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To prevent low levels of iron and folic acid in the blood during pregnancy.

Pregnant women: Take 1 capsule a day.

Do not give to children, men or non-pregnant women unless your doctor tells you to.

Active ingredients per capsule: ferrous fumarate 305mg, folic acid 350 micrograms. ^ Peel where shown for precautions.

MA holder and distributor: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK. PL 00240/0105

Peel here for Patient Information Leaflet.

Important warning: Contains iron. Keep out of the sight and reach of children as overdose may be fatal.

Store in a cool place. Keep container tightly closed.

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Product Title

Galfer FA Capsules UK (Strides)

Colours Used

Fonts Used

■

Process Black

Helvetica

Component

Label Leaflet

Process Yellow

Pack Size

100's

□

PANTONE 424 C

IG Code

24348305

□

PANTONE 471 C

Dimensions

40mm x 120mm

□

PANTONE 287 C

Proof No.

1 Date 06.05.2016

B

Keyline (Does not print)

□

Braille

Dose

Pregnant women

• Take one capsule a day, or as directed by the doctor.

►3 Children, non-pregnant women and men

Do not give to children, non-pregnant women or men 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

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

Important side effects:

f 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:

•    Feeling sick or being sick • Constipation • Diarrhoea • Other stomach problems

•    Darkening of the stools.

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

Reporting of side effects

f 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 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 ingredients per capsule are: ferrous fumarate 305mg equivalent to 100mg elemental iron), folic acid 350 micrograms.

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

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

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 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 FA Capsules are taken to prevent low levels of iron and folic acid in the blood during pregnancy. They contain iron in the form of ferrous fumarate and folic acid.

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.

•    Vitamin B12 deficiency.

•    Or are currently having iron injections.

This medicine is not suitable for children, non-pregnant women or men. Talk to your doctor if you have..

•    Blood problems related to folic acid deficiency.

•    Erythropoietic protoporphyria, a rare condition affecting red blood cells.

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

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

•    Penicillamine for arthritis.

•    Indigestion remedies (e.g. antacids, magnesium salts), calcium supplements, zinc phosphates, oxalates and proton pump inhibitors to reduce stomach acid.

•    Colestyramine mainly used for high cholesterol.

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

•    Bisphosphonates for osteoporosis.

•    Trientine for Wilson’s Disease.

•    Methyldopa for high blood pressure.

•    Medicine to control fits (e.g. phenobarbital, phenytoin, primidone).

•    Ascorbic or citric acids as these increase absorption of iron.

•    Acetohydroxamic acid to treat some urinary tract problems.

•    Dimercaprol used to treat effects of heavy metal poisoning.

•    Levothyroxine for an underactive thyroid gland.

•    Mycophenolate, an immunosuppressant drug.

•    Eltrombopag for blood platelet problems.

•    Raltitrexed, an anticancer drug.

•    Sulfasalazine to treat some bowel diseases and rheumatoid arthritis.

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

Allow 2-3 hours between taking this and other medicines (or 4 hours for Eltrombopag).

Pregnant or breastfeeding..

Galfer FA Capsules can be used at various stages of pregnancy and while breastfeeding, however, ask your doctor for advice before using this medicine to make sure you need to take it whilst pregnant.

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 FA Capsules upset your stomach, take them with or after food.

•    Some foods such as tea, coffee, wholegrain cereals, 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 FA Capsules may make your stools darker than usual. This is a normal effect of medicines containing iron.

24348305