Package Insert: Information for the Patient

Amlodipino Sandoz 5 mg Tablets EFG

Amlodipino Sandoz 10 mg Tablets EFG

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Amlodipino belongs to a group of medications known as calcium antagonists.

Amlodipino Sandoz is used to treat:

• high blood pressure (hypertension),
• 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 medication works by relaxing blood vessels, allowing blood to flow through them more easily.

In patients with angina, amlodipino improves blood flow to the heart muscle, allowing it to receive more oxygen and thereby preventing chest pain. Amlodipino does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Sandoz

• if you are allergic to amlodipine, any other calcium channel blocker, or any of the other ingredients in this medication (listed in section 6). These may cause itching, skin redness, 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 condition in which the heart is unable to pump enough blood to the body),
• if you have heart failure after a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amlodipine.

Inform your doctor or pharmacist if you have or have had any of the following conditions:

• recent heart attack,
• heart failure,
• severe high blood pressure (hypertensive crisis),
• liver disease,
• you are an elderly person and your dose needs 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 more information, consult your doctor.

Other medications and Amlodipino Sandoz

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

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

• ketoconazole, itraconazole (antifungal medications),
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• Hypericum perforatum(St. John's Wort),
• verapamil, diltiazem (heart medications),
• dantrolene (in infusion for severe body temperature abnormalities),
• simvastatin (medication to lower high blood cholesterol levels),
• tacrolimus, sirolimus, everolimus, and cyclosporin (used to prevent organ transplant rejection and for cancer),
• temsirolimus (used for cancer).

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

Taking Amlodipino Sandoz with food and drinks

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

Pregnancy, breastfeeding, and fertility

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Breastfeeding

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

Driving and operating machinery

Amlodipine may affect your ability to drive or operate machinery. If amlodipine makes you feel sick, dizzy, or tired, or gives you a headache, do not drive or operate machinery and contact your doctor immediately.

Amlodipino Sandoz contains sodium

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

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

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

You can take your medication before or after meals and drinks. It should be taken at the same time every day, with a glass of water. Do not take amlodipino with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6 and 17 years of age), the usual recommended initial dose is 2.5 mg per day. The maximum recommended dose is 5 mg per day.

It is essential not to interrupt the administration of the tablets. Do not wait for the tablets to run out before consulting your doctor.

The tablet can be split into equal doses.

If you take more Amlodipino Sandoz than you should

Consuming too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, experience postural dizziness when standing up, or weakness.

If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin is cold and wet, and you could lose consciousness.

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

If you have taken more amlodipino than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Amlodipino Sandoz

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 compensate for the missed doses.

If you interrupt treatment with Amlodipino Sandoz

Your doctor will indicate for how long you should take this medication. Your condition may reappear if you stop taking this medication before your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctorimmediatelyif you experience any of the following side effects

after taking this medicine.

• Sudden hissing sounds when breathing, chest compression, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes severe difficulty breathing.
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, intense itching, flu-like symptoms followed by blister formation, skin peeling, and inflammation of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heart rhythm.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a strong feeling of discomfort.
• Liver inflammation (hepatitis) that can cause yellowing of the skin and the white of the eyes, fever, chills, fatigue, loss of appetite, stomach pain, feeling of discomfort, and dark urine.

The followingvery common side effectshave been reported. If they cause you problems or ifthey last more than a week, consult your doctor.

Very common:may affect more than 1 in 10 people

• Edema (fluid retention)

The followingcommon side effectshave been reported. If they cause you problems or ifthey last more than a week, consult your doctor.

Common:may affect up to 1 in 10 people.

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Palpitations (feeling the heartbeat), shortness of breath.
• Difficulty breathing.
• Abdominal pain, feeling of discomfort (nausea).
• Alteration of bowel habit, diarrhea, constipation, indigestion.
• Swelling of the ankles.
• Fatigue, weakness.
• Visual disturbances, double vision.
• Muscle cramps.

The following other side effects have been reported. If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people.

• Changes in mood, anxiety, depression, insomnia.
• Tremor, alterations in taste, fainting.
• Numbness or tingling in the extremities, loss of pain sensation.
• Ringing in the ears.
• Decreased blood pressure.
• Nasal secretion and runny nose caused by inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (discomfort).
• Hair loss, increased sweating, itching skin, rashes, red spots on the skin, skin discoloration.
• Urinary disorders, increased need to urinate at night, increased frequency of urination.
• Impotence, discomfort, or breast enlargement in men.
• Chest pain.
• Pain, feeling of discomfort.
• 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.

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising.
• High blood sugar (hyperglycemia).
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling.
• Gingivitis.
• Abdominal swelling (gastritis).
• Abnormal liver function, yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests.
• Increased muscle tension.
• Inflammation of the blood vessels, often with skin eruptions.
• Sensitivity to light.

Not known:cannot be estimated from available data:

• Tremors, stiffness, face with a mask-like appearance, slow movements, and walking slowly and without balance.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the blister or in the bottle after CAD/EXP. The expiration date is the last day of the month indicated.

Blister: Store in the original packaging to protect it from light. Do not store at a temperature above 30°C.

HDPE Bottle: Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipine Sandoz

• The active ingredient is amlodipine.

Each Amlodipine Sandoz 5 mg tablet contains 5 mg of amlodipine (as besilate).

Each Amlodipine Sandoz 10 mg tablet contains 10 mg of amlodipine (as besilate).

• The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, carboxymethylstarch sodium (type A) (from potato) and magnesium stearate.

Appearance of Amlodipine Sandoz and packaging contents

Amlodipine Sandoz 5 mg tablets

White or almost white, oblong tablets with beveled edges, with a notch on one face and with the mark "5" on the other.

Amlodipine Sandoz 10 mg tablets

White to almost white, oblong tablets with beveled edges, with a notch on one face and with the mark "10" on the other.

The tablets are packaged in Alu/PVC or Alu/OPA/Alu/PVC blisters packaged in cardboard boxes or HDPE containers with screw caps (tamper-evident seal).

Packaging sizes:

Alu/PVC or Alu/OPA/Alu/PVC blisters: 10, 14, 20, 28, 30, 50, 50x1, 60, 100 and 120 tablets.

HDPE containers: 20, 30, 50, 60, 90, 100, 105, 120, 200 and 250 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturers responsible

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

SALUTAS PHARMA GMBH

Otto Von Guericke Alle, 1 (Barleben)

D-39179

Germany

or

ROWA PHARMACEUTICALS LIMITED

Newtown (Bantry, Co Cork)

Ireland

or

LEK, S.A.

UlDomaniewska50 C

Warszawa, PL 02-672

Poland

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

Lek S.A.

Ul. Podlipie 16,

95 010 Strykow

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D,9220

Lendava

Slovenia

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria:Amlodipin Sandoz 5 mg – Tabletten

Amlodipin Sandoz 10 mg – Tabletten

Bélgica:Amlodipin besilaat Sandoz 5 mg tabletten

Amlodipin besilaat Sandoz 10 mg tabletten

Bulgaria:???????5 MG????????

???????10 MG????????

República Checa:Orcal Neo

Dinamarca:Amlodipin "Sandoz"

Estonia:Amlocard 5 mg

Amlocard 10 mg

Finlandia:Amlodipin Sandoz 5 mg tabletit

Amlodipin Sandoz 10 mg tabletit

Grecia:Amlibon Bes 10 mg δισκ?α

Italia:AMLODIPINA SANDOZ

Holanda:Amlodipine (als besilaat) Sandoz 5 mg, tabletten

Amlodipine (als besilaat) Sandoz 10 mg, tabletten

Noruega:Amlodipin Sandoz 5 mg tabletter

Amlodipin Sandoz 10 mg tabletter

Portugal:Amlodipina Sandoz

Eslovaquia:AMLOPIN S 5 mg tablety

AMLOPIN S 10 mg tablety

Eslovenia:Amlopin 5 mg tablete

Amlopin 10 mg tablete

Suecia:Amlodipin Sandoz 5 mg tabletter

Amlodipin Sandoz 10 mg tabletter

Reino Unido (Irlanda del Norte):

Amlodipine 5 mg Tablets

Amlodipine 10 mg Tablets

Last review date of this leaflet:September 2022

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