Aspirin +C Forte 10 Effervescent tablets

Aspirin + C forte is used

• for symptomatic relief of mild to moderate pain such as headaches, toothache and menstrual pain
• for symptomatic relief of pain and fever in colds and flu-like infections

Aspirin + C forte is used in adults and adolescents over 12 years of age.

Contraindications

Do not take Aspirin + C forte,

• if you are allergic to acetylsalicylic acid, ascorbic acid or any of the other ingredients of this medicine (listed in section 6), or are other nonsteroidal anti-inflammatory medicines (NSAIDS) used to
  treat pain, fever or
  inflammation.
• if you have too many mast cells (existing mastocytosis). The use of acetylsalicylic acid may cause severe hypersensitivity reactions (including circulatory shock with reddening of the skin, low blood pressure, palpitations and vomiting).
• if you have had asthma attacks in the past caused by the use of acetylsalicylic acid or similar substances (especially NSAIDS).
• in the 3rd trimester of pregnancy (if you are more than 24 weeks pregnant).
• if you suffer from gastrointestinal ulcers.
• if you have bleeding or are at risk of bleeding (hemorrhagic diathesis);
• if you suffer from severe liver or kidney dysfunction;
• if you suffer from severe uncontrolled heart muscle weakness (heart failure);
• if you are being treated with methotrexate at doses of 15 mg per week or more.
• if you are taking "blood thinning" medicines (oral anticoagulants) at the same time and you have a history of stomach or intestinal ulcers.

Interactions

Do not take Aspirin + C forte if you are being treated with:

• Methotrexate at doses of 15 mg/week or more: a medicine used to treat serious rheumatic diseases, cancers and the skin disease psoriasis. The toxicity of methotrexate is increased.
• Anticlotting medicines ("blood thinners", oral anticoagulants) if you have a history of stomach or intestinal ulcers. The risk of bleeding is increased.

Talk to your doctor or pharmacist before taking Aspirin + C forte if you are taking any of the following medicines:

Not recommended combinations:

• Anticoagulant medicines (oral anticoagulants) if you have not had a history of stomach or intestinal ulcers. The risk of bleeding is increased.
• clopidogrel (except for the approved indication for this combination) and ticlopidine: medicines that inhibit blood clotting. The risk of bleeding is increased.
• Medicines for pain, fever and inflammation, which belong to the group of so-called non-steroidal anti-inflammatory drugs. The risk of stomach or intestinal ulcers and bleeding is increased.
• Heparin in doses used to treat (e.g. blood clots in a vessel) or in patients over 65 years of age, regardless of the heparin dose. The risk of bleeding is increased. Another painkiller or antipyretic medicine should be used.
• Benzbromarone, probenecid: medicines to increase urinary acid excretion for the treatment of gout. The effect of these medicines is reduced.

Combinations that require special care:

• Methotrexate at doses below 15 mg/week: Increased toxicity of methotrexate. Close monitoring of patients with renal impairment and elderly patients over 65 years of age is required. See also the first point under "Other medicines and aspirin + C forte".
• Medicines that have a dehydrating effect (diuretics) and medicines that treat high blood pressure and other heart diseases whose names end in "pril" or "sartan" (angiotensin-converting (ACE) enzyme inhibitors, angiotensin II receptor antagonists):
  Rapid loss of kidney function may occur in dehydrated patients. In addition, there may be an antihypertensive effect.
• clopidogrel (within the approved indication for this combination): a medicine used to inhibit blood clotting: the risk of bleeding is increased.
• medicines that act locally in the stomach or intestines, medicines that neutralise or bind stomach acid (antacids) or activated charcoal, a medicine used to treat diarrhoea and acute poisoning: take these medicines at least 2 hours apart from aspirin + C forte.
• Heparin at doses for prevention (e.g. against blood clots) in patients under 65 years of age:
  The risk of bleeding is increased.
• Medicines that dissolve blood clots (thrombolytics), such as streptokinase:
  The risk of bleeding is increased.
• Medicines containing cortisone or cortisone-like substances (glucocorticoids), with the exception of hydrocortisone replacement therapy:
  The risk of bleeding is increased.
• Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), medicines used to treat depression:
  The risk of bleeding is increased.
• Digoxin: A medicine used to treat heart failure and irregular heartbeat.
  The concentration of digoxin in the blood is increased. It is recommended that the doctor check the amount of digoxin in the blood and, if necessary, adjust the dose.
• Medicines to lower blood sugar (antidiabetics), e.g. insulin, sulfonylureas:
  Monitoring of blood sugar levels is recommended.
• Valproic acid: a medicine used to treat epilepsy.
  The toxicity of valproic acid is increased.

Combinations that should be taken into account:

• Deferasirox, deferoxamine: medicines that remove excess iron from the body:Deferasirox:
  the risk of stomach or intestinal bleeding or ulcers is increased. Taking deferoxamine and ascorbic acid can increase the toxicity of iron to tissues, especially in the heart.
• Iron and aluminum: The administration of ascorbic acid leads to increased absorption by the stomach and intestines. This is particularly important in the case of impaired kidney function, iron replacement and the administration of aluminium-containing antacids (gastric acid-binding or neutralising drugs).
• Laboratory tests: Both acetylsalicylic acid and ascorbic acid in high dosages can affect various laboratory tests such as detection of hidden blood in the stool, liver function tests. Tell your doctor that you are taking Aspirin + C forte.

Taking aspirin + C forte together with alcohol Avoid drinking alcohol
during the treatment period with aspirin + C forte.

Pregnancy, lactation and childbearing If
you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
Do not take this medicine in the third trimester of pregnancy (after 24 weeks) of your pregnancy, as it can cause serious harm to you and your unborn baby.
During the first six months of pregnancy, you can take Aspirin + C forte only after consulting your doctor.
If you have taken this medicine during pregnancy, please tell your doctor immediately.

Lactation:
During the use of aspirin + C forte, breastfeeding is not recommended as it is excreted in breast milk.

Childbearing:
This medicine belongs to a group of medicines (NSAIDs) that can affect women's fertility. This effect is reversible after discontinuation of the drug.

Aspirin + C forte contains sodium
This medicine contains 20.61 mmol (or 473.72 mg) of sodium per dose. If you need to follow a low-sodium diet, you should take this into account.

Application

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you're not sure.

Oral dosage
. Completely dissolve an effervescent tablet in a glass of water and drink. Do not take on an empty stomach to prevent irritation of the stomach.

The recommended dose is:

Adults:

• Single dose: 1 effervescent tablet
  The single dose can be repeated at intervals of 4 - 8 hours if necessary.
• Maximum daily dose: 3 effervescent tablets

Use in children and adolescents:Adolescents:
12 years and older
The lowest effective dose should be used.
The dosage depends on the body weight of the adolescents. This medicine should only be used in adolescents weighing more than 53 kg. The age indicated is for information only.
The recommended single dose is an effervescent tablet (800 mg acetylsalicylic acid / 480 mg ascorbic acid) if this dosage is suitable. The maximum daily dose must not exceed 3 effervescent tablets.
The strength of aspirin + C forte (800 mg acetylsalicylic acid / 480 mg ascorbic acid) may be unsuitable for the treatment of adolescents.
Other products with less acetylsalicylic acid are available for this age group.

Use in children under 12 years of age:
Aspirin + C forte should not be used in children under 12 years of age. In case of accidental administration, see section "What you need to know before taking Aspirin + C forte?" and "If you take more Aspirin + C forte than you should".

Elderly people (65 years of age and older) and underweight people:
The lowest effective dose should be used because of possible other diseases. See also section 2 "Do not take aspirin + C forte" and "Warnings and precautions"

Patients with hepatic or renal dysfunction or circulatory diseases:
The dose must be reduced or the interval between two doses extended if you are suffering from

• suffer from mild or moderate impairment of liver or kidney function.
• Circulatory problems such as heart failure or severe bleeding.

Do not take Aspirin + C forte if you have severe kidney or liver dysfunction or severe uncontrolled heart problems. See section 2 "Do not take aspirin + C forte".

Duration of use
Do not take this medicine for more than 3 days in case of fever and no more than 3 - 4 days in case of pain without a doctor's order.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Aspirin + C forte and seek immediate medical attention or go to the nearest hospital if you notice any of the following:

• Swelling of the face, tongue or trachea with great difficulty breathing, which are signs of a serious allergic reaction (angioedema).
• Stomach pain, black stools, vomiting blood, vomiting like coffee grounds, which are signs of stomach or intestinal bleeding.

Side effects can occur with the following frequency:Common:
may affect up to 1 in 10 people
Gastrointestinal symptoms such as heartburn, nausea, vomiting, upset stomach

Uncommon: may affect up to 1 in 100 people

• Stomach, intestinal and abdominal pain
• Hives (urticaria), rash, itching (pruritus)

Rare: may affect up to 1 in 1,000 people

• Inflammation or ulceration in the stomach or intestines (inflammation and ulcers of the esophagus, stomach or intestines). These reactions may occur with or without bleeding, regardless of the dose of acetylsalicylic acid and with or without warning symptoms or previous gastrointestinal complaints
• Hypersensitivity reactions such as asthma, runny or stuffy nose

Very rare: may affect up to 1 in 10,000 people

• Hidden or open bleeding of the stomach or intestines (vomiting of blood, black stools, etc.) followed by iron deficiency anemia. The risk of bleeding is dose-dependent.
• Breakthrough of the stomach and intestines
• decreased uric acid excretion. This can trigger a gout attack in patients prone to low uric acid excretion.

Not known: frequency cannot be estimated from the available data

• Increase in liver enzymes (liver enzymes called transaminases), decreased liver function
• Liver damage, mainly of liver cells
• decreased number of red blood cells (anemia) caused by bleeding
• decreased red blood cell count and decay in patients with severe forms of glucose-6-phosphate dehydrogenase deficiency
• decreased number of platelets
• low levels of glucose in the blood (hypoglycemia)
• Skin reactions
• Hypersensitivity reactions, severe allergic reactions (anaphylactic reactions) Hypersensitivity reactions can affect the skin, respiratory tract, circulatory system, stomach and intestines, especially in patients with asthma. Symptoms may include
  : swelling due to accumulation of water in the tissues
  Drop in blood pressure
  wheezing, breathlessness
  Heart trouble or shortness
  of breath life-threatening allergic shock reaction Rash, hives, itching, severe allergic reaction
  with swelling of the face or neck
  Asthma symptoms, inflammation in the nose that causes sneezing, runny or stuffy nose
• Bleeding with prolonged bleeding time such as nosebleeds, bleeding gums, punctiform bleeding under the skin, bleeding of the urinary and genital organs The risk of bleeding may persist for 4 to 8 days after stopping taking Aspirin+C forte. It can cause an increased risk in case of surgery. Bleeding in the skull or stomach/intestines may also occur. Bleeding in the skull can be fatal, especially in elderly patients.
• Severe bleeding, cerebral haemorrhage, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulant drugs. In individual cases, this can potentially be life-threatening.
• Fluid accumulation in the lungs (non-cardiogenic pulmonary edema) in chronic use associated with a hypersensitivity reaction to acetylsalicylic acid.
• Impaired renal function up to rapid loss of kidney function, kidney stones due to ascorbic acid
• Diarrhea at high doses of ascorbic acid
• Headache, dizziness, hearing loss, ringing in the ears are signs of overdose
• Reye's syndrome (impaired consciousness or abnormal behaviour or vomiting) (see section 2. "What you need to know before you take aspirin + C forte?")

Composition

• The active ingredients are acetylsalicylic acid and ascorbic acid.
  Each effervescent tablet contains:
  800 mg of acetylsalicylic acid and 480 mg of ascorbic acid
• The other ingredients are: sodium bicarbonate (modified), citric acid, povidone, colloidal anhydrous silica

Usually ships out within 3-4 days