AMLODIPINE TEVAGEN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine Tevagen 5 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 and other information:

1. What Amlodipine Tevagen 5 mg Tablets are and what they are used for
2. What you need to know before you take Amlodipine Tevagen 5 mg Tablets
3. How to take Amlodipine Tevagen 5 mg Tablets
4. Possible side effects
5. Storage of Amlodipine Tevagen 5 mg Tablets
6. Contents of the pack and other information

1. What Amlodipine Tevagen 5 mg Tablets are and what they are used for

Amlodipine Tevagen 5 mg Tablets contain the active substance amlodipine (as besylate), which belongs to a group of medicines called calcium antagonists.

Amlodipine 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 angina 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 Tevagen 5 mg Tablets work by improving blood supply to the heart muscle, which then 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 Tevagen 5 mg Tablets

Do not take Amlodipine Tevagen 5 mg Tablets

• if you are allergic to amlodipine or any other ingredients of this medicine (listed in section 6), or to other calcium antagonists. This may be 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 in your heart (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to your body)
• if you have heart failure after a heart attack

Warnings and precautions

Consult your doctor or pharmacist before taking Amlodipine 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
• increase in blood pressure (hypertensive 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 old. Amlodipine Tevagen 5 mg Tablets should only be used for hypertension in children and adolescents from 6 to 17 years old (see section 3). For more information, consult your doctor.

Other medicines and Amlodipine Tevagen 5 mg Tablets

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

Amlodipine Tevagen 5 mg Tablets may affect or be affected by other medicines, such as:

• ketoconazole and itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics: for infections caused by bacteria)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of your immune system)
• simvastatin (a medicine to lower cholesterol)
• cyclosporin (an immunosuppressant)

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

Taking Amlodipine Tevagen 5 mg Tablets with food and drinks

People taking Amlodipine Tevagen 5 mg Tablets should not take grapefruit juice or grapefruit. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of amlodipine, which can cause an unpredictable increase in the blood-pressure-lowering effect of Amlodipine Tevagen 5 mg Tablets.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before taking Amlodipine 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 Amlodipine Tevagen 5 mg Tablets.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Amlodipine Tevagen 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 Tevagen 5 mg Tablets

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

The recommended initial dose is one tablet of Amlodipine Tevagen 5 mg once daily. The dose can be increased to one tablet of Amlodipine Tevagen 10 mg once daily.

This medicine can be taken before or after food and drinks. You should take your medicine every day at the same time with a glass of water. Do not take Amlodipine Tevagen 5 mg with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years) the recommended initial dose is 2.5 mg daily.

The maximum recommended dose is 5 mg daily.

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

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

It is important to keep taking the tablets. Do not wait until you run out of tablets to go to your doctor.

If you take more Amlodipine Tevagen 5 mg Tablets than you should

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

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

Seek medical attention immediately if you take too many Amlodipine Tevagen 5 mg Tablets.

If you have taken too many Amlodipine Tevagen 5 mg Tablets, contact your doctor, an emergency service, or the Toxicology Information Service (telephone: 91.562.04.20).

If you forget to take Amlodipine Tevagen 5 mg Tablets

Do not worry. If you forget to take a tablet, skip the missed dose completely. Take the next dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine Tevagen 5 mg Tablets

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

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.

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

• 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, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis (frequency not known: cannot be estimated from the available data)) or other allergic reactions.
• Heart attack, abnormal heartbeats
• Pancreatitis, which can cause severe abdominal and back pain, accompanied by a feeling of being unwell.

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

Common: may affect up to 1 in 10 people

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

Other side effects have been reported, including those listed below. If any of these are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremors, altered taste, fainting
• Numbness or tingling in the limbs; loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing / nasal congestion 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 number of times urinating
• Impotence, breast tenderness or enlargement in men
• Pain, feeling unwell
• 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

• Decrease in white blood cell count, decrease in platelet count in the blood that can cause unusual bleeding or bruising
• High blood sugar (hyperglycemia)
• Nerve disorder that can cause muscle weakness, tingling, or numbness
• Gingivitis, bleeding gums
• Abdominal distension (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes that can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light

Frequency not known: cannot be estimated from the available data

• Tremors, rigid posture, “mask-like” face, slow movements, and unsteady gait

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Tevagen 5 mg Tablets

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 blister and carton after the abbreviation EXP. The expiry date is the last day of the month stated.

Blister

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

HDPE Bottles

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

Keep the container tightly closed.

Shelf life after first opening: 4 months.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Tevagen 5 mg Tablets

• The active substance is amlodipine.

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

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

Appearance and packaging

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

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

1. White opaque PVC/PVdC-aluminum blisters in cartons

5 mg:

Packs: 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 pack: 50 tablets

10 mg:

Packs 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 pack: 50 tablets

1. White opaque HDPE bottles with a safety seal and a PP screw cap

Container of polyethylene white opaque tablets

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

Not all pack 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

Manufacturer

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 under the following names:

Spain: Amlodipine Tevagen 5 mg Tablets EFG

Portugal: Amlodipine Mepha

Date of last revision of this leaflet: June 2022

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