500 mg film-coated tablets
paracetamol
WHAT PANODIL IS AND WHAT IT IS USED FOR
Panodil contains paracetamol which is analgesic and antipyretic.
Panodil is used to treat temporary fever and pain of a mild nature,
eg fever with cold, headache, toothache, menstrual pain, muscle, and joint pain.
Panodil is used for aches and pains of various kinds (eg headache, toothache, menstrual pain, muscle, and joint pain, and rheumatic pain) and fever (eg for colds).
Panodil can be used by people with sensitive stomachs or ulcers and people with an increased tendency to bleed.
BEFORE YOU USE PANODIL
Do not use Panodil
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Take special care with Panodil
- caution in liver disease
- if you have asthma and are at the same time sensitive to acetylsalicylic acid
Do not use Panodil without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Panodil with alcohol. The intoxicating effect of alcohol does not increase with the addition of Panodil. If you are taking other painkillers that contain paracetamol, do not use Panodil without first talking to your doctor or pharmacist.
Never take Panodil 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 entail a 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.
Talk to your doctor before using Panodil if you have liver or kidney disease.
Talk to your doctor before using Panodil if you have a serious infection such as sepsis, as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include deep, rapid, strained breathing; nausea, vomiting; loss of appetite. Contact a doctor immediately if you get a combination of these symptoms.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, (traditional) herbal medicines, herbal medicines, or other natural products.
Panodil may affect or be affected by certain medicines / herbal medicines:
- metoclopramide (antiemetic and antiemetic).
- warfarin (blood thinner). Contact your treating physician if you take more than 2 Panodil (500 mg) per day for 5 consecutive days. There is a risk that the effect of warfarin will be affected.
- probenecid (anti-gout ).
- certain remedies for epilepsy:
- phenytoin
- phenobarbital
- carbamazepine
- rifampicin (remedy for tuberculosis ).
- cholestyramine (means for high blood fats). The medication should be taken at least one hour apart.
- chloramphenicol for injection (means for bacterial infections). (However, chloramphenicol against infection in your eye and Panodil can be used at the same time.)
- St. John’s wort extract (included in some (traditional) herbal and herbal remedies).
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Pregnancy and breastfeeding
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, Panodil 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 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 you use Panodil more than temporarily during breastfeeding.
Driving and using machines
Panodil does not affect your ability to drive or use machines.
HOW TO USE PANODIL
Note! Higher doses than those recommended carry a risk of very serious liver damage.
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults and children over 40 kg (over 12 years): 1-2 tablets every 4-6 hours, maximum 8 tablets per day.
Panodil should not be used for long-term use other than as prescribed by a doctor.
Children
For children, dose one should primarily be calculated according to the child’s weight (10-15 mg/kg body weight).
Children 15-25 kg (3-7 years): ½ tablet every 4-6 hours, maximum 4 times per day, maximum 2 tablets per day.
Children 25-40 kg (7-12 years): ½ -1 tablet every 4-6 hours, maximum 4 times a day, maximum 4 tablets per day.
(For calculation of dose based on the child’s weight, 10-15 mg/kg body weight applies, every 4-6 hours, no more than 4 times per day.)
The tablet can be divided into two equal doses.
Panodil tablets are provided with a film coating that becomes slippery on contact with 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 Panodil than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested a medicine, contact a doctor or hospital for risk assessment and advice.
There is a risk of liver damage even if you feel well.
To prevent possible liver damage, the antidote must be inserted by a doctor as early as possible (preferably within 10-12 hours after ingestion).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Panodil can cause side effects, although not everybody gets them.
Rare (affects less than 1 user in 1,000):
- Angioedema: Stop taking Panodil and contact a doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
- Allergic reactions such as skin rash and hives. If you get allergic reactions, you should stop taking Panodil. Contact a doctor as soon as possible.
- Liver effects
Very rare (affects less than 1 user in 10,000):
- Bleeding from the skin and mucous membranes and bruising, general lethargy, the tendency to inflammation ( infections ) especially sore throat and fever due to changes in the blood (decreased number of white blood cells and platelets ). Contact a doctor as soon as possible.
- Severe difficulty breathing with wheezing. Contact a doctor as soon as possible.
- Kidney side effects.
- Paleness, fatigue, and jaundice due to severe anemia. Contact a doctor as soon as possible.
- Very rare cases of severe skin reactions have been reported. Contact a doctor as soon as possible.
- Anaphylaxis: hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure. Contact a doctor as soon as possible.
HOW TO STORE PANODIL
Keep out of sight and reach of children and young people.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Do not use Panodil if the foil was not intact at the time of purchase. In such cases, contact the pharmacy.
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.
FURTHER INFORMATION
Content declaration
- The active substance is paracetamol, 500 mg
- The other ingredients are corn starch, pregelatinized starch, povidone, potassium sorbate, talc, and stearic acid.
- Coating: Hypromellose, triacetin.
What the medicine looks like and the contents of the pack
White, film-coated tablets with flat edges, with a triangular logo embossed on one side and a break notch on the other side. The tablets can be divided into two equal doses.
Over-the-counter packaging: 20 pcs Prescription packaging: 30 pcs., 96 pcs., 98×1 pcs., 100 pcs., 300 pcs., 30×300 pcs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Perrigo Sverige AB
Box 7009
164 07 Kista
Manufacturer :
GlaxoSmithKline Dungarvan Ltd., Knockbrack Dungarvan, Ireland
Omega Pharma Manufacturing GmbH & Co. KG, Herrenberg, Germany
Catalent UK Swindon Zydis Limited, Swindon, UK