Ansimar
Italy
Table of Contents
Package leaflet: Information for the patient
ANSIMAR 400 mg tablets, 200 mg powder for oral solution in sachets, 20 mg/ml syrup
Doxofilline
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What ANSIMAR is and what it is used for
- What you need to know before taking ANSIMAR
- How to take ANSIMAR
- Possible side effects
- How to store ANSIMAR
- Contents of the pack and other information
1. What ANSIMAR is and what it is used for
ANSIMAR contains doxofylline, which is indicated for the treatment of bronchial asthma and pulmonary diseases characterized by bronchial constriction.
2. What you need to know before taking ANSIMAR
Do not take ANSIMAR
- if you are allergic to doxofylline, to similar substances (xanthine derivatives), or to any of the other ingredients of this medicine (listed in section 6);
- if you have a current or recent heart attack;
- if you have low blood pressure;
- if you are breastfeeding (see Pregnancy and breastfeeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking ANSIMAR.
Inform your doctor:
- if you have heart problems (congestive heart failure, heart disease, chronic pulmonary heart disease, congestive cardiac insufficiency);
- if you have lung problems (chronic obstructive pulmonary diseases);
- if you suffer from high blood pressure (hypertension);
- if you are elderly;
- if you are a smoker;
- if you have a severe reduction in oxygen levels in the blood (severe hypoxaemia);
- if you have a thyroid disorder (hyperthyroidism);
- if you have liver problems (hepatopathy);
- if you have kidney problems (impaired renal function);
- if you have a lesion of the inner stomach wall (peptic ulcer);
- if you currently have infections.
Other medicines and ANSIMAR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are being treated with:
xanthine derivatives, medicines similar to ANSIMAR, used for respiratory diseases;
ephedrine and other sympathomimetic medicines (medicines acting on the central nervous system);
- erythromycin, lincomycin, clindamycin, antibiotics used for bacterial infections;
- oral anticoagulants (TAO), used to delay blood clotting;
- allopurinol, used for gout (a disease causing joint inflammation and pain);
- cimetidine, used for stomach problems;
- propranolol, used for heart conditions;
- influenza vaccine, used to prevent flu;
- phenytoin and other anticonvulsants, used to treat epilepsy.
ANSIMAR with food and drink
Consume moderate amounts of food and beverages containing caffeine during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will prescribe ANSIMAR only if strictly necessary.
ANSIMAR must not be taken during breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
ANSIMAR 400 mg tablets contain lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
ANSIMAR 400 mg tablets contain sodium
ANSIMAR 400 mg tablets contain less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
ANSIMAR 200 mg oral solution powder in sachets contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
ANSIMAR 200 mg oral solution powder in sachets contains 0.03 g of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
ANSIMAR 20 mg/ml syrup contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
ANSIMAR 20 mg/ml syrup contains ethanol
This medicine contains 9.6 vol% ethanol (alcohol). Each dose contains 1.6 g of alcohol, equivalent to 0.83 ml of beer and 2 ml of wine per dose. It may be harmful for alcoholics. This should be taken into consideration in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicine may impair your ability to drive or operate machinery.
ANSIMAR 20 mg/ml syrup contains methyl p-hydroxybenzoate
May cause allergic reactions (including delayed reactions).
3. How to use ANSIMAR
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
ANSIMAR 400 mg tablets
Adults
The recommended dose is 1 tablet 2–3 times daily.
ANSIMAR 20 mg/ml syrup
Adults
The recommended dose is one 20 ml measuring cup 2–3 times daily.
ANSIMAR 200 mg oral solution powder in sachets
Adults and adolescents over 12 years of age
The recommended dose is 2 sachets 2–3 times daily.
Children (6–12 years)
The recommended dose is 1–3 sachets daily, dissolved in plenty of water.
If you take more ANSIMAR than you should
In case of overdose, serious disturbances in heart rhythm (cardiac arrhythmias) and tonic-clonic seizures with involuntary muscle contractions may occur.
If you accidentally ingest or take an excessive dose of ANSIMAR, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about using 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.
The following side effects may occur:
- nausea, vomiting, epigastric pain (stomach ache);
- headache, irritability, insomnia;
- tachycardia (increased heart rate), extrasystoles (alteration of heart rhythm), tachypnea (increased respiratory rate);
- hyperglycemia (increased blood sugar levels);
- albuminuria (presence of a protein called albumin in the urine).
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 through 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 ANSIMAR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store this medicine at room temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What ANSIMAR contains
ANSIMAR 400 mg tablets
- The active substance is doxofylline. Each tablet contains 400 mg of doxofylline.
- The other ingredients are: monohydrate lactose, microcrystalline cellulose and sodium carboxymethylcellulose, pregelatinized corn starch, anhydrous colloidal silica, hydrated colloidal silica, talc, magnesium stearate, Povidone K30.
ANSIMAR 200 mg powder for oral solution in sachets
- The active substance is doxofylline. Each sachet contains 200 mg of doxofylline.
- The other ingredients are: sucrose, ammonium glycyrrhizinate, strawberry flavour, aspartame.
ANSIMAR 20 mg/ml syrup
- The active substance is doxofylline. 100 ml of syrup contain 2 g of doxofylline.
- The other ingredients are: sucrose, ethanol, methyl p-hydroxybenzoate, peppermint essence, ammonium glycyrrhizinate, purified water.
Description of the appearance of ANSIMAR and contents of the pack
ANSIMAR 400 mg tablets
20 tablets in PVC/AL blisters.
ANSIMAR 200 mg powder for oral solution in sachets
20 sachets.
ANSIMAR 20 mg/ml syrup
200 ml bottle.
Marketing Authorization Holder
ABC Farmaceutici S.p.A., Corso Vittorio Emanuele II 72, 10121, Torino, Italy.
Manufacturers
Tablets and syrup
ABC Farmaceutici S.p.A., Canton Moretti n° 29, Ivrea, Torino, Italy.
Powder for oral solution in sachets
LA.FA.RE. S.r.l., Via Benedetto Cozzolino, 77, 80056 Ercolano (NA), Italy.
Package leaflet: Information for the user
ANSIMAR
100 mg/10 ml solution for intravenous injection
Doxofylline
Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What ANSIMAR is and what it is used for
- What you need to know before using ANSIMAR
- How to use ANSIMAR
- Possible side effects
- How to store ANSIMAR
- Contents of the pack and other information
1. What ANSIMAR is and what it is used for
ANSIMAR contains doxofylline, indicated for the treatment of bronchial asthma and pulmonary diseases characterized by bronchoconstriction.
2. What you need to know before taking ANSIMAR
Do not use ANSIMAR
- if you are allergic to doxofylline, to similar substances (xanthine derivatives), or to any of the other ingredients of this medicine (listed in section 6);
- if you have an ongoing or recent heart attack;
- if you have low blood pressure;
- if you are breastfeeding (see Pregnancy and breastfeeding).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking ANSIMAR.
Inform your doctor:
- if you have heart problems (congestive heart failure, heart disease, chronic pulmonary heart disease, congestive cardiac insufficiency);
- if you have lung problems (chronic obstructive lung diseases); if you suffer from high blood pressure (hypertension);
- if you are elderly;
- if you are a smoker;
- if you have a severe reduction in the amount of oxygen in the blood (severe hypoxaemia);
- if you have a thyroid disorder (hyperthyroidism);
- if you have liver problems (hepatopathy);
- if you have kidney problems (impaired renal function); if you have a lesion of the inner wall of the stomach (peptic ulcer);
- if you currently have infections.
Other medicines and ANSIMAR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are being treated with:
xanthine derivatives, medicines similar to ANSIMAR, used for respiratory diseases;
ephedrine and other sympathomimetic medicines (medicines acting on the central nervous system);
- erythromycin, lincomycin, clindamycin, antibiotics used for infections caused by bacteria;
- oral anticoagulants (OAC), used to delay blood clotting;
- allopurinol, used for gout (a disease causing joint inflammation and pain);
- cimetidine, used for stomach problems;
- propranolol, used for heart conditions;
- influenza vaccine, used to prevent flu; phenytoin and other anticonvulsants, used to treat epilepsy.
ANSIMAR with food and drinks
Consume moderate amounts of food and drinks containing caffeine during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will prescribe ANSIMAR only if strictly necessary.
ANSIMAR must not be taken during breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
3. How to use ANSIMAR
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 2 vials administered by slow intravenous injection (15–20 minutes).
Lie down during administration.
The administration may be repeated every 12 hours, at the doctor’s discretion.
If you use more ANSIMAR than you should
In case of overdose, severe disturbances in heart rhythm (cardiac arrhythmias) and tonic-clonic seizures with involuntary muscle contractions may occur.
In the event of accidental ingestion or administration of an excessive dose of ANSIMAR, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur:
- nausea, vomiting, epigastric pain (stomach ache);
- headache, irritability, insomnia;
- tachycardia (increased heart rate), extrasystoles (irregular heartbeat), tachypnea (increased respiratory rate);
- hyperglycemia (increased blood sugar levels);
- albuminuria (presence of a protein called albumin in the urine).
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to store ANSIMAR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine 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 ANSIMAR contains
- The active substance is doxofylline. Each 10 ml vial contains 100 mg of doxofylline.
- The other component is water for injections.
Description of the appearance of ANSIMAR and pack contents
3 Vials.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin – Italy
Manufacturers
BIOLOGICI ITALIA LABORATORIES - Via Filippo Serpero, 2 – Masate (MI) – Italy
EUROFINS BIOLAB S.P.A. (Pyrogen testing) - Via Buozzi, 2 – 20090 Vimodrone (MI) – Italy
FARMA MEDITERRANIA S.L. - C/Sant Sebastià, s/n – Sant Just Desvern - Barcelona (Spain)
ESSETTI Farmaceutici S.r.l. - Via Campobello, 15 - 00040 Pomezia (Rome)