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 recognisable risk of iron deficiency developing.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Floradix with iron oral solution for adults and children aged 6 and over
Active ingredient: iron(II) gluconate

Read the entire package leaflet carefully, as it contains important information for you about what you should consider when using this medicine. This medicine is available without a prescription. However, to achieve the best possible treatment results, Floradix with iron must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after a few weeks, you must consult a doctor.
• If any of the side effects listed affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. PHARMACOTHERAPEUTIC GROUP AND AREAS OF APPLICATION
2. IMPORTANT NOTES BEFORE USE
3. NOTES ON TAKING/USING
4. SIDE EFFECTS
5. STORAGE INSTRUCTIONS AND SHELF LIFE
6. COMPOSITION AND CONTENTS OF THE PACK
7. FURTHER INFORMATION

1. PHARMACOTHERAPEUTIC GROUP AND AREAS OF APPLICATION

Iron deficiency prophylactic. In case of increased iron requirement, if there is a recognisable risk of iron deficiency developing.

2. IMPORTANT NOTES BEFORE USE

Contraindications

When should you not take Floradix with iron?
You should not take Floradix with iron:

• in case of iron accumulation, iron utilisation disorders.
• if you know that you have reacted with hypersensitivity to one of the ingredients.

Warnings and precautions for use

What should you consider before taking Floradix with iron?
To avoid the risk of a possible iron overdose, special care should be taken if dietary or other iron salt supplements are used. In the case of pre-existing inflammation or ulcers of the gastrointestinal mucosa, the benefit of treatment should be carefully weighed against the risk of worsening the gastrointestinal disease.

This medicine contains fructose and invert sugar (mixture of glucose and fructose):
Please only take Floradix with iron after consulting your doctor if you know that you suffer from an intolerance to certain sugars. Floradix with iron can be harmful to teeth (caries).

Children

What should you consider with children and adolescents?
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.

Pregnancy and breastfeeding

What should you consider during pregnancy and breastfeeding?
If you are pregnant or breastfeeding, or if you suspect that you are pregnant or intend to become pregnant, ask your doctor for advice before taking this medicine.

Driving and operating machinery

No impairments are known.

Important information about certain other ingredients of Floradix with iron

None.

Interactions 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 the simultaneous use of cholestyramine, antacids (Ca++, Mg++, Al+++ salts) and calcium and magnesium supplements.
• The simultaneous intake of iron salts with salicylates or non-steroidal anti-inflammatory drugs can increase the irritant effect of iron on the mucous membrane of the gastrointestinal tract.
• Iron-binding substances such as phosphates, pyruvates or oxalates as well as dairy products, coffee and black and green tea inhibit iron absorption.

Floradix with iron should be taken either half an hour before or 2 hours after these substances. Please inform your doctor or pharmacist or another qualified healthcare professional if you are taking or using other medicines or have recently taken or used other medicines, even if they are non-prescription medicines.

3. NOTES ON TAKING

Dosage instructions, type and duration of use

Please follow the dosage instructions, otherwise Floradix with iron will not work properly.

Dosage

Unless otherwise prescribed, adults and adolescents aged 10 and over take 3 x 15 ml per day with the enclosed measuring cup. 45 ml of Floradix with iron contains 36.8 mg of utilisable iron(II). Children aged 6 - 10 years: 2 x 15 ml. 30 ml of Floradix with iron corresponds to 24.5 mg of iron(II). Use is not intended for children under 6 years of age.

Type of use

Shake before use. It is best to take it chilled ½ hour before meals.

Duration of use

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

Note for diabetics

15 ml corresponds to 0.3 BE.

Overdose and errors in use

If you have taken a significantly larger amount of 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 have forgotten to take Floradix with iron

Do not take twice the amount the next time, but continue taking it as described in the dosage instructions.

4. SIDE EFFECTS

Like all medicines, Floradix with iron can have side effects, although not everybody gets them.

Possible side effects:

• Allergic reactions may occur. At the first signs of an allergic reaction (e.g. facial swelling, rash), taking Floradix with iron should be stopped immediately.
• Gastrointestinal disorders, such as stomach pressure, a feeling of fullness and constipation.
• As with all iron-containing medicines, a completely harmless darkening of the stool may occur. This stool colouration is harmless.
• Taking liquid iron preparations can, in individual cases, lead to darkening of the tooth surfaces, which can 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 leaflet. 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. STORAGE INSTRUCTIONS AND SHELF LIFE

Do not use the medicine after the expiry date (date after "use by") stated on the folding box (outer carton) and the container (label). Do not store above 25°C. The bottle must be closed immediately after use and stored in the refrigerator. Shelf life after opening the container: 4 weeks. Keep medicines out of the reach of children.

6. COMPOSITION AND CONTENTS OF THE PACK

100 ml (corresponding to approx. 109 g) of solution contain as active ingredient: 703.3 - 773.9 mg of iron(II) gluconate (Ph. Eur.) corresponding to 81.75 mg of iron(II) ions. Other ingredients: ascorbic acid, aqueous extract (1:28.2) from a mixture of hibiscus flowers, bitter fennel, carrot, couch grass rhizome, yarrow herb, angelica root, horsetail herb, ribwort leaves, juniper berries, chicory root, bitter orange peel (3:2.3:2.3:2.3:2.3:2.3:1.15:1.15:1.15:1.15:1:0.64), extraction agent: water, yeast autolysate, red grape juice concentrate, cherry juice concentrate, pear juice concentrate, blackberry juice concentrate, blackcurrant juice concentrate, honey, rose hip thick extract, fructose syrup 70%, orange flavouring, orange flavouring, water.

Dosage form and contents

15 ml, 250 ml, 500 ml, 700 ml, 2 x 500 ml, 3 x 500 ml solution and 15 ml non-saleable sample. Not all pack sizes may be marketed.

7. FURTHER INFORMATION

Pharmaceutical entrepreneur and manufacturer

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

Marketing authorisation holder

SALUS Haus GmbH & Co. KG
Bahnhofstraße 24
83052 Bruckmühl

Further notes

An increased iron requirement exists in particular in case of increased iron loss, e.g. during menstruation. Furthermore, there is an increased iron requirement during pregnancy and breastfeeding as well as during the recovery period after illnesses. Due to the contained plant-based raw materials, the product may contain natural turbid substances. However, this does not affect the quality.

This package leaflet was last revised in July 2016.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: iron(II) gluconate. Areas of application: in case of increased iron requirement, if there is a recognisable risk of iron deficiency developing.