AMLODIPINO 5 mg Tablets

2. What you need to know before you take 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 can 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),
• if you suffer from heart failure after a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take amlodipine.

Tell 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,
• 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 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, talk to your doctor.

Other medicines and Amlodipine Sandoz

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

Amlodipine can 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 perfusion for severe body temperature anomalies),
• simvastatin (a medicine to lower high cholesterol levels in the blood),
• tacrolimus, sirolimus, everolimus and cyclosporin (used to prevent organ rejection and for cancer),
• temsirolimus (used for cancer).

If you are already taking other medicines for 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 can cause an increase in the levels of the active substance amlodipine in the blood, which can 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 may be pregnant or are planning to have a baby, ask your doctor for advice 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 amlodipine.

Driving and using machines

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

Amlodipine Sandoz contains sodium

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

3. How to take Amlodipine Sandoz

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

The usual 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 your medicine before or after meals and drinks. 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 (from 6 to 17 years old), the recommended initial dose is 2.5 mg per day. The maximum recommended dose is 5 mg per day.

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

The tablet can be divided into equal doses.

If you take more Amlodipine Sandoz 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 dizziness when standing up or weakness.

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

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

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

If you forget to take Amlodipine 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 Amlodipine Sandoz

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 product, 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.

These include:

• Sudden wheezing, tightness of the chest, difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat, which can cause great difficulty in breathing.
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, intense itching, flu-like symptoms followed by skin 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.
• Pancreatitis, which can cause severe abdominal pain and back pain accompanied by a feeling of being unwell.
• Hepatitis (inflammation of the liver) which can cause yellowing of the skin and the whites of the eyes, fever, chills, tiredness, loss of appetite, stomach pain, feeling unwell and dark urine.

The following very common side effectshave been reported. If they cause problems or last 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 they 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.
• Difficulty breathing.
• Abdominal pain, feeling unwell (nausea).
• Altered bowel habit, diarrhea, constipation, indigestion.
• Swelling of the ankles.
• Tiredness, weakness.
• Visual disturbances, double vision.
• Muscle cramps.

Other side effects have been reported, which are listed below. If you think you are experiencing any of these side effects, or if you experience any side effect not listed in this leaflet, talk to your doctor or pharmacist.

Uncommon:may affect up to 1 in 100 people.

• Mood changes, anxiety, depression, insomnia.
• Trembling, altered 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 of the skin, rash, red spots on the skin, skin discoloration.
• Urination disorder, increased need to urinate at night, increased number of times of urination.
• Impotence, discomfort or enlargement of the breasts in men.
• Chest pain.
• 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 the number of white blood cells, decrease in blood platelets which can cause easy bleeding or unusual bruising.
• Excess sugar in the blood (hyperglycemia).
• A disorder of the nerves which can cause muscle weakness, tingling or numbness.
• Inflammation of the gums.
• Abdominal swelling (gastritis).
• Abnormal liver function, yellowing of the skin (jaundice), increase in liver enzymes which can affect some medical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with skin rash.
• Sensitivity to light.

Not known:cannot be estimated from the available data:

• Tremors, stiffness, mask-like face, slow movements and unsteady walking.

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 Agency's website: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister or on the bottle after EXP. The expiry date is the last day of the month stated.

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

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

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 further 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 ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch (type A) (potato) and magnesium stearate.

Appearance of Amlodipine Sandoz and contents of the pack

Amlodipine Sandoz 5 mg tablets

White or almost white, oblong tablet with beveled edges, with a score line on one side and with the mark "5" on the other.

Amlodipine Sandoz 10 mg tablets

White or almost white, oblong tablet with beveled edges, with a score line on one side 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 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.

Not all pack sizes may be marketed.

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

Lek S.A.

Ul. Podlipie 16,

95 010 Strykow

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava

Slovenia

This medicine 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 last revision of this leaflet:September 2022

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