Solpadeine Plus Capsules carefully to get – patient leaflet, side effects, dosage

1. What Solpadeine Plus Capsules do

Solpadeine Plus Capsules 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 capsules 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 Capsules

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 Capsules:

• 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

If you are taking other medicines:

Talk to your doctor or pharmacist before taking these capsules if you are taking any prescribed medicines; particularly

metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]);

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

•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 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 medicines 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

Capsules

Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date

shown on the pack. Store below 25°C.

6.Further information

Active ingredients Each capsule contains

Paracetamol 500 mg, Codeine Phosphate

Hemihydrate 8 mg and Caffeine 30 mg.

Other ingredients Maize starch, magnesium

stearate, titanium dioxide (E 171),

erythrosine (E 127), patent blue V (E 131),

quinoline yellow (E 104), gelatin.

Packs of Solpadeine Plus Capsules contain 24

capsules, they have an opaque red cap and

opaque white body, plain on both halves.

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:

Wrafton Laboratories Limited, Exeter Road,

Wrafton, Braunton, EX33 2DL, United Kingdom

or

Swiss Caps GmbH Grassingerstraße 9

83043 Bad Aibling, Germany

(Aenova Group).

This leaflet was last revised in February 2025.

colestyramine (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

Capsules 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 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

Capsules, 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 Capsules:

• 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 Capsules 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.

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 Capsules’

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 Capsules 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.

If you use Solpadeine Plus Capsules during

pregnancy, your baby may become dependent

and experience withdrawal symptoms after the

birth which may need to be treated.

Do not take Solpadeine Plus Capsules while you

are breastfeeding. 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

Capsules

Adults:

Swallow 2 capsules every 4-6 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 8 capsules 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:

Swallow 1-2 capsules every 6 hours as needed.

Do not take more frequently than every 6 hours.

Do not take more than 8 capsules in 24 hours.

Adolescents aged 12-15 years:

Swallow 1 capsule every 6 hours as needed.

Do not take more frequently than every 6 hours.

Do not take more than 4 capsules 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 Capsules 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

LF32342C-W F1H62SXJ2

Body Text

= Frutiger LT Pro 8pt

Horizontal scaling 95% x height = 1,43 mm

= Times New Roman 9pt

• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.
• This medicine has been provided to you and should not be given to anyone else.
• 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 Plus Capsules 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. 1. What Solpadeine Plus Capsules do
2. 2. Check before you take Solpadeine Plus Capsules
3. 3. How to take Solpadeine Plus Capsules
4. 4. Possible side effects
5. 5. How to store Solpadeine Plus Capsules
6. 6. Further information
7. 1. What Solpadeine Plus Capsules do

Solpadeine Plus Capsules 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 capsules 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.

1. 2. Check before you take Solpadeine Plus Capsules

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 Capsules:

• 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

  If you are taking other medicines

  Talk to your doctor or pharmacist before taking these capsules 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 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 Capsules 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 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 Capsules, 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 Capsules:

• 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 Capsules 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.

  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 Capsules’ 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 Capsules 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.

  If you use Solpadeine Plus Capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

  Do not take Solpadeine Plus Capsules while you are breastfeeding. 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

1. 3. How to take Solpadeine Plus Capsules Adults:

Swallow 2 capsules every 4-6 hours as needed. Do not take more frequently than every 4 hours.

Do not take more than 8 capsules 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:

Swallow 1-2 capsules every 6 hours as needed.

Do not take more frequently than every 6 hours. Do not take more than 8 capsules in 24 hours.

Adolescents aged 12-15 years:

Swallow 1 capsule every 6 hours as needed.

Do not take more frequently than every 6 hours. Do not take more than 4 capsules 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 Capsules 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.

  1. 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
• 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 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 medicines 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 Capsules Keep out of the reach and sight of children.

Do not use this medicine after the ‘EXP’ date shown on the pack. Store below 25°C.

6. Further information

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

Other ingredients Maize starch, magnesium stearate, titanium dioxide (E 171), erythrosine (E 127), patent blue V (E 131), quinoline yellow (E 104), gelatin.

Packs of Solpadeine Plus Capsules contain 24 capsules, they have an opaque red cap and opaque white body, plain on both halves.

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 Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton, EX33 2DL, United Kingdom or

Swiss Caps GmbH Grassingerstraße 9

83043 Bad Aibling, Germany (Aenova Group). This leaflet was last revised in February 2025.

LF32342B 11030633 LF32342B 11030633 Paracetamol, Codeine,

Caffeine

150 mm