Vitaminum pp 50 mg polfarmex

Package leaflet: information for the user

VITAMINUM PP 50 POLFARMEX, 50 mg, tablets
VITAMINUM PP 200 POLFARMEX, 200 mg, tablets
Nicotinamidum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex is and what it is used for
2. Important information before taking Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex
3. How to take Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex
4. Possible side effects
5. How to store Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex
6. Contents of the pack and other information

1. What Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex is and what it is used for

Vitamin PP belongs to the B-complex group of vitamins. It participates in the transfer of hydrogen and electrons in cellular respiration, glycolysis, and lipid biosynthesis.
Vitamin PP plays an important role in the metabolism of carbohydrates, fats, proteins, purine and pyrimidine bases, and porphyrins, and also participates in the synthesis of high-energy compounds. Together with vitamin C and methionine, it accelerates regeneration of visual purple (rhodopsin). It stimulates liver and pancreatic function, increases gastric juice secretion, enhances intestinal peristalsis, and plays an important role in the metabolism of skin, muscles, and the peripheral and central nervous systems.
After oral administration, vitamin PP is well absorbed from the gastrointestinal tract.
Vitamin PP is excreted in urine, mainly as N-methylated derivatives; only a small amount is excreted unchanged.
Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex is indicated for:

• prevention and treatment of vitamin PP deficiency states.

Due to the frequent coexistence of deficiencies in multiple B-complex vitamins and proteins, it is simultaneously recommended to administer other B-complex vitamins in therapeutic doses and to follow a high-protein diet.

2. Information before using Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex

When not to use Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex:

• if the patient is allergic to vitamin PP or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute liver failure;
• if the patient has active peptic ulcer disease of the stomach and/or duodenum;
• if the patient has gout.

Warnings and precautions
Before starting treatment with Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex,
consult a doctor or pharmacist.
Special caution is advised when using Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex in patients:

• with diabetes;
• who have previously experienced: jaundice, gastrointestinal peptic ulcer disease, or gout.
  With long-term use of high doses, periodic monitoring of liver function, serum uric acid levels, and blood glucose levels in diabetic patients is recommended. Consult a doctor, even if the above warnings refer to conditions from the past.

Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines planned for future use.
Vitamin PP increases the risk of myopathy (muscle damage) when used concomitantly with cholesterol-lowering drugs of the statin group (e.g. simvastatin, pravastatin, and others).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.

Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Vitaminum PP 50 Polfarmex, 50 mg
If symptoms indicate a mild deficiency of vitamin PP, or if the patient's diet is poor in vitamin PP for various reasons, the usual preventive dose is 1 tablet 1 to 2 times daily.
Vitaminum PP 200 Polfarmex, 200 mg
For therapeutic use, depending on the degree of deficiency, 1 tablet 2 to 3 times daily; exceptionally, up to 5 tablets daily in divided doses.
The tablet should be swallowed with water. To avoid or reduce irritation of the gastrointestinal mucosa, take after meals.
The doctor may adjust the dose individually depending on the patient's condition and expected duration of treatment.
Taking more than the recommended dose of Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex
Symptoms of vitamin PP overdose may include headache, tingling, itching of the head, tinnitus, feeling of indigestion, and occasionally jaundice and cardiac rhythm disturbances. Overdose of vitamin PP is associated with the risk of liver damage.
Seek immediate medical advice.
If you miss a dose of Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The medicine is usually well tolerated.
Very rarely (in less than 1 person in 10,000) skin redness, facial flushing, urticaria, or exanthema have been observed.
When high doses of the medicine are used (3 to 6 g per day), the following may occur: headache, dizziness, visual disturbances, nausea, vomiting, diarrhoea, increased blood uric acid or blood glucose levels.
Cases of liver injury have been reported during long-term use or when doses exceeding 3 g/day are used.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: (22) 49 21 301
Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system 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 Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex contains

• The active substance is nicotinamide. Each tablet contains 50 mg or 200 mg of nicotinamide.
• Other ingredients are: maize starch, lactose monohydrate, povidone K-25, magnesium stearate.

What Vitaminum PP 50 Polfarmex / Vitaminum PP 200 Polfarmex looks like and contents of the pack
Pack
The pack contains 20 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: 24 357 44 44