Ferrous Sulphate Tablets Bp 200mg
Package leaflet: Information for the patient Ferrous Sulphate 200 mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Ferrous Sulphate 200 mg Tablets. It will be referred to as Ferrous sulphate across this leaflet.
What is in this leaflet
1. What Ferrous sulphate is and what it is used for
2. What you need to know before you take Ferrous sulphate
3. How to take Ferrous sulphate
4. Possible side effects
5. How to store Ferrous sulphate
6. Contents of the pack and other information
1. What Ferrous sulphate is and what it is used for
Ferrous sulphate is an anti-anaemic preparation used to treat or prevent iron deficiency conditions.
2. What you need to know before you take Ferrous sulphate Do not take Ferrous sulphate:
- If you are allergic to Ferrous sulphate or any of the other ingredients of this medicine (listed in section 6)
- If you are receiving repeated blood transfusions
- If you are receiving iron intravenously
- If you have a disorder in which there is excessive absorption and storage of iron such as haemochromatosis
Warnings and precautions
Talk to you doctor or pharmacist or nurse before taking Ferrous sulphate if:
- You suffer from any form of anaemia
- You suffer from a blood disease called haemoglobinopathy
- You suffer from an iron storage or absorption disease
- You suffer from gastrointestinal (affecting the stomach and the intestines) disease Other medicines and Ferrous sulphate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
- Antibiotics (medicines used to treat infections): tetracyclines, ciprofloxacin, norfloxacin, ofloxacin, as absorption may be affected
- Bisphosphonates (medicines used to prevent bone loss in the treatment of osteoporosis), as absorption may be affected
- Cholestyramine (medicine used in the treatment of high blood cholesterol), as absorption may be affected
- Antiacids (medicines used to relieve heartburn, between others), as absorption may be affected
- Medicines containing zinc, calcium or phosphorus, as absorption may be affected
- Trientine (medicine used in the treatment of a condition called Wilson's Disease, a disease in which there is too much copper in the body), as absorption may be affected
- Methyldopa (medicine used in the treatment of high blood pressure, as absorption may be affected
- Levodopa (medicine used in the treatment of Parkinson’s disease), as absorption may be affected
- Penicillamine (medicine used in the treatment of rheumatoid arthritis), as absorption may be affected
- Dimercaprol (medicine used in the treatment of metal poisoning)
- Levothyroxine (medicine used in the management of thyroid problems), as absorption may be affected. The administration should be done at least two hours apart.
Ferrous sulphate with food and drink
meat and products ingestion of these
This medicine should not be taken with tea, coffee, milk, eggs and whole grains or containing vitamin C, as the absorption may be affected.
Iron supplements should not be taken within one hour before or two hours after products.
Pregnancy and breast-feeding
Ferrous salts are recommended for use in pregnancy and lactation, and no contraindications to such are known.
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
Ferrous sulphate contains glucose, sucrose and lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ferrous sulphate contains castor oil
May cause stomach upset and diarrhoea.
Ferrous sulphate contains methylhydroxybenzoate and propylhydroxybenzoate
May cause allergic reactions (possibly delayed).
3. How to take Ferrous sulphate
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and older people Treatment: one tablet 2-3 times a day.
Prevention: 1 tablet a day.
Use in children and adolescents
Children 6-12 years
Children weighing over 22kg: one tablet a day.
Children weighing over 44kg: one tablet twice a day.
Children weighing over 66kg: one tablet three times a day.
Children under 6 years or weighing less than 22kg Not recommended.
Swallow the tablets whole with water. Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side effects.
If you take more Ferrous sulphate than you should
If you take too many tablets, contact your nearest hospital casualty department or doctor immediately.
Iron overdosage can be dangerous, particularly in children, and treatment is necessary.
Overdosage can be divided into four stages:
- In the first stage (up to 6 hours after ingestion) you may experience vomiting, diarrhoea, low blood pressure, fast heart beat, high blood sugar, excessive acidity of the blood, tiredness or even coma.
- In the second stage (6-24 hours after ingestion) you may experience a temporary improvement of the symptoms.
- In the third stage vomiting and diarrhoea occur again with excessive acidity of the blood, fits, coma, liver damage and yellowing of the skin, low blood glucose, clotting affected, decreased output of urine, kidney failure and fluid on the lungs.
- In the fourth stage (several weeks after ingestion) you may experience blockage of the stomach and intestines and late liver damage.
Take any remaining tablets and this leaflet with you so that the medical staff know exactly what you have taken.
If you forget to take Ferrous sulphate
Do not take a double dose to make up a forgotten tablet, but take the next dose at the usual time.
If you stop taking Ferrous sulphate
If you are having no problems with your tablets, do not stop taking them until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ferrous sulphate can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you experience any of the following symptoms:
- itchy skin rash
- swelling of the face, lips, tongue or throat
- difficulty in breathing or swallowing.
If you experience any of the following symptoms while taking this medicine contact your doctor as soon as possible:
Not known: frequency cannot be estimated from the available data:
- upset stomach
- stomach discomfort
- feeling or being sick
- diarrhoea
- constipation
blackened stools
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 national reporting system listed in Yellow Card Scheme Website: 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 sulphate
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label .The expiry date refers to the last day of that month.
Store in a cool, dry place and protected from light.
Do not store above 25°C.
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 protect the environment.
6. Contents of the pack and other information What Ferrous sulphate contains
The active substance is Ferrous Sulphate. Each tablet contains 200mg ferrous sulphate.
The other excipients are dextrose monohydrate, lactose, maize starch, glycerol, povidone, industrial methylated spirits, calcium carbonate, magnesium stearate, shellac, castor oil no. 1, talc, titanium dioxide, sucrose, mineral water sugar, purified water, methylhydroxybenzoate, propylhydroxybenzoate, acacia, polyethylene glycol 6000.
What Ferrous sulphate looks like and contents of the pack
Each tablet is white, sugar-coated and available in polypropylene securitainers with tamper evident polypropylene caps containing, 50, 100 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd Capital House,
85 King William Street,
London EC4N 7BL, UK