergic reaction or hypersensitivity reaction with fever
- Rash
- Swelling
- 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 (hepatitis)
- Renal changes (severe renal impairment, blood in the urine, difficulty in urinating)
- A disease of the stomach or intestines
- Dizziness
How To Store Paracetamol Evolan
- Keep this medicine out of the sight and reach of children and adolescents.
- Do not use paracetamol evolan after the expiry date which is stated on the carton/jar/blister after EXP. 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 1 g of paracetamol.
- The other ingredients are tablet core: 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.
- Pack sizes:
- Blisters: 1, 10, 20 and 30, 50, 100, 105 tablets.
- Tablet can: 100, 105, 200, 300, 400, 500, 600, 700, 800, 900, 1000 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