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Ferrous Sulfate 200mg Coated Tablets

Active Ingredient:
ferrous sulfate
Company:  
Wockhardt UK Ltd See contact details
About Medicine
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Pharmacy
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 02 Dec 2016
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0220.

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Ferrous Sulfate 200mg Coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ferrous Sulfate 200mg Coated Tablets

Ferrous Sulfate 200 mg

Read all of this leaflet carefully before you start to take this medicine.
  • Keep this leaflet. You may need to read it again while you are receiving your treatment.
  • If you have any further questions, please 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 their symptoms are the same as yours.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ferrous Sulfate Tablets are and what they are used for
2. Before you take Ferrous Sulfate Tablets
3. How to take Ferrous Sulfate Tablets
4. Possible side effects
5. How to store Ferrous Sulfate Tablets
6. Further information

1. What Ferrous Sulfate Tablets are and what they are used for

The name of your medicine is Ferrous Sulfate Tablets.

These tablets contain iron, a mineral essential in the production of red blood cells.

Ferrous Sulfate Tablets are used to treat anaemia caused by lack of iron in the diet or loss of iron from the body.

2. Before you take Ferrous Sulfate Tablets

Do not take Ferrous Sulfate Tablets if you:

  • are allergic (hypersensitive) to ferrous sulfate or any other of the ingredients in Ferrous Sulfate Tablets (see section 6, Further information)
  • have an ulcer of your stomach or small intestine
  • suffer from iron storage diseases, where the body contains more iron than it should
  • have had repeated blood transfusions
  • suffer from haemolytic anaemia (anaemia due to the destruction of red blood cells)
  • have anaemia caused by a deficiency of vitamin B12 or folic acid
  • are already being treated with iron supplements
  • suffer from rare intolerances to sugar

Ferrous Sulfate Tablets are not recommended for use in children.

Talk to your doctor before taking Ferrous Sulfate Tablets if you:

  • have had a gastrectomy (operation to remove all or part of your stomach)
  • have a history of stomach ulcers
  • suffer from diabetes
  • suffer from inflammatory bowel disease
  • suffer from diverticular disease (where pouches form in the bowel wall)
  • have intestinal strictures (abnormal narrowing of the bowel caused by inflammation).

Taking other medicines

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

The following medicines can affect or be affected by treatment with Ferrous Sulfate Tablets:

  • medicines used to treat indigestion (antacids and mineral supplements e.g. calcium, magnesium, bicarbonates, carbonates, oxalates, and phosphates). It is important not to take this medicine for two hours before or after taking Ferrous Sulfate Tablets.
  • medicines used to treat bacterial infections (antibiotics e.g. tetracyclines, quinolones, chloramphenicol). It is important not to take this medicine for two hours before or after taking Ferrous Sulfate Tablets
  • medicines used to treat bone problems (e.g. bisphosphonates). It is important not to take this medicine for two hours before or after taking Ferrous Sulfate Tablets
  • medicines used to treat Parkinson’s disease (e.g. co-careldopa, entacapone, and levodopa)
  • levothyroxine used to treat under-active thyroid glands. It is important not to take this medicine for two hours before or after taking Ferrous Sulfate Tablets
  • colestyramine used to treat high blood cholesterol and itching caused by liver disease
  • dimercaprol used to treat metal poisoning
  • methyldopa used to treat high blood pressure
  • mycophenolate mofetil , used to suppress the immune system stop organ rejection after transplant
  • penicillamine used to treat rheumatic diseases
  • trientine used in Wilson’s disease, a disorder where the body stores too much copper
  • zinc supplements.

Warnings and precautions

Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water.

If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.

Taking Ferrous Sulfate tablets with food and drink

Do not take this medicine with tea, milk or eggs as they reduce the absorption of it in the stomach.

Pregnancy and breast-feeding

During the first 12 weeks of pregnancy only take this medicine if your doctor has specifically recommended it. For the remainder of the pregnancy Ferrous Sulfate Tablets can be taken to prevent iron deficiency.

Driving and using machinery

This medicine does not affect your ability to drive a car or operate machinery.

Important information about some of the ingredients in Ferrous Sulfate Tablets

This medicine contains sucrose and glucose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Ferrous Sulfate Tablets

Always take Ferrous Sulfate Tablets as your doctor has told you. Your doctor will decide the right dose for you; this will be on the pharmacist’s label. This medicine should be swallowed whole with water.

Swallow the tablet whole with water. Do not suck, chew or keep the tablet in your mouth.

Adults and the elderly

Prevention of Iron-deficiency Anaemia

  • One tablet per day.

Treatment of Iron-deficiency Anaemia

  • One tablet two or three times per day.

Treatment should not last more than three months after anaemia is controlled.

If you take more Ferrous Sulfate Tablets than you should

If you (or anybody else, especially a child) takes more Ferrous Sulfate Tablets than you should contact your nearest hospital casualty department or doctor immediately. Always take the container of tablets and this leaflet with you.

If you forget to take Ferrous Sulfate Tablets

If you forget a dose, take another one as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the missed one.

4. Possible side effects

Like all medicines, Ferrous Sulfate Tablets can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately;

  • rash, itching, or difficulty breathing.

Side effects that have been reported are:

  • stomach pains
  • constipation
  • dark stools
  • feeling or being sick
  • diarrhoea

Not known (frequency cannot be estimated from the available data)

Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth).

Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.

Irritation and ulceration of the gullet can occur if the tablets become stuck so take with water.

If you take this medicine for longer than you should you are at an increased risk of tooth decay and infections.

If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

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. How to store Ferrous Sulfate Tablets

Keep out of the sight and reach of children.

  • Ferrous Sulfate Tablets should not be stored above 25°C. Store in the original container to protect from moisture.
  • Ferrous Sulfate Tablets should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.

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

6. Further information
What Ferrous Sulfate Tablets contain

The active ingredient is ferrous sulfate 200mg equivalent to 65mg of ferrous iron Fe(II). The other ingredients are: kaolin, glucose, povidone, stearic acid, magnesium stearate, sodium lauryl sulfate, starch, opaglos, titanium dioxide (E171) and sucrose.

What Ferrous Sulfate Tablets look like and the contents of pack

Ferrous Sulfate Tablets are white, sugar coated tablets. The medicine is supplied in packs of 50, 100, 250, 500, and 1000 tablets contained in a screw cap plastic containers or blister packs of 28 tablets.

Marketing Authorisation Holder:
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:
CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call free of charge 0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference number

Ferrous Sulfate 200mg Coated Tablets 29831/0220

This service is provided by the Royal National Institute of Blind people.

This leaflet was last revised in 09/2016.

104564/7

Wockhardt UK Ltd
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Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
WWW
www.wockhardt.co.uk
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
Medical Information e-mail
[email protected]