Calpol product Information 

CalCough Children’s Syrup (Glycerol, Sucrose)

Presentation:
A dark red, blackcurrant flavoured syrup containing glycerol 0.75ml, sucrose 1.7g and (excipient with known effect) liquid glucose 2.15g per 5ml.
Indication:
For the relief of irritating, tickling dry coughs and sore throats.
Dosage and Administration:
Adults, elderly and children over 5 years: 10ml. Children 1 – 5 years: 5ml. The dose may be repeated three or four times a day.
Contraindications:
In children under 1 year. Hypersensitivity to the active substances or to any of the excipients listed in SPC section 6.1.
Precautions:
Diabetics should take note of the carbohydrate content of this product. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains 3.53mg propylene glycol (E1520) in each 5ml dose, which is equivalent to 0.71mg/ml. This medicine contains 10mg sodium benzoate (E211) in each 5ml which is equivalent to 2mg/ml. This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’. This medicine contains 0.000053mg benzyl alcohol in each 5ml which is equivalent to 0.000011mg/ml. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. This is due to an increased risk due to accumulation in young children.
Fertility, pregnancy and lactation:
The safety of this medicine during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.
Side-effects:
Hypersensitivity reactions, including anaphylaxis.
RRP (ex-VAT): 125ml, £3.82
Legal category: GSL
REF-PI-CAR-0020
PL Holder: McNeil Products Ltd, 50 - 100 Holmers Farm Way, High Wycombe,
Buckinghamshire, HP12 4EG
PL Numbers: 15513/0392
Date of Preparation: 10 March 2021

Calcough Infant Syrup (Glycerol)

Presentation:
Syrup containing 0.75ml Glycerol per 5ml (15%v/v).
Indications:
Relief of dry tickly coughs.
Dosage and Administration:
Children aged 1 – 5 years: 10ml three to four times daily; Children 3 months – 1 year: 5ml three to four times daily; Children under 3 months: not recommended.
Contraindications:
Hypersensitivity to ingredients; fructose intolerance.
Precautions:
Diabetics should take note that glycerol may affect blood sugar levels. If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor. Contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’. Contains 10 mg sodium benzoate (E211) in each 5ml which is equivalent to 2mg/ml. Contains 18.24 mg propylene glycol (E1520) in each 5ml which is equivalent to 3.65 mg/5ml.
Pregnancy and Lactation:
Not applicable.
Side Effects:
Possible mild laxative effect.
RRP (ex-VAT): 125ml: £3.82
Legal Category: GSL
PL Holder: McNeil Products Ltd, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
PL Number: 15513/0168
Date of Preparation: 10 March 2021

Calgel Teething Gel (Lidocaine hydrochloride)

Presentation:
Topical gel containing Lidocaine hydrochloride 0.33% w/w and Cetylpyridinium chloride
0.1% w/w.
Uses: Relief of pain and discomfort associated with teething in children from 5 months, where non-pharmacological treatments have failed to provide sufficient relief.
Dosage and Administration:
Children over 5 months: apply a pea-sized amount (0.2g) of gel onto affected area of gum. The dose can be reapplied after 3 hours if necessary up to a maximum of 6 times in 24hours. Treatment should be stopped once symptoms have resolved.
Contraindications:
Hypersensitivity to ingredients.
Precautions: Do not exceed stated dose. Do not use for more the 7 days. Avoid in patients with rare fructose intolerance. Do not use more than once lidocaine containing product at the same time.
Fertility, pregnancy and lactation: Not applicable.
Side effects: Not known frequency: Hypersensitivity (including Dermatitis) or Application site reactions (including Erythema).
RRP (ex-VAT): 10g £2.83
Legal category: P
PL holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG
PL Number: 15513/0015
Date of Preparation: 10 August 2018

Calpol Infant Suspension (incl. Sachets), Calpol Sugar-Free Infant Suspension (incl. Sachets) (Paracetamol)

Presentation:
Suspension containing 120mg Paracetamol per 5ml
Indication:
Treatment of mild to moderate pain and as an antipyretic. Can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post immunisation fever.
Dosage and Administration:
For the relief of fever after vaccinations at 2,3 and 4 months; 2.5ml up to 4 times a day starting at the time of vaccination. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist. Dosage for the relief of pain and other causes of fever in babies aged 2-3 months (if your baby weighs over 4kg and was born after 37 weeks); 2.5ml. If necessary give a second dose after 4-6 hours. Dosage for Children over 3 months; Children 3 to 6 months: 2.5 ml. Children 6 to 24 months: 5 ml. Children 2 years to 4 years: 7.5 ml. Children 4 to 6 years: 10ml. Do not give more than 4 doses in 24 hours and leave at least 4 hours between doses.
Contraindications:
Hypersensitivity to paracetamol or other ingredients.
Precautions:
Do not exceed recommended dose or take with other paracetamol-containing medicines. Caution in severe hepatic or renal impairment and chronic alcohol use. Interactions with domperidone, metoclopramide, cholestyramine, anticoagulants, alcohol, drugs that induce hepatic microsomal enzymes, carbamazepine, fosphenytoin, phenytoin, phenobarbital, and primidone (also isolated reports of hepatotoxicity). Due to the presence of sucrose and sorbitol in the Infant Suspension, patients with rare hereditary problems of fructose intolerance, glucose-galactosemalabsorption or sucrose-isomaltase insufficiency should not take this medicine. Due to the presence of maltitol liquid and sorbitol liquid in the Sugar Free Suspension, patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol and maltitol (Sugar-Free only) may have a mild laxative effect. Parahydroxybenzoates and carmoisine may cause allergic reactions. Benzyl alcohol (Sugar-Free only) may cause allergic reactions. Large amounts of benzyl alcohol can build-up in your body and may cause metabolic acidosis. Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Fertility, pregnancy and lactation: Consult doctor before use.
Side effects:
Uncommon: nephropathy toxic.
Very rare: hypersensitivity, anaphylactic reactions and rash.
Not Known: blood disorder (including thrombocytopenia and agranulocytosis), liver injury, fixed eruption, rash pruritic, urticaria, renal papillary necrosis, and transaminases increased.
Very rare cases of skin reactions. Chronic hepatic necrosis has been reported.
RRP (ex-VAT): 100ml bottle: £3.58; 200ml bottle: £5.91; 12 x 5ml sachets: £3.74; 20 x 5ml sachets (sugar free only): £6.08
Legal category: 200ml bottle: P; 100ml bottle: GSL; Sachets: GSL
PL Holder: McNeil Products Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
PL Numbers: Calpol Infant suspension: 100ml bottle: 15513/0122; 200ml bottle: 15513/0004; Sachets: 15513/0154. Calpol Sugar-free Infant Suspension: 100ml bottle: 15513/0123; 200ml bottle: 15513/0006; Sachets:15513/0155
Date of Preparation: 4 January 2021

Calpol Infant Sugar Free Colour Free 120mg/5ml Oral Suspension (Paracetamol)

Presentation:
Suspension containing 120mg Paracetamol per 5ml
Indications:
Treatment of mild to moderate pain and as an antipyretic. Can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post-immunisation fever.
Dosage and Administration:
For the relief of fever after vaccinations at 2,3 and 4 months; 2.5ml up to 4 times a day starting at the time of vaccination. If your baby still needs this medicine two days after receiving the vaccine talk to you doctor or pharmacist. Dosage for the relief of pain and other causes of fever in babies aged 2-3 months (if your baby weighs over 4kg and was born after 37 weeks); 2.5ml. If necessary give a second dose after 4-6 hours. Dosage for Children aged 3 to 6 months: 2.5 ml. Children 6 to 24 months: 5 ml. Children 2 years to 4 years: 7.5 ml. Children 4 to 6 years: 10ml. Do not give more than 4 doses in 24 hours and leave at least 4 hours between doses.
Contraindications:
Hypersensitivity to paracetamol or other ingredients.
Precautions:
Caution in severe hepatic or renal impairment and chronic alcohol use. Do not exceed recommended dose. Concomitant use of other paracetamol-containing products should be avoided. Interactions with domperidone, metoclopramide, cholestyramine, anticoagulants, alcohol, drugs that induce hepatic microsomal enzymes, carbamazepine, fosphenytoin, phenytoin, phenobarbital, and primidone (also isolated reports of hepatotoxicity). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol and maltilol may have a mild laxative effect. Parahydroxybenzoates may cause allergic reactions. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Benzyl alcohol may cause allergic reactions. Large amounts of benzyl alcohol can build-up in the body and may cause metabolic acidosis if patients are pregnant or breastfeeding, or have a liver or kidney disease.
Fertility, pregnancy and lactation:
Consult doctor before use.
Side effects:
Uncommon: nephropathy toxic.
Very rare: hypersensitivity, anaphylactic reactions and rash.
Not Known: blood disorder (including thrombocytopenia and agranulocytosis), liver injury, fixed eruption, rash pruritic, urticaria, renal papillary necrosis, and transaminases increased.
Very rare cases of skin reactions. Chronic hepatic necrosis has been reported.
RRP (ex-VAT): 100ml bottle: £3.58
Legal category: GSL
PL Holder: McNeil Products Ltd, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
PL Numbers: 15513/0300.
Date of Preparation: 04 January 2021

Calpol Six Plus Fastmelts (Paracetamol)

Presentation:
Orodispersible tablet containing 250mg paracetamol.
Indications:
Treatment of mild to moderate pain and as an antipyretic, including headache, toothache, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever.
Dosage and Administration:
Tablets should be placed in the mouth to melt on tongue. Adults and children over 16 years: 2-4 tablets; children 12-16 years: 2-3 tablets; children 9-12 years: 2 tablets; children 6-9 years: 1 tablet. Under 6 years: Not recommended. Repeat dose every 4 to 6 hours if necessary, up to 4 doses in 24 hours.
Contraindications:
Hypersensitivity to ingredients.
Precautions:
Severe hepatic or severe renal impairment; interactions with domperidone, metoclopramide, cholestryamine, anticoagulants, alcohol, drugs that induce hepatic microsomal enzymes such as carbamazepine, fosphenytoin, phenytoin, phenobarbital and primidone. The phenylalanine in the tablets may be harmful to people with phenylketonuria. This product contains mannitol which may have a mild laxative effect. The use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Do not use any other paracetamol containing products whilst using this product.
Fertility, pregnancy and lactation:
Consult doctor before use.
Side effects:
Uncommon: Nephropathy toxic.
Very rare: Anaphylactic reactions, hypersensitivity and rash.
Not known: Blood disorder (including thrombocytopenia and agranulocytosis), liver injury, rash pruritic, urticaria, renal papillary necrosis, transaminases increased.
Chronic hepatic necrosis has been reported.
RRP (ex-VAT): 12s £4.16; 24s £6.49
Legal cat: 12s: GSL, 24s: P
PL Holder: McNeil Products Ltd, Foundation Park, Maidenhead, Berks, SL6 3UG
PL Numbers: 12s: 15513/0121, 24s: 15513/0082
Date of Preparation: 28 January 2020

Calpol Six Plus Suspension (Paracetamol), Calpol Six Plus Sugar Free Suspension (Paracetamol) and Calpol Six Plus Suspension Sugar Free (Paracetamol)

Presentation:
Suspension containing 250mg paracetamol per 5ml.
Indications:
Treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever.
Dosage and Administration:
Adults and Children over 16 years: 10 ml to 20 ml; Children 12-16 years: 10 ml to 15 ml; Children 10 to 12 years: 10 ml; Children 8 to 10 years 7.5 ml; Children 6 to 8 years; 5 ml; Children under 6 years: not recommended. Do not give more than 4 doses in 24 hours. Leave at least 4 hours between doses.
Contraindications:
Hypersensitivity to paracetamol or other ingredients.
Precautions:
Taking more than the recommended dose (overdose) may cause liver damage. Caution in severe hepatic or renal impairment and chronic alcohol use. Do not dilute. Patients with rare hereditary problems of fructose intolerance, glucose‐galactose malabsorption or sucrose‐isomaltase insufficiency should not take Six Plus Suspension. Patients with rare hereditary problems of fructose intolerance should not take Six Plus Sugar Free Suspension. Do not take with other paracetamol containing medicines. Parahydroxybenzoates may cause allergic reactions (possibly delayed). Interaction with domperidone, metoclopramide, cholestyramine, anticoagulants, alcohol, drugs that induce hepatic microsomal enzymes, carbamazepine, fosphenytoin, phenytoin, phenobarbital, and primidone (also isolated reports of hepatotoxicity). Sorbitol and maltitol (Sugar-Free) may have a mild laxative effect. Benzyl alcohol (Sugar-Free) may cause allergic reactions. If patient is pregnant or breastfeeding, or if patient has kidney or liver disease, large amounts of benzyl alcohol (Sugar-Free) can build up (metabolic acidosis). Contains propylene glycol. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. See relevant Summary of Product Characteristics (SmPC) for full details.
Fertility, pregnancy and lactation:
Consult doctor before use.
Side effects:
Uncommon: nephropathy toxic.
Very rare: hypersensitivity, anaphylactic reactions and rash.
Not Known: blood disorder (including thrombocytopenia and agranulocytosis), liver injury, rash pruritic, urticaria, fixed eruption, renal papillary necrosis, and transaminases increased.
Very rare cases of skin reactions. Chronic hepatic necrosis has been reported.
RRP (ex-VAT):
Six Plus Suspension 200ml bottle, £6.91; Six Plus Sugar Free Suspension, 100ml bottle, £4.16, 200ml bottle, £6.91, 12 x 5ml sachets, £4.58; Six Plus Suspension Sugar Free, 80 ml bottle £3.74
Legal category: Six Plus Suspension 200ml bottle: P; Six Plus Sugar Free Suspension 100ml and 200ml bottle: P; Sachets: GSL and Six Plus Suspension Sugar Free 80 ml bottle: GSL.
PL Holder: McNeil Products Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
PL Numbers: Six Plus Suspension: 15513/0002; Six Plus Sugar Free Suspension 100 ml and 200 ml bottles & sachets: 15513/0003, Six Plus Suspension Sugar Free 80 ml bottle 15513/0164.
Date of Preparation: 4 January 2021

Calprofen 100mg/5ml Oral Suspension Ibuprofen, Calprofen 100mg/5ml Ibuprofen Suspension and Calprofen Ibuprofen Suspension

Presentation:
Sachets and suspension containing 100mg Ibuprofen per 5ml. Calprofen 100mg/5ml Ibuprofen Suspension also contains maltitol syrup (E965), sodium methylhydroxybenzoate (E219), sodium propylhydroxybenzoate (E217), propylene glycol (E1520), sodium (1.86mg/5ml) and ethanol.
Uses:
Treatment of mild to moderate pain, headache, fever, post-immunisation pyrexia, symptoms of colds and flu and minor aches and pains.
Dosage:
For Pain and Fever: Infants 3-6 months, weighing over 5kg: One 2.5 ml dose may be taken 3 times in 24 hours; Infants 6-12 months: 2.5ml three times a day; Children 1-2 years: 2.5ml three to four times a day; Children 3-7 years: 5ml three to four times a day; Children 8-12 years: 10ml three to four times a day. Post-immunisation fever: 2.5ml (50mg) followed by one further 2.5ml (50mg) dose six hours later if necessary. No more than 2 doses in 24 hours. Leave 6 – 8 hours between dose.
Contraindications:
Hypersensitivity to ingredients, or to aspirin or other NSAIDs. Peptic ulceration/haemorrhage, perforation or GI bleeding. Concomitant use with NSAIDs. Severe hepatic, renal or heart failure (NYHA Class IV). Women in the last trimester of pregnancy.
Precautions:
The elderly; women tying to conceive; dehydrated children; history of GI toxicity; concomitant medications increasing the risk of GI toxicity; hepatic or renal dysfunction; bronchial asthma or allergic disease; hypertension or heart failure; ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease; long term treatment if risk factors for cardiovascular events exist; SLE; mixed connective tissue disease; use in relation to infections; use immediately before or after heart surgery; excessive alcohol intake; fructose intolerance. Should be used with caution in patients receiving anticoagulants, antihypertensives and diuretics, corticosteroids, anti-platelet agents and SSRIs, cardiac glycosides, lithium, methotrexate, ciclosporin, mifepristone, tacrolimus, zidovudine, and quinolone antibiotics.
Pregnancy and lactation:
Not recommended.
Side effects:
Uncommon: Hypersensitivity reactions with urticaria and pruritus, abdominal pain, nausea and dyspepsia, headache, various skin rashes.
Rare: diarrhoea, flatulence, gastrointestinal ulcer haemorrhage, constipation and vomiting.
Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and
laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock). Exacerbation of asthma and bronchospasm, peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis. ulcerative stomatitis, gastritis, exacerbation of colitis and Crohn's disease. Acute renal failure, papillary necrosis especially in long term use, associated with increased serum urea and oedema. Liver disorders, haematopoietic disorders, severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme, toxic epidermal necrolysis and aseptic meningitis.
Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP), photosensitivity reactions, renal impairment.
Price (ex-VAT): Sachets: 12 x 5ml: £3.45, Bottle 200ml: £5.91; 100ml: £3.58.
Legal category: Sachets: GSL. 200ml bottle: P. 100ml bottle: GSL.
PL holder: McNeil Products Ltd, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG. PL numbers: Sachets: 15513/0158, 200ml: bottle 15513/0120. 100ml bottle: 15513/0147.
Date of preparation: 20 April 2021.