Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.
Aldomet contains the active substance called methyldopa. This belongs to a group of medicines called ‘antihypertensives’.
Your doctor has prescribed Aldomet to treat high blood pressure (hypertension).
Do not take Aldomet if you have:
Do not take Aldomet if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Aldomet.
Take special care with Aldomet
Talk to your doctor or pharmacist before taking Aldomet if you have:
Check with your doctor while taking this medicine if you are going to have:
There is the possibility to develop a tolerance to this medicine. If you have any concerns you should talk to your doctor.
Tests you may have while taking Aldomet
Your doctor may do blood tests to check how your liver is working during the first 6 – 12 weeks. He or she may use similar tests if you have a fever at any time while you are taking Aldomet. Tell your doctor you are taking Aldomet if you have a laboratory test where a urine or blood sample is taken. This is because Aldomet may affect the results of some types of tests. Rarely, in patients taking Aldomet urine may darken when it is exposed to air after voiding, If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Aldomet.
Other medicines and Aldomet
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as some drugs may affect each other’s action. This includes herbal medicines.
Do not take Aldomet if you are taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) used to treat depression.
It is particularly important that you tell your doctor or pharmacist if you are taking any of the following before taking Aldomet
If you have to have surgery, including dental, that requires an anaesthetic, you must inform the dentist or hospital that you are taking Aldomet tablets.
Aldomet with alcohol
You are advised not to drink alcohol while taking Aldomet tablets. Discuss this with your doctor if you have any questions.
Pregnancy and breast-feeding
You should check with your doctor before taking Aldomet if you are or think you may be pregnant, if you are planning to become pregnant or if you are breast-feeding.
Driving and using machines
You may feel drowsy or light-headed while taking Aldomet. If this happens do not drive or use any tools or machines.
Always take Aldomet exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
You should take this medicine by mouth and exactly as advised by your doctor or pharmacist. The amount you take each day will depend upon your condition. It is very important to continue taking Aldomet for as long as your doctor has prescribed. Do not take more or less than your doctor has prescribed.
The usual doses of Aldomet are:
Your doctor will work out the number of tablets you should take. Follow this dosage.
The doctor will work out the number of tablets. The dose is based on the weight of the child.
If you take more Aldomet than you should
If you take too many tablets by mistake, contact your doctor immediately or seek medical attention.
If you forget to take Aldomet
If you stop taking Aldomet
Do not stop taking Aldomet without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Aldomet can cause side effects, although not everybody gets them.
Contact your doctor IMMEDIATELY if you have any of the following side effects as they are serious and require medical attention:
Other unwanted effects which may occur while taking Aldomet Tablets are:
Nose and chest:
Stomach and gut:
Skin and hair:
Joints and muscles:
Your doctor may need to carry out simple blood tests during the first few months of therapy with Aldomet. Results could show:
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: firstname.lastname@example.org
By reporting side effects, you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children.
Do not use the medicine past the expiry date. For the blister strip refer to the expiry information on the side of the carton. Expiry date is on the side of the carton or bottle after 'Ext'.
Do not store above 25°C.
Blisters: Store in the original package in order to protect from light.
Bottles: Keep the container tightly closed in order to protect from light.
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.
What Aldomet contains
The active ingredient in Aldomet tablets is methyldopa.
Aldomet tablets are available in two different strengths containing methyldopa equivalent to either 250 mg anhydrous methyldopa, or 500 mg anhydrous methyldopa.
Cellulose powder, anhydrous citric acid, colloidal anhydrous silica, ethylcellulose, guar gum, magnesium stearate, sodium calcium edetate, hypromellose, propylene glycol, quinoline yellow aluminium lake E104, red iron oxide E172, talc, titanium dioxide, carnauba wax.
What Aldomet looks like and contents of the pack
Aldomet is available as film-coated tablets which come in two different strengths. They are yellow-coloured, round tablets containing methyldopa equivalent to either 250 mg anhydrous methyldopa, or 500 mg anhydrous methyldopa.
Aldomet Tablets 250 mg are available in packs of 60.
Aldomet Tablets 500 mg are available in packs of 30.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
The Marketing Authorisation Holder is Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Aspen Bad Oldesloe GmbH Industriestrasse 32-36, 23843 Bad Oldesloe, Germany