Label: information for the user

Aldomet Forte® 500 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 Forte contains methyldopa as the active substance. Aldomet Forte belongs to a group of medications known as antihypertensives, which reduce blood pressure.

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

Do not take Aldomet Forte

• if you are allergic to methyldopa or any of the other ingredients 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 Forte, 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 Forte 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 Forte. They will also perform these tests if you develop fever without apparent cause at any time during treatment with Aldomet Forte.

Laboratory tests

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

Aldomet Forte may affect the results of some tests.

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

Use of Aldomet Forte 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 Forte: 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 mainly 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 Forte with food and alcohol

Avoid drinking alcoholic beverages while taking Aldomet Forte. Alcohol consumption may increase the risk of side 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 Forte may cause drowsiness. In these cases, do not drive or use any hazardous tools or machinery that require you to be alert.

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 Forte than you should

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

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 Forte

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 Forte

If you stop taking Aldomet Forte, 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 while breathing), skin rashes or itching, 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 abdomen 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, nasal bleeding, sore throat, infections, or fever.
• Decrease in the 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, decrease in 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:

• Congestion of the 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 spots accompanied by intense itching).

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 system and breasts:

• 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. It 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 Forte.

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

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aldomet Forte 500 mg coated tablets

• The active ingredient is metildopa. Each coated tablet contains 500 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, red iron oxide (E-172), titanium dioxide (E-171), talc, yellow quinoline aluminum lake, Carnauba wax

Appearance of the product and content of the container

Aldomet Forte 500 mg are coated tablets, round, biconvex, yellow in color, marked with “ALDOMET” on one face and “500” on the other. They are presented in blister packs containing 30 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 Hildebrandstrasse 10-12

Goettingen, Lower Saxony

37081 Germany

O

ROVI PHARMA INDUSTRIAL SERVICES S.A.

Via Complutense, 140

Alcala de Henares (Madrid)

28805 Spain

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

Barcelona - Spain

Phone: + 34 932 684 208

Fax: + 34 933 150 469

Date of the last review of this prospectus:June 2018

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/.