PACKAGE LEAFLET

Ibuprofen and pseudoephedrine hydrochloride 200 mg/30 mg film coated tablets Patient Informaion Leaflet What is in this leaflet

1.    What ibuprofen and pseudoephedrine hydrochloride is and what it is used for

2.    What you need to know before you take ibuprofen and pseudoephedrine hydrochloride

3.    How to take ibuprofen and pseudoephedrine hydrochloride

4.    Possible side effects

5.    How to store ibuprofen and pseudoephedrine hydrochloride

6.    Contents of the pack and other information

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 have 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 3 days in adolescents and 5 days in adults.

This medicine is called Ibuprofen and pseudoephedrine hydrochloride 200 mg/30 mg film-coated tablets but will be referred to as ibuprofen and pseudoephedrine hydrochloride throughout this leaflet.

1. WHAT IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Ibuprofen and pseudoephedrine hydrochloride contains the active substances ibuprofen, a non-steroidal antiinflammatory drug (NSAID), and pseudoephedrine, which is a nasal decongestant.

•    Ibuprofen reduces pain, swelling and high temperature.

•    Pseudoephedrine acts on the blood vessels in the nose to relieve nasal congestion.

Ibuprofen and pseudoephedrine hydrochloride is indicated for the symptomatic relief of nasal congestion with headache, fever and/or pain associated with common colds and flu

Ibuprofen and pseudoephedrine hydrochloride is indicated in adults and adolescent over 15 years.

Use this combination product only if you have blocked nose with pain or fever. Do not use this product if you have only one of these symptoms.

Talk to a doctor if you do not feel better or if you feel worse after 3 days in adolescents and 5 days in adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Do NOT take ibuprofen and pseudoephedrine hydrochloride if you:

-    are allergic to ibuprofen, pseudoephedrine or any of the other ingredients in this medicine (listed in Section 6 and end of Section 2)

-    are younger than 15 years

-    are pregnant or breast feeding

-    have ever had an allergic reaction (such as wheezing, worsening of asthma, itchy runny nose, facial swelling or hives) when previously taking aspirin or other painkillers, other fever-reducing or antiinflammatory drugs

-    have a stomach ulcer or have previously had stomach ulcers,

-    have previously had perforation or bleeding related to taking NSAIDs

-    have severe liver or kidney failure

-    have severe heart failure

-    have severe heart or circulation problems (heart disease, high blood pressure, angina, fast heart rate), an overactive thyroid gland, diabetes, phaeochromocytoma (a tumour of the adrenal gland)

-    have history of heart attack (myocardial infarction)

-    have uncontrolled high blood pressure

-    have had a stroke or you are at risk of having a stroke

-    have history of seizures

-    have any unexplained blood disorders

-    have glaucoma (pressure in the eye)

-    have difficulty in urinating related to prostate problems

-    have Systemic Lupus Erythematosus (LSE), an illness affecting the immune system causing e.g. joint pain and skin changes

-    are taking:

-    aspirin (more than 75 mg a day) or other non steroidal anti-inflammatory drugs (NSAIDs) or other painkillers

-    other nasal decongestants as e.g. phenylpropanolamine, phenylephrine or ephedrine or methylphenidate

-    non-selective monoamine oxidase inhibitors (known as MAOIs and used in the treatment of Parkinson’s disease or depression) or have taken them in the last 2 weeks

Do NOT give ibuprofen and pseudoephedrine hydrochloride to children under 15 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking ibuprofen and pseudoephedrine hydrochloride:

- if you have asthma; risk of an asthma attack

- if you have been told by your doctor that you have a blood clotting disorder

- if you are taking medicines to thin the blood e.g. warfarin, low dose aspirin

- if you are taking medicines which could increase the risk of stomach ulcers or bleeding e.g. steroids, antidepressants of the selective serotonin-reuptake inhibitors (SSRI) class (e.g. fluoxetine, paroxetine) or NSAIDs including aspirin

- if you have high blood pressure, heart problems , heart failure, psychosis or diabetes

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

- if you have kidney or liver problems

- if you are taking antimigraine agents.

Medicines such as ibuprofen and pseudoephedrine hydrochloride may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, previously had a 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 if you are a smoker) you should discuss your treatment with your doctor or pharmacist.

You should avoid alcohol intake during the treatment.

There is a risk of renal impairment in dehydrated adolescents.

Contact a doctor if symptoms persist or worsen.

Ibuprofen and pseudoephedrine hydrochloride should not be given to children below 15 years.

Other medicines and ibuprofen and pseudoephedrine hydrochloride

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

Ibuprofen and pseudoephedrine hydrochloride must not be used if you are taking:

-    aspirin (more than 75 mg a day)

-    other non-steroidal anti-inflammatory drugs (NSAIDs)

-    other painkillers or fever-reducing drugs

-    or have taken in the last 2 weeks monoamine oxidase inhibitors (MAOIs used in the treatment of Parkinson’s disease or depression)

-    other vasoconstrictor agents used as nasal degongestants (e.g. phenylpropanolamine, phenylephrine and ephedrine, administered orally or nasally).

In particular tell your doctor or pharmacist if you are taking the following as their effects may be changed:

-    medicines to thin the blood (anti-coagulants and anti-aggregants) e.g. warfarin or aspirin

-    medicines which could increase the risk of stomach ulcers or bleeding e.g. steroids, antidepressants of the SSRI class (e.g. fluoxetine, paroxetine) or NSAIDs including aspirin and cyclo-oxygenase (COX)-2 selective inhibitors

-    medicines for high blood pressure, irregular heart rhythm, angina, heart failure or fluid retention (e.g. ACE-inhibitors, betablockers, angiotensin II agonists, cardiac glycosides) because ibuprofen and pseudoephedrine hydrochloride may reduce their effects or increase the risk of abnormal heart rhythm, high blood pressure or impaired kidney function

-    cyclosporin (an immunosuppressant) as there may be an increased risk of impaired kidney function

-    medicines for depression (lithium, tricyclic antidepressants) may increase the risk of side effects

-    concomitant use of phenytoin may increase serum levels of these medicinal products. A check of serum-phenytoin levels is not as a rule required on correct use (maximum over 5 days)

-    other decongestants or medicines to reduce appetite as these may increase the risk of side effects

-    probenecid or sulfinpyrazone may delay excretion of ibuprofen

-    sulphonylureas (antidiabetics): although interactions with ibuprofen have not been described, a check of blood-glucose values is recommended as a precaution on concomitant intake

-    medicines to increase urination (diuretics/ water tablets)

-    methotrexate in high dose (over 20mg per week), as it may lead to elevated effect of methotrexate

-    quinolone antibiotics due to increased risk of developing convulsions

-    ciclosporin, tacrolimus and trimethoprim

-    anti-migraine agents

-    zidovudine (for treating HIV)

-    injectable heparin or and preparations containing Gingko biloba due to increased risk of bleeding.

Due to pseudoephedrine administration an acute hypertensive response may develop in the perioperative period. Therefore, discontinue treatment with ibuprofen and pseudoephedrine hydrochloride several days before surgery and inform your anaesthetist.

Ibuprofen and pseudoephedrine hydrochloride with food and drink

Swallow the tablets with water, preferably on a full stomach.

Pregnancy, breast-feeding and fertility

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

Ibuprofen and pseudoephedrine hydrochloride must not be taken during pregnancy or if you are breastfeeding. The active ingredients, ibuprofen and pseudoephedrine, can cause serious problems in unborn children and have been shown to be present in breastfed infants of women who have taken them.

Ibuprofen and pseudoephedrine hydrochloride contains ibuprofen which belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

Driving and using machines

Ibuprofen and pseudoephedrine hydrochloride has no known effects on the ability to drive and use machines. Dizziness or hallucinations may appear in exceptional cases and this possibility should be taken into account.

Ibuprofen and pseudoephedrine hydrochloride contains:

•    FD&C Yellow number 5/Tartrazine Aluminium Lake (E102, 0.47 mg/film-coated tablet) and FD&C Yellow number 6/Sunset Yellow FCF Aluminium Lake (E110, 0.07 mg/film-coated tablet) which are colouring agents and may cause allergic reactions

•    Soya lecithin (E322, 0.37 mg/film-coated tablet) - if you are allergic to soya or peanut oil, do not use this medicinal product

•    Sodium - this medicinal product contains 0.28 mg sodium per tablet. To be taken into consideration by those on a controlled sodium diet.

3. HOW TO TAKE IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Always take ibuprofen and pseudoephedrine hydrochloride 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.

Ibuprofen and pseudoephedrine hydrochloride is for oral use only.

The recommended dose is:

Adults and adolescents aged 15 and over: ltablet every 4-6 hours as necessary. For more severe symptoms 2 tablets every 6-8 hours as necessary

Do not exceed the maximum daily dose of 6 tablets.

Swallow the tablets with water, preferably on a full stomach. Do not break or crush the tablets.

Use in children and adolescents

Do not give to children under 15 years of age.

Duration of treatment

This product is intended for short term use only. You should use the lowest dose for the shortest time necessary to relieve your symptoms. Do not take longer than 5 days.

If symptoms persist or worsen, consult your doctor.

If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen, consult your doctor.

If you take more ibuprofen and pseudoephedrine hydrochloride than you should

Seek medical advice immediately if you, or someone else, accidentally take more ibuprofen and

pseudoephedrine hydrochloride than is recommended.

If you forget to take ibuprofen and pseudoephedrine hydrochloride

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

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKING ibuprofen and pseudoephedrine hydrochloride and seek medical help immediately:

- if you have any of the following which may be signs of a severe allergic reaction:

•    difficulty breathing or swallowing

•    swelling of face, lips, tongue or throat

•    severe itching of the skin with hives (nettle rash)

•    severe skin reactions involving blisters under the skin

•    heart racing with low blood pressure

- if you have signs of intestinal bleeding as

•    bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles looking like coffee grounds

Other side effects may include:

Common (may affect up to 1 in 10 people):

-    stomach disorders such as abdominal discomfort, indigestion, nausea, vomiting, flatulence, diarrhoea, constipation

Uncommon (may affect up to 1 in 100 people):

-    headache, dizziness, difficulty in sleeping, agitation, irritability or tiredness

-    visual disturbances

-    stomach pain or ulcer, sometimes with bleeding or perforation, worsening of colitis and Crohn’s disease

-    skin rashes

Rare (may affect up to 1 in 1,000 people):

-    tinnitus

-    headache, dizziness and hallucinations

-    nervousness, tremor, hallucinations.

-    kidney-tissue damage, elevated uric acid concentration in blood Very rare (may affect up to 1 in 10,000 people):

-    infectious inflammations, symptoms of meningitis (headache, fever, neck stiffness)

-    blood disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding from the nose and bruising

-    severe allergic reactions

-    psychotic reactions, depression

-    kidney failure or other kidney disorders

-    liver disorders

-    severe skin reactions.

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 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.

This medicine does not require any special storage conditions.

Do not use ibuprofen and pseudoephedrine hydrochloride after the expiry date which is stated on the blister/carton after ”EXP”. The expiry date refers to the last day of that month.

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 ibuprofen and pseudoephedrine hydrochloride contains

-    The active substances are ibuprofen (200mg per tablet) and pseudoephedrine hydrochloride (30mg per tablet, equivalent to pseudoephedrine base 24.6 mg)

-    The other ingredients are

microcrystalline cellulose, pregelatinised starch (maize), povidone K-30, colloidal anhydrous silica, stearic acid 95, crosscarmellose sodium , sodium laurilsulfate, polyvinyl alcohol - part. hydrolyzed, talc (E553b), titanium dioxide (E171), macrogol 3350, FD&C Yellow #5/Tartrazine Aluminum Lake (E102), lecithin (Soya) (E322), FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake (E110), MICA-based pearlescent pigment (mixture of potassium aluminium silicate (E555)-[mica], titanium dioxide (E171)), polysorbate 80 (See end of Section 2 for further information on colouring agents and sodium).

What ibuprofen and pseudoephedrine hydrochloride looks like and contents of the pack

Ibuprofen and pseudoephedrine hydrochloride tablets are yellow coloured, oval shaped film-coated tablets (dimension: approx. 15.6 mm x 7.7 mm).

The tablets are available in blister packs of 12 or 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Limited,

Weybridge, Surrey, KT13 0XP, UK

Manufacturer

Teva Operations Poland Sp. z.o.o. ul. Mogilska 80. 31-546, Krakow Poland

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89143 Blaubeuren Germany

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

This leaflet was last revised in September 2014.

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