Folicombin coated tablets, 100 pcs

Instructions for use for Folicombin coated tablets, 100 pcs

Important notes (compulsory information):

Folicombin coated tablets. Applications: For the treatment of a combined iron and folic acid deficiency.

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


LEAFLET: INFORMATION FOR THE USER

Folicombin coated tablets
Active ingredient: ammonium iron (II) sulfate · 6 H2O and folic acid

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this leaflet:

1. What is Folicombin and what is it used for?
2. What should you consider before taking Folicombin?
3. How to take Folicombin?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Folicombin?
6. Content of the pack and further information

1. What is Folicombin and what is it used for?

Folicombin is an iron substitution preparation in combined iron and folic acid deficiency states. Folicombin is used to treat a combined iron and folic acid deficiency.

2. What should you consider before taking Folicombin?

Folicombin must not be taken,

• if they are allergic to ammonium iron (II) sulfate, folic acid or one of the other ingredients of this medicinal product referred to in section 6
• if you suffer from iron accumulation (hemochromatosis iron storage disease or chronic hemolysis destruction of red blood cells
• if you have iron recycling disorders (sideroachrestic anemia, lead anemia, thalassemia
• if you suffer from a megaloblast anemia due to a vitamin B12 deficiency.

Warnings and Precautions:
Please talk to your doctor or pharmacist before taking Folicombin.

Special care when taking Folicombin is required:

• in patients with intestinal ulcers.
• in anemia due to severe renal disease. Then Folicombin should be taken together with erythropoietin.

Due to the risk of oral ulcer (mouth turzera) and tooth displacements, the tablets must not be sucked, chewed or left longer in the mouth, but should be swallowed with water. If you can not follow this application or have difficulty swallowing, talk to your doctor.

Children:
Children under 6 should not take Folicombin. An overdose can cause poisoning especially in children (See section 3. "How to take Folicombin?" / "If you take a larger amount of Folicombin than you should").

Older people:
Especially in older people with initially non-explained blood or iron losses must be very carefully searched for the cause of the anemia or the bleeding source.

Taking Folicombin together with other medicines:
Inform your doctor or pharmacist if you take / apply other medicines, recently taken / applied / applied or intend to take / use other medicines.

Folicombin is influenced as follows:

• Simultaneous administration of tetracyclines, both the absorption of iron and the absorption of the tetracycline is reduced.
• The simultaneous administration of Colestyramine and Antacid (Calcium, Magnesium, aluminum salts) inhibits iron resorption.
• A mucosal irritating effect in the intestine can be reinforced by the oral administration of salicylates, phenylbutazone and oxyphenebutazone.
• Cytostatics, sulfonamides, antiepileptics and barbiturates affect folic acid resorption.

Folicombin influences the effect of the following medicines:

• Penicillamine, oral gold connections and tetracycline are poorly absorbed with simultaneous administration of iron.
• When used high dosages, the variety can increase under anticonvulsive therapy.
• Since both folic acid and vitamin B12 cause a reticulocyte increase (precursor of the red blood cells) in the blood, the administration of one of the two vitamins can alone (e.g. The administration of folic acid in Folicombin) may obscure the lack of the other vitamin.

During iron treatment, the benzidal sample can be positive.

Taking Folicombin along with food and beverages:
The absorption of iron at the resorption site - the upper small intestine - It is inhibited by some food ingredients, which are present, for example in cereal products and vegetables in different amounts, such as the so-called phytine, oxalates or phosphates, as well as drinks such as coffee, tea or milk. These foods and drinks should not be taken at the same time with the intake of Folicombin tablets. Here is a temporally different intake of these foods with Folicombin tablets.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Since there is an increased demand for iron and folic acid for the body during pregnancy and lactation, a sufficient supply of folic acid and iron must be ensured during this time (see section 3. "How to take Folicombin"). If you are pregnant or breastfeed, you should take Folicombin only with detected folic acid and iron deficiency, which can not be remedied nutritionally. Since the safety of a higher dosage is not guaranteed, a dosage of more than 5 mg of folic acid in pregnancy and lactation is not allowed.

Driving and ability to operate machines:
There are no special precautions required.

Folicombin contains glucose, lactose and sucrose:
Please take Folicombin only after consulting your doctor if you are familiar with any intolerance to certain sugars.

3. How to take Folicombin?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: usually adults and children from 6 Years of 2 to 3 tablets Folicombin distributed over the day.

Type of application:
To take. Take the tablet inadequer with water. Slip or chew the tablet and do not let the tablet in the mouth longer. Depending on the gastrointestinal compatibility, the coated tablets must be taken before or on the meals. The treatment should be continued until the physicians are replenished. This can usually - depending on the severity of the anemia and the individual circumstances - between 3 and 6 months, in individual cases even longer.

pregnancy and breast feeding period
Since there is an increased need for iron and folic acid for the body during pregnancy and during lactation, it is particularly carefully careful during this time that Folicombin ruleis taken moderately. If it comes to the occurrence of gastrointestinal complaints, Folicombin can also be taken with or after meals.

If you take a larger amount of Folicombin than you should:
In the case of an intended or accidental overdose, the section 4. "Which side effects are possible?" Symptoms described. Should there be overdose with clinical signs of poisoning, the usual rules apply to inxication therapy. In order to delay or prevent the absorption of iron in the body, milk should be drunk or chicken egg whites. If Folicombin tablets were taken in excessive quantities, the doctor should be informed immediately.

If you forget to take Folicombin:
If you have forgotten the intake of Folicombin tablets inadvertently one or more times, thereby extends the overall treatment period and thus the period until normalization of the serum fountain value.

If you have further questions about taking this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

Frequently (can concern up to 1 of 10 treated):
Faults of the gastrointestinal tract (gastrointestinal disturbances) such as diarrhea (diarrhea), blockages (commitment), heartburn or vomiting (vomitus) may occur. The frequency increases with increasing dose. A dark discoloration of the chair occurring in the course of the treatment may be due to the iron content and is harmless.

Rarely (can concern up to 1,000 treated):
Sleep disorders, excitement or depression at very high doses.

Very rare (can be up to 1 out of 10,000 treated):
Allergic reactions, including hypersensitivity reactions (anaphylactoid reactions), e.g. Skin symptoms such as skin rotation (erythema) and nettle rash (Urticaria) as well as clamping of smooth bronchial muscles (Bronchospasm) or anaphylactic shock.

Unknown (frequency based on the available data not estimable):
Oral ulcers (false application when the tablets are chewed, sucked or longer in the mouth). In the case of older patients or patients with swallowing problems, there is also the risk of ulcers in the area of the throat, the esophagus (the connection between the mouth and stomach) or the bronchi (the main air tubes of the lungs) when the tablets enter the respiratory tract.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Folicombin?

Keep this medicine inaccessible to children. You may follow this medicine after the on the outer carton "Usable until" or the label after "Ver. Until" specified expiry date no longer use. The expiry date refers to the last day of the specified month. Do not store more than 25 ° C. Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What contains Folicombin:
The active ingredients are: ammonium iron (II) sulfate and folic acid. Each coated tablet contains: 280.87 mg ammonium iron (II) sulfate · 6 H2O, corresponding to 40 mg of divalent iron and 0.50 mg of folic acid. The other ingredients are: sucrose, lactose monohydrate, microcrystalline cellulose, potato starch, glucose syrup, calcium carbonate, talcum, macrogol 35 000, titanium dioxide (E 171), Polyvinyl alcohol, magnesium stearate, gelatin, povidone, iron oxides (E 172), carnauba wax.

Like Folicombin looks and content of the pack:
Shining, yellow-brown, round, arched coated tablet. Folicombin is available in packs with 20, 50 and 100 plated tablets. Not all pack sizes may be placed on the market.

Pharmaceutical entrepreneur and manufacturer:
MIBE GmbH medicine
Munich Straße 15
06796 Brehna
Tel.: 034954 / 247-0
Fax: 034954 / 247-100

This leaflet was last revised in September 2016.

Source: Information of the leaflet
Status: 02/2017