Scorbolamid extra hot

Patient Information Leaflet: Information for the Patient

Scorbolamid EXTRA Hot
(300 mg + 300 mg + 50 mg + 5 mg)/sachet, granules for oral suspension
Salicylamide + Ascorbic acid + Rutoside + Zinc
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or worsen, contact your doctor.

Table of Contents

1. What Scorbolamid EXTRA Hot is and what it is 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. Contents of the pack and other information

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

Scorbolamid EXTRA Hot is a combination medicinal product with multiple actions:
Salicylamide – exerts antipyretic, analgesic, and anti-inflammatory effects.
Ascorbic acid (vitamin C) – replenishes vitamin C deficiency and supports the body's immune response during infections.
Rutoside – stimulates the immune system and supports the body during viral infections. It enhances the absorption of vitamin C and prolongs its action.
Zinc – replenishes zinc deficiency and supports immune function.
Indications
Fever and symptoms associated with cold or flu, headache, support of immune function in conditions of increased demand for vitamin C and zinc, and strengthening of capillary walls.

2. Important information before using Scorbolamid EXTRA Hot

When not to use Scorbolamid EXTRA Hot:

• if the patient is allergic to salicylamide, ascorbic acid, rutin, zinc, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has asthma with nasal polyps;
• if the patient has active peptic ulcer disease of the stomach and/or duodenum and/or gastrointestinal inflammatory conditions;
• if the patient has acid-base balance disorders (e.g. diabetes, uremia, tetany);
• if the patient has blood coagulation disorders (e.g. hemophilia, thrombocytopenia);
• if the patient has genetically determined glucose-6-phosphate dehydrogenase deficiency;
• if the patient has kidney stones;
• if the patient has hemochromatosis (bronze diabetes), sideroblastic anemia, excess 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 currently taking methotrexate at doses of 15 mg per week or higher;
• in children and adolescents under 16 years of age (except in rare diseases such as Kawasaki disease), due to the risk of Reye's syndrome, a rare but serious condition causing liver and brain damage.

Warnings and precautions
Before starting treatment with Scorbolamid EXTRA Hot, consult your doctor or pharmacist.
Exercise particular caution when using Scorbolamid EXTRA Hot:

• if the patient has bronchial asthma;
• if the patient has liver or kidney impairment;
• in patients with a history of peptic ulcer or gastrointestinal bleeding;
• if the patient has hypertension.

Scorbolamid EXTRA Hot and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take, especially:

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

Scorbolamid EXTRA Hot with food, drink and alcohol
See section 3.
Alcohol may intensify adverse effects.

Pregnancy, breastfeeding and fertility
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.
This medicine should not be used during pregnancy and breastfeeding.
This medicine belongs to a group of drugs that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
There is no information available regarding contraindications for driving vehicles or operating machinery during treatment with this medicine.

3. How to use Scorbolamid EXTRA Hot

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults and adolescents over 16 years of age:
1 sachet 3 times daily. Empty the contents of one sachet of Scorbolamid EXTRA Hot into half a glass of warm water and stir thoroughly. Drink the suspension immediately after dissolving the granules.

Note: The granules do not dissolve completely.

Take the medicine after meals.

Use the lowest effective dose. Symptomatic treatment without medical advice should be continued for the shortest possible time.

If symptoms do not improve within 3–5 days of treatment or worsen (even before this time has elapsed), contact a doctor as soon as possible.

Use of a higher than recommended dose of Scorbolamid EXTRA Hot

In case of overdose, seek medical advice immediately.

Paracetamol (Acetaminophen)
Overdose of paracetamol may cause central nervous system depression, hypotension, respiratory depression, metabolic acidosis, or hypoprothrombinemia (deficiency of prothrombin in the blood).

Ascorbic acid (Vitamin C)
Symptoms of vitamin C overdose may include gastrointestinal disturbances such as diarrhea, vomiting, and heartburn, as well as skin flushing, headache, and insomnia. High doses may lead to hyperoxaluria and kidney stones. Daily doses of 600 mg or more may have a diuretic effect.

Rutoside (Rutin)
No cases of rutoside overdose have been reported.

Zinc
Symptoms of zinc overdose include burning pain in the mouth and throat, watery or bloody diarrhea, painful urge to defecate, belching, hypotension (dizziness), jaundice (yellowing of eyes and skin), pulmonary edema (chest pain, difficulty breathing), and vomiting. Other possible symptoms include hematuria, anuria, collapse, convulsions, and hemolysis.

In case of acute poisoning, induce vomiting. Then administer activated charcoal and provide symptomatic treatment, with fluid replacement as the cornerstone of therapy.

Missed dose of Scorbolamid EXTRA Hot

If a dose is missed, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions associated with the use of acetaminophen (paracetamol)
The most common adverse reactions affect the gastrointestinal tract and the central nervous system.
They may include:

• nausea, vomiting, abdominal cramps, heartburn, loss of appetite, diarrhoea, irritation of the gastric and duodenal mucosa (erosions and ulcers), dryness of the oral cavity. There has been no clear association observed between the use of acetaminophen and gastrointestinal bleeding.
• dizziness, drowsiness, headache;
• facial flushing, rash, excessive sweating.

This medicine should not be used in patients in whom acetylsalicylic acid or non-steroidal anti-inflammatory drugs have previously caused rash, angioedema (swelling of the face, tongue, and trachea causing breathing difficulties), bronchospasm, rhinitis, or anaphylactic shock, as there is a possibility that these adverse reactions may occur after administration of Scorbolamid EXTRA Hot.
Adverse reactions associated with the use of ascorbic acid

• ascorbic acid decreases urine pH, which facilitates precipitation of urates, cystine, or oxalates;
• ascorbic acid may interfere with the results of certain tests performed by redox methods (e.g. determination of glucose or creatinine in blood and urine, faecal occult blood testing).

Adverse reactions associated with the use of zinc

• nausea, vomiting, diarrhoea;
• headache.

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: +48 22 49 21 301
Fax: +48 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 Scorbolamid EXTRA Hot

Keep this medicine out of sight and reach of children.
Do not store at temperatures above 25 °C.
Do not use this medicine after the expiry date stated on the carton and sachet following EXP.
The expiry date refers to the last day of the stated 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 pack and other information

What Scorbolamid EXTRA Hot contains

• The active substances 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, hydroxypropylcellulose, anhydrous citric acid, lemon flavor, sucralose, and colloidal anhydrous silica.

What Scorbolamid EXTRA Hot looks like and contents of the pack
Scorbolamid EXTRA Hot is a yellow granulate with a lemon scent, containing visible larger agglomerates; a few particles with dark discolorations may also be present.
The pack contains 8 or 12 sachets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
POLPHARMA Pharmaceutical Works S.A.
Production Branch in Nowa Dęba
Metalowca Street 2, 39-460 Nowa Dęba