ANSIMAR 400 mg Coated Tablets

Зміст інструкції

1. ANSIMAR 400 mg tablets, 200 mg oral solution powder in sachets, 20 mg/ ml syrup
   1. What is ANSIMAR and what is it used for
   2. What you need to know before taking ANSIMAR
   3. How to use ANSIMAR
   4. Possible side effects
   5. How to store ANSIMAR
   6. Contents of the pack and other information
2. ANSIMAR
   1. What is ANSIMAR and what is it used for
   2. What you need to know before using ANSIMAR
   3. How to use ANSIMAR
   4. Possible side effects
   5. How to store ANSIMAR
   6. Contents of the pack and other information

ANSIMAR 400 mg tablets, 200 mg oral solution powder in sachets, 20 mg/ ml syrup

Doxofilline
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ANSIMAR and what is it used for

ANSIMAR contains doxofylline which is indicated for the treatment of bronchial asthma and lung diseases
characterized by narrowing of the bronchi.

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 are having or have recently had a 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.
Tell your doctor:

• if you have heart problems (congestive heart failure, heart disease, chronic pulmonary heart disease, congestive heart failure);
• if you have lung problems (chronic obstructive lung disease);
• if you suffer from high blood pressure (hypertension);
• if you are elderly;
• if you are a smoker;
• if you have a severe reduction in blood oxygen levels (severe hypoxemia);
• if you have a thyroid disorder (hyperthyroidism);
• if you have liver problems (hepatopathy);
• if you have kidney problems (impaired kidney function);
• if you have a lesion of the inner wall of the stomach (peptic ulcer);
• if you have ongoing infections.

Other medicines and ANSIMAR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking:
xanthine derivatives, medicines similar to ANSIMAR, used for respiratory diseases;
ephedrine and other sympathomimetic medicines (medicines that act on the central nervous system);

• erythromycin, lincomycin, clindamycin, antibiotics used for infections caused by bacteria;
• oral anticoagulants (TAO), used to delay blood clotting;
• allopurinol, used for gout (a disease that causes inflammation and pain in the joints);
• cimetidine, used for stomach problems;
• propranolol, used for heart problems;
• influenza vaccine, used for the prevention of influenza;
• phenytoin and other anticonvulsants, used to treat epilepsy

ANSIMAR with food and drink
Take moderate amounts of drinks and foods containing caffeine during treatment with this
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
The doctor will prescribe ANSIMAR only if absolutely necessary.
ANSIMAR should not be taken during breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.

ANSIMAR 400 mg tablets contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

ANSIMAR 400 mg tablets contains sodium
ANSIMAR 400 mg tablets contains less than 1 mmol (23 mg) of sodium per dose, which is
essentially ‘sodium-free’.

ANSIMAR 200 mg powder for oral solution in sachets contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

ANSIMAR 200 mg powder for oral solution in sachetscontains 0.03 g of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disorder that causes a build-up of phenylalanine because the body cannot process it
correctly.

ANSIMAR 20 mg/ml syrup contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

ANSIMAR 20 mg/ml syrup contains ethyl alcohol
This medicine contains 9.6 vol% ethyl alcohol. Each dose provides 1.6 g of alcohol equivalent to
0.83 ml of beer and 2 ml of wine per dose. It may be harmful to alcoholics. To be considered in
pregnant or breastfeeding women, children and high-risk groups such as people with liver or epilepsy.
The amount of alcohol in this medicine may impair your ability to drive vehicles and operate machinery.

ANSIMAR 20 mg/ml syrup contains methyl p-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use ANSIMAR

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult
your doctor or pharmacist.

ANSIMAR 400 mg tablets
Adults
The recommended dose is 1 tablet 2-3 times a day

ANSIMAR 20 mg/ ml syrup
Adults
The recommended dose is 1 measuring spoon of 20 ml 2-3 times a day.

ANSIMAR 200 mg powder for oral solutionin sachets
Adults and adolescents over 12 years of age
The recommended dose is 2 sachets 2-3 times a day.
Children (6-12 years)
The recommended dose is 1-3 sachets per day dissolved in plenty of water.

If you use more ANSIMAR than you should
In case of overdose, serious alterations in heart rhythm (cardiac arrhythmias) and convulsive crises with involuntary muscle contractions (tonic-clonic) may occur.
In case of accidental ingestion/intake of an excessive dose of ANSIMAR, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts 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 following side effects 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)
• albuminuria (presence of a protein called albumin in the urine).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 which is 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 in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment .

6. Contents of the pack and other information

What ANSIMAR contains
ANSIMAR 400 mg tablets

• The active ingredient is doxofylline. Each tablet contains 400 mg of doxofylline.
• The other ingredients are: lactose monohydrate, 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 ingredient is doxofylline. Each sachet contains 200 mg of doxofylline.
• The other ingredients are: sucrose, ammonium glycyrrhizate, strawberry aroma, aspartame

ANSIMAR 20 mg/ ml syrup

• The active ingredient is doxofylline. 100 ml of syrup contain 2 g of doxofylline.
• The other ingredients are: sucrose, ethyl alcohol, methyl p-hydroxybenzoate, peppermint essence, ammonium glycyrrhizate, 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 Authorisation Holder
ABC Farmaceutici S.p.A., Corso Vittorio Emanuele II 72, 10121, Turin, Italy.

Manufacturers
Tablets and syrup
ABC Farmaceutici S.p.A., Canton Moretti n° 29, Ivrea, Turin, Italy.

Powder for oral solution in sachets
LA.FA.RE. S.r.l., Via Benedetto Cozzolino, 77, 80056 Ercolano (NA), Italy.

ANSIMAR

100 mg/10 ml injectable solution for intravenous use
Doxofilline
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is ANSIMAR and what is it used for

ANSIMAR contains doxofylline which is indicated for the treatment of bronchial asthma and lung diseases
characterized by narrowing of the bronchi.

2. What you need to know before using 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 are having a heart attack or have recently had one;
• if you have low blood pressure;
• if you are breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions
Consult your doctor, pharmacist or nurse before using ANSIMAR
Tell your doctor:

• if you have heart problems (congestive heart failure, heart disease, chronic cor pulmonale, congestive heart failure);
• 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 blood oxygen levels (severe hypoxemia),
• 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 have ongoing infections.

Other medicines and ANSIMAR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking:
xanthine derivatives, medicines similar to ANSIMAR, used for respiratory diseases;
ephedrine and other sympathomimetic medicines (medicines that act on the central nervous system);

• erythromycin, lincomycin, clindamycin, antibiotics used for infections caused by bacteria;
• oral anticoagulants (TAO), used to delay blood clotting;
• allopurinol, used for gout (disease that causes inflammation and pain in the joints);
• cimetidine used for stomach problems;
• propranolol, used for heart problems;
• influenza vaccine, used for influenza prevention phenytoin and other anticonvulsants, used to treat epilepsy ANSIMAR with food and drinkTake moderate amounts of beverages and foods containing caffeine during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
The doctor will prescribe ANSIMAR only if really necessary.
ANSIMAR should not be taken during breastfeeding.

Driving and using machines
This medicine does not alter the ability to drive vehicles and operate machinery.

3. How to use ANSIMAR

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
Adults
The recommended dose is 2 vials intravenously slowly (15-20 minutes).
During administration, assume a lying position.
Administration may be repeated every 12 hours, at the doctor's discretion.

If you use more ANSIMAR than you should
In case of overdose, serious alterations of the heart rhythm (cardiac arrhythmias) and seizures
with involuntary muscle contractions (tonic-clonic) may occur.
In case of accidental ingestion/administration of an excessive dose of ANSIMAR, immediately
inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:

• nausea, vomiting, epigastric pain (stomach ache);
• headache, irritability, insomnia;
• tachycardia (increased heart rate, extrasystoles (altered heart rhythm), tachypnea (increased respiratory rate);
• hyperglycemia (increased blood sugar levels)
• albuminuria (presence of a protein called albumin in the urine). Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

By reporting side effects you can contribute to providing 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 which is reported on the packaging after Expiry
The expiry date indicated refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment .

6. Contents of the pack and other information

What ANSIMAR contains

• The active ingredient 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 contents of the pack
3 Vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABC Farmaceutici S.p.A – Corso Vittorio Emanuele II, 72 – 10121 Turin – Italy

Manufacturer
BIOLOGICI ITALIA LABORATORIES - Via Filippo Serpero, 2 – Masate (MI) – Italy
EUROFINS BIOLAB S.P.A. (Pyrogen controls) - Via Buozzi, 2 – 20090 Vimodrone (MI) – Italy
FARMA MEDITERRANIA S.L. - C/Sant Sebastià, s/n – Sant Just Desvem - Barcelona (Spain)
ESSETTI Farmaceutici S.r.l. - Via Campobello, 15 - 00040 Pomezia (Rome)