Amlodipine Sandoz 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amlodipine Sandoz 5 mg tablets EFG

Amlodipine Sandoz 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Amlodipine belongs to a group of medicines known as calcium antagonists.

Amlodipine 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 medicine works by relaxing the blood vessels, allowing blood to flow through them more easily.

In patients with angina, amlodipine improves blood flow to the heart muscle, thereby increasing oxygen supply to the heart and preventing chest pain. Amlodipine does not provide immediate relief of angina-related chest pain.

2. What you need to know before taking Amlodipine Sandoz

Do not take Amlodipine Sandoz

• if you are allergic to amlodipine, to any other calcium antagonist, or to any of the other ingredients of this medicine (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 heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body),
• if you suffer from heart failure following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking amlodipine.

Inform your doctor or pharmacist 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,
• if 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.

Other medicines and Amlodipine Sandoz

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

Amlodipine may affect or may 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 (by infusion for serious body temperature abnormalities),
• simvastatin (a medicine to lower high cholesterol levels in the blood),
• tacrolimus, sirolimus, everolimus, and cyclosporine (used to prevent rejection of transplanted organs and in cancer treatment),
• temsirolimus (used in cancer treatment).

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

Taking Amlodipine Sandoz with food and drinks

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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

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.

Driving and using machines

Amlodipine may affect your ability to drive or use machines. If amlodipine makes you feel unwell, dizzy, tired, or causes headache, do not drive or operate machinery and contact your doctor immediately.

Amlodipine Sandoz contains sodium

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

3. How to take Amlodipino Sandoz

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

The usual starting dose is 5 mg of amlodipine once daily. The dose may be increased to 10 mg of amlodipine once daily.

You may take your medicine before or after meals and drinks. 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 (between 6 and 17 years of age), the recommended starting dose is usually 2.5 mg daily. The maximum recommended dose is 5 mg daily.

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

The tablet may be divided into equal doses.

If you take more Amlodipino Sandoz 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.

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

If you have taken more amlodipine than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount taken.

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 make up for forgotten doses.

If you stop taking Amlodipino Sandoz

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

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 may cause adverse effects, although not everyone experiences them.

Go to your doctor immediately if you experience any of the following adverse effects
after taking this medicine.

• Sudden wheezing, chest tightness, 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, flu-like symptoms followed by blistering, peeling, and inflammation of the skin, mouth, eyes, and genitals (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.
• Inflammation of the liver (hepatitis) which may cause yellowing of the skin and whites of the eyes, fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, and darkening of the urine.

The following very common adverse effects have been reported. If they cause you problems or if they last 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 they cause you 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.
• Difficulty breathing.
• Abdominal pain, feeling unwell (nausea).
• Changes in bowel habits, diarrhea, constipation, indigestion.
• Swelling of the ankles.
• Fatigue, weakness.
• Visual disturbances, double vision.
• Muscle cramps.

Other adverse effects have been reported and are included in the following list. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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.
• 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, rashes, 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 breast enlargement in men.
• Chest pain.
• 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 white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising.
• High blood sugar (hyperglycemia).
• A nerve disorder which may cause muscle weakness, tingling, or numbness.
• Inflammation of the gums.
• Abdominal swelling (gastritis).
• Abnormal liver function, 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.

Not known: cannot be estimated from the available data:

• Tremors, stiffness, mask-like facial appearance, slow movements, and slow, unbalanced walking.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Sandoz

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

Do not use this medicine after the expiry date stated on the packaging, blister, or bottle following CAD/EXP. The expiry date is the last day of the month indicated.

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

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

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

6. Contents of the pack and other information

Composition of Amlodipine Sandoz

• The active substance is amlodipine.

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

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

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

Appearance of Amlodipine Sandoz and pack contents

Amlodipine Sandoz 5 mg tablets

White or almost white, oblong, bevel-edged tablets, with a score line on one side and the mark "5" on the other.

Amlodipine Sandoz 10 mg tablets

White to almost white, oblong, bevel-edged tablets, with a score line on one side and the mark "10" on the other.

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

Pack sizes:

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

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturers

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.

Ul. Domaniewska 50 C

Warszawa, PL 02-672

Poland

or

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

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

or

Lek S.A.

Ul. Podlipie 16,

95 010 Strykow

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava

Slovenia

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

Austria: Amlodipin Sandoz 5 mg – Tabletten

Amlodipin Sandoz 10 mg – Tabletten

Belgium: Amlodipin besilaat Sandoz 5 mg tabletten

Amlodipin besilaat Sandoz 10 mg tabletten

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

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

Czech Republic: Orcal Neo

Denmark: Amlodipin "Sandoz"

Estonia: Amlocard 5 mg

Amlocard 10 mg

Finland: Amlodipin Sandoz 5 mg tabletit

Amlodipin Sandoz 10 mg tabletit

Greece: Amlibon Bes 10 mg δισκ?α

Italy: AMLODIPINA SANDOZ

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

Amlodipine (als besilaat) Sandoz 10 mg, tabletten

Norway: Amlodipin Sandoz 5 mg tabletter

Amlodipin Sandoz 10 mg tabletter

Portugal: Amlodipina Sandoz

Slovakia: AMLOPIN S 5 mg tablety

AMLOPIN S 10 mg tablety

Slovenia: Amlopin 5 mg tablete

Amlopin 10 mg tablete

Sweden: Amlodipin Sandoz 5 mg tabletter

Amlodipin Sandoz 10 mg tabletter

United Kingdom (Northern Ireland):

Amlodipine 5 mg Tablets

Amlodipine 10 mg Tablets

Date of the most recent review of this summary: September 2022

Detailed 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/