Ferrous fumarate 322mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Ferrous fumarate
Available from:
Advanz Pharma
ATC code:
B03AA02
INN (International Name):
Ferrous fumarate
Dosage:
322mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 09010101; GTIN: 5021691032243
Authorization number:
PL 10972/0041

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ferrous Fumarate 322mg

Film-Coated 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 or pharmacist.

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 or pharmacist. This includes any possible side effects not listed in

this leaflet. See section 4.

The name of your medicine is Ferrous Fumarate 322mg Film-Coated Tablets. It will be referred to as Ferrous

Fumarate Tablets for ease hereafter.

What is in this leaflet

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

2. What you need to know before you take Ferrous Fumarate Tablets

3. How to take Ferrous Fumarate Tablets

4. Possible side effects

5. How to store Ferrous Fumarate Tablets

6. Contents of the pack and other information

1. WHAT FERROUS FUMARATE TABLETS ARE AND WHAT THEY ARE USED FOR

Ferrous Fumarate Tablets contain a form of iron called ferrous fumarate. Iron is usually found in foods and is

necessary for the normal development of red blood cells. A lack of iron affects the development of the red blood cells

and causes iron deficiency anaemia.

Ferrous Fumarate Tablets are used to prevent or treat iron deficiency anaemia.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERROUS FUMARATE TABLETS

Do not take Ferrous Fumarate Tablets if

You are allergic to Ferrous fumarate or any of the other ingredients of this medicine (listed in section 6), or to any

other medicine containing iron

You have noticed blood in your urine

You suffer from any form of anaemia, other than iron deficiency anaemia, or from any other condition where your

body’s iron is affected (your doctor will be able to advise you)

You have bronze markings on your skin or you have been told that you have increased stores of iron in your tissues

You are suffering from a recently diagnosed stomach or duodenal ulcer

You are undergoing repeated blood transfusions

You suffer from ulcerative colitis or any other inflammatory condition of the bowels.

Speak to your doctor if any of these apply to you before you take your medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ferrous Fumarate Tablets if:

You have had a stomach or duodenal ulcer in the past, or have one which is now under control with treatment

You have problems associated with narrowing of your intestine (stricture) or outpocketing of the inner layer of your

intestine (diverticular disease)

You have had major surgery to your stomach.

If any of these conditions apply to you, speak to your doctor before you take these tablets.

Your doctor will want to watch you closely, and will advise you if any additional medicine is required to treat your

condition.

Other medicines and Ferrous Fumarate Tablets

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

The effects of any of these medicines or of Ferrous Fumarate Tablets may change, particularly if you are taking:

Certain

medicines

treating

infections

(e.g.

chloramphenicol,

tetracyclines,

ciprofloxacin,

levofloxacin,

moxifloxacin, ofloxacin, norfloxacin)

Medicines containing zinc, calcium or magnesium salts

Levothyroxine, used for thyroid gland problems

Medicines used for a disease known as ‘Parkinson’s disease’ (e.g. levodopa, entacapone)

Methyl dopa, used for increase in blood pressure

Antacids used to treat indigestion

Penicillamine used in the treatment of rheumatoid arthritis

Cholestyramine used to reduce cholesterol and fats in the blood

Medicines for bone diseases (bisphosphonates)

Trientine, used for high copper levels in blood

Dimercaprol, used for various metal poisonings

Mycophenolate, used during change of organs (transplant).

Ferrous Fumarate Tablets with food and drink

Ferrous Fumarate Tablets may be taken with meals. This may help to relieve any stomach-related side-effects.

However, it is advisable not to take your medicine with tea, eggs or milk as this may reduce the effect of the tablets.

Ferrous Fumarate Tablets should be taken with a glass of water.

Pregnancy and breast feeding

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 this medicine.

Ferrous Fumarate Tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE FERROUS FUMARATE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if

you are not sure.

The recommended dose:

The recommended dose is one tablet a day. Occasionally it may be increased to one tablet twice a day.

To help you to remember to take your medicine, select the tablet(s) for the appropriate day of the week marked on

the strips.

Swallow the tablets with a glass of water. Taking Ferrous Fumarate Tablets with meals may help to relieve any

stomach related side effects.

Your doctor will advise you on how long you should take the tablets. Normally this will be for 3 – 6 months after the

anaemia has been rectified.

If you have to go to another doctor or to hospital, tell them you are taking Ferrous Fumarate Tablets.

Use in children

Ferrous Fumarate Tablet is not suitable for children.

Your medicine is very dangerous if taken by young children and great care should be taken to keep the medicine

safely out of sight and reach of children. If a child has taken or is suspected of taking any of the tablets, immediate

medical advice should be sought (see below - If you take more Ferrous Fumarate Tablets than you should).

If you take more Ferrous Fumarate Tablets than you should

If you take too many tablets, or a child takes or is suspected of taking any tablets at all, contact your nearest hospital

casualty department or doctor immediately. Take any remaining tablets and this leaflet with you so that the medical

staff know exactly what has been taken.

If you forget to take your Ferrous Fumarate Tablets

Take another from the pack as soon as you remember, according to the day of the week. Then go on as before. If it

is almost time for the next dose, then do not take the missed dose at all.

If you stop taking Ferrous Fumarate Tablets

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 or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness,

difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should

be reported to a doctor immediately.

Not known: frequency cannot be estimated from the available data

Stomach discomfort

Pain in upper part of the stomach

Vomiting sensation

Difficulty in passing stools

Loose stools.

Also, you may find that your stools are darker in colour after you have taken this medicine. This is quite commonly

seen with all iron preparations and is normal.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. HOW TO STORE FERROUS FUMARATE TABLETS

Keep this medicine out of the sight & reach of children, as overdose may be fatal.

Do not use this medicine after the expiry date which is stated on the carton and blister after “Exp”. The expiry date

refers to the last day of that month.

Store below 25°C.

Store in the original package in order to protect from light.

Do not use your medicine if the pack is damaged.

Disposal of the product:

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 to protect the environment.

REMEMBER

This medicine is for YOU. Never give it to anyone else. It may harm them, even if their signs of illness are the

same as yours.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ferrous Fumarate tablets contain:

The active substance is ferrous fumarate. Each tablet contains 322 mg ferrous fumarate (equivalent to approximately

100 mg ferrous iron). Ferrous fumarate is an iron compound.

The other ingredients are maize starch, sodium lauryl sulphate, gelatin and liquid paraffin. The film coating of the

tablets contains hypromellose, acetylated monoglyceride, hydroxypropyl cellulose, titanium dioxide (E171), talc, iron

oxide yellow (E172) and iron oxide red (E172).

What Ferrous Fumarate Tablets look like and contents of the pack

Each film coated tablet is brown ochre in colour and engraved FE on one face and 322 on the other. Ferrous

Fumarate Tablets are usually available in cartons containing two blister strips of 14 tablets, therefore 28 tablets

altogether. However, pots of 1000 tablets may also be available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London, EC4N 7BL, UK

Manufacturer:

Lusomedicamenta S.A.Sociedade Técnica, Farmaceutica 2730 055 Barcarena, Portugal

This leaflet was last revised in September 2019.

Read the complete document

Object 1

Ferrous Fumarate 322mg Tablets

Summary of Product Characteristics Updated 10-Oct-2019 | ADVANZ Pharma

1. Name of the medicinal product

2. Qualitative and quantitative composition

3. Pharmaceutical form

4. Clinical particulars

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

5. Pharmacological properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

1. Name of the medicinal product

Fersaday 322mg Tablets

Ferrous Fumarate 322mg Film-Coated Tablets

2. Qualitative and quantitative composition

Each tablet contains 322.0mg Ferrous Fumarate BP (equivalent to approximately 100 mg ferrous iron)

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Film-coated Tablets

Each film coated tablet is brown ochre in colour and engraved 'FE' on one face and '322' on the other.

4. Clinical particulars

4.1 Therapeutic indications

Prophylaxis and treatment of iron deficiency states.

4.2 Posology and method of administration

Posology

Adults and the elderly: One tablet daily (the foil enclosing the tablet is printed with days of the week in

sequence).

In severe or refractory iron deficiency, one tablet may be given twice a day.

Paediatric population: Ferrous Fumarate tablets are not intended for the treatment of children.

Method of administration:

Oral

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated

blood transfusions, regional enteritis, and ulcerative colitis. Ferasday tablets must not be used in anaemias

other than those due to iron deficiency.

4.4 Special warnings and precautions for use

Some post gastrectomy patients show poor absorption of iron. Care is needed when treating patients with

iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment of

uncomplicated iron deficiency anaemia should not usually exceed 6 months (or 3 months after reversal of

the anaemia has been achieved).

Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type,

patients with microytic anaemia resistant to therapy with iron alone should be screened for vitamin B12

or folate deficiency.

Paediatric Population

Ferrous Fumarate tablets should be kept out of the sight and reach of children.

The label will state:

Important Warning: Contains Iron.

Keep out of the sight and reach of children, as overdose may be fatal.

This will appear on the front of the pack within a rectangle, in which there is no other information.

This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially 'sodium-

free'.

4.5 Interaction with other medicinal products and other forms of interaction

Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa,

levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate,

norfloxacin, ofloxacin, zinc. Absorption of both iron and antibiotic may be reduced if Ferrous Fumarate

tablet is given with tetracycline. Absorption of oral iron is reduced by calcium salts, Magnesium salts (as

magnesium trisilicate), Trientine.

Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes

with erythropoiesis. Some inhibition of iron absorption may occur if it is taken with cholestyramine, tea,

eggs or milk.

Avoid concomitant use of iron with dimercaprol.

Oral iron antagonises hypotensive effect of methyldopa.

4.6 Fertility, pregnancy and lactation

Pregnancy

Ferrous fumarate tablets can be used during pregnancy if clinically indicated.

Breast-feeding

No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous

fumarate tablets can be used during breast-feeding if clinically indicated.

4.7 Effects on ability to drive and use machines

Not relevant

4.8 Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of

frequency using the following convention:

Not known: frequency cannot be estimated from the available data

Gastrointestinal disorders:

Gastro-intestinal irritation and darkening of stools can occur with iron salts. Nausea and epigastric pain

are dose-related but the relationship between dose and altered bowel habit (constipation or diarrhoea) is

less clear. Oral iron, particularly modified-release preparations, can exacerbate diarrhoea in patients with

inflammatory bowel disease; care is also needed in patients with intestinal strictures and diverticular

disease.

Iron preparations taken orally can be constipating, particularly in older patients and occasionally lead to

faecal impaction.

If side-effects occur, the dose may be reduced; alternatively, another iron salt may be used but an

improvement in tolerance may simply be a result of a lower content of elemental iron.

Paediatric population

Iron preparations are a common cause of accidental overdose in children

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms:

Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal. No single

method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be

taken into account. The serum iron taken at about 4 hours after ingestion is the best laboratory measure of

severity.

Serum Iron

Severity

< 3 mg/L (55 micromol/L)

Mild toxicity

3-5 mg/L (55-90 micromol/L)

Moderate toxicity

> 5 mg/L (90 micromol/L)

Severe toxicity

Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea. The vomit and stools

may be grey or black. In mild cases early features improve but in more serious cases there may be

evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity.

In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after

ingestion. Shock can result from hypovolaemia or direct cardiotoxicity.

Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia,

encephalopathy and positive anion gap metabolic acidosis. Poor tissue perfusion may lead to renal failure.

Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial

or complete bowel obstruction 2-5 weeks after ingestion.

Management:

Supportive and symptomatic measures include ensuring a clear airway, monitoring of cardiac rhythm, BP

and urine output, establishing IV access and administering sufficient fluids to ensure adequate hydration.

Consider whole bowel irrigation. If metabolic acidosis persists despite correction of hypoxia and adequate

fluid resuscitation, an initial dose of 50 mmol sodium bicarbonate may be given and repeated as

necessary, for adults guided by arterial blood gas monitoring (aim for a pH of 7.4). Consider the use of

desferrioxamine, if the patient is symptomatic (other than nausea), serum iron concentration is between 3-

5 mg/L (55-90 micromol/L) and still rising. Haemodialysis does not remove iron effectively but should be

considered on a supportive basis for acute renal failure as this will facilitate removal of the iron-

desferrioxamine complex.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Iron bivalent, oral preparations

ATC code: B03AA02

Iron is an essential constituent of the body, and is necessary for haemoglobin formation and the oxidative

processes of living tissues. Iron and iron salts should be given for the treatment or prophylaxis of iron

deficiency anaemias. Preparations of iron are administered by mouth, by intramuscular or intravenous

injection.

Soluble ferrous salts are most effective by mouth. Ferrous fumarate is an easily absorbed source of iron

for replacement therapy. It is a salt of ferrous iron with an organic acid and is less irritant to the gastro-

intestinal tract than salts with inorganic acids.

5.2 Pharmacokinetic properties

Absorption

Once in the stomach, the acid conditions of the gastric contents cause the dissociation of ferrous fumerate

and ferrous ions are liberated. These ions are absorbed through the proximal portion of the duodenum.

The ferrous iron absorbed by the mucosal cells of the duodenum is oxidised to the ferric form, and this is

bound to protein to form Ferritin.

Distribution

Ferritin in the mucosal cells releases iron into the blood, where it is bound to transferrin and is passed

onto the iron stores in the liver, spleen, and bone marrow.

These stores constitute a reserve of iron for synthesis of haemoglobin, myoglobin, and iron containing

enzymes.

Elimination

Iron is lost from the body through loss of cells i.e, urine, faeces, hair, skin, sputum, nails, sloughing of

mucosal cells, and through blood loss.

Ferrous fumarate has the same pattern of absorption and excretion as dietary iron.

5.3 Preclinical safety data

No further data

6. Pharmaceutical particulars

6.1 List of excipients

Tablet Core

Maize Starch BP

Sodium Lauryl Sulphate BP

Gelatin BP

Paraffin Liquid BP

Film Coating

Acetylated Monoglyceride

Opadry20A270006

Opadry20A270006 contains:

Hypromellose

Iron Oxide Yellow

Titanium dioxide

Talc

Hydroxypropyl cellulose

Iron Oxide Red

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Protect from light.

Store below 25°C.

6.5 Nature and contents of container

Cartons containing two blister packs of 14 tablets, prepared from White 250/60 micron PVC/PVDC film

and printed 30 micron hard-tempered aluminium foil. 28 tablets in each carton or dispensing pack of 1000

tablets in Polypropylene container with tamper evident low density polyethylene cap.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7. Marketing authorisation holder

Mercury Pharma Group Ltd

Capital House, 85 King William Street,

London EC4N 7BL, UK

8. Marketing authorisation number(s)

PL 10972/0041

9. Date of first authorisation/renewal of the authorisation

07/01/2009

10. Date of revision of the text

09/10/2019

Company Contact Details

ADVANZ Pharma

Address

Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK

Telephone

+44 (0)208 588 9131

Medical Information Direct Line

08700 70 30 33

Customer Care direct line

+44 (0)208 588 9273

www.advanzpharma.com

+44 (0)208 588 9200

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)20 8588 9200

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