Scorbolamid Extra Hot

Leaflet attached to the packaging: patient information

Scorbolamid EXTRA Hot

(300 mg + 300 mg + 50 mg + 5 mg)/sachet, granules for oral suspension preparation
Salicylamide + Ascorbic acid + Rutin + Zinc

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this 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 leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

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

Scorbolamid EXTRA Hot 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.
Rutin - stimulates the immune system and supports the body during viral infections. Increases vitamin C absorption and 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 states of increased demand for vitamin C and zinc, and sealing blood vessels.

2. Important information before taking Scorbolamid EXTRA Hot

When not to take Scorbolamid EXTRA Hot:

• if the patient is allergic to salicylamide, ascorbic acid, rutin, zinc, or any other component of this medicine (listed in section 6);
• if the patient is allergic to non-steroidal anti-inflammatory drugs;
• 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 has severe heart failure;
• if the patient is pregnant;
• if the patient is breastfeeding;
• if the patient is taking methotrexate at doses of 15 mg per week or higher;
• in children and adolescents under 16 years of age, (except for rare diseases, such as Kawasaki disease), due to the possibility of Reye's syndrome, a rare but severe disease causing liver and brain damage.

Warnings and precautions

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

• 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;
• if the patient has hypertension.

Scorbolamid EXTRA Hot 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 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 serum;
• tetracycline, products containing copper or iron, as zinc may decrease their absorption. The medicine should be taken at least 2 hours after using 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 taking penicillamine and zinc salts;
• thiazide diuretics, as they increase zinc excretion in the urine.

Scorbolamid EXTRA Hot with food, drink, and alcohol

See section 3.
Alcohol may increase side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, 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 treatment is completed.

Driving and using machines

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

3. How to take Scorbolamid EXTRA Hot

This medicine should always be taken exactly as described in this patient leaflet 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:
1 sachet 3 times a day. Pour the contents of one sachet of Scorbolamid EXTRA Hot into half a glass of warm water and stir well. Drink the suspension immediately after the granules have dissolved.
Note: The granules do not dissolve completely.
Take the medicine after a meal.
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), consult a doctor as soon as possible.

Taking a higher dose of Scorbolamid EXTRA Hot than recommended

If you have taken a higher dose of the medicine than recommended, consult a doctor immediately.
Salicylamide
Overdose of salicylamide may cause depression of the central nervous system, hypotension, respiratory arrest, metabolic acidosis, or hypoprothrombinemia.
Ascorbic acid
Symptoms of vitamin C overdose may include gastrointestinal disorders, such as diarrhea, vomiting, heartburn, and skin redness, headache, and insomnia. High doses may cause hyperoxaluria and kidney stones. Daily doses of 600 mg may have a diuretic effect.
Rutin
No cases of rutin overdose have been reported.
Zinc
Symptoms of zinc overdose include burning pain 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 Hot

If you miss 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, Scorbolamid EXTRA Hot can cause side effects, although not everybody gets them.
Side effects associated with taking salicylamide

• The most common side effects occur in the gastrointestinal tract and 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 (erosions and ulcers), dry mouth. No clear relationship has been observed between salicylamide use 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, or anaphylactic shock after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs, as these side effects may occur after taking Scorbolamid EXTRA Hot.
Side effects associated with taking ascorbic acid

• ascorbic acid decreases urine pH, which facilitates the precipitation of urates, 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 taking zinc

• nausea, vomiting, diarrhea;
• headaches.

Reporting side effects

If you experience any side effects, including those not listed in this 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 gather more information on the safety of this medicine.

5. How to store Scorbolamid EXTRA Hot

Store the medicine out of 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 sachet 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. Package contents and other information

What Scorbolamid EXTRA Hot contains

• The active substances of the medicine are salicylamide, ascorbic acid, rutin, and zinc. Each sachet contains 300 mg of salicylamide, 300 mg of ascorbic acid, 50 mg of rutin, and 5 mg of zinc in the form of zinc gluconate.
• Other ingredients are: mannitol SD100, mannitol M100, hydroxypropyl cellulose, anhydrous citric acid, lemon flavor, sucralose, anhydrous colloidal silica.

What Scorbolamid EXTRA Hot looks like and what the package contains

Scorbolamid EXTRA Hot is a yellow granulate with a lemon scent, with visible larger agglomerates, and occasional dark discoloration of the granulate is acceptable.
The package contains 8 or 12 sachets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last leaflet update: