Document: document 0 change

• document 0
• document 1

---

Package leaflet: Information for the user

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

Ibuprofen/Phenylephrine hydrochloride

What is in this leaflet

1.    What Ibuprofen and Phenylephrine 200mg/5mg film coated tablets is and what it is used for

2.    What you need to know before you take

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

3.    How to take

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

4.    Possible side effects

5.    How to store

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

6.    Contents of the pack and other information

1. What_

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets is and what it is used for

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

contains ibuprofen and phenylephrine hydrochloride, which are effective in relieving the symptoms associated with colds and flu., including relief of aches and pains, sore throats, headache, nasal congestion (blocked nose) and lowering of temperature.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and is effective against aches and pains (including headache), swelling and can also reduce a fever. Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.

2. What you need to know before you take_

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets DO NOT take this medicine if you:

• are allergic to ibuprofen, phenylephrine hydrochloride or any of the other ingredients of this medicine (see section 6), or to acetylsalicylic acid or other painkillers

•    have ever had a stomach ulcer, perforation or bleeding

•    have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, acetylsalicylic acid or similar medicines

•    have had gastrointestinal bleeding or perforation when previously taking NSAIDs (NonSteroidal Anti-Inflammatory Drugs)

•    are taking other NSAID painkillers

•    are taking more than 75 mg of acetylsalicylic acid a day. If you are on low-dose acetylsalicylic acid (up to 75 mg daily) talk to your doctor or pharmacist before you take this medicine.

•    have severe liver or kidney problems

•    have severe heart problems (severe heart failure), high blood pressure or blood coagulation disorder

•    have breathing difficulties

•    have an overactive thyroid

•    are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (usually used to treat depression)

•    are in the last 3 months of pregnancy

•    are under 12 years old

Warnings and precautions

Talk to your doctor or pharmacist before taking

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

if you:

•    have or have had asthma

•    have kidney, heart, liver or bowel problems

•    have high cholesterol or previously have had a heart attack or stroke

•    have a history of gastrointestinal disease (such as ulcerative colitis or Crohn’s disease)

•    have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes or other organ disorders)

•    are a smoker

•    are in the first 6 months of pregnancy Medicines such as

Ibuprofen and Phenylephrine 200mg/5mg film-coated tablets

may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses or prolonged treatment.

Do not exceed the recommended dose or duration of treatment (10 days).

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Other medicines and

Ibuprofen and Phenylephrine 200mg/5mg film-coated tablets

To reduce the risk of side effects, do not take this medicine with other NSAID containing products (e.g. acetylsalicylic acid, ibuprofen). If you are on low-dose acetylsalicylic acid (up to 75 mg daily) talk to your doctor or pharmacist before you take this medicine.

Some medicines may affect the way in which ibuprofen and phenylephrine hydrochloride work or may themselves be affected by this medicine.

Avoid taking this medicine with medicines

•    used for the treatment of asthma and various inflammatory conditions (corticosteroid tablets, e.g. prednisolone, beclomethasone)

•    to treat certain bacterial infections (quinolone antibiotics, e.g. ciprofloxacin, norfloxacin, levofloxacin).

•    to thin your blood or prevent clotting (e.g. warfarin)

•    to stimulate your heart (e.g. glycosides) or treat high blood pressure (e.g. captopril, atenolol, losartan)

•    to help you pass water (diuretics)

•    for the temporary suppression of your immune system (e.g. methotrexate, ciclosporin, tacrolimus)

•    for mania or depression (e.g. lithium or SSRIs)

•    for pregnancy termination (e.g. mifepristone)

•    for HIV treatment (e.g. zidovudine)

Talk to your doctor or pharmacist before taking this product with other medicines.

Pregnancy, breast-feeding and fertility

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking this medicine. It is unlikely that if you only take <Product Name> occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

Tell your doctor if you become pregnant whilst taking Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise.

Talk to your doctor or pharmacist before taking this medicine if you are breast-feeding.

3. How to take_

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

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

Method of administration

Tablets must be swallowed whole with water.

It is important to drink plenty of fluids when suffering from colds and flu.

Dosage

Adults, the elderly and children over 12 years:

Take two tablets every 8 hours. Leave at least 4 hours between doses and do not exceed 6 tablets in any 24 hour period.

Duration of treatment

This medicine is for short-term use only. Take the lowest dose for the shortest time necessary to relieve your symptoms.

Do not take Ibuprofen and Phenylephrine 200mg/5mg film coated tablets for longer than 10 days.

If you do not get better, or get worse, talk to your doctor.

Do not give to children under 12 years.

If you take more Ibuprofen and Phenylephrine 200mg/5mg film coated tablets than you should:

You may feel drowsy or nauseous. You should seek immediate medical advice, even if you feel well.

If you forget to take Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

Refer to the directions above on how to take this medicine and do not take more than is advised. DO NOT take a double dose to make up for forgotten tablets.

Like all medicines this medicine can cause side effects, although not everybody gets them. Side effects may be minimized by taking the lowest dose for the shortest time necessary to relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below).

If you get any of the following at any time during treatment STOP TAKING this medicine and seek immediate medical help:

•    signs of intestinal bleeding such as:

-    bright red faeces (stools/motions), black tarry stools

-    vomiting blood or dark particles that look like coffee grounds

•    signs of serious allergic reaction such as:

-    difficulties in breathing or unexplained wheezing

-    dizziness or faster heartbeat

-    severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g. Steven-Johnson syndrome)

-    swelling of your face, tongue or throat

•    signs of kidney problems such as:

-    passing less or more urine

-    cloudy urine or blood in urine

-    pain in the back and/or swelling (particularly in the legs)

•    signs of aseptic meningitis such as:

-    neck stiffness

-    headache

-    feeling sick, being sick

-    fever or disorientation. Patients with autoimmune disorders (Systemic Lupus Erythematosus, mixed connective-tissue disease) may be more likely to be affected.

STOP TAKING this medicine and tell your doctor if you experience the following uncommon side effects which may affect up to 1 in 100 people:

•    indigestion, heartburn or feeling sick

•    pains in your stomach (abdomen) or other abnormal stomach problems

TELL YOUR DOCTOR if you have any of the following side effects, they become worse or you notice any effects not listed:

Uncommon side effects which may affect up to 1 in 100 people:

•    allergic reactions, such as skin rashes (urticaria), itching, peeling

•    headaches, dizziness, tinnitus (ringing in the ears)

Rare side effects which may affect up to 1 in 1,000 people:

•    flatulence (wind), diarrhoea, constipation and vomiting

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

•    blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion

•    drop in blood pressure or irregular heart beat

•    liver problems

Side effects for which the frequency cannot be estimated from the available data:

•    worsening of asthma or bronchospasm

•    swelling (oedema), high blood pressure, heart failure or attack

•    worsening of colitis and Crohn's disease

•    difficulties in passing urine (in men only)

Medicines such as

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets

may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. See section 2 “Warnings and precautions”.

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.

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

Do not use this medicine after the expiry date (EXP month/year) which is stated on the pack. The expiry date refers to the last day of that month.

Do not store above 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 protect the environment.

What Ibuprofen and Phenylephrine 200mg/5mg film coated tablets contains

The active substances are:

• ibuprofen

phenylephrine hydrochloride

Each film-coated tablet contains:

•    200 mg ibuprofen

•    5 mg phenylephrine hydrochloride

The other ingredients are:

The core consists of:

•    microcrystalline cellulose

•    sodium starch glycolate

•    hypromellose

•    sodium stearyl fumarate

•    purified water

The film consists of:

•    opadry 200 white 200F280000 (consisting of polyvinyl alcohol, talc, macrogol, titanium dioxide, methacrylic acid copolymer, sodium bicarbonate,)

•    purified water

What Ibuprofen and Phenylephrine 200mg/5mg film coated tablets looks like and contents of the pack

Ibuprofen and Phenylephrine 200mg/5mg film coated tablets are white, round, biconvex, film-coated tablets.

The product is available in cartons of 12, 16, 20 and 24 tablets.

Marketing Authorisation Holder and Manufacturer

Thornton & Ross Ltd Linthwaite Huddersfield HD7 5QH

This leaflet was last revised in March 2015