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Effortile drops, 30 ml

Effortile drops, 30 ml

In circular control disorders with reduced blood pressure (hypotension)

Manufacturers: Sanofi-Aventis Deutschland GmbH GB Selbstmedikation /Consumer-Ca

PZN: 03194803

Dosage: Lösung

Content: 30 ml

Reward Points: 107

Availability: Out of stock

$23.23

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Effortile drops, 30 ml

Instructions for use for Effortile drops, 30 ml

Instructions for use for: Effortile drops, 30 ml

Important notes (compulsory information):

Effortil® Drop. Active substance: Etilefrinhydrochloride. Application areas: in circulation control disorders with reduced blood pressure (hypotension), which change the body layer (For example, when getting up from lying or sitting) with complaints such as dizziness, weakness, pale, sweat outbreak, flicker or black, in front of the eyes as well as with a significant blood pressure drop without an increase in heart rate rates. Warning:Contains sodium disulfite, methyl (4-hydroxybenzoate), propyl (4-hydroxybenzoate).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Effortil® drops
7.5 mg / ml drops to take, solution
Active substance: Etilefrinhydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information.
Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.
  • Lift the package leaflet. You might want to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
  • If you do not feel better or even worse after 3 - 4 days, contact your doctor.

What is in this leaflet:
1. What are effortile drops and what are they used for?
2. What should you pay attention to drops before taking effortile?
3. What are the effortile to take drops?
4. What side effects are possible?
5. How to keep effortile drops?
6. Content of the pack and further information

1. What are effortile drops and what are they used for?

Effortile drops are a blood pressure increase drug.
Effortile drops are used in circulation control disorders with reduced blood pressure (Hypotonie), which when changing the body layer (eg when getting up from lying or sitting) with complaints such as dizziness, weakness, pale, sweat outbreak, flicker or black before the eyes as well as with a significant blood pressure drop without an increase in heart rate.

2. What should you pay attention to drops before taking effortile?

Effortile drops must not be taken
  • if they are allergic to Etillefrinhydrochloride or one of the other ingredients of this medicinal product referred to in section 6.
  • in circular control disorders with reduced blood pressure, when blood pressure and heart rate rates rise in the standest (hypertone reaction).
  • in hypertension (hypertension).
  • when drawing a thyroid overfill (Thyreotoxicosis).
  • at a tumor of the adrenal (pheochromocytom).
  • with an increase in intraocular pressure (Engewinkelglaukom).
  • for emptying disorders of the urinary bladder with residual harvesting, especially when enlarging the protrusion gland (ProstatatadaOM).
  • with a hardening of the blood vessels (sclerotic vascular changes).
  • with severe constriction of the coronary vessels with oxygen deficiency in the heart (coronary heart disease).
  • in case of inadequate pumping function of the heart (decompensated heart failure).
  • for cardiac arrhythmias in conjunction with highly accelerated heartbeat rate (Tachykard heart rhythm disorders).
  • with a constriction on the heart valves (heart valve stenosis) or a narrowing of the major arteries.
  • in a special disease of the heart muscle, which is associated with excessive and consecutive growth of the heart muscle (Hypertrophic obstructive cardiomyopathy).
  • in the first 3 months of pregnancy (see section of pregnancy, lactation and procurement / signability).
  • during lactation (see section of pregnancy, lactation and procilability).

Warnings and Precautions
Special care when taking effortile drops is required
  • Diabetes mellitus (see section Intake of Effortil Drops together with other medicines)
  • Thyroid overfunction
  • increased calcium content of the blood (hypercalcaemia)
  • reduced potassium content of blood (hypocalemia)
  • heavy malfunctions of the kidney
  • a certain heart disease due to lung disease (Cor pulmonary)
  • Heart rhythmism
  • serious diseases concerning the heart and blood vessels

In these cases, they should advise and examine themselves from their doctor before they start taking effortile drops.
EFFORTIL Drops contain the auxiliary sodium disulfite, which can cause severe hypersensitivity reactions and bronchospasm in rare cases.

Note:
The use of effortile drops can lead to positive results for doping controls.

Taking Effortil Drops together with other medicines:
Inform your doctor or pharmacist if you take other medicines, recently taken other medicines, or intend to take other medicines.

Medicines that can influence the effect of effortile drops:
Active ingredients or active ingredient groups possible effect
  • Medicines for the blood pressure reduction: reserpin, guanethidine
  • Certain medicines for blood pressure increase: Mineralocorticoids
  • Medicines for the treatment of mental moods and neurological diseases (eg Parkin's disease): Tricyclic antidepressants, mayhemmer
  • Other medicines that mimic the effect of the sympathetic nervous system (sympathomimetics), such. B. medicines for the treatment of respiratory constrictions
  • Thyroid hormones
  • Medicines for the treatment of allergies: antihistamines
  • Medicines for the treatment of circulatory disorders, migraine, tension headaches: dihydroergotamine
Promotion of Etilefrinhydrochloride
(unwanted blood pressure increase)
  • Scamed medicines: Atropin (eg before anesthesia or at urinary bladder complaints)
Rise of heartbeat rate
  • Medicines for the blood pressure reduction: Alphabzw. Beata receptor blocker
Blood pressure drop or increase
with slow heart rate
(Bradycardia)

Medicines whose effect can be influenced by effortile drops:
Active ingredients or active ingredient groups possible effect
  • Medicines for the treatment of a diabetic disease (AntiDiabetika)
Blood sugar reduction is reduced
  • Medicines for the treatment of heart muscle weakness (Incessive glycosides): z. B. Digitalis
  • Anesthetic for inhalation: halogenated aliphatic hydrocarbons, e.g. B. Halothan
possible occurrence of
Heart rhythmism

Sodium disulfite is a very reactive connectionnG. It must therefore be expected that thiamine (vitamin B1) occupied with effortile drops.

Pregnancy, breastfeeding and procilability:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
Effortile drops must not be taken in the first 3 months of pregnancy.
From the 4th month of pregnancy, an ingestion is possible if the attending physician supports this.
Latving:
During breast-feeding, effortile drops are not allowed to be taken, as passing into the breast milk is not excluded and there is no experience in infants.
Certificate and Gardenability:
No animal experimental studies were carried out with regard to the procurement and bearing capability.
No studies have been carried out on the impact on human procurement and giveability.

Driving and ability to operate machines:
There were no studies on the impact on the ability to drive and the ability to serve machines.
Please note that side effects can occur, which could theoretically affect the guiding vehicles and the operation of machines.

3. What are the effortile to take drops?

Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed. Ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the recommended dose is:
For adults and children over 6 years:
3 times a day 10 - 20 drops. This corresponds to a daily dose of 15 - 30 mg of etilefrinhydrochloride.

For children between 2 and 6 years:
3 times a day 5 - 10 drops. This corresponds to a daily dose of 7.5 - 15 mg of etilefrinhydrochloride.

For children under 2 years:
3 times a day 2 - 5 drops. This corresponds to a daily dose of 3 7.5 mg of etilefrinhydrochloride.

Remove effortile drops preferably before eating with a glass of liquid.
For children, the gift is recommended in a teaspoon of juice or sweetened tea.
Effortile drops should not be taken in the late afternoon or evening, as their stimulating effect can complicate falling asleep.

Hold the bottle of the drop perpendicular. To drop slightly on the bottle floor for dripping.

The need to take effortile drops should be checked regularly. Please talk to your doctor or pharmacist if you have the impression that the effect of effortile drops is too strong or too weak.

If you take a greater amount of effortile drops than you should:
In the event of an overdose of effortile drops, the following symptoms can occur: strong acceleration of the heart rate (tachycardia), cardiac arrhythmias, excessive blood pressure rise (possibly with headache), Sweat outbreak, excitement, nausea, vomiting. For infants and toddlers, overdose can cause a damping of breathing (Central respiratory depression) and deep unconsciousness (coma) to lead.
Please inform immediately a doctor. He will decide on the need to remove the medicine from the magend arm tract and the administration of medical coal. In severe cases, intensive care monitoring and treatment may be necessary.

If you forget the intake of effortile drops:
Do not take the double amount when you forget the previous taking.

If you cancel the intake of effortile drops:
When interrupting or premature discontinuation of treatment is expected to recur the complaints.

4. Which side effects are possible?

Like all medicines, effortile drops of side effects that do not have to occur.

The frequency information on side effects is based on the following categories:
Very common: More than 1 treated from 10
Frequently: 1 to 10 treated from 100
Occasionally: 1 to 10 treated from 1,000
Rarely: 1 to 10 Treated from 10,000
Very rare: less than 1 treated from 10,000
Unknown: Frequency on the basis of the available data is not estimable

The following side effects can occur:

Diseases of the immune system:
Frequency not known: Hypersensitivity (allergic reaction) Psychiatric diseases
Occasionally: Anxiety

Diseases of the nervous system:
Often: headache
Occasionally: unrest, insomnia, muscle scraper (tremor), dizziness

Heart diseases:
Occasionally: palpitations (palpitations), accelerated heartbeat (tachycardia), cardiac arrhythmias with extra strokes (ventricular cardiac arrhythmias)
FREQUENCY not known: pressure feeling over the heart (pektanginose complaints), blood pressure rise (possibly with headache)

Gastrointestinal tract:
Often: magic arms
Occasionally: nausea

General diseases:
Frequency not known: increased welding

Sodium disulfite can rarely cause hypersensitivity reactions and bronchial cramps (bronchospasms.
The preservatives methyl (4hydroxybenzoate) and propyl (4hydroxybenzoate) can cause hypersensitivity reactions, even late reactions.

Measures if they are affected by side effects:
If side effects occur, you should not take effortile drops again and ask your doctor for advice.
If a hypersensitivity response should occur, you will not take effortile drops again and immediately notify a doctor so that it can decide on necessary further action depending on the severity of severity.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also add side effects directly to the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurtgeorgkiesingerallee 3, D53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep effortile drops?

Keep this medicine inaccessible to children.
You must not use the drug after the expiry date specified on the folding box and on the bottle label according to "usable until". The expiry date refers to the last day of the month.

Special storage conditions:
Do not freeze.
Note on durability after breaking:
This medicine is stable for 6 months after the first opening of the bottle.

6. Content of the pack and further information

What effect stock drops contain
The active ingredient is etilefrinhydrochloride.
1 ml of solution (= 15 drops) contains 7.5 mg of etilefrinhydrochloride.
The other ingredients are: purified water, sodium disulfite, methyl (4hydroxybenzoate), Propyl (4hydroxybenzoate).

How effortile drops look and content of the pack:
Clear, colorless liquid in a brown glass bottle with drip insert and screw cap.
Effortile drops are in packs with 15 ml, 30 ml, 50 ml and 100 ML (2 x 50 ml) solution available.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutic entrepreneur:
Sanofiaventis
Germany GmbH
65926 Frankfurt am Main
Postal address:
Mailbox 80 08 60
65908 Frankfurt am Main
Telephone: 0800 56 56 010
Fax: 0800 56 56 011

Manufacturer:
Istituto de Angeli, S.R.L.
Località prulli, 103 / C
50066 Reggello (Firenze)
Italy

This leaflet was last revised in June 2017.

Source: Information of the leaflet
Status: 08/2017

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.

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