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FERROUS SULFATE TABLETS BP 200MG

Active substance(s): FERROUS SULFATE DRIED / FERROUS SULFATE DRIED / FERROUS SULFATE DRIED

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Package leaflet: Information for the patient

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor
or pharmacist.
•  Do not pass this medicine onto 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.

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.
Talk to your doctor or pharmacist before taking
Ferrous Sulfate tablets if you have:
• h aemolytic anaemia
• a blood disease (haemoglobinopathy)
• an iron storage or absorption disease
• g astrointestinal disease

Other medicines and Ferrous Sulfate
tablets

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.
• tetracyclines (to treat infections)
• ciprofloxacin, norfloxacin, ofloxacin (to treat infections)
• colestyramine
• antacids (containing magnesium or aluminium)
• medicines containing zinc, calcium, phosphorus or
trientine
• methyldopa (to treat high blood pressure)
• penicillamine (for rheumatoid arthritis)
• levodopa (for Parkinson’s disease)
• ascorbic acid (vitamin C)

What is in this leaflet
1. What Ferrous Sulfate tablets are and
what they are used for
2. What you need to know 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. Contents of the pack and other
information

Ferrous Sulfate tablets contain glucose,
sucrose and lactose

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

Ferrous Sulfate tablets belong to a group of medicines
called iron supplements. These medicines work by
replacing body iron. Iron is a mineral that the body needs
to produce red blood cells. When the body does not get
enough iron, it cannot produce the number of normal
red blood cells needed to keep you in good health. This
condition is called iron-deficiency anaemia.
Ferrous Sulfate tablets are used for the prevention and
treatment of iron-deficiency anaemia.

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine, as it contains glucose, sucrose
and lactose.

3. How to take Ferrous Sulfate tablets

2. What you need to know before you
take Ferrous Sulfate tablets

Do not take Ferrous Sulfate tablets if you:
• are allergic to dried ferrous sulfate or any of the
other ingredients of this medicine (listed in section 6).
• are receiving repeated blood transfusions
• are receiving iron intravenously
• have a disorder in which there is excessive
absorption and storage of iron such as
haemochromatosis.

Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.

Ferrous Sulfate tablets with food and
drink

Ferrous Sulfate tablets should not be taken within one
hour before or two hours after eating or drinking the
following products: tea, coffee, milk, eggs and whole
grains. These products can reduce the absorption of
iron. Meat and products containing vitamin C can
increase the absorption of iron. Follow the advice of your
dietician or doctor when taking Ferrous Sulfate tablets
with any of the food or drink listed.

Continued over page

Continued top of next column

130x210 Leaflet Reel Fed Profile (BST)

Ferrous Sulfate Tablets
200mg x 60’s (UK)

Ferrous Sulfate 200mg 30 & 60 Tablets PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0176

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
31.10.16
23.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
130 x 210
Min Body Text Size: 7.5pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2. pms cool gray

2.

3. pms 205

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50913932

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles
Pharmacode: 2062
Date Sent:
25/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Swallow the tablets whole with water. Do not
suck, chew or keep the tablet in your mouth. Although
iron preparations are best absorbed on an empty
stomach, they may be taken after food to reduce
gastrointestinal side effects.
The recommended dose is
Adults and the elderly
Treatment: 2-3 tablets a day in divided doses.
Prevention: 1 tablet a day.
Children 6-12 years
Treatment:
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.

If you take more Ferrous Sulfate tablets
than you should

If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed any
contact your nearest hospital casualty department or
tell your doctor immediately. Symptoms of an overdose
include:
 p to 24 hours: stomach and intestinal poisoning
•U
including being sick and diarrhoea, heart disorders
such as low blood pressure (hypotension) and a racing
heart (tachycardia), metabolic changes such as too
much acid in the body (acidosis) and high blood sugar
(hyperglycaemia), nervous system depression ranging
from tiredness to coma, temporary relief of symptoms
may occur.
 fter 24 hours: stomach and intestinal poisoning
•A
and obstruction, shock, too much acid in the body
(acidosis), fits, coma, liver failure, jaundice (yellowing
of the skin or whites of the eyes), low blood sugar,
problems with blood clotting, low production of urine,
kidney failure, fluid in the lungs.

If you forget to take Ferrous Sulfate tablets

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right time.
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.

Contact your doctor at once if you have an allergic
reaction e.g itchy skin rash, swelling of the face, lips,
tongue or throat, or difficulty breathing or swallowing.
Tell your doctor if you notice any of the following side
effects:
• constipation occasionally causing faecal impaction,
diarrhoea, stomach pain, feeling sick and blackened
stools.

 ot known (frequency cannot be estimated from the
N
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.

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

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date which is
stated on the label/carton/bottle. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer require. These measures will
help protect the environment.

6. Contents of the pack and other
information

What Ferrous Sulfate tablets contain

• T he active substance (the ingredient that makes the
tablets work) is dried ferrous sulfate BP. Each tablet
contains 200mg dried ferrous sulfate BP equivalent to
65mg ferrous iron.
• T he other ingredients are spray dried liquid glucose,
stearic acid, magnesium stearate, microcrystalline
cellulose (101) (E460), lactose granules containing
lactose, maize starch, pregelatinised maize starch,
purified talc (E553), acacia (E414), gelatin, sucrose,
titanium dioxide (E171) and yellow carnauba wax.
What Ferrous Sulfate tablets look like and the
contents of the pack
Ferrous Sulfate tablets are white, circular, biconvex,
sugar-coated tablets.
Pack size is 60.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in November 2016.

If you would like a leaflet with
larger text, please contact
01271 385257.

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

50913932 BBBA0176

130x210 Leaflet Reel Fed Profile (BST)

Ferrous Sulfate Tablets
200mg x 60’s (UK)

Ferrous Sulfate 200mg 30 & 60 Tablets PIL - UK
approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0176

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
31.10.16
23.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
130 x 210
Min Body Text Size: 7.5pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2. pms cool gray

2.

3. pms 205

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50913932

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles
Pharmacode: 2062
Date Sent:
25/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Package leaflet: Information for the patient

Ferrous Sulfate 200mg tablets
Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
you.
Always take this medicine exactly as
described in this leaflet or as your doctor
or pharmacist has told 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.

What is in this leaflet
1 What Ferrous Sulfate tablets are and
what they are used for
2 What you need to know before you take
Ferrous Sulfate tablets
3 How to take Ferrous Sulfate Tablets
4 Possible side effects
5 How to store Ferrous Sulfate Tablets
 ontents of the pack and other
6 C
information
1 What Ferrous Sulfate tablets are and

what they are used for

Ferrous Sulfate tablets belong to a group of
medicines called iron supplements. These medicines
work by replacing body iron. Iron is a mineral that
the body needs to produce red blood cells. When the
body does not get enough iron, it cannot produce
the number of normal red blood cells needed to
keep you in good health. This condition is called irondeficiency anaemia.
Ferrous Sulfate tablets are used for the prevention
and treatment of iron-deficiency anaemia.

2 What you need to know before you take

Ferrous Sulfate tablets

Do not take Ferrous Sulfate tablets if you:
• are allergic to dried ferrous sulfate or any of the
other ingredients of this medicine (listed in section
6).
• are receiving repeated blood transfusions

Continued top of next column

• are receiving iron intravenously
• have a disorder in which there is excessive
absorption and storage of iron such as
haemochromatosis.

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.
Talk to your doctor or pharmacist before taking
Ferrous Sulfate tablets if you have:
• haemolytic anaemia
• a blood disease (haemoglobinopathy)
• an iron storage or absorption disease
• gastrointestinal disease

Other medicines and Ferrous Sulfate tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
• tetracyclines (to treat infections)
• ciprofloxacin, norfloxacin, ofloxacin (to treat
infections)
• colestyramine
• antacids (containing magnesium or aluminium)
• medicines containing zinc, calcium, phosphorus or
trientine
• methyldopa (to treat high blood pressure)
• penicillamine (for rheumatoid arthritis)
• levodopa (for Parkinson’s disease)
• ascorbic acid (vitamin C)

Ferrous Sulfate tablets contain 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 medicine, as it contains glucose,
sucrose and lactose.

3 How to take Ferrous Sulfate tablets

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.

Ferrous Sulfate tablets with food and drink

Ferrous Sulfate tablets should not be taken within
one hour before or two hours after eating or drinking
the following products: tea, coffee, milk, eggs
and whole grains. These products can reduce the
absorption of iron. Meat and products containing
vitamin C can increase the absorption of iron. Follow
the advice of your dietician or doctor when taking
Ferrous Sulfate tablets with any of the food or drink
listed.

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Ferrous Sulfate Tablets
200mg x 28’s (UK)

Ferrous Sulfate 200mg 28 & 100 Tablets PIL - UK
approved for print/date

Proof Round

3

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0174

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
28.10.16
23.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
148 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50913916

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4194
Date Sent:
25/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Swallow the tablets whole with water. Do not suck,
chew or keep the tablet in your mouth. Although iron
preparations are best absorbed on an empty stomach,
they may be taken after food to reduce gastrointestinal
side effects.

The recommended dose is

Adults and the elderly
Treatment: 2-3 tablets a day in divided doses.
Prevention: 1 tablet a day.
Children 6-12 years
Treatment:
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.

If you take more Ferrous Sulfate tablets than
you should

If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed any
contact your nearest hospital casualty department or
tell your doctor immediately. Symptoms of an overdose
include:
•U
 p to 24 hours: stomach and intestinal poisoning
including being sick and diarrhoea, heart disorders
such as low blood pressure (hypotension) and a racing
heart (tachycardia), metabolic changes such as too
much acid in the body (acidosis) and high blood sugar
(hyperglycaemia), nervous system depression ranging
from tiredness to coma, temporary relief of symptoms
may occur.
•A
 fter 24 hours: stomach and intestinal poisoning and
obstruction, shock, too much acid in the body (acidosis),
fits, coma, liver failure, jaundice (yellowing of the skin
or whites of the eyes), low blood sugar, problems with
blood clotting, low production of urine, kidney failure,
fluid in the lungs.

If you forget to take Ferrous Sulfate tablets

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right
time.
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.
Contact your doctor at once if you have an allergic
reaction e.g itchy skin rash, swelling of the face, lips,
tongue or throat, or difficulty breathing or swallowing.
Tell your doctor if you notice any of the following side
effects:
• c onstipation occasionally causing faecal impaction,
diarrhoea, stomach pain, feeling sick and blackened
stools.

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.

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

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date which is
stated on the label/carton/bottle. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer require. These measures
will help protect the environment.

 ontents of the pack and other information
6  C
What Ferrous Sulfate tablets contain
• The active substance (the ingredient that makes the
tablets work) is dried ferrous sulfate BP. Each tablet
contains 200mg dried ferrous sulfate BP equivalent to
65mg ferrous iron.
• The other ingredients are spray dried liquid glucose,
stearic acid, magnesium stearate, microcrystalline
cellulose (101) (E460), lactose granules containing
lactose, maize starch, pregelatinised maize
starch, purified talc (E553), acacia (E414),
gelatin, sucrose, titanium dioxide (E171) and
yellow carnauba wax.

What Ferrous Sulfate tablets look like
and the contents of the pack
Ferrous Sulfate tablets are white, circular,
biconvex, sugar-coated tablets.
Pack size is 28 and 100.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in November 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
50913916 BBBA0174

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Ferrous Sulfate Tablets
200mg x 28’s (UK)

Ferrous Sulfate 200mg 28 & 100 Tablets PIL - UK
approved for print/date

Proof Round

3

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0174

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
28.10.16
23.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
148 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50913916

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4194
Date Sent:
25/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Package leaflet: Information for the patient

Ferrous Sulfate Tablets 200mg
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
Always take this medicine exactly
as described in this leaflet or as your
doctor or pharmacist has told you.
• K eep 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.

What is in this leaflet
1 What Ferrous Sulfate tablets are and
what they are used for
2 What you need to know 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 Contents of the pack and other
information
1 What Ferrous Sulfate tablets are and

what they are used for

Ferrous Sulfate tablets belong to a group of
medicines called iron supplements. These
medicines work by replacing body iron. Iron is a
mineral that the body needs to produce red blood
cells. When the body does not get enough iron, it
cannot produce the number of normal red blood
cells needed to keep you in good health. This
condition is called iron-deficiency anaemia.
Ferrous Sulfate tablets are used for the prevention
and treatment of iron-deficiency anaemia.

2 What you need to know before you

take Ferrous Sulfate tablets

Do not take Ferrous Sulfate tablets if you:
• are allergic to dried ferrous sulfate or any of
the other ingredients of this medicine (listed in
section 6).
• are receiving repeated blood transfusions
• are receiving iron intravenously

• have a disorder in which there is excessive
absorption and storage of iron such as
haemochromatosis.

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.
Talk to your doctor or pharmacist before taking
Ferrous Sulfate tablets if you have:
•h
 aemolytic anaemia
• a blood disease (haemoglobinopathy)
• an iron storage or absorption disease
•g
 astrointestinal disease

Other medicines and Ferrous Sulfate
tablets

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
• tetracyclines (to treat infections)
• ciprofloxacin, norfloxacin, ofloxacin (to treat
infections)
• colestyramine
• antacids (containing magnesium or aluminium)
• medicines containing zinc, calcium, phosphorus
or trientine
• methyldopa (to treat high blood pressure)
• penicillamine (for rheumatoid arthritis)
• levodopa (for Parkinson’s disease)
• ascorbic acid (vitamin C)

Ferrous Sulfate tablets contain 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 medicine, as it contains
glucose, sucrose and lactose.

3 How to take Ferrous Sulfate tablets
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

Ferrous Sulfate tablets with food and
drink

Ferrous Sulfate tablets should not be taken
within one hour before or two hours after eating
or drinking the following products: tea, coffee,
milk, eggs and whole grains. These products can
reduce the absorption of iron. Meat and products
containing vitamin C can increase the absorption
of iron. Follow the advice of your dietician or
doctor when taking Ferrous Sulfate tablets with
any of the food or drink listed.

Continued top of next column

Continued over page

130x210 Leaflet Reel Fed Profile (BST)

Ferrous Sulfate Tablets
200mg x 100’s (UK)

Ferrous Sulfate 200mg 100 Tablets PIL - UK

JDE No.:

approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0175

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
28.10.16
23.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
130 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50913924

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles
Pharmacode: 3725
Date Sent:
25/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Swallow the tablets whole with water. Do not suck,
chew or keep the tablet in your mouth. Although
iron preparations are best absorbed on an empty
stomach, they may be taken after food to reduce
gastrointestinal side effects.

• 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.

The recommended dose is

Reporting of side effects

Adults and the elderly
Treatment: 2-3 tablets a day in divided doses.
Prevention: 1 tablet a day.
Children 6-12 years
Treatment:
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.

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

Keep this medicine out of the sight and reach of
children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date which is
stated on the label/carton/bottle. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer require. These measures
will help protect the environment.

Children under 6 years or weighing less than 22kg
Not recommended.

If you take more Ferrous Sulfate tablets than
you should

If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed
any contact your nearest hospital casualty department
or tell your doctor immediately. Symptoms of an
overdose include:
•U
 p to 24 hours: stomach and intestinal poisoning
including being sick and diarrhoea, heart disorders
such as low blood pressure (hypotension) and a
racing heart (tachycardia), metabolic changes such as
too much acid in the body (acidosis) and high blood
sugar (hyperglycaemia), nervous system depression
ranging from tiredness to coma, temporary relief of
symptoms may occur.
•A
 fter 24 hours: stomach and intestinal poisoning
and obstruction, shock, too much acid in the body
(acidosis), fits, coma, liver failure, jaundice (yellowing
of the skin or whites of the eyes), low blood sugar,
problems with blood clotting, low production of
urine, kidney failure, fluid in the lungs.

6 Contents of the pack and other

If you forget to take Ferrous Sulfate tablets

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right
time.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 Possible side effects

information

What Ferrous Sulfate tablets contain

• The active substance (the ingredient that makes the
tablets work) is dried ferrous sulfate BP. Each tablet
contains 200mg dried ferrous sulfate BP equivalent to
65mg ferrous iron.
• The other ingredients are spray dried liquid glucose,
stearic acid, magnesium stearate, microcrystalline
cellulose (101) (E460), lactose granules containing
lactose, maize starch, pregelatinised maize starch,
purified talc (E553), acacia (E414), gelatin, sucrose,
titanium dioxide (E171) and yellow
carnauba wax.

What Ferrous Sulfate tablets look
like and the contents of the pack

Ferrous Sulfate tablets are white, circular,
biconvex, sugar-coated tablets.
Pack size is 100.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.

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

This leaflet was last revised in November
2016.

Contact your doctor at once if you have an allergic
reaction e.g itchy skin rash, swelling of the face, lips,
tongue or throat, or difficulty breathing or swallowing.

If you would like a
leaflet with larger
text, please contact
01271 385257.

Tell your doctor if you notice any of the following side
effects:
• constipation occasionally causing faecal impaction,
diarrhoea, stomach pain, feeling sick and blackened
stools.
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).
Continued top of next column
50913924 BBBA0175

Actavis, Barnstaple, EX32 8NS, UK

130x210 Leaflet Reel Fed Profile (BST)

Ferrous Sulfate Tablets
200mg x 100’s (UK)

Ferrous Sulfate 200mg 100 Tablets PIL - UK

JDE No.:

approved for print/date

Proof Round

2

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0175

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
28.10.16
23.11.16
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
130 x 210
Min Body Text Size: 8pts
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50913924

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles
Pharmacode: 3725
Date Sent:
25/10/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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