Ultramol Soluble

Each effervescent tablet contains 500mg paracetamol, 8mg codeine phosphate and 30mg caffeine.For a full list of excipients, see section 6.1.

Effervescent tablet.

Flat white tablets with bevelled edges, plain on one side and scored on the other.

For the short-term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone such as headaches, migraine, neuralgia, toothache, dysmenorrhoea and rheumatic pain.

The product is for oral administration.

Adults, including the elderly, and children over 12 years of age

Two tablets dissolved in a glass of water up to 4 times a day as required.

These doses should not be repeated more frequently than every 4 hours. No more than 4 doses should be given in any 24 hour period. Do not take for more than 3 days without medical review.

Not recommended for children under 12 years of age.

Hypersensitivity to paracetamol, codeine phosphate, caffeine or any of the other constituents.

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

Do not exceed the recommended dose.

Do not take with any other paracetamol-containing products.

Excessive intake of coffee, tea, or cola together with these tablets may make you tense and irritable.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach and sight 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.

Each tablet contains 362mg sodium which may be harmful to people on a low sodium diet.

This medicine contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The label will state:

Front of pack

• Can cause addiction

• For three days use only

• For pain relief

Back of pack

• For the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

• Headaches, migraine, toothache, neuralgia, period pains and rheumatic pains

• If you need to take this medicine for more than 3 days you should see your doctor or pharmacist.

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. If you take this medicine for headaches for more than 3 days, it can make them worse

The leaflet will state:

Important things you should know about Ultramol Soluble

• This medicine can only be used for the short term treatment of acute moderate pain when other painkillers have not worked.

• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days this can give you withdrawal symptoms from the medicine when you stop taking it

• If you take this medicine for headaches for more than 3 days it can make them worse

Section 1: What Ultramol Soluble is and what it is used for

• It is an analgesic (painkiller) and is used for the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

Section 2: Before you take Ultramol Soluble

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take a painkiller for headaches for more than 3 days it can make them worse

Section 3: How to take Ultramol Soluble

• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist

• This medicine contains codeine and can cause addiction if you take it for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Section 4: Possible side effects

This will appear immediately after the heading:

If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy.

This will appear at the end of section 4:

How do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time

• You need to take more than the recommended dose

• When you stop taking this medicine you feel very unwell but you feel better if you start taking the medicine again

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the Caucasian population may be ultra-rapid metabolisers.

The leaflet will state in the "Pregnancy and breast-feeding" subsection of section 2 "Before taking your medicine":

Usually it is safe to take Ultramol Soluble while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk.

If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. 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.

Pregnancy

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol or caffeine used in the recommended dose. Codeine has been used for many years without apparent ill consequence and animal studies have not shown any hazard. Patients should follow the advice of their doctor regarding the use of this product.

Lactation

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. Caffeine is excreted into breast milk and accumulation may occur in breast fed infants. Irritability and poor sleeping patterns have been observed in breast fed infants during periods of heavy maternal use of caffeine. Nursing mothers should be advised to avoid excessive consumption of caffeine containing beverages whilst taking these tablets.

At normal therapeutic doses codeine may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of codeine may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases, consideration should be given to prescribing naloxone to reverse these effects.

Ultramol tablets may cause dizziness and drowsiness. If affected patients should be warned not to drive or operate machinery.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity. Tolerance and dependence can occur especially with prolonged high dosage of codeine.

There have been very rare occurrences of pancreatitis.

Caffeine may produce headache, tremor, nervousness, irritability, sleeplessness, palpitations and GI tract irritation. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse.

Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg. Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least 4 hours after ingestion, or 8 hours if a sustained release preparation has been taken.

Paracetamol

Liver damage is possible in adults who have taken 10g or more of pracetamol. 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.

• regularly consumes ethanol in excess of recommended amounts

• 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, coma 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 ermote 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.

Caffeine

Symptoms of caffeine overdose may include nervousness, irritability, insomnia, breathlessness, tachycardia and gastrointestinal disturbances. The lethal oral dose of caffeine for an adult human is estimated to be about 10g, although a death has been reported following ingestion of 6.5g. Fatal poisoning with caffeine is rare, and high doses of caffeine produce gastric irritation and vomiting before ingestion of toxic amounts.

Pharmacotherapeutic group: Analgesics, N02B E51

The combination of paracetamol and caffeine is a well established analgesic combination.

Codeine phosphate is a centrally acting analgesic and also has a weak cough suppressant activity.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma reaches a peak in 30 - 60 minutes. Plasma half-life is 1 - 4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids, plasma protein binding is variable.

Codeine phosphate is well absorbed after oral administration and is widely distributed. About 86% is excreted in the urine in 24 hours, 40 - 70% is free or conjugated morphine and 10 - 20% is free or conjugated norcodeine.

Caffeine is absorbed readily after oral administration. In adults, plasma elimination half-life ranges from 1.9 to 12.2 hours, with a mean of about 4.9 hours. Adults eliminate less than 2% of a dose of caffeine unchanged in the urine; the rest of the dose is metabolised to demethylated xanthines and urates. The mean plasma protein binding of caffeine is 35%.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sorbitol (E420)

Saccharin sodium

Sodium hydrogen carbonate (sodium bicarbonate)

Povidone K25

Sodium laurilsulfate

Citric acid anhydrous

Sodium carbonate

Dimeticone

Not applicable.

2 years.

Do not store above 30°C. Store in the original package.

Laminate strip of paper/polyethylene/aluminium foil/polyethylene sachets of 4, 12, 16, 24 and 32 tablets packed into a cardboard carton.

Not all pack sizes may be marketed.

No special requirements.

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

PL 17780/0082

13 November 2001/04 March 2009

02 February 2011

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