Patient leaflet - Paracetamol Hualan 650 mg tablets
1. What Paracetamol Hualan 650 mg Tablets are and what they are used for
Paracetamol is effective in reducing pain and fever.
It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, muscular pain, lumbago and in fever.
Paracetamol Hualan 650 mg Tablets are indicated in adults and adolescents over15 years of age.
2. What you need to know before you take Paracetamol Hualan 650 mg Tablets
Do not take Paracetamol Hualan 650 mg Tablets:
- If you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol Hualan 650 mg Tablets.
Warning and precautions
- Do not take more medicine than recommended in section 3.
- Taking this medicine with other medicines that contain paracetamol, for example flu or cold medicines, should be avoided, because high doses of paracetamol can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting a doctor.
- Chronic alcoholics should be careful not to take more than 2 g of paracetamol in 24 hours.
- Patients with kidney, liver, heart or lung diseases and patients with anemia should consult a doctor before taking this medicine. • If you are being treated with any medicines to treat epilepsy, you should consult your doctor before taking this medicine, because when used at the same time, the effectiveness is decreased and paracetamol liver toxicity is possible, especially in high-dose treatments of paracetamol.
- Asthmatic patients sensitive to acetylsalicylic acid (aspirin) should consult their doctor before taking this medicine.
During treatment with Paracetamol, tell your doctor straight away if:
If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).
Children and adolescents
Not suitable for children and adolescents under 15 years old.
Other medicines and Paracetamol Hualan 650 mg Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, if you are using any of the following medicines, since it may be necessary to modify the dose or to interrupt the treatment:
- Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
- Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines to treat tuberculosis (isoniazid, rifampicin).
- Medicines to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
- Medicines to lower blood cholesterol levels (cholestyramine).
- Medicines used to increase urine output (loop diuretics such as those in the furosemide group).
- Medicines used to treat gout (probenecid and sulfinpyrazone).
- Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
- Medicines used in the treatment of high blood pressure (hypertension) and disturbances of the heart rhythm (cardiac arrhythmias): propranolol.
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
Interferences with analytical tests:
If you are going to have an analytical test (including blood tests, urine tests etc.), tell you doctor that you are taking this medicine, as it may alter the results.
Paracetamol Hualan 650 mg Tablets with food, drink and alcohol
The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages, e.g. beer, wine or liquor, per day) can cause liver damage.
This medicine can be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are breastfeeding, talk to your doctor or pharmacist before taking this medicine. Paracetamol passes into breast milk, so women who are breast-feeding should consult their doctor or pharmacist before taking this medicine.
Driving and using machines
Paracetamol should not affect your ability to drive or use machines.
3. How to take Paracetamol Hualan 650 mg Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents over 15 years old (weight >55 kg):
Swallow 1 tablet every 4-6hours, as needed. Do not take more than 6 tablets (equivalent to 3900 mg of Paracetamol) in 24 hours.
Patients with liver disease:
Before taking this medicine, you must consult your doctor.
You must take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between each dose. You should not take more than 3 tablets of paracetamol in 24 hours, divided into 3 doses.
Patients with kidney disease:
Before taking this medicine, you must consult your doctor.
You should take 1 tablet every 8 hours. Paracetamol Hualan 650 mg Tablets are not indicated for patients with severe kidney disease.
The effective and safe use of Paracetamol Hualan 650 mg Tablets have not been established in children below the age of 14 years. Treatment is therefore not recommended in this population.
The tablets should be swallowed with a glass of liquid, preferably water. The tablets can be swallowed whole or broken in half; the tablets have a score line, which is only there to help you break the tablet if you have difficulty swallowing it whole.
Always take the lowest dose that is effective.
The use of high daily doses of paracetamol should be avoided for prolonged periods of time, because the risk of suffering adverse effects such as liver damage is increased.
Only take this medicine at the start of pain or fever symptoms and stop taking it when the symptoms disappear. If the pain lasts for more than 5 days, the fever lasts for more than 3 days, or if the pain or fever gets worse or other symptoms appear, you should stop the treatment and consult your doctor.
If you take more Paracetamol Hualan 650 mg Tablets than you should
You should immediately consult your doctor or pharmacist.
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice) and abdominal pain.
These symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Treatment for an overdose is most effective if started within 4 hours of ingesting the medicine.
Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of an overdose of paracetamol.
4. Possible side effects
Like all medicines, Paracetamol Hualan 650 mg Tablets can have side effects, although not everybody gets them.
You should stop taking this medicine and consult your doctor immediately if you experience:
Rare: may affect up to 1 in 1,000 people
- Several blood disorders including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hemolytic anemia leukopenia platelet disorders (clotting disorders) and stem cell disorders (disorders of the blood forming cells in bone marrow).
- Allergic reactions.
- Depression, confusion, hallucinations.
- Tremor, headache.
- Disturbed vision. • Oedema (abnormal accumulation of fluid under the skin).
- Abdominal pain, stomach or intestinal bleeding, diarrhoea, nausea, vomiting.
- Abnormal liver function, liver failure, jaundice (with symptoms like yellowing of the skin and eyes), hepatic necrosis (death of liver cells).
- Rash, itching, sweating, hives, red patches on skin, angioedema with symptoms like swollen face, lips, throat or tongue.
- Dizziness, generally feeling unwell (malaise), fever, sedation, interactions with medicines.
- Overdose and poisoning.
Very rare: may affect up to 1 in 10,000 people
- Pancytopenia (reduction in the number of blood cells).
- Allergic reactions where treatment should be stopped, including angioedema, difficulty breathing, sweating, nausea, hypotension, shock, and anaphylaxis.
- Low level of blood glucose in the blood.
- Hepatotoxicity (damage caused to the liver due to chemicals).
- Cloudy urine and kidney disorders.
- Bronchospasm (difficulty in breathing) in patients sensitive to aspirin and other anti-inflammatory medicines.
- Hematuria (blood in urine).
- Anuresis (inability to urinate).
Not known: frequency cannot be estimated from the available data
- Acute generalised exanthemateus pustulosis (drug eruption characterised by numerous small, primarily non-follicular, sterile pustules).
- Severe skin rash or peeling of the skin.
- Stevens–Johnson syndrome (a severe life-threatening skin disorder).
- Reddening of skin, blisters or rash due to intake of paracetamol.
- A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
Paracetamol can damage the liver when taken in high doses or in prolonged treatments.
Reporting of side events
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Paracetamol Hualan 650 mg Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the package after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Paracetamol Hualan 650 mg Tablets contain
The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
The other ingredients are povidone K30, pregelatinized starch, stearic acid and magnesium stearate.
What Paracetamol Hualan 650 mg Tablets look like and the contents of the pack
The tablets are white, capsule shaped engraved with a score line between “H” and “Y” on one side and “650” on the other side.
Paracetamol Hualan 650 mg Tablets are available in PVC and PVC/Al blister pack in pack sizes of 8, 10, 12, 15, 16, 20, 24, 28, 30, 32, 40, 50, 56, 60, 84, 90 tablets.
Paracetamol Hualan 650 mg Tablets are available in PVC and polyester/Al blister pack in pack sizes of 8, 10, 12, 15, 16, 20, 24, 28, 30, 32, 40, 50, 56, 60, 84, 90 tablets.
Paracetamol Hualan 650 mg Tablets are available in HDPE container with polyolefin lid with PE foam liner in pack size of 100 tablets.
Paracetamol Hualan 650 mg Tablets are available in HDPE container with polyolefin lid and laminated extruded PE foam liner in pack size of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hualan Pharmaceuticals Limited
16/17 College Green
Dublin 2
Dublin
D02 V078
Ireland
Manufacturer
DDSA Pharmaceuticals Limited
84 Pembroke Road
London
W8 6NX
United Kingdom