Ferrous Sulphate 200mg Coated Tablets Bp
CP.FES.200T.V1P2
PACKAGE LEAFLET
FERROUS SULPHATE
200 MG COATED TABLETS BP
The name of your medicine is Ferrous Sulphate 200 mg coated tablets BP, referred to as Ferrous Sulphate tablets or ferrous sulphate throughout this leaflet.
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 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 gets serious, or if you notice any side effects not listed in this leaflet, please tel) your doctor or pharmacist.
In this leaflet:
1. What Ferrous Sulphate Tablets are and what they are used for
2. Before you take Ferrous Sulphate Tablets
3. How to take Ferrous Sulphate Tablets
4. Possible side effects
5. How to store Ferrous Sulphate Tablets
6. Further information
1. WHAT FERROUS SULPHATE TABLETS ARE _AND WHAT THEY ARE USED FOR_
Ferrous Sulphate tablets contain the active ingredient ferrous sulphate which is a form of iron. They belong to the group of medicines called iron supplements.
Iron is needed by the body to maintain good health, particularly for making red blood cells that carry oxygen around the body.
A shortage of iron may mean that the body cannot produce enough normal red blood cells to keep you healthy. This is known as iron deficiency anaemia. This can cause tiredness, breathlessness, palpitations, dizziness and headache.
Iron is found naturally in certain foods, but for some people who do not get enough iron from their diet an iron supplement can be necessary. Some conditions can also cause iron deficiency anaemia, such as pregnancy or heavy periods.
Ferrous Sulphate tablets are used to treat iron deficiency anaemia.
2. BEFORE YOU TAKE FERROUS SULPHATE
_TABLETS_
Do not take Ferrous Sulphate Tablets:
• If you are allergic (hypersensitive) to ferrous sulphate or any of the other ingredients in the tablets (see section 6 of this leaflet).
• If you are receiving repeated blood transfusions
• If you are receiving iron intravenously
• If you have a disorder in which there is too much iron in your blood.
Tell your doctor before taking Ferrous Sulphate tablets if you think any of the above applies to you.
Take special care with Ferrous Sulphate Tablets and tell your doctor or pharmacist:
• If you suffer from any disease which affects your stomach and intestines (gastro-intestinal tract).
• If you suffer from any form of anaemia other than iron deficiency anaemia or from any other condition which affects your body's iron levels.
Before starting treatment with Ferrous Sulphate tablets it is important to exclude any underlying cause of the anaemia such as heavy periods, or blood loss in the stool or urine.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ferrous Sulphate tablets.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Especially if you are taking any of the following, as ferrous sulphate can reduce the effect of these medicines:
• Tetracycline antibiotics (to treat infections), such as tetracycline or doxycyline
• Ciprofloxacin, norfloxacin, levofloxacin or ofloxacin (antibiotics to treat infections)
• Methyldopa (to treat high blood pressure)
• Levodopa or entacapone (for Parkinson's disease)
• Penicillamine (for rheumatoid arthritis)
• Levothyroxine (to treat thyroid problems)
• Bisphosphonates such as alendronate or dodronate (to prevent loss of bone mass or to treat osteoporosis)
Please also tell your doctor or pharmacist if you are taking:
• Chloramphenicol by mouth or injection (to treat an infection), as this can reduce the response to treatment with ferrous sulphate
• Dimercaprol (to treat poisoning with certain metals), as this causes a toxic (harmful) complex with ferrous sulphate
• Colestyramine (to reduce blood cholesterol), as this can prevent the absorption of iron
Some other medications can also affect the absorption of iron. Do not take Ferrous Sulphate tablets within one hour before or two hours after taking antacids (for indigestion), trientine (for Wilson's disease) or medicines containing zinc, calcium, phosphorus.
Taking Ferrous Sulphate tablets with food and drink
Some foods can affect the absorption of iron. It is advisable not to take your medicine within one hour before or two hours after eating wholegrain foods or eggs or drinking tea, coffee or milk, as this may reduce the " effect of the tablets.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. You should let your doctor know if you are pregnant, think you are pregnant, are planning to become pregnant or if you are breast-feeding.
Important information about some of the ingredients of Ferrous Sulphate tablets Ferrous Sulphate tablets contain the colour E124 which may cause allergic reactions.
This product contains lactose and sucrose. 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 SULPHATE TABLETS Method of administration
Swallow the tablets whole with a glass of water.
Do not break, crush or chew the tablets, or put them in water before swallowing.
It is best to take Ferrous Sulphate tablets on an empty stomach, but they may be taken after food to reduce gastro-intestinal side effects.
Dosage
Always take Ferrous Sulphate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how much you should take and how often.
Adults including the elderly:
The usual dose is one tablet two or three times a day. Children:
Children weighing over 44kg: one tablet twice a day. Children and adolescents weighing over 66kg: one tablet three times a day.
Ferrous Sulphate tablets should not be given to children weighing less than 44kg.
Your doctor will advise you on how long you should take the tablets.
If you have taken more Ferrous Sulphate Tablets than you should
If you take too many tablets or you think a child may have swallowed any, go to your nearest hospital casualty department or contact your doctor immediately even if you feel well, because of the risk of serious side effects. Take the tablet pack with you so that the medical staff know exactly what you have taken.
The initial symptoms of an overdose may include being sick, diarrhoea, a racing heart (tachycardia) and tiredness. If you forget to take Ferrous Sulphate Tablets If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you have any further questions about these tablets, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines. Ferrous Sulphate tablets can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Ferrous Sulphate tablets and tell your doctor immediately:
An allergic reaction which may occur as
• Swollen face or tongue
• Shortness of breath or difficulty breathing
• Itchy skin rashes
Tell your doctor as soon as possible if you notice any of the following side effects:
• Stomach discomfort
• Feeling sick or being sick
• Constipation
• Diarrhoea
Also, you might find your stools are darker in colour after you have taken this medicine. This is quite commonly seen with all iron preparations and is normal.
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.
5. HOW TO STORE FERROUS SULPHATE TABLETS IMPORTANT WARNING: Contains iron KEEP OUT OF THE REACH AND SIGHT OF CHILDREN, as overdose may be fatal.
Do not use Ferrous Sulphate tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Store the tablets in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ferrous Sulphate Tablets contain
The active substance is dried ferrous sulphate BP.
Each tablet contains 200 mg dried ferrous sulphate BP equivalent to 65 mg ferrous iron (the ingredient that makes the tablets work).
The other ingredients are maize starch, maltodextrin, calcium stearate, lactose monohydrate, cellulose powdered, co-povidone, sucrose, Macrogol 4000, talc, sodium starch glycollate, sodium dodecyl sulphate. Ponceau 4R red colour and red lacquer (E124), povidone, calcium carbonate, titanium dioxide (E171), magnesium stearate, shellac, theobroma oil.
What Ferrous Sulphate Tablets look like and contents of the pack
The tablets are red circular biconvex coated tablets.
The tablets come in packs of 28 tablets.
Marketing authorisation holder
Quantum Generics Limited, Crown House,
2-8 Gloucester Road, Redhill, Surrey, RH1 1FH
Manufacturer
Lomapharm - Rudolf Lohmann GmbH KG Langes Feld 5, D - 31860 Emmerthal, Germany Distributor
Kent Pharmaceuticals Limited,
Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last approved in September 2014
04/11/2014