Scorbolamid

Package Leaflet: Information for the Patient

Scorbolamid, 300 mg + 100 mg + 5 mg, Effervescent Tablets

Salicylamidum + Acidum ascorbicum + Rutosidum

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.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Scorbolamid and what is it used for

Scorbolamid is a multi-component medicine with a combined effect:
Salicylamid - 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 effect.
The indications for use of the medicine are: fever and pain associated with colds or flu, headaches, neuralgia.

2. Important information before taking Scorbolamid

When not to take Scorbolamid

• if the patient is allergic to salicylamid, ascorbic acid, rutoside, nonsteroidal anti-inflammatory drugs, or any other component of this medicine (listed in section 6);
• if the patient has asthma with nasal polyps;
• if the patient has active gastric or duodenal ulcer disease and/or inflammatory conditions of the gastrointestinal tract;
• if the patient has acid-base balance disorders (diabetes, uremia, tetany);
• if the patient has blood coagulation disorders (e.g., hemophilia, thrombocytopenia);
• if the patient has a genetically determined deficiency of glucose-6-phosphate dehydrogenase;
• if the patient has kidney stones;
• if the patient has hemochromatosis (bronze diabetes), sideroblastic anemia, excessive uric acid in the blood, or oxalates in the urine;
• if the patient is pregnant;
• if the patient is breastfeeding;
• in children 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 starting to take Scorbolamid, the doctor or pharmacist should be consulted.
Particular caution should be exercised when taking Scorbolamid:

• if the patient has bronchial asthma;
• if the patient has liver or kidney failure;
• in patients who have had gastric ulcer disease and gastrointestinal bleeding.

Scorbolamid and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken by the patient, as well as any medicines planned to be taken.
Caution should be exercised when taking Scorbolamid with:

• medicines containing acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac);
• corticosteroids (strong anti-inflammatory medicines), as salicylamid may exacerbate gastrointestinal side effects;
• oral antidiabetic medicines, anticoagulants, methotrexate (a medicine used in cancer treatment), valproic acid (a medicine used in epilepsy treatment), sulfonamides (antibacterial medicines), medicines used in gout treatment; before taking Scorbolamid, a doctor's opinion should be sought;
• ascorbic acid, which may reduce the effectiveness of warfarin (an anticoagulant) and the concentration of flufenazine (a medicine used in schizophrenia treatment) in the blood.

Scorbolamid with food, drink, and alcohol

The medicine is best taken during meals or with a large amount of water or milk.
Alcohol may exacerbate side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
The medicine is contraindicated in pregnant and breastfeeding women.

Driving and using machines

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

Scorbolamid contains sucrose and quinoline yellow (E104)

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
The medicine may cause allergic reactions.

3. How to take Scorbolamid

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Adults and adolescents over 16 years of age:
Orally, usually 1 to 2 effervescent tablets 3 times a day.
The medicine is best taken during meals or with a glass of water or milk.
The smallest effective dose should be used. Symptomatic treatment without medical advice should be carried out for as short a time as possible.
If symptoms persist or worsen, or if new symptoms occur, a doctor should be consulted.

Taking a higher dose of Scorbolamid than recommended

In case of taking a higher dose of Scorbolamid than recommended, a doctor or pharmacist should be consulted immediately.
As a result of overdosing Scorbolamid, transient side effects may occur, which occur during treatment with this medicine (see section 4 "Possible side effects").
After overdosing on salicylamid, central nervous system depression may occur, manifested by drowsiness, slurred speech, hypotension, respiratory arrest, metabolic acidosis (a condition characterized by a decrease in blood pH, manifested by rapid breathing, impaired consciousness), or hypoprothrombinemia (manifested by a tendency to bleeding).
In case of acute poisoning, vomiting should be induced. Then, activated charcoal should be administered, and symptomatic treatment should be carried out, the basis of which is fluid replacement.

Missing a dose of Scorbolamid

In case of missing a dose, the next dose should be taken at the scheduled time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Scorbolamid can cause side effects, although not everybody gets them.
The most common side effects occur in the gastrointestinal tract and central nervous system.

Gastrointestinal disorders

nausea, vomiting, abdominal cramps, burning sensation behind the breastbone, loss of appetite, diarrhea, irritation of the gastric and duodenal mucosa (erosions and ulcers), dry mouth.
No clear relationship has been observed between the use of salicylamid and gastrointestinal bleeding.

Nervous system disorders

dizziness, drowsiness, headaches.

Skin and subcutaneous tissue disorders

flushing, rash, excessive sweating.
The medicine should be used with caution in patients who have experienced a rash, angioedema (swelling of the face, tongue, and trachea, which can cause breathing difficulties), bronchospasm, rhinitis, or anaphylactic shock after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, as there is a possibility of these side effects occurring after taking Scorbolamid.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed. 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Scorbolamid

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a dry place, at a temperature not exceeding 25°C.
The medicine should not be used after the expiry date stated on the package and blister. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the package and other information

What Scorbolamid contains

• The active substances of Scorbolamid are salicylamid, ascorbic acid, and rutoside. Each effervescent tablet contains 300 mg of salicylamid, 100 mg of ascorbic acid, and 5 mg of rutoside.
• The other ingredients are: potato starch, gelatin, talc, purified water (constituting the core of the effervescent tablet) and sucrose, talc, gum arabic, quinoline yellow (E104), carnauba wax, and purified water (constituting the coating).

What Scorbolamid looks like and what the package contains

Round, biconvex effervescent tablets, yellow in color.
The package contains 6, 10, 20, or 40 effervescent tablets.

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 the last update of the package leaflet: