Package Insert: Information for the User

Amlodipino Tevagen 5 mg Tablets EFG

Read this package insert carefully before taking this medicine, as 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 you should not give it to others even if they have the same symptoms as you, 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 Tevagen 5 mg tablets contain amlodipine (as besilate) as the active ingredient, which belongs to a group of medicines called calcium antagonists.

Amlodipino Tevagen 5 mg tablets are used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipino Tevagen 5 mg tablets work by improving blood flow to the heart muscle, which then receives more oxygen and as a result, chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Tevagen 5 mg tablets

• if you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. 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 valve of the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply 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 Amlodipino Tevagen 5 mg tablets. You should inform your doctor if you have or have had any of the following conditions:

• recent heart attack
• heart failure
• high blood pressure crisis
• liver disease
• you are an elderly person and need to increase the dose

Children and adolescents

Amlodipine has not been studied in children under 6 years of age. Amlodipino Tevagen 5 mg tablets should only be used for hypertension in children and adolescents aged 6 to 17 years (see section 3). For further information, consult your doctor.

Other medicines and Amlodipino Tevagen 5 mg tablets

Inform your doctor or pharmacist if you are taking/using, have taken/used recently or may have to take/use any other medicine.

Amlodipino Tevagen 5 mg tablets may affect or be affected by other medicines such as:

• ketoconazole and itraconazole (anti-fungal medicines)
• ritonavir, indinavir, nelfinavir (called protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics: for bacterial infections)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe temperature anomalies)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the functioning of your immune system)
• simvastatin (medicine to lower cholesterol)
• ciclosporin (an immunosuppressant)

Amlodipino Tevagen 5 mg tablets may lower your blood pressure even further if you are already taking other medicines to treat high blood pressure.

Taking Amlodipino Tevagen 5 mg tablets with food and drinks

People taking Amlodipino Tevagen 5 mg tablets should not take grapefruit juice or grapefruit. This is because grapefruit and grapefruit juice may lead to an increase in blood levels of amlodipine, which may cause unpredictable lowering of blood pressure.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before using Amlodipino Tevagen 5 mg tablets.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, inform your doctor before taking Amlodipino Tevagen 5 mg tablets.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Amlodipino Tevagen 5 mg tablets may affect your ability to drive or operate machinery.If the tablets make you feel unwell, dizzy or tired, or give you a headache, do not drive or operate machinery and consult your doctor immediately.

Amlodipino Tevagen contains sodium

This medicine 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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is one Amlodipino Tevagen 5 mg tablet once a day. The dose can be increased to one Amlodipino Tevagen 10 mg tablet once a day.

This medication can be taken before or after meals and beverages. You must take your medication every day at the same time with a glass of water. Do not take Amlodipino Tevagen 5 mg with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years), the usual recommended initial dose is 2.5 mg per day.

The maximum recommended dose is 5 mg per day.

Amlodipino Tevagen 5 mg can be divided into equal doses to provide a dose of 2.5 mg.

Amlodipino Tevagen 10 mg can also be divided into equal doses.

It is essential to continue taking the tablets. Do not wait for the tablets to run out before consulting your doctor.

If you take more Amlodipino Tevagen 5 mg tablets than you should

Taking too many tablets can cause your blood pressure to be low or even dangerously low. You may feel dizzy, disoriented, or weak. You may experience shock if the drop in blood pressure is severe enough. You may feel your skin is cold and clammy and lose consciousness.

Fluid accumulation can occur in the lungs (pulmonary edema) causing breathing difficulties that may develop within 24-48 hours after ingestion.

Seek immediate medical attention if you take too many Amlodipino Tevagen 5 mg tablets.

If you have taken too many Amlodipino Tevagen 5 mg tablets, contact your doctor, an emergency service, or the Toxicological Information Service (phone: 91.562.04.20).

If you forget to take Amlodipino Tevagen 5 mg tablets

Do not worry. If you forget to take a tablet, skip the missed dose entirely. 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 Tevagen 5 mg tablets

Your doctor will tell you for how long you should take this medication. If you stop taking this medication before, your symptoms may return.

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

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

If you experience any of the following side effects after taking this medicine, consult your doctorimmediately.

• Sudden hissing sounds, chest pain,shortness of breath or difficulty breathing
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat that causes severe difficulty breathing
• Severe skin reactions including intense skin rash, urticaria, skin redness all over the body, intense itching, blisters, peeling and skin swelling, inflammation of mucous membranes (Stevens-Johnson syndrome,toxic epidermal necrolysis (unknown frequency:cannot be estimated from available data) ) or other allergic reactions.
• Heart attack, abnormal heartbeats
• Pancreatitis that can cause severe abdominal and back pain accompanied by a feeling of discomfort.

The followingvery common side effectshave been reported. If any of these cause problems or ifthey last more than a week,you shouldconsult your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

The followingcommon side effectshave been reported. If any of them cause problems or ifthey last more than a week,you shouldconsult your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (note the heartbeats), flushing
• Abdominal pain, discomfort (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

The following other side effects are included in the following list. If any of them 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
• Tremors, taste disturbances, fainting
• Numbness or tingling in the extremities; loss of pain sensation
• Tinnitus in the ears
• Low blood pressure
• Runny nose / nasal congestion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (dizziness)
• Hair loss, increased sweating, itching skin, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, breast tenderness or enlargement in men
• Pain, feeling of discomfort
• Joint or muscle pain, 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 in the blood that can cause unusual bleeding or bruising
• High blood sugar (hyperglycemia)
• Nerve disorder that can cause muscle weakness, numbness or tingling
• Gingivitis, bleeding gums
• Abdominal distension (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light

Unknown frequency:cannot be estimated from available data

• Tremors, rigid posture, "mask-like" face, slow movements and unsteady gait dragging the feet

Reporting of side effects

If you experience any type of side effects,consult your doctor or pharmacist,evenifthey are not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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 blister and packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Blister

Do not store above 25°C. Store in the original packaging to protect it from light and moisture. Store the blister in the outer packaging.

HDPE Bottles

Do not store above 25°C. Store in the original packaging to protect it from light and moisture.

Keep the packaging tightly closed.

Validity period after the first opening: 4 months.

Do not use these tablets if there are any signs of discoloration or deterioration of the tablets.

Medications 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 at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Amlodipino Tevagen 5 mg Tablets Composition

• The active ingredient is amlodipine.

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

• The other components are microcrystalline cellulose, calcium hydrogen phosphate, sodium glycolate starch, and magnesium stearate.

Appearance of the product and contents of the package

• Amlodipino Tevagen 5 mg tablets are white, round, 8 mm in diameter. One side is slightly concave with a groove and engraved with “A5”. The other side is slightly convex and smooth.

• Amlodipino Tevagen 10 mg tablets are white, round, 11 mm in diameter. One side is slightly concave with a groove and engraved with “A10”. The other side is slightly convex and smooth.

1. White opaque PVC/PVdC-aluminum blisters in cardboard containers

5 mg:

Packages: 15, 20, 28, 30, 30 (3 x 10), 50, 56, 60, 84, 90, 98, 100, 112, 200, 250, and 300 (10 x 30) tablets.

Calendar blister: 28 tablets

Hospital package: 50 tablets

10 mg:

Packages of 14, 15, 20, 28, 30, 30 (3 x 10), 50, 56, 60, 84, 90, 98, 100, 112, 200, and 250 tablets.

Calendar blister: 28 tablets

Hospital package: 50 tablets

1. HDPE white opaque bottles with safety cap and PP screw cap

Polystyrene white opaque tablet container

5 mg:

35 ml: 30, 98, and 100 tablets/bottle

75 ml: 200 and 250 tablets/bottle

10 mg:

35 ml: 30 tablets/bottle

75 ml: 98 and 100 tablets/bottle

150 ml: 200 and 250 tablets/bottle

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen,

Hungary

Or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

Or

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Amlodipino Tevagen 5 mg tablets EFG

Portugal:Amlodipina Mepha

Last review date of this leaflet: June 2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/