FLORADIX

FLORADIX with iron oral solution

Important notes (mandatory information)

Floradix with Iron Solution. Active ingredient: Iron(II) gluconate. Areas of application: in case of increased iron requirement, if there is a recognizable risk of developing iron deficiency.Warning: Contains invert sugar (honey), fructose and glucose.

For risks and side effects, read the package insert and consult your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Floradix with Iron Solution for oral use for adults and children aged 6 and over, in case of increased iron requirement, if there is a recognizable risk of developing iron deficiency
Active ingredient: Iron(II) gluconate

Read the entire package insert carefully before you start taking this medicine, as it contains important information.

• Always take this medicine exactly as described in this package insert or exactly as instructed by your doctor, pharmacist or healthcare professional.
• Keep the package insert. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist or healthcare professional. This also applies to side effects not listed in this package insert. See section 4.
• If you do not feel better or even worse after a few weeks, contact your doctor.

What this package insert contains

1. WHAT IS FLORADIX WITH IRON AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FLORADIX WITH IRON?
3. HOW SHOULD FLORADIX WITH IRON BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FLORADIX WITH IRON BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS FLORADIX WITH IRON AND WHAT IS IT USED FOR?

Floradix with Iron is an iron deficiency prophylactic. The medicine is used in case of increased iron requirement, if there is a recognizable risk of developing iron deficiency.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FLORADIX WITH IRON?

Floradix with Iron must not be taken:

• in case of iron accumulation, iron utilization disorders
• if you are allergic to the active ingredient iron or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist or healthcare professional before taking Floradix with Iron.

To avoid the risk of a possible iron overdose, special caution is required if dietary or other iron salt supplements are used.

In case of pre-existing inflammation or ulcers of the gastrointestinal mucosa, the benefit of the treatment should be carefully weighed against the risk of worsening the gastrointestinal disease.

Children

There are no sufficient studies on the use of this medicine in children under 6 years of age. Therefore, Floradix with Iron should not be used in children of this age group.

Taking Floradix with Iron together with other medicines:

• Iron salts reduce the absorption of tetracyclines, penicillamine, gold compounds, levodopa and methyldopa.
• Iron salts affect the absorption of quinolone antibiotics (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
• Iron salts reduce the absorption of thyroxine in patients receiving thyroxine replacement therapy.
• The absorption of iron is reduced by concomitant use of cholestyramine, antacids (Ca++, Mg++, Al+++ salts) and calcium and magnesium supplements.
• Concomitant intake of iron salts with salicylates or non-steroidal anti-inflammatory drugs may increase the irritant effect of iron on the gastrointestinal mucosa.

Floradix with Iron should be taken either half an hour before or 2 hours after these substances.

Proton pump inhibitors (medicines that reduce the production of stomach acid), such as omeprazole, can reduce the absorption of oral iron. Talk to your doctor or pharmacist if you are taking these medicines at the same time.

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or intend to take / use any other medicines.

Taking Floradix with Iron together with food and drink

Iron-binding substances contained in plant-based foods (e.g. cereal products and vegetables) such as phosphates, pyruvates or oxalates as well as components of milk and dairy products, coffee, cola drinks and black and green tea inhibit the absorption of iron into the blood.

Floradix with Iron should be taken either half an hour before or 2 hours after these foods or drinks.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Driving and using machines

No impairments are known.

Floradix with Iron contains invert sugar (honey), fructose and glucose.
Invert sugar is a mixture of glucose and fructose. 15 ml contain a total of 2 g fructose and 1 g glucose; 22.5 ml contain a total of 3 g fructose and 1.5 g glucose. If you need to follow a diabetic diet, you should take this into account.

Talk to your doctor before you (or your child) take or receive this medicine if your doctor has told you (or your child) that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare congenital condition in which fructose cannot be broken down.

Floradix with Iron can be harmful to the teeth (caries).

Note for diabetics

15 ml correspond to approx. 0.3 BE, 22.5 ml correspond to approx. 0.4 BE.

3. HOW SHOULD FLORADIX WITH IRON BE TAKEN?

Always take this medicine exactly as described in this package insert or exactly as instructed by your doctor or pharmacist or healthcare professional. Ask your doctor or pharmacist or healthcare professional if you are not sure.

Shake before use.

Dosage

Adults and adolescents aged 10 and over take 45 ml per day. 45 ml of Floradix with Iron contain 36.8 mg of utilizable iron(II).

The dosage can be chosen as follows

2 x 22.5 ml (morning and evening) or 3 x 15 ml (morning, noon and evening).

Children aged 6-10:
2 x 15 ml. 30 ml of Floradix with Iron correspond to 24.5 mg of iron(II).

Use is not intended for children under 6 years of age.

Method of administration

The medicine is best taken chilled half an hour before meals. Please use the enclosed measuring cup for taking the medicine.

Duration of use

If you have any questions about the duration of use, please ask your doctor or pharmacist.

The user should consult a doctor or other qualified healthcare professional if symptoms of the disease persist or if side effects other than those mentioned in the package insert occur.

If you have taken more Floradix with Iron than you should

Please notify your doctor. He/she can decide on any necessary measures. The side effects listed below may occur more frequently.

If you forget to take Floradix with Iron

Do not take double the amount if you have forgotten to take the previous dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist or healthcare professional.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

• Allergic reactions may occur. At the first signs of an allergic reaction, such as swelling of the face, swelling of the throat, rash or discomfort in the mouth and throat, e.g. a burning or tingling sensation, the intake of Floradix with Iron should be stopped immediately.
• Gastrointestinal disorders, such as stomach pressure, a feeling of fullness and constipation may occur.
• As with all iron-containing medicines, a completely harmless darkening of the stool may occur. This stool coloration is harmless.
• In individual cases, taking liquid iron preparations may lead to darkening of the tooth surfaces, which can usually be removed by thorough brushing.
• The frequency of occurrence of side effects is not known.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD FLORADIX WITH IRON BE STORED?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the folding box (outer carton) and the container (label) after "use by". Do not store above 25°C. The bottle must be closed immediately after use and stored upright in the refrigerator.

Shelf life after first opening of the container:
4 weeks.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Floradix with Iron contains

100 ml (corresponding to approx. 109 g) of liquid contain 81.75 mg of iron (as iron(II) gluconate (Ph.Eur.)).

The other ingredients are

Ascorbic acid, aqueous extract (1 : 27.6 - 30.4) from a mixture of hibiscus flowers, carrots, couch grass rhizome, yarrow herb, angelica root, horsetail herb, ribwort leaves, juniper berries, chicory root, bitter orange peel (3 : 2.3 : 2.3 : 2.3 : 1.15 : 1.15 : 1.15 : 1.15 : 1 : 0.64) Extractant: water, yeast autolysate, red grape juice concentrate, cherry juice concentrate, pear juice concentrate, blackberry juice concentrate, blackcurrant juice concentrate, honey, rose hip juice concentrate, fructose syrup 70%, orange oil, water.

What Floradix with Iron looks like and

Contents of the pack

Floradix with Iron is a dark, reddish to brown liquid.

Due to the contained plant-based raw materials, the product may contain natural turbidities. However, this does not represent an impairment of the quality.

Contents of the pack

250 ml, 500 ml, 700 ml, 2 x 500 ml, 3 x 500 ml liquid.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Salus Pharma GmbH
Bahnhofstraße 24
83052 Bruckmühl
info@saluspharma.de

Marketing authorization holder:
Salus Haus GmbH & Co. KG
Bahnhofstraße 24
83052 Bruckmühl

This package insert was last revised in November 2023.

Source: Information from the package insert
Status: 01/2025
Active ingredient: Iron(II) gluconate. Areas of application: in case of increased iron requirement, if there is a recognizable risk of developing iron deficiency.Warning: Contains invert sugar (honey), fructose and glucose.