Scorbolamid Extra

Package Leaflet: Information for the Patient

Scorbolamid EXTRA

300 mg + 200 mg + 50 mg + 5 mg, coated tablets
Salicylamide + Ascorbic Acid + Rutoside + Zinc

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 for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, so you can read it again if you need to.
• 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 there is no improvement or if you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Scorbolamid EXTRA and what is it used for

Scorbolamid EXTRA is a multi-component medicine with a combined effect:
Salicylamide - has antipyretic, analgesic, and anti-inflammatory effects.
Ascorbic acid (vitamin C) - supplements vitamin C deficiency, supporting the body's immunity during infections.
Rutoside - stimulates the immune system and supports the body during viral infections. It increases the absorption of vitamin C and also prolongs its action.
Zinc - supplements zinc deficiency, supporting the body's immunity.

Indications for Use

Fever and symptoms associated with colds or flu, headaches, supporting the body's immunity in conditions of increased demand for vitamin C and zinc, and sealing blood vessels.

2. Important Information Before Taking Scorbolamid EXTRA

When Not to Take Scorbolamid EXTRA:

excessive amounts of uric acid in the blood or oxalates in the urine;

• in children and adolescents under 16 years of age (except for rare diseases, such as Kawasaki disease), due to the risk of Reye's syndrome, a rare but serious disease that causes liver and brain damage.

Warnings and Precautions

Before taking Scorbolamid EXTRA, consult a doctor or pharmacist.
Particular caution should be exercised when taking Scorbolamid EXTRA:

• in patients who have had gastric ulcer disease and gastrointestinal bleeding;

Scorbolamid EXTRA and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, especially:

• medicines containing acetylsalicylic acid, non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac);
• corticosteroids, as salicylamide may increase the risk of gastrointestinal side effects;
• oral antidiabetic drugs, anticoagulants, valproic acid, sulfonamides;
• methotrexate at doses less than 15 mg per week;
• digoxin, as salicylamide may increase the effect of this medicine;
• medicines used in gout;
• warfarin and flufenazine, as ascorbic acid may decrease the effectiveness of warfarin and the concentration of flufenazine in the blood;
• tetracycline, products containing copper or iron, as zinc may decrease their absorption. The medicine should be taken at least 2 hours after the administration of these compounds;
• chemotherapeutic antibacterial agents from the quinolone group, including fluoroquinolones, as zinc may decrease their absorption;
• folic acid, calcium and iron compounds, as they may decrease zinc absorption;
• penicillamine and other chelating agents. There should be at least a 2-hour interval between the administration of penicillamine and zinc salts;
• thiazide diuretics, as they increase zinc excretion in the urine.

Scorbolamid EXTRA with Food, Drink, and Alcohol

See section 3.
Alcohol may increase the risk of side effects.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy and breastfeeding.
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and Using Machines

There is no information on contraindications for driving and operating machinery while taking this medicine.

Scorbolamid EXTRA Contains Tartrazine (E 102), Orange Yellow FCF (E 110), and Soy Lecithin (E 322)

The medicine may cause allergic reactions.
Do not take if you are hypersensitive to peanuts or soy.

3. How to Take Scorbolamid EXTRA

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Adults and adolescents over 16 years of age:
Orally, 1 tablet 3 times a day.
The medicine is best taken with food, washed down with a glass of water.
Use the smallest effective dose. Symptomatic treatment without medical advice should be carried out for as short a time as possible.
If symptoms do not improve after 3-5 days of treatment or worsen (even before this time), contact a doctor as soon as possible.

Taking a Higher Dose of Scorbolamid EXTRA Than Recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor immediately.
Salicylamide
After an overdose of salicylamide, central nervous system depression, hypotension, respiratory arrest, metabolic acidosis, or hypoprothrombinemia may occur.
Ascorbic Acid
Symptoms of vitamin C overdose may include gastrointestinal disorders, such as diarrhea, vomiting, heartburn, as well as skin redness, headache, and insomnia. High doses may cause hyperoxaluria and kidney stones. Daily doses of 600 mg may have a diuretic effect.
Rutoside
No cases of rutoside overdose have been reported.
Zinc
Symptoms of zinc overdose include a burning sensation in the mouth and throat, watery or bloody diarrhea, painful defecation, belching, hypotension (dizziness), jaundice (yellowing of the eyes and skin), pulmonary edema (chest pain, difficulty breathing), vomiting. Other symptoms may include: hematuria, anuria, shock, seizures, hemolysis.
In case of acute poisoning, induce vomiting. Then, administer activated charcoal and provide symptomatic treatment, which is based on fluid replacement.

Missing a Dose of Scorbolamid EXTRA

In case of missing a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side Effects Associated with Salicylamide

• The most common side effects are related to the gastrointestinal tract and the central nervous system.
  They may include:
• nausea, vomiting, abdominal cramps, burning sensation behind the breastbone, loss of appetite, diarrhea, irritation of the gastric and duodenal mucosa (ulcers and erosions), dry mouth. No clear relationship has been observed between the use of salicylamide and gastrointestinal bleeding.
• dizziness, drowsiness, headaches;
• flushing, rash, excessive sweating.

This medicine should not be taken by patients who have experienced a rash, angioedema (swelling of the face, tongue, and larynx, which can cause breathing difficulties), bronchospasm, rhinitis, or anaphylactic shock after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs, as there is a risk of these side effects occurring after taking Scorbolamid EXTRA.
Side Effects Associated with Ascorbic Acid

• Ascorbic acid decreases the pH of urine, which facilitates the precipitation of uric acid, cystine, or oxalates;
• Ascorbic acid may interfere with the results of some tests performed using oxidation-reduction methods (e.g., glucose or creatinine measurement in blood and urine, stool test for occult blood).

Side Effects Associated with Zinc

• nausea, vomiting, diarrhea;
• headaches.

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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 this medicine.

5. How to Store Scorbolamid EXTRA

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
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 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 Package and Other Information

What Scorbolamid EXTRA Contains

• The active substances of the medicine are salicylamide, ascorbic acid, rutoside, and zinc. Each coated tablet contains 300 mg of salicylamide, 200 mg of ascorbic acid, 50 mg of rutoside, and 5 mg of zinc in the form of zinc gluconate.
• Other ingredients are: Tablet core - microcrystalline cellulose, crospovidone type B, hydroxypropyl cellulose, talc. Tablet coating I - Opadry White YS-1-7027: hypromellose 2910 (6cP), triacetin, titanium dioxide (E 171); Tablet coating II - sucralose, Opadry Orange 85G33255: polyvinyl alcohol (E 1203), talc, macrogol 3350, titanium dioxide (E 171), orange yellow FCF (E 110), tartrazine (E 102), soy lecithin (E 322).

What Scorbolamid EXTRA Looks Like and Contents of the Package

Round, biconvex, coated tablets, orange in color.
The package contains 10, 20, or 30 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of Last Revision of the Package Leaflet: