BENERVA 300 мг Энтеросолюбильные таблетки

Содержание инструкции

1. Benerva 100 mg/1 ml injectable solution for intramuscular use
   1. What is Benerva and what is it used for
   2. What you need to know before using Benerva
   3. How to use Benerva
   4. Possible side effects
   5. How to store Benerva
   6. Contents of the pack and other information
2. Benerva 300 mg gastro-resistant tablets
   1. What Benerva is and what it is used for
   2. What you need to know before taking Benerva
   3. How to take Benerva
   4. Possible side effects
   5. How to store Benerva
   6. Contents of the pack and other information

Benerva 100 mg/1 ml injectable solution for intramuscular use

Thiamine hydrochloride (Vitamin B₁)

Read this leaflet carefully before you use this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Benerva is and what it is used for
• 2. What you need to know before you use Benerva
• 3. How to use Benerva
• 4. Possible side effects
• 5. How to store Benerva
• 6. Contents of the pack and other information

1. What is Benerva and what is it used for

Benerva contains the active ingredient thiamine hydrochloride (also known as vitamin B ).
Benerva is indicated:

• in the prevention and treatment of vitamin B deficiency caused by increased demand or reduced absorption
• in cases of inflammation or degeneration of the peripheral nerves, caused by alcohol abuse, which manifests with movement disorders, sensory disturbances and muscle tone (alcoholic deficiency polyneuritis)
• in the treatment of heart diseases caused by alcohol abuse (alcoholic cardiomyopathy)
• at high doses, as supportive therapy in the treatment of nerve inflammation (neuritis and polyneuritis) not caused by vitamin B deficiency.

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Benerva

Do not use Benerva

• if you are allergic to vitamin B or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Benerva.
In particular, tell your doctor if you have previously experienced sensitization or
manifestations due to allergies.
Repeated administration into a muscle increases the risk of allergic reactions; in this
case, your doctor may prefer, where possible, alternative oral therapy.

Other medicines and Benerva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking the following medicines as they may
inhibit the activity of Vitamin B:

• thiosemicarbazone (a medicine used in tuberculosis)
• 5-fluorouracil (a medicine used in the treatment of some cancers).

Laboratory tests and Benerva
The use of Benerva may alter the determination of the values of:

• urobilinogen in urine (test to evaluate liver and biliary function)
• theophylline in blood (medicine for the treatment of asthma) Inform the Analysis Center if you are undergoing a blood or urine test during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
This medicine is not indicated during pregnancy or breastfeeding with breast milk.

Driving and operating machinery
Benerva does not affect the ability to drive vehicles and operate machinery.
However, before driving or operating machinery, make sure you do not have reactions to the
medicine.

Benerva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically
“sodium-free”.

3. How to use Benerva

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose ranges from 50 mg (half a vial) to 200 mg (two vials) per day, as prescribed by your doctor, through intramuscular injection.
The frequency and duration of treatment will be established by the doctor.
Parenteral administration is reserved for cases with altered intestinal absorption, as well as in the initial treatment of acute deficiencies, accompanied by polyneuropathies, psychiatric and cardiac disorders, particularly in chronic alcoholism.

Instructions for the correct opening of the vial

The contents of the vial must notbe mixed with other products or injection liquids.
Discard the vial after opening it, even if the contents have not been completely used.

If you use more Benerva than you should
If you accidentally take high quantities of the medicine, contact your doctor or go to the nearest hospital.

If you forget to use Benerva
Do not take a double dose to make up for a missed dose.

If you stop using Benerva
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with Benerva, contact

immediatelyyour doctor, who will STOPthe treatment:
Not known (the frequency cannot be estimated based on available data):

• Allergic reactions, even severe (anaphylactic reactions) with symptoms such as: o itching o appearance of spots and/or hives on the skin (urticaria) o swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema) o abdominal pain o difficulty breathing o accelerated heartbeat (tachycardia) o increased awareness of heartbeat (palpitations) o shock.

These reactions are often preceded by sneezing or transient itching.
The following side effects have been observed and reported during treatment with Benerva:
Not known (the frequency cannot be estimated based on available data):

• Pain at the injection site

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
contact your doctor. You can also report side effects directly through the
national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Benerva

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C, store in the original package to
protect the medicine from light.
Do not take this medicine after the expiry date which is reported on the package after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Benerva contains

• the active ingredient is thiamine (vitamin B1) 1 ml of solution contains 100 mg of thiamine.
• the other ingredients are: phenol, glycerol, sodiummonobasic phosphate dihydrate, sodiumbicarbonate (see section “Benerva contains sodium”), water for injections

Description of the appearance of Benerva and contents of the pack
Benerva is presented as a colorless or slightly straw-colored solution, packaged in
a carton containing 6 colorless glass vials.

Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
DOPPEL FARMACEUTICI S.R.L
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano (Milano)

Benerva 300 mg gastro-resistant tablets

Thiamine hydrochloride (Vitamin B)

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

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

1. What Benerva is and what it is used for

Benerva contains the active ingredient thiamine hydrochloride (also known as vitamin B ).
Benerva is indicated:

• in the prevention and treatment of vitamin B deficiency caused by increased demand or reduced absorption
• in cases of inflammation or degeneration of the peripheral nerves, caused by alcohol abuse, which manifests with movement disorders, sensory disturbances and muscle tone (alcoholic deficiency polyneuritis)
• in the treatment of heart diseases caused by alcohol abuse (alcoholic cardiomyopathy)
• at high doses, as supportive therapy in the treatment of nerve inflammation (neuritis and polyneuritis) not caused by vitamin B deficiency.

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Benerva

Do not take Benerva

• if you are allergic to vitamin B or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Benerva.
In particular, tell your doctor if you have previously experienced sensitization or
manifestations due to allergies.

Other medicines and Benerva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking the following medicines as they can
inhibit the activity of Vitamin B:

• thiosemicarbazone (a medicine used in tuberculosis)
• 5-fluorouracil (a medicine used in the treatment of some cancers).

Laboratory tests and Benerva
The use of Benerva may alter the determination of the values of:

• urobilinogen in urine (test to assess liver and biliary function)
• theophylline in the blood (medicine for the treatment of asthma) Inform the Analysis Center if you are to undergo a blood or urine test during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you
are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
This medicine is not indicated during pregnancy or breastfeeding with breast milk.

Driving and using machines
Benerva does not affect the ability to drive vehicles and use machinery.
However, before driving or operating machinery, make sure you do not have reactions to the
medicine.

3. How to take Benerva

Take this medicine following exactly as indicated in this leaflet or
by your doctor or pharmacist instructions. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of vitamin B in mild cases is 100 mg once a day.
The recommended dose of Benerva in severe cases is 600-1200 mg (2-4 tablets) per day
for 1-2 weeks, then 300 mg (1 tablet) per day for more weeks.

If you take more Benerva than you should
No cases of overdose of this medicine have been reported.
If you accidentally take high quantities of medicine, contact your doctor
or go to the nearest hospital.

If you forget to take Benerva
Do not take a double dose to make up for a missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with Benerva, contact

immediatelyyour doctor, who will STOPthe treatment:
Not known (frequency cannot be estimated based on available data):

• Allergic reactions, including severe ones (anaphylactic reactions) with symptoms such as: o itching o appearance of spots and/or hives on the skin (urticaria) o swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema) o abdominal pain o difficulty breathing o increased heart rate (tachycardia) o heightened perception of heartbeat (palpitations) o shock.

The following side effects have been observed and reported during treatment with Benerva:
Not known (frequency cannot be estimated based on available data):
o nausea
o vomiting
o diarrhea
o abdominal pain

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
contact your doctor. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Benerva

Keep this medicine out of the sight and reach of children.
Storage Store in the original packaging.
Do not take this medicine after the expiry date which is stated on the pack after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Benerva contains

• the active ingredient is thiamine (vitamin B ). Each tablet contains 300 mg of thiamine.
• the other ingredients are: talc, povidone K90, magnesium stearate, methacrylic acid - ethyl acrylate copolymer (1:1), macrogol 6000, sodium carboxymethylcellulose.

Description of the appearance of Benerva and contents of the pack
Benerva 300 mg is presented as gastro-resistant tablets in blisters of 20 tablets.

Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia

This leaflet tells you