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PARACETAMOL 500 MG TABLETS - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - PARACETAMOL 500 MG TABLETS

2. what you need to know before you take paracetamol tablets

Some people must not take these tablets.

Do not take Paracetamol Tablets:

  • If you are allergic to paracetamol or to any other of the other ingredients of this medicine (listed in section 6).

Do not take anything else containing paracetamol while taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Tablets

  • If you suffer from any liver or kidney problems
  • If you suffer from alcoholic liver disease
  • If you suffer from mild arthritis and need to take painkillers every day
  • If you are pregnant or breastfeeding

Other medicines and Paracetamol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This means medicines you have bought yourself as well as those you have on prescription from doctor.

  • Paracetamol Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking/using any of the following: Anticoagulants to thin the blood (e.g. warfarin) Colestyramine (used to lower the amount of fats in your blood). Should not be taken at least one hour before and after taking paracetamol
  • Metoclopramide or domperidone (used to treat nausea and vomiting)
  • Chloramphenicol (used to treat conjunctivitis).
  • Imatinib (used to treat leukaemia and some stomach tumours).

Pregnancy and breast-feeding

If necessary, Paracetamol Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Other special warnings

If you are suffering from a headache and it becomes persistent, consult your doctor.

Driving and using machines

Paracetamol Tablets should not affect your ability to drive or operate machinery.

3. how to take paracetamol tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed with a drink of water

Adults, the elderly and children 16 years and over: One or two tablets to be taken up to four times daily. Maximum dose of 8 tablets in 24 hours.

Children 10 to 15 years of age: One tablet to be taken up to four times a day

Children under 10 years of age: Not recommended.

Alternative presentations of paracetamol are recommended for paediatric usage in order to obtain suitable doses of less than 500mg

The dose should not be repeated more frequently than every 4 hours and not more than 4 doses should be taken in any 24 hour period.

Dosage should not be continued for more than 3 days without consulting a doctor.

Do not take more medicine than the label tells you to.

If you do not get better, talk to your doctor.

If you take more Paracetamol 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 you forget to take Paracetamol Tablets

If you miss a dose don’t worry. Do not take a double dose to make up for the forgotten dose, just carry on with the normal routine.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious. Stop taking the tablets and tell your doctor straight away if you notice the following effects:

  • Swelling of the face, lips or throat, difficulty in breathing or dizziness. These may be signs of a serious allergic reaction
  • Allergic skin reactions including rash, blistering of the skin, mouth, eyes and genitals
  • Breathing problems or wheezing. These effects are more likely if you have asthma and have experienced them before when taking aspirin or other medicines called NSAIDs e.g. ibuprofen
  • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin
  • Very rare cases of serious skin reactions have been reported.
  • Changes in blood which may lead to bruising or bleeding gums. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store paracetamol tablets

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package in order to protect the tablets from moisture.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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 Tablets contains

Each tablet contains 500mg of the active ingredient, paracetamol. The other ingredients are Pregelatinised maize starch, Povidone, Stearic Acid. This product dose NOT contain Lactose.

What Paracetamol Tablets looks like and contents of the pack

The tablets are white and capsule shaped with a break line on one side. The tablets are available in blister packs and container as below:

Blister packs: 24 and 32 tablets.

Not all the pack sizes may be available.

Marketing Authorisation Holder:

RIA Generics Limited

  • 36 Ingleby Way, Wallington, Surrey, SM6 9LR, United Kingdom.

Manufacturer:

RIA Generics Limited

  • 36 Ingleby Way, Wallington, Surrey, SM6 9LR, United Kingdom.

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is paracetamol 500 mg used for?

Paracetamol 500 mg is commonly used to relieve mild to moderate pain, such as headaches, toothaches, and muscle aches. It also helps reduce fever.

How does paracetamol work in the body?

Paracetamol works by inhibiting certain chemicals in the brain that signal pain and temperature regulation, which helps lower fever and alleviate discomfort.

Can I take paracetamol 500 mg with other medications?

Always consult your healthcare provider before combining paracetamol with other medications to avoid potential interactions, especially with blood thinners or other pain relievers.

Is paracetamol safe for children?

Yes, but the dosage depends on the child’s age and weight. Always follow your doctor's recommendations for children.

What are the common side effects of paracetamol?

Common side effects include nausea, stomach pain, and allergic skin reactions. Serious side effects are rare when taken at recommended doses.

Can I take paracetamol if I am pregnant or breastfeeding?

Paracetamol is generally considered safe during pregnancy and breastfeeding; however, consult your doctor for personalized advice.

How often can I take paracetamol 500 mg tablets?

You can typically take paracetamol every 4 to 6 hours as needed. Do not exceed the maximum daily dosage of 4 grams unless directed by a physician.

What should I do if I miss a dose of paracetamol?

If you miss a dose, take it as soon as you remember but skip it if it's almost time for your next dose. Do not double up on doses.

Can paracetamol cause liver damage?

Excessive intake can lead to liver damage. Always adhere to recommended dosages and avoid alcohol while taking it.

What should I do in case of a paracetamol overdose?

Seek emergency medical help immediately if you suspect an overdose or experience symptoms like nausea, vomiting, or confusion.

Are there any dietary restrictions while taking paracetamol?

There are no specific dietary restrictions; however, avoiding alcohol is advisable due to potential liver strain.

Can I take paracetamol for arthritis pain?

Yes, many individuals with arthritis find relief from joint pain using paracetamol as part of their pain management strategy.

What is the shelf life of paracetamol 500 mg tablets?

Typically, the shelf life is around 2 to 3 years. Check the packaging for specific expiration dates before use.

Can elderly patients take paracetamol safely?

Yes, elderly patients can usually take paracetamol safely; however, they should discuss any existing health conditions with their doctor.

Are there any alternatives to paracetamol for pain relief?

Alternatives include ibuprofen and aspirin; however, your choice should be based on individual health conditions and advice from a healthcare provider.

Is it safe to take paracetamol every day for chronic pain management?

Long-term use should be monitored by a healthcare professional to prevent potential side effects, especially regarding liver health.

Does paracetamol interact with alcohol?

Combining alcohol with high doses of paracetamol can increase the risk of liver damage; moderation is key.

What should I do if my pain persists after taking paracetamol?

If your pain continues despite taking paracetamol as directed, consult your healthcare provider for further evaluation and treatment options.

Where should I store my paracetamol tablets?

Store them in a cool, dry place away from direct sunlight and out of reach of children.

Can you mix liquid medicine with crushed paracetamol tablets?

Yes, if you have difficulty swallowing pills, consult your pharmacist about safely crushing them and mixing them with liquid for easier consumption.