Antalgil for pain and fever: detailed information

Patient Information Leaflet

Antalgil Pain and Fever

400 mg oral granules for oral solution
ibuprofen
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.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days of treatment in adolescents or after 4 days of treatment for pain or after 3 days of treatment for fever in adults.

Contents of this leaflet

What ANTALGIL PAIN AND FEVER is and what it is used for
What you need to know before taking ANTALGIL PAIN AND FEVER
How to take ANTALGIL PAIN AND FEVER
Possible side effects
How to store ANTALGIL PAIN AND FEVER
Package contents and other information

1. What ANTALGIL PAIN AND FEVER is and what it is used for

ANTALGIL PAIN AND FEVER belongs to a group of analgesic and anti-inflammatory medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by altering the way the body responds to pain and inflammation.
ANTALGIL PAIN AND FEVER is used in adults and adolescents weighing at least 40 kg (from 12 years of age):

for the symptomatic treatment of mild to moderate pain of various origins, such as headache, bone and joint pain (musculoskeletal), muscle pain, painful conditions associated with cold and flu, toothache, nerve pain (neuralgia), menstrual pain;
for the symptomatic treatment of fever.

For musculoskeletal pain and neuralgia, the medicine should be used only on medical advice.

Consult a doctor if you do not feel better or if you feel worse:

after 3 days in adolescents
after 3 days of treatment for fever or after 4 days of treatment for pain in adults

2. What you should know before taking ANTALGIL PAIN AND FEVER

Do not take ANTALGIL PAIN AND FEVER

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
if you have had allergic reactions such as bronchospasm (tightening of the muscles in the lungs that may cause difficulty breathing), asthma, runny nose, itching and nasal inflammation with sneezing, skin rash (urticaria), or angioedema (swelling under the skin) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (medicines for pain or fever);
if you are a woman in the last three months of pregnancy (see "Pregnancy, breastfeeding and fertility");
if you suffer from stomach or intestinal diseases (e.g. active or severe gastric or duodenal ulcer or gastrointestinal bleeding);
if you have previously experienced perforation or bleeding in the stomach or small intestine related to prior use of NSAIDs;
if you have previously had two or more episodes of stomach or small intestine ulcer or bleeding;
if you suffer from severe heart failure;
if you suffer from severe liver or kidney failure;
if you are in a state of significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
if you suffer from phenylketonuria, a rare genetic disorder affecting the metabolism of the amino acid phenylalanine (see section “ANTALGIL PAIN AND FEVER contains aspartame”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ANTALGIL PAIN AND FEVER:

if you suffer from asthma, runny nose (chronic rhinitis), nasal polyps, inflammation of the nasal mucosa (sinusitis), or if you suffer/have suffered from allergies to substances other than NSAIDs, as you may experience breathing difficulties (bronchospasm), skin redness with itching (urticaria), or swelling of the skin and throat (angioedema);
if you are taking other NSAIDs (including COX-2 inhibitors (an enzyme involved in inflammatory processes)), as this may increase the risk of ulcers and bleeding (see section "Other medicines and ANTALGIL PAIN AND FEVER");
if you have kidney, heart or liver problems, or if you are taking diuretics or ACE inhibitors, as you may be more prone to developing kidney problems. In addition, habitual and concomitant use of multiple painkillers may further increase this risk;
if you have mild to moderate liver problems (hepatic dysfunction) or mild to moderate kidney disease;
if you are elderly, as you are more likely to develop adverse effects, particularly bleeding and perforation of the digestive tract;
if you have blood clotting disorders or are taking blood-thinning medicines (anticoagulants). See section "Other medicines and ANTALGIL PAIN AND FEVER";
if you suffer from a disease that may affect various organs and tissues of the body (systemic or disseminated lupus erythematosus) or from a connective tissue disease affecting many parts of the body such as bones and cartilage, as symptoms of "aseptic meningitis" have been observed in rare cases in patients treated with ibuprofen. Although aseptic meningitis is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients without chronic concomitant diseases;
if you have an infection – see the following section "Infections";
if you intend to become pregnant (see section "Pregnancy, breastfeeding and fertility");
if you have difficulty conceiving or are undergoing fertility investigations (see section "Pregnancy, breastfeeding and fertility"). Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop taking ANTALGIL PAIN AND FEVER and contact your doctor or emergency medical services if you notice any of these signs.

Gastrointestinal precautions
NSAIDs may cause gastrointestinal bleeding, ulceration or perforation, which may be fatal, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk is higher if NSAIDs are used at high doses, in patients with a previous history of ulcers, especially if complicated by haemorrhage or perforation (see section "Other medicines and ANTALGIL PAIN AND FEVER"), and in elderly patients.
Discuss treatment with your doctor or pharmacist before taking ANTALGIL PAIN AND FEVER

if you are elderly or have previously suffered from ulcers, especially if complicated by perforation or accompanied by bleeding (see section "Do not take ANTALGIL PAIN AND FEVER"), as the risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses of anti-inflammatory drugs. In these cases, treatment should be started with the lowest available dose, and your doctor may prescribe a medicine to protect your stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of stomach and/or intestinal diseases (see section "Other medicines and ANTALGIL PAIN AND FEBBRE");
if you suffer or have previously suffered from chronic inflammatory bowel diseases, such as ulcerative colitis (inflammation of the colon with ulcers) or Crohn's disease (inflammation of the digestive tract), as these conditions may worsen (see section 4 "Possible side effects");
if you have previously experienced stomach or intestinal diseases related to drug use, and especially if you are elderly, you should inform your doctor of any unusual intestinal symptoms (especially bleeding), particularly during the initial stages of treatment;
if you are taking other medicines that may increase the risk of ulcer or bleeding, such as oral corticosteroids (e.g. prednisolone), blood-thinning medicines (e.g. warfarin), selective serotonin reuptake inhibitors (a medicine for depression) or antiplatelet agents (e.g. acetylsalicylic acid). See section "Other medicines and ANTALGIL PAIN AND FEVER". If gastrointestinal bleeding or ulceration occurs in patients taking ANTALGIL PAIN AND FEVER, treatment must be discontinued.

Cardiovascular precautions
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking ANTALGIL PAIN AND FEVER if you:

have heart problems including heart failure, angina pectoris (chest pain), or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-stroke" or "TIA", transient ischaemic attack);
have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). Stop using ANTALGIL PAIN AND FEVER and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Infections
ANTALGIL PAIN AND FEVER may mask signs of infection such as fever and pain. Therefore, ANTALGIL PAIN AND FEVER may delay appropriate treatment of the infection, increasing the risk of complications. This phenomenon has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
Contact a doctor immediately if you take this medicine during an infection and symptoms of infection persist or worsen.
Medicines such as ANTALGIL PAIN AND FEVER may:

be associated with the development of serious kidney diseases (such as renal papillary necrosis, analgesic nephropathy and kidney failure), especially with prolonged and/or habitual use; if necessary, your doctor will monitor your kidney function;
cause eye disorders, so periodic eye examinations are recommended in case of prolonged treatment. If you experience visual disturbances, discontinue treatment with ANTALGIL PAIN AND FEVER.

Adolescents
If the adolescent is dehydrated, there is a risk of developing kidney disease.
Other medicines and ANTALGIL PAIN AND FEVER
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ANTALGIL PAIN AND FEVER may affect or be affected by other medicines.
Consult your doctor before taking ANTALGIL PAIN AND FEVER with other medicines, particularly with:

corticosteroids (e.g. cortisone);
anticoagulant medicines (that thin the blood/prevent clotting, e.g. warfarin, heparin);
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan). ANTALGIL PAIN AND FEVER may reduce the effect of these medicines. If you are being treated with these medicines, are elderly or suffer from kidney disease, monitoring of kidney function is recommended;
antiplatelet agents (e.g. acetylsalicylic acid, clopidogrel, ticlopidine) and selective serotonin reuptake inhibitors (a medicine for depression), as they may increase the risk of stomach or intestinal bleeding. Therefore, your doctor may prescribe a medicine to protect your stomach;
acetylsalicylic acid, COX-2 inhibitors or other NSAIDs (used for inflammatory conditions). The concomitant use of these medicines with ANTALGIL PAIN AND FEVER should be avoided, as it may increase the possible adverse effects on the stomach and intestine;
lithium (used to treat depression and mania) or phenytoin (used to prevent epileptic seizures): monitoring of blood levels of these substances is recommended during combined use;
methotrexate, used in the treatment of cancer, autoimmune diseases or rheumatoid arthritis;
moclobemide (a medicine used to treat depressive disorders or social phobia);
aminoglycosides (medicines used against certain types of bacteria);
cardiac glycosides (medicines used for heart diseases). Medicines such as ANTALGIL PAIN AND FEVER may worsen heart diseases;
colestyramine (used to treat high cholesterol);
cyclosporine (to suppress the immune response after organ transplantation), as medicines such as ANTALGIL PAIN AND FEVER may increase the risk of kidney damage;
herbal extracts: Ginkgo biloba may increase the risk of bleeding;
mifepristone (used for medical termination of pregnancy);
quinolone antibiotics (medicines used to treat infections), as taking these together with NSAIDs may increase the risk of seizures;
sulfonylureas (medicines for diabetics): monitoring of blood sugar levels is recommended as a precaution during combined use;
tacrolimus (a medicine to suppress the immune response), as it increases the risk of renal toxicity;
zidovudine and ritonavir (medicines for the treatment of AIDS), monitoring of blood cell count is recommended as a precaution during combined use;
probenecid, a medicine used to treat gout (an acute inflammatory disease);
CYP2C9 inhibitors, e.g. voriconazole and fluconazole (used in fungal infections);
bisphosphonates, medicines used to treat bone diseases, as they may increase adverse effects on the stomach and intestine;
oxpentifylline, used to treat circulatory diseases of the arteries in the legs or arms, as it may increase adverse effects on the stomach and intestine;
baclofen (a muscle relaxant).

Other medicines may affect or be affected by treatment with ANTALGIL PAIN AND FEVER. Therefore, always consult your doctor or pharmacist before using ANTALGIL PAIN AND FEVER with other medicines.
ANTALGIL PAIN AND FEVER with alcohol
Avoid drinking alcohol while taking this medicine, as alcohol may increase adverse effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney, heart and lung problems in the unborn child. It may affect your and your baby's tendency to bleed and may cause labour to start later or last longer than expected.
Do not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and after consulting your doctor. If treatment is required during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days starting from the 20th week of pregnancy, ANTALGIL PAIN AND FEVER may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment lasts for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk. However, as no harmful effects on newborns have been reported to date, it is usually not necessary to stop breastfeeding during short-term use of ibuprofen at the recommended dose.
Fertility
If you have difficulty conceiving or are undergoing fertility investigations, stop taking this medicine as it may impair fertility.
Driving and use of machinery
Ibuprofen generally has no negative effects on the ability to drive or use machinery. However, if you perform an activity requiring alertness, be cautious if you experience adverse effects such as drowsiness, dizziness or visual disturbances during treatment with ANTALGIL PAIN AND FEVER.
ANTALGIL PAIN AND FEVER contains:

Sodium: this medicine contains 45 mg of sodium (a main component of table salt) per sachet. This corresponds to 2.3% of the maximum daily dietary intake recommended for an adult;
Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine;
Potassium: this medicine contains 2.25 mmol (or 88 mg) of potassium per sachet. This should be taken into account in patients with reduced kidney function or in patients following a low-potassium diet;
Aspartame (E 951): this medicine contains 20 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take ANTALGIL PAIN AND FEVER

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The lowest effective dose should be taken for the shortest duration necessary to relieve symptoms. If you have an infection, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents weighing at least 40 kg (from 12 years of age):
The recommended dose is one sachet 2–3 times daily, as needed, with an interval of at least 4–6 hours between doses.
Do not take more than 3 sachets of ANTALGIL PAIN AND FEVER within 24 hours.
Dissolve the contents of one sachet in a glass of water (200 ml), hot or cold, stirring with a teaspoon until dissolved, and drink the solution immediately (do not let it stand for more than one hour).
ANTALGIL PAIN AND FEVER may be taken on an empty stomach for faster absorption. For patients with a sensitive stomach, it is recommended to take ANTALGIL PAIN AND FEVER with food.

Patients with renal or hepatic impairment
If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the appropriate dose for you.
If you have severe liver or kidney disease, do not take ANTALGIL PAIN AND FEVER.

Elderly
Consult your doctor, who will determine the appropriate dose, which should be the lowest possible, especially if you have reduced renal or hepatic function.

Children and adolescents
This medicine is not intended for use in children under 12 years of age or in adolescents weighing less than 40 kg. Other pharmaceutical forms or dosages may be more suitable for administration.

Duration of treatment
If you are an adult, consult your doctor if symptoms worsen or do not improve after 4 days for pain or after 3 days for fever.
In adolescents, consult your doctor if symptoms worsen or if this medicine is needed for more than 3 days.
Consult your doctor if you notice recent changes in the characteristics of the condition.

If you take more ANTALGIL PAIN AND FEVER than you should
If you have taken more ANTALGIL PAIN AND FEVER than recommended or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital for advice on the potential risk and necessary actions.
Most patients who have ingested significant amounts of ibuprofen develop symptoms within 4–6 hours. Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, and uncontrolled eye movements. Agitation, drowsiness, disorientation, or coma may also occur.
Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may also occur. In asthmatic patients, asthma exacerbation is possible. Moreover, low blood pressure and reduced breathing may occur. Disorientation, agitation, fainting, and cardiovascular toxicity may develop, including low blood pressure (hypotension) or slow heart rate (bradycardia) or fast heart rate (tachycardia). In cases of severe poisoning, serious kidney and liver damage may occur.

If you forget to take ANTALGIL PAIN AND FEVER
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects can be minimised by taking the lowest effective dose for the shortest duration necessary to relieve symptoms.
If you develop a stomach ulcer, gastrointestinal bleeding and/or skin and/or mucosal lesions, stop taking ANTALGIL DOLORE E FEBBRE and contact your doctor immediately. These side effects are usually more common in elderly patients.
Stop taking this medicine and contact a doctor immediately if you experience any of the following:

mucosal lesions
signs of an allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock)
vision problems
liver disorders (hepatic dysfunction)
severe upper abdominal pain, vomiting blood, blood in stools and/or black stools (may indicate gastrointestinal bleeding, ulceration or perforation, which can be fatal, especially in elderly patients)
flat, non-elevated red spots, target-like or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
widespread, red, scaly rash with subcutaneous bumps and blisters mainly affecting skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear early in treatment (generalised exanthematous pustulosis)

In case of any of the allergic reactions listed above, go to hospital immediately, as emergency treatment facilities, medications, and trained personnel must be available without delay. Severe adverse reactions, sometimes fatal, have been reported with ibuprofen use, even in the absence of known allergies.
The risk of experiencing these symptoms is higher during the initial stages of treatment: in most cases, the reaction occurs within the first month of therapy.

In addition, other side effects may occur that have also been reported with similar medicines to ANTALGIL DOLORE E FEBBRE, listed below by frequency:

Common (may affect up to 1 in 10 people):

malaise
dizziness
fatigue
heartburn (pyrosis), abdominal pain, nausea, vomiting, stomach heaviness, indigestion, excessive intestinal gas (flatulence), diarrhoea, constipation, and mild gastrointestinal blood loss

Uncommon (may affect up to 1 in 100 people):

stomach inflammation (gastritis)
gastrointestinal ulcers, sometimes with bleeding and perforation
blood in stools (melena), vomiting blood (haematemesis), mouth sores (ulcerative stomatitis), intestinal inflammation, and worsening of colonic inflammation (colitis) or digestive tract disorders (Crohn’s disease) (see section "Warnings and precautions")
anxiety, insomnia
numbness of limbs or other body parts, drowsiness
nasal congestion (rhinitis)
breathing difficulties (bronchospasm, dyspnoea)
temporary cessation of breathing (apnoea)
visual disturbances
hearing disturbances
tinnitus (ringing in the ears)
dizziness (vertigo)
liver disorders (altered liver function)
liver inflammation (hepatitis)
yellowing of the skin and eyes (jaundice)
kidney disorders (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome, and renal failure)
allergic reactions such as skin rash, urticaria, itching, red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, breathing difficulties (bronchospasm or wheezing), asthma attacks with low blood pressure
skin reactions to light (photosensitivity)

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

reduction in blood cells: reduced white blood cells (leucopenia, neutropenia, agranulocytosis), reduced red blood cells (aplastic anaemia, haemolytic anaemia), reduced platelet concentration in blood (thrombocytopenia)
reduced blood clotting ability
depression, confusion, hallucinations
inflammation of the optic nerve (optic neuritis)
inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders (see section "Warnings and precautions"), with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation
eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
swelling due to fluid accumulation in tissues
lupus erythematosus syndrome
elevated blood nitrogen levels
changes in liver function tests (increased transaminases, increased alkaline phosphatase)
abnormal blood tests (reduced haemoglobin, reduced haematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

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

pancreatitis
heightened awareness of heartbeat (palpitations)
heart disorders (heart failure)
heart attack (myocardial infarction)
accumulation of fluid in the lungs (acute pulmonary oedema)
liver disorders (liver failure)
high blood pressure (hypertension)
severe allergic reactions, which may include symptoms such as swelling of the face, tongue, and throat causing breathing difficulties, rapid heartbeat, severe and rapidly occurring allergic reaction that may be fatal (anaphylaxis)
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis. In exceptional cases, severe skin infections and soft tissue complications may occur during chickenpox infection
worsening of inflammation caused by an existing infection (e.g., development of necrotising fasciitis)

Not known (frequency cannot be estimated from available data):

DRESS syndrome
generalised exanthematous pustulosis
chest pain, which may indicate a potentially severe allergic reaction known as Kounis syndrome

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: 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 ANTALGIL PAIN AND FEVER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and the outer carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture.
The shelf life after reconstitution in warm water is 60 minutes.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ANTALGIL PAIN AND FEVER contains:
The active substance is ibuprofen. Each single-dose sachet contains 512 mg of ibuprofen sodium dihydrate, equivalent to 400 mg of ibuprofen.
The other components are sucrose, potassium hydrogen carbonate (E 501), acesulfame potassium (E 950), orange flavour [containing flavouring preparations, flavouring substances, natural flavouring substances, maize maltodextrin, acacia gum (E 414), ascorbic acid (E 300), butylated hydroxyanisole (E 320)], aspartame (E 951).
Description of the appearance of ANTALGIL PAIN AND FEVER and contents of the pack
ANTALGIL PAIN AND FEVER is a granulate for oral solution, white to off-white in colour. Each single-dose sachet contains 3 g of granulate. Each pack contains 10 single-dose sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
V.I.M. G. Ottaviani S.p.A., P.zza Giovanni XXIII 5, 06012 Città di Castello (PG)
Manufacturer
E-Pharma Trento S.p.A., via Provina 2, 38123 Trento (TN).
This medicinal product is authorized in the EEA Member States under the following names: