AMLODIPINE RATIOPHARM 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine ratiopharm 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 is Amlodipine ratiopharm and what is it used for
2. What you need to know before you take Amlodipine ratiopharm
3. How to take Amlodipine ratiopharm
4. Possible side effects
5. Storage of Amlodipine ratiopharm

1. Contents of the pack and further information

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

Amlodipine ratiopharm contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a rare type 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 improves blood supply to the heart muscle, which 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 ratiopharm

Do not take Amlodipine ratiopharm

• if you are allergic to amlodipine or any other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. 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 (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

Consult your doctor or pharmacist before starting to take Amlodipine ratiopharm.

You must inform your doctor if you have or have had any of the following diseases:

• recent heart attack,
• heart failure,
• severe increase in blood pressure (hypertensive crisis),
• liver disease,
• you are elderly and your dose needs to be increased.

Children and adolescents

Amlodipine has not been studied in children under 6 years old. Amlodipine ratiopharm 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, consult your doctor.

Taking Amlodipine ratiopharm with other medicines

Tell your doctor or pharmacist that you are taking/using, have recently taken/used, or might take/use any other medicines.

Amlodipine ratiopharm may 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 for bacterial infections)
• Hypericum perforatum(St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature anomalies)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of your immune system)
• simvastatin (a medicine to lower cholesterol)
• cyclosporin (an immunosuppressant)

If you are already taking other medicines for high blood pressure, Amlodipine ratiopharm may further lower your blood pressure.

Taking Amlodipine ratiopharm with food and drinks

People taking Amlodipine ratiopharm should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine ratiopharm.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant or are planning to become pregnant, you must inform your doctor before taking Amlodipine ratiopharm.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Amlodipine ratiopharm.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amlodipine ratiopharm may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or cause you headaches, do not drive or use machinery and consult your doctor immediately.

Amlodipine ratiopharm 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 ratiopharm

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

Dosage

The recommended initial dose is 1 tablet (corresponding to 5 mg of amlodipine) once a day. The dose can be increased to 2 tablets (corresponding 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 this medicine with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years old), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day.

The 2.5 mg dose can be obtained with the 5 mg amlodipine tablets, as these tablets can be divided into equal doses.

Amlodipine ratiopharm can be divided into equal doses.

If your doctor has indicated that you should take ½ (half) a tablet per day, we suggest that you do not use any device to reduce the tablet to half. Please consult the following instructions on how to break the tablet:

Place the tablet on a smooth, hard surface (e.g., a board or countertop) with the inscription facing up. Break the tablet by pressing it with the index fingers of both hands placed along the break line.

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

If you take more Amlodipine ratiopharm than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, or experience 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 damp, and you could lose consciousness.

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

If you take too many amlodipine tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine ratiopharm

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 the forgotten dose.

If you stop taking Amlodipine ratiopharm

Your doctor will indicate how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor indicates.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Go to your doctor immediatelyif you experience any of the following side effects after taking this medicine.

• 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 breathing
• Severe skin reactions, including intense skin rash, hives, skin redness all over the body, itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis, which can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort

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

Common:may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling the heartbeat), hot flashes
• Abdominal pain, feeling unwell (nausea)
• Alteration of bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles (edema)

Other side effects have been reported, which are included in the following list. If you consider that any of the side effects you are experiencing is serious 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

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, 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, red spots on the skin, skin discoloration
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or enlargement of the breasts in men
• 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
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis, gum bleeding
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rashes
• 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 of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System, https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine ratiopharm

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

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

HDPE bottles:

Expiry after first opening: 4 months.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amlodipine ratiopharm

• The active substance is amlodipine besylate.

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

• The other ingredients are microcrystalline cellulose (E-460), calcium hydrogen phosphate (E-341), sodium starch glycolate (potato starch), magnesium stearate (E-470b).

Appearance and packaging of the product

Round, white tablets. One side is slightly concave with a score line and engraved with "A5". The other side is slightly convex and smooth.

Available in PVC/PVDC/Al blister packs of 10, 14, 20, 28, 30, 30 x 1, 50, 50 x 1, 56, 60, 90, 98, 100, 100 x 1, 200, 250 tablets.

HDPE bottles of 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 - Blaubeuren (Germany)

Or

Teva Pharmaceutical Works Private Limited Company

Debrecen - Hungary

Or

Teva Pharma S.L.U.

Polígono Malpica, c/C nº 4.

50016 Zaragoza (Spain)

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Amlodipin-ratiopharm 5 mg N Tabletten

Austria: Amlodibene 5 mg-Tabletten

Czech Republic: Amloratio 5 mg

Estonia: Amlodipin-ratiopharm 5 mg

Finland: Amloratio 5 mg tablet

Luxembourg: Amlodipin-ratiopharm 5 mg N Tabletten

Netherlands: Amlodipine (as besylate) ratiopharm 5 mg, tablets

Portugal: Amlodipina ratiopharm

Slovakia: Amlodipin ratiopharm 5 mg

Spain: Amlodipino ratiopharm 5 mg tablets EFG

Date of the last revision of this leaflet:June 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/