Patient leaflet - Solpadeine Plus soluble tablets

1. What Solpadeine Plus Soluble Tablets do

Solpadeine Plus Soluble 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, rheumatic pain and sciatica. The tablets contain three active ingredients; paracetamol, codeine and caffeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Paracetamol is another analgesic to relieve pain. Caffeine acts to further help the effectiveness of paracetamol.

2. Check before you take

Solpadeine Plus Soluble 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.
This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
If you take a painkiller for headaches for more than 3 days it can make them worse.
Do not take Solpadeine Plus Soluble Tablets:
If you have ever had an allergic reaction to paracetamol, caffeine, 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
If you are under 12 years
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 pregnant or breastfeeding.
If you have respiratory depression or chronic constipation.
Ask your doctor before you take this medicine:
If you have been told by your doctor that you have an intolerance to some sugars
If you are on a controlled sodium diet. Each tablet contains 427 mg of sodium. This is equivalent to 22% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you take this medicine daily for a prolonged period or repeatedly for two days every week, especially if you have been advised to follow a low salt (sodium) diet.

This medicine contains 50mg sorbitol (E420) per 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. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

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] and vomiting [being sick]); cholestyramine (to lower blood cholesterol); monoamine oxidase inhibitors (MAOIs) prescribed for depression in the last 2 weeks, or substances that make you drowsy (e.g. sedatives, antidepressants or alcohol) or sedated (e.g. benzodiazepines or related medicines). 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 Plus Soluble Tablets at the same time as anticoagulants. If you take medicine treat gout and hyperuricemia (e.g. probenecid). Flucloxacillin (antibiotic), due to a serious risk of blood and ﬂuid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). Pregabalin and gabapentin as there is an increased risk of respiratory depression.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 on a controlled sodium diet.
If you have hypotension or hypothyroidism
If you have experienced a recent head injury or raised intracranial pressure.
If you have asthma and have been told by your doctor that you are sensitive to aspirin.
If you have Gilbert’s Syndrome (familial non-haemolytic jaundice)
If you are taking other medicines that can affect liver function
If you have glucose-6-phosphatase dehydrogenase deﬁciency
If you have haemolytic anaemia
If you have glutathione deﬁciency
If you are dehydrated
If you have a poor diet such that the diet causes health problems
If you weigh less that 50kg
If you are elderly
If you have a condition called myasthenia gravis which weakens the muscles They may reduce your dose or increase the time interval between doses of your medicine.

During treatment with Solpadeine Plus Soluble Tablets, tell your doctor straight away 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). 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

Talk to your doctor or pharmacist before taking Solpadeine Plus Soluble Tablets:

If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal substances.
If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
If you feel you need to take more of Solpadeine Plus Tablets to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Taking higher doses or more frequent doses of opioids, such as codeine (an active ingredient of this medicine), may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. Paracetamol, Codeine,

Caffeine

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor or pharmacist about your treatment. Please refer Section 3 ‘How to take Solpadeine Plus Soluble Tablets’ for information on correct dosages and time intervals. Do not take this medicine continuously for longer than 3 days.

Possible withdrawal effect:

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. If you become addicted, when you stop taking it you may get withdrawal symptoms. Withdrawal symptoms can include restlessness, difﬁculty sleeping, irritability, agitation, anxiety, feeling your heartbeat

(palpitations), increased blood pressure, feeling of being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. You should talk to your doctor if you think you are suffering from withdrawal symptoms.

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

Do not take Solpadeine Plus Tablets if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the beneﬁts of treatment are considered to outweigh the potential harm to the baby.

Do not take Solpadeine Plus Soluble Tablets while you are breast-feeding. Codeine and morphine passes into breast milk and will affect your baby.

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 Plus Soluble Tablets

Adults:

Take 2 tablets dissolved in a full tumbler of water (200ml), 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.

A reduced maximum daily dose should be considered if you are underweight (under 50kg)

For the elderly a reduced dose may be required.

Adolescents aged 16 – 18 years: Take 1-2 tablets dissolved in a full tumbler of water (200ml), every 6 hours as needed.

Do not take more frequently than every 6 hours.

Do not take more than 8 tablets in 24 hours.

Adolescents aged 12 – 15 years: Take 1 tablet dissolved in a full tumbler of water (200ml), 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.
Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difﬁculty sleeping, shaking and an uncomfortable feeling in the chest.
Solpadeine Plus Soluble 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.
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, dry mouth, nausea and vomiting if you have recently had your gall bladder removed
Nervousness, dizziness, irritability, drowsiness or restlessness
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, itching or sweating
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, upset stomach, sudden weight loss, loss of appetite and yellowing of the eyes and skin
Cloudy urine or difﬁculties urinating. Frequency “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).

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 on the pack, it is unlikely you will become addicted to the medicine. However, if you notice any of the following signs signs 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.
You are using the medicine for reasons other than instructed.
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 Plus Soluble Tablets

Keep out of the reach and sight of children.

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

Store below 30°C.

Protect from light and moisture.

6. Further information

Active ingredients Each effervescent tablet contains Paracetamol 500 mg, Codeine Phosphate Hemihydrate 8 mg and Caffeine 30 mg.

Other ingredients Sodium bicarbonate, sorbitol powder (E 420), saccharin sodium, sodium lauryl sulfate, citric acid, sodium carbonate, polyvinylpyrrolidone and silicone ﬂuid.

Packs of Solpadeine Plus Soluble Tablets contain 24 effervescent tablets.

The marketing authorisation holder is Omega Pharma Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom and all enquiries should be sent to this address. The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or

Swiss Caps GmbH Grassingerstraβe 9, 83043 Bad Aibling, Germany (Aenova Group).

This leaﬂet was last revised in February 2025.

148 mm

Prescription needed?	No, but it is sold only in pharmacies (P)
Controlled drug	Yes, Schedule 5 of the Misuse of Drugs Regulations? Controlled drugs are medicines that UK law controls more strictly because they can be misused or cause dependence. The Misuse of Drugs Regulations 2001 divide them into 5 schedules: schedule 1 has the strictest rules, schedule 5 the lightest. Schedule 5 has the lightest rules: low-strength preparations, for example of codeine or morphine, with a low risk of misuse. You can buy it in a pharmacy without a prescription. Never give it to anyone else.
Active substances	Caffeine, Codeine phosphate, Paracetamol
Strength	500 mg + 30 mg + 8 mg
Pharmaceutical form	Soluble tablet
How is it taken	Oral
Excipients	Sodium bicarbonate, sorbitol powder, saccharin sodium, sodium lauryl sulphate, citric acid, sodium carbonate, polyvinylpyrrolidone, silicone fluid 200/350, purified water.
Pack sizes	24 tablet
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	48 months.
Storage	Do not store above 30°C
Drug group (ATC)	Opioids in combination with non-opioid analgesics: codeine and paracetamol N Nervous system drugs N02 Analgesics N02B Other analgesics and antipyretics N02BE Anilide analgesics and antipyretics N02BE51 paracetamol, combinations excl. psycholeptics
Marketing authorisation	PL 02855/0080 (first authorised 5 March 2009)
Marketing authorisation holder	Omega Pharma Ltd
Codes	GTIN 5012616268007 · BNF 04070100

Solpadeine Plus soluble tablets – patient leaflet, side effects, dosage