ALDOMET FORTE 500 mg FILM-COATED TABLETS

1. What is Aldomet Forte and what is it used for

Aldomet Forte contains methyldopa as the active substance. Aldomet Forte belongs to a group of medicines called antihypertensives, which lower blood pressure.

Aldomet Forte tablets are used to treat high blood pressure (hypertension).

2. What you need to know before you take Aldomet Forte

Do not take Aldomet Forte

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Tell your doctor if you suffer or have suffered from any of the following conditions:

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

Tell your doctor:

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

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

Laboratory tests

If you need a urine or blood test, tell 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, the urine may darken when exposed to air.

Using Aldomet Forte with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Certain medicines may interact with Aldomet Forte: In these cases, it may be necessary to change the dose or interrupt treatment with one of the other medicines.

This is especially important if you are taking:

• lithium used to treat depression and mental illnesses
• other medicines used to treat high blood pressure
• iron or iron supplements, such as multivitamins with minerals
• sympathomimetic medicines used mainly for coughs and colds
• non-steroidal anti-inflammatory drugs, used for pain relief
• anxiolytic medicines used to treat anxiety or insomnia
• medicines used to treat Parkinson's disease
• antipsychotic medicines used to treat mental illnesses
• 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 occurrence of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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

Aldomet Forte may cause drowsiness. In these cases, do not drive or use any tool or machinery that requires you to be alert.

3. How to take Aldomet Forte

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will tell you the dose you should take and the duration of the 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 until the desired response is obtained.

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 until an adequate response is obtained.

The maximum dose is 65 mg/kg or 3.0 g per day, whichever is lower.

Elderly

The initial dose in elderly patients 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 until the desired response is obtained.

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, contact your doctor or pharmacist immediately or go to a hospital or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of an overdose include drowsiness, weakness, slow heart rate, low blood pressure, dizziness, fainting, bloating, 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 scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Aldomet Forte

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

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.

The following side effects have been reported, although their frequency cannot be estimated from the available data.

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

• Severe allergic reaction, such as difficulty breathing, wheezing, skin rash, or itching, 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 the white part of the eyes) sometimes with fever, pale stools, and dark urine
• Pain in the intestine and diarrhea caused by inflammation of the intestine (colitis)
• Severe 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. Tell your doctor if you notice unexplained bruising, nosebleeds, sore throat, infections, or fever.
• Decrease in the number of red blood cells (anemia). This can make your skin look pale and make you feel weak or short of breath.
• Bruising and prolonged bleeding after an injury

Nervous system:

• Drowsiness or fatigue. This can occur at the start of treatment or when the dose is increased. It usually disappears.
• Headache or feeling of weakness. This can occur at the start of treatment and usually disappears.
• Feeling of pins and needles
• Parkinsonism, such as tremors and shuffling gait, decreased body movements with inability to move muscles
• Partial facial paralysis
• Involuntary movements
• Decreased mental agility
• Dizziness when standing up or frequent fainting, probably due to low blood pressure

Nose and throat:

• Nasal congestion

Digestive system:

• Nausea, vomiting, abdominal pain, bloating, constipation, diarrhea, gas
• Dry mouth, black tongue, and tongue pain

Skin and hair:

• Eczema, skin rash, peeling, urticaria (red patches with intense itching)

Joints and muscles:

• Joint pain and inflammation
• Muscle pain and cramps

Infections:

• Inflammation of the salivary glands

General disorders:

• Fluid retention causing swelling and weight gain
• Fever, weakness

Reproductive system and breast:

• Enlargement of the breasts in both men and women
• Absence of menstruation
• Abnormal milk secretion not associated with breastfeeding
• Impotence, ejaculation failure
• Decreased sexual desire

Psychiatric disorders:

• Mental disorders including nightmares, confusion, dizziness, depression
• Delirium and paranoia. This disappears when the medicine 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:

• a decrease in the production of blood cells
• an increase in 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aldomet Forte

Keep this medicine out of the sight and reach of children.

No special storage conditions are required

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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 protect the environment.

6. Contents of the pack and further information

Composition of Aldomet Forte 500 mg film-coated tablets

• The active substance is methyldopa. Each film-coated tablet contains 500 mg of methyldopa.
• The other ingredients are:

Core of the tablet:anhydrous citric acid, 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, aluminum lake of quinoline yellow (E-104), carnauba wax

Appearance of the product and contents of the pack

Aldomet Forte 500 mg are film-coated tablets, round, biconvex, yellow, marked with “ALDOMET” on one side and “500” on the other. They are available in blister packs containing 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

H.A.C. Pharma

Péricentre II

43 Avenue de la Côte de Nacre

14000 Caen

France

Manufacturer

ALLPHAMED PHARBIL Hildebrandstrasse 10-12

Goettingen, Lower Saxony

37081 Germany

Or

ROVI PHARMA INDUSTRIAL SERVICES S.A.

Via Complutense, 140

Alcala de Henares (Madrid)

28805 Spain

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

Euromed Pharma Spain, S.l.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Tel: + 34 932 684 208

Fax: + 34 933 150 469

Date of the last revision of this leaflet:June 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.