What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL02855/0074.

Solpadeine Max

PATIENT INFORMATION LEAFLET

Solpadeine® MAX Tablets

Paracetamol, Codeine

  • This medicine is 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 3 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.

Please read right through this leaflet before you start using this medicine.

This medicine is available without prescription, but you still need to use Solpadeine Max Tablets carefully to get the best results from them.

  • Keep this leaflet you may need to read it again.
  • If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leaflet:

1. What Solpadeine Max Tablets do
2. Check before you take Solpadeine Max Tablets
3. How to take Solpadeine Max Tablets
4. Possible side effects
5. How to store Solpadeine Max Tablets
6. Further information

1. What Solpadeine Max Tablets do

Solpadeine Max Tablets can be used in patients over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica. The tablets contain two active ingredients; paracetamol and codeine are both painkillers. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other painkillers.

2. Check before you take Solpadeine Max Tablets

  • 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.

Do not take Solpadeine Max Tablets:

  • If you have ever had an allergic reaction to paracetamol, codeine, other opioid painkillers or to any of the other ingredients (listed in Section 6)
  • If you are taking other medicines containing paracetamol or codeine
  • For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
  • If you know that you metabolise very rapidly codeine into morphine
  • If you are breastfeeding.

Ask your doctor before you take this medicine:

  • If you have liver or kidney disease, including alcoholic liver disease
  • If you have bowel problems including blockage of your bowel
  • If you have had an operation to remove your gall bladder
  • If you have been told by your doctor that you have an intolerance to some sugars.

If you are taking other medicines

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]); colestyramine (to lower blood cholesterol); monoamine oxidase inhibitors (MAOIs) prescribed for depression or medicines that make you drowsy. If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Solpadeine Max Tablets at the same time as anticoagulants.

Warnings and precautions

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery:

Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems:

Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Pregnancy and breast feeding

Talk to your doctor before taking Solpadeine Max Tablets if you are pregnant. Do not take Solpadeine Max Tablets while you are breast-feeding. Codeine and morphine passes into breast milk.

Driving and using machines

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.

It is an offence to drive if this medicine affects your ability to drive.

However, you would not be committing an offence if:

  • The medicine has been taken to treat a medical or dental problem and
  • You have taken it according to the information provided with the medicine and
  • It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: www.gov.uk/drug-driving-law

3. How to take Solpadeine Max Tablets

Adults:

Swallow 2 tablets every 4-6 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 8 tablets in 24 hours.

Children aged 16 – 18 years:

Swallow 1-2 tablets every 6 hours as needed.

Do not take more frequently than every 6 hours.

Do not take more than 8 tablets in 24 hours.

Children aged 12 – 15 years:

Swallow 1 tablet every 6 hours as needed.

Do not take more frequently than every 6 hours.

Do not take more than 4 tablets in 24 hours.

  • Do not take more than the recommended dose.
  • Solpadeine Max Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.
  • This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

Possible withdrawal effects

This medicine contains codeine and can cause addiction if you take it continuously 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.

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 your symptoms continue or your headache becomes persistent, see your doctor

4. Possible side effects

Some people may have side effects when using this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.

When using this product you may experience:

  • Constipation

Stop taking this medicine and tell your doctor immediately if you experience:

  • Severe abdominal pain, nausea and vomiting if you have recently had your gall bladder removed
  • Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
  • Skin rash or peeling or mouth ulcers
  • Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
  • Unexplained bruising or bleeding
  • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. 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

By reporting side effects you can help provide more information on the safety of this medicine.

How do I know if I am addicted?

If you take this medicine according to the instructions the pack, it is unlikely 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 the medicine you feel very unwell but you feel better if you start taking the medicine again.

5. How to store Solpadeine Max Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack.

6. Further information

Active ingredients Each tablet contains Paracetamol 500 mg and Codeine Phosphate Hemihydrate 12.8 mg.

Other ingredients Starch pregelatinised, povidone, potassium sorbate (E 202), maize starch, talc, magnesium stearate, stearic acid, microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, macrogol, quinoline yellow (E 104), erythrosine (E 127) and titanium dioxide (E 171).

Packs of Solpadeine Max Tablets contain 20 or 30 tablets with MAX embossed one side or plain on both sides.

The marketing authorisation holder is

Omega Pharma Ltd
32 Vauxhall Bridge Road
London
SW1V 2SA
United Kingdom

and all enquiries should be sent to this address.

The manufacturer is

Omega Pharma Manufacturing GmbH & Co. KG
Benzstraße 25
71083, Herrenberg
Germany

or

SmithKline Beecham S.A.
Carretera de Ajalvir
Km 2500
Alcala de Henares
28806 Madrid
Spain

or

Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling
Germany (Aenova Group)

This leaflet was last revised in November 2016.

LF03519C 11017636