Amlodipine Tevagen 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amlodipine Tevagen 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amlodipine Tevagen 5 mg tablets are and what they are used for
2. What you need to know before taking Amlodipine Tevagen 5 mg tablets
3. How to take Amlodipine Tevagen 5 mg tablets
4. Possible side effects
5. How to store 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 besilate), 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 known as angina, including the rare 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, Amlodipine Tevagen 5 mg tablets improve blood supply to the heart muscle, thereby increasing oxygen delivery and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.

2. What you need to know before starting to take Amlodipino Tevagen 5 mg tablets

Do not take Amlodipine Tevagen 5 mg tablets

• if you are allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. This may include itching, skin redness, or difficulty breathing.
• if you have very low blood pressure (hypotension)
• if you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply 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 starting to take Amlodipine Tevagen 5 mg tablets. You must inform your doctor if you have or have had any of the following conditions:

• recent heart attack
• heart failure
• increased blood pressure (hypertensive crisis)
• liver disease
• you are elderly and require a dose increase

Children and adolescents

Amlodipine has not been studied in children under 6 years of age. Amlodipine 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 Amlodipine Tevagen 5 mg tablets

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

Amlodipine Tevagen 5 mg tablets may interact with 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 bacterial infections)
• 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 function of your immune system)
• simvastatin (a medicine to lower cholesterol)
• cyclosporine (an immunosuppressant)

Amlodipine Tevagen 5 mg tablets may lower your blood pressure even further 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 consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of amlodipine, which could lead to an unpredictable increase in the hypotensive 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 using Amlodipine Tevagen 5 mg tablets.

Breastfeeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, inform your doctor before taking Amlodipine Tevagen 5 mg tablets.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Amlodipine Tevagen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Amlodipine Tevagen 5 mg tablets

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

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

This medicine may 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 usual recommended starting dose is 2.5 mg daily.

The recommended maximum dose is 5 mg daily.

Amlodipine Tevagen 5 mg tablets may be divided into equal doses to provide a 2.5 mg dose.

Amlodipine Tevagen 10 mg tablets may also be divided into equal doses.

It is important to continue taking the tablets as prescribed. Do not wait until you run out of tablets before seeing your doctor.

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

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

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

Seek immediate medical attention if you have taken 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, simply skip the missed dose. Take the next dose at the usual 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 how long you should take this medicine. If you stop taking this medicine too early, your symptoms may return.

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.

If you experience any of the following adverse 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 severe difficulty in breathing
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis (frequency not known: cannot be estimated from available data)) or other allergic reactions
• Heart attack, abnormal heartbeats
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by feeling unwell

The following very common adverse effects have been reported. If any of these cause you problems or if they last longer than one week, you should 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 any of these cause you problems or if they last longer than one week, you should 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), flushing
• Abdominal pain, discomfort (nausea)
• Changes in bowel habits, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

Other adverse effects have been reported, included in the following list. If any of them are 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
• Tremors, taste disturbances, fainting
• Numbness or tingling sensation in the limbs; loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/nasal congestion due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (nausea)
• Hair loss, increased sweating, skin itching, 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
• Pain, feeling unwell
• Joint or muscle 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 cell count, decrease in platelets in blood which may cause unusual bleeding or bruising
• High blood sugar (hyperglycemia)
• Nerve disorders which may cause muscle weakness, tingling or numbness
• Gum inflammation, bleeding gums
• Abdominal distension (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes which may affect certain medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• Light sensitivity

Frequency not known: cannot be estimated from available data

• Tremors, rigid posture, "mask-like" face, slow movements and unbalanced gait with shuffling steps

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 Tevagen 5 mg Tablets

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

Do not use this medicine after the expiry date stated on the blister and packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Blister

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

HDPE bottles

Do not store above 25°C. Keep in the original container 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Package contents 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 components are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate and magnesium stearate.

Appearance of the product and package contents

• Amlodipine Tevagen 5 mg tablets are white, round tablets, 8 mm in diameter. One side is slightly concave with a score line and engraved with "A5". The other side is slightly convex and smooth.

• Amlodipine Tevagen 10 mg tablets are white, round tablets, 11 mm in diameter. One side is slightly concave with a score line and engraved with "A10". The other side is slightly convex and smooth.

1. Opaque white PVC/PVdC-aluminum blisters in cardboard packs

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 pack: 50 tablets

10 mg:

Packages: 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. Opaque white HDPE bottles with child-resistant closure and polypropylene screw cap

White opaque polyethylene 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 pack sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer responsible

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen,

Hungary

OR

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The 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 medicinal product 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 the most recent review of this summary: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/