Propain Plus – patient leaflet, side effects, dosage

1. What Propain Plus is and what it is used for

The name of your medicine is Propain Plus.

Propain Plus contains four different medicines called caffeine, codeine phosphate, doxylamine succinate and paracetamol.

Paracetamol acts as an analgesic (painkiller). Doxylamine is an antihistamine and caffeine is a mild stimulant which also acts to help the effectiveness of paracetamol. Codeine is an analgesic.

This medicine can be used for the short term treatment of: ! backache

! neuralgia

! muscular aches and pains

! toothache

! rheumatic pain

! headache and tension headache

! period pain

! migraine

This medicine can also be used to relieve pain following operations and dental surgery.

Codeine can be used in children over 12 years of age for the short term relief of moderate pain that is not relieved by other painkillers such as paracetamol, ibuprofen or aspirin alone but not if they are under 18 years of age and have had their tonsils or adenoids removed due to Obstructive Sleep Apnoea Syndrome.

2. What you need to know before you take Propain Plus

• This medicine contains codeine which can cause

  addiction if you take it continuously for more than three 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

  three days it can make them worse.

Do not take Propain Plus

• If you are allergic to paracetamol, codeine, caffeine,

  doxylamine succinate, antihistamines or to any of the other ingredients in this medicine (listed in section 6). · If you are having an asthma attack or have severe

  breathing problems

• If you have recently had a head injury.

• If you have been told by your doctor that you have

  increased pressure in your head. Signs of this include headaches, being sick (vomiting) and blurred eyesight. · If you have severe liver problems

• If you have recently had an operation on your liver, gall

  bladder or bile duct (biliary tract).

• If you are at risk of blocked intestine (paralytic ileus). · If you are taking other medicines containing codeine or

  any other paracetamol-containing products. · If you are taking a medicine of the class known as

  Monoamine Oxidase Inhibitors (MAOIs, e.g. selegiline, moclobemide), which are used as antidepressants, or if you had taken any medicine of this group in the past 14 days.

• If you are an alcoholic

• For pain relief in children and adolescents (0-18 years

  of age) and 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 or planning to breastfeed.

Do not take Propain Plus if any of the above apply to you.

Warnings and precautions

During treatment with Propain Plus, 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).

• You experience pain or increased sensitivity to pain

  (hyperalgesia) which does not respond to a higher dosage of your medicine.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system

Talk to your doctor or pharmacist before taking this medicine if you:

! have liver, kidney, thyroid or heart problems. ! are an elderly person.

! have a history of drug abuse.

! have emotional problems.

! have or suffer from: high blood pressure, problems with

the prostate gland, obstructive bowel problems, acute abdominal conditions (e.g. peptic ulcer), hormonal problems, problems passing urine or have had recent gastrointestinal surgery.

• are in shock, have gallstones, glaucoma, or a disease

  called myasthenia gravis (a condition which weakens muscles) or a history of fits.

• have a history of mood swings, alcohol or drug abuse

  or are under psychiatric treatment.

• regularly drink, or have recently stopped drinking

  excessive amounts of alcohol.

• are taking a benzodiazepine (used for the treatment of

  anxiety or sleep disorders), e.g. diazepam, clobazam, lorazepam, chlordiazepoxide, oxazepam, temazepam, nitrazepam, loprazolam, lormetazepam or clonazepam. · have low glutathione reserves

• have Glucose-6-phosphate-dehydrogenase deficiency · have Gilbert's syndrome
• have chronic constipation

• are addicted to opioids or are being treated for opioid

  addiction

• suffer from breathing problems
• have Addison's disease
• have thyroid problems
• are elderly
• suffer from anxiety
• have an irregular heartbeat.

Tolerance, dependence, and addiction

This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Propain Plus can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Propain Plus if:

• You or anyone in your family have ever abused or been

  dependent on alcohol, prescription medicines or illegal drugs ("addiction").

• You are a smoker.

• You have ever had problems with your mood

  (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Propain Plus, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised

  by your doctor

• You need to take more than the recommended dose

• You might feel that you need to carry on taking your

  medicine, even when it doesn't help to relieve your pain

• You are using the medicine for reasons other than

  prescribed, for instance, 'to stay calm' or 'help you sleep'

• You have made repeated, unsuccessful attempts to

  quit or control the use of the medicine

• When you stop taking the medicine you feel unwell,

  and you feel better once taking the medicine again ('withdrawal effects')

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Propain Plus).

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine and relieves pain. 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.

Sleep-related breathing disorders

Propain Plus can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Propain Plus

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Propain Plus can affect the way some other medicines work. Also, some other medicines can affect the way Propain Plus works.

While taking Propain Plus you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of medicines available from your doctor and more widely in shops.

Do not take this medicine and tell your doctor or pharmacist if you are taking

! Medicines to treat depression called MAOIs

(monoamine oxidase inhibitors) or have recently taken them in the last two weeks. MAOIs are medicines such as moclobemide, phenelzine, tranylcypromine.

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:

• Medicines which make you drowsy or sleepy (CNS

  depressants) e.g. barbiturates, anaesthetics, hypnotics, other opioid analgesics, anxiolytic sedatives, antipsychotics, tricyclic antidepressants and phenothiazines) or a benzodiazepine used to treat anxiety or sleep disorders (to help you sleep or treat epilepsy)

• Medicines for the treatment of high blood pressure

  (diuretics and antihypertensives)

• Medicines to treat or prevent clinical depression

  (antidepressants)

• Medicines used to treat mental distress or disorder

  (antipsychotics)

• Any of the group called antimuscarinics (e.g. atropine,

  hyoscine)

• Any of the group called neuromuscular blockers (e.g.

  tubocurarine)

• Medicines used to thin the blood such as warfarin (or

  other coumarins)

• Metoclopramide or domperidone - used to stop you

  feeling sick (nausea) or being sick (vomiting) · Colestyramine – for lowering blood cholesterol levels · Hydroxyzine - to treat anxiety and tension

  • Mexiletine – to treat irregular heartbeat
  • Kaolin or loperamide - for the treatment of diarrhoea · Naloxone - to treat a narcotic overdose

  • Naltrexone - used as part of a treatment program for

    drug or alcohol dependence

  • Cimetidine – to treat stomach ulcers
  • Cisapride - to treat gastro-oesophageal reflux disease · Quinidine – to treat irregular heart rate

  • Theophylline – used for wheezing or difficulty in

    breathing

  • Medicines for infections (antibiotics) such as enoxacin,

    ciprofloxacin, rifampicin and flucloxacillin · The oral contraceptive pill

! Ergot alkaloids (for migraine)

! Cinacalcet – to treat thyroid problems

! Methadone – used for treating drug (opioid)

dependence and severe chronic pain.

! Enzyme-inducing agents such as alcohol or anti-

epileptic medicines

! Phenylbutazone, indometacin (anti-inflammatory

medicine)

! Aspirin

! Central nervous system depressants including alcohol ! Flucloxacillin (antibiotic), due to a serious risk of blood

and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). ! Gabapentin or pregabalin to treat epilepsy or pain due

to nerve problems (neuropathic pain).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Propain Plus.

Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, you should only take these together if prescribed by a doctor. Please follow your doctor's dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Propain Plus with food, drink and alcohol

You should not drink alcohol while taking this medicine. Alcohol may increase the sedative effects of this medicine and make you very sleepy. It can increase the risk of some side effects.

Avoid drinking too much coffee, or other drinks containing caffeine, while taking these tablets.

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

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Propain Plus and speak to your doctor if: ! you are in the last three months of pregnancy ! in labour

! you are breast-feeding. Codeine and morphine passes

into the breast milk.

Driving and using machines

Propain Plus 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 prescribed to treat a

  medical or dental problem and

• You have taken it according to the instructions

  given by the prescriber or in 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.

3. How to take Propain Plus

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is described below.

These tablets are for oral administration. They should be swallowed with a glass of water.

Dosage instructions

Adults: Take 1-2 tablets every 6 hours as needed for relief. Do not take more than 8 tablets in 24 hours.

Children aged 16 years or above: Take 1-2 tablets every 6 hours, as needed. Do not take more than 8 tablets in 24 hours.

Children aged 12 years to 15 years: Take one tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.

Propain Plus should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

Do not take Propain Plus for more than three days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist. Propain Plus should be used for 3 days only to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a healthcare professional.

If you take more Propain Plus than you should

• Signs of overdose may include unusually pale skin,

  nausea, vomiting, loss of appetite, abdominal pain, pupils that may be pin-point in size, difficulty in breathing, an increased or irregular heart rate, and loin (kidney) pain.

• 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.

• Remember to take any remaining tablets and the pack

  with you. This is so the doctor knows what you have taken.

If you have forgotten to take Propain Plus

If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.

If you stop taking Propain Plus

This medicine contains codeine and can cause addiction if you take it continuously for more than three 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.

4. Possible side effects

Like all medicines, Propain Plus can cause side effects although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Propain Plus and see a doctor or go to a hospital straight away if:

! You have a rash, fever, swelling, bruising or tiredness ! You have difficulty in breathing, are wheezing or have tightness in the chest or you feel dizzy

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction.

! You get serious skin reactions. Very rare cases have been reported.

Talk to your doctor straight away if you notice the following serious side effects:

! Severe stomach pain, which may reach to your back.

This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect. ! You get infections or bruise more easily than usual.

This could be because of a blood problem (such as agranulocytosis, thrombocytopenia, neutropenia or leukopenia)

! Yellowing of the skin or the white of the eyes ! You get chest pain, shortness of breath, clammy, sweaty and a grey complexion

! Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage ! You have a fit (seizure)

! Ringing in the ears (tinnitus)

! Blurred vision

! 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).

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days: ! Feeling sick (nausea)

! Being sick (vomiting)

! Low blood pressure (causing light headedness or fainting when standing up)

! Headache

! Dizziness

! Somnolence

! Feeling unusually tired

! Confusion

! Depression

! Feeling overly happy (euphoria)

! A feeling of unease or dissatisfaction

! Difficulties sleeping

! Restlessness

! Shaking, fits

! Irregular heart beat

! Increased heart rate

! Stomach pain

! Sweating

! Facial flushing

! General discomfort

! Loss of appetite

! Very slow or shallow breathing

! Shortness of breath

! Hallucinations, nightmares

! Cramps or stiffness

! Becoming dependent on codeine

! Difficulty in passing water

! A decrease in the number of red blood cells (anaemia)

in patients with underlying glucose 6-phosphate-dehydrogenase deficiency.

Not known (frequency cannot be estimated from the available data):

• Problem affecting a valve in the intestines (sphincter of

  Oddi dysfunction)

Other effects that may occur are; constipation, headache, drowsiness, dizziness, restlessness, difficulties passing urine, dry mouth, blurred vision, diarrhoea, thick phlegm.

How do I know if I am addicted?

If you take the 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 the medicine you feel very unwell but you feel better if you start taking the medicine again

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Propain Plus

Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date on the container. The expiry date refers to the last day of that month.

o Store in a dry place, below 25 C and protect from light.

If you notice any visible signs of deterioration such as broken or chipped tablets please take this medicine to your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Propain Plus contains

The active ingredients in this medicine are paracetamol 450 mg, doxylamine succinate 5 mg, caffeine anhydrous 30 mg and codeine phosphate 10 mg.

The other ingredients are maize starch, povidone, magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose. The film coat contains hypromellose, hydroxypropylcellulose, glycerol and carnauba wax.

What Propain Plus looks like and contents of the pack

This medicine is a capsule-shaped tablet called a caplet. The tablets are available in packs of 8, 10, 16, 20 or 32.

Not all pack sizes are marketed.

Marketing Authorisation Holder

Ennogen IP Ltd, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK

Manufacturer

Sandoz Ltd, Woolmer Way, Bordon, Hampshire GU35 9QE.

This leaflet was last revised in April 2026.

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