Amlodipine Tecnigen 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine TecniGen 10 mg tablets EFG

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

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

Leaflet contents:

1. What Amlodipine TecniGen 10 mg tablets are and what they are used for
2. What you need to know before taking Amlodipine TecniGen 10 mg tablets
3. How to take Amlodipine TecniGen 10 mg tablets
4. Possible adverse effects
5. How to store Amlodipine TecniGen 10 mg tablets
6. Contents of the pack and other information

1. What Amlodipino TecniGen 10 mg tablets is and what it is used for

Amlodipino TecniGen contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.

Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a less common type known as Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing the walls of the blood vessels, allowing blood to flow more easily. In patients with angina, Amlodipino TecniGen improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. What you need to know before taking Amlodipine TecniGen 10 mg tablets

Do not take Amlodipine TecniGen:

• If you are allergic (hypersensitive) to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. This may cause itching, skin redness, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the

body).

• If you have heart failure following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Amlodipine TecniGen.

You should inform your doctor if you have or have had any of the following conditions:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are elderly and your dose may need to be increased

Children and adolescents

Amlodipine has not been studied in children under 6 years of age. Amlodipine TecniGen should only be used to treat high blood pressure in children and adolescents aged 6 to 17 years (see section 3). For further information, consult your doctor.

Taking Amlodipine TecniGen with other medicines

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

Amlodipine TecniGen may affect or be affected by other medicines, such as:

? ketoconazole, itraconazole (antifungal medicines)

? ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)

? rifampicin, erythromycin, clarithromycin (antibiotics)

? Hypericum perforatum (St. John's Wort)

? verapamil, diltiazem (heart medicines)

? dantrolene (administered by infusion for serious disturbances in body temperature)

? tacrolimus (a medicine used to alter the way your immune system works)

? simvastatin (a medicine that lowers cholesterol)

? ciclosporin (an immunosuppressant)

If you are already taking other medicines to treat high blood pressure, Amlodipine TecniGen may lower your blood pressure even further.

Taking Amlodipine TecniGen with food, drinks or alcohol

People taking Amlodipine TecniGen must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active ingredient amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine TecniGen.

Pregnancy, breastfeeding and fertility

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

Pregnancy

The safety of amlodipine in pregnant women has not yet been established.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or intend to breastfeed, you should speak with your doctor before taking amlodipine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amlodipino may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy or tired, or cause you to have a headache, do not drive or use machinery and consult your doctor immediately.

Amlodipino TecniGen contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Information on sodium content

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Amlodipino TecniGen 10 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 5 mg of Amlodipino TecniGen once daily. The dose may be increased to 10 mg of Amlodipino TecniGen once daily.

You may take this medicine before or after meals. Take it at the same time each day with a glass of water. Do not take Amlodipino TecniGen with grapefruit juice.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

Use in children and adolescents

The usual recommended starting dose for children and adolescents (6 to 17 years of age) is 2.5 mg daily. The recommended maximum daily dose is 5 mg. Amlodipino TecniGen 5 mg tablets may be divided into two equal parts to provide 2.5 mg doses.

It is important not to interrupt treatment with the tablets. Do not wait until you run out of tablets before seeing your doctor.

If you take more Amlodipino TecniGen than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop.

You may feel dizzy, lightheaded, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy and could lose consciousness. If you have taken too many Amlodipino TecniGen tablets, consult your doctor immediately or call the Toxicology Information Service at 91 562 04 20.

If you forget to take Amlodipine TecniGen:

Do not worry. If you forget to take a tablet, simply miss that dose completely. Take your next dose at the recommended time. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of the following adverse effects after taking this medicine:

? Sudden wheezing, chest pain, shortness of breath or difficulty breathing

? Swelling of the eyelids, face or lips

? Swelling of the tongue and throat causing severe difficulty in breathing

? Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions

? Heart attack, irregular heartbeat

? Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise

The following very common adverse effect has been reported. If this causes problems or if it lasts longer than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

? Swelling of the ankles (edema)

The following common adverse effects have been reported. If any of these cause problems or if

they last longer than one week, consult your doctor.

Common: may affect up to 1 in 10 people

? Headache, dizziness, drowsiness (especially at the beginning of treatment)

? Palpitations (awareness of heartbeat), hot flush

? Abdominal pain, feeling unwell (nausea)

? Changes in bowel habits, diarrhea, constipation, indigestion

? Tiredness, weakness

? Visual disturbances, double vision

? Muscle cramps

Other adverse effects have been reported and are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

? Mood changes, anxiety, depression, insomnia

? Tremor, taste disturbances, fainting, weakness

? Numbness or tingling sensation in the limbs, loss of pain sensation

? Ringing in the ears (tinnitus)

? Decrease in blood pressure

? Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)

? Cough

? Dry mouth, vomiting (feeling unwell)

? Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration

? Urinary disorders, increased need to urinate at night, increased frequency of urination

? Inability to achieve an erection, discomfort or enlargement of the breasts in men

? Pain, feeling unwell

? Muscle or joint pain, back pain

? Weight gain or weight loss

Rare: may affect up to 1 in 1,000 people

? Confusion

Very rare: may affect up to 1 in 10,000 people

? Decrease in the number of white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)

? High blood sugar (hyperglycemia)

? A nerve disorder which may cause weakness, tingling or numbness

? Swelling of the gums

? Abdominal swelling (gastritis)

? Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests

? Increased muscle tension

? Inflammation of blood vessels, often with skin rashes

? Light sensitivity

? Disorders combining stiffness, tremor and/or movement disorders

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine TecniGen 10 mg tablets

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine TecniGen 10 mg tablets

• The active substance is amlodipine (as besylate).
• The other components are:

sodium starch glycolate (from potato),

microcrystalline cellulose,

lactose monohydrate,

magnesium stearate.

Appearance of the medicinal product and contents of the pack

Amlodipine TecniGen 10 mg are white, round, flat tablets, marked on one side.

Each pack contains 10, 14, 20, 28, 30, 60, 100 or 500 tablets.

Only some pack sizes may be marketed.

Other presentations

Amlodipine TecniGen 5 mg tablets EFG

Marketing Authorization Holder and Manufacturing Responsibility Holder

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturing Responsibility Holder

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This patient information leaflet does not contain all the information about this medicinal product. If you have any questions or are unsure about anything, consult your doctor or pharmacist.

This medicine is authorized in the Member States of the EEA under the following names:

Portugal: Amlodipina Tecnimede 5 mg/10 mg tablets

Spain: Amlodipino Tecnigen 5 mg/10 mg tablets EFG

Date of the most recent review of this leaflet: March 2023

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