Patient leaflet - Paracetamol Hualan 500 mg tablets
1. What Paracetamol Hualan 500 mg Tablets is and what it is used for
Paracetamol Hualan Tablets are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain.
They also relieve sore throat and the fever, aches and pains of colds and flu and are recommended for the relief of pain due to mild arthritis.
The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have a fever.
2. What you need to know before you take Paracetamol Hualan 500 mg Tablets
Do not take Paracetamol Hualan 500 mg Tablets:
- if you have ever had an allergic reaction to paracetamol or to any of the other ingredients (listed in Section 6).
- if you are taking any other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.
If you are not sure, check with your doctor or pharmacist before taking Paracetamol.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you take Paracetamol Hualan 500 mg Tablets:
- if you suffer from mild arthritis and need to take painkillers every day.
- If you have liver problems, particularly those due to drinking too much alcohol
- If you have kidney problems.
- if you are underweight or malnourished.
- if you have a severe infection as this may increase the risk of metabolic acidosis.
Signs of metabolic acidosis include:
- deep, rapid, difficult breathing.
- feeling sick (nausea), being sick (vomiting).
- loss of appetite.
During treatment with Paracetamol, tell your doctor straight away 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).
Contact a doctor immediately if you get a combination of these symptoms.
You may need to avoid using this product altogether or limit the amount of paracetamol that you take.
Other medicines and Paracetamol Hualan 500 mg Tablets
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This is because Paracetamol can affect the way some medicines work. Also, some medicines can affect the way Paracetamol works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- medicines to treat epilepsy such as phenobarbital
- doxorubicin, used in the treatment of cancer
- aspirin, used to treat pain, inflammation or fever
- Medicines for nausea [feeling sick] or vomiting [being sick]: metoclopramide or domperidone.
- Medicines to lower blood cholesterol: colestyramine. • If you take blood thinning drugs (anticoagulants e.g., warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol Hualan Tablets at the same time as anticoagulants.
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (section 2).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Paracetamol.
Paracetamol with food and drink
Avoid alcohol whilst taking Paracetamol, as it can increase the risk of the side effects.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Hualan Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or fever and use it for the shortest time possible. Contact your doctor or midwife if your pain and/or fever are not reduced or if you need to take the medicine more often.
Driving and using machines
Paracetamol Hualan Tablets have no effect on the ability to drive and use machines.
3. How to take Paracetamol Hualan 500 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.
When taking this medicine
- Do not exceed the recommended dose
- Do not take with other paracetamol-containing products
- If your symptoms persist for more than three days, you should consult your doctor
- Swallow the tablets with a drink of water
The recommended dose is
Adults, elderly and children aged 16 years and over:
- Take 1 or 2 tablets every 4-6 hours, as needed.
- Wait at least 4 hours between doses
- Do not take more than 8 tablets (4000 mg) in 24 hours.
Children aged 10-15 years:
- Give 1 tablet every 4-6 hours, as needed.
- Do not give more than 4 tablets (2000 mg) in 24 hours.
- Do not give for more than 3 days at a time unless your doctor tells you to.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
- Do not take more frequently than every 4 hours.
- Do not take more than the recommended dose.
Children under 10 years:
Paracetamol 500 mg Tablets is not recommended for use in children under 10 years of age. A liquid form of this medicine may be more suitable for use in children of this age.
If you take more Paracetamol Hualan 500 mg Tablets than you should
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.
If your symptoms continue or your headache becomes persistent, see your doctor.
If you forget to take Paracetamol Hualan 500 mg Tablets
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. The minimum time interval between two doses should be 4 to 6 hours. Never take a double dose to make up for the one you have missed. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Paracetamol Hualan 500 mg Tablets can have side effects, although not everybody gets them.
A small number of people have had side effects. Very rare cases of serious skin reactions have been reported.
STOP TAKING this medicine and see a doctor or go to a hospital straight away if you notice any of the following side effects:
- an allergic reaction, the symptoms of which may include skin rash, itching, blistering or peeling of the skin, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, sudden wheezing or collapse.
If you get any of the following side effects, stop taking this medicine and talk to your doctor as soon as possible:
- unexplained bruising or bleeding, red-purple spots of discolouration on the skin, sore throats or infections. These may be signs of changes to your blood cells.
- Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath.
- Skin rash or peeling, or mouth ulcers.
- Breathing problems. This is more likely if you suffer from asthma and have experienced similar problems before when taking painkillers such as aspirin or ibuprofen.
- .
- Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin. These may be signs of changes to your liver.
Frequency “Not known’’ (frequency cannot be estimated from the available data):
“A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)”
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 500 mg Tablets
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original package. Keep blister in the outer carton.
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.
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 500 mg Tablets contain
The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
The other ingredients are povidone K30, pregelatinized starch, stearic acid and magnesium stearate.
What Paracetamol Hualan 500 mg Tablets looks like and the contents of the pack
The tablets are white, capsule shaped engraved with a score line.
Paracetamol Hualan 500 mg Tablets are available in PVC and PVC/Al blister pack in pack sizes 8, 10, 12, 15, 16, 20, 24, 28 and 32 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hualan Pharmaceuticals Limited
16/17 College Green
Dublin
D02 V078
Ireland.
Manufacturer
DDSA Pharmaceuticals Limited
84 Pembroke Road
London
W8 6NX
United Kingdom.