Flamingo Cold and Chesty Cough All-in-one 250mg/100mg/5mg Film-coated tablets

This medicine is available without prescription but you still need to use Flamingo Cold and Chesty Cough All-in-one 250mg/100mg/5mg Film-coated 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.

The full name of this medicine is Flamingo Cold and Chesty Cough All-in-one 250mg/100mg/5mg Film-coated tablets. It is referred to as Flamingo All-in-one tablets throughout this leaflet.

1. What Flamingo All-in-one tablets are and what they are used for
2. What you need to know before you take Flamingo All-in-one tablets
3. How to take Flamingo All-in-one tablets
4. Possible side effects
5. How to store Flamingo All-in-one tablets
6. Contents of the pack and other information

• if you have ever had an allergic reaction to paracetamol, guaifenesin, phenylephrine hydrochloride or to any of the other ingredients (listed in section 6)
• if you have kidney or liver problems (including alcoholic liver disease), overactive thyroid, diabetes, high blood pressure or heart disease
• if you have phaeochromocytoma or glaucoma
• if you are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression
• if you are taking beta-blockers (e.g. atenolol)
• if you have an enlarged prostate

Contains paracetamol.

Taking too much paracetamol can cause serious harm to your liver.

Do not take anything else containing paracetamol while taking this medicine.

Do not take with any other flu, cold, decongestant products or cough suppressants.

This product may cause dizziness. If affected do not drive or operate machinery.

• if you have blood vessel disease such as Raynaud's phenomenon
• if you have asthma or chronic cough
• if you have liver or kidney problems
• if you have a severe infection as this may increase the risk of metabolic acidosis.
• Signs of metabolic acidosis include:
  • deep, rapid, difficult breathing
  • feeling sick (nausea), being sick (vomiting)
  • loss of appetite

Contact a doctor immediately if you get a combination of these symptoms.

During treatment with this tablet, tell your doctor straight away if:

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).

Talk to your doctor or pharmacist before taking Flamingo All-in-one tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]), or ergotamine or methylsergide (for migraine), or colestyramine (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants or stimulants; drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin) or if you take blood thinning drugs (anticoagulants e.g. warfarin); flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Talk to your doctor before taking this product if you are pregnant or breastfeeding.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

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 symptoms persist, see your doctor.

• 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 or aspirin.
• Unexplained bruising or bleeding.
• Reoccurring fevers or infections.
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
• Visual disturbances. This is rare but is more likely in those with glaucoma.
• Unusually fast pulse rate or sensation of an unusually fast or irregular heartbeat.
• Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland.
• Metabolic acidosis: Frequency not known: A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)”

The following side effects may also occur.

Tell your doctor if you get them:

• Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea or sickness.

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.

Flamingo All-in-one tablets are white, capsule shaped, film coated tablet, embossed with “PGP” on one side and plain on the other The tablets are 17.6mm in length, 7.3mm in width and 6.1 mm in thickness.

Tablets are available in cartons containing aluminium-PVC/PVDC and aluminium- PVC white opaque film child-resistant blister packs of 8, 12 and 16 tablets.

Not all pack sizes may be marketed.

PL 43461/0158