Neurovit Fast

Leaflet included in the packaging: patient information

Neurovit Fast, (100 mg + 100 mg + 1 mg)/2 ml, solution for injection

Thiamine hydrochloride (vitamin B), pyridoxine hydrochloride (vitamin B), cyanocobalamin
(vitamin B).
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific purpose. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Neurovit Fast and what is it used for
• 2. Important information before using Neurovit Fast
• 3. How to use Neurovit Fast
• 4. Possible undesirable effects
• 5. How to store Neurovit Fast
• 6. Contents of the packaging and other information

1. What is Neurovit Fast and what is it used for

Neurovit Fast contains a mixture of vitamins B, B, and B, which play important roles in maintaining
proper nerve metabolism. Like other vitamins, they are essential components of nutrition that the body cannot produce on its own.
In the treatment of nervous system disorders, B vitamins work by supplementing vitamin B deficiencies in the body and stimulating natural processes in nerve cells.
Neurovit Fast is used in the following cases:

• treatment of clinical (visible) and subclinical (hidden) vitamin B deficiencies;
• supportive treatment in nervous system disorders of various origins (e.g., pain associated with nerve damage caused by diabetes or alcohol abuse), supportive treatment in neuritis and neuralgia (e.g., nerve irritation due to degenerative spinal diseases, lower back pain or sciatica).
• 2.

Important information before using Neurovit Fast

When not to use Neurovit Fast

• in case of allergy to thiamine hydrochloride (vitamin B), pyridoxine hydrochloride (vitamin B), cyanocobalamin (vitamin B), or any of the other ingredients of the medicine (listed in section 6);
• in children and adolescents under 18 years of age, due to the high content of vitamins.

Warnings and precautions

Before starting to use Neurovit Fast, you should discuss it with your doctor.
In case of taking high doses of vitamin B (over 50 mg per day) for a long period (from 6 to 12 months) or doses exceeding 1 g of vitamin B per day for a shorter period (over 2 months), numbness or tingling of the hands or feet (symptoms of peripheral neuropathy or paresthesia) may occur. If the patient experiences numbness or tingling, or any other undesirable effects, they should contact their doctor, who may change the dosage or decide to discontinue treatment.
Only a clear solution with a red color can be used for injections.

Children and adolescents

Due to the high content of active substances, Neurovit Fast, solution for injection, must not be used in children and adolescents under 18 years of age.

Neurovit Fast and other medicines

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

• Cytostatic 5-fluorouracil (a medicine used in cancer) inhibits the action of vitamin B.
• Long-term use of diuretics may cause a deficiency of vitamin B, as large amounts of it are excreted in the urine.
• Neurovit Fast may reduce the effect of L-dopa (a medicine used in Parkinson's disease).
• If medicines that act on vitamin B (so-called pyridoxine antagonists, such as isoniazid (INH), hydralazine, D-penicillamine, or cycloserine) are used together with Neurovit Fast, the need for vitamin B may increase.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
As a rule, Neurovit Fast should not be used during pregnancy or breastfeeding.
Daily vitamin requirements during pregnancy and breastfeeding should be met by a balanced diet. Due to the high content of vitamins, this medicine is intended only for the treatment of vitamin deficiencies and should be used only after careful consideration of the benefit-to-risk ratio.
Vitamins B, B, and B pass into breast milk. High doses of vitamin B reduce milk production.
Your doctor will decide whether Neurovit Fast can be used in exceptional cases during pregnancy or lactation.

3. How to use Neurovit Fast

This medicine should always be used exactly as prescribed by your doctor. In case of doubts, you should consult your doctor or pharmacist.

Recommended dosage

• In severe and painful cases: 1 injection per day until symptoms subside.
• In less severe conditions: 1 injection 2 to 3 times a week.

Method of administration

Neurovit Fast, solution for injection, should be injected deeply into the gluteal muscle by trained medical personnel. Injections into the veins should be avoided.

Duration of treatment

Neurovit Fast should not be used for longer than necessary. Your doctor will decide on the duration of treatment. After a period of use not exceeding 4 weeks (injections and oral administration combined), your doctor should decide on a dose reduction.

Use in children and adolescents

Neurovit Fast should not be used in children and adolescents under 18 years of age.

Use in the elderly and in patients with renal or hepatic impairment

No dose adjustment is necessary.

Overdose of Neurovit Fast Vitamin B

Thiamine has a wide therapeutic range. Very high doses (over 10 g) have a nerve-blocking effect and, like curare, suppress nerve impulse conduction.
Vitamin B
Taking more than 50 mg per day of vitamin B for a period longer than 6-12 months or for a shorter period (over 2 months) at doses exceeding 1 g per day may lead to nerve damage (neurotoxic effect). Taking a dose of more than 2 g per day has caused nerve damage, manifested by movement disorders, sensitivity disorders (tingling, numbness), seizures, and very rarely changes in blood tests and inflammatory skin reactions.
Vitamin B
In rare cases, allergic reactions, skin rashes, and a mild form of angioedema have been observed after administration of high doses of vitamin B.
You should consult your doctor if you suspect an overdose.
Information for doctors:
Treatment of overdose is symptomatic.
In case of doubts related to the use of the medicine, you should consult your doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Neurovit Fast can cause undesirable effects, although not everybody gets them.
Rarely(affecting 1 to 10 in 10,000 patients)

• Gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain.
• Headache, dizziness. Very rarely(affecting less than 1 in 10,000 patients)
• Hypersensitivity reactions such as sweating, rapid heartbeat, and skin reactions such as flushing and urticaria.
• There have been reports of allergic reactions, mainly after intravenous administration, but also after intramuscular administration of vitamin B and vitamin B. Frequency not known(cannot be estimated from the available data)
• Prolonged administration (over 6-12 months) of vitamin B at a daily dose exceeding 50 mg may cause peripheral neuropathy (nerve damage causing tingling and burning sensations).
• Local reactions and rarely inflammation at the injection site may occur.

Reporting undesirable effects

If you experience any undesirable effects, including any undesirable effects not mentioned in the leaflet, you should inform your doctor or pharmacist or nurse. Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
By reporting undesirable effects, you can help provide more information on the safety of the medicine.

5. How to store Neurovit Fast

Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect from light.
Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Neurovit Fast contains

Active substances:
thiamine hydrochloride (vitamin B), pyridoxine hydrochloride (vitamin B), cyanocobalamin (vitamin B).
1 ampoule (2 ml) contains:
thiamine hydrochloride (vitamin B)
100 mg
pyridoxine hydrochloride (vitamin B)
100 mg
cyanocobalamin (vitamin B)
1 mg
Excipients are:
water for injections, sodium hydroxide for pH adjustment, hydrochloric acid for pH adjustment

What Neurovit Fast looks like and contents of the pack

Clear red solution
pH 3.2-3.8
5 ampoules of 2 ml

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: