Niferex

Package leaflet: Information for the user

Niferex 100 mg gastro-resistant hard capsules

Iron (Fe)
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Niferex is and what it is used for
2. What you need to know before taking Niferex
3. How to take Niferex
4. Possible side effects
5. How to store Niferex
6. Contents of the pack and other information

1. What Niferex is and what it is used for

Niferex is a form of iron that can be taken by mouth to treat or prevent iron deficiency. Iron is essential for oxygen transport and energy transfer in the body. The capsules are called gastro-resistant because they do not release their contents in the stomach. They release iron in the intestine, where it can be absorbed.
Niferex is used for the treatment of iron deficiency.

2. What you need to know before taking Niferex

DO NOT take Niferex

• if you are allergic to iron complex or to any of the excipients of this medicine (listed in section 6)
• if you have narrowing of the oesophagus
• if you suffer from an inherited iron overload disease (haemochromatosis)
• if you suffer from conditions caused by iron overload (chronic haemolysis, thalassemia, other haemoglobinopathies)
• if you suffer from disorders of iron utilization (sideroachrestic anaemia, lead poisoning anaemia)
• if you receive repeated blood transfusions.

Children

• Children under 6 years of age must not take Niferex.
• Children aged 6 years and older with body weight below 20 kg must not take Niferex.

Warnings and precautions
Talk to your doctor or pharmacist before taking Niferex.
Particular caution is required when taking Niferex:

• if you already suffer from a disease affecting your digestive system, such as chronic inflammatory bowel disease, intestinal or oesophageal stricture, intestinal pouches (diverticula), gastritis, stomach or intestinal ulcers.
• if you suffer from chronic kidney disease requiring administration of erythropoietin, iron should be administered intravenously because orally administered iron is poorly absorbed in individuals with uraemia.
• if you suffer from impaired liver function and/or alcoholism.
• if you are an elderly person with blood or iron loss of unknown origin. In this case, the cause of anaemia/bleeding must be carefully investigated.
• your teeth may change colour during treatment with Niferex. (This discolouration may disappear when you stop taking Niferex. If it does not, you may need to remove it using abrasive toothpaste or professional dental cleaning).

Children

• Exercise particular care when administering to children, as an excessive dose may 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.
Increased efficacy and possible increase in adverse effects

• Painkillers (analgesics) and anti-rheumatic drugs (e.g. salicylates and phenylbutazone): may worsen irritation of the stomach mucosa caused by Niferex.
• Concomitant treatment with intravenous iron and oral iron may lead to low blood pressure (hypotension) or even collapse due to too rapid release of iron and possible overload. This combination is not recommended.

Decreased efficacy and possible increase in adverse effects

• Certain antibiotics (tetracyclines) or medicines (bisphosphonates) used to treat weakened bones (osteoporosis): if you are also taking Niferex, absorption of both iron and tetracyclines or bisphosphonates is reduced. This means that the effects of all these medicines will be reduced. Ask your doctor whether you need to increase the doses of these medicines.
• Medicines containing calcium, magnesium or aluminium, such as antacids, calcium- and magnesium-based salt substitutes: these medicines reduce or prevent absorption of iron contained in Niferex. You may need to increase the amount of Niferex you take.
• Medicines for arthritis, such as penicillamine and oral gold salts, medicines for Parkinson's disease, such as L-methyldopa and levodopa, and L-thyroxine, used to treat thyroid insufficiency: these medicines are less well absorbed when you take Niferex. Ask your doctor whether you need to increase the doses of these medicines.
• Medicines for treating infections (antibiotics) in the group known as fluoroquinolones, such as ciprofloxacin, levofloxacin, norfloxacin and ofloxacin: iron greatly reduces the amount of these drugs that you absorb. Inform your doctor that you are taking Niferex before starting a course of treatment with these medicines.

The time interval between administration of Niferex and any of the medicines listed above
should be at least 2 hours.
The time between administration of Niferex and tetracyclines other than doxycycline (see below) should
be at least three hours.

• You must not take doxycycline and Niferex together, as doxycycline may inhibit the absorption and systemic availability of Niferex.

Other possible adverse effects

• You may experience darkening of stools, which is not due to occult intestinal bleeding.
• Niferex contains vitamin C, which may cause common tests for occult blood in stools to give false-negative results.

Niferex with food and drinks
Niferex should not be taken with food. Substances present in plant-derived foods (e.g.
cereals and vegetables) may form complexes with iron (e.g. phytates, oxalates and phosphates). These complexes
prevent you from absorbing iron. Ingredients in coffee, tea, milk and cola-based drinks may also
reduce iron absorption into the blood.
The time between consumption of these foods and Niferex should be at least two hours.
Pregnancy, breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
There are no known risks associated with the use of Niferex during pregnancy and breastfeeding.
Driving and using machines
Niferex should not affect your ability to drive or use machinery.
Niferex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Niferex

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not take more than 5 mg of Niferex per kilogram of body weight. For example, if you weigh 60 kg, the maximum daily dose would be 5 x 60 = 300 mg (three capsules).
If your doctor has not prescribed a different dose, the usual dose is:
Children from 6 years of age (with a body weight of at least 20 kg), adolescents and adults

Adolescents from the age of 15 years (with a body weight of at least 50 kg) and adults
In adults and adolescents from the age of 15 years, the following dosage is recommended at the beginning of therapy in cases of severe iron deficiency:

Children and adolescents
Niferex must not be administered to children under 6 years of age (body weight below 20 kg) (see paragraph 2).
Children aged at least 6 years (minimum body weight 20 kg) may be given 1 capsule daily. For further dosage recommendations, see the table.

Method of administration
Take Niferex capsules with a sufficient amount of water. DO NOT chew the capsules. Capsules should be taken away from meals (e.g., on an empty stomach in the morning or between two main meals), as absorption may be reduced by food components.

Note
If you are unable or prefer not to swallow the capsules, you may empty the capsule and swallow the contents. To do this, carefully separate the two halves of the capsule over a small bowl. Gently shake out the contents, collect them with a teaspoon, and swallow. You should drink some water after swallowing the capsule contents.

Duration of treatment
Your doctor will decide how long you should continue taking Niferex.
Treatment should continue until normal iron levels in the blood are achieved, which usually takes between 10 and 20 weeks, or longer if there are underlying persistent conditions.
The duration of treatment for prevention of iron deficiency varies depending on the situation (pregnancy, blood donation, chronic haemodialysis, and planned autologous transfusion).

If you take more Niferex than you should
Following intentional or accidental overdose, the symptoms described in section 4 “Possible side effects” are more likely to occur and may be more severe.
If you have taken an excessive dose of Niferex, you must inform your doctor immediately.
Overdose can cause poisoning, especially in children.
Iron intoxication may cause symptoms such as restlessness, stomach pain, nausea, vomiting, and diarrhoea. Stools may appear tarry, and vomit may contain blood. Symptoms may progress to shock, acidosis (excess acid in the body), and coma. Death may occur due to seizures, Cheyne-Stokes respiration (an abnormal breathing pattern characterised by alternating periods of shallow and deep breathing), coma, and pulmonary oedema.

If you forget to take Niferex
Do not take a double dose to make up for the missed dose. If you have forgotten one or more doses of Niferex, continue taking it for a slightly longer period.

If you stop taking Niferex
You do not need to take any special precautions before stopping treatment with Niferex.
If you have any doubts about using Niferex, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Niferex may in some cases (for which the frequency cannot be estimated) cause a severe allergic reaction (anaphylactic).
If you develop a severe skin rash, itching, or difficulty breathing, you should contact your doctor immediately.

Common side effects (may affect from 1 to 10 users in 100)

• Stomach or intestinal discomfort (abdominal discomfort)
• Heartburn
• Vomiting
• Soft stools (diarrhoea)
• Nausea
• Constipation
• Dark-coloured stools

Rare side effects (may affect from 1 to 10 users in 10,000)

• Discoloration (see also “Warnings and precautions” in section 2)
• Hypersensitivity (e.g. skin reactions, rash, skin eruption, urticaria)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Abdominal pain and upper abdominal pain
• Gastrointestinal haemorrhage
• Discoloration of the tongue
• Discoloration of the inside of the mouth

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Niferex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.

6. Package contents and other information

What Niferex contains
The active substance is iron(II)-glycine sulfate complex.
Each capsule contains:
567.7 mg of iron(II)-glycine sulfate complex (equivalent to 100 mg of Fe).
The other components are:
Granules with the iron(II)-glycine sulfate complex:
ascorbic acid, microcrystalline cellulose, hypromellose, hydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (Eudragit L30 D-55) (containing methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80), acetyltriethylcitrate, talc.
Capsule shell:

• body: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
• cap: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), sodium lauryl sulfate.

Description of the appearance of Niferex and pack sizes
Niferex is a hard gastro-resistant capsule with a chocolate-brown cap and an orange body. It contains greyish-brown granules.
Niferex is available in packs containing 30, 50, 90, 100 and 500 x 1 gastro-resistant capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
UCB Pharma S.p.A.
Via Varesina 162
20156 Milan (Italy)
Manufacturer:
Aesica Pharmaceuticals GmbH
Alfred Nobel Strasse, 10
D-40789 Monheim, Germany
Telephone: 02173/48-0
Fax: 02173-18-1608
This medicinal product is authorized in the Member States of the European Economic Area under the following names: