ALKAEFFER*20EFF TABS

Alkaeffer effervescent tablets
Acetylsalicylic acid

What it is and what it is used for
Alkaeffer is an analgesic (pain reliever: reduces pain) and antipyretic (fever reducer: reduces fever).
Alkaeffer is used for the symptomatic treatment of feverish conditions, flu-like syndromes, and colds, and for the symptomatic treatment of headaches, toothaches, neuralgia (nerve pain), menstrual pain, and rheumatic and muscular pain (affecting joints and muscles).
The product is for adult patients only.
Consult your doctor if you do not notice any improvement or if symptoms worsen after 3-5 days.

What you need to know before taking this medicine
Do not take Alkaeffer
- if you are allergic to acetylsalicylic acid or other analgesics (pain relievers) / antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
- if you suffer from hemorrhagic diathesis (tendency to bleed);
- if you suffer from severe kidney, liver or heart failure (reduced function of the kidneys, liver or heart);
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose genetically determined absence causes a disease characterized by reduced red blood cell survival);
- if you suffer from hypophosphatemia (decreased phosphates in the blood);
- if you are already taking methotrexate (at doses of 15 mg/week or more) or warfarin (see Other medicines and Alkaeffer);
- if you have previously suffered from asthma induced by the administration of salicylates or similar substances, particularly non-steroidal anti-inflammatory drugs;
- if you are in the last trimester of pregnancy or if you are breastfeeding (see Pregnancy, breastfeeding and fertility);
- if you are under 16 years of age (see Children and adolescents).

Warnings and precautions
Talk to your doctor or pharmacist before taking Alkaeffer.

Take the medicine only on a full stomach.

Alkaeffer contains sodium
This medicine contains 445 mg of sodium (main component of table salt) per effervescent tablet. This is equivalent to 22.2% of the maximum recommended daily dietary intake for an adult. The sodium content per effervescent tablet (445 mg) should be taken into account in the case of a low-sodium/salt-restricted diet in patients with heart failure, high blood pressure, and kidney failure.

Before administering any medicine, you must take all useful precautions to prevent unwanted reactions:
• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious side effects. If in doubt, consult your doctor or pharmacist;
• do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes), or urticaria (small spots on the skin accompanied by itching)].
The risk is greater in individuals who have previously had an allergic reaction after using this type of medicine (see Do not take Alkaeffer) and in individuals who have allergic reactions (e.g., skin reactions, itching, urticaria) to other substances.
In individuals with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe.

Tell your doctor if:
- you need to undergo surgery (even minor, such as a tooth extraction), as pre-operative use of this medicine may make it more difficult to stop bleeding during the operation (intraoperative hemostasis);
- you need to perform a fecal occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe this medicine only after a careful assessment of the risk/benefit ratio:
• if you have a higher risk of allergic reactions, for example, if you suffer from asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria;
• if you have a higher risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation); for this reason, these medicines should not be used in individuals who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding or who consume high amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect) (see Do not take Alkaeffer);
• if you have blood clotting defects or if you are undergoing treatment with anticoagulants (medicines used to slow down or inhibit the blood clotting process);
• if you suffer from impaired kidney, heart, or liver function;
• if you suffer from asthma;
• if you have hyperuricemia/gout (increased uric acid level in the blood).
It is advisable to consult your doctor even if the disorders listed above have occurred in the past.
• if you are taking medicines not recommended or that require special precautions or a dosage adjustment (see Other medicines and Alkaeffer);
• if you are over 70 years old, especially if you are taking concomitant therapies;
• if you are in the first or second trimester of pregnancy (see Pregnancy, breastfeeding and fertility);
• if you are following a low-sodium diet.

Children and adolescents
This medicine should not be taken by children and adolescents under 16 years of age (see Do not take Alkaeffer). Products containing acetylsalicylic acid should not be used in children and adolescents under 16 years of age with viral infections, regardless of the presence or absence of fever. In certain viral affections, especially influenza A, influenza B, and chickenpox, there is a risk of Reye's Syndrome, a very rare but life-threatening disease that requires immediate medical attention. The risk may be increased with concomitant intake of acetylsalicylic acid, although a causal relationship has not been demonstrated. Persistent vomiting in patients affected by these diseases may be a sign of Reye's Syndrome.

Elderly
The risk of serious side effects is greater in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine should be used with caution (see warnings and precautions).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequently observed side effects affect the gastrointestinal system.
These disorders can be partially relieved by taking the medicine on a full stomach.
Most side effects are dependent on both the dose and the duration of treatment.
The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on blood vessels
- Epistaxis (nosebleed)

Blood effects
- prolonged bleeding time,
- anemia from gastrointestinal bleeding,
- reduction in platelets (thrombocytopenia) in extremely rare cases.
Following bleeding, post-hemorrhagic/iron-deficiency anemia (due to iron deficiency) may occur (due, for example, to occult micro-hemorrhages) with related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (fatigue), pallor, and hypoperfusion (reduced blood supply to tissues).

Effects on the nervous system
- headache,
- dizziness.
Rarely, the following may occur:
- Reye's syndrome (*), an acute brain and liver disease, potentially fatal, which affects almost exclusively children.
Rarely to very rarely, the following may occur:
- cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or on anticoagulant therapy (medicines used to slow down or inhibit the blood clotting process), which, in isolated cases, can be potentially fatal.

Effects on the ear
- tinnitus (ringing/hissing/tinkling/whistling in the ear).

Effects on the respiratory system
- Respiratory disease exacerbated by acetylsalicylic acid
- asthmatic syndrome
- rhinitis (runny nose)
- nasal congestion (blocked nose) (associated with allergic reactions).

Effects on the heart
- cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye
- conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal system
- gastrointestinal bleeding (occult),
- gastric disorders,
- heartburn (stomach burning),
- gastrointestinal pain,
- gingivorrhagia (bleeding gums),
- vomiting,
- diarrhea,
- nausea,
- cramp-like abdominal pain (associated with allergic reactions).
Rarely, the following may occur:
- gastrointestinal inflammation,
- gastrointestinal erosion,
- gastrointestinal ulceration,
- hematemesis (vomiting blood or coffee-ground material),
- melena (passage of black, tarry stools),
- esophagitis (inflammation of the esophagus).
Very rarely, the following may occur:
- hemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with related clinical signs and symptoms and changes in laboratory parameters.
Intestinal diaphragmatic disease may occur with unknown frequency (especially in long-term treatment).

Effects on the liver
- rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases.

Skin effects**
- skin rash,
- edema (swelling),
- urticaria,
- itching,
- erythema (redness),
- angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract
- altered kidney function and acute kidney injury (in the presence of altered blood circulation in the kidneys),
- urogenital hemorrhages (of the urinary and genital system).

Effects on the body as a whole
- procedural bleeding (just before, during, and just after surgery),
- hematomas (collections of blood outside the blood vessels).

Effects on the immune system
- Hypersensitivity reactions
- rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and other signs of varying degrees of encephalic distress: from apathy, drowsiness, or personality changes (irritability or aggressiveness) to disorientation, confusion, or delirium, up to convulsions or loss of consciousness. The variability of the clinical picture should be noted: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following a flu-like episode (or chickenpox or another viral infection) during which acetylsalicylic acid or other salicylate-containing medicines were administered, the doctor's attention should immediately be directed to the possibility of RS.

(**) Serious skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.