Package Insert: Information for the User

Amlodipine ratiopharm 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Amlodipino 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, which includes a less common type known as 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 improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, prevents chest pain. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino ratiopharm

• if you are allergic to amlodipino, or to any of the 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 condition in which the heart is unable to pump 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 ratiopharm.

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

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

Children and adolescents

Amlodipino has not been studied in children under 6 years of age. Amlodipino ratiopharm should only be used to treat high blood pressure in children and adolescents from 6 to 17 years of age (see section 3).

For more information, consult your doctor.

Taking Amlodipino ratiopharm with other medicines

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

Amlodipino ratiopharm may affect or be affected by other medicines, such as:

• ketoconazol, itraconazol (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV/AIDS)
• rifampicina, eritromicina, claritromicina (antibiotics, for bacterial infections)
• Hypericum perforatum(St. John's Wort)
• verapamilo, diltiazem (heart medicines)
• dantroleno (in infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the functioning of your immune system)
• simvastatina (medicine to lower cholesterol)
• ciclosporina (an immunosuppressant)

If you are already taking other medicines to treat high blood pressure, Amlodipino ratiopharm may lower your blood pressure even further.

Taking Amlodipino ratiopharm with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipino 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 Amlodipino ratiopharm.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Amlodipino ratiopharm contains sodium

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

Follow exactly the administration instructions of this medication 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 medication before or after meals and drinks. It should be taken at the same time every day, with a glass of water. Do not take this medication with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), 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 amlodipine 5 mg tablets, as these tablets can be divided into equal doses.

Amlodipino ratiopharm can be divided into equal doses.

If your doctor has instructed you to take½ (half) 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 flat and hard surface (for example a table or countertop) with the inscription facing upwards. Break the tablet by pressing it with your index fingers of both hands placed along the break line.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets run out to visit your doctor

If you take more Amlodipino ratiopharm than you should

The ingestion of too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, disoriented, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, it can cause shock. You may feel your skin cold and wet, and you could lose consciousness.

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

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

If you forgot to take Amlodipino ratiopharm

Do not worry. If you forgot to take a tablet, do not take that dose. Take the next doseat the correct time. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Amlodipino ratiopharm

Your doctor will indicate for how long you should take this medication. Your disease may reappear if you stop taking this medication before your doctor tells you to.

If you have any other doubts 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.

See your doctorimmediatelyif you experience any of the following side effectsafter taking this medicine.

• Sudden hissing sounds when breathing (sudden sibilance), chest pain,shortness of breath or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat that causes great difficulty breathing
• Severe skin reactions that include intense skin rash, blisters, skin redness all over the body, itching, blister formation, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome,toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by great discomfort

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

Very common:can affect more than 1 in 10 people

• Edema (fluid retention)

The followingcommon side effectshave been reported.If any ofthesecause problemsorifthey lastmore thanone week,consult your doctor.

Common:can affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), hot flushes
• 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)

The following side effects have also been reported.If you consider that any of the side effects you are experiencing are severeor if you noticeany side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Uncommon:can affect up to 1 in 100 people

• Changes in mood,anxiety,depression,insomnia
• Tremor,alterationsof taste,syncope
• Numbnessortinglinginthe extremities, lossofpain sensation
• Ringing in the ears
• Decreased blood pressure
• Nasal secretion and runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth,vomiting(feeling unwell)
• Hair loss,increased sweating,itching skin,red spotson the skin,skin discoloration
• Urinary disorders,increased needto urinate at night,increased frequencyof urination
• Impotence,discomfort orenlargementof the breastsin men
• Pain, feeling unwell
• Painin the muscles or joints,back pain
• Weight gain or loss

Rare:can affect up to 1 in 1,000 people

• Confusion

Very rare:can affect up to 1 in 10,000 people

• Decreased white blood cell count, decreased platelet count that can cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, numbness or tingling
• Gingivitis, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (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

Frequency not known: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 effect, consult your doctor or pharmacist, even if it is a side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light and moisture.

HDPE bottles:

Expiration date after first opening: 4 months.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Amlodipino ratiopharm

• The active ingredient is amlodipine besilate.

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

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

Appearance of the product and packaging contents

Round white tablets. One side is slightly concave with a groove and engraved with “A5”. The other side is slightly convex and smooth.

They are available in PVC/PVDC/Al blister packs with 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 with 100 and 250 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U

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

28108 Alcobendas, Madrid (Spain)

Responsible 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 with 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 tabletti

Luxembourg:Amlodipin-ratiopharm 5 mg N Tabletten

Netherlands:Amlodipine (as besilate) ratiopharm 5 mg, tabletten

Portugal:Amlodipina ratiopharm

Slovakia:Amlodipin ratiopharm 5 mg

Spain:Amlodipino ratiopharm 5 mg comprimidos EFG

Last review date of this leaflet:June 2022

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/