Biotinozin

Package Leaflet: Information for the Patient

BiotinoZin, 10 mg + 25 mg Zn, Tablets

Biotin + Zinc Gluconate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

• 1. What is BiotinoZin and what is it used for
• 2. Important information before taking BiotinoZin
• 3. How to take BiotinoZin
• 4. Possible side effects
• 5. How to store BiotinoZin
• 6. Contents of the pack and other information

1. What is BiotinoZin and what is it used for

BiotinoZin contains two active substances: biotin and zinc gluconate.
Biotin (vitamin H) is a water-soluble vitamin belonging to the B group of vitamins.
Biotin supports hair and nail growth and improves skin condition by affecting keratinization and cell differentiation processes.
Zinc is an essential trace element involved in cellular metabolism. It ensures proper skin and mucous membrane function and limits hair loss. Its deficiency causes dry hair, and in case of significant deficiency, hair may fall out and break. Zinc has a beneficial effect on wound healing and tissue regeneration.
BiotinoZin is indicated for the treatment of biotin and zinc deficiencies with symptoms such as: hair loss, hair and nail growth disorders and their excessive fragility, skin inflammation localized around the eyes, nose, mouth, and ears, and for the prevention of deficiency consequences, but only after excluding other causes by a doctor.
If after 4 weeks there is no improvement or you feel worse, consult a doctor.

2. Important information before taking BiotinoZin

When not to take BiotinoZin

• if you are allergic to biotin and/or zinc or any of the other ingredients of this medicine (listed in section 6);
• with nutritional supplements containing multiple vitamins and minerals, including biotin and zinc, due to the risk of overdose.

Warnings and precautions

Before starting to take BiotinoZin, discuss it with your doctor or pharmacist.
In case of need for long-term use of the medicine, diagnostic laboratory tests should be performed to monitor copper levels in the blood.
Do not take other products containing biotin and/or zinc at the same time.
Effect on laboratory tests
BiotinoZin contains 10 mg of biotin in one tablet. If you are to undergo laboratory tests, you must inform your doctor or laboratory personnel that you have recently taken or are taking BiotinoZin, as biotin may interfere with the results of such tests. Depending on the type of test, the results may be falsely elevated or falsely low due to biotin. Your doctor may recommend stopping the use of BiotinoZin before undergoing laboratory tests.
Also, remember that other products you may be taking, such as multivitamin preparations or dietary supplements for hair, skin, and nail improvement, may also contain biotin and/or zinc and thus affect laboratory test results. If you are taking such products, tell your doctor or laboratory personnel.
It is recommended to stop taking the medicine for 3 days before a planned test, unless the laboratory provides other recommendations in this regard.

Children and adolescents

BiotinoZin is not intended for use in children and adolescents under 18 years of age.

BiotinoZin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Antiepileptic drugs (phenytoin, carbamazepine, phenobarbital, primidone), as they can reduce biotin levels in the blood.
• Steroid hormones may accelerate biotin breakdown in tissues.
• Valproic acid reduces the activity of enzymes metabolizing biotin.
• Antibiotics may reduce biotin levels or activity by disrupting gut microflora.
• Thiazide diuretics increase zinc excretion in the urine.
• Folic acid (vitamin B) may slightly interfere with zinc absorption.
• Avidin, a basic glycoprotein found in egg white, has the ability to bind to biotin, inactivating it and preventing its absorption. In case of biotin deficiency or use of its preparations, do not consume raw egg white.

Keep at least a 2-hour interval between taking BiotinoZin and the following medicines:

• antibiotics from the tetracycline and quinolone groups (e.g., norfloxacin, ciprofloxacin) and fluoroquinolones (e.g., ofloxacin), as zinc reduces their absorption from the gastrointestinal tract;
• oral copper, iron, and calcium preparations, as high doses of zinc may reduce copper and iron absorption, while iron, copper, and calcium salts may reduce zinc absorption;
• chelating agents (used to remove heavy metals from the body), such as:
• D-penicillamine, dimercaptopropanesulfonic acid (DMPS), dimercaptosuccinic acid (DMSA), or ethylenediaminetetraacetic acid (EDTA), as they may worsen zinc absorption or increase its excretion from the body.

BiotinoZin and smoking

Smoking accelerates biotin breakdown in women, which may lead to its deficiency and reduced treatment efficacy.

Using BiotinoZin with food, drinks, and alcohol

The medicine is usually taken about 2 hours before or 2 hours after a meal, as many food products listed below may interfere with biotin and zinc absorption.
A high-fiber diet (e.g., bran), high-phosphorus diet (e.g., dairy products), and foods with high phytate content (e.g., whole grain bread, grain products, some vegetables, nuts) reduce zinc absorption. There is evidence that coffee also reduces zinc bioavailability.
Raw egg white inhibits biotin absorption, so do not consume raw egg white while taking BiotinoZin.
Alcohol causes a decrease in biotin levels in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The amount of biotin in the medicine far exceeds the recommended daily intake for pregnant women. BiotinoZin should not be taken during pregnancy.
Breastfeeding
The amount of biotin in the medicine far exceeds the recommended daily intake for breastfeeding women. Biotin passes into breast milk, but it has not been shown to affect the breastfed baby. BiotinoZin should not be taken during breastfeeding.
Fertility
There is no data on the effect of the medicine on fertility.

Driving and using machines

BiotinoZin has no or negligible influence on the ability to drive and use machines.

BiotinoZin contains lactose monohydrate and sodium

Lactose monohydrate
The medicine contains 97.99 mg of lactose monohydrate in one tablet.
If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
Sodium
The medicine contains 1.52 mg of sodium in one tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take BiotinoZin

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
BiotinoZin should be taken orally, with water. The medicine is usually taken about 2 hours before or 2 hours after a meal.

Adults:

The recommended dose is 5 mg of biotin and 12.5 mg of zinc ions per day, which corresponds to half a tablet.
The tablet can be divided into equal doses.
In case of severe symptoms, the recommended dose is 10 mg of biotin and 25 mg of zinc ions per day (1 tablet) for 4 weeks. Then, the dose should be reduced to 5 mg of biotin and 12.5 mg of zinc ions.
The duration of treatment depends on the patient's condition and the course of the disease. Improvement of symptoms has been observed after about 4 weeks of taking the medicine.
BiotinoZin should not be taken for more than 4 weeks without consulting a doctor.
If a doctor decides to start treatment, they may recommend a different dosage regimen for the medicine.
Note: the medicine should be taken regularly.

Use in children and adolescents

BiotinoZin is not intended for use in children and adolescents under 18 years of age.

Overdose of BiotinoZin

In case of overdose, consult a doctor or pharmacist.
Symptoms related to overdose of BiotinoZin:
gastrointestinal disorders (abdominal pain, nausea, vomiting), metallic taste in the mouth, drowsiness, headache, anemia (reduced red blood cell count), and dizziness.

Missed dose of BiotinoZin

If you miss a dose, take the medicine as soon as possible.
If it is almost time for the next dose, skip the missed dose and continue taking the medicine as usual.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, BiotinoZin can cause side effects, although not everybody gets them.

After taking BiotinoZin, the following side effects may occur:

Very rare(occurring in less than 1 in 10,000 people):

• hives, allergic reactions;
• gastrointestinal disorders (abdominal pain, nausea, indigestion, diarrhea). These symptoms may occur at the beginning of treatment, especially if zinc is taken on an empty stomach. After stopping the medicine, the symptoms disappear quickly.

Frequency not known(cannot be estimated from the available data):

• headache;
• rash;
• metallic taste in the mouth.

Long-term use of zinc in high doses may lead to copper deficiency and related hematological disorders, such as:

• leukopenia (fever, chills, sore throat);
• neutropenia (mouth and throat ulcers);
• sideroblastic anemia (feeling tired, weakness).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store BiotinoZin

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage. Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What BiotinoZin contains

• The active substances of the medicine are biotin and zinc in the form of zinc gluconate. Each tablet contains 10 mg of biotin and 25 mg of zinc ions in the form of zinc gluconate.
• The other ingredients are: crospovidone (type A), microcrystalline cellulose, povidone K30, lactose monohydrate, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

What BiotinoZin looks like and contents of the pack

BiotinoZin is a white or almost white, oval, biconvex tablet with a length of 13.7 mm and a width of 6.9 mm, with a single break line on one side.
The tablet can be divided into equal doses.
BiotinoZin is available in PVC/PVDC/Aluminum blisters.
The pack is a cardboard box containing 15 or 30 tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Szkolna 31
95-054 Ksawerów

Date of last revision of the package leaflet: