2.5 mg 5 mg tablets
midodrin hydrochloride
What Midodrin is and what it is used for
This medicine is called Midodrin Evolan. It contains midodrine hydrochloride and belongs to a group of medicines called adrenergic and dopaminergic drugs. Midodrine hydrochloride is a drug that raises your blood pressure and is used to treat certain severe forms of low blood pressure in adults when other treatments have not worked.
Midodrine contained in Midodrin Evolan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Midodrin
Do not use Midodrin
- if you are allergic to midodrin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you have high blood pressure
- if you have a low heart rate
- if you have difficulty urinating
- if you have certain forms of cardiovascular disease (ask your doctor if this applies to you)
- if you have high blood pressure in the eye ( glaucoma ) or poor eyesight due to diabetes
- if you have an overactive thyroid gland
- if you have hormonal disorders due to a tumor in the adrenal medulla ( pheochromocytoma )
- if you have acute kidney disease or severe renal impairment
- if you have an enlarged prostate .
Warnings and cautions
Talk to your doctor or pharmacist before taking this medicine and during treatment
- if you get high blood pressure while lying down. Symptoms of high blood pressure are e.g. palpitations, shortness of breath, chest pain, headache and blurred vision. If this applies to you, it is important that your blood pressure is checked regularly, when you lie down and when you get up, as there may be a risk that your blood pressure will rise at night when you e.g. is sleeping. Your doctor will then decide if your dose should be adjusted or if you should stop taking Midodrin Evolan. It is important that you do not take this medicine late in the evening (see section “How to take Midodrin Evolan”) .
- if your blood pressure drops further when standing up: in this case, treatment with this medicine should be stopped
- if you experience any signs or symptoms that indicate a low heart rate ( bradycardia ) such as low heart rate , dizziness or increased heart awareness contact your doctor as you may be advised to stop taking Midodrin Evolan.
- if you have problems with blood circulation, which can, for example, manifest itself as pain or cramps in the stomach (especially after you have eaten), or in the legs.
- if you have prostate problems, as you may find it difficult to urinate while taking their medicines.
Your kidney and liver function as well as your blood pressure are checked by your doctor before you start using this medicine and then regularly during treatment, and if necessary, dose one will be adjusted.
Children and young people
Not recommended for children and adolescents under 18 years of age, as the safety and efficacy of Midodrin Evolan have not been established in this age group.
Other medicines and Midodrin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- Drugs that when used concomitantly with Midodrin Evolan can cause your blood pressure to rise a lot:
- certain medicines used to lower high blood pressure (eg reserpine and guanetidine)
- medicines used to treat allergies ( antihistamines )
- hormone er used when the thyroid gland is not functioning properly
- certain medicines used to treat depression ( tricyclic antidepressants and MAO inhibitors )
- drugs that cause the blood vessels to constrict (so-called vasoconstrictors )
- drugs that have a stimulating effect on certain parts of the nervous system ( sympathomimetics ).
- certain medicines used to treat heart disease (eg prazosin and phentolamine), as the effect of Midodrin Evolan is prevented by these medicines.
- medicines containing digitalis (a type of medicine used to treat heart disease), as concomitant use with Midodrin Evolan may lead to impaired heart function.
- corticosteroids (a type of anti-inflammatory drug), as the antihypertensive effect of both drugs can be enhanced when taken together.
- drugs that lower the heart rate.
Pregnancy, breastfeeding and fertility
The use of this medicine during pregnancy is not recommended. Tell your doctor if you are pregnant or if you wish to have it during the period you are being treated with this medicine.
Do not use this medicine if you are breastfeeding.
Driving and using machines
This medicine should not affect your ability to drive or use machines. However, you must be careful if you get dizzy or if you feel dizzy after taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
How to use Midodrin
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Swallow the tablets together with a glass of water. This medicine can be taken with or without food.
How much to take: Your doctor will prescribe dose one and tell you how long to take this medicine. The treatment generally takes place over a longer period.
The recommended starting dose is a 2.5 mg tablet three times a day. This dose can be increased once a week up to four 2.5 mg tablets or two 5 mg tablets three times a day (up to a total of 30 mg per day).
Time of evening dose: Avoid taking this medicine late in the evening. The last dose should be taken at least 4 hours before bedtime to prevent your blood pressure from rising when you lie down. The risk of high blood pressure lying down during the night can be reduced by raising your head. For more information, see the “Warnings and Cautions” section of this leaflet.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Elderly patients
If you are older, your doctor will increase your dose especially carefully as the dosage information for the elderly is limited.
If you use more Midodrin than you should
If you take too much of this medicine, you may experience a rise in blood pressure (with symptoms such as palpitations, shortness of breath, chest pain, headache, and blurred vision), slow heart rate, difficulty urinating, goosebumps, or a feeling of guilt.
If you forget to use Midodrin
If you forget to take a dose, take the next dose as usual and then continue to take the medicine that your doctor has told you to. Do not take a double dose to make up for a forgotten dose, as this will increase the risk of your blood pressure rising when you lie down.
If you stop using Midodrin
Always talk to your doctor if you are considering stopping your treatment with this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Midodrin Evolan and contact a doctor immediately or see your nearest emergency department if you experience the following symptoms, see also the section “What you need to know before taking Midodrin Evolan”
- palpitations, shortness of breath, chest pain, headache and blurred vision when lying down are signs of high blood pressure , a common side effect that can occur in up to 1 in 10 users.
- Slow heartbeat is a sign of bradycardia , a less common side effect that can affect up to 1 in 100 people.
Other side effects that may occur:
Very common (may affect more than 1 user in 10): goosebumps, itching of the scalp, and pain when urinating.
Common (may affect up to 1 in 10 people): tingling and itching, headache, nausea, heartburn, inflammation of the mouth, redness, rash, cold, difficulty urinating.
Uncommon (may affect up to 1 in 100 people): sleep disorders including difficulty sleeping, restlessness, agitation and irritation, urinary incontinence.
Rare (may affect up to 1 in 1,000 people): palpitations, fast heartbeat, abnormal liver function including the increased number of liver enzymes (seen in blood tests).
Has been reported (occurs in an unknown number of users): abdominal pain, vomiting, diarrhea, anxiety, feeling confused.
How to store Midodrin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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.
Contents of the package and other information
Content declaration
The active substance is midodrine hydrochloride.
Each tablet contains either 2.5 mg or 5 mg of midodrine hydrochloride.
The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, and colloidal, anhydrous silica.
What the medicine looks like and contents of the pack
The 2.5 mg tablets are white, flat, round tablets imprinted with “2.5”
The 5 mg tablets are white, flat, round tablets imprinted with “5”
The 2.5 mg tablets are available in packs of 10, 30, 40, 50, 60, 70, 80, 90, 100 and 500 tablets.
The 5 mg tablets are available in packs of 10, 30, 40, 50, 60, 70, 80, 90, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer
Medis International as
virtuoso zavod Bolatice
Premyslov 961/16
747 23 Police
Czech Republic