RobiCold™ Cold & Flu Relief 200mg/30mg Soft Capsules

Contains: Ibuprofen 200 mg / Pseudoephedrine hydrochloride 30 mg

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

•    What is in this leaflet

1.    What RobiCold Cold & Flu Relief is and what it is used for

2.    What you need to know before you take RobiCold Cold & Flu Relief

3.    How to take RobiCold Cold & Flu Relief

4.    Possible side effects

5.    How to store RobiCold Cold & Flu Relief

6.    Contents of the pack and other information

•    1. What RobiCold Cold & Flu Relief is and what it is used for

What RobiCold Cold & Flu Relief is

RobiCold Cold & Flu Relief contains two active substances, ibuprofen and pseudoephedrine.

•    Ibuprofen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs). It helps to reduce pain and lower a high temperature (fever).

•    Pseudoephedrine belongs to a group of medicines called ‘vasoconstrictors’. It helps to clear the nasal passages and eases nasal congestion. What RobiCold Cold & Flu Relief is used for

RobiCold Cold & Flu Relief is used to treat symptoms of the common cold and flu, including headache, high temperature (fever), sore throat, aches and pains, blocked nose, in adults and young people aged 12 and over.

Only use this medicine if you have a blocked nose together with the symptoms listed above such as headache and high temperature. Do not use if you only have one of the symptoms listed above.

•    2. What you need to know before you take RobiCold Cold & Flu Relief

Do not take RobiCold Cold & Flu Relief if:

•    you are allergic to ibuprofen or pseudoephedrine, or any of the other ingredients of this medicine listed in section 6, or you have had an allergic reaction to a similar medicine in the past such as aspirin or other NSAIDs. Signs of an allergic reaction include skin rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips or tongue

•    you have ever had stomach problems after taking RobiCold Cold & Flu Relief, ibuprofen, aspirin or other NSAIDs in the past, such as stomach ulcers, stomach bleeding or a perforation

•    you currently have a stomach ulcer or stomach bleeding, or any other signs of bleeding

•    you have severe liver or severe kidney problems

•    you are pregnant or breast-feeding

•    you are under 12 years of age

•    you have severe problems with your heart including:

-    severe heart failure

-    very high blood pressure

-    severe heart disease

-    angina

•    you have ever had a stroke

•    you are taking:

-    other medicines containing NSAIDs for pain relief such as ibuprofen, or more than 75 mg of aspirin each day

-    other medicines to clear the nasal passages either orally (by mouth) or nasally (through your nose) such as pseudoephedrine, phenylpropanolamine, phenylephrine or ephedrine

-    medicines to treat depression called non-selective monoamine oxidase inhibitors (MAOIs) such as iproniazid, or if you have taken them in the last 14 days

-    other medicines to treat depression called tricyclic anti-depressants such as amitriptyline

•    you have diabetes, problems with your thyroid gland or a tumour on your adrenal gland (called phaeochromocytoma)

•    you have glaucoma (raised pressure in the eye)

•    you have problems passing urine, due to prostate problems or other causes.

Do not take RobiCold Cold & Flu Relief if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking RobiCold Cold & Flu Relief.

Warnings and Precautions

Talk to your doctor or pharmacist before taking RobiCold Cold & Flu Relief if:

•    you smoke, have high cholesterol, high blood pressure or diabetes - this is because you may be at risk of having a heart attack or stroke (see ‘Heart attack and stroke’ below for more information)

•    you have asthma - this is because there is a risk of having an asthma attack

•    you have liver, kidney or heart problems

•    you have problems with your prostate

•    you have bleeding problems

•    you have ever had stomach problems in the past such as stomach ulcers, stomach bleeding, ulcerative colitis or Crohn’s disease

•    you have systemic lupus erythematosus (SLE) - an illness affecting the immune system causing joint pain, skin changes and other problems.

If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking RobiCold Sinus Relief.

Heart attack and stroke

Medicines like RobiCold Cold & Flu Relief may be linked with a small increase in the risk of heart attack or stroke.

The risk is higher if the medicine is taken at a high dose or for a long time.

It is important that you do not take more than the recommended dose of RobiCold Cold & Flu Relief and that you do not take it for longer than 5 days. For more information about the recommended dose of RobiCold Cold & Flu Relief, see section 3.

Look out for side effects

RobiCold Cold & Flu Relief can cause some side effects that mean you need to stop taking the medicine straight away and see a doctor. See ‘Stop taking RobiCold Cold & Flu Relief straight away and tell your doctor or pharmacist if you notice any of the following side effects’ at the beginning of section 4 for more information.

Older people

If you are an older person taking RobiCold Cold & Flu Relief you are more likely to get side effects such as stomach bleeding or a perforation (signs may include stomach pain and heartburn). This may be life threatening. See ‘Side effects to look out for at the start of treatment’ in section 4 for more information.

Children and young people

Do not give RobiCold Cold & Flu Relief to children under 12 years of age. Talk to your doctor or pharmacist before taking RobiCold Cold & Flu Relief if you are 12 to 17 years of age and you have not been drinking fluids or you are dehydrated due to diarrhoea or being sick. This is because there is a higher risk of kidney problems with RobiCold Cold & Flu Relief when you are dehydrated.

Operations

Tell your doctor you are taking RobiCold Cold & Flu Relief if you need to have an anaesthetic before an operation or procedure. Your doctor will ask you to stop taking RobiCold Cold & Flu Relief a few days before your anaesthetic.

You should also tell your anaesthetist (the doctor giving you the anaesthetic) you have been taking RobiCold Cold & Flu Relief.

Other medicines and RobiCold Cold & Flu Relief

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines.

Do not take RobiCold Cold & Flu Relief if you are taking any of the following medicines:

•    other medicines containing NSAIDs for pain relief such as ibuprofen, or more than 75 mg of aspirin each day

•    other medicines to clear the nasal passages either orally (by mouth) or nasally (through your nose) such as pseudoephedrine, phenylpropanolamine, phenylephrine or ephedrine

•    medicines to treat depression called non-selective monoamine oxidase inhibitors (MAOIs) such as iproniazid, or if you have taken them in the last 14 days

•    other medicines to treat depression called tricyclic anti-depressants such as amitriptyline.

Do not take RobiCold Cold & Flu Relief if any of the above apply to you. If you are not sure talk to your doctor or pharmacist before taking RobiCold Cold & Flu Relief.

Talk to your doctor or pharmacist before taking RobiCold Cold & Flu Relief if you are taking any of the following medicines:

•    medicines to treat depression called reversible inhibitors of monoamine oxidase A (RIMAs) and selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine

•    linezolid

•    bromocriptine, pergolide, lisuride, cabergoline, ergotamine or dihydroergotamine

•    oral anticoagulants such as warfarin and other medicines used to thin the blood, such as low dose aspirin (75mg each day or less), clopidogrel or ticlopidine - this is because taking RobiCold Cold & Flu Relief as well may lead to stomach bleeding

•    heparin when it is being used to treat or prevent a blood clot

•    lithium when it is being used to treat severe mood problems

•    methotrexate

•    medicines used to treat high blood pressure such as ACE inhibitors (ramipril), beta-blockers (atenolol), angiotensin II receptor antagonists (losartan) or any water tablets (diuretics)

•    digoxin or quinidine used to treat heart problems

•    ciclosporin or tacrolimus used after a transplant

•    potassium sparing diuretics such as amiloride or spironolactone

•    phenytoin used to treat epilepsy

•    probenecid and sulfinpyrazone used to treat gout

•    zidovudine used to treat HIV

•    sulfonylureas such as gliclazide or glimepiride used to treat diabetes

•    quinolone antibiotics such as ciprofloxacin

•    ginkgo biloba

•    antacids

•    mifepristone used in pregnancy terminations

•    corticosteroids (a type of anti-inflammatory medicine) such as hydrocortisone

•    aminoglycosides such as gentamicin or amikacin

•    furazolidone, an anti-bacterial

•    guanethidine, reserpine or methyldopa.

If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking RobiCold Cold & Flu Relief.

RobiCold Cold & Flu Relief with alcohol

Do not drink alcohol while you are taking RobiCold Cold & Flu Relief.

Pregnancy and breast-feeding

•    Do not take RobiCold Cold & Flu Relief if you are pregnant or breast-feeding.

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

Fertility

Ibuprofen may affect a woman’s ability to become pregnant. This effect is reversed once treatment with ibuprofen is stopped. It is unlikely that ibuprofen, if used occasionally, will affect your chances of becoming pregnant. Talk to your doctor before taking this medicine if you have had problems becoming pregnant in the past.

Sports players

Pseudoephedrine may cause a positive reaction in anti-doping checks. Do not take RobiCold Cold & Flu Relief if this may affect you.

Driving and using machines

After taking RobiCold Cold & Flu Relief you may feel dizzy, have unusual headaches, or problems with your sight or hearing, including seeing or hearing things that are not there (hallucinations). If this happens, do not drive, cycle or use any tools or machines.

RobiCold Cold & Flu Relief contains sorbitol (E 420), soya lecithin and potassium

RobiCold Cold & Flu Relief contains sorbitol (E 420), (a type of sugar). If you have been told by your doctor that you cannot

tolerate or digest some sugars, talk to your doctor before taking this medicine.

RobiCold Cold & Flu Relief contain soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product. RobiCold Cold & Flu Relief contains 0.41 mmol potassium per capsule. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

•    3. How to take RobiCold Cold & Flu Relief

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

How much to take

•    The recommended dose is 1 capsule every 4 to 6 hours.

•    If your symptoms are more severe you can take 2 capsules at the same time.

•    Do not take more than 6 capsules in 24 hours.

Taking this medicine

Swallow the capsules whole with a large glass of water How long to take this medicine for Do not take this medicine for more than 5 days.

•    This medicine is for short term use only, take the lowest dose for the shortest time necessary to treat your symptoms.

•    You must talk to a doctor if you do not feel better or if you feel worse after 5 days. They will tell you if it is safeto carry on taking this medicine.

If you take more RobiCold Cold & Flu Relief than you should

If you take more RobiCold Cold & Flu Relief than you should, talk to a doctor or go to a hospital straight away, you may need medical help. Take the medicine pack with you.

Do not continue to take RobiCold Cold & Flu Relief if you accidently take more than you should (overdose).

If you forget to take RobiCold Cold & Flu Relief

•    Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

•    4. Possible side effects

Like all medicines, RobiCold Cold & Flu Relief can cause side effects, although not everybody gets them. The chance of getting side effects can be lowered by taking the lowest dose for the shortest time necessary to treat your symptoms.

The following side effects may happen with this medicine:

Stop taking RobiCold Cold & Flu Relief straight away and tell your doctor or pharmacist if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

•    feeling sick (nausea)

•    bleeding from the stomach or bowel, signs include vomiting blood, blood in faeces, or black coloured faeces.

Uncommon: may affect up to 1 in 100 people

•    severe headaches or headaches that are more painful than usual.

Very rare: may affect up to 1 in 10,000 people

•    heart attack

•    fast heartbeat or palpitations

•    allergic reaction to RobiCold Cold & Flu Relief, signs include skin rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips or tongue

•    blistering lesions on the skin or mucous membranes such as the inside of your mouth, signs include burning feeling, with redness, blisters and ulcers.

Not Known: it is not known how often these happen

•    stroke

•    behavioural problems such as feeling excited, agitated, anxious, restless or nervous.

Stop taking RobiCold Cold & Flu Relief straight away and tell your doctor or pharmacist if you notice any of the side effects listed above.

Other side effects

Tell your doctor or pharmacist if you get any of the following side effects:

Common: may affect up to 1 in 10 people

•    indigestion, stomach ache, being sick (vomiting), diarrhoea, constipation, wind.

Uncommon: may affect up to 1 in 100 people

•    stomach ulcer

•    not being able to sleep

•    feeling drowsy or tired

•    feeling dizzy or irritable

•    problems with your sight

•    headaches that do not go away

•    breakouts on the skin such as rash or itching

•    inflamed stomach or bowel, worsening of existing inflammatoiybowml disease

•    hypersensitivity such as wheezing and difficulty breathing in patients who have ever had bronchial asthma or allergic disease. Rare: may affect up to 1 in 1,000 people

•    kidney problems

•    ringing in your ears (tinnitus).

Very rare: may affect up to 1 in 10,000 people

•    depression

•    heart failure

•    kidney failure

•    high blood pressure

•    sore or inflamed mouth

•    inflamed pancreas (pancreatitis)

•    narrowing of the gut (intestinal stricture)

•    aseptic meningitis, worsening of infectious inflammations

•    problems with your blood cells - you may be more likely to bruise or get infections

•    liver problems including abnormal liver function, hepatitis or jaundice (yellowing of the skin or eyes).

Not Known: it is not known how often these happen

•    chest pain

•    dry mouth, feeling thirsty

•    abnormal spasm, seizures

•    spinning sensation (vertigo)

•    haematocrit levels decreased and haemoglobin decreased

•    seeing or hearing things that are not there (hallucinations)

•    skin rash, red or purple skin discolouration, fluid retention (oedema)

•    passing urine less often, blood or protein in your urine (shown in tests).

Tell your doctor or pharmacist if you get any of the side effects listed above.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any 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.

•    5. How to store RobiCold Cold & Flu Relief

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

•    Do not use this medicine after the expiry date which is stated on the box and blister pack after EXP. The expiry date refers to the last day of that month.

•    Do not store above room temperature (30°C).

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

•    6. Contents of the pack and other information

What RobiCold Cold & Flu Relief contains

•    The active substances are ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg

•    The other ingredients are:

-    Liquid fill: potassium hydroxide, polyethylene glycol 600, purified water

-    Gelatine capsule: sorbitol (E420), gelatine, black printing ink [ Macrogol 400, polyvinyl acetate phthalate, propylene glycol, iron oxide black (E172)], soya lecithin in triglycerides.

What RobiCold Cold & Flu Relief looks like and contents of the pack

RobiCold Cold & Flu Relief is a clear oval shaped, soft capsule. It is imprinted with 200/30 logo in black ink.

RobiCold Cold & Flu Relief is available from your pharmacist white, opaque, heat sealed Glassine/Aluminium foil blister strips of 2, 4, 8, 10, 12, 16, 20 or 24 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder Pfizer Consumer Healthcare Ltd Ramsgate Road Sandwich Kent, CT13 9NJ United Kingdom

Tel. 0333 555 2526 or email: carelineUK@pfizer.com.

Manufacturer

Pfizer Consumer Manufacturing Italy Srl Via Nettunense 90 04011 Aprilia, Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland: Advil Sinus Relief Soft Capsules Ibuprofen 200 mg / Pseudoephedrine 30 mg

Malta: Advil Sinus Relief Soft Capsules Ibuprofen 200 mg / Pseudoephedrine 30 mg

Romania: RobiCold Sinus & Raceala 200 mg/30 mg capsule moi

Slovakia: Robicold Rapid 200mg/30mg makke kapsuly

United Kingdom: RobiCold Cold & Flu Relief 200mg / 30mg Soft Capsules

This leaflet was last revised in August 2016.

PL 00165/0388

WMQ215