Amlodipine Ratiopharm 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amlodipine ratiopharm 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because 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 pass it on to others, 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Amlodipine ratiopharm

3. How to take Amlodipine ratiopharm

4. Possible side effects

5. How to store Amlodipine ratiopharm

6. Contents of the pack and other information

1. What Amlodipine ratiopharm is and what it is 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 less common type known as Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing the blood vessels, allowing blood to pass through them more easily. In patients with angina, amlodipine improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.

2. What you need to know before taking Amlodipine ratiopharm

Do not take Amlodipine ratiopharm

• if you are allergic to amlodipine 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 heart 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 following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine ratiopharm.

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

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

Children and adolescents

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

For further information, consult your doctor.

Taking Amlodipine ratiopharm with other medicines

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

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics for bacterial infections)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (administered by infusion for serious body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the function of your immune system)
• simvastatin (a medicine to lower cholesterol)
• ciclosporin (an immunosuppressant)

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

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 may increase blood levels of the active ingredient amlodipine, which could 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, inform your doctor before taking Amlodipine ratiopharm.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Amlodipine ratiopharm contains sodium

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

3. How to take Amlodipine ratiopharm

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

Dosage

The recommended starting dose is 1 tablet (corresponding to 5 mg of amlodipine) once daily. The dose may be increased to 2 tablets (corresponding to 10 mg of amlodipine) once daily.

You may take your medicine before or after meals and drinks. It should be taken 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 of age), the usual recommended starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily.

The 2.5 mg dose can be obtained using amlodipine 5 mg tablets, since these tablets can be divided into equal doses.

Amlodipine ratiopharm tablets can be divided into equal doses.

If your doctor has instructed you to take ½ (half) tablet daily, we recommend that you do not use any device to split the tablet in half. Please follow the instructions below on how to break the tablet:

Place the tablet on a smooth, hard surface (for example a cutting board or countertop) with the inscription facing upwards. Break the tablet by pressing with the index fingers of both hands placed along the break line.

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

If you take more Amlodipine ratiopharm than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness.

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

If you have taken too many amlodipine tablets, consult your doctor immediately or call the Toxicology Information Service at telephone number 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 missed dose.

If you stop taking Amlodipine ratiopharm

Your doctor will advise you how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to stop.

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 can cause adverse effects, although not everyone will experience them.

Seek medical advice immediately if you experience any of the following adverse 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 severe difficulty breathing
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, itching, blistering, peeling and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heartbeat
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise

The following very common adverse effects have been reported. If any of these cause problems or if they last longer than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

• Oedema (fluid retention)

The following common adverse effects have been reported. If any of these cause problems or if they last longer than one week, 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), hot flushes
• Abdominal pain, feeling unwell (nausea)
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles (oedema)

Other adverse effects have been reported and are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse 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
• Tremor, taste disturbances, fainting
• Numbness or tingling sensation in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling unwell)
• 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 enlargement of the breasts in men
• Pain, feeling of discomfort
• Muscle or joint 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 the number of white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising
• High blood sugar (hyperglycaemia)
• A nerve disorder which may cause muscle weakness, tingling or numbness
• Gum inflammation, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased 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 the available data

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

Reporting of adverse effects

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

5. Storage of Amlodipine ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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:

Shelf-life after first opening: 4 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine ratiopharm

• The active substance 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 from potato type A (potato starch), magnesium stearate (E-470b).

Appearance of the product and contents of the pack

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 blisters containing 10, 14, 20, 28, 30, 30 x 1, 50, 50 x 1, 56, 60, 90, 98, 100, 100 x 1, 200, and 250 tablets.

HDPE bottles containing 100 and 250 tablets.

Only certain 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 1st floor
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 medicinal product 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 tabletti
Luxembourg: Amlodipin-ratiopharm 5 mg N Tabletten
Netherlands: Amlodipine (als besilaat) ratiopharm 5 mg, tabletten
Portugal: Amlodipina ratiopharm
Slovakia: Amlodipin ratiopharm 5 mg
Spain: Amlodipino ratiopharm 5 mg comprimidos EFG

Date of the most recent review of this leaflet: June 2022

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