Solpadeine Tablets (OTC)

The body produces prostaglandins in response to injury and certain diseases. One of the effects of prostaglandins is to sensitise nerve endings, causing pain (presumably to prevent us from causing further harm to the area). As paracetamol reduces the production of these nerve sensitising prostaglandins it is thought it may increase our pain threshold, so that although the cause of the pain remains, we don't feel it as much.

It is thought paracetamol reduces fever by affecting an area of the brain that regulates our body temperature (the hypothalamic heat-regulating centre).

Paracetamol is about as effective as aspirin at relieving mild to moderate pain and fever, but unlike aspirin it has no anti-inflammatory effect.

Codeine is a slightly stronger painkiller known as an opioid. Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.

Codeine mimicks the action of natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.

Solpadeine max tablets are effective at relieving mild to moderate pain, such as headache, migraine, sinusitis, toothache, sore throat, arthritic and rheumatic pain, sciatica and backache (lumbago), strains and sprains and period pain.

What is it used for?

• Short-term (up to three days) treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Warning!

Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.

Do not take this medicine with any other products that contain paracetamol. Many over-the-counter painkillers and cold and flu remedies contain paracetamol. It is important to check the ingredients of any medicines you buy without a prescription before taking them in combination with this medicine. Seek further advice from your pharmacist.

An overdose of paracetamol is dangerous and capable of causing serious damage to the liver and kidneys. You should never exceed the dose stated in the information leaflet supplied with this medicine. Immediate medical advice should be sought in the event of an overdose with this medicine, even if you feel well, because of the risk of delayed, serious liver damage.

Alcohol increases the risk of liver damage that can occur if an overdose of paracetamol is taken. The hazards of paracetamol overdose are greater in persistent heavy drinkers and in people with alcoholic liver disease.

Do not take this medicine for longer than three days without consulting your doctor. If this medicine is taken regularly for long periods of time, the body can become tolerant to it and it may become less effective at relieving pain. With prolonged use, the body may also become dependent on codeine. As a result, when you then stop taking the medicine you may get withdrawal symptoms such as restlessness and irritability.

If you find you need to use this medicine all the time you should consult your doctor for advice.

Taking a painkiller for headaches too often or for too long can actually make the headaches worse.

Use with caution in

• Decreased kidney function.
• Decreased liver function.

Not to be used in

Children under 12 years of age.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

Paracetamol is not known to be harmful when used during pregnancy. However, the safety of codeine has not been established. If codeine is used in the third trimester it may cause withdrawal symptoms in the baby after birth. As a result, this medicine should be used with caution during pregnancy, and only if the expected benefit to the mother outweighs any potential risk to the infant. Seek medical advice from your doctor before using this medicine if you are pregnant.

Paracetamol and codeine may pass into breast milk in amounts that are probably too small to be harmful in most people. However, on very rare occasions, codeine taken by a nursing mother may cause side effects in the breastfed baby. These side effects may include drowsiness or sedation, difficulty breastfeeding, vomiting, breathing difficulties and floppiness in the nursing baby. The baby may be more likely to experience side effects if the mother experiences side effects such as drowsiness, nausea, vomiting, loss of appetite or breathing difficulties after taking codeine. You should seek medical advice from your doctor before taking this medicine if you are breastfeeding. You should stop taking this medicine and consult your doctor immediately or seek emergency medical care if your baby shows any of the symptoms just mentioned.

Label warnings

Do not take more than two at any one time. Do not take more than eight in 24 hours.

Do not take this medication with any other products containing paracetamol.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Constipation.
• Skin rash.
• Nausea.
• Dizziness.
• Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you take this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

You should not take other medicines that contain paracetamol in combination with this medicine, as this can easily result in exceeding the maximum recommended daily dose of paracetamol. Many cold and flu remedies and over-the-counter painkillers contain paracetamol, so be sure to check the ingredients of any other medicines before taking them with this one.

This medicine should be used with caution in people taking a monoamine oxidase inhibitor (MAOI), for example the antidepressants phenelzine, tranylcypromine or isocarboxacid. Ask your doctor or pharmacist for advice before taking this medicine if you have taken an MAOI in the last 14 days.

Cholestyramine reduces the absorption of paracetamol from the gut. It should not be taken within an hour of taking paracetamol or the effect of the paracetamol will be reduced.

Metoclopramide and domperidone may increase the absorption of paracetamol from the gut.

Long-term or regular use of paracetamol may increase the anti-blood-clotting effect of warfarin and other anticoagulant medicines, leading to an increased risk of bleeding. This effect does not occur with occasional painkilling doses. If you are taking an anticoagulant medicine and you are also taking co-codamol regularly, your blood clotting time (INR) should be regularly monitored.

In the unlikely event that this medicine makes you feel drowsy, this may be enhanced by other medicines that can cause drowsiness, such as the following:

• antipsychotics, eg haloperidol
• barbiturates, eg phenobarbital, amobarbital
• benzodiazepines, eg diazepam, temazepam
• other opioids, eg morphine, dihydrocodeine
• sedating antihistamines, eg chlorphenamine, hydroxyzine
• sleeping tablets, eg zopiclone
• tricyclic antidepressants, eg amitriptyline.

References:

http://www.netdoctor.co.uk/aches-and-pains/medicines/solpadeine-max.html

http://www.nhs.uk/medicine-guides/pages/MedicineOverview.aspx?medicine=Solpadeine%20headache%20tablets

http://www.medicines.ie/medicine/11508/PIL/Solpadeine+Tablets/