AMLODIPINE TAD 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine TAD 5 mg tablets EFG

Amlodipine TAD 10 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 is Amlodipine TAD and what is it used for
2. What you need to know before you take Amlodipine TAD
3. How to take Amlodipine TAD
4. Possible side effects
5. Storage of Amlodipine TAD
6. Contents of the pack and other information

1. What is Amlodipine TAD and what is it used for

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

Amlodipine is used to treat high blood pressure (hypertension) in adults, adolescents, and children aged 6 years and older, or a certain type of chest pain called angina in adults, which includes a rare type 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 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 TAD

Do not take Amlodipine TAD if:

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

Warnings and precautions

Consult your doctor or pharmacist before taking amlodipine.

You should tell 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 needs to be increased

Children and adolescents

Amlodipine has not been studied in children under 6 years old. Amlodipine 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.

Other medicines and Amlodipine TAD

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Amlodipine 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, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system)
• simvastatin (a medicine that lowers cholesterol)
• ciclosporin (immunosuppressant)

If you are already taking other medicines for high blood pressure, this medicine may lower your blood pressure even further.

Taking Amlodipine TAD with food and drinks

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

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.

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant or think you might be pregnant, or are planning to have a baby, tell your doctor before taking this medicine.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, tell your doctor before taking this medicine.

Driving and using machines

This medicine 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 machines and consult your doctor immediately.

Amlodipine TAD 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 TAD

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

You can take this medicine before or after food. You should 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 recommended initial dose is 2.5 mg once daily for the indication of hypertension. The maximum recommended dose is 5 mg once daily. The 5 mg tablet can be divided into equal halves.

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

If you take more Amlodipine TAD than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, or weak. If the drop in blood pressure is severe, it can lead to shock. You may feel your skin cold and sweaty and you may lose consciousness. Seek medical attention immediately if you have taken too many tablets of this medicine.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amlodipine TAD

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 TAD

Your doctor will tell you for how long you should take this medicine. Your condition may come back if you stop taking this medicine before your doctor tells you to.

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

4. Possible side effects

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

See 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, causing great difficulty in 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
• Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a feeling of being very unwell.

The following side effects have also been reported.

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

Very common:may affect more than 1 in 10 people

• Edema (fluid retention)

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

Common:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, feeling sick (nausea)
• Changes in bowel habits, diarrhea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other side effects have been reported, which are listed below. If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Trembling, changes in taste, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion 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 disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• Pain in the muscles or joints, 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 white blood cell count, decrease in blood platelets, which can cause easy bruising or bleeding
• High blood sugar (hyperglycemia)
• A disorder of the nerves, which can cause muscle weakness, tingling, or numbness (peripheral neuropathy)
• Inflammation of the gums, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests
• Increased muscle tone (hypertonia)
• Inflammation of blood vessels, often with skin rash (vasculitis)
• Sensitivity to light

Frequency not known:cannot be estimated from the available data

• Tremor, rigid posture, mask-like face, slow movements, and an unsteady, shuffling walk

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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine TAD

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

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

Store in the original package to protect from light.

This medicine does not require any special storage temperature

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 other information

Composition of Amlodipine TAD

• The active substance is amlodipine.

Amlodipine TAD 5 mg tablets EFG

Each tablet contains 5 mg of amlodipine (as amlodipine besylate).

Amlodipine TAD 10 mg tablets EFG

Each tablet contains 10 mg of amlodipine (as amlodipine besylate).

• The other ingredients (excipients) are: microcrystalline cellulose (E460), pregelatinized corn starch, sodium carboxymethylcellulose (type A) (from potato), anhydrous colloidal silica, and magnesium stearate (E470b).

See section 2 "Amlodipine TAD contains sodium".

Appearance of Amlodipine TAD and contents of the pack

Amlodipine TAD 5 mg tablets EFG:

The tablets are white, round (diameter 8 mm), slightly biconvex, with beveled edges, scored on one side.

The tablet can be divided into equal halves.

Amlodipine TAD 10 mg tablets EFG:

The tablets are white, round (diameter 11 mm), slightly biconvex, with beveled edges.

The tablets are available in cardboard boxes in:

• Non-perforated blisters of 28, 30, and 90 tablets
• Perforated unit-dose blisters of 28 x 1, 30 x 1, and 90 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

Manufacturers

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

or

KRKA, d. d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

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

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:March 2023

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