Aldomet Forte 500 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aldomet Forte® 500 mg film-coated tablets

Methyldopa

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

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

Contents of the package leaflet:

1. What Aldomet Forte is and what it is used for
2. What you need to know before taking Aldomet Forte
3. How to take Aldomet Forte
4. Possible adverse effects
5. Storage of Aldomet Forte
6. Contents of the package and other information

1. What Aldomet Forte is and what it is 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 for the treatment of high blood pressure (hypertension).

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

Do not take Aldomet Forte

• if you are allergic to methyldopa or to any of the other ingredients of this medicine (listed in section 6).
• if you have a 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 belonging to the group known as monoamine oxidase inhibitors (MAOIs)
• if you have porphyria (an inherited metabolic disorder)

Warnings and precautions

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

Inform your doctor if you have or have had 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

Inform your doctor:

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

Your doctor may want to check that your liver is functioning properly and may carry out blood tests during the first 6–12 weeks of treatment with Aldomet Forte. Your doctor may also carry out these tests if you develop a fever of unknown cause at any time during treatment with Aldomet Forte.

Laboratory tests

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

Aldomet Forte may affect the results of certain tests.

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

Use of Aldomet Forte with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Aldomet Forte: In such cases, it may be necessary to adjust the dose or discontinue 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, mainly used for cough and colds
• non-steroidal anti-inflammatory drugs (NSAIDs), 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 being treated with Aldomet Forte. Alcohol consumption may increase the occurrence of adverse effects.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Aldomet Forte may cause drowsiness. In such cases, do not drive or operate any tools or machinery that require alertness.

3. How to take Aldomet Forte

Follow exactly the instructions for use of this medicine as given 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 starting 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 achieved.

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 achieved.

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

Elderly patients

The initial dose in elderly patients should be kept as low as possible, not exceeding 250 mg daily.

The daily dose may be increased or decreased every two days or more until the desired response is achieved.

The recommended maximum 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, go to a medical center, or call the Toxicology Information Service at 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, lightheadedness, feeling of 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 the missed dose.

If you stop taking Aldomet Forte

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse 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 adverse effects, as they are serious and require medical attention:

• Severe allergic reaction, such as difficulty breathing, wheezing (whistling sounds when breathing), skin rash or itching, hives, 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 whites of the eyes), sometimes accompanied by fever, pale stools, and dark urine
• Abdominal pain and diarrhea caused by inflammation of the intestine (colitis)
• Severe abdominal and back pain caused by inflammation of the pancreas (pancreatitis)

The following adverse effects have also been reported:

Blood:

• Changes in the number and type of blood cells. Inform your doctor if you develop unexplained bruising, nosebleeds, sore throat, infections, or fever
• Decrease in the number of red blood cells (anaemia). This may cause your skin to appear pale and make you feel weak or short of breath
• Bruising and prolonged bleeding after injury

Nervous system:

• Drowsiness or fatigue. This may occur at the beginning of treatment or when the dose is increased. It usually resolves
• Headache or feeling of weakness. This may occur at the beginning of treatment and usually resolves
• Tingling sensation like pins and needles
• Parkinsonism, such as tremors and shuffling gait, decreased body movements with inability to move muscles
• Partial facial paralysis
• Involuntary movements
• Impaired mental agility
• Dizziness upon standing or frequent fainting, possibly due to low blood pressure

Nose and chest:

• Nasal congestion

Digestive system:

• Nausea, vomiting, stomach pain and bloating, constipation, diarrhea, flatulence (gas)
• Dry mouth, black discoloration of the tongue, and tongue pain

Skin and hair:

• Eczema, skin rash, peeling, urticaria (rose-colored patches accompanied by intense itching)

Joints and muscles:

• Joint pain and inflammation
• Muscle pain and cramps

Infections:

• Inflammation of the salivary glands

General condition:

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

Reproductive system and breasts:

• Breast enlargement in both men and women
• Absence of menstruation
• Abnormal milk secretion not associated with breastfeeding
• Impotence, failure to ejaculate
• Decreased sexual desire

Psychiatric disorders:

• Mental disturbances including nightmares, confusion, drowsiness, depression
• Delusions and paranoia. These resolve when the medicine is discontinued

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 blood cell production
• an increase in certain white blood cells
• abnormal levels of prolactin (a hormone that stimulates milk secretion)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components are:

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

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

Appearance of the product and contents of the package

Aldomet Forte 500 mg are film-coated tablets, round, biconvex, yellow in color, marked with “ALDOMET” on one side and “500” on the other. It is supplied 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 responsible

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

For further information about this medicinal product, please contact 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 latest review of this leaflet: June 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.