500 mg film-coated tablets
paracetamol
What Pamol is and what it is used for
Pamol contains the active substance paracetamol.
Pamol is used for treating 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 Pamol may also be approved for the treatment of other conditions not mentioned in this product information. 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 taking Pamol
Do not take Pamol
– if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Pamol.
– if you suffer from severe liver failure.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Pamol if you:
– have a liver failure (impaired liver function)
– suffers from chronic alcoholism
– has a renal failure (severe renal impairment)
– take other medicines containing paracetamol (to avoid overdose)
– has poor nutritional status ( chronic malnutrition)
Never take Pamol more than what is stated in the dosing instructions. 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 immediately if you have taken too large a dose, even if you are feeling well.
Do not use Pamol without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Pamol with alcohol. The intoxicating effect of alcohol does not increase with the addition of Pamol.
Pay attention to the following
– If you have a high fever, signs of sequelae, or if your symptoms do not go away within 3 days, contact your doctor.
– If you take painkillers for a long period, you may experience that you get a headache or a headache that worsens. Headaches should not be treated with higher doses of Pamol. Contact your doctor.
Simultaneous use of several different painkillers over a long period can cause kidney damage.
Other medicines and Pamol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor before using Pamol if you are also taking:
Probenecid (medicine to treat gout ). The dose of Pamol may need to be changed by your doctor.
• Painkillers containing salicylamide and diflunisal.
• Medicines for nausea and vomiting (metoclopramide and domperidone).
This can lead to the rapid uptake of Pamol.
• Cholestyramine (cholesterol-lowering agent). The dose of Pamol may need to be changed by your doctor.
• Medicines for epilepsy (carbamazepine and phenytoin ).
Pamol may increase the effect of vitamin K antagonists, such as warfarin or other coumarins if used several times over more than 1 week.
Talk to your doctor if you are taking medicines that affect the liver function or that can cause liver damage.
To avoid overdose, make sure that you do not use other medicines containing paracetamol at the same time. If you are taking other painkillers that contain paracetamol, do not use Pamol without first talking to a doctor or pharmacist.
Pamol with food and alcohol
You can take Pamol with or without food.
Do not use Pamol with alcohol. Pamol does not potentiate the effects of alcohol.
Children
Pamol tablets should not be given to children under 4 years of age.
For children over 4 years of age, the maximum dose is 45 mg/kg per day.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If necessary, Pamol 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 a doctor or midwife if the pain and/or fever do not decrease or if you need to take the medicine more often.
Can be used during breastfeeding.
Driving and using machines
Pamol does not influence the ability to drive or use machines.
How to use Pamol
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Note! Higher doses than those recommended carry a risk of very serious liver damage.
The recommended dose is:
Adults: 2 tablets (1,000 mg) 3-4 times a day. Maximum 8 tablets (4,000 mg) per day. In some cases, 1 tablet (500 mg) 3-4 times daily is enough.
Use for children and adolescents
Children: the recommended daily dose of paracetamol is up to 45 mg/kg in 3-4 doses (see table below):
Children
| Weight | Age | Dosage |
|---|---|---|
| 17-25 kg | 4-7 years | ½ tablet (250 mg) 3 times daily |
| 25-40 kg | 7-12 years | ½-1 tablet (250-500 mg) 3 times daily |
| More than 40 kg | Over 12 years | 1-2 tablets (500-1000 mg) 3 times daily 1000 mg paracetamol 3 times daily should only be given to children weighing 67 kg or more. |
Other formulations of this medicine may be better suited for children, ask your doctor or pharmacist.
Do not use Pamol in children under 12 years of age for more than 2 days unless your doctor prescribes otherwise.
Pamol tablets should not be used by children under 4 years of age.
The tablet should be swallowed with a glass of water.
The tablet can be divided into two equal doses.
Impaired kidney or liver function
It may be necessary to reduce dose one. Talk to a doctor.
If you use more Pamol than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice. You must contact healthcare even if you do not experience any symptoms of overdose. Too much paracetamol can cause severe liver damage and the symptoms may appear only after a few days. In case of overdose, an antidote must be used as soon as possible.
In case of overdose, the following symptoms can be expected: nausea, vomiting, loss of appetite, pallor, and abdominal pain.
Especially children, the elderly and people with hepatic impairment, alcoholics, malnourished people, or those who use drugs that affect the liver, are at risk of overdose.
Never take more Pamol than recommended. A higher dose does not provide better pain relief.
If you forget to take Pamol
Do not take a double dose to make up for a forgotten dose. You should never take more than the recommended daily dose.
4, Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Very rare (may affect up to 1 in 10,000 people) – Not known (can not be calculated from the available data):
– Bleeding skin and mucous membranes and bruising due to blood changes (fewer platelets ).
– Feeling sick, easy to get inflammation ( infection ) especially sore throat and fever. It may be due to blood changes (decreased number of white blood cells ). If you have a fever, contact a doctor immediately. It can be a serious condition.
– Sudden rash on the skin, swelling of the face, fainting, and difficulty breathing. The symptoms appear within minutes to hours and are due to a strong hypersensitivity reaction ( anaphylactic reaction ) which can lead to death. Call 112 immediately.
– Difficulty breathing ( bronchospasm = tracheal muscle contractions).
Prolonged use may cause damage to the kidneys.
If you experience any of these side effects, you should contact your doctor or emergency room.
Other side effects ar
Rare side effects ( may affect up to 1 in 1,000 people):
– Allergic reactions ( hypersensitivity reactions ) with rash ( hives ) and swelling. This can be serious so you should consult a doctor.
– Effects on the liver, jaundice may occur. If you have jaundice, consult your doctor.
Rash
Hives _
– One or more round or oval, red spots on the skin that appear in the same place in connection with taking this medicine (drug-triggered skin rash).
How to store Pamol
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. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
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.
– Each tablet contains 500 mg paracetamol .
The other ingredients are povidone, potato starch, microcrystalline cellulose, hypromellose, magnesium stearate, propylene glycol, and talc.
What the medicine looks like and the contents of the pack
Pamol is a white, oblong, film-coated tablet with a notch on one side and “PAMOL” embossed on the other side.
Pamol is available in pack sizes of 10 and 20 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orifarm Healthcare A / S
Energizer 15
5260 Odense S
Denmark
info@orifarm.com
Local representative
Orifarm Healthcare
Box 56048
102 17 Stockholm
Manufacturer
Takeda GmbH
Plant Oranienburg
Lehnitzstr. 70 – 98
16515 Oranienburg
Germany
Orifarm Manufacturing Poland Sp. z oo
Ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland