PACKAGE LEAFLET: INFORMATION FORTHE USER

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nogen Pharma

Pseudoephedrine 60mg Tablets

[Pseudoephedrine Hydrochloride]

|Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if , theirsymptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

l please tell your doctor or pharmacist.

Take special care with Pseudoephedrine Tablets i

Consult your doctor before taking Pseudoephedrine Tablets if you have:    I

•    an overactive thyroid gland    i

•    diabetes

•    heart disease    I

•    glaucoma (increased pressure in the eye)    i

•    prostate problems (difficulty with passing water

or needing to pass water often)    I

•    liveror kidney problems    I

•    mild to moderately high blood pressure

|ln this leaflet:

|1. What are Pseudoephedrine Tablets and what are they used for

l2. Before you take Pseudoephedrine Tablets p. How to take Pseudoephedrine Tablets 4. Possible side effects

15.    How to store Pseudoephedrine Tablets

16.    Further information

1. WHAT ARE PSEUDOEPHEDRINE TABLETS ANDWHATARE THEY USED FOR

This medicine contains pseudoephedrine [hydrochloride, a decongestant. It can be used to provide relief from cold, flu and allergy symptoms such as a blocked nose, stuffy nose and blocked Minuses to help you breathe more easily without causing drowsiness.

2. BEFORE YOU TAKE PSEUDOEPHEDRINE TABLETS

|Do not take Pseudoephedrine Tablets if you:

p are hypersensitive (allergic) to pseudoephedrine or any of the ingredients.

• have very high blood pressure p coronary heart disease - a condition where the arteries in the heart become narrowed and hard L are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).

I have been told by your doctor that you have a rare hereditary disease called Lapp-lactase deficiency or glucose-galactose malabsorption I as this medicine contains lactose

Taking other medicines    |

Please tell your doctor or pharmacist if you are taking! any of the following medicines:-

•    Monoamine-oxidase inhibitors (MAOIs) drugs|

used to treat depression e.g phenelzine., Pseudoephedrine tablets should not be taken at the same time as or within 2 weeks of stoppingl taking a MAOI.    ,

•    Antihypertensives (drugs used to treat high blood' pressure), such as guanethidine, methyldopaj alpha and betablockers, debrisoquine, bretyliumi and betanidine

•    Sympathomimetic drugs (stimulants or appetitel suppressants) and drugs used to treatj congestion and asthma

•    Tricyclic antidepressants (used to treat moodl

disorders) e.g imiprimine    i

Pregnancy and breastfeeding    I

Ask your doctor or pharmacist for advice if you arel pregnant, planning on becoming pregnant or breastfeeding before taking this medicine. YouJ doctor will decide whether you should take this] medicine.

Important information about some of the| ingredients

This medicine contains lactose (a type of sugar), if you have been told by your doctor that you have an| intolerance to some sugars talk to your doctor before, taking this medicine.

This medicine also contains sunset yellow (E110)| and ponceau (E124) which can cause allergi^ reactions.

3. HOW TO TAKE PSEUDOEPHEDRINE TABLETS

• Chest pain and fast heart beat These are especially common in the elderlyl

Always take PseudoephedrineTablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

I

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole with a glass of water.

' Do not crush orchewyourtablets.

Occasionally, the following adverse effects have been seen:

•    Tremor

•    Dry mouth, nausea, vomiting, appetite|

loss and ischaemic colitis (abdominal pain and diarrhoea)    I

•    High blood pressure

• Changes in your heart beat    '

• Skin rashes    |

If any of these effects become worse or upsetting go| and see your doctor or pharmacist for advice.

5. HOW TO STORE PSEUDOEPHEDRINE TABLETS

Children under 12 years: not recommended

.Elderly: the same dose as adult dose

[Patient with liver and kidney problems: should be treated with caution

.If you take more PseudoephedrineTablets than you should

This medicine is to be taken at regular intervals. If you take too many tablets by mistake contact your |nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

.If you stop taking PseudoephedrineTablets

Keep taking your tablets until your doctor tells you to ^top. Do not stop taking your tablets just because you feel better. If you stop taking this medicine your symptoms may come back.

If you forget to take PseudoephedrineTablets

|lf you forget to take a dose, take the next dose when needed provided that the last dose was taken at least |4 hours ago. Do nottake a double dose.

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on thel label.    ,

Do not store above 25°C.    Store    in    the    original'

package.    |

In case of any visible signs of    deterioration,    you

should discard the package.    |

Medicines should not be disposed of via waste water or household waste. Ask you pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the reach and sight of children

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pseudoephedrine Tablets can ^ause side effects, although not everyone gets them.

Ilf you experience any of the following then STOP taking the medicine and contact a doctor 'immediately

[• Allergic reactions may occur with symptoms such as rash, itching, swelling of the face,

I wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy ' particularly when standing up.

[• A few people have had hallucinations, but this is rare

|* A few men, especially men with prostate problems may have trouble passing water

The most frequently reported adverse effects are:

•    Anxiety, restlessness, insomnia

•    Headaches, dizziness, and psychosis

What PseudoephedrineTablets contain:    |

Pseudoephedrine tablets contain pseudoephedrine hydrochloride. Each tablet contains 60mg oil pseudoephedrine hydrochloride.    .

The other ingredients are: cellactose, magnesium] stearate, colloidal anhydrous silica, lactose, hypromellose, macrogol 4000, Ponceau 4R| aluminium lake (E124), titanium dioxide (E171V sunset yellow aluminium lake (E110), macrogol 6000I

What PseudoephedrineTablets look like and' contents of the pack    |

Pseudoephedrine tablets are packed in blisters packs in pack sizes of 12 tablets    I

MarketingAuthorisation Holder    ¹

Ennogen Pharma Limited    |

UnitG4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.    |

Manufacturer:    I

QuailpharNV    |

Rijksweg 9,

B-2880 Bornem    |

Belgium

This leafletwas last amended in May 2011.    .

SIZE :160X 270 (mm) Back