Label: Information for the User

Aldomet® 250 mg Film-Coated Tablets

Metildopa

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Aldomet contains methyldopa as the active ingredient. Aldomet belongs to a group of medications known as antihypertensives, which reduce blood pressure.

Aldomet tablets are used for the treatment of high blood pressure (hypertension)

Do not take Aldomet

• if you are allergic to methyldopa or any of the other components of this medication (listed in section 6).
• if you have any liver disease
• if you suffer from depression
• if you have high blood pressure due to the presence of a tumor near the kidney called pheochromocytoma or paraganglioma.
• if you are taking any medication for depression that belongs to the group of monoamine oxidase inhibitors (MAOIs)
• if you have porphyria (a hereditary metabolic disease)

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication. Inform your doctor if you suffer or have suffered from any of the following conditions:

• any liver disease or jaundice (yellow discoloration of the skin)
• kidney problems
• blood disorders such as hemolytic anemia
• fever
• involuntary movements

Inform your doctor:

• if you are to undergo surgery, including dental surgery, Aldomet, in combination with some anesthetics, may cause a drop in blood pressure.
• if you are to undergo dialysis,
• if you are to receive a blood transfusion or if you are to have blood tests, as Aldomet may alter the results of the tests.

Your doctor may want to check the proper functioning of your liver and perform blood tests during the first 6-12 weeks of treatment with Aldomet. They will also perform these tests if you develop fever, without apparent cause, at any time during treatment with Aldomet.

Laboratory tests

If you need a urine or blood test, inform your doctor or the laboratory staff that you are taking Aldomet.

Aldomet may affect the results of some tests.

In rare cases, in patients taking Aldomet, urine may darken when exposed to air.

Use of Aldomet with other medications

Inform your doctor or pharmacist if you are using or have used recently, or may need to use any other medication.

Certain medications may interact with Aldomet. In these cases, it may be necessary to change the dose or discontinue treatment with one of the other medications.

This is especially important if you are taking:

• lithium used to treat depression and mental disorders
• other medications used to treat high blood pressure
• iron or iron supplements, such as multivitamins with minerals
• sympathomimetic medications used primarily for coughs and colds
• nonsteroidal anti-inflammatory drugs, used for pain relief
• anxiolytic medications used to treat anxiety or insomnia
• medications used to treat Parkinson's disease
• antipsychotic medications used for the treatment of mental disorders
• monoamine oxidase inhibitors (MAOIs), used to treat depression
• muscle relaxants, such as tizanidine

Taking Aldomet with food and alcohol

Avoid drinking alcoholic beverages while taking Aldomet. Theconsumption of alcohol may increase the occurrence of adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Aldomet may cause drowsiness. In these cases, do not drive or use any hazardous tools or machinery that require alertness.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you the dose you should take and the duration of treatment.

Adults

The recommended initial dose is 250 mg two or three times a day for two days.

The daily dose may be increased or decreased, every two days or more, to achieve the desired response.

The maximum recommended daily dose is 3 g.

Use in children and adolescents

The recommended initial dose is 10 mg per kg of body weight per day, divided into 2 to 4 doses.

The daily dose may be increased or decreased to achieve an adequate response. The maximum dose is 65 mg/kg or 3.0 g per day, whichever is less.

Older adults

The initial dose in older adults should be kept as low as possible, not exceeding 250 mg per day.

The daily dose may be increased or decreased, every two days or more, to achieve the desired response.

The maximum recommended daily dose is 2 g.

If you take more Aldomet than you should

If you have taken more Aldomet tablets than you should, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose include drowsiness, weakness, slow heart rate, low blood pressure, dizziness, confusion, feeling of swelling, gas, nausea, or vomiting.

If you forget to take Aldomet

If you forget a dose, take it as soon as you remember and then take the next dose at the time it is due. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Aldomet

If you stop taking Aldomet, your blood pressure may increase again. Therefore, do not stop treatment without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported, although it is not possible to estimate their frequency from the available data.

Contact your doctor IMMEDIATELY if you experience any of the following side effects, as they are serious and require medical attention:

• Severe allergic reaction, such as difficulty breathing, wheezing ("popping" sounds when breathing), rashes or itching on the skin, urticaria, swelling of the lips, face, or tongue
• Chills, fever, or joint pain
• Chest pain, slow heart rate. Worsening of angina, difficulty breathing, palpitations, fever.
• Severe skin reactions (such as painful redness, followed by blistering and peeling of the skin).
• Jaundice (yellowing of the skin and white part of the eyes) sometimes with fever, pale stools, and dark urine.
• Abdominal pain and diarrhea caused by inflammation of the intestine (colitis).
• Intense pain in the intestine and back caused by inflammation of the pancreas (pancreatitis).

The following side effects have also been reported:

Blood:

• Alteration in the number and type of blood cells. Inform your doctor if you experience unexplained petechiae, nosebleeds, sore throat, infections, or fever.

• Decreased number of red blood cells (anemia). This may cause your skin to appear pale and make you feel weak or short of breath.

• Bruising and prolonged bleeding after an injury.

Nervous system:

• Drowsiness or fatigue. This may occur at the beginning of treatment or when the dose is increased. It usually disappears.
• Headache or feeling of weakness. This may occur at the beginning of treatment and usually disappears.
• Sensation of needle pricks and pins.
• Parkinsonism, such as tremors and dragging the feet, decreased body movements with inability to move muscles.
• Partial facial paralysis.
• Involuntary movements.
• Decline in mental agility.
• Frequent dizziness or fainting, probably due to low blood pressure.

Nose and chest:

• Congested nose.

Digestive system:

• Nausea, vomiting, abdominal pain, bloating, constipation, diarrhea, flatulence (gas).
• Dry mouth, black tongue discoloration, and tongue pain.

Skin and hair:

• Eczema, skin rash, peeling, urticaria (red, itchy patches).

Joints and muscles:

• Joint pain and inflammation.
• Muscle pain and cramps.

Infections:

• Salivary gland inflammation.

General state:

• Fluid retention causing inflammation and weight gain.
• Fever, weakness.

Reproductive and breast system:

• Enlargement of breasts in both men and women.
• Absence of menstruation.
• Abnormal milk secretion not associated with lactation.
• Impotence, ejaculation failure.
• Decreased libido.

Mental disorders:

• Mental disorders that include nightmares, confusion, drowsiness, depression.
• Delirium and paranoia. Disappears when the medication is stopped.

Laboratory tests:

Your doctor may need to perform blood tests during the first few months of treatment with Aldomet.

The results may show:

• Decreased production of blood cells
• Increased levels of some white blood cells
• Abnormal levels of prolactin (hormone that stimulates milk secretion)

Aldomet may also interfere with the interpretation of certain blood and urine tests.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines Pharmacovigilance System of Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Aldomet 250 mg coated tablets

• The active ingredient is metildopa. Each coated tablet contains 250 mg of metildopa.
• The other components are:

Tablet core:anhydrous citric acid, calcium disodium edetate, ethylcellulose, guar gum, powdered cellulose, colloidal silicon dioxide, magnesium stearate.

Coating:monohydrate citric acid, hypromellose, propylene glycol, iron oxide red (E-172), titanium dioxide (E-171), talc, quinoline yellow aluminium lake, carnauba wax

Appearance of the product and contents of the packaging

Aldomet 250 mg are coated tablets, round, biconvex, yellow in color, marked with “ALDOMET” on one face and “250” on the other. They are presented in blister packs containing 30 or 60 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

H.A.C. Pharma

Péricentre II

43 Avenue de la Côte de Nacre.

14000 Caen

France

Responsible for manufacturing

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstrasse 10-12

37081 Göttingen -Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Euromed Pharma Spain, S.L.

C/Eduard Maristany, 430-432

08918 Badalona -Spain

Phone: + 34 932 684 208

Fax: + 34 933 150 469

Last review date of this leaflet:June 2018

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.