ALKAEFFER EFFERVESCENT TABLETS 20 TABLETS

Name
Alkaeffer effervescent tablets
Acetylsalicylic acid


What is it and what is it for?
Alkaeffer is an analgesic (painkiller: reduces pain), antipyretic (antifebrile: reduces fever).
Alkaeffer is used for the symptomatic treatment of feverish states and flu and cold syndromes and for the symptomatic treatment of headache and toothache, neuralgia (pain affecting the nerves), menstrual pain, rheumatic and muscular pain (affecting the joints and muscles).
The product is intended for use by adult patients only.
Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 3-5 days.


What you need to know before taking the medicine
Do not take Alkaeffer
- if you are allergic to acetylsalicylic acid or other analgesics (painkillers) / antipyretics (fever relievers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from gastroduodenal ulcer (ulcer in the stomach or first part of the intestine);
- if you suffer from haemorrhagic diathesis (tendency to bleed);
- if you suffer from severe renal (reduced kidney function) or hepatic (liver) or cardiac (heart) insufficiency;
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose genetically determined absence leads to a disease characterized by reduced survival of red blood cells);
- if you suffer from hypophosphatemia (decrease in 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 suffered in the past from asthma induced by the administration of salicylates or substances with similar activity, in particular 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 consideration when following a low-sodium/low-salt diet in patients with heart failure, high blood pressure, and renal insufficiency.

Before administering any medicine you must take all necessary precautions to prevent adverse 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 itchy spots on the skin)].
The risk is higher in people who have already had an allergic reaction after using this type of medicine in the past (see "Do not take Alkaeffer") and in people who have allergic reactions (e.g. skin reactions, itching, hives) to other substances.
In subjects 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 are due to undergo surgery (even a minor one such as tooth extraction), as pre-operative use of this medicine may make it more difficult to stop bleeding during the operation (intraoperative haemostasis);
- you should perform a blood occult test, since acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe this medicine only after a careful risk/benefit assessment:
• 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, since acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation); for this reason these medicines must not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding or who use large quantities of alcohol or higher doses of acetylsalicylic acid (dose-related effect) (see "Do not take Alkaeffer");
• if you have blood clotting problems or if you are undergoing treatment with anticoagulant 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 level of uric acid in the blood).
It is also advisable to consult your doctor if the above-mentioned disorders have occurred in the past.
• if you are taking any medicines that are not recommended or that require special precautions or dosage adjustment (see "Other medicines and Alkaeffer");
• if you are over 70 years of age, especially in the presence of 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 whether fever is present or not. In certain viral infections, especially influenza A, influenza B, and chickenpox, there is a risk of Reye's syndrome, a very rare but life-threatening illness that requires immediate medical attention. The risk may be increased if acetylsalicylic acid is taken concomitantly, although a causal relationship has not been proven. Persistent vomiting in patients with these illnesses may be a sign of Reye's syndrome.

Elderly people
The risk of serious side effects is higher in older people.
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 symptoms can be partially alleviated 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)

Effects on the blood
- prolongation of bleeding time,
- anemia due to gastrointestinal bleeding,
- reduction of platelets (thrombocytopenia) in extremely rare cases.
Following haemorrhage, post-haemorrhagic/iron deficiency anaemia (due, for example, to occult microhaemorrhages) may occur with related alterations in laboratory parameters and related clinical signs and symptoms such as asthenia (tiredness), pallor and hypoperfusion (reduced blood supply to the tissues).

Effects on the nervous system
- heachache,
- dizziness.
Rarely, the following may occur:
- Reye's syndrome (*), an acute, potentially fatal disease of the brain and liver that affects almost exclusively children.
Rarely to very rarely, the following may occur:
- cerebral haemorrhage, 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 life-threatening.

Effects on the ear
- tinnitus (ringing/buzzing/ringing/ringing 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 (pyrosis),
- gastrointestinal pain,
- gingivorrhagia (bleeding gums),
- vomit,
- diarrhea,
- nausea,
- crampy 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 (emission of black, tarry stools),
- esophagitis (inflammation of the esophagus).
Very rarely, the following may occur:
- haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with related clinical signs and symptoms and alterations in laboratory parameters.
It may occur with unknown frequency (especially in long-term treatment):
- Disease of the intestinal diaphragms

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

Effects on the skin**
- skin rash,
- edema (swelling),
- hives,
- itching,
- erythema (redness),
- angioedema (associated with allergic reactions).

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

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

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

(*) Reye's Syndrome (RS)
RSD initially manifests with vomiting (persistent or recurrent) and other signs of brain damage of varying degrees, ranging from listlessness, drowsiness, or personality changes (irritability or aggressiveness) to disorientation, confusion, or delirium, even convulsions or loss of consciousness. The variability of the clinical picture must be kept in mind: vomiting may also be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an episode of influenza (or flu-like illness or chickenpox or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates were administered, the doctor's attention should be immediately drawn to the possibility of RS.

(**) Severe 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 experience 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.