DOXOVENT 400 мг Коированная таблетка

Содержание инструкции

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

DOXOVENT

400 mg tablets
200 mg powder for oral solution 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, pharmacist or nurse.
• 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is DOXOVENT and what is it used for

DOXOVENT contains the active ingredient doxofylline which belongs to the group of medicines used
to treat asthma (systemic anti-asthmatics). This medicine is used to treat breathing difficulties and
cough caused by bronchial asthma and lung or bronchial diseases characterized by narrowing
of the bronchi and resulting shortness of breath.

2. What you need to know before you take 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 are having a current or recent heart attack;
• if you have low blood pressure (hypotension);
• if you are pregnant or breastfeeding.

Warnings and precautions
Always talk to your doctor or pharmacist before taking DOXOVENT.
Take this medicine with caution in the following cases:

• if you have heart problems (cardiopaties, chronic pulmonary heart disease, congestive heart failure);
• if you suffer from high blood pressure (hypertension);
• if you are elderly;
• if you have poor blood oxygenation (severe hypoxemia);
• if your thyroid gland produces high amounts of hormones (hyperthyroidism);
• if you have severe liver problems (chronic hepatopathy) or kidney problems (renal insufficiency);
• if you suffer from gastritis or stomach or duodenal ulcer;

Tell your doctor if any of the following situations apply to you because a
reduction in the dosage of the medicine may be necessary:

• if you are elderly;
• if your heart is functioning poorly (heart failure);
• if you have severe liver problems (hepatic insufficiency);
• if you have ongoing infections.

Tell your doctor if you smoke cigarettes because an increase in the dosage of the
medicine may be necessary.

Other medicines and DOXOVENT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Do not take DOXOVENT together with other substances chemically similar
(xanthine derivatives).
The administration of DOXOVENT together with ephedrine or other sympathomimetic medicines
(medicines that act on the central nervous system) requires caution.
The simultaneous administration of the following medicines may require a reduction in
dosage (see Warnings and precautions):

• erythromycin, lincomycin, clindamycin, antibiotics used for some types of infections;
• oral anticoagulants (TAO), used to prevent blood clotting;
• allopurinol, used for gout, hyperuricemia with resulting inflammation of the joints causing pain and swelling;
• cimetidine, used for gastric ulcer;
• propranolol, used for high blood pressure and arrhythmias;
• influenza vaccine, used for the prevention of influenza. If you are taking phenytoin and other medicines used for convulsions (anticonvulsants) or if you smoke cigarettes, it may be necessary to increase the dosage of the medicine (see “Warnings and precautions”).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine with caution 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 vehicles and operate machinery

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

DOXOVENT 200 mg powder for oral solutioncontains 0.03 g of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful to you if you suffer from phenylketonuria, a rare
genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it
correctly.

DOXOVENT 20 mg / ml syrupcontains 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 following the instructions of your doctor exactly. If you have any doubts, consult
your doctor or pharmacist.
The recommended dose in adults is 1 tablet 2-3 times a day or 2 measuring spoons of 10 ml of
syrup (1 measuring spoon of 10 ml corresponding to 200 mg of doxofylline) 2-3 times a day.
The recommended dose in children aged between 6 and 12 years is 1-3 sachets per day (12-18
mg/kg) dissolved in plenty of water.
If these doses are exceeded, monitoring of doxofylline levels in the blood is recommended.

If you take more DOXOVENT than you should
If you take an excessive amount of this medicine, serious alterations in heart rhythm
(cardiac arrhythmias) and epileptic seizures with convulsions and involuntary muscle contractions
(tonic-clonic crises) may occur. These manifestations may constitute the first signs of intoxication.
In case of accidental ingestion/taking of an excessive dose of DOXOVENT, inform
your doctor immediately or go to the nearest hospital.

If you stop taking DOXOVENT
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 everyone will experience them.
The following side effects may occur:

• nausea, vomiting, stomach pain (epigastric pain);
• headache, irritability, insomnia;
• increased heart rate (tachycardia), irregular heartbeat (extrasystoles), increased breathing rate (tachypnea);
• increased blood sugar (hyperglycemia) occasionally;
• increased protein, albumin, in the blood (albuminuria).

If side effects occur, inform your doctor, who may decide to discontinue treatment and,
if necessary, resume it at lower doses after the disappearance of all signs and symptoms of toxicity.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact
your doctor or pharmacist. You can also report side effects directly through
adverse . Reporting side effects can help provide more information about 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.
Store this medicine at room temperature.
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 DOXOVENT contains
DOXOVENT 400 mg tablets

• The active ingredient is doxofylline. Each tablet contains 400 mg of doxofylline.
• The other ingredients are: Colloidal silica, corn starch, mannitol, polyvinylpyrrolidone, microcrystalline cellulose, talc, magnesium stearate.
• “200 mg powder for oral solution in sachetsThe active ingredient is doxofylline. Each sachet contains 200 mg of doxofylline.
• The other ingredients are: sucrose, ammonium glycyrrhizinate, strawberry aroma, aspartame.

DOXOVENT 20 mg /ml syrup

• The active ingredient is doxofylline. 100 ml of syrup contains 2 g of doxofylline.
• The other ingredients are: sucrose, methyl p-hydroxybenzoate, peppermint essence, ammonium glycyrrhizinate, purified water.

Description of the appearance of DOXOVENT and contents of the pack
DOXOVENT 400 mg tablets
It is available in a box of 20 tablets.

DOXOVENT 200 mg powder for oral solution in sachets
It is available in a box of 20 sachets.

DOXOVENT 20 mg / ml syrup
It is available in a 200 ml bottle.

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

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.

DOXOVENT

100 mg/10 ml solution for infusion
Doxofilline
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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is DOXOVENT and what is it used for

DOXOVENT contains the active ingredient doxofylline which belongs to the group of medicines used
to treat asthma (systemic anti-asthmatics). This medicine is used to treat breathing difficulties and
cough caused by bronchial asthma and lung or bronchial diseases characterized by narrowing
of the bronchi and resulting shortness of breath.

2. What you need to know before using DOXOVENT

Do not use DOXOVENT

• if you are allergic to doxofylline, to chemically similar substances (xanthine derivatives) or to any of the other components 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 (hypotension);
• if you are pregnant or 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 (cardiopaties, chronic pulmonary heart disease, congestive heart failure);
• if you suffer from high blood pressure (hypertension);
• if you are elderly;
• if you have poor blood oxygenation (severe hypoxemia);
• if your thyroid gland produces high amounts of hormones (hyperthyroidism);
• if you have severe liver problems (chronic hepatopathy) or kidney problems (renal insufficiency);
• if you suffer from gastritis or stomach or duodenal ulcer.
• Tell your doctor if any of the following situations apply to you because a reduction in the dosage of the medicine may be necessary:
• if you are elderly;
• if your heart is functioning poorly (heart failure);
• if you have severe liver problems (hepatic insufficiency);
• if you have ongoing infections.

Tell your doctor if you smoke cigarettes because an increase in the dosage of the
medicine may be necessary.

Other medicines and DOXOVENT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
DOXOVENT should not be administered together with other chemically similar substances
(xanthine derivatives).
The administration of DOXOVENT together with ephedrine or other sympathomimetic medicines
(medicines that act on the central nervous system) requires caution.
The simultaneous administration of the following medicines may require a reduction in the
dosage (see “Warnings and precautions”):

• erythromycin, lincomycin, clindamycin, antibiotics used for some types of infections;
• oral anticoagulants (TAO), used to prevent blood clotting;
• allopurinol, used for gout, hyperuricemia with resulting inflammation of the joints causing pain and swelling;
• cimetidine, used for gastric ulcer;
• propranolol, used for high blood pressure and arrhythmias;
• influenza vaccine, used for influenza prevention.

If you are taking phenytoin and other medicines used for convulsions (anticonvulsants) or if you smoke
cigarettes, it may be necessary to increase the dosage of the medicine (see “Warnings and
precautions”).

DOXOVENT with food and drink
Consume 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 a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 operating machinery
This medicine does not alter the ability to drive vehicles and operate machinery.

3. How to use DOXOVENT

This medicine must be administered always following exactly the doctor's instructions.
If you have any doubts, consult your doctor, pharmacist or nurse.
The recommended dose in adults is 2 vials via intravenous route administered to patients in a lying
position and slowly (15-20 minutes), preferably diluted, in the acute phase. The administration may
be repeated every 12 hours, at the doctor's discretion.
If these doses are exceeded, monitoring of doxofylline levels in the blood is recommended.

If you use more DOXOVENT than you should
If you take an excessive amount of this medicine, serious alterations of the heart rhythm
(cardiac arrhythmias) and epileptic seizures with convulsions and involuntary muscle contractions
(tonic-clonic crises) may occur. These manifestations may constitute the first signs of intoxication.
In case of accidental ingestion/administration of an excessive dose of DOXOVENT, immediately
inform your doctor or go to the nearest hospital.

If you stop taking DOXOVENT
If you have any doubts about the use of this medicine, consult your doctor or pharmacist or
nurse.

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 pain (epigastric pain);
• headache, irritability, insomnia;
• increased heart rate (tachycardia), irregular heartbeat (extrasystoles), increased breathing rate (tachypnea);
• increased blood sugar (hyperglycemia) occasionally;
• increased protein, albumin, in the blood (albuminuria).

If side effects occur, inform your doctor, who can decide to stop treatment and,
if necessary, to resume it at lower doses after the disappearance of all signs and symptoms of toxicity.

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 Italian Medicines Agency - Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can contribute to providing 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 expiry date 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 DOXOVENT contains

• The active ingredient is doxofylline. Each 10 ml vial contains 100 mg of doxofylline.
• The other component is water for injectable preparations.

Description of the appearance of DOXOVENT and contents of the pack
DOXOVENT 100 mg/10 ml injectable solution for intravenous use. It is available in packs of 3
Vials.

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

Manufacturer
ESSETI S.r.l., Via Campobello, 15 – 00071 Pomezia (RM)