Amlodipine Tarbis Farma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine Tarbis Farma 10 mg tablets EFG

Read this entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Amlodipine Tarbis Farma is and what it is used for
2. What you need to know before taking Amlodipine Tarbis Farma
3. How to take Amlodipine Tarbis Farma
4. Possible side effects
5. How to store Amlodipine Tarbis Farma
6. Contents of the pack and other information

1. What Amlodipine Tarbis Farma is and what it is used for

Amlodipine Tarbis Farma contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine Tarbis Farma 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 blood vessels, allowing blood to pass through them more easily. In patients with angina, amlodipine 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 Tarbis Farma

Do not take Amlodipine Tarbis Farma

• If you are allergic 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 starting to take this medicine. You must 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 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.

Use of Amlodipine Tarbis Farma with other medicines

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

Amlodipine 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 (medicines for the heart)
• dantrolene (by infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of the immune system)
• simvastatin (a cholesterol-lowering medicine)
• ciclosporin (an immunosuppressant)

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

Taking Amlodipine Tarbis Farma with food and drink

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

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant, or are planning to become pregnant, you must inform your doctor before taking amlodipine.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to breastfeed, you must inform your doctor before taking amlodipine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Amlodipine Tarbis Farma contains sodium

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

3. How to take Amlodipine Tarbis Farma

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

The recommended starting dose is 5 mg of amlodipine once daily. The dose may be increased to 10 mg of amlodipine 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 amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (aged 6–17 years), the usual recommended starting dose is 2.5 mg daily*. The recommended maximum dose is 5 mg daily.

*Amlodipine Tarbis Farma is not suitable when a 2.5 mg dose is required. Alternative products are available for this dose.

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

If you take more Amlodipine Tarbis Farma 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 your skin cold and moist and you could lose consciousness. If you take too many amlodipine tablets, consult your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Amlodipine Tarbis Farma

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

If you stop taking Amlodipine Tarbis Farma

Your doctor will advise you on how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to do so.

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 everybody gets 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 inflammation of the skin, 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 marked feeling of illness

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

• Edema (fluid retention)

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 flushes
• Abdominal pain, feeling unwell (nausea)
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

Other adverse effects that have been reported 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
• 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
• High blood sugar (hyperglycaemia)
• A nerve disorder which may cause muscle weakness, tingling or numbness
• Inflammation 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 rigidity, tremor and/or movement disorders

Reporting of adverse effects

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

5. Storage of Amlodipine Tarbis Farma

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

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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

This medicine does not require any special storage temperature.

. Store in the original packaging to protect from light.

6. Contents of the pack and other information

Composition of Amlodipine Tarbis Farma

The active substance in Amlodipine Tarbis Farma 10 mg tablets is 10 mg of amlodipine (as amlodipine besilate).

The other components are microcrystalline cellulose (E460), sodium carboxymethylstarch (type A), colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Appearance of the medicinal product and contents of the container

10 mg tablets: white to off-white, round, biconvex tablets, engraved with a "J" on one side and "21" on the other.

This medicine is available in aluminum – PVC/PVDC blisters in pack sizes of 14, 20, 28, 30, 50, 90, 100, and 105 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Person

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturing Responsible Person

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

PLA 3000 Paola

Malta

Amarox Pharma B.V.

Rounoslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Netherlands Amlodipine ARX 5mg, 10mg tabletten

Germany Amlodipin Amarox 5mg, 10mg Tabletten

Italy Amlodipina Amarox

Spain Amlodipino Tarbis Farma 5mg, 10 mg comprimidos EFG

Sweden Amlodipin Amarox 5mg, 10mg Tablett

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

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