FERRO-FOLGAMMA NEO 114mg/0.8 mg x 100 tabl
FERO-FOlgamma NEO tablets * 100
Leaflet: Information for the user
Ferro-Folgamma Neo 114 mg/0.8 mg gastro-resistant tablets
Ferro-Folgamma Neo 114 mg/0.8 mg gastro-resistant tablets
Ferrosulphate / folic acid
(Ferrous sulphate / Folic acid)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 20 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What Ferro-Folgamma Neo is and what it is used for
2. What you need to know before you take Ferro-Folgamma Neo
3. How to take Ferro-Folgamma Neo
4. Possible side effects
5. How to store Ferro-Folgamma Neo
6. Contents of the package and additional information
1. What Ferro-Folgamma Neo is and what it is used for
Ferro-Folgamma Neo is recommended for the treatment of anemia caused by a simultaneous deficiency of iron and folic acid, as well as for the prevention of such deficiency during pregnancy.
2. What you need to know before you take Ferro-Folgamma Neo
Do not take Ferro-Folgamma Neo:
if you are allergic to ferrous sulfate or folic acid, or to any of the other ingredients of this medicine (listed in section 6);
if you have anemia that is the result of vitamin B12 deficiency, as it requires other treatment;
if you know that you suffer from other diseases, such as obstruction of the small intestine or intestinal inflammation (diverticulitis), congenital problems with iron storage (hemochromatosis, hemosiderosis);
" if you have had a blood transfusion, an injection containing iron or have taken a medicine containing iron;
if you are being treated for heavy metal poisoning.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ferro-Folgamma Neo.
Children and adolescents
The use of this medicinal product is not recommended for children under 12 years of age.
Pay special attention when using Ferro-Folgamma Neo
If you are taking the following medicines: antibiotics, such as tetracyclines, quinolones, penicillamine (for heavy metal poisoning, arthritis); drugs in the treatment of dyspepsia; zinc products; trientine (in Wilson's disease); as Ferro-Folgamma Neo can significantly reduce their effects. More information can be found in "Taking other medicines".
Other drugs and Ferro-Folgamma Neo
Do not take Ferro-Folgamma Neo if you have had an injection containing iron or have taken a medicine containing iron. Do not take Ferro-Folgamma Neo if you are being treated for heavy metal poisoning.
Observe the following instructions, otherwise the mentioned medicines will not work for you:
Type of drug. Taking the drug in relation to the use of Ferro-Folgamma Neo
Tetracycline antibiotics 2 hours before or 3 hours after
Quinolone antibiotics;
penicillamines
2 hours before or 2 hours after
Antacids; calcium products; oxalates; phosphates 1 hour before or 2 hours after
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ferro-Folgamma Neo with food and drink
Ferro-Folgamma Neo should be administered 1 hour before or 2 hours after taking the following foods and drinks: tea, coffee, eggs, milk and dairy products, black bread and cereals, dietary fiber. Otherwise, it will not have the expected effect.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.
Pregnancy
Ferro-Folgamma Neo is recommended as an iron and folic acid supplement for pregnant women and for the prevention of anemia caused by iron and folic acid deficiency during pregnancy.
Breastfeeding
Folic acid passes into breast milk, so you should consult your doctor.
Driving and using machines
It does not affect the ability to drive and operate machinery.
Important information about some of the ingredients of Ferro-Folgamma Neo
Ferro-Folgamma Neo contains 28 mg of milk sugar (lactose). In case you are sensitive to milk sugar (lactose intolerance), this should be taken into account.
3. How to take Ferro-Folgamma Neo
Always take this medicine exactly as described in the leaflet or as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
If your doctor has not prescribed otherwise, the usual dose is 3 x 1 or 2 tablets daily. Tablets should be taken before meals, whole, without chewing.
If you have taken more than the required dose of Ferro-Folgamma Neo
If you have accidentally taken more than your daily dose of Ferro-Folgamma Neo, seek medical advice immediately. If a child accidentally swallows this medicine, please consult a doctor urgently.
If you forget to take Ferro-Folgamma Neo
Do not take a double dose to make up for a missed dose, as you will be at risk of an overdose.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders
Very common (may affect more than 1 in 10 patients):
During treatment with Ferro-Folgamma Neo, stools may darken. This is not important unless you have had a stool test for occult bleeding. In this case, please inform your doctor that you are taking Ferro-Folgamma Neo, as this may affect the test results.
Common (may affect up to 1 in 10 people):
Ferro-Folgamma Neo can cause gastrointestinal disturbances such as lack of appetite, feeling full, gastrointestinal irritation, heartburn, belching, nausea, vomiting, abdominal pain or discomfort, diarrhea and constipation.
Disorders of the nervous system
Uncommon (may affect up to 1 in 100 patients):
Ferro-Folgamma Neo may cause sleep disturbances, anxiety or depression.
Disorders of the skin and subcutaneous tissue
Uncommon (may affect up to 1 in 100 patients):
Ferro-Folgamma Neo can cause allergic skin reactions, such as reversible skin rashes, roughening of the skin in which the skin is less elastic, changes color and scales (lichenification), reddening of the skin (erythema), itching (pruritus) .
Rare (may affect up to 1 in 1,000 patients):
Ferro-Folgamma Neo may cause photosensitivity with a skin rash.
Respiratory, thoracic, and mediastinal disorders
Very rare (may affect up to 1 in 10,000 patients):
Ferro-Folgamma Neo can cause narrowing of the airways (bronchospasm).
In this case, it is necessary to seek emergency medical help.
Disorders of the immune system
Very rare (may affect up to 1 in 10,000 patients):
anaphylactic shock.
Not known (frequency cannot be estimated from the available data):
severe allergic reaction (anaphylactic reaction).
In this case, it is necessary to seek emergency medical help.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Bulgaria,
Medicines Executive Agency,
8 Damyan Gruev Street,
1303 Sofia,
Phone: +35 928903417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Ferro-Folgamma Neo
This medicinal product does not require special storage conditions. Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date corresponds to the last day of the month indicated.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Ferro-Folgamma Neo contains
The active substances are: 114 mg (= 37 mg Fe) ferrous sulfate, dried and 0.8 mg folic acid.
The other ingredients are: ascorbic acid, corn starch, maltodextrin, sodium starch glycolate (type A), calcium stearate, lactose monohydrate 2.8 mg/tablet, cellulose, sodium lauryl sulfate, silicon dioxide, anhydrous, sucrose, talc, titanium dioxide, calcium carbonate, magnesium stearate, hypromellose (viscosity type 6cP and 5cP), macrogol (4000, 6000), methacrylic acid-ethylacrylate copolymer (1:1), simethicone emulsion, triethyl citrate, propylene glycol, sicovit red (E 172), sicovit brown ( E172).
What Ferro-Folgamma Neo looks like and contents of the pack
Round, biconvex, red-brown gastro-resistant tablets. Gastro-resistant tablets packed in transparent PVC/PE/PVdC/Al/paper blister packs of 20, 50 and 100 tablets.
Not all pack sizes may be available for sale.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Worwag Pharma GmbH & Co., Germany.
Manufacturer:
Lomapharm, Germany.
Date of last revision of leaflet: 05/2018
