NIFEREX 100 mg enteric iron (Fe 2+ ) Hard Capsules
What Niferex Is And What It Is Used For
Niferex is a form of iron that is taken by mouth to treat, or to prevent, iron deficiency. Iron is essential for oxygen transport and the transfer of energy in the body. The capsules are called enteric capsules because they do not excrete their contents in the stomach. They release the iron into the intestine where it is absorbed.
Niferex is used to treat iron deficiency.
What You Need To Know Before You Take Niferex
Do Not Use Niferex
- If you are allergic to the iron complex or any of the other ingredients of this medicine (listed in section 6).
- If you have a narrow esophagus.
- If you suffer from a hereditary blood disease in which iron is stored in the body ( hemochromatosis ).
- If you suffer from diseases with elevated iron value ( chronic hemolysis , thalassemia , other hemoglobinopathies)
- If you suffer from diseases where iron can not be used by the body (eg sideroblastic anemia , lead anemia)
- If you receive repeated blood transfusions .
Children
- Children under 6 years of age should not take Niferex.
- Children from 6 years of age weighing less than 20 kg should not take Niferex.
Warnings And Cautions
Talk to your doctor or pharmacist before using Niferex. Special care should be taken when taking Niferex
- If you already have diseases of the gastrointestinal tract such as chronic inflammatory bowel disease, narrow esophagus and intestinal constriction, diverticula (intestinal pockets), gastritis, gastrointestinal ulcers.
- If you have chronic kidney disease that requires erythropoietin, in that case iron should be given intravenously as iron taken by mouth is poorly absorbed in people with kidney failure .
- If you have impaired liver function or alcohol problems.
- If you are an elderly person with anemia or iron deficiency of unknown origin. In this case, the cause of anemia / the source of bleeding should be carefully investigated.
- Your teeth may become discolored during treatment with Niferex. (Discoloration may disappear when you stop taking Niferex. If it does not go away, it must be removed with an abrasive toothpaste or by a professional toothbrush).
Children
- Take special care with Niferex 100 mg english in children, as an overdose can lead to poisoning in children.
Other Medicines And Niferex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Increase in effect or possible increase in side effects
- Analgesics and rheumatism (eg salicylates and phenylbutazone): may lead to an increase in irritation of the intestinal mucosa caused by Niferex.
- Intravenous treatment with iron at the same time as iron treatment taken by mouth can lead to low blood pressure ( hypotension ) or even collapse due to too rapid release of iron and a possible overload. This combination is not recommended.
Decrease in effect and the possible increase in side effects
- Certain antibiotics ( tetracyclines ) or medicines (bisphosphonates) for the treatment of skeletal diseases (osteoporosis): if you also take Niferex, both absorption of iron and absorption of tetracyclines or bisphonates will decrease. This means that the effects of all these medications are reduced. Ask your doctor if you need to increase the dose of any of these medicines.
- Drugs that contain calcium , magnesium or aluminum, e.g. antacids, calcium and magnesium salts for substitution: these medicines reduce or prevent the uptake of iron by Niferex. You may need to increase the amount of Niferex you are taking.
- Arthritis drugs such as penicillamine and oral gold compounds, anti- Parkinson’s drugs such as L-methyldopa, levodopa and L – thyroxine used to treat thyroid disease: these medicines are less well absorbed when you take this supplement with iron. You should ask your doctor if you need to increase the dose of any of these medicines.
- Treatments of infection ( antibiotics ) in a group of drugs called fluoroquinols, such as ciprofloxacin , levofloxacin, norfloxacin and ofloxacin: iron greatly reduces the absorption of one of these drugs. You should tell your doctor that you are taking Niferex 100 mg English before you start taking these medicines.
The time interval between taking this supplement and any of the above medicines should be at least 2 hours.
The time interval between taking Niferex and tetracyclines other than doxycycline (see below) should be at least 3 hours.
- You should not take doxycycline and Niferex together, as doxycycline may impede the absorption and circulation of Niferex.
Other possible side effects are
- Dark staining of the stool, not caused by gastrointestinal bleeding, may occur.
- Niferex contains vitamin C which can cause the now common tests for detecting traces of blood in the stool to be false negative.
Niferex With Food And Drink
Niferex should not be taken with food. Substances in vegetarian food (eg flakes and vegetables) can form complexes with iron (eg phytates, oxalates, and phosphates ). These complexes prevent you from absorbing the iron. Ingredients in coffee, tea, milk, and carbonated drinks can also reduce the absorption of iron in the blood.
The time between taking these products and this supplement should be at least 2 hours.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no known risks associated with the use of Niferex 100 mg pregnancy and lactation.
Driving And Using Machines
Niferex iron does not affect the ability to drive or use machines.
Niferex Contains Sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
How To Take Niferex
- Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
- Do not take more than 5 mg Niferex for every kilogram you weigh. For example, if you weigh 60 kg, the maximum daily dose is 5 x 60 = 300 mg (3 capsules).
Unless otherwise prescribed by your doctor, the usual dose is:
Children from 6 years (from a bodyweight of 20 kg), adolescents, and adults:
| Body weight (kg) | Capsules per intake | Dosage frequency | Total Fe 2+ dose (mg) |
| ≥ 20 | 1 | Once a day | 100 |
Adolescents from 15 years (with a bodyweight of 50 kg) and adults.
Adults and adolescents from 15 years of age with severe iron deficiency are recommended the following dosage at the beginning of treatment:
| Body weight (kg) | Capsules per intake | Dosage frequency | Total Fe 2+ dose (mg) |
| 50- <60 | 1 | 2 times daily | 200 |
| ≥ 60 | 1 | 2-3 times daily distributed throughout the day | 200-300 |
- Children and young people
- Niferex should not be used in children under 6 years of age (weighing less than 20 kg) (see section 2).
- Children from 6 years (at least 20 kg body weight) can be given 1 capsule daily. See table for further dosage information.
- In case of severe iron deficiency, adolescents with a bodyweight of at least 50 kg can be given a 2 to 3 times higher dose at the beginning of treatment.
- Method of administration
- Take this supplement with enough water. DO NOT chew the capsule. The capsules should be taken at sufficient intervals from meals (eg on an empty stomach in the morning or between two main meals), as the content of the food may reduce uptake.
Note
If it is difficult to swallow the capsule, the capsule may be emptied and the contents swallowed. To do this, carefully pull the two capsule halves apart over a bowl. Gently shake out the contents and collect the grains on a spoon. After consuming the contents of the spoon, you should drink some water.
- Treatment time
- Your doctor will decide how long you need to take Niferex.
- Treatment should continue until normal blood counts have been reached, which normally takes 10-20 weeks or longer depending on how long the underlying condition remains.
- Treatment time to prevent iron deficiency varies depending on the situation (pregnancy, blood donation, chronic hemodialysis, and planned autologous transfusion ).
If You Use More Niferex Than You Should
- If you have intentionally or accidentally ingested an overdose, it is likely that symptoms, as described in section 4 “Possible side effects”, will occur and become more pronounced.
- If you take more this supplement than you should, inform your doctor immediately.
- An overdose can cause poisoning, especially in children.
- Iron poisoning can cause symptoms such as
- Restlessness
- Stomach pain
- Nausea
- Vomiting
- Diarrhea. The stool may be dark in color, the vomit may contain blood. Shock, acidosis (too much acid in the body), and unconsciousness can occur. Death can occur after seizures, Cheyne-Stokes breathing (abnormal breathing patterns characterized by alternating periods of shallow and deep breathing), unconsciousness, and pulmonary edema.
- If you have ingested too much of this supplement or if e.g. If a child has ingested the medicine by mistake, always contact a doctor or hospital for risk assessment and advice.
If You Forget To Take Niferex
Do not take a double dose to make up for a forgotten dose. If you forget to take one or more doses of Niferex, just keep taking the capsules a little longer.
If You Stop Taking Niferex
No special measures need to be taken when stopping treatment with Niferex.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Niferex Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. This supplement can in rare cases (for which the frequency can not be calculated) cause a severe allergic (anaphylactic) reaction. If you get a
- Severe rash
- Itching
- Difficulty breathing
Seek medical advice immediately.
Common side effects ( affects 1-10 people in 100):
- Feelings of discomfort in the stomach and intestines
- Heartburn
- Vomiting
- Diarrhea
- Nausea
- Constipation
- Dark-colored stools
Rare side effects ( affects 1 to 10 people in 10,000):
- Discoloration of the teeth (see also section 2 “Take special care with Niferex”)
- Hypersensitivity (eg skin conditions, redness of the skin, rash, urticaria ( hives ))
No known frequency (can not be calculated from the available data)
- Stomach pain and upper abdominal pain
- Gastrointestinal bleeding
- Discoloration of the tongue
- Discoloration of the oral mucosa
How To Store Niferex
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is ferrous (II) glycine sulfate complex. One capsule contains 567.7 mg of ferrous (II) glycine sulphate complex (equivalent to 100 mg of iron Fe 2+).
- Other ingredients are:
- Granules with ferrous (II) glycine sulfate complex:
- Ascorbic acid, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, methacrylic acid ethyl acrylate copolymer (1: 1) dispersion 30% (Eudragit L 30 D-55) (contains methacrylic acid-ethyl acrylate copolymer (1: 1), sodium lauryl sulfate, polysorbate 80c, acetyl citrate 80) talc.
- The shell of the capsule:
- Lower part: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172)
- Upper: gelatin, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), sodium lauryl sulfate.
What The Medicine Looks Like And Contents Of The Pack
- Niferex is a hard enteric capsule containing one half chocolate brown and the other half orange. It contains gray-brown grains.
- Niferex is available in packs of 30 (non-prescription), 50 (non-prescription), 90 (prescription) and 500×1 (prescription) enteric capsules.
- Not all pack sizes may be marketed.
Marketing Authorization Holder
UCB Pharma GmbH
Alfred Nobelstraße 10
40789 Monheim, Germany
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred Nobelstraβe 10
40789 Monheim, Germany
Information is provided by
UCB Nordic A / S
Edvard Thomsens Vej 14
DK – 2300 Köpenhamn S
Denmark
Tel: + 46 / (0) 40 29 49 00
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Niferex
Greece: Ferro sanol duodenal
Italy: Niferex
Norway: Niferex
Spain: Ferro sanol
Sweden: Niferex