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FERRACIN 100 MG GASTRO-RESISTANT CAPSULE HARD

Active substance(s): FERROUS SULPHATE

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Package leaflet: Information for the patient
Ferracin 100 mg gastro-resistant capsules, hard
Iron
The na me of your m edicine i s F erracin 100 m g g astro-resistant c apsules, ha rd, r eferred t o a s
Ferracin 100 mg capsules throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always t ake t his m edicine ex actly as d escribed in this l eaflet or as your doc tor or pha rmacist
have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse after 30 days.
What is in this leaflet
1.
2.
3.
4.
5.
6.
1.

What Ferracin 100 mg capsules is and what it is used for
What you need to know before you take Ferracin 100 mg capsules
How to take Ferracin 100 mg capsules
Possible side effects
How to store Ferracin 100 mg capsules
Contents of the pack and other information
What Ferracin 100 mg capsules is and what it is used for

Ferracin 100 m g capsules c ontain 100 m g e lemental i ron in t he f orm of 309 m g dried ferrous
sulfate w hich is a w ell-known and widely us ed i ron s alt. They belong t o a group of m edicines
known as oral iron supplements.
Ferracin 100 m g c apsules a re us ed t o t reat i ron de ficiency ( with or w ithout t he pr esence of
anaemia) in adults and children aged 12 years or older.
Iron i s an i mportant component of t he bod y. It i s particularly needed for t he production of red
blood cells which transport oxygen around the body. Iron is also necessary for the formation of
myoglobin, a protein that stores oxygen in muscles for use during exercise.
Administration of i ron s upplements m ay be come ne cessary f or pe ople w ho do not g et e nough
iron from their diet. This medicine corrects iron deficiency and its associated symptoms such as
tiredness, breathlessness, palpitations, dizziness or headache.
2.

What you need to know before you take Ferracin 100 mg capsules

Do not take Ferracin 100 mg capsules:

- If you are allergic to ferrous sulfate 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 your body is overloaded with iron (e.g. haemochromatosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ferracin 100 mg capsules:
- If you suffer from any condition which affects your stomach or intestines.
- If you suffer from any disease which affects the iron levels of your body.
- If you take dietary or other iron salt supplements.
Before tr eatment w ith Ferracin 100 mg c apsules s tarts, it is important to e xclude a ny s pecific
underlying cause of iron deficiency such as heavy periods, or blood loss in the stool or urine.
In case of doubt whether any of the above applies to you, ask your doctor or pharmacist before
you take Ferracin 100 mg capsules.
Children and adolescents
This medicine should not be given to children under 12 years or weighing less than 44 kg.
Other medicines and Ferracin 100 mg capsules
Tell your doc tor o r pha rmacist i f you a re t aking or ha ve r ecently t aken an y ot her medicines,
including those obtainable without a prescription.
Especially, you must tell your doctor or pharmacist if you are taking
Dimercaprol (to treat poisoning with certain metals) as this forms a toxic (harmful) complex with
iron and should not be taken together.
Please also tell your doctor or pharmacist if you are taking any of the medicines listed below as
they can reduce the effect of Ferracin capsules:
Chloramphenicol by m outh or i njection ( to t reat a n i nfection), Cholestyramine ( to treat hi gh
blood cholesterol), Proton pump inhibitors (to treat ulcers or other stomach problems), Antacids
(to t reat i ndigestion) or Preparations c ontaining Zinc, Magnesium, A luminium, C alcium or
Phosphorus.
Please also tell your doctor or pharmacist if you are taking any of the medicines listed below as
iron can reduce the effect of these medications:
- Tetracycline antibiotics such as doxycycline (to treat infections).
- Fluoroquinolone antibiotics such as ciprofloxacin, norfloxacin, levofloxacin or ofloxacin (to
treat infections).
- Bisphosphonates such as alendronate or clodronate (to treat bone diseases, e.g. osteoporosis)
- Methyldopa (to treat high blood pressure).
- Levodopa and entacapone (to treat Parkinson’s disease).
- Penicillamine (to treat rheumatoid arthritis).
- Levothyroxine (to treat thyroid disorders).

The pot ential i nteractions m entioned above can be reduced b y s eparating the administration of
each product by at least 2 hours, for tetracyclines at least 3 hours.
Iron preparations such as Ferracin 100 mg capsules may lead to false positive blood stool tests.
Ferracin 100 mg capsules with food and drink
The a bsorption of i ron i s e nhanced b y ascorbic acid a nd m eat. The e ffect of F erracin 100 m g
capsules m ay b e r educed if t aken with tea, coffee, coke, milk, eggs, ve getable food and whole
grain food (see section 3).These products can reduce the absorption of iron; consumption should
therefore be separated from the intake of Ferracin capsules by at least 2 hours. Follow the advice
of your dietician or doctor when taking Ferracin 100 mg capsules with any of the food or drink
listed.
Pregnancy and breast-feeding
Ferracin 100 m g c apsules c an be us ed dur ing pr egnancy a nd br east-feeding if c linically
indicated. If you are pr egnant or b reast-feeding, t hink you m ay b e pr egnant or are pl anning t o
have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No effects of Ferracin 100 mg capsules are known.
3.

How to take Ferracin 100 mg capsules

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.
Method of administration
Swallow the capsules whole with 100 – 200 ml of water without crushing or chewing them. Take
Ferracin 100 m g c apsules e ither i n t he m orning on a n e mpty s tomach ( approximately 1 hour
before br eakfast) or w ith a t ime i nterval o f 2 hours be fore o r after a m eal. Although i ron
preparations ar e b est ab sorbed on a n e mpty s tomach, they may be t aken after f ood t o r educe
gastrointestinal side effects.
Use in adults (including the elderly)
The recommended dose is one capsule per day.
Use in children and adolescents (aged 12 years or older and weighing at least 44 kg)
The recommended dose is one capsule per day.
If s evere i ron deficiency i s pr esent, the ini tial daily dos e c an be i ncreased up t o t wo or t hree
capsules i n a dults a nd a dolescents≥ 15 years o f age or with a bod y w eight of a t le ast 50 kg,
taken in divided doses throughout the day.
Ferracin 100 m g capsules are not recommended for children younger than 12 years or weighing
less than 44 kg. Other forms of iron supplements may be more suitable for children (e.g. liquid
preparations); ask your doctor or pharmacist.
Duration of treatment
Your doctor will advise you on how long you should take Ferracin 100 mg capsules. Usually, the
treatment should be continued for at least 3 months.

After nor malisation of ha emoglobin values in t he bl ood (normally w ithin t he f irst 10 w eeks,
depending on the severity of anaemia/iron deficiency), the oral iron therapy should be continued
under surveillance of certain iron blood values (ferritin) until the iron stores are filled; this can
last up to 3 to 6 months.
If you take more Ferracin 100 mg capsules than you should
If you, or a nyone e lse, has t aken t oo m any c apsules, c ontact your doc tor or ne arest hos pital
casualty de partment i mmediately. T ake t he capsule pa ck w ith you so that t he m edical s taff
knows what dose has been taken. Overdose in case of children may be fatal.
The initial symptoms of an overdose may include stomach pain, diarrhoea, blood present in the
vomit or stool, feeling of being sick and collapse.
If you forget to take Ferracin 100 mg capsules
If you f orget t o t ake a d ose, t ake i t a s s oon a s you r emember. T hen, t ake t he ne xt dos e a t t he
usual time. However, if it is nearly time for the next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten dose.
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.
Ferracin 100 mg caps ules m ay c ause al lergic r eactions. The f requency of oc currence i s not
known for oral iron preparations but isolated cases have been reported.
If you e xperience any o f t he f ollowing s ide effects, s top t aking Ferracin 100 m g capsules and
contact your doctor straight away:
- Swollen face, tongue or throat
- Difficulty in breathing
- Itchy skin, rash
If you experience any of the following side effects while you are taking this medicine tell your
doctor as soon as possible:
Very common (may affect more than 1 in 10 people):
Nausea, epigastric or abdominal pain, constipation
Common (may affect up to 1 in 10 people):
Diarrhoea, discoloured faeces, vomiting, rash
Not known (frequency cannot be estimated from the available data):
Hypersensitivity reaction
After you have taken this medicine, you may notice that your stool is darker in colour than usual.
This is commonly seen with all iron supplements and is harmless.
Reporting of side effects

If you get an y s ide ef fects, talk t o your doctor or pha rmacist. T his i ncludes a ny pos sible s ide
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system; please see https://yellowcard.mhra.gov.uk. B y r eporting s ide e ffects you c an he lp
provide more information on the safety of this medicine.
5.

How to store Ferracin 100 mg capsules

Keep this medicine out of the sight and reach of children.
Do not us e thi s me dicine a fter th e e xpiry date which is s tated on the c arton after “E XP”. T he
expiry date refers to the last day of that month.
Store the capsules in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to t hrow a way m edicines you no l onger us e. T hese m easures w ill he lp t o pr otect t he
environment.
6.

Contents of the pack and other information

What Ferracin 100 mg capsules contains
The active substance is ferrous sulfate. Each capsule contains dried ferrous sulfate equivalent to
100 mg of elemental iron.
The other ingredients a re ascorbic acid, microcrystalline cellulose, colloidal a nhydrous s ilica,
copovidone, calcium stearate, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%,
triethyl citrate, talc, titanium dioxide (E171), sodium hydroxide, gelatin, iron oxide, red (E 172),
iron oxide, black (E172), shellac, propylene glycol, ammonia.
What 100 mg capsules looks like and contents of the pack
Ferracin 100 mg is a h ard gastro-resistant capsule. Each capsule contains mini-tablets of ferrous
sulphate with a covering to protect them from stomach acid.
The capsules are red and white and are printed with ‘FER 100’.
Ferracin 100 mg gastro-resistant capsules are a vailable i n p acks o f 10, 20, 30, 50, 60, 90
and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ACINO AG
Am Windfeld 35
83714 Miesbach
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:

Austria: Ferrum Acino 100 mg magensaftresistente Hartkapseln

Germany: Ferracin 100 mg magensaftresistente Hartkapseln
This leaflet was last revised in 11/2014.
The Medicines and Healthcare Products Regulatory Agency will review any new information on
this medicine every year and this leaflet will be updated as necessary.
Other sources of information
Detailed information on thi s me dicine i s ava ilable on the w eb site o f the Medicines and
Healthcare Products Regulatory Agency (www.mhra.gov.uk).

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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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