5 mg tablets 
ethylphrine hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
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 packaging and other information 

1. What Effortil is and what it is used for

Effortil stabilizes blood pressure in patients who are bothered by orthostatism, ie blood pressure drops when standing up (from lying to sitting and from sitting to standing position). People with orthostatism are mainly bothered by dizziness, palpitations, and fainting attacks in connection with changes in body position.

The treatment with Effortil causes the body’s blood vessels to constrict, especially the vessels in the legs. The backflow of blood to the heart then increases at the same time as the pumping power of the heart increases. The result is an improved regulation of blood pressure.


Please note that the doctor may have prescribed the medicine for another use and/or with a different dosage than that stated in the package leaflet. Always follow your doctor’s prescription and the instructions on the label on the medicine pack.

2. What you need to know before using Effortil

Do not use Effortil

  • If you are allergic to ethylphrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer from any of the following conditions:
    • have too high blood pressure when you get up compared to if you sit or lie down when you have low blood pressure ( hypotensive dysregulation)
    • high blood pressure
    • hypothyroidism ( thyrotoxicosis )
    • overproduction of norepinephrine ( pheochromocytoma )
    • glaucoma with narrow ventricular angle (eye irritation, pain, visual disturbances, and red, irritated eyes)
    • prostate enlargement or benign glandular tumor of the prostate ( prostate – adenoma ) with difficulty urinating
    • the disease of the coronary arteries of the heart
    • heart failure, difficult to control (decompensated heart failure )
    • a certain type of heart muscle disease (so-called hypertrophic obstructive cardiomyopathy )
    • narrowing of heart valves or central arteries ( stenosis of heart valves or central arteries )
    • during the first three months of pregnancy.

Warnings and cautions

Talk to your doctor or pharmacist before using Effortil:

  • if you have fast or uneven heart rhythm or another serious cardiovascular disease.
  • if you have diabetes
  • if you have an increased level of thyroid hormone ( hyperthyroidism )

Other medicines and Effortil

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

Concomitant use of the following drugs may, for example, enhance the effect of Effortil:

  • thyroid hormone (levothyroxine, liothyronine)
  • certain antidepressants (amitriptyline, clomipramine, moclobemide)
  • anti-allergy drugs ( antihistamines )
  • medicines for certain diseases of the adrenal glands ( mineral corticosteroids )
  • certain medicines for migraine (dihydroergotamine)
  • Atropine (including some eye drops for eg glaucoma )

High doses of cardiac glycosides ( digoxin, etc.) and certain types of anesthesia can affect the heart if you take Effortil.

Drugs for diabetes can be affected and have a lower blood sugar lowering effect if Effortil is given at the same time.

Some antihypertensive drugs (alpha- and beta-blockers ) may reduce the effect of Effortil and also affect the heart rhythm.

Pregnancy and breastfeeding

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

Pregnancy

Effortil should not be used at all during the first three months of pregnancy. During the rest of your pregnancy, Effortil should only be used after your doctor has carefully assessed the risks and benefits of the treatment.

Breast-feeding

It is unknown whether Effortil is excreted in human milk.

Driving and using machines

Effortil can cause dizziness. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Effortil contains sodium metabisulfite and lactose

Effortil contains sodium metabisulfite (E223). In rare cases, this can cause severe hypersensitivity reactions and convulsions in the trachea.

Effortil contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Effortil contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

3. How to use Effortil

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.


The recommended dose is:

Adults and children over 7 years: 1-2 tablets 3 times daily

Children 1-7 years: ½-1 tablet 3 times daily


If you have the impression that the effect of Effortil is too strong or too weak, talk to your doctor or pharmacist.

If you take more Effortil than you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Effortil

Do not take a double dose to make up for a forgotten tablet.


If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people):

  • headache

Uncommon (may affect up to 1 in 100 people):

  • concern
  • difficulty falling asleep
  • tremors
  • restlessness
  • dizziness
  • palpitation
  • fast heartbeat
  • heart rhythm disorders
  • nausea

Has been reported (occurs in an unknown number of users):

  • hypersensitivity s
  • angina
  • high blood pressure
  • sweating

5. How to store Effortil

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ethylphrine hydrochloride 5 mg per tablet
  • The other ingredients are lactose monohydrate (32 mg), corn starch, anhydrous colloidal silica, modified starch, sodium metabisulfite (E223), glyceryl palmitostearate.

What the medicine looks like and the contents of the pack

Effortil tablets are white and round with beveled edges. One side is notched and has the designation 05E / 05E.

The diameter of the tablets is 6 mm. 100 tablets in pressure pack (aluminum / PVC).

Marketing Authorization Holder and Manufacturer

Sanofi AB 
Box 30052

104 25 Stockholm

Manufacturer :

Delpharm Reims, 10 Rue Colonel Charbonneaux, 51100 Reims, France

Muhammad Nadeem

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