EFFORTIL 10 mg /1 Ml Injectable Solution

Зміст інструкції

1. EFFORTIL 7.5 mg/ ml oral drops, solution
   1. What is Effortil and what is it used for
   2. What you need to know before taking Effortil
   3. How to take Effortil
   4. Possible side effects
   5. How to store Effortil
   6. Contents of the pack and other information
2. EFFORTIL 10 mg/ml injectable solution
   1. What is Effortil and what is it used for
   2. What you need to know before using Effortil
   3. How to use Effortil
3. Effortil injectable solution must not be mixed with levulose solution or with
   1. Possible side effects
   2. How to store Effortil
   3. Contents of the pack and other information

EFFORTIL 7.5 mg/ ml oral drops, solution

Ethylnorepinephrine hydrochloride

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

1. What is Effortil and what is it used for

Effortil contains ethylfrine hydrochloride, a medicine that works by stimulating the heart and
increasing blood pressure.
Effortil is indicated to increase blood pressure in cases of orthostatic hypotension
(a sudden drop in blood pressure when moving from a sitting or
lying position to an upright position, accompanied by symptoms such as dizziness/feeling of lightheadedness).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Effortil

Do not take Effortil

• if you are allergic to ethylnoradrenaline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a blood pressure disorder (hypotensive dysregulation), which causes an increase in pressure when you assume the upright position;
• if you suffer from high blood pressure (hypertension);
• if you suffer from an excessive increase in the blood of a type of hormones produced by the thyroid, a gland in the neck (thyrotoxicosis);
• if you suffer from a disease that causes the release into the body of substances that increase blood pressure (pheochromocytoma);
• if you suffer from a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained inside the eye (closed-angle glaucoma);
• if you suffer from prostate diseases (the gland in men that produces seminal fluid), which cause an increase in volume and are associated with difficulty in the urinary bladder emptying completely (prostatic hypertrophy or prostatic adenoma with urinary retention);
• if you suffer from a heart disease characterized by an obstruction of the coronary arteries, the blood vessels that carry blood to the heart (coronary insufficiency);
• if you suffer from a disease characterized by the heart's inability to provide the body with an adequate amount of blood (decompensated heart failure);
• if you suffer from a severe disease of the heart muscle that manifests with fatigue and difficulty breathing (hypertrophic obstructive cardiomyopathy);
• if you suffer from narrowing of the heart valves that regulate blood flow inside the heart (stenosis of the heart valves);
• if you suffer from narrowing of the blood vessels that carry blood to the heart (stenosis of the central arteries);
• if you suffer from heart rhythm disorders;
• if you are in the first 3 months of pregnancy and if you are breastfeeding;
• if you suffer from rare hereditary conditions, which may be incompatible with one of the components of this medicine (see “Effortil oral drops contains parabens and sodium metabisulfite”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Effortil:

• if you suffer from an increased heart rate (tachycardia) and alteration of the heart rhythm (cardiac arrhythmias);
• if you suffer from severe heart and blood vessel disorders (severe cardiovascular disorders);
• if you suffer from a disease characterized by an excess of sugars in the blood (diabetes mellitus);
• if you suffer from a dysfunction of the thyroid, a gland in the neck (hyperthyroidism);
• if you are taking MAO inhibitors (medicines to treat depression) or have stopped taking them less than two weeks ago (see below “Other medicines and Effortil”).

Children
EFFORTIL 7.5 mg/ml oral drops, solutionmust be used with caution in children
under two years of age due to their limited ability to metabolize
the excipient propyl-parahydroxybenzoate (propylparabens). If you have any doubts about the use of
this medicine, consult your doctor or pharmacist.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may in any case result in positive anti-doping tests.

Other medicines and Effortil
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking the following medicines:

• guanethidine and reserpine(medicines used for high blood pressure);
• mineralocorticoids(medicines used to treat conditions in which there is insufficient production of steroid hormones);
• thyroid hormones(medicines used for thyroid disorders, a gland in the neck);
• tricyclic antidepressants, MAO inhibitors(medicines to treat depression);
• antihistamines (medicines used for allergies);
• cardiac glycosides(medicines for the treatment of heart disorders);
• dihydroergotamine(medicine for treating headaches);
• atropine(a substance that acts on the nervous system);
• deoxycorticosterone acetate(a medicine that acts by regulating salts dissolved in the blood);
• antidiabetics(medicines to treat diabetes, which work by reducing blood sugar);
• alpha-blockers(medicines used to treat high blood pressure and prostate disorders);
• beta-blockers(medicines that slow down the heartbeat, used to treat high blood pressure and heart problems);
• quinidine(medicine for treating heart rhythm disorders);
• halogenated aliphatic hydrocarbons(inhalation anesthetics, used for surgical operations).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your
doctor or pharmacist for advice before using this medicine.

Pregnancy

Do nottakeEffortil in the first three months of pregnancy (see section “Do not take
Effortil”).

UseEffortil from the fourth to the ninth month of pregnancy only after consulting your doctor, who
will carefully assess the risk/benefit ratio.
Effortil may decrease blood flow to the fetus and cause uterine relaxation.

Breastfeeding

Do nottake Effortil if you are breastfeeding (see section “Do not take
Effortil”).

Fertility
No studies have been conducted on animals on the effect of Effortil on fertility.
No studies have been conducted on the effect of Effortil on human fertility.

Driving and operating machinery
No studies have been conducted on the ability to drive and operate machinery.
If you experience side effects such as dizziness while taking Effortil, be careful if you need to drive vehicles or use machinery.

Effortil oral drops contains parabens, sodium and sodium metabisulfite

Parabens: may cause allergic reactions (even delayed).

Sodium metabisulfite: rarely may cause severe hypersensitivity reactions and bronchospasm.

Sodium:this medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose
(30 drops), i.e. it is essentially “sodium-free”.

3. How to take Effortil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 5-10 drops, 3 times a day.
The oral drop bottle is equipped with a child-resistant safety closure, to open
follow the instructions below:

If you take more Effortil than you should
In case of accidental ingestion/intake of an excessive dose of Effortil, immediately inform your doctor or go to the nearest hospital.

Symptoms
If you take an excessive dose of Effortil, you may experience a worsening of the
serious undesirable effects reported in the “Possible side effects” section. In addition, you may
experience agitation and vomiting. If an excessive dose of Effortil is accidentally
taken by newborns and infants in early childhood, they may experience reduction and/or
cessation of breathing (central respiratory depression) and coma.

Treatment
The doctor will carry out the appropriate supportive therapy.

If you forget to take Effortil
Do not take a double dose to make up for a missed dose.

If you stop taking Effortil
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 everybody gets them.
The possible side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• headache.

Uncommon (may affect up to 1 in 100 people)

• anxiety;
• insomnia;
• tremor;
• restlessness;
• dizziness;
• vertigo;
• irregular heartbeat (arrhythmia);
• increased heart rate (tachycardia);
• awareness of heartbeats (palpitations);
• nausea.

Not known (frequency cannot be estimated from available data)

• allergic reactions (hypersensitivity);
• chest pain (angina pectoris);
• increased blood pressure;
• excessive sweating (hyperhidrosis).

Other side effects reported are vomiting and decreased heart rate with increased
blood pressure (reflex bradycardia).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 Effortil

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not take this medicine after the expiry date which is stated on the pack after
“Exp”. The expiry date refers to the last day of that month.
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 Effortil contains

• the active ingredient is ethylfrine hydrochloride 7.5 mg (1 ml of solution (approximately 15 drops) contains 7.5 mg of ethylfrine).
• the other components are: methyl-parahydroxybenzoate,propyl-para-hydroxybenzoate, sodium metabisulfite(see paragraph “Effortil oral drops contains parahydroxybenzoates, sodium and sodium metabisulfite”), purified water.

Description of the appearance of Effortil and contents of the pack
It is presented in a clear and colorless solution, contained in a dark glass bottle of 15 ml,
with a dropper. The bottle is equipped with a child-resistant safety closure.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
SERB SA
Avenue Louise 480
1050 Brussels, Belgium

Manufacturer
Istituto De Angeli S.r.l.
Loc. Prulli 103/c - 50066 Reggello (FI)

EFFORTIL 10 mg/ml injectable solution

Ethylnorepinephrine hydrochloride

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 or pharmacist.
• 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 harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Effortil and what is it used for

Effortil contains ethylfrine hydrochloride, a medicine that works by stimulating the heart and
increasing blood pressure.
Effortil is indicated to increase blood pressure in cases of orthostatic hypotension
(sudden drop in blood pressure when moving from a sitting or
lying position to an upright position, accompanied by symptoms such as dizziness/feeling of lightheadedness).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Effortil

Do not use Effortil

• if you are allergic to ethylnoradrenaline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a blood pressure disorder (hypotensive dysregulation), which causes an increase in blood pressure when you assume the upright position;
• if you suffer from high blood pressure (hypertension);
• if you suffer from an excessive increase in the blood of a type of hormones produced by the thyroid, a gland in the neck (thyrotoxicosis);
• if you suffer from a disease that causes the release into the body of substances that increase blood pressure (pheochromocytoma);
• if you suffer from a severe form of glaucoma, i.e., an eye disease caused by an increase in the pressure of the fluid contained within the eye (closed-angle glaucoma);
• if you suffer from diseases of the prostate (the gland in men that produces seminal fluid), which cause an increase in volume and are associated with difficulty of the urinary bladder emptying completely (prostatic hypertrophy or prostatic adenoma with urinary retention);
• if you suffer from a heart disease characterized by an obstruction of the coronary arteries, the blood vessels that carry blood to the heart (coronary insufficiency);
• if you suffer from a disease characterized by the heart's inability to provide the body with an adequate amount of blood (decompensated heart failure);
• if you suffer from a severe disease of the heart muscle that manifests with fatigue and difficulty breathing (hypertrophic obstructive cardiomyopathy);
• if you suffer from narrowing of the heart valves that regulate blood flow within the heart (stenosis of the heart valves);
• if you suffer from narrowing of the blood vessels that carry blood to the heart (stenosis of the central arteries);
• if you suffer from heart rhythm disorders;
• if you are in the first 3 months of pregnancy and if you are breastfeeding;
• if you are taking cardiac glycosides (see “Other medicines and Effortil”).

Warnings and precautions
Consult your doctor or pharmacist before using Effortil:

• if you suffer from an increased heart rate (tachycardia) and alteration of the heart rhythm (cardiac arrhythmias);
• if you suffer from severe heart and blood vessel disorders (severe cardiovascular disorders);
• if you suffer from a disease characterized by an excess of sugars in the blood (diabetes mellitus);
• if you suffer from a dysfunction of the thyroid, a gland in the neck (hyperthyroidism);
• if you are taking MAO inhibitors (medicines to treat depression) or have stopped taking them less than two weeks ago (see below “Other medicines and Effortil”).

For athletes
The use of the drug without therapeutic necessity constitutes doping and may in any case result in positive anti-doping tests.

Other medicines and Effortil
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
Tell your doctor if you are taking the following medicines:

• guanethidine and reserpine(medicines used in case of high blood pressure);
• mineralocorticoids(medicines used to treat conditions in which there is insufficient production of steroid hormones);
• thyroid hormones(medicines used in case of thyroid disorders, a gland in the neck);
• tricyclic antidepressants, MAO inhibitors(medicines to treat depression);
• antihistamines(medicines used for allergies);
• cardiac glycosides(medicines for the treatment of heart disorders);
• dihydroergotamine(medicine for treating headaches);
• atropine(a substance that acts on the nervous system). If you are taking this medicine simultaneously with Effortil, you may experience an increased heart rate;
• deoxycorticosterone acetate(a medicine that acts by regulating salts dissolved in the blood).
• antidiabetics(medicines to treat diabetes, which act by reducing blood sugar);
• alpha-blockers(medicines used to treat high blood pressure and prostate disorders);
• beta-blockers(medicines that slow down the heart rate, used to treat high blood pressure and heart problems);
• quinidine(a medicine to treat heart rhythm disorders);
• halogenated aliphatic hydrocarbons(inhalation anesthetics, used for surgical procedures).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your
doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not useEffortil in the first three months of pregnancy (see section “Do not use Effortil”).

UseEffortil from the fourth to the ninth month of pregnancy only after consulting your doctor, who
will carefully assess the risk/benefit ratio.
Effortil may decrease blood flow to the fetus and cause uterine relaxation.

Breastfeeding

Do not useEffortil if you are breastfeeding (see section “Do not use Effortil”).

Fertility
No studies have been conducted on animals on the effect of Effortil on fertility.
No studies have been conducted on the effect of Effortil on human fertility.

Driving and using machines
No studies have been conducted on the ability to drive and use machines.
If you experience side effects such as dizziness while being treated with Effortil, be
careful if you need to drive vehicles or use machines.

3. How to use Effortil

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, ask your doctor or pharmacist.
This medicine can be administered by healthcare professionals with an injection under the skin, into a muscle, or
into a vein.

Adults
One vial and if necessary, multiple times a day at intervals of two hours.
The vial is equipped with a pre-break line, therefore a file is not needed.

Effortil injectable solution must not be mixed with levulose solution or with

hydroxyethyl starch solution. Effortil is compatible with physiological saline solution or
Ringer's lactate solution, without further additives.

If you use more Effortil than you should
In case of accidental intake of an excessive dose of Effortil, immediately inform
your doctor or go to the nearest hospital.

Symptoms
If you take an excessive dose of Effortil, you may experience a worsening of the
serious undesirable effects reported in the “Possible undesirable effects” section. In addition, you may
experience agitation and vomiting. If an excessive dose of Effortil is accidentally taken by
newborns and infants in early childhood, they may experience reduced and/or
blockage of breathing (central respiratory depression) and coma.

Treatment
The doctor will carry out the appropriate supportive therapy.

If you forget to use Effortil
Do not use a double dose to make up for a missed dose.

If you stop using Effortil
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 everybody gets them.
The possible side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• headache.

Uncommon (may affect up to 1 in 100 people)

• anxiety;
• insomnia;
• tremor;
• restlessness;
• dizziness;
• irregular heartbeat (arrhythmia);
• increased heart rate (tachycardia);
• awareness of heartbeats (palpitations);
• nausea.

Not known (frequency cannot be estimated from available data)

• allergic reactions (hypersensitivity);
• chest pain (angina pectoris);
• increased blood pressure;
• excessive sweating (hyperhidrosis).

Other side effects reported are vomiting and slowed heartbeat with increased
blood pressure (reflex bradycardia), changes in the sensitivity of the limbs or of
other parts of the body (paresthesia), goosebumps (piloerection), feeling cold, chills.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
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 Effortil

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not take this medicine after the expiry date which is stated on the pack after
“Exp”. The expiry date refers to the last day of that month.
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 Effortil contains

• the active ingredient is ethylnorepinephrine hydrochloride 10 mg (1 ml of solution contains 10 mg of ethylnorepinephrine).
• the other component is: water for injections.

Description of the appearance of Effortil and contents of the pack
It is presented as a clear and colourless solution, contained in dark glass vials of 1 ml. The vials
are packaged in a carton containing 6 vials of 1 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
SERB SA
Avenue Louise 480
1050 Brussels, Belgium
Manufacturer
Cenexi
52 rue Marcel et Jacques Gaucher
94120 Fontenay sous Bois, France

The following information is intended exclusively for doctors or healthcare
professionals:
No incompatibilities with other medicinal products are known.
Effortil injectable solution is incompatible with levulose solution or with hydroxyethyl starch solution.
Effortil is compatible with sodium chloride solution or Ringer's lactate solution, without
further additives.
The chemical and physical stability after first opening has been demonstrated for up to 48 hours at 30°C
when diluted with sodium chloride solution or Ringer's lactate solution to a
concentration equal to one vial in 250 ml or 500 ml.
From a microbiological point of view, the ready-to-use injectable solution must be used
immediately. If not used immediately, the time and conditions of storage
before use are the responsibility of the user.