Boots Decongestant with Pain Relief Tablets

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice

• If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)
• If you are allergic to other decongestants
• If you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure
• If you have heart or blood vessel disease, including poor circulation in your hands or feet
• If you have severe liver problems
• If you have very high blood pressure or hypertension not controlled by your medication (including that due to a tumour near your kidney)
• If you have diabetes
• If you have an overactive thyroid
• If you are a man with prostate problems
• If you have glaucoma or you have been told you have raised pressure in the eye
• If you are taking any of these medicines:
  • Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them within the last 14 days
  • Medicines called beta-blockers (normally taken for heart problems or blood pressure)
  • Other decongestants

• If you are pregnant or breastfeeding
• If you have other kidney or liver problems (including a disease caused by drinking alcohol)
• If you are dependent on alcohol
• If you develop a feverish generalised erythema associated with pustules, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 'Possible side effects'
• Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inflammation of the colon (ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking this medicine and contact your doctor or seek medical attention immediately. See 'Possible side effects' section.
• Reduction of blood flow to your optic nerve may occur with pseudoephedrine.

If you develop sudden loss of vision, stop taking Boots Decongestant with Pain Relief Tablets and contact your doctor or seek medical attention immediately.

See ‘Possible side effects’ section.

• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using this medicine immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see 'Possible side effects' for symptoms).
• One of the active ingredients in this medicine, pseudoephedrine, has the potential to be abused and large doses of pseudoephedrine can be toxic. Continuous use may lead to taking more of this medicine than the recommended dose to get the desired effect, resulting in an increased risk of overdosing. The recommended maximum dose and treatment duration should not be exceeded (see Possible side effects section).

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

Information about some of the ingredients in this medicine

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.

This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Medicines to treat high blood pressure
• Medicines for heart problems (e.g. digoxin)
• Medicines which may cause a dry mouth (e.g. tricyclic antidepressants)
• Medicines to reduce your appetite or stimulant medicines
• Ergot alkaloids (for migraine)
• Oxytocin (to induce labour and stop excessive bleeding after the birth)
• Medicines for epilepsy
• Contraceptive tablets
• Non-steroidal anti-inflammatory drugs (for pain and swelling)
• Warfarin or other blood thinners – if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin
• Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with this medicine. See section ‘Before you take this medicine’.

Frequency not known:

Inflammation of the colon due to insufficient blood supply (ischaemic colitis).

Reduced blood flow to the optic nerve, loss of vision (Ischaemic optic neuropathy)

Serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Stop using this medicine immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset
• feeling sick
• vomiting
• confusion
• seizures changes in vision

• Hallucinations
• Restlessness
• Sleep disturbances

• Other allergic reactions including skin rash
• Feeling sick, being sick
• Anxiety, feelings of paranoia, irritability, excitability, tremors, headache, dizziness, difficulty sleeping, nightmares
• Fast, slow or irregular heart beat, palpitations
• High blood pressure
• Difficulty in passing urine
• Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood

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 or search for 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.