Yofolvit 200/400/2 micrograms tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Yofolvit 200/400/2 micrograms tablets
iodine/folic acid/vitamin B12
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Yofolvit is and what it is used for
- What you need to know before taking Yofolvit
- How to take Yofolvit
- Possible adverse effects
- How to store Yofolvit
- Contents of the pack and other information
1. What Yofolvit is and what it is used for
Yofolvit is indicated for the prevention of disorders due to iodine deficiency (IDD), folic acid, and vitamin B12 in pregnant women during the first trimester of pregnancy and during the month preceding conception, as a preventive measure against abnormalities in fetal central nervous system development (neural tube defects and neurological disorders).
2. What you need to know before taking Yofolvit
Do not take Yofolvit
- If you are allergic to potassium iodide, folic acid, vitamin B12, or any of the other ingredients of this medicine (listed in section 6).
Especially related to potassium iodide:
- If you have acute bronchitis.
- If you have manifest (symptomatic) hyperthyroidism (increased thyroid function).
- If you have latent (asymptomatic) hyperthyroidism (increased thyroid function), you should not take an iodine dose exceeding 150 micrograms per day.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Yofolvit.
- Treatment with Yofolvit in patients with epilepsy should be carried out under strict medical supervision.
- This medicine contains potassium iodide. Some individuals are particularly sensitive to iodine, so treatment should be initiated with caution.
- Due to its potassium iodide content, this medicine may affect the thyroid gland. Its administration may interfere with laboratory tests assessing thyroid function.
- Disinfectants containing iodine should not be used for disinfection of the newborn or the pregnant mother.
If you suffer from any of the following conditions, remember to inform your doctor before taking this medicine:
- Hypocomplementemic vasculitis (inflammation of blood vessels), goiter (enlargement of the thyroid gland), or autoimmune thyroid disease (enlargement of the thyroid gland), as patients with these conditions may experience adverse effects following iodine administration.
- Patients with renal disease, hyperkalemia (high blood potassium levels), goiter, or active tuberculosis should exercise special caution when starting treatment.
Other medicines and Yofolvit
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Yofolvit; in such cases, it may be necessary to adjust the dose, interrupt treatment with one of the medicines, or wait at least 3 hours between administrations.
It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:
- Antiulcer agents (medicines for gastric acidity)
- Chloramphenicol (an antibiotic)
- Phenytoin (a medicine for seizures)
- Folic acid antagonists (methotrexate)
- Fluorouracil (a medicine for cancer)
- Potassium-sparing diuretics
- Lithium salts
- Antithyroid drugs (for treatment of hyperthyroidism)
- Other possible interactions: antiepileptic drugs, estrogens, prolonged use of corticosteroids, trimethoprim/sulfamethoxazole combination (treatment for certain infections), and alcohol abuse.
Interference with diagnostic tests
This medicine, due to its potassium iodide content, may affect the thyroid gland. Its administration may interfere with laboratory tests assessing thyroid function.
Inform your doctor that you are taking this medicine if you need to undergo blood or urine tests.
Taking Yofolvit with food and drink
No interactions between Yofolvit and food or drink are known.
Pregnancy and breastfeeding
Yofolvit is indicated for the prevention of deficiencies of iodine, folic acid, and vitamin B12 before and during pregnancy, as it contains these three active ingredients at the doses recommended for pregnancy. Administration of potassium iodide, folic acid, and vitamin B12 to pregnant women at doses exceeding the recommended daily doses should be performed under medical supervision, with careful assessment of the benefit-risk balance.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Yofolvit contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take Yofolvit
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The usual dose is 1 tablet per day, preferably before meals.
If you take more Yofolvit than you should
If you have taken more Yofolvit than you should, or in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20.
Deliberate or accidental poisoning with this medicine is unlikely.
Taking doses much higher than those indicated in this leaflet or for prolonged periods may cause a metallic taste, burning sensation in mouth and throat, painful sensitivity in teeth and gums, increased salivation, nasal mucosa irritation, sneezing, and eye irritation with eyelid swelling (symptoms known as "iodism").
Severe headache, cough, pulmonary edema (fluid accumulation in the lungs), and swelling and discomfort of the parotid and submandibular glands (glands located below the lower jaw) may also occur.
In oily skin areas (seborrheic areas), moderate rashes may appear, and rarely severe rashes.
Gastrointestinal irritation is common whenever very high doses are ingested and may result in diarrhea, sometimes with blood in the stools.
Signs and symptoms of iodism usually disappear spontaneously within a few days after stopping treatment.
The use of large doses of potassium iodide or for prolonged periods may cause thyroid gland hyperplasia (enlargement), goiter, and severe hypothyroidism (reduced thyroid function).
If you forget to take Yofolvit
Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals (24 hours apart).
If you stop taking Yofolvit
Your doctor will advise you on the duration of treatment. Do not stop treatment prematurely, as it will not have the expected efficacy.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed, classified by organ systems and frequencies. The adverse reactions observed after treatment with Yofolvit are considered uncommon (may affect up to 1 in 100 people); frequency not known (cannot be estimated from available data).
Blood and lymphatic system disorders:
Thrombotic thrombocytopenic purpura (a blood disorder characterized by low platelet and red blood cell counts).
Endocrine disorders:
Goiter.
Hyper- and hypothyroidism (abnormal thyroid function).
Gastrointestinal disorders:
Transient diarrhea, nausea, vomiting, abdominal bloating/pain, flatulence (gas), metallic taste, and increased salivation.
Skin and subcutaneous tissue disorders:
Itching, skin rashes, erythema (inflammatory redness of the skin), urticaria (rash with hives and itching), and angioedema (development of large swellings, especially around the eyes, lips, and throat).
Vascular disorders:
Vasculitis (drug hypersensitivity leading to inflammation and damage of blood vessels in the skin).
Fatal periarteritis (a vascular disease in which small and medium-sized arteries become inflamed and damaged).
Immune system disorders:
Edema (swelling), including facial and glottal edema.
Frequency not known: severe allergic reaction (anaphylactic reaction).
General disorders and administration site conditions:
Hypersensitivity reactions (allergies) and general malaise.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Yofolvit Storage
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Yofolvit
The active substances are potassium iodide, folic acid, and vitamin B12 (cyanocobalamin). Each tablet contains 262 micrograms of potassium iodide (equivalent to 200 micrograms of iodine), 400 micrograms of folic acid (as folic acid hydrate), and 2 micrograms of vitamin B12.
The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), calcium stearate, trisodium citrate, citric acid, and maltodextrins.
Appearance of the medicine and contents of the pack
Yofolvit is presented as yellow, round tablets for oral administration, in packs of 28 tablets.
The tablets are arranged according to a calendar showing the days of the week to facilitate correct administration.
Marketing Authorization Holder
Laboratorios Farmacéuticos Logogen, S.A.
C/ San Rafael 3
28108 Alcobendas, Madrid
Spain
Tel.: 91 657 23 23
Manufacturer
ITALFARMACO S.p.A.
Viale Fulvio Testi 330
20126 Milan
Italy
Further information on this medicine can be obtained by contacting the local representative of the Marketing Authorization Holder:
Italfarmaco, S.A.
C/ San Rafael 3
28108 Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: April 2018
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.