Ferracin 100 Mg Gastro-Resistant Capsule Hard
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 mg g astro-resistant c apsules, ha rd, r eferred to as 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 take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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. What Ferracin 100 mg capsules is and what it is used for
2. What you need to know before you take Ferracin 100 mg capsules
3. How to take Ferracin 100 mg capsules
4. Possible side effects
5. How to store Ferracin 100 mg capsules
6. Contents of the pack and other information
1. What Ferracin 100 mg capsules is and what it is used for
Ferracin 100 mg capsules contain 100 mg elemental iron in the form of 309 mg dried ferrous sulfate which is a w ell-known and widely used iron salt. They belong to a group of medicines known as oral iron supplements.
Ferracin 100 m g c apsules a re us ed to 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 is an i mportant component of the body. It i s particularly needed for the 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 iron supplements may become necessary for people who do not get enough 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 treatment with Ferracin 100 mg capsules starts, it is important to exclude any specific 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 doctor or pharmacist i f you are taking or have recently taken any other 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 treat an 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 potential interactions mentioned above can be reduced by separating 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 absorption of iron is enhanced by ascorbic acid and meat. The effect of Ferracin 100 m g capsules may be reduced if taken with tea, coffee, coke, milk, eggs, vegetable 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 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
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 mg capsules either in the morning on an empty stomach (approximately 1 hour before br eakfast) or w ith a t ime i nterval of 2 hours be fore o r after a m eal. Although i ron preparations are b est ab sorbed on an empty stomach, they may be taken after food to reduce 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 severe iron deficiency i s present, the initial daily dose can be increased up to two or three capsules i n adults and adolescents 15 years of age or with a body weight of at least 50 kg, taken in divided doses throughout the day.
Ferracin 100 mg 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 normalisation of haemoglobin values in the blood (normally within the first 10 weeks, 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 too m any c apsules, c ontact your doc tor or ne arest hos pital casualty department i mmediately. T ake the capsule pack with you so that the m edical staff 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 forget to take a dose, take it as soon as you remember. Then, take the next dose at the 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 capsules may cause allergic reactions. The frequency of occurrence is not known for oral iron preparations but isolated cases have been reported.
If you experience any of the following side effects, stop taking 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 any side effects, talk to your doctor or pharmacist. This i ncludes any pos sible side 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. By 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 use thi s medicine after the expiry date which is stated on the carton after “EXP”. The 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 to 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 are ascorbic acid, microcrystalline cellulose, colloidal anhydrous silica, 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 hard 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 available 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).