Folacid

Package Leaflet: Information for the Patient

Folacid, 5 mg, Tablets

Folic Acid

Folacid, 15 mg, Tablets

Folic Acid

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• Ask Your Doctor or Pharmacist if You Have any Further Questions.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others.
• The Medication may Harm Another Person, even if their Symptoms are the Same.
• If any of the Side Effects get Serious, or if You Notice any Side Effects not Listed in this Leaflet, Please Tell Your Doctor or Pharmacist.

Table of Contents of the Package Leaflet:

• 1. What is Folacid and What is it Used for
• 2. Important Information Before Taking Folacid
• 3. How to Take Folacid
• 4. Possible Side Effects
• 5. How to Store Folacid
• 6. Contents of the Package and Other Information

1. What is Folacid and What is it Used for

Folacid 5 mg and Folacid 15 mg are Available in the Form of Tablets and Contain Folic Acid.
Folic Acid (Pteroylglutamic Acid) is a Vitamin of the B Group. It is Essential for the Proper Functioning and Development of the Body. In the Body, it is Converted into its Active Form - Tetrahydrofolic Acid - through Reduction, which as a Coenzyme of many Enzymatic Reactions Participates in the Synthesis of Pyrimidine and Purine Compounds, Deoxyribonucleic Acid, and in the Metabolism of Amino Acids and Formic Acid.
Folic Acid Plays an Important Role in Tissues where there are Frequent Cell Divisions (Hematopoietic System, Gastrointestinal Tract Epithelium, Fetal Tissues).
Folic Acid is Necessary in the Process of Myelination of Nerve Fibers.
Taking Folic Acid in a Dose of 0.4 mg per Day and Higher Reduces the Risk of Occurrence in Offspring of Congenital Nervous System Defects, such as Spina Bifida and Other Defects of the Central Nervous System Resulting from Disruption of the Process of Neural Tube Formation. Disruption of Neural Tube Closure in the Fetal Period can Lead to so-called Anencephaly and Meningomyelocele.
Folic Acid Deficiency Manifests as Megaloblastic Anemia with Leukopenia and Thrombocytopenia.
The Daily Requirement for Folic Acid in an Adult is about 0.4 mg. It Increases Twice in Pregnant and Breastfeeding Women, as well as in People who Abuse Alcohol.
Higher Doses of Folic Acid (5 mg per Day) are Recommended to be Taken for at Least Three Months Before a Planned Pregnancy in Women who have Given Birth to a Child with a Genetic Defect of the Neural Tube.
Folacid is Used for the Prevention and Treatment of Conditions Resulting from Folic Acid Deficiency, such as Megaloblastic Anemia, Hemolytic Anemia.

2. Important Information Before Taking Folacid

When not to Take Folacid

• If the Patient is Hypersensitive to Folic Acid or any of the other Ingredients of this Medication (Listed in Point 6).

Warnings and Precautions

Before Starting to Take Folacid, Consult a Doctor or Pharmacist.
Particular Caution should be Exercised when Taking Folacid:
In the Treatment of Undiagnosed Megaloblastic Anemia due to the Possibility of Masking the Cause of the Disease;
In Patients with Epilepsy;
In Patients with Brain Tissue Damage;
In Patients with Spinal Cord Damage.

Other Medications and Folacid

Tell Your Doctor or Pharmacist about all Medications You are Currently Taking or have Recently Taken, as well as any Medications You Plan to Take.
Antiepileptic Medications (Phenytoin, Phenobarbital, Primidone), Antituberculosis Medications, Alcohol (Ethanol), Oral Contraceptives, Folic Acid Antagonists (Sulfonamides, Methotrexate, Trimethoprim, Aminopterin, Pyrimethamine, Salazosulfapyridine) may Lead to Folic Acid Deficiency in the Body.
When Taking Folic Acid and Antiepileptic Medications Together, it is Necessary to Monitor their Concentration due to Changes in their Metabolism Rate and the Possibility of Exacerbating Epileptic Symptoms.
Antacids Containing Aluminum or Magnesium Compounds may Reduce Folic Acid Absorption. A 2-hour Interval should be Maintained when Taking these Medications.

Folacid with Food and Drink

The Medication can be Taken Before a Meal, During a Meal, or After Eating.

Pregnancy and Breastfeeding

In Pregnancy and Breastfeeding, or if You Suspect You are Pregnant, or Plan to Become Pregnant, Consult a Doctor or Pharmacist Before Taking this Medication.
Folacid can be Safely Used During Pregnancy.
Folacid can be Safely Used During Breastfeeding. Folic Acid Passes into Breast Milk.

Driving and Operating Machines

Folacid does not Affect the Ability to Drive and Operate Machines.

Folacid Contains Lactose

The Medication Contains Lactose. If You have been Diagnosed with Intolerance to some Sugars, Consult a Doctor Before Taking the Medication.

3. How to Take Folacid

Always Take this Medication Exactly as Described in the Package Leaflet or as Directed by a Doctor or Pharmacist. If You are Uncertain, Consult a Doctor or Pharmacist.
The Recommended Dose is:

Folacid, 5 mg, Tablets

In Megaloblastic Anemia: Adults 5 mg per Day for 4 Months to 15 mg per Day in Malabsorption Disorders.
Women who have Given Birth to a Child with a Genetic Defect of the Neural Tube: 5 mg per Day for at Least Three Months Before a Planned Pregnancy.

Folacid, 15 mg, Tablets

In Megaloblastic Anemia: 15 mg per Day for 4 Months in Malabsorption Disorders.
The Medication should be Taken Orally with a Sufficient Amount of Liquid, e.g., a Glass of Water.

Taking a Higher Dose of Folacid than Recommended

No Serious Symptoms of Folic Acid Overdose have been Observed After Oral Administration. In Case of Overdose, Side Effects (Listed in Point 4) may Occur.

Missing a Dose of Folacid

Continue Taking the Medication as Prescribed.
Do not Take a Double Dose to Make up for a Missed Dose.
If You have any Further Questions about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, this Medication can Cause Side Effects, although not Everybody gets them.
Folic Acid is Generally Well Tolerated. Allergic Reactions (Skin Rash, Redness, Bronchospasm, Fever), Malaise, Gastrointestinal Disorders, Nausea, Vomiting, Sleep Disorders, Depression, Excitement may Occur. If Side Effects Occur, Stop Taking the Medication and Consult a Doctor.
In Some People, other Side Effects may Occur During Treatment with Folacid. If You Experience any Side Effects, including those not Listed in this Leaflet, Consult a Doctor or Pharmacist.

5. How to Store Folacid

Store Below 25°C.
Store in the Original Package to Protect from Light.
Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication After the Expiration Date Stated on the Carton after the Words "Expiration Date".
The Expiration Date is the Last Day of the Specified Month.
Medications should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Folacid Contains

• The Active Substance of the Medication is Folic Acid (Acidum Folicum)
• The Other Excipients are: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Carboxymethylcellulose, Colloidal Silica, Magnesium Stearate, Sodium Lauryl Sulfate.

What Folacid Looks Like and What the Package Contains

Folacid, 5 mg, Tablets, are Round, Biconvex Tablets of Light Yellow Color.
Folacid, 15 mg, Tablets, are Round, Biconvex Tablets of Yellow Color.
The Tablets are Packaged in PVC/PVDC/Aluminum Blisters in a Cardboard Box.
30 Tablets - 1 Blister of 30 Tablets
60 Tablets - 2 Blisters of 30 Tablets
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

SYNTEZA Pharmaceutical and Chemical Company Ltd.
ul. Św. Michała 67/71, 61-005 Poznań
tel. +48 61 879 20 81
fax +48 61 876 51 79
e-mail [email protected]

Date of the Last Update of the Package Leaflet: