Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Paracetamol 500mg Soluble Tablets (GSL)

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Paracetamol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Paracetamol

Equivalent medicines (same active substance, strength and form)

and 15 more with the same active substance, strength and form

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

FOR The name of your medicine is Paracetamol 500mg Soluble Tablets (called paracetamol throughout this leaflet). This medicine contains paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used to treat pain (including headache, toothache and period pain) and cold or flu symptoms.

What you need to know before you take it

E PARACETAMOL Do not take paracetamol and tell your doctor if:

  • You are allergic (hypersensitive) to the active substance or any of the other ingredients in your medicine (listed in section 6). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue Children Paracetamol 500mg Soluble Tablets must not be given to children under 10 years of age Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking paracetamol. Warnings and precautions Take special care and check with your doctor before taking paracetamol if:
  • You have severe kidney or liver problems
  • You have a liver problem caused by alcohol If you are not sure if any of the above apply to you, talk to your doctor or pharmacist 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). Other medicines and paracetamol Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also, some other medicines can affect the way paracetamol works. Please inform your doctor or pharmacist if you are taking:
  • Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). While taking paracetamol you should not take any other medicines which contain paracetamol. This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops. Tell your doctor if you are taking any of the following medicines:
  • Medicines used to thin the blood such as warfarin
  • Metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick (vomiting)
  • Colestyramine – for lowering blood cholesterol levels If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking paracetamol. Paracetamol with alcohol You should not drink alcohol while you are taking these tablets. Taking alcohol with paracetamol can increase your chances of getting side effects. Pregnancy and breast-feeding Talk to your doctor before taking these tablets if:
  • You are pregnant, think you may be pregnant or plan to get pregnant
  • You are breast-feeding or planning to breast-feed If necessary, paracetamol 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 or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often. Paracetamol tablets contain:
  • Sodium: This medicine contains 388 mg sodium (main component of cooking/table salt) in each soluble tablet. This is equivalent to 19.4 % of the recommended maximum daily dietary intake of sodium for an adult.
  • Sorbitol: This medicine contains 50 mg sorbitol in each soluble tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

How to take it

PARACETAMOL Always take paracetamol exactly as it says in this leaflet. Check with your doctor or pharmacist if you are not sure.

  • Do not take more than the recommended dose
  • If you need to use this medicine for more than three days at a time, see your doctor Adults and children over 16
  • The usual dose of paracetamol is 2 effervescent tablets
  • Dissolve the effervescent tablets in a full glass of water before taking
  • Wait at least 4 hours before taking another dose
  • Do not take more than 4 doses in any 24-hour period Use in children Paracetamol 500mg Soluble Tablets should not be given to children under 10 years of age. Children aged 10 to 15 years Take one tablet every four to six hours when necessary to a maximum of four doses in 24 hours. If you take more paracetamol 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.
  • Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken If you forget to take paracetamol If you forget to take a dose at the right time, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Stop taking paracetamol and see a doctor or go to a hospital straight away if:
  • You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to paracetamol
  • You get serious skin reactions. Very rare cases have been reported. Tell your doctor or pharmacist if any of the following

Possible side effects

gets serious or lasts longer than a few days:

  • You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia). This side effect has only happened in a few people taking paracetamol 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). If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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: www.mhra.gov.uk/yellowcard 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.

How to store it

PARACETAMOL

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.
  • Store your medicine in the original packaging in order to protect from moisture.
  • Do not store above 25°C.
  • 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.

Contents of the pack and other information

What Paracetamol 500mg Soluble Tablets contain

  • The active substance is paracetamol. Each tablet contains 500mg of paracetamol.
  • The other ingredients are sorbitol, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, sodium bicarbonate, povidone, and dimeticone. Contents of the pack Paracetamol 500mg Soluble Tablets come in cartons of 12, 16, 24, 32, 48, 60 and 100. Not all pack sizes may be sold. The Marketing Authorisation Holder is Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom The Manufacturer is LAMP SAN PROSPERO SPA, VIA DELLA PACE 25/A, SAN PROSPERO (MO) 41030, Italy This leaflet was last updated in January 2025

1065044587

PM CODE: PRODUCT NAME: SAP ID / GMID: AW VERSION: CREATION DATE: AW BY: SUPPLIER:

GENERAL INFO: 1065044587 PIL COMON PARACETAMOL 500MG TABEF GB 935390; 935394 V4 17.01.2025 MiU LAMP

REASON OF REVISION: Site transfer from cologne to CMO-Lamp; ZNtbc; FORMAT (size): LAETUS (pharma code): FONT + MIN. SIZE: MATERIAL TYPE (TS): COLOURS: [ 1 ] Black

TECHNICAL INFO: 180 × 430 mm N/A Helvetica Neue LT W1G 8.5 pt N/A TECH. COLOURS: [ 1 ] DieCut 1065044587

Frequently asked questions about Paracetamol 500mg Soluble Tablets (GSL)

How do I take Paracetamol 500mg Soluble Tablets (GSL)?

Paracetamol 500mg Soluble Tablets (GSL) comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Paracetamol 500mg Soluble Tablets (GSL)?

The active substance in Paracetamol 500mg Soluble Tablets (GSL) is paracetamol.

Are there equivalent medicines to Paracetamol 500mg Soluble Tablets (GSL)?

Medicines with the same active substance, strength and form include: Boots Paracetamol 500 mg Effervescent Tablets, Boots Paracetamol 500 mg tablets (P), Boots Paracetamol 500mg Caplets. In total there are 20 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Paracetamol 500mg Soluble Tablets (GSL), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Paracetamol 500mg Soluble Tablets (GSL) without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Paracetamol (185 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Paracetamol Soluble is a mild analgesic and antipyretic. The tablets are recommended for the treatment of most painful conditions for example, headache, including migraine, toothache, sore throat, dysmenorrhoea, rheumatic pains and the symptomatic relief of colds and influenza.

4.2. Posology and method of administration

Posology

Adults, Elderly and Children over 16 years:

1-2 tablets in at least half a tumbler full of water, up to 4 times daily as required. Do not take for more than 3 days without consulting your doctor.

These doses should not be given more frequently than every 4 hours, and not more than 4 doses should be given in any 24 hour period.

Paediatric population

Not recommended for children under the age of 10 years.

Children aged 10 to 15 years

One tablet every four to six hours when necessary to a maximum of four doses in 24 hours. Do not take for more than 3 days without consulting your doctor.

Method of administration

The tablets should be dissolved in water and are for oral administration only.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Paediatric population

Not recommended for children under the age of 10 years.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Do not take with any other paracetamol-containing products.

If symptoms persist consult your doctor.

Keep out of the reach of children.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

This medicinal product contains sodium. This medicinal product contains 388 mg sodium per effervescent tablet, equivalent to 19.4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Each soluble tablet contains sorbitol powder (E420) at 50mg per tablet. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5. Interaction with other medicinal products and other forms of interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4)

4.6. Fertility, pregnancy and lactation

Pregnancy

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Breastfeeding

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7. Effects on ability to drive and use machines

Paracetamol has no influence on the ability to drive and use machines.

4.8. Undesirable effects

The information below lists reported adverse reactions, ranked using the following frequency classification:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Hypersensitivity including skin rash may occur.

Not known: anaphylactic shock; angioedema

Blood and lymphatic system disorders

Not known: blood dyscrasias including thrombocytopenia and agranulocytosis

Skin and subcutaneous disorders

Very rare cases of serious skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption have been reported.

Metabolism and nutrition disorders

Not known: high anion gap metabolic acidosis.

Description of selected adverse reactions

High anion gap metabolic acidosis

Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient:

• is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes, or

• regularly consumes ethanol in excess of recommended amounts, or

• is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, gastrointestinal bleeding, disseminated intravascular coagulation and death.

Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage.

Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines (see BNF overdose section).

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

💬 Ask about this leaflet

Ask anything about Paracetamol 500mg Soluble Tablets (GSL). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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