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Product Title

Galfer Capsules UK (Strides)

Colours Used

Fonts Used

■

Process Black

Dax

Component

Label Leaflet

Process Yellow

Helvetica

Pack Size

100's

□

PANTONE 424 C

Helvetica LT

IG Code

24343206

□

PANTONE Process Magenta C

Helvetica Neue LT Std

Dimensions

40mm x 120mm

□

PANTONE 287 C

Proof No.

1 Date 06.05.2016

B

Keyline (Does not print)

□

Braille

Adults and children over 12 years Prevention of iron deficiency

•    Take one capsule a day.

Treatment of iron deficiency

•    Take one capsule twice a day.

Children under 12 years

Do not give to children under 12 unless your doctor tells you to.

If you take too many

f you accidentally take too many, see a doctor immediately as an overdose may be fatal. Take the pack with you to show which medicine you have swallowed.

If you forget a dose

Take the next dose as soon as you remember.

You can then carry on with the next dose at the correct time.

Do not take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Galfer Capsules can have side effects, although these don’t affect everyone.

Important side effects:

If you think you have any of the following side effects or symptoms, stop using this medicine immediately and see a doctor as soon as possible.

•    Allergic reactions which cause difficulty in breathing, fever, swelling of the mouth, lips or skin, severe rashes, itching or stomach pain.

Other possible side effects are:

•    Loss of appetite • Nausea and sickness • Stomach discomfort • Constipation

•    Diarrhoea • Darkening of the stools • Accumulation of iron in body cells.

•    Constipation may be more pronounced in the elderly.

•    Diarrhoea may be more pronounced in people with inflammatory bowel disease, eg. IBS, colitis or diverticulitis.

If you notice any of these side effects which are usually mild, tell your doctor or pharmacist.

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.

5. Storing this medicine

•    This product contains iron. Keep it out of the sight and reach of children as an overdose may be fatal.

•    Store in a cool place.

•    Keep container tightly closed.

•    Do not use after the expiry date shown on the label.

6. Further information

The active ingredient per capsule is: ferrous fumarate 305mg equivalent to 100mg elemental iron).

The other ingredients are: gelatin, quinoline yellow (E104), ndigotine (E132), titanium dioxide (E171) erythrosine (E127).

Galfer Capsules are red and green capsules with ‘Galfer’ printed on them. They are supplied in tubs of 100 and 250.

Manufacturer: Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK. This leaflet was revised in May 2016.

Galfer is a Trade Mark of Thornton & Ross Ltd

Read all ot the leaflet before you use this medicine. It includes other information which might be especially important for you.

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

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What the medicine is for

Galfer Capsules are used to treat and prevent anaemia caused by iron deficiency. They contain iron in the form of ferrous fumarate.

2.    Before you use this medicine

Do not use the medicine if you have....

•    An allergy to any of the ingredients listed in section 6.

•    Other problems with iron in the blood (including conditions that lead to iron building up in soft tissues, or problems with red blood cells).

•    A stomach ulcer or other stomach or bowel problem.

•    Had repeated blood transfusions in the past.

•    Anaemia not related to low levels of iron before.

•    Are currently having iron injections.

•    Are currently having dimercaprol injections for treatment of metal poisioning.

•    Or are under 12 years old.

Talk to your doctor if you have..

•    A history of stomach ulcers.

•    Had part or all of the stomach removed.

•    Vitamin deficiency particularly vitamin B12 or folic acid.

•    Or are a male, as iron deficiency is less common in men than women, and the causes may need investigating further by the doctor.

Talk to your doctor or pharmacist if you are taking..

•    Antibiotics for infections such as neomycin, tetracyclines (e.g. oxytetracycline), chloramphenicol or fluoroquinolones (e.g. ciprofloxacin).

•    Penicillamine for arthritis.

•    Indigestion remedies, antacids, calcium supplements and zinc.

•    Colestyramine mainly used for high cholesterol.

•    Levodopa, carbidopa or entacapone for Parkinson’s Disease.

•    Levothyroxine for treatment of low thyroid hormone.

•    Bisphosphonates for osteoporosis.

•    Trientine for Wilson’s Disease.

•    Methyldopa for high blood pressure.

•    People having tests on stool samples should tell the doctor as this medicine may turn stools black and affect test results.

Pregnant or breastfeeding..

Ask your doctor for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. Do not take Galfer Capsules during the first 3 months of pregnancy unless the doctor has told you to do so.

You may also need to take Folic Acid during your pregnancy. Your doctor will advise you about this.

• Galfer Capsules can be taken during breastfeeding if the doctor thinks it necessary.

Driving and using machines....

Galfer Capsules do not affect your ability to drive or use machines.

3. How to use this medicine

Important things you need to know first..

•    Take this medicine before meals on an empty stomach if possible. If Galfer Capsules upset your stomach, take them with or after food.

•    Some foods such as tea, eggs and milk may reduce the amount of iron absorbed by the body. Check with the doctor or pharmacist about which foods to avoid.

•    Galfer Capsules may make your stools darker than usual. This is a normal effect of medicines containing iron.

•    Treatment should not normally carry on for more than 3 months after the iron deficiency has been corrected. Your doctor will advise you when to stop.

•    Use of Galfer Capsules in children should also be under medical supervision. Prolonged use in children may lead to toxic accumulation of iron and needs to

24343206 be carefully controlled by the doctor. Turn over

Read all of the leaflet before you use this medicine. It includes other information which might be especially important for you.

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

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What the medicine is for

Galfer Capsules are used to treat and prevent anaemia caused by iron deficiency. They contain iron in the form of ferrous fumarate.

2.    Before you use this medicine

□ Do not use the medicine if you have....

•    An allergy to any of the ingredients listed in section 6.

•    Other problems with iron in the blood (including conditions that lead to iron building up in soft tissues, or problems with red blood cells).

L J

•    A stomach ulcer or other stomach or bowel problem.

•    Had repeated blood transfusions in the past.

•    Anaemia not related to low levels of iron before.

•    Are currently having iron injections.

•    Are currently having dimercaprol injections for treatment of metal poisioning.

•    Or are under 12 years old.

ATalk to your doctor if you have..

•    A history of stomach ulcers.

•    Had part or all of the stomach removed.

•    Vitamin deficiency particularly vitamin B12 or folic acid.

•    Or are a male, as iron deficiency is less common in men than women, and the causes may need investigating further by the doctor.

L J

A Talk to your doctor or pharmacist if you are taking..

•    Antibiotics for infections such as neomycin, tetracyclines (e.g. oxytetracycline), chloramphenicol or fluoroquinolones (e.g. ciprofloxacin).

•    Penicillamine for arthritis.

•    Indigestion remedies, antacids, calcium supplements and zinc.

•    Colestyramine mainly used for high cholesterol.

•    Levodopa, carbidopa or entacapone for Parkinson’s Disease.

•    Levothyroxine for treatment of low thyroid hormone.

•    Bisphosphonates for osteoporosis.

•    Trientine for Wilson’s Disease.

•    Methyldopa for high blood pressure.

•    People having tests on stool samples should tell the doctor as this medicine may turn stools black and affect test results.

L_ _J

APregnant or breastfeeding..

Ask your doctor for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. Do not take Galfer Capsules during the first 3 months of pregnancy unless the doctor has told you to do so.

You may also need to take Folic Acid during your pregnancy. Your doctor will advise you about this.

• Galfer Capsules can be taken during breastfeeding if the doctor thinks it necessary.

ADriving and using machines....

Galfer Capsules do not affect your ability to drive or use machines.

l l

L J

3. How to use this medicine O Important things you need to know first..

•    Take this medicine before meals on an empty stomach if possible. If Galfer Capsules upset your stomach, take them with or after food.

•    Some foods such as tea, eggs and milk may reduce the amount of iron absorbed by the body. Check with the doctor or pharmacist about which foods to avoid.

•    Galfer Capsules may make your stools darker than usual. This is a normal effect of medicines containing iron.

•    Treatment should not normally carry on for more than 3 months after

the iron deficiency has been corrected. Your doctor will advise you when to stop.

•    Use of Galfer Capsules in children should also be under medical supervision.

Prolonged use in children may lead to toxic accumulation of iron PM/01/732 and needs to be carefully controlled by the doctor.

24344009 Turn over

4. Possible side effects

If you notice any of these side effects which are usually mild, tell your doctor or

Like all medicines, Galfer Capsules can have side effects, although these don’t

pharmacist.

affect everyone.

Reporting of side effects

Important side effects:

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

If you think you have any of the following side effects or symptoms, stop using

any possible side effects not listed in this leaflet. You can also report side effects

this medicine immediately and see a doctor as soon as possible.

directly via the yellow card scheme at: www.mhra.gov.uk/yellowcard

• Allergic reactions which cause difficulty in breathing, fever, swelling of

By reporting side effects you can help provide more information on the safety of

the mouth, lips or skin, severe rashes, itching or stomach pain.

this medicine.

Other possible side effects are:

5. Storing this medicine

• Loss of appetite • Nausea and sickness • Stomach discomfort

• This product contains iron. Keep it out of the sight and reach of children

• Constipation • Diarrhoea • Darkening of the stools • Accumulation of iron in

as an overdose may be fatal.

body cells.

• Store in a cool place.

• Constipation may be more pronounced in the elderly.

• Keep container tightly closed.

• Diarrhoea may be more pronounced in people with inflammatory bowel

• Do not use after the expiry date shown on the label.

disease, eg. IBS, colitis or diverticulitis.

L — — — — — — — — J

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3N

VARNISH

FREE

=XP

AREA

Product Title

Galfer Capsules UK (Strides)

Colours Used

Fonts Used

■

Process Black

Dax

Component

Label Leaflet

Process Yellow

Helvetica LT

Pack Size

250's

□

PANTONE 424 C

Helvetica Neue LT Std

IG Code

24346706

□

PANTONE Process Magenta C

Dimensions

50mm x 124mm

□

PANTONE 287 C

Proof No.

2 Date 10.05.2016

1

Keyline (Does not print)

□

Braille

Read all of the leaflet before you use this medicine. It includes other • A stomach ulcer or other stomach or bowel problem. information which might be especially important for you. • Had repeated blood transfusions in the past.

•    Keep this leaflet. You may need to read it again. • Anaemia not related to low levels of iron before.

•    Ask your pharmacist if you need any more information or advice. • Are currently having iron injections.

•    If any of the side effects gets serious, or if you notice any side effects • Are currently having dimercaprol injections for treatment of metal not listed in this leaflet, please tell your doctor or pharmacist. poisioning.

1.    What the medicine is for • ^{Or are} under 12 years ol^d.

Galfer Capsules are used to treat and prevent anaemia caused by iron Talk to your doctor if you have.... deficiency. They contain iron in the form of ferrous fumarate. • A history of stomach ulcers.

2.    Before you use this medicine • ^Had p^{art or a}" ^{of the stomach removed}.

Do not use the medicine if you have.. *V^{itamin def}f^ncy .^pa“^{y vitamin B12 or folic acid}.

•    An allergy to any of the ingredients listed in section 6. ' ^ ^{a male}’ ^{as iron deficiency is}'^essf ^coth^mm°^on '^{n lmen han women},

and the causes may need investigating further by the doctor.

•    Other problems with iron in the blood (including conditions that lead to iron building up in soft tissues, or problems with red blood cells).

Talk to your doctor or pharmacist if you are taking..

•    Antibiotics for infections such as neomycin, tetracyclines (e.g. oxytetracycline), chloramphenicol or fluoroquinolones (e.g. ciprofloxacin).

•    Penicillamine for arthritis.

•    Indigestion remedies, antacids, calcium supplements and zinc.

•    Colestyramine mainly used for high cholesterol.

•    Levodopa, carbidopa or entacapone for Parkinson’s Disease.

•    Levothyroxine for treatment of low thyroid hormone.

•    Bisphosphonates for osteoporosis.

•    Trientine for Wilson’s Disease.

•    Methyldopa for high blood pressure.

•    People having tests on stool samples should tell the doctor as this medicine may turn stools black and affect test results.

Pregnant or breastfeeding.. 3. How to use 'his medicine

Ask your doctor for advice before using this medicine if you are pregnant, Important things you need to know first..

might be pregnant or are breastfeeding. Do not take Galfer Capsules during • Take this medicine before meals on an empty stomach if possible.

the first 3 months of pregnancy unless the doctor has told you to do so. If Galfer Capsules upset your stomach, take them with or after food.

You may also need to take Folic Acid during your pregnancy. Your doctor • ^{Some foods such as tea}, ^{eggs and milk may reduce the amount of ir}°n _will _ad_vi_se y_{ou a}b_out this absorbed by the body. Check with the doctor or pharmacist about which

• Galfer Capsules can be taken during breastfeeding if the doctor thinks it ^{foods to avoid}. _necessary • Galfer Capsules may make your stools darker than usual.

Driving' and using machines.... ™^s_t^{is a of me}f^{ines con}t^{aining iro}". _t.

•    Treatment should not normally carry on for more than 3 months after

Galfer Capsules do not affect your ability to drive or use machines.

the iron deficiency has been corrected. Your doctor will advise you when to stop.

•    Use of Galfer Capsules in children should also be under medical supervision Prolonged use in children may lead to toxic accumulation of iron and needs

24346706 to be carefully controlled by the doctor. Turn over^