PROFER 80 MG ORAL SOLUTION GRANULES
How to use PROFER 80 MG ORAL SOLUTION GRANULES
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
- Introduction
- What Profer 80 mg granules for oral solution is and what it is used for
- What you need to know before taking Profer 80 mg granules for oral solution
- How to take Profer 80 mg granules for oral solution
- Possible side effects
- Storage of Profer 80 mg granules for oral solution
- Contents of the pack and further information
Introduction
Package Leaflet: Information for the User
PROFER 80 mg Granules for Oral Solution
ferrimanitol ovoalbúmina
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the pack:
- What Profer 80 mg granules for oral solution is and what it is used for
- What you need to know before you take Profer 80 mg granules for oral solution
- How to take Profer 80 mg granules for oral solution
- Possible side effects
- Storage of Profer 80 mg granules for oral solution
- Contents of the pack and further information
1. What Profer 80 mg granules for oral solution is and what it is used for
Profer contains the active substance ferrimanitol ovoalbúmina, and belongs to a group of medicines called oral iron preparations. It is used in adult patients for the treatment of iron deficiency anaemia and iron deficiency conditions. This medicine normalizes the altered hematological parameters in iron deficiency conditions.
2. What you need to know before taking Profer 80 mg granules for oral solution
Do not take Profer 80 mg
- If you are allergic to ferrimanitol ovoalbúmina or any of the other ingredients of this medicine (listed in section 6). Do not take this medicine if you are allergic to egg or egg proteins.
- If you have haemosiderosis and hemochromatosis (iron overload diseases).
- If you have anaemias not related to iron deficiency, such as aplastic anaemia, haemolytic anaemia and sideroblastic anaemia.
- If you have chronic pancreatitis or liver cirrhosis.
Warnings and precautions:
Consult your doctor or pharmacist before starting to use Profer 80 mg
- if you have or have had stomach or duodenal ulcers, inflammatory bowel disease, ulcerative colitis or liver failure.
- if you are taking or are about to take any anti-acid medicine, tetracyclines, quinolones, calcium salts or levodopa.
Other medicines and Profer 80 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Profer 80 mg must not be administered together with:
- Tetracyclines or penicillamine, as they may decrease each other's oral absorption.
- Calcium salts, quinolones (ciprofloxacin, etc.) and levodopa, as iron preparations may decrease the absorption of these medicines.
- Anti-acids, as they may decrease the absorption of iron preparations.
The intake of any of these medicines should be spaced at least 2 hours apart from the administration of Profer 80 mg.
Taking Profer 80 mg with food and drinks
Profer 80 mg should not be administered together with milk or dairy products.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
In case of pregnancy or breast-feeding, your doctor will decide whether to use this medicine.
Pregnancy
No problems have been detected in studies with ferrimanitol ovoalbúmina in pregnant women.
Breast-feeding
No data are available on the excretion of ferrimanitol ovoalbúmina in breast milk.
Driving and using machines
No signs of impaired ability to drive or operate machinery have been reported.
Profer 80 mg contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
Profer 80 mg contains sucrose
This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
It may cause tooth decay.
Profer 80 mg contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per dose, which is essentially "sodium-free"
3. How to take Profer 80 mg granules for oral solution
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is 1 sachet daily after the main meal. Pour the contents of the sachet into 200 ml of water and shake until a uniform solution is obtained. The solution should be taken immediately.
If you think that the action of Profer 80 mg is too strong or too weak, tell your doctor or pharmacist.
If you take more Profer 80 mg than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Profer 80 mg
In case you have forgotten a dose, take another one as soon as possible and continue with the usual schedule. Do not take a double dose to make up for forgotten doses.
If you stop taking Profer 80 mg
Your doctor will indicate the duration of treatment with Profer 80 mg. Do not stop treatment before, even if you feel better, as there is a risk of relapse of the disease.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Profer 80 mg can cause side effects, although not everybody gets them.
Occasionally, gastrointestinal disorders (stomach pain, nausea, constipation or diarrhoea) have been reported, which usually disappear when the dose is reduced or, if necessary, after treatment is stopped. Black pigmentation of stools.
Reporting of side effects:
If you experience any of the side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Profer 80 mg granules for oral solution
Keep out of the sight and reach of children.
No special storage conditions are required.
Do not use Profer 80 mg after the expiry date stated on the carton and sachet after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. In the pharmacy, there is a SIGRE collection point 
where you can dispose of the packaging and any unused medicines. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
6. Contents of the pack and further information
Composition of Profer 80 mg granules for oral solution
The active substance is ferrimanitol ovoalbúmina. Each sachet contains approximately 600 mg of ferrimanitol ovoalbúmina (equivalent to 80 mg of Fe3+).
The other ingredients (excipients) are: banana flavour, ethyl vanillin, lactose, sodium chloride and sucrose.
Appearance and pack contents
Profer 80 mg granules are presented in sachet form. Each pack contains 15 or 30 sachets.
Marketing authorisation holder and manufacturer
Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares, Madrid (Spain)
Date of last revision of this leaflet: October 2020
Other sources of information
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es
- Country of registration
- Average pharmacy price14.05 EUR
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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