Active ingredients: Ipratropium bromide (Ipratropium bromide monohydrate)
ATEM 0.5 mg / 2 ml, nebuliser solution
Why is Atem used? What is it for?
ATEM is a medicine that contains ipratropium bromide monohydrate, an active substance belonging to the group of anticholinergic medicines, which relaxes the muscles in the small airway walls of the lungs.
ATEM is used to treat asthma and chronic obstructive pulmonary disease, a disease caused by inflammation of the lungs and airways associated with asthma.
Contraindications When Atem should not be used
Do not take ATEM if:
- you are allergic (hypersensitive) to "ipratropium bromide monohydrate or any of the other ingredients of this medicine
- you are allergic to atropine or to drugs belonging to the same class;
- have an enlarged prostate volume (prostatic hypertrophy);
- have an eye disease which causes increased pressure in the eye with worsening vision (glaucoma);
- have problems passing urine (urinary retention);
- has an "intestinal obstruction that manifests itself with inability to evacuate, pain and swelling in the abdomen";
- are pregnant or breastfeeding.
Precautions for use What you need to know before taking Atem
Talk to your doctor before taking ATEM if you have heart problems, including diseases of the vessels of the heart (coronary artery disease).
Pay particular attention:
- ATEM begins to act 3-5 minutes after the start of administration;
- if the medicine accidentally comes into contact with your eyes, you could experience an eye or vision disorder, for example problems focusing images (visual accommodation disturbances); consult your doctor carefully and do not forget to tell him the previous hiring of ATEM;
- if your asthma gets worse or does not improve or you have more breathing difficulties during treatment with ATEM. Tell your doctor who may change your therapy.
Children
This medicine is not recommended for children under 3 years of age.
Interactions What medications or foods can change the effect of Atem
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, do not take ATEM.
Driving and using machines
ATEM does not affect the ability to drive or use machines.
Dosage and method of use How to use Atem: Dosage
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Adults and adolescents over 14 years of age
1 single-dose container, 1 or 2 times a day, unless otherwise indicated by the doctor.
The maximum dose is 1 single-dose container, 4 times a day
Children from 3 to 14 years old
Half single-dose container, 1 or 2 times a day, unless otherwise indicated by the doctor.
To take half the dose, use the graduation on the container.
The maximum dose is half a single-dose container, 3 times a day.
Method of administration
This medicine must be nebulized (made into very small drops) by means of an "aerosol device", equipped with devices for administration by mouth and / or nose.
Take ATEM by inhalation, through the mouth and / or nose. The prescribed dose can be diluted by adding the same amount of distilled water (1: 1 ratio) to the nebulizer ampoule.
Before use, carefully read the following instructions, which tell you what to do and what to pay attention to.
To use, perform the following operations:
Flex the single-dose container in both directions.
Detach the single-dose container from the strip first above and then in the center.
Open the single-dose container by turning the flap in the direction indicated by the arrow.
By exerting moderate pressure on the walls of the single-dose container, let the medicine come out in the prescribed quantity and put it in the nebulizer ampoule (aerosol device).
To check that you have used half the dose, put the single-dose container up to the light and compare the level of medication left with the graduation found in the container (corresponding to half the dose). If you use half the dose, the remaining amount should be discarded.
Overdose What to do if you have taken too much Atem
If you take more ATEM than you should
If you accidentally ingest / take excessive doses of this medicine, notify your doctor immediately.
If you forget to take ATEM
Continue with your therapy regularly, without doubling the next dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Atem
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
Dry mouth
Very rare side effects (may affect up to 1 in 10,000 people)
Dizziness and sleepiness.
Problems in focusing images (visual accommodation disturbances).
Problems passing urine (urinary retention) or constipation.
Heart rhythm disturbances (arrhythmia)
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
Reactions due to allergy (hypersensitivity).
Eye disorders: increased pressure in the eye with possible worsening of vision, blurred vision, pupils of the eyes with different diameters (anisocoria), dilation of both pupils (mydriasis).
Wheezing, coughing, shortness of breath and wheezing (paradoxical bronchospasm)
Swelling (angioedema) of the face, eyes, lips, throat with difficulty in breathing.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Store below 30 ° C.
In case of using half the dose, the amount left in the container must be thrown away.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What ATEM contains
The active ingredient is: ipratropium bromide monohydrate.
A single-dose container of 2 ml contains: 0.5218 mg of ipratropium bromide monohydrate, corresponding to 0.50 mg ipratropium bromide.
The other ingredients are: monobasic sodium phosphate monohydrate, dibasic sodium phosphate dihydrate, sodium chloride, purified water.
Description of the appearance of ATEM and contents of the pack
This medicine is available in cartons of 10 or 20 single-dose containers, each containing 2 ml of solution. Each single-dose container has a half-dose graduation.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ATEM 0.5 MG / 2 ML SOLUTION FOR NEBULIZER
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A single-dose container of 2 ml contains:
Active ingredient: ipratropium bromide monohydrate 0.5218 mg equal to ipratropium bromide 0.50 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Nebulizer solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of bronchial asthma, chronic obstructive pulmonary disease with asthmatic component.
04.2 Posology and method of administration
Adults: one single-dose container per session on average 1-2 times a day. In relation to the severity, the dosage can be increased according to medical prescription up to a maximum of one single-dose container 4 times / day.
Children (3-14 years): half the contents of a single-dose container per session on average 1-2 times a day. In relation to age and severity, the dosage can be increased according to medical prescription up to a maximum of half single-dose container 3 times / day.
If necessary, the solution can be diluted with sterile physiological solution in the ratio 1: 1.
The single-dose container bears a graduation corresponding to half the dose.
To use the single-dose container carry out the following operations:
1) flex the single dose in both directions;
2) detach the single-dose container from the strip first above and then in the center;
3) open the single-dose container by turning the flap;
4) exerting moderate pressure on the walls of the single-dose container to release the medicine in the prescribed quantity;
5) place the single-dose container against the light to check the accuracy of half the dose. Do not reuse the residual quantity if half the dose is used.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; hypersensitivity to atropine-like substances.
Subjects with glaucoma, prostatic hypertrophy, urinary retention syndromes or intestinal obstruction.
Generally contraindicated in pregnancy and lactation (see par. 4.6).
04.4 Special warnings and appropriate precautions for use
The drug should be administered with caution in coronary and cardiac patients.
If, carelessly, the substance is sprayed into the eyes, visual disturbances, however slight and reversible, may occur, albeit rarely.
For the use of the solution to be nebulized, strictly adhere to the medical prescription.
The prescribed dose must not be changed and, if the benefits do not occur, it will be necessary to report to the treating doctor who will adjust the dose in an optimal way; it should be borne in mind that the drug begins to act 3-5 minutes after administration.
As with other inhalation administrations, paradoxical bronchospasm may rarely occur. In this case, immediately interrupt the administration and institute suitable therapy.
The medicine is not contraindicated for people with celiac disease.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Not known.
04.6 Pregnancy and lactation
In known or suspected pregnancy and during lactation, the drug must be used with caution and under the continuous supervision of the doctor.
Fertility see section 5.3.
04.7 Effects on ability to drive and use machines
Atem does not affect the ability to drive or use machines.
04.8 Undesirable effects
Many of the listed side effects can be attributed to Atem's anticholinergic properties. In controlled clinical trials, the most commonly observed side effect was dry mouth.
Frequency is defined using the following convention: Very common (≥1 / 10); common (≥1 / 100,
The frequency of adverse reactions from post-marketing experience is indicated as not known.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address" www.agenziafarmaco.gov.it/it/responsabili ".
04.9 Overdose
The overdoses used in the literature for aerosols for experimental purposes have never given rise to unpleasant effects.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for obstructive respiratory tract syndromes for aerosols, anticholinergics.
ATC code: R03BB01.
Atem contains as the active ingredient ipratropium bromide, an anticholinergic derivative for the treatment of dyspnoea, in the course of chronic bronchitis and asthma.
Ipratropium bromide acts locally on the respiratory tract in extremely small doses with a particularly high specificity of action and considerable tolerability. Ipratropium bromide blocks, with a competitive mechanism, the bronchial muscarinic receptors thus preventing the action of acetylcholine. It therefore carries out an anticholinergic action at the bronchial level. The bronchospasmolytic action begins 3-5 minutes after inhalation and persists for 4-6 hours. The administration of ipratropium bromide can also be implemented in case of acute bronchospasm of medium intensity: in this case the improvement of the bronchial condition begins to manifest itself within 10 minutes of inhalation.
05.2 Pharmacokinetic properties
Kinetic studies with C14-labeled ipratropium bromide have shown that, after inhalation of a single dose of 555 mcg, the maximum blood concentration reached between the 1st and 3rd hours, is negligible and equal to 0.033% of the total inhaled dose and referred to the plasma volume.
05.3 Preclinical safety data
Acute toxicity
LD50 (male mouse, per os): 1001 mg / kg;
LD50 (female mouse, per os): 1083 mg / kg;
LD50 (male rat, per os): 1663 mg / kg;
LD50 (female rat, per os): 1779 mg / kg;
LD50 (dog, per os): 1300 mg / kg;
LD50 (rat, monkey for aerosol): absent.
Subacute and chronic toxicity
Rats: per os (55 weeks), dose up to 200 mg / kg; by inhalation (26 weeks), dose up to 512 mcg / day.
Dogs: per os (52 weeks), dose up to 75 mg / kg.
Monkeys: by inhalation (6 months), dose up to 1600 mcg / day.
Rabbits: per os (4 weeks), dose up to 400 mg / day.
The use of ipratropium bromide for inhalation, even at maximum dosages, did not show any toxic effect and no difference between treated and control animals.
Tests of teratogenesis and fertility
Mice, rats and rabbits were used. In none of the three species was found an increase in malformations or in any case of alterations that could be related to treatment with ipratropium bromide.
The offspring did not show organic alterations. No lesions were observed in the prenatal and postnatal developmental process. Ipratropium bromide did not damage male and female genetic capacity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Monobasic sodium phosphate monohydrate, dibasic sodium phosphate dihydrate, sodium chloride, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
This period is intended for the specialty properly stored and with intact packaging.
06.4 Special precautions for storage
Store below 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Inner packaging: single-dose polypropylene containers with half-dose graduation, resealable. External packaging: printed cardboard box.
Box of 10 or 20 single-dose containers of 2 ml
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
PROMEDICA s.r.l., Via Palermo 26 / A - Parma
Dealer for sale: CHIESI FARMACEUTICI S.p.A., Via Palermo 26 / A - Parma
08.0 MARKETING AUTHORIZATION NUMBER
024153052 0.5 mg / 2 ml nebuliser solution - 10 single-dose containers
024153064 0.5 mg / 2 ml nebuliser solution - 20 single-dose containers
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
06/06/2000
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of July 2015.
