AMLODIPINE TECNIGEN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine TecniGen 5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Amlodipine TecniGen 5 mg Tablets are and what they are used for

Amlodipine 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 rare form called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine TecniGen improves blood supply to the heart muscle, which receives more oxygen and as a result, chest pain is prevented. This medicine does not provide immediate relief of chest pain due to angina.

2. What you need to know before you take Amlodipine TecniGen 5 mg Tablets

Do not take Amlodipine TecniGen:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine TecniGen.

You must inform your doctor if you have or have had any of the following diseases:

• recent heart attack
• heart failure
• severe increase in blood pressure (hypertensive crisis)
• liver disease
• you are elderly and your dose needs to be increased

Children and adolescents

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

Using Amlodipine TecniGen with other medicines

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

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

? ketoconazole, itraconazole (antifungal medicines)

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

? rifampicin, erythromycin, clarithromycin (antibiotics)

? Hypericum perforatum(St. John's Wort)

? verapamil, diltiazem (heart medicines)

? dantrolene (in infusion for severe body temperature abnormalities)

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

? simvastatin (a medicine that lowers cholesterol)

? cyclosporin (an immunosuppressant)

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

Using Amlodipine TecniGen with food, drinks, or alcohol

People taking Amlodipine TecniGen should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or want to start breastfeeding, talk to your doctor before taking amlodipine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amlodipine may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or use machinery and consult your doctor immediately.

Amlodipine TecniGen contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them 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 Amlodipine TecniGen 5 mg Tablets

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 5 mg of Amlodipine TecniGen, once a day. The dose can be increased to 10 mg of Amlodipine TecniGen, once a day.

You can take this medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Amlodipine TecniGen with grapefruit juice.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

Use in children and adolescents

The usual initial recommended dose for children and adolescents (from 6 to 17 years old) is 2.5 mg per day. The maximum recommended daily dose is 5 mg. Amlodipine TecniGen 5 mg tablets can be divided into two equal doses to provide 2.5 mg doses.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more Amlodipine TecniGen than you should

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

You may feel dizzy, faint, suffer from postural dizziness when getting up, or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin cold and wet, and you could lose consciousness. If you take too many Amlodipine TecniGen tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine TecniGen:

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Go to your doctor immediatelyif you experience any of the following side 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 that causes great difficulty breathing

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

? Heart attack, abnormal heartbeat

? Inflammation of the pancreas that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort

The following very common side effecthas been reported. If this causes problems or lasts more than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

? Swelling of the ankles (edema)

The following common side effectshave been reported. If any of these cause problems or last more than one week, consult your doctor.

Common: may affect up to 1 in 10 people

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

? Palpitations (feeling the heartbeat), flushing

? Abdominal pain, feeling unwell (nausea)

? Change in bowel habit, diarrhea, constipation, indigestion

? Fatigue, weakness

? Visual disturbances, double vision

? Muscle cramps

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell 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 in the limbs, loss of pain sensation

? Ringing in the ears

? Decrease in blood pressure

? Runny nose/sneezing caused by inflammation of the nasal mucosa (rhinitis)

? Cough

? Dry mouth, vomiting (nausea)

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

? Urination disorder, increased need to urinate at night, increased number of times urinating

? Impotence, discomfort or breast enlargement in men

? Pain, feeling unwell

? Muscle or joint pain, back pain

? Weight gain or 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 that can cause easy bleeding or unusual bruising (red blood cell damage)

? High blood sugar (hyperglycemia)

? A nerve disorder that can cause weakness, numbness, or tingling

? Gum inflammation

? Abdominal swelling (gastritis)

? Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests

? Increased muscle tension

? Inflammation of blood vessels, often with skin rashes

? Sensitivity to light

? Disorders combining stiffness, tremor, and/or movement disorders

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine TecniGen 5 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 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. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine TecniGen 5 mg Tablets

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

potato starch glycolate,

microcrystalline cellulose,

lactose monohydrate,

magnesium stearate.

Appearance of the product and pack contents

Amlodipine TecniGen 5 mg are white, round tablets, marked on one face.

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

Not all pack sizes may be marketed.

Other presentations

Amlodipine TecniGen 10 mg Tablets EFG

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tecnimede España Industria Farmacéutica S.A.

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

28108 Alcobendas (Madrid) SPAIN

Manufacturer

Atlantic Pharma – Produções Farmacêuticas SA

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

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about something, ask your doctor or pharmacist.

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

Portugal: Amlodipina Tecnimede 5 mg/10 mg tablets

Spain: Amlodipino Tecnigen 5 mg/10 mg tablets EFG

Date of last revision of this leaflet: March 2023

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/