Patient leaflet - Indoramin 20 mg film-coated tablets
1. What Indoramin is and what it is used for
Indoramin belongs to a group of medicines called alpha-blockers. Indoramin can treat high blood pressure (hypertension) by relaxing the blood vessels in the body and lowering blood pressure. Indoramin can also be given to men suffering from an enlarged prostate gland, as it can relax the muscles allowing urine to be passed more easily.
2. What you need to know before you take Indoramin
Do not take Indoramin:
- if you have taken medicine containing indoramin or a similar medicine (e.g. prazosin, alfuzosin, terazosin, tamsulosin, doxazosin) and you suffered an allergic reaction
- if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you have established heart failure
if you are being treated for depression with a type of medicine called a monoamine oxidase inhibitor
(MAOI) e.g. phenelzine, tranylcypromine, moclobemide.
Warnings and precautions
Talk to your doctor or pharmacist before taking Indoramin:
- if you suffer from swollen ankles and breathlessness. These symptoms should be treated before treatment with Indoramin
- if you have liver or kidney problems
- if you have Parkinson’s disease
- if you have epilepsy
- if you have suffered from depression.
If you are an older person, your doctor may tell you to take a lower or less frequent dose of Indoramin.
If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are taking or have previously taken Indoramin. This is because Indoramin may cause complications during the surgery which can be managed if your specialist is prepared in advance.
Other medicines and Indoramin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including the following:
- diuretics (water tablets) e.g. furosemide
medicines that lower blood pressure (e.g. atenolol, doxazosin, alfuzosin), vasodilators
(e.g. hydralazine, moxisylyte), hypnotics (e.g. temazepam) and some medicines used to treat anxiety or depression.
Indoramin and alcohol
You should not drink alcohol if Indoramin makes you feel drowsy. Alcohol can increase the amount of Indoramin absorbed by the body, so you could feel more drowsy.
Pregnancy and breast-feeding
Indoramin should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. 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.
Driving and using machines
Indoramin may make you feel drowsy. Do not drive, operate machinery or perform any hazardous tasks if you feel drowsy. This is more likely to occur at the beginning of the treatment, or when dosage is increased rapidly.
Indoramin contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Indoramin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Tablets should be swallowed whole with a glass of water. If you need to take two different doses each day, the higher dose should be taken at night to stop you feeling sleepy during the day.
Indoramin can be taken with or without food.
Use in adults: The recommended dose is one tablet (20 mg) of indoramin twice a day. If needed, the dose may be increased by 20 mg every two weeks. The maximum dose is 100 mg per day.
Use in older people: The recommended dose is one tablet (20 mg) of indoramin taken at night.
Use in children: Indoramin is not recommended for use in children.
If you take more Indoramin than you should
If you take more Indoramin than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose have included deep sedation leading to coma, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), abnormally low blood pressure and fits.
If you forget to take Indoramin
If you forget to take Indoramin take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Indoramin
Do not suddenly stop taking your medicine as this may cause serious changes in your blood pressure. If you want to stop the treatment or you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Indoramin and tell your doctor immediately or go to your nearest hospital emergency department:
- Allergic reactions such as rash, itching, swelling of the face, lips, tongue or throat, shortness of breath or difficulty breathing
- worsening of existing Parkinson’s disease.
Other side effects
The most common side effects are feeling drowsy or sedated. This is most likely to occur at the start of treatment and if dosage is increased too quickly.
Less common side effects are: dry mouth, nasal congestion, weight gain, dizziness, failure of ejaculation, depression, fatigue, headache, low blood pressure including dizziness on standing up, especially when getting up from a sitting or lying position (which may or may not be accompanied by fainting).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Indoramin
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 label after EXP. The expiry date refers to the last day of that month.
Do not store above 25ºC.
| Keep | the | container | tightly | closed | / | Store | in | original | package. |
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Indoramin contains
- The active substance is indoramin as indoramin hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, polacrilin potassium
(amberlite IRP88) and magnesium stearate. The coating includes titanium dioxide (E171), lactose monohydrate, macrogol 4000, hypromellose and purified water.
What Indoramin looks like and contents of the pack
Indoramin tablets are white, shield shaped, normal convex film-coated tablets, debossed ‘G’ on one side and ‘IR 20’ on the other.
Indoramin tablets are available in containers of 60 tablets.
Marketing Authorisation Holder
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland