2.5 mg tablets; 5 mg tablets, 10 mg tablets
1. What Hypotron is and what it is used for
The name of your medicine is Hypotron. Hypotron tablets contain the active substance midodrin hydrochloride. It belongs to a group of drugs called adrenergic and dopaminergic drugs.
Midodrin hydrochloride is a drug that raises blood pressure and is used to treat certain severe forms of low blood pressure in adults when other treatments have not worked.
Midodrin hydrochloride contained in Hypotron may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you take Hypotron
Do not take Hypotron if:
- you are allergic to midodrin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- you have high blood pressure
- you have a slow heart rate
- you have difficulty urinating
- you have certain cardiovascular diseases
- you have increased eye pressure ( glaucoma ) or visual impairment due to diabetes
- you have an overactive thyroid gland
- you have hormonal disorders caused by a tumor in the adrenal medulla ( pheochromocytoma )
- you have a severe kidney disease
- you have prostate enlargement.
Warnings and cautions
Talk to your doctor or pharmacist before taking Hypotron if you have been told that you have high blood pressure while lying down. If this applies to you:
- your blood pressure should be monitored regularly both when you lie down and when you get up, as there may be a risk that your blood pressure rises when you lie down, e.g. at night. If your blood pressure rises when you lie down and the problem is not remedied by reducing the dose , treatment with this medicine must be stopped.
- it is important that you do not take the medicine late in the evening. Take the last dose of the day at least 4 hours before bedtime. The risk of high blood pressure when you lie down is less if you have your head in an elevated position at night.
Also, talk to a doctor:
- if you have a severe disorder of the nervous system (disorder of the autonomic nervous system ) because taking this medicine may lead to a further decrease in blood pressure when you get up. If this happens, treatment with this medicine should be stopped.
- if you have blood circulation problems, especially if you have symptoms such as pain or cramps in the stomach after eating, or pain or cramps in the legs when walking.
- if you have a disease of the prostate, as you may have difficulty urinating while taking this medicine.
Your doctor should check your kidney function and blood pressure before starting treatment. During treatment, your blood pressure will be checked from time to time and the dose will be adjusted as needed.
It is important that you immediately report symptoms associated with high blood pressure, such as chest pain, palpitations, shortness of breath, headache, and blurred vision. Your doctor will decide if your dose needs to be adjusted or if Hypotron treatment needs to be stopped.
Talk to your doctor if any of these warnings apply or have affected you.
Children and young people
This medicine should not be given to children or adolescents under 18 years of age, as the safety and efficacy of Hypotron have not been established in this age group.
Other medicines and Hypotron
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Concomitant use with these drugs may cause a sharp rise in blood pressure:
- Reserpine and guanetidine (antihypertensive drugs)
- Antihistamines (used to treat allergies )
- Thyroid hormone (used if the thyroid gland is not working properly)
- Tricyclic antidepressants and MAO inhibitors (both used to treat depression)
- Other vasoconstrictors (vasoconstrictors) or sympathomimetics (medicines that have a stimulating effect on certain parts of the nervous system)
- Prazosin and Phentolamine (medicines used to treat heart disease) because they prevent the effects of this medicine.
- Digitalis preparations (medicines used to treat heart disease) as concomitant use with this medicine may impair heart function.
- Corticosteroids are such as fludrocortisone acetate (anti-inflammatory drug) as these drugs may increase the effect of Hypotron.
- Drugs that directly or indirectly reduce the heart rate. It is recommended that your doctor closely monitor you if Hypotron is used at the same time as these medicines.
Pregnancy, breastfeeding and fertility
The use of this drug is not recommended during pregnancy or in women of childbearing potential not using contraception. Tell your doctor if you are pregnant or want to become pregnant during treatment.
Do not use this medicine while breastfeeding.
Driving and using machines
This medicine is unlikely to have any effect on the ability to drive or use machines. However, you should be careful if you experience dizziness or unsteadiness after taking the medicine. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
Hypotron 5 mg tablets contain para-orange aluminum lacquer (E110)
Para-orange aluminum lacquer (E110) can cause allergic reactions.
3. How to take Hypotron
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 with water.
This medicine can be taken with or without food.
The breaker is not for dividing the tablet into equal doses, but only for easier swallowing.
How much to take
Your doctor will decide on a dose and will tell you how long to take the medicine. The treatment is usually long-lasting.
The recommended starting dose is usually 2.5 mg three times daily. This dose can be increased weekly up to 10 mg three times daily, which is equivalent to the usual maintenance dose of 30 mg per day.
The recommended total daily dose should be evenly distributed over three doses per day.
Time for the evening dose
Avoid taking the medicine late in the evening. Take the last dose at least 4 hours before bedtime. Having your head in an elevated position during the night reduces the risk of high blood pressure when you lie down. See the Warnings and Cautions section of this leaflet for further information.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
If you take more Hypotron than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
An overdose of the drug can cause:
- high blood pressure ( hypertension ), e.g. palpitations, shortness of breath, chest pain, headache and blurred vision
- slow heart rate ( bradycardia )
- urination difficulties
- feeling cold.
If you forget to take Hypotron
If you forget to take a dose, take the next dose at the usual time and then continue to take the medicine exactly as your doctor has told you. Do not take a double dose to make up for a forgotten dose, as it increases the risk of high blood pressure when you lie down.
If you stop taking Hypotron
No sudden drop in blood pressure will occur.
Always consult a doctor if you are considering stopping this medicine.
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.
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 , high blood pressure when lying down, headache, nausea, heartburn, inflammation of the oral mucosa, redness , rash, chills, difficulty urinating.
Uncommon (may affect up to 1 in 100 people):
- sleep disorders including difficulty sleeping, restlessness, agitation and irritability, slow heart rate, urinary incontinence.
Rare (may affect up to 1 in 1,000 people):
- palpitations, rapid heartbeat, abnormal liver function including increase in liver enzymes.
Has been reported (occurs in an unknown number of users):
- abdominal pain, vomiting, diarrhea, anxiety, feeling of confusion
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Hypotron
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 outer carton and blister after EXP. The expiration date is the last day of the specified month. Do not store above 30 ° 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.
6. Contents of the packaging and other information
- The active substance is midodrine hydrochloride. Each tablet contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride.
- The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate and anhydrous colloidal silica. Hypotron 5 mg tablets also contain para-orange aluminum lacquer (E110). Hypotron 10 mg tablets also contain brilliant blue FCF aluminum lacquer (E133).
What the medicine looks like and contents of the pack
The 2.5 mg tablets are white, round, and marked on one side with “MID” above the incision and “2.5” below the incision.
The 5 mg tablets are orange, round, and marked on one side with “MID” above the notch and “5” below the notch.
The 10 mg tablets are blue, round and marked on one side with “APO” and on the other side with “MID” above the scoreline and “10” below the scoreline.
The medicine is available in cartons containing 50 or 100 tablets in aluminum/aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Brancaster Pharma Ireland Ltd.
Dublin 3, D03X0Y5