500 mg film-coated tablets
paracetamol
What Paracetamol Orifarm is and what it is used for
Paracetamol Orifarm is a painkiller and antipyretic ( analgesics and antipyretics).
Paracetamol Orifarm is used to treat temporary fever and pain conditions of a mild nature, such as fever in colds, headaches, toothaches, menstrual cramps, and muscle and joint pain.
Paracetamol contained in Paracetamol Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Paracetamol Orifarm
Do not take Paracetamol Orifarm
- 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
Talk to your doctor, pharmacist, or nurse before taking Paracetamol Orifarm:
- if you have kidney or liver disease
- if you have reduced nutrient uptake, e.g. due to alcohol abuse
- if you are taking other medicines containing paracetamol
- if you have severe anemia (abnormal red blood cell breakdown )
- if you have asthma and are at the same time sensitive to acetylsalicylic acid.
Do not use paracetamol often for a long time, as long-term use can cause liver problems. Talk to your doctor or pharmacist if you will be using paracetamol for a long time.
In children treated with a daily dose of paracetamol of 60 mg/kg, combination therapy with other antipyretic drugs is not justified, except in case of insufficient effect.
Paracetamol treatment in patients with severe renal failure or mild to moderate liver failure should be performed with caution.
The risk of overdose is greater in users with alcohol-related liver disease (without cirrhosis). Treatment should be performed with caution in patients with chronic alcohol abuse. The daily dose should not exceed 2 grams (4 tablets) in this case.
Do not use Paracetamol Orifarm without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Paracetamol Orifarm with alcohol. The intoxicating effect of alcohol is not increased by the addition of Paracetamol Orifarm.
If you have a serious infection, this can increase the risk of so-called metabolic acidosis. Signs of metabolic acidosis include:
- Deep, fast, strained breathing.
- Nausea, vomiting.
- Loss of appetite.
Contact a doctor immediately if you get a combination of these symptoms.
If you are taking other painkillers that contain paracetamol, do not use Paracetamol Orifarm without talking to your doctor or pharmacist first. If you are taking other medicines containing paracetamol at the same time, there is a risk of overdose.
Never take more Paracetamol Orifarm than stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but instead entail a risk of serious liver damage. The symptoms of liver damage usually come only after a few days. It is therefore important that you contact a doctor as soon as possible if you have taken too large a dose.
After improper use of high-dose painkillers for a long time, headaches may occur. This headache should not be treated with higher doses of the drug.
Habitual use of painkillers, especially in combination with several painkillers, can lead to permanent kidney damage with a risk of kidney failure ( analgesic nephropathy ).
Abruptly stopping paracetamol after prolonged use can lead to headaches, fatigue, muscle aches, nervousness, dizziness, or fainting. These symptoms disappear within a few days. During this time, the use of painkillers should be avoided and not restarted except on the advice of a doctor.
Do not take Paracetamol Orifarm for long periods or in high doses without first talking to a doctor.
Children and young people
Paracetamol Orifarm is not recommended for children under 3 years of age.
Contact a doctor before using Paracetamol Orifarm if:
- the child is difficult to carry or has abdominal pain, stiff neck, or back pain.
- the child has severe problems with the ears, throat, 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 did not have any effect on the pain or fever after the first day.
- new symptoms appear or stomach pain/stomach upset worsens or lasts a long time.
Other medicines and Paracetamol Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:
- chloramphenicol (to treat infections )
- zidovudine (to treat AIDS )
- rifampicin (to treat infections )
- cimetidine (to treat acid reflux)
- metoclopramide or domperidone (to treat nausea and vomiting)
- Cholestyramine (Cholesterol-Lowering Drug)
- probenecid (to treat eg gout )
- anti-coagulants (blood thinners such as warfarin ), if you need to take painkillers daily for a long time.
- glutetimide, phenobarbital, carbamazepine (to treat epilepsy )
- the traditional herbal medicine St. John’s wort
Effects on laboratory tests: Paracetamol may affect test results for uric acid and blood sugar.
Paracetamol Orifarm should be used with caution in combination with drugs that affect the liver function or that are known to be harmful to the liver and with alcohol.
To avoid overdose, other medicines used concomitantly with Paracetamol Orifarm should be controlled so that they do not contain paracetamol.
Paracetamol Orifarm with food, drink, and alcohol
You can take Paracetamol Orifarm with or without food. The tablets should be taken with liquid. Concomitant use of paracetamol and large amounts of alcohol should be avoided.
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 Orifarm can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use the medicine for the shortest possible time. Contact a doctor if the pain and/or fever do not decrease or if you need to take the medicine more often.
Therapeutic doses of paracetamol can be used during breastfeeding.
Driving and using machines
Paracetamol Orifarm does not affect your ability to drive or use machines.
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 take Paracetamol Orifarm
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Do not take more Paracetamol Orifarm than recommended in the dosing instructions. Use the lowest possible dose needed for the shortest possible time. Do not take a higher dose than recommended.
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.
Paracetamol Orifarm should be taken with a sufficient amount of water.
Note! Higher doses than those recommended carry a risk of very serious liver damage.
The recommended dose is:
Adults (including the elderly) and adolescents over 40 kg (over 12 years):
1-2 tablets every 4-6 hours, maximum 8 tablets per day.
Children
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.
The tablet can be divided into two equal doses.
Do not use Paracetamol Orifarm in children under 12 years of age for more than 2 days unless your doctor prescribes otherwise.
Paracetamol Orifarm is not recommended for children under 3 years and under 15 kg. Other more suitable strengths and/or formulations are available for children with low body weight or for children who are unable to swallow a tablet.
Hepatic or renal impairment
In patients with hepatic or renal impairment, the dose must be reduced or the interval between doses extended. Consult your doctor or pharmacist.
If you take more Paracetamol Orifarm than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice, even if you are feeling well, due to the risk of serious liver damage.
If you forget to take Paracetamol Orifarm
If you forget to take a dose, take it as soon as you notice it. Do not take a double dose to make up for a forgotten dose and never exceed the maximum daily dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
The following side effects are very serious and may require immediate treatment. Stop taking the medicine immediately and contact a doctor immediately if the following serious side effects occur.
Very rare (may affect up to 1 in 10,000 people):
- Bleeding from the skin and mucous membranes and bruising, due to changes in the blood (decreased number of platelets ).
- General lethargy, the tendency to inflammation ( infection ) especially sore throat and fever due to changes in the blood (decreased number of white blood cells ).
- Severe anemia with jaundice due to degradation of blood cells (hemolytic anemia ).
- Sudden rash, difficulty breathing, and fainting (within minutes to hours) due to hypersensitivity reaction ( anaphylactic reaction ).
- Severe rash fever and inflammation of the skin, especially on the hands and feet and in and around the mouth ( Stevens-Johnson syndrome ).
- Severe peeling and rejection of the skin.
- Respiratory problems in some people with a predisposition to this ( bronchospasm ).
- Angioedema with symptoms such as a swollen face, swollen lips, throat, or tongue.
Other side effects ar
Rare (may affect up to 1 in 1,000 people):
- Hives, skin rash.
- Increase in liver enzyme values.
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions ( hypersensitivity reactions ).
- Hepatic impairment. Can get serious. If you experience yellowing of the eyes (jaundice), consult your doctor.
- With long-term use, the risk of kidney damage can not be ruled out.
How to store Paracetamol Orifarm
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Medicines 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.
- The other ingredients are pregelatinized starch, povidone, sodium starch glycolate, stearic acid, hypromellose, and macrogol.
What the medicine looks like and the contents of the pack
White to off-white, film-coated tablets debossed with “PARA 500” on one side and
breaker notch on the other side.
Blister: 10 and 20 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Paracetamol Orifarm