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Atropine POS 0.5%

Current wording of the label on the package insert

Leaflet: Information for the User

Atropin-POS® 0.5%, eye drops

Active ingredient: atropine sulfate (Ph.Eur.)

Read all of this leaflet carefully before using this

Because it contains important information.

Keep this leaflet. You might want to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you personally. Do not pass it on to others.

It can harm other people, even if they have the same symptoms as

You.

If you get any side effects, talk to your doctor or pharmacist. this applies

also for side effects not listed in this leaflet. See section

What is in this leaflet

What is Atropin-POS® 0.5% and what is it used for?

What should you know before using Atropin-POS® 0.5%?

How should Atropin-POS® 0.5% be used?

What side effects are possible?

How should Atropin-POS® 0.5% be stored?

Contents of the pack and other information

1.

What is Atropin-POS® 0.5% and what is it used for?

Atropin-POS® 0.5% is a drug to dilate the pupil (mydriatic,

Cycloplegic, parasympatholytic).

Atropin-POS® 0.5% is used to eliminate accommodation for diagnostic purposes

Purposes, e.g. B. for pretreatment for refraction determination; for penalization if a

Occlusion treatment is not possible; for solving accommodation spasms in hyperopia

(Farsightedness), mydriatic (pupil-expanding drug) to immobilize the iris

(Iris) and ciliary body (radiation body) in acute and chronic intraocular

Inflammation of these tissues, e.g. B. iritis (inflammation of the iris); Concomitant inflammation

Corneal diseases; for injuries to the iris or pupil (uveal tract), such as B. after

Iridectomy (removal of the iris), detachment of the ciliary body (detachment of the

Radiating body); with ciliolenticular block; for rupturing synechiae (adhesions)

2.

What should you know before using Atropin-POS® 0.5%?

Atropin-POS® 0.5% must not be used

in infants and young children under 3 months of age, increased intraocular pressure (primary

Forms of glaucoma, narrow-angle glaucoma), chronic dry nasal mucosal inflammation

(Rhinitis sicca), if you are allergic to atropine sulphate (Ph.Eur.) Or any of the in section 6.

are the other ingredients of this medicine.

Note:

You should tell your eye doctor as well as the internist or family doctor any medication that

Take it or apply it locally to the eye, name it or present it.

Warnings and Precautions

Please talk to your doctor or pharmacist before using Atropin-POS® 0.5%.

Particular caution is required when using Atropin-POS® 0.5%

Heart failure, certain cardiac arrhythmias, narrowing of the coronary arteries

(Coronary stenosis)

Overactive thyroid gland (hyperthyroidism)

Constrictions in the gastrointestinal tract

Paralysis of the small intestine (paralytic ileus)

Colon enlargements (megacolon)

Urination disorders due to obstruction of the flow of urine, existing enlargement of the

Prostate gland (prostatic hypertrophy)

Muscle weakness (myasthenia gravis)

acute pulmonary edema

pregnancy-related illnesses

known hypersensitivity to atropine and other substances of this class

(Anticholinergics)

Spastic paralysis (paralysis with muscle cramps)

Children and the elderly

Infants and toddlers up to the age of two and adults over 65 years of age

particularly sensitive to the toxic effects of atropine sulfate, as are patients with

Down syndrom. A particularly careful dosage is therefore advisable in these cases.

Atropine sulfate inhibits sweat secretion and thereby impairs the ability to

Temperature regulation.

In febrile patients, especially children, and when the air temperature is high, the

Use particular caution as it quickly overheats and heats up

(Hyperthermia) can occur.

Atropin-POS® 0.5% should be used with particular care in older people.

Not only with angle-closure glaucoma, but also with open-angle glaucoma, after the

Application an increase in intraocular pressure may occur.

A significant increase in pressure can be an indication of latent open-angle glaucoma, among other things

(primary or secondary open-angle glaucoma). Monitoring of intraocular pressure

especially in the case of multiple applications.

Bright light should be avoided as it can cause glare. pleas e ask your question

please your doctor!

Parents of children with squint are advised to follow the ophthalmologist's instructions

follow.

Note:

If, in rare cases, disturbances occur during treatment (e.g. bright red face,

severe tiredness, restlessness, fever, increased heartbeat, urinary obstruction), you should take the treatment

stop and contact your doctor immediately. As a simple countermeasure, a

Cooling can be done with damp cloths and a fan.

Use of Atropin-POS® 0.5% together with other medicaments

Tell your doctor or pharmacist if you are using any other medicines recently

have used or intend to use other medicines, too

if it is a non-prescription drug.

Certain drugs (sympathomimetics) increase the pupil-expanding effect. There too

when applied externally to the eye, effects on the entire organism cannot be ruled out,

may affect the effects of some medicines that affect the peripheral nervous system

(Anticholinergics, such as antihistamines, phenothiazines, tricyclic and tetracyclic

Antidepressants, amantadine, quinidine, disopyramide, metoclopramide).

The effect of atropine sulfate is due to the intraocular pressure lowering substances pilocarpine and

Physostigmine weakened or abolished. Atropine sulfate, on the other hand, also inhibits them

Effect.

Simultaneous use of cisapride and atropine leads to a complete reversal of the

Effect of cisapride. As a result of atropine reduced bowel motility (bowel motility)

Simultaneously administered digoxin and nitrofurantoin are strengthened, phenothiazines and

Levodopa is less absorbed.

Note:

Please note that this can also apply to recently used drugs. If you are

You should also use other eye drops or eye ointments a certain time apart

of 15 minutes between the applications of the individual preparations. Eye ointments

should always be applied last.

pregnancy and breast feeding period

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or

are planning to become pregnant, ask your doctor before using this medicine

Doctor or pharmacist for advice. Atropin-POS® 0.5% should be used during pregnancy,

especially in the last 3 months and when breastfeeding only if absolutely necessary and

be used under medical supervision. Atropine sulfate crosses the placenta and occurs in minor amounts

Amounts into breast milk.

Driving and using machines

Even when used as directed, this medicinal product can reduce visual performance and the

Change the ability to react to the extent that the ability to actively participate in the

Traffic, the use of machines or the work without a secure footing impaired

become. This applies to a greater extent in conjunction with alcohol. The effect of this

Drug can last up to 14 days.

Important information about certain other ingredients of Atropin-POS® 0.5%

As a rule, contact lenses must not be worn with the present eye disease.

If the ophthalmologist permits the wearing of hard contact lenses in exceptional cases

Please note the following: Benzalkonium chloride can cause irritation to the eyes. avoid

contact with soft contact lenses. Benzalkonium chloride may cause discoloration to soften

Wear contact lenses. You must remove contact lenses before use and are allowed to use them

Use again at least 15 minutes after use.

3.

How should Atropin-POS® 0.5% be used?

Always use this medicine exactly as your doctor has told you. Ask at

Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is:

to initiate a visual defect determination (refraction determination) 1 drop 3 times a day

to break up adhesions / adhesions 3 times a day 1 drop

to eliminate accommodation, 1 drop 2-3 times a day

for penalization 1 drop 1 time a day in the morning

Use Atropin-POS® 0.5% as instructed by your doctor and distribute several times

Applications evenly throughout the day.

To avoid possible systemic absorption, especially in young children,

after application of the eye drops, the lower teardrop in the corner of the eyelid for 2 to 3 minutes

be held shut.

In the case of inflammation, the need for appropriate additional medication (e.g. with

Anti-inflammatory drugs and / or antibiotics).

Eye drops should always be used in such a way that the dropper comes into contact with the eye

or facial skin is avoided. Unscrew the protective cap, put your head a little

back, pull the lower eyelid slightly away from the eye and apply gentle pressure to the

Bottle a drop in the conjunctival sac. Close your eyelids slowly. To

The bottle should be carefully closed again after use.

Please talk to your doctor or pharmacist if you have the impression that the effect

of Atropin-POS® 0.5% is too strong or too weak.

If you have used more Atropin-POS® 0.5% than you should,

a doctor must be consulted or called immediately. Typical symptoms of overdose or

Poisoning is dryness of the skin and mucous membranes, accelerated heartbeat, dilatation

of the pupils, central excitement, motor restlessness, and unconsciousness in large doses

Respiratory paralysis.

Medical measures: after accidental oral ingestion, gastric lavage and administration of, if necessary

medicinal charcoal, physostigmine 1-2 mg IV, if necessary repeated every hour

Cramps 10-20 mg diazepam IV (Children initially 1-2 mg). Keep cool if the body temperature is high

Envelopes as an accompanying measure.

If you forget to use Atropin-POS® 0.5%

Do not use double the amount to make up for a forgotten application,

Instead, make up for the application as soon as possible and then add the dose

the same amount and at the same time interval / rhythm as specified above or as yours

Doctor continues to prescribe.

If you have any further questions about the use of this medicine, ask yours

Doctor or pharmacist.

4.

What side effects are possible?

Like all medicines, this medicine can have side effects, but not for

each must occur.

The frequency of side effects is based on the following categories:

Very often:

more than 1 patient in 10

Often:

1 to 10 patients in 100

Occasionally:

This affects 1 to 10 users in 1,000

Rare:

This affects 1 to 10 users in 10,000

Very rare: less than 1

Treated out of 10,000

Not known: frequency based on

cannot be estimated from the available data.

Possible side effects:

Disturbances of the distance adjustment of the eye (s) can rarely occur, to an increased

Sensitivity to glare and occasionally inflammation of the eyelid margin and conjunctiva

with burning eyes, lacrimation, photophobia and blistering. In rare cases it can

a glaucoma attack (strong increase in intraocular pressure) in persons who are prepared to do so

to be triggered.

General side effects:

Occasionally, especially in children, dry mouth, redness and dryness of the skin,

moderately high temperature and an accelerated heartbeat occur. With pre-existing

Urinary tract constrictions can lead to problems with urination or urinary behavior

come.

Angina pectoris symptoms and a sharp increase in blood pressure have been observed rarely. At

Prolonged treatment can affect the parotid gland as a result of the inhibition of saliva

ignite. Digestive disorders and swallowing disorders can occur.

Individual cases

were

Signs

central nervous system

Disruptions

Irritability,

Restlessness,

Confusion,

Hallucination,

Insomnia,

aggressive

Behavior,

Linguistic

Movement disorders observed. With small children it can be life-threatening in individual cases

Conditions come like B. drowsiness, convulsions, high fever, and coma. In such cases

a doctor must be consulted or called immediately.

Symptoms of poisoning occur within minutes to hours and can last up to 24

Last hours or longer.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. this applies

also for side effects not listed in this leaflet.

You can also report side effects directly to the Federal Institute for Drugs and

Medical devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn,

Website: www.bfarm.de show.

By reporting side effects you can help provide more information about the

Safety of this drug will be provided.

5.

How should Atropin-POS® 0.5% be stored?

Keep this medicine out of the sight and reach of children.

You may use the medicine after the expiry date which is stated on the label and the carton

do not use anymore. The expiry date refers to the last day of the month indicated.

Do not store above 25 ° C.

Do not throw away this medicine via wastewater or household waste. Ask your

Pharmacist how to throw away medicines you no longer use. they wear

thus helping to protect the environment.

Note on shelf life after opening

Use Atropin-POS® 0.5% 4 weeks after opening.

6.

additional Information

What Atropin-POS® 0.5% contains

The active ingredient is atropine sulfate (Ph.Eur.) 5.0 mg / ml.

The other ingredients are benzalkonium chloride, sodium chloride and water for

Injections

What Atropin-POS® 0.5% looks like and contents of the pack:

Atropin-POS® 0.5% are clear, colorless eye drops that come in 10 ml plastic dropper bottles with

Screw caps are filled.

Each pack contains 1 dropper bottle with a screw cap.

Marketing Authorization Holder and Manufacturer:

URSAPHARM, Industriestr., D-66129 Saarbrücken, Tel .: 06805/92 92-0,

Fax: 06805/92 92-88, Email: [email protected]

This leaflet was last revised in:

March 2014

Further information on this preparation is available at www.ursapharm.de.