Ascalcin Plus o smaku malinovim

Package Leaflet: Information for the Patient

Ascalcin Plus Raspberry Flavor,

500 mg + 300 mg + 200 mg, Effervescent Powder

( Acetylsalicylic Acid + Ascorbic Acid + Calcium)

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 the patient leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Ascalcin Plus Raspberry Flavor and what is it used for

Ascalcin Plus Raspberry Flavor contains acetylsalicylic acid, ascorbic acid (vitamin C), and calcium.
Acetylsalicylic acid belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). It has antipyretic, analgesic, and anti-inflammatory effects.
Ascorbic acid (vitamin C) and calcium affect the proper functioning of blood vessel walls. They reduce their permeability, have anti-edema and anti-exudative effects.
Ascalcin Plus Raspberry Flavor contains substances that enable rapid and complete dissolution of its components in water. Thanks to this, it is easily absorbed and well tolerated.
A medicine with analgesic, antipyretic, and anti-inflammatory effects.
Treatment:

• symptoms of colds and flu;
• fever;
• muscle and joint pains;
• headaches, including migraines;
• toothaches;
• neuralgia.

If after 3 to 5 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Ascalcin Plus Raspberry Flavor

When not to take Ascalcin Plus Raspberry Flavor

if you are allergic to acetylsalicylic acid (found in many medicines used for colds and flu) or other salicylates, ascorbic acid, calcium, or any of the other ingredients of this medicine (listed in section 6);
if you have active stomach or duodenal ulcers, inflammatory conditions of the digestive tract;
if you have an increased tendency to bruising or bleeding (hemophilia, blood clotting disorders);
if you are taking anticoagulant medications, antiplatelet agents;
if you have disturbances of acid-base balance (diabetes, uremia, tetany);
if you have significantly elevated calcium levels in the blood;
if you have a history of asthma attacks triggered by the administration of salicylates or substances with similar effects, especially nonsteroidal anti-inflammatory drugs;
if you have severe kidney disease;
if you have severe liver disease;
if you have severe heart failure;
if you are in the last trimester of pregnancy;
if you have phenylketonuria (a genetic disorder characterized by a deficiency of the enzyme called phenylalanine hydroxylase);
in children under 12 years of age with viral infections, as it may cause the development of Reye's syndrome;
do not administer simultaneously with methotrexate used in doses of 15 mg per week or higher.

Warnings and precautions

Be particularly cautious when taking Ascalcin Plus Raspberry Flavor:
if you are allergic to other nonsteroidal anti-inflammatory drugs;
if you have allergies (e.g., hay fever) or asthma;
if you have menstrual bleeding or excessive menstrual bleeding;
if you are scheduled for surgery (do not take the medicine at least 5 days before the procedure);
if you have gout;
if you have had stomach or intestinal ulcers, as well as gastrointestinal bleeding;
if you have mild kidney or liver disease;
if you have moderate heart failure (heart disease that may manifest as shortness of breath and swelling of the feet);
if you are using an intrauterine contraceptive device;
if you have high blood pressure;
if your body does not produce the enzyme called glucose-6-phosphate dehydrogenase;
if you are on a low-sodium diet: the medicine contains 178-356 mg of sodium per dose, which should be taken into account in patients with reduced kidney function and in patients controlling sodium intake in their diet;
the medicine contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Other important information:
Taking medications containing acetylsalicylic acid may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses or longer treatment than recommended for 3-5 days.
In case of heart disorders, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol, smoking), consult your doctor or pharmacist about the treatment method.
Young people and children suffering from viral infections (with or without fever) should not take Ascalcin Plus Raspberry Flavor without consulting a doctor. Otherwise, they may develop Reye's syndrome – a rare but life-threatening disease.

Ascalcin Plus Raspberry Flavor and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ascalcin Plus Raspberry Flavor should not be used simultaneously with methotrexate taken in doses of 15 mg per week or higher, as it increases the toxic effect of methotrexate on the bone marrow.
Taking selective serotonin reuptake inhibitors (SSRIs, medicines used for depression) simultaneously with acetylsalicylic acid increases the risk of bleeding from the upper gastrointestinal tract due to the synergistic effect of these medicines.
Ascalcin Plus Raspberry Flavor should not be used if you are also taking:
anticoagulant medications, antiplatelet agents (e.g., coumarin derivatives, heparin, ticlopidine);
antidiabetic medications (insulin, sulfonylurea derivatives);
sulfonamides (used in bacterial infections);
phenytoin or valproic acid (antiepileptic medications);
digoxin (used in the treatment of heart failure);
methotrexate in doses less than 15 mg (used in cancer and rheumatoid arthritis).
Ascalcin Plus Raspberry Flavor may weaken or enhance the effect of other medicines. Be particularly cautious when taking:
corticosteroids and other nonsteroidal anti-inflammatory drugs, as gastrointestinal side effects and kidney damage may occur;
cardiac glycosides (digoxin and strophanthin derivatives, medicines used for heart diseases), as cardiac arrhythmias may occur;
medicines used to treat gout (e.g., probenecid);
diuretics (e.g., furosemide, thiazide diuretics);
blood pressure-lowering medications (captopril, enalapril);
amfetamine derivatives;
tricyclic antidepressants (e.g., opipramol, doxepin);
fluorine compounds;
certain antibiotics (fluoroquinolones and tetracyclines, medicines used in bacterial infections); a 3-hour interval should be maintained between these medicines and Ascalcin Plus Raspberry Flavor;
vitamin D and calcium channel blockers (a group of medicines used in hypertension).

Ascalcin Plus Raspberry Flavor with food, drink, and alcohol

The medicine is recommended to be taken after a meal.
Drinking alcohol during treatment with the medicine may enhance the irritating effect of acetylsalicylic acid on the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Ascalcin Plus Raspberry Flavor during pregnancy and breastfeeding.
Ascalcin Plus Raspberry Flavor may adversely affect fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and using machines

Ascalcin Plus Raspberry Flavor, when used in the recommended doses, has no or negligible influence on the ability to drive and use machines.

Ascalcin Plus Raspberry Flavor contains sodium.

The medicine contains 178-356 mg of sodium per dose(1-2 sachets), which should be taken into account in patients with reduced kidney function and in patients controlling sodium intake in their diet.
Ascalcin Plus Raspberry Flavor contains aspartame- a source of phenylalanine. It may be harmful to patients with phenylketonuria.

Ascalcin Plus Raspberry Flavor contains a small amount of sucrose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Ascorbic acid (vitamin C) contained in the medicine may affect the results of some tests performed using redox methods (e.g., glucose or creatinine determination in blood and urine, stool test for occult blood).

3. How to take Ascalcin Plus Raspberry Flavor

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
Ascalcin Plus Raspberry Flavor is indicated for use in adults and children over 12 years of age.
Recommended dose:
Adults:
1 or 2 sachets 3 times a day.
Maximum daily dose is 6 sachets.
Patients over 65 years of age:
1 sachet 3 times a day.
Maximum daily dose is 3 sachets.

Use in children and adolescents

Children over 12 years of age:
1 sachet 3 times a day.
Maximum daily dose is 3 sachets.
Dissolve the contents of one sachet in ½ glass of cool water, mix, and drink.
The medicine is recommended to be taken after a meal.
Do not use Ascalcin Plus Raspberry Flavor for longer than the recommended 3-5 days.

Using a higher dose of Ascalcin Plus Raspberry Flavor than recommended

In case of accidental ingestion of a dose exceeding the recommended daily dose, symptoms of overdose may occur (related to the presence of acetylsalicylic acid): rapid breathing, nausea, vomiting, vision and hearing disturbances (tinnitus), headaches and dizziness, acid-base and electrolyte disturbances (e.g., potassium deficiency), decreased blood glucose levels, skin changes.
In case of acute poisoning, the following may occur: hallucinations, tremors, shortness of breath, excessive sweating, psychomotor agitation, high fever, coma.
In case of ingestion of a higher dose than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Ascalcin Plus Raspberry Flavor

Ascalcin Plus Raspberry Flavor is used as needed. If you miss a dose and symptoms persist, take the next dose of the medicine.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Ascalcin Plus Raspberry Flavor

In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult your doctor if you experience the following serious side effects:

• gastrointestinal bleeding in the form of coffee grounds vomiting and black stools;
• ulcers of the mucous membrane of the digestive tract;
• allergic reactions (such as severe breathing difficulties or wheezing, shortness of breath).

Other side effects may also occur:

• increased risk of bleeding;
• exacerbation or recurrence of peptic ulcer disease;
• nausea, vomiting, abdominal pain;
• increased menstrual bleeding;
• skin changes: rash, urticaria;
• edema;
• hypertension;
• heart failure;
• dizziness;
• tinnitus;
• sweating.

Taking medications containing acetylsalicylic acid may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
The medicine is generally well tolerated when used in the recommended doses.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: ndl@urpl.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 the medicine.

5. How to store Ascalcin Plus Raspberry Flavor

Do not store above 25°C.
Store in the original packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month. Do not use the medicine if you notice a change in the appearance of the powder in the sachets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ascalcin Plus Raspberry Flavor contains

• The active substances of the medicine are:
• acetylsalicylic acid 500 mg
• ascorbic acid (vitamin C) 300 mg
• calcium (in the form of calcium lactogluconate) 200 mg
• Other ingredients (excipients) are: sodium bicarbonate, anhydrous citric acid, povidence K-25, raspberry flavor, aspartame, beta-carotene 1% (contains sucrose), sodium lauryl sulfate.

What Ascalcin Plus Raspberry Flavor looks like and what the pack contains

The medicine is a pink-colored effervescent powder, packaged in sachets.
The outer packaging – a cardboard box, contains 6, 8, 10, 14, 20, or 28 sachets and a patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

URGO Sp. z o.o.
Al. Jerozolimskie 142 B
02-305 Warsaw
tel/fax: 22 616 33 48 / 22 617 69 21

Manufacturer

SENSILAB Polska Spółka z ograniczoną odpowiedzialnością – Spółka komandytowo-akcyjna
ul. gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki
Date of last revision of the leaflet:September 2022