Doxovent
Italy
Table of Contents
Package leaflet: Information for the patient
DOXOVENT
400 mg tablets
200 mg powder for oral solution in sachets
20 mg/ml syrup
doxofylline
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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What DOXOVENT is and what it is used for
- What you need to know before taking DOXOVENT
- How to take DOXOVENT
- Possible side effects
- How to store DOXOVENT
- Contents of the pack and other information
1. What DOXOVENT is and what it is used for
DOXOVENT contains the active substance doxofylline, which belongs to the group of medicines used to treat asthma (systemic antiasthmatics). This medicine is used to treat breathing difficulties and cough caused by bronchial asthma and by lung or bronchial diseases characterized by narrowing of the bronchi and resulting shortness of breath.
2. What you need to know before taking DOXOVENT
Do not take DOXOVENT
- if you are allergic to doxofylline, to chemically 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 (hypotension);
- if you are pregnant or breastfeeding.
Warnings and precautions
Always consult your doctor or pharmacist before taking DOXOVENT.
Take this medicine with caution in the following cases:
- if you have heart problems (heart disease, chronic pulmonary heart disease, congestive heart failure);
- if you suffer from high blood pressure (hypertension);
- if you are elderly;
- if you have poor oxygenation of the blood (severe hypoxaemia);
- if your thyroid gland produces excessive amounts of hormones (hyperthyroidism);
- if you have severe liver problems (chronic hepatopathy) or kidney problems (renal failure);
- if you suffer from gastritis or stomach or duodenal ulcer;
Inform your doctor if any of the following conditions apply to you, as a reduction in the dosage of the medicine may be necessary:
- if you are elderly;
- if your heart function is impaired (heart failure);
- if you have severe liver problems (hepatic failure);
- if you have ongoing infections.
Inform your doctor if you smoke cigarettes, as this may require an increase in the dosage of the medicine.
Other medicines and DOXOVENT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not take DOXOVENT together with other chemically similar substances (xanthine derivatives).
The administration of DOXOVENT together with ephedrine or other sympathomimetic medicines (medicines acting on the central nervous system) requires caution.
Concurrent administration of the following medicines may necessitate a reduction in dosage (see Warnings and precautions):
- erythromycin, lincomycin, clindamycin, antibiotics used for certain types of infections;
- oral anticoagulants (OAC), used to prevent blood clotting;
- allopurinol, used for gout and hyperuricaemia, which can cause joint inflammation leading to pain and swelling;
- cimetidine, used for gastric ulcer;
- propranolol, used for high blood pressure and arrhythmias;
- influenza vaccine, used to prevent flu.
If you are taking phenytoin and other medicines used for seizures (anticonvulsants), or if you smoke cigarettes, an increase in the dosage of the medicine may be necessary (see "Warnings and precautions").
DOXOVENT with food and drinks
Consume moderate amounts of beverages and foods containing caffeine during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine carefully and only if necessary during pregnancy, and always under direct medical supervision.
This medicine is contraindicated during breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
DOXOVENT 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.
DOXOVENT 200 mg oral solution powder contains 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 causing accumulation of phenylalanine because the body cannot properly eliminate it.
DOXOVENT 20 mg/ml syrup contains 7.5 g of sucrose per dose and should be administered with caution in patients with diabetes mellitus.
DOXOVENT 20 mg/ml syrup contains methyl p-hydroxybenzoate
This medicine contains methyl p-hydroxybenzoate which may cause allergic reactions (including delayed reactions).
3. How to take DOXOVENT
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults is 1 tablet 2-3 times daily or 2 measuring cups of 10 ml of syrup (1 measuring cup of 10 ml corresponds to 200 mg of doxofylline) 2-3 times daily.
The recommended dose in children aged between 6 and 12 years is 1-3 sachets per day (12-18 mg/kg), dissolved in a large amount of water.
If these doses are exceeded, monitoring of doxofylline blood levels is recommended.
If you take more DOXOVENT than you should
If you take an excessive amount of this medicine, serious disturbances in heart rhythm (cardiac arrhythmias) and epileptic seizures with convulsions and involuntary muscle contractions (tonic-clonic seizures) may occur. These symptoms may represent the first signs of intoxication.
In case of accidental ingestion/overdose of DOXOVENT, contact your doctor immediately or go to the nearest hospital.
If you stop treatment with DOXOVENT
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 everybody gets them.
The following side effects may occur:
- nausea, vomiting, stomach ache (epigastric pain);
- headache (cephalalgia), irritability, insomnia;
- increased heart rate (tachycardia), irregular heartbeat (extrasystoles), accelerated breathing (tachypnea);
- increased blood sugar levels (hyperglycaemia), occasionally;
- increased levels of a protein, albumin, in the blood (albuminuria).
If any side effects occur, inform your doctor, who may decide to discontinue treatment and, if necessary, restart it at lower doses after all signs and symptoms of toxicity have disappeared.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store DOXOVENT
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container 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 DOXOVENT contains
DOXOVENT 400 mg tablets
- The active substance is doxofylline. Each tablet contains 400 mg of doxofylline.
- The other components are: colloidal silicon dioxide, maize starch, mannitol, polyvinylpyrrolidone, microcrystalline cellulose, talc, magnesium stearate.
200 mg oral solution powder in sachets
The active substance is doxofylline. Each sachet contains 200 mg of doxofylline.
- The other components are: sucrose, ammonium glycyrrhizinate, strawberry flavour, aspartame.
DOXOVENT 20 mg/ml oral syrup
- The active substance is doxofylline. 100 ml of syrup contain 2 g of doxofylline.
- The other components are: sucrose, methyl p-hydroxybenzoate, peppermint essence, ammonium glycyrrhizinate, purified water.
Description of the appearance of DOXOVENT and package contents
DOXOVENT 400 mg tablets
Available in boxes containing 20 tablets.
DOXOVENT 200 mg oral solution powder in sachets
Available in boxes containing 20 sachets.
DOXOVENT 20 mg/ml oral syrup
Available in 200 ml bottles.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Turin, Italy
Manufacturer
Tablets
ABC FARMACEUTICI S.p.A., Canton Moretti, 29, 10090 San Bernardo d’Ivrea (TO), Italy.
Sachets
LA.FA.RE. S.r.l., Via Benedetto Cozzolino, 77, 80056 Ercolano (NA), Italy.
Syrup
ABC FARMACEUTICI S.p.A., Canton Moretti, 29, 10090 San Bernardo d’Ivrea (TO), Italy.
Package leaflet: Information for the user
DOXOVENT
100 mg/10 ml solution for infusion
Doxofilline
Please read this leaflet carefully before using 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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What DOXOVENT is and what it is used for
- What you need to know before using DOXOVENT
- How to use DOXOVENT
- Possible side effects
- How to store DOXOVENT
- Contents of the pack and other information
1. What DOXOVENT is and what it is used for
DOXOVENT contains the active substance doxofylline, which belongs to a group of medicines used for asthma (systemic antiasthmatics). This medicine is used to treat breathing difficulties and cough caused by bronchial asthma and by pulmonary or bronchial diseases characterized by narrowing of the bronchi and the resulting shortness of breath.
2. What you need to know before using DOXOVENT
Do not use DOXOVENT
- if you are allergic to doxofylline, to substances chemically similar to it (xanthine derivatives), or to any of the other ingredients of this medicine (listed in section 6);
- if you have a current or recent myocardial infarction;
- if you have low blood pressure (hypotension);
- if you are pregnant or during breastfeeding.
Warnings and precautions
Always consult your doctor, pharmacist, or nurse before DOXOVENT is administered to you.
This medicine should be administered with caution in the following cases:
- if you have heart problems (cardiopathy, chronic pulmonary heart disease, congestive heart failure);
- if you suffer from high blood pressure (hypertension);
- if you are elderly;
- if you have poor oxygenation of the blood (severe hypoxia);
- if your thyroid gland produces excessive amounts of hormones (hyperthyroidism);
- if you have severe liver problems (chronic hepatopathy) or kidney problems (renal failure);
- if you suffer from gastritis or stomach or duodenal ulcer.
Inform your doctor if any of the following situations apply to you, as a dosage reduction may be necessary:
- if you are elderly;
- if your heart function is impaired (heart failure);
- if you have severe liver problems (hepatic insufficiency);
- if you currently have infections.
Inform your doctor if you smoke cigarettes, as an increased dosage of the medicine may be required.
Other medicines and DOXOVENT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
DOXOVENT must not be administered together with other substances chemically similar to it (xanthine derivatives).
Administration of DOXOVENT together with ephedrine or other sympathomimetic medicines (medicines acting on the central nervous system) requires caution.
Concomitant administration of the following medicines may require a dosage reduction (see "Warnings and precautions"):
- erythromycin, lincomycin, clindamycin, antibiotics used for certain types of infections;
- oral anticoagulants (OAC), used to prevent blood clotting;
- allopurinol, used for gout and hyperuricemia, which causes joint inflammation, pain, and swelling;
- cimetidine, used for gastric ulcer;
- propranolol, used for high blood pressure and arrhythmias;
- influenza vaccine, used to prevent influenza.
If you are taking phenytoin or other medicines used for seizures (anticonvulsants), or if you smoke cigarettes, an increased dosage of the medicine may be required (see "Warnings and precautions").
DOXOVENT with food and drinks
Consume moderate amounts of beverages and foods containing caffeine during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should be administered with caution and only if necessary during pregnancy and breastfeeding, and always under direct medical supervision.
This medicine is contraindicated during breastfeeding.
Driving and use of machinery
This medicine does not impair the ability to drive vehicles or operate machinery.
3. How to use DOXOVENT
This medicinal product must be administered exactly as directed by the physician.
If in doubt, consult the doctor, pharmacist, or nurse.
The recommended dose in adults is 2 vials administered intravenously, slowly (15–20 minutes), preferably diluted, to patients lying down, during the acute phase. Administration may be repeated every 12 hours at the physician's discretion.
If these doses are exceeded, monitoring of blood levels of doxofylline is recommended.
If you use more DOXOVENT than you should
If an excessive amount of this medicinal product is taken, serious disturbances in heart rhythm (cardiac arrhythmias) and epileptic seizures with convulsions and involuntary muscle contractions (tonic-clonic seizures) may occur. These symptoms may represent the first signs of intoxication.
In case of accidental ingestion/overdose of DOXOVENT, contact your doctor immediately or go to the nearest hospital.
If you stop treatment with DOXOVENT
If you have any doubts about using this medicinal product, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
- nausea, vomiting, stomach ache (epigastric pain);
- headache (cephalaea), irritability, insomnia;
- increased heart rate (tachycardia), irregular heartbeat (extrasystoles), accelerated breathing (tachypnea);
- increased blood sugar levels (hyperglycaemia), occasionally;
- increased levels of a protein, albumin, in the blood (albuminuria).
If any side effects occur, inform your doctor, who may decide to discontinue treatment and, if necessary, restart it at lower doses after all signs and symptoms of toxicity have disappeared.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the Italian Medicines Agency - 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 DOXOVENT
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.
The stated expiry date applies to the product in its original, unopened packaging, stored correctly.
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 DOXOVENT 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 DOXOVENT and contents of the pack
DOXOVENT 100 mg/10 ml solution for injection for intravenous use. Supplied in packs of 3 vials.
Marketing Authorization Holder and manufacturer
Marketing Authorization Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Turin, Italy
Manufacturer
ESSETI S.r.l., Via Campobello, 15 – 00071 Pomezia (RM)