Alkaeffer

Package leaflet: Information for the patient

Alkaeffer effervescent tablets

acetylsalicylic acid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3–5 days.

Contents of this leaflet:

1. What Alkaeffer is and what it is used for
2. What you need to know before taking Alkaeffer
3. How to take Alkaeffer
4. Possible side effects
5. How to store Alkaeffer
6. Contents of the pack and other information

1. What Alkaeffer is and what it is used for

Alkaeffer is an analgesic (painkiller: reduces pain) and antipyretic (febrifuge: reduces fever).
Alkaeffer is used for the symptomatic treatment of feverish conditions and influenza-like and cold syndromes, as well as for the symptomatic relief of headache, toothache, neuralgias (nerve-related pain), menstrual pain, and rheumatic and muscular pain (affecting joints and muscles).
This product is intended for use in adult patients only.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3–5 days.

2. What you should know before taking Alkaeffer

Do not take Alkaeffer

• if you are allergic to acetylsalicylic acid or to other analgesics (painkillers) / antipyretics (fever reducers) / 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 of the stomach or the first part of the intestine);
• if you suffer from haemorrhagic diathesis (tendency to bleed);
• if you suffer from severe renal (kidney), hepatic (liver), or cardiac (heart) insufficiency;
• if you have glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency, genetically determined, which causes a disease characterized by reduced survival of red blood cells);
• if you suffer from hypophosphataemia (decreased phosphate levels 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 salicylates or substances with similar activity, 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 after meals.
Alkaeffer contains sodium
This medicine contains 445 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 22.2% of the maximum daily dietary intake recommended for an adult. The sodium content per effervescent tablet (445 mg) should be considered if you are on a low-sodium/salt-free diet due to heart failure, high blood pressure, or renal insufficiency.
Before taking any medicine, take all necessary precautions to prevent unwanted reactions:

• rule out any history of allergic reactions to this or other medicines;
• rule out the presence of other contraindications or conditions that may increase the risk of potentially serious adverse 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 may cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes), or urticaria (small skin rashes accompanied by itching)].
The risk is higher in individuals who have previously experienced an allergic reaction after using this type of medicine (see "Do not take Alkaeffer") and in those who have allergic reactions (e.g. skin reactions, itching, urticaria) to other substances.
In patients with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe.
Inform your doctor if:

• you are scheduled for surgery (even minor procedures such as tooth extraction), as pre-operative use of this medicine may make it more difficult to control bleeding during surgery (intraoperative haemostasis);
• you are undergoing testing for occult blood, since acetylsalicylic acid may cause gastrointestinal bleeding.

Your doctor will prescribe this medicine only after careful evaluation of the benefit-risk ratio in the following cases:

• if you have an increased risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyps) and/or urticaria;
• if you have an increased risk of gastrointestinal injury, as acetylsalicylic acid and other NSAIDs may cause serious gastrointestinal adverse effects (bleeding, ulcer, perforation); for this reason, these medicines should not be used in patients who have or have previously had gastrointestinal ulcers or gastrointestinal bleeding, or who consume large amounts of alcohol or higher doses of acetylsalicylic acid (dose-dependent effect) (see "Do not take Alkaeffer");
• if you have blood coagulation disorders or are being treated with anticoagulant medicines (used to slow down or inhibit blood clotting);
• if you suffer from impaired kidney, heart, or liver function;
• if you have asthma;
• if you have hyperuricaemia/gout (elevated levels of uric acid in the blood). You should consult your doctor even if any of the above conditions occurred in the past.
• if you are taking medicines that are not recommended or require special precautions or dosage adjustments (see "Other medicines and Alkaeffer");
• if you are over 70 years of age, especially if you are taking other 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 must not be taken by children or adolescents under 16 years of age (see "Do not take Alkaeffer"). Products containing acetylsalicylic acid must not be used in children or adolescents under 16 years of age who have viral infections, regardless of the presence or absence of fever. In certain viral illnesses, particularly influenza A, influenza B, and varicella, there is a risk of Reye's syndrome, a very rare but life-threatening condition requiring immediate medical intervention. The risk may be increased by concomitant use of acetylsalicylic acid, although a causal relationship has not been proven. Persistent vomiting in patients with these diseases may be a sign of Reye's syndrome.
Elderly
The risk of serious adverse effects is higher in elderly patients.
If you are over 70 years of age, consult your doctor before taking this medicine.
Patients with impaired kidney or liver function
This medicine should be used with caution (see "Warnings and precautions").
Other medicines and Alkaeffer
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Alkaeffer together with the following medicines (see "Do not take Alkaeffer"):

• Methotrexate (used in certain cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin [used to make blood less likely to clot (anticoagulant)].

Take Alkaeffer together with the following medicines only on prescription and under medical supervision:

• Selective Serotonin Re-uptake Inhibitors (SSRIs) (used to treat depression);
• ACE inhibitors (used to treat high blood pressure);
• Acetazolamide (used in certain types of oedema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs (excluding those for local use);
• Antacids (used for digestive disorders);
• Antiplatelet agents (used for prevention and treatment of blood clots in arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit blood clotting) taken orally or by injection;
• Antidiabetics, such as insulin and oral hypoglycaemics (used to stimulate insulin production by the pancreas);
• Digoxin (used in heart failure);
• Diuretics (used to increase urine production);
• Phenytoin (used in epilepsy);
• Corticosteroids (excluding those for local use and those used in replacement therapy for adrenal insufficiency);
• Metoclopramide (used to treat vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents, such as probenecid, benzbromarone, and sulfinpyrazone (used to increase excretion of uric acid);
• Zafirlukast (used for asthma).

Alkaeffer contains buffering systems that could reduce the effects of the thyroid hormone Levotiroxine.
Do not take other oral medicines within 1 or 2 hours of taking this medicine.
Alkaeffer and alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy – last trimester
Do not take Alkaeffer during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond normal.
Pregnancy – first and second trimesters
You should not take Alkaeffer during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Alkaeffer may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Do not take Alkaeffer while breastfeeding.
Fertility
If you are a woman with fertility problems or undergoing fertility investigations, note that the use of acetylsalicylic acid, like any medicine that inhibits prostaglandin synthesis and cyclooxygenase, may interfere with fertility.
Driving and using machines
Due to the possible occurrence of headache or dizziness, this medicine may impair your ability to drive or operate machinery.
Alkaeffer contains sodium
This medicine contains 445 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 22.2% of the maximum daily dietary intake recommended for an adult.

3. How to take Alkaeffer

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose: 1 or 2 tablets as a single dose, repeated if necessary every 4–8 hours, up to 4 times daily. Never exceed the maximum daily dose of 8 tablets.

An Alkaeffer tablet must always be completely dissolved in a glass of water before use.

Take the product with food, preferably after main meals.

Warning: Do not exceed the recommended doses without medical advice.

Always use the lowest effective dose, and increase it only if it is insufficient to relieve symptoms (pain and fever).

Patients at higher risk of serious adverse effects, who may use the medicine only if prescribed by a doctor, must strictly follow the doctor's instructions.

Do not take this medicine for longer than 3–5 days without consulting a doctor. Consult your doctor if symptoms persist. Use the medicine for the shortest duration possible.

Consult your doctor if the condition recurs or if you have noticed any recent changes in its characteristics.

Use in children and adolescents

This medicine must not be taken by children and adolescents under 16 years of age (see "Do not take Alkaeffer").

Elderly

Elderly patients should adhere to the minimum recommended doses indicated above.

If you take more Alkaeffer than you should

In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

Salicylate toxicity (a dosage exceeding 100 mg/kg/day for 2 consecutive days may induce toxicity: for example, in a 70 kg individual, salicylate toxicity occurs with intake of more than 7 g of acetylsalicylic acid per day, equivalent to more than 21 Alkaeffer tablets) may result from chronic ingestion of excessive doses or from acute overdose, which can be potentially life-threatening, including accidental ingestion in children.

• Chronic intoxication (repeated use of considerable doses): Symptoms include dizziness, vertigo, tinnitus (ringing or buzzing in the ear), hearing loss, sweating, nausea and vomiting, headache, and confusion. These symptoms can be controlled by reducing the dose.

• Acute intoxication: Signs, symptoms, and results of biochemical and instrumental investigations may include:
  Signs and symptoms of mild/moderate overdose: tachypnea (rapid breathing), hyperventilation (excessively deep breathing), respiratory alkalosis (disturbance of acid-base balance due to altered respiration), sweating, nausea, vomiting, headache, dizziness.
  Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (disturbance of acid-base balance due to altered respiration and accumulation of acids in the body), fever, hyperventilation (excessively deep breathing), pulmonary edema (fluid in the lungs), respiratory failure, asphyxia, arrhythmias (abnormal heart rhythm), hypotension (low blood pressure), cardiocirculatory arrest (cessation of heart function), dehydration, oliguria (reduced urine output) progressing to renal failure (impaired kidney function), ketosis ("acetone"), hyperglycemia (increased blood sugar levels), severe hypoglycemia (severe drop in blood sugar levels), tinnitus (ringing or buzzing in the ear), hearing loss, gastrointestinal bleeding, gastric ulcer, coagulopathy (impaired blood clotting), iron deficiency anemia, encephalopathy (brain dysfunction), and depression of the central nervous system, ranging from lethargy (extreme drowsiness) and confusion to coma and convulsions, cerebral edema (swelling of brain tissue), and liver damage.

• At high doses, disturbances in taste and skin eruptions (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric) may also occur, along with pruritus (itching).

• Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), reduced visual acuity (reduced ability to see objects clearly), somnolence (drowsiness).

• Rarely, the following may occur: aplastic anemia (failure to produce red blood cells), agranulocytosis (lack of white blood cells called granulocytes), disseminated intravascular coagulation (widespread formation of blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (low white blood cell count), thrombocytopenia (low platelet count), eosinopenia (low eosinophil count), purpura (reddish skin patches), eosinophilia (increased eosinophils) associated with drug-induced hepatotoxicity, renal toxicity (allergic tubulo-interstitial nephritis), hematuria (blood in urine).

Acute allergic reactions following acetylsalicylic acid intake may, if necessary, be treated with adrenaline, corticosteroids, and an antihistamine.

If you forget to take Alkaeffer

Continue treatment as per the recommended dose. Do not take a double dose to make up for the missed dose.

If you stop taking Alkaeffer

Stopping treatment with Alkaeffer does not cause any adverse effects.

If you have any questions about 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.
The most frequently observed side effects involve the gastrointestinal system.
These disturbances may be partially reduced by taking the medicine with food.
Most side effects depend on both the dose and the duration of treatment.
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 blood

• prolonged bleeding time,
• anaemia due to gastrointestinal haemorrhage,
• reduced platelet count (thrombocytopenia) in extremely rare cases. Following haemorrhage, post-haemorrhagic/iron-deficiency anaemia (due, for example, to occult microbleeding) may occur, with associated laboratory parameter changes and corresponding clinical signs and symptoms such as asthenia (weakness), pallor, and hypoperfusion (reduced blood supply to tissues).

Effects on the nervous system

• headache,
• dizziness. Rarely:
• Reye's syndrome (*), an acute illness affecting the brain and liver, potentially fatal, which affects almost exclusively children. From rare to very rare:
• cerebral haemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or anticoagulant therapy (medicines used to slow down or inhibit blood clotting), which in isolated cases may be potentially life-threatening.

Effects on the ear

• tinnitus (ringing/buzzing/rustling/whistling in the ear).

Effects on the respiratory system

• respiratory disease exacerbated by acetylsalicylic acid,
• asthma syndrome,
• rhinitis (runny nose),
• nasal congestion (stuffy 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 disturbances,
• heartburn,
• gastrointestinal pain,
• gingival bleeding,
• vomiting,
• diarrhoea,
• nausea,
• cramp-like abdominal pain (associated with allergic reactions). Rarely:
• gastrointestinal inflammation,
• gastrointestinal erosion,
• gastrointestinal ulceration,
• haematemesis (vomiting blood or "coffee-ground" material),
• melena (passage of black, tarry stools),
• oesophagitis (inflammation of the oesophagus). Very rarely:
• haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation, with corresponding clinical signs and symptoms and changes in laboratory parameters. May occur with unknown frequency (especially with long-term treatment):
• Intestinal diaphragm disease

Effects on the liver

• rarely: hepatotoxicity (hepatocellular damage, generally mild and asymptomatic), manifesting as increased transaminase levels.

Effects on the skin**

• skin rash,
• oedema (swelling),
• urticaria,
• pruritus,
• erythema (redness),
• angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• impaired renal function and acute kidney injury (in conditions of impaired blood circulation to the kidneys),
• urogenital haemorrhage (bleeding from the urinary and genital tract).

Effects on the body as a whole

• procedural haemorrhages (immediately before, during, and immediately after surgery),
• haematomas (collections of blood outside blood vessels).

Effects on the immune system

• Hypersensitivity reactions
• rarely: anaphylactic shock (severe allergic reaction, potentially fatal), with associated laboratory parameter changes and clinical manifestations.

(*) Reye's syndrome (RS)
RS initially presents with vomiting (persistent or recurrent) and other signs of encephalopathy of varying severity: from lethargy, drowsiness, or personality changes (irritability or aggressiveness) to disorientation, confusion, or delirium, progressing to seizures or loss of consciousness. The clinical picture may vary: vomiting may even be absent or replaced by diarrhoea.
If these symptoms occur in the days immediately following an influenza (or influenza-like) episode, chickenpox, or another viral infection during which acetylsalicylic acid or other medicines containing salicylates were administered, physicians should immediately consider the possibility of RS.
(**) Severe skin reactions, including 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alkaeffer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Alkaeffer contains

• Active substance: acetylsalicylic acid. One effervescent tablet contains 324 mg of acetylsalicylic acid.
• Excipients: sodium hydrogen carbonate, citric acid.

Description of the appearance of Alkaeffer and package contents
Alkaeffer is presented as effervescent tablets.
Pack sizes: 2, 10, 20, 30 or 40 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa 130 - Milan, Italy
Manufacturer
Bayer Bitterfeld GmbH - Greppin, Germany