EFFORTIL

EFFORTIL tablets

Important notes (mandatory information)

Effortil 5 mg tablets. Active ingredient: Etilefrine hydrochloride. Areas of application: for circulatory regulation disorders with low blood pressure (hypotension), which occur when changing body position (e.g. when standing up from lying or sitting) with symptoms such as dizziness, weakness, paleness, sweating, flickering or blackening before the eyes as well as with a significant drop in blood pressure without an increase in heart rate.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Effortil 5 mg tablets for use in adults and children aged 2 years and over
Active ingredient: Etilefrine hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse after 3 – 4 days, contact your doctor.

What this leaflet contains

1. WHAT IS EFFORTIL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING EFFORTIL?
3. HOW TO TAKE EFFORTIL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE EFFORTIL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS EFFORTIL AND WHAT IS IT USED FOR?

Effortil is a blood pressure raising medicine. Effortil is used for circulatory regulation disorders with low blood pressure (hypotension), which occur when changing body position (e.g. when standing up from lying or sitting) with symptoms such as dizziness, weakness, paleness, sweating, flickering or blackening before the eyes as well as with a significant drop in blood pressure without an increase in heart rate.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING EFFORTIL?

Effortil must not be taken:

• if you are allergic to etilefrine hydrochloride, sodium disulfite or any of the other ingredients of this medicine listed in section 6.
• in the case of circulatory regulation disorders with low blood pressure, if blood pressure and heart rate increase in the standing test (hypertensive reaction).
• in the case of high blood pressure (hypertension).
• in the case of uncontrolled hyperthyroidism (thyrotoxicosis).
• in the case of a tumour of the adrenal gland (phaeochromocytoma).
• in the case of increased intraocular pressure (narrow-angle glaucoma).
• in the case of voiding disorders of the urinary bladder with residual urine, especially in the case of enlargement of the prostate gland (prostate adenoma).
• in the case of hardening of the blood vessels (sclerotic vascular changes).
• in the case of severe narrowing of the coronary arteries with oxygen deficiency in the heart (coronary heart disease).
• in the case of insufficient pumping function of the heart (decompensated heart failure).
• in the case of cardiac arrhythmias in connection with a very fast heart rate (tachycardic cardiac arrhythmias).
• in the case of a narrowing of the heart valves (heart valve stenosis) or a narrowing of the large arteries.
• in the case of a specific disease of the heart muscle, which is associated with excessive and constricting growth of the heart muscle (hypertrophic obstructive cardiomyopathy).
• in the first 3 months of pregnancy (see section Pregnancy, breast-feeding and fertility).
• during breast-feeding (see section Pregnancy, breast-feeding and fertility).
• by children under 2 years of age; Effortil drops for oral administration are available for this patient group.
• in the case of rare congenital conditions that may involve an intolerance to a component of the medicine (see below, section "Important information about certain other ingredients of Effortil").

Warnings and precautions

In these cases, you should consult and be examined by your doctor before starting to take Effortil:

• Diabetes mellitus (see section Taking Effortil with other medicines)
• Hyperthyroidism
• increased calcium levels in the blood (hypercalcaemia)
• decreased potassium levels in the blood (hypokalaemia)
• severe kidney dysfunction
• a specific heart disease resulting from a lung disease (cor pulmonale)
• Cardiac arrhythmias
• severe diseases affecting the heart and blood vessels

Children

Effortil tablets must not be used in children under 2 years of age. Effortil drops for oral administration are available for this patient group.

Note

The use of Effortil can lead to positive results in doping controls.

Taking Effortil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Medicines that can affect the effect of Effortil

Active ingredients or groups of active ingredients	possible effect
• Medicines to lower blood pressure: Reserpine, guanethidine	Increased effect of etilefrine hydrochloride (undesirable increase in blood pressure)
• Certain medicines to increase blood pressure: Mineralocorticoids
• Medicines for the treatment of mental disorders and neurological diseases (e.g. Parkinson's disease): tricyclic antidepressants, MAO inhibitors
• Other medicines that mimic the effect of the sympathetic nervous system (sympathomimetics), such as medicines for the treatment of airway constriction
• Thyroid hormones
• Medicines for the treatment of allergies: Antihistamines
• Medicines for the treatment of circulatory disorders, migraine, tension headaches: Dihydroergotamine
• Antispasmodic medicines: Atropine (e.g. before anaesthesia or for urinary bladder problems)	Increased heart rate
• Medicines to lower blood pressure: Alpha or beta-receptor blockers	Drop or increase in blood pressure with slowed heart rate (bradycardia)

Medicines whose effect can be influenced by Effortil drops

Active ingredients or groups of active ingredients	possible effect
• Medicines for the treatment of diabetes (antidiabetics)	Reduced blood sugar lowering
• Medicines for the treatment of heart muscle weakness (cardiac glycosides): e.g. digitalis	possible occurrence of cardiac arrhythmias
• Inhalation anaesthetics: halogenated aliphatic hydrocarbons, e.g. halothane

Sodium disulfite is a very reactive compound. It must therefore be assumed that thiamine (vitamin B1) taken together with Effortil will be broken down.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Effortil must not be taken in the first 3 months of pregnancy. From the 4th month of pregnancy, it can be taken if the attending physician approves.

Breast-feeding

Effortil must not be taken during breast-feeding, as it cannot be ruled out that it will pass into breast milk and there is no experience with infants.

Fertility

No animal studies have been conducted with regard to fertility. No studies have been conducted on the effects on human fertility.

Driving and using machines

No studies have been conducted on the effect on driving and using machines. Please note that side effects may occur that could theoretically impair the ability to drive and operate machinery.

Effortil contains lactose

One tablet contains approx. 31.8 mg lactose (milk sugar), which corresponds to 190.8 mg lactose in the recommended maximum daily dose for adults. Please only take Effortil tablets after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE EFFORTIL?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• For adults and children over 6 years of age: 1 -- 2 tablets 3 times a day. This corresponds to a daily dose of 15 -- 30 mg etilefrine hydrochloride.
• For children between 2 and 6 years of age: 1/2 -- 1 tablet 3 times a day. This corresponds to a daily dose of 7.5 -- 15 mg etilefrine hydrochloride.

Take Effortil preferably before meals with a glass of liquid. Effortil should not be taken in the late afternoon or evening, as its stimulating effect can make it difficult to fall asleep. The need to take Effortil should be reviewed regularly. Please talk to your doctor or pharmacist if you have the impression that the effect of Effortil is too strong or too weak.

If you have taken more Effortil than you should

In the event of an overdose of Effortil, the following symptoms of poisoning may occur: severe acceleration of the heart rate (tachycardia), cardiac arrhythmias, excessive increase in blood pressure (possibly with headache), sweating, agitation, nausea, vomiting. In this case, please inform a doctor immediately. He will decide on the need to remove the medicine from the gastrointestinal tract and to administer medical charcoal. In severe cases, intensive medical monitoring and treatment may be necessary.

If you forget to take Effortil

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Effortil

If you interrupt or discontinue treatment prematurely, the symptoms are likely to recur.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

The following side effects may occur

Immune system disorders

Frequency not known: Hypersensitivity (allergic reaction)

Psychiatric disorders

Uncommon: Anxiety

Nervous system disorders

Common: Headache
Uncommon: Restlessness, insomnia, muscle tremor, dizziness

Heart disorders

Uncommon: Palpitations, rapid heartbeat (tachycardia), cardiac arrhythmias with extrasystoles (ventricular cardiac arrhythmias)
Frequency not known: Pressure sensation over the heart (anginal complaints), increase in blood pressure (possibly with headache)

Gastrointestinal tract

Common: Gastrointestinal complaints
Uncommon: Nausea

General disorders

Frequency not known: Increased sweating

Sodium disulfite can rarely cause hypersensitivity reactions and bronchial spasms (bronchospasms).

Measures to be taken if you are affected by side effects

If side effects occur, you should not take Effortil again and consult your doctor for advice. If a hypersensitivity reaction occurs, do not take Effortil again and notify a doctor immediately so that he can decide on any necessary further measures, depending on the severity.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE EFFORTIL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and on the blister pack after "Use by". The expiry date refers to the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Effortil contains

The active ingredient is etilefrine hydrochloride. 1 tablet contains 5 mg etilefrine hydrochloride. The other ingredients are: sodium disulfite, lactose monohydrate, maize starch dried, highly dispersed silicon dioxide, modified starch, long-chain partial glycerides.

What Effortil looks like and contents of the pack

Round, white tablets with a break line on the upper side and the
inscription "05E" above and below the break line. The tablets can be divided into equal halves. Effortil is available in packs of 50 tablets.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

SanofiAventis
Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main

Telephone: 0800 56 56 010
Telefax: 0800 56 56 011

Manufacturer

Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France

This leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Etilefrine hydrochloride. Areas of application: for circulatory regulation disorders with low blood pressure (hypotension), which occur when changing body position (e.g. when standing up from lying or sitting) with symptoms such as dizziness, weakness, paleness, sweating, flickering or blackening before the eyes as well as with a significant drop in blood pressure without an increase in heart rate.