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PARACETAMOL 500 MG TABLETS, ACTAVIS 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, ACTAVIS PARACETAMOL 500 MG TABLETS

PARACETAMOL 500mg TABLETS

Read all of this leaflet carefully because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What Paracetamol Tablets are and what they are used for

  • 2. What you need to know before you take Paracetamol Tablets

  • 3. How to take Paracetamol Tablets

  • 4. Possible side effects

  • 5. How to store Paracetamol Tablets

  • 6. Contents of the pack and other information

  • 1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR

Paracetamol Tablets contain the active ingredient paracetamol and are used for the relief of mild to moderate pain including:

  • rheumatic aches and pains
  • neuralgia (severe nerve pain), period pain
  • migraine, headache
  • sore throat, toothache
  • fevers, colds, flu and influenza.

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

DO NOT take Paracetamol Tablets if you are:

  • allergic (hypersensitive) to Paracetamol, other pain relievers or any of the other ingredients in the product (see Section 6 and end of Section 2)
  • taking any other Paracetamol-containing medicines, i.e. over-the-counter cold remedies.

This medicine is NOT recommended for children under 6 years of age.

Warnings and precautions

Consult your doctor before taking these tablets if you:

  • have kidney or liver problems
  • are an alcoholic.

Other medicines and Paracetamol Tablets

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:

  • other products containing paracetamol (see 'DO NOT take Paracetamol Tablets’)
  • warfarin and other drugs which thin the blood
  • cholestyramine (reduces blood cholesterol levels)
  • metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems).

3. HOW TO TAKE PARACETAMOL TABLETS

4. POSSIBLE SIDE EFFECTS


Always take Paracetamol Tablets exactly as your doctor has told you. Swallow each tablet with a drink of water.

Adults, the elderly and children over 16 years:

Take one or two tablets every 4 to 6 hours, up to a maximum of 8 tablets in any 24 hour period.

Children 12–15 years of age:

Take one to one & half tablets every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

200 mm


Children 10–12 years of age:

Take one tablet every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

Children 6–10 years of age:

Take half tablet every 4–6 hours when necessary to a maximum of 4 doses in 24 hours.

Do not give this medicine to children under 6 years of age, except on medical advice.

The dose should not be repeated more frequently than 4 hourly intervals. You should not take Paracetamol Tablets for longer than 3 days.

WARNING: DO NOT EXCEED THE STATED DOSE Contains paracetamol. Do not take with other paracetamol containing products.

Do not exceed the treatment for more than 3 days and if symptoms persist seek medical advice before continuing treatment.

If symptoms persist for more than 3 days, speak to your doctor.

If you take more Paracetamol Tablets than you should

It is extremely important to follow the dosage instructions that have been given to you. Do not change your dose without discussing it with your doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If you accidentally take more than the recommended dose, or know someone who has, contact your doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.

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, take it as soon as you remember. NEVER take a double dose to make up for the dose you have forgotten.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Paracetamol Tablets can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include skin rashes, hives. If this happens to you, stop taking the tablets immediately and seek urgent medical help.

There have been few reports of blood abnormalities in patients taking Paracetamol, but these were not necessarily due to the Paracetamol treatment.

Reporting of side effects

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 or search for 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 tablets

Keep out of sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not use Paracetamol Tablets after the expiry date shown on the pack.

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.

6. contents of the pack and other information

What Paracetamol Tablets contain

The active substance is paracetamol 500mg.

The other ingredients are povidone, lactose, starch (maize), magnesium stearate, sodium starch glycollate, colloidal anhydrous silica (see also end of Section 2 on 'Important information about some of the ingredients of Paracetamol Tablets’).

What Paracetamol Tablets look like and contents of the pack

Paracetamol Tablets are white capsule shaped tablets with break-line. They are supplied in child-resistant blister packs of 16s, 24s, 32s, 48s, 96s and 100s (not all pack sizes may be marketed).

Marketing Authorisation Holder: Fourrts (UK) Pharmacare Ltd,

5, Braemore Court, Cockfosters Road, Barnet, Hertfordshire, EN4 OAE, UK.

Manufacturer: i

Rx Farma Limited, Unit 3 colonial Way, Watford, Hertfordshire, £

WD24 4YR, UK.

Marketing Authorisation Number: PL 39484/0038

This leaflet was last revised in November/2019.

Name of the artwork


Printed leaflet 200 × 180mm Paracetamol 500mg Tablets

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

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N02 ANALGESICS

N02B OTHER ANALGESICS AND ANTIPYRETICS in ATC

N02BE Anilide analgesics and antipyretics

N02BE01 paracetamol

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 is also effective in reducing fever.

Can I take Paracetamol 500 mg during pregnancy?

Paracetamol is generally considered safe for use during pregnancy, but it's always best to consult your healthcare provider before taking any medication.

Is it safe to take Paracetamol with other medications?

While Paracetamol can be taken with many medications, some can interact. Always check with your doctor or pharmacist before combining medications.

What should I do if I miss a dose of Paracetamol 500 mg?

If you miss a dose, take it as soon as you remember. If it's close to your next dose, skip the missed dose and continue with your regular schedule. Do not double up.

How long does it take for Paracetamol 500 mg to work?

Paracetamol typically starts to relieve pain and reduce fever within 30 minutes after taking it, with peak effects around 1-2 hours.

How often can I take Paracetamol 500 mg?

You can usually take Paracetamol every 4 to 6 hours, but do not exceed the recommended dosage stated on the package or prescribed by your doctor.

Are there any side effects of Paracetamol 500 mg?

Side effects are rare but may include allergic reactions like rashes or breathing difficulties. Overdose can lead to liver damage; seek medical attention immediately if overdosed.

Can children take Paracetamol 500 mg tablets?

Paracetamol is suitable for children, but the dosage depends on their age and weight. Always use pediatric formulations specifically designed for children.

Is it safe to drink alcohol while taking Paracetamol?

It's advisable to limit alcohol consumption while taking Paracetamol, as combining them can increase the risk of liver damage.

What should I do if I suspect an overdose of Paracetamol?

If you think you've taken too much Paracetamol, seek emergency medical help immediately, even if you feel fine. Symptoms may not appear until later.

Can I use Paracetamol for arthritis pain?

Yes, many people with arthritis find relief from pain using Paracetamol. However, consult your doctor about the best treatment plan for your condition.

Does Paracetamol cause drowsiness?

No, Paracetamol typically does not cause drowsiness. If you feel unusually tired after taking it, consult your healthcare provider.

What forms does Paracetamol come in besides tablets?

Paracetamol is also available in liquid form, effervescent tablets, dissolvable powders, and suppositories for those who prefer alternatives to tablets.

Can I take expired Paracetamol 500 mg tablets?

It's not recommended to take expired medications as they may be less effective or potentially harmful. Always check expiration dates before use.

How should I store Paracetamol 500 mg tablets?

Store in a cool and dry place away from direct sunlight and out of reach of children. Avoid storing in damp areas like bathrooms.

Is there a difference between generic and brand-name Paracetamol?

The active ingredient is the same in both generic and brand-name versions; however, inactive ingredients may differ and affect tolerability for some individuals.

Can I crush or split my Paracetamol tablets?

Yes, you can crush or split most paracetamols if you have difficulty swallowing them; however, verify with a healthcare professional if this affects how they work.

What lifestyle changes can help manage pain without medications like Paracetamol?

Regular exercise, a balanced diet, good hydration, stress management techniques like yoga or meditation can help manage pain alongside appropriate medications.

Will taking more than the recommended dose of Paracetamol provide faster relief?

No. Taking more than the recommended dose is dangerous and does not increase effectiveness but significantly raises the risk of serious side effects.