PATIENT INFORMATION LEAFLET

Amlodipino Ortodrol 5 mg Tablets EFG

Amlodipine

Read this leaflet carefully before you start taking this medicine.

• 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you are having a serious side effect or if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Amlodipino Ortodrol contains the active substance amlodipine which belongs to a group of medicines known as calcium antagonists.

Amlodipino Ortodrol 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, Amlodipino Ortodrol improves blood flow to the heart muscle, which receives more oxygen as a result, and as a consequence, chest pain is prevented. This medicine does not provide immediate relief from chest pain due to angina.

Do not take Amlodipino Ortodrol

• If you are allergic (hypersensitive) to amlodipino, or any of the other components of the medication 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) in your heart 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.

Be especially careful with Amlodipino Ortodrol

You must 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
• You are an elderly person and your dose needs to be increased

Use in children and adolescents

Amlodipino Ortodrol has not been studied in children under 6 years of age. Amlodipino Pensa 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.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Amlodipino Ortodrol may affect or be affected by other medications, such as:

• ketoconazol, itraconazol (antifungal medications)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicina, eritromicina, claritromicina (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamilo, diltiazem (heart medications)
• dantroleno (in perfusion for severe body temperature abnormalities)
• rifampicina, eritromicina, claritromicina (antibiotics)

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

Taking Amlodipino Ortodrol with food and beverages

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

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 Ortodrol.

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 Ortodrol.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Amlodipino Ortodrol may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, or tired, or cause headaches, do not drive or operate machinery and consult your doctor immediately.

Always take your medicine exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.

The usual initial dose is 5 mg of Amlodipino Ortodrol, once a day. The dose can be increased to 10 mg of Amlodipino Pensa, once a day.

You can take your medicine before or after meals. It should be taken at the same time every day, with a glass of water. Do not take Amlodipino Ortodrol with grapefruit juice.

Use in children and adolescents

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

Amlodipino 2.5 mg is currently not available and the 2.5 mg dose cannot be obtained with the Amlodipino Ortodrol 5 mg tablets as these tablets are not manufactured to be divided into equal parts.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets are finished before consulting your doctor.

If you take more Amlodipino Ortodrol than you should

Consuming 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 is cold and moist and could lose consciousness. If you take too many Amlodipino Ortodrol tablets, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Amlodipino Ortodrol

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 compensate for the missed dose.

If you interrupt treatment with Amlodipino Ortodrol

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

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

Like all medicines, Amlodipino Ortodrol may cause side effects, although not everyone will experience them.

See your doctorimmediatelyif you experience any of the following serious side effects, which are very rare after 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, skin peeling, 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 followingcommon side effectshave been reported. If any of these cause problems or if theylast more than a week, consult your doctor.

Common:affect between 1 and 10 in every 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), shortness of breath
• Abdominal pain, feeling of discomfort (nausea)
• Swelling of the ankles (edema), fatigue

The following side effects have also been reported. 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:affect between 1 and 10 in every 1,000 patients

• Changes in mood, anxiety, depression, insomnia
• Tremor, taste alterations, fainting, weakness
• Numbness or tingling sensation in the extremities, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decreased blood pressure
• Runny nose/ nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Alteration of bowel habit, diarrhea, constipation, indigestion, dry mouth, vomiting (discomfort)
• Hair loss, increased sweating, itching skin, red patches on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast tenderness in men
• Weakness, pain, feeling of discomfort
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

Rare:affect between 1 and 10 in every 10,000 patients

• Confusion

Very rare:affect fewer than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising (damage to red blood cells)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, tingling, or numbness
• Cough, gum inflammation
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin eruptions
• Sensitivity to light
• Movements combining stiffness, tremor, and/or movement disorders

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

Keep out of reach and sight 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.

Store below 30°C.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino Ortodrol

The active ingredient of Amlodipino Ortodrol 5 mg tablets is amlodipine (as besilate).

• The other components are microcrystalline cellulose, calcium phosphate dibasic (dihydrate), sodium carboxymethylstarch potato, anhydrous colloidal silica, and magnesium stearate.

Appearance of Amlodipino Ortodrol and packaging contents

White or almost white, round, flat tablets.

Amlodipino Ortodrol 5 mg tablets are available in blister packs containing 30 tablets.

Marketing authorization holder and manufacturer responsible

Industria Química Farmacéutica VIR, S.A.

C/ Laguna 66-68-70.Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain

This leaflet was approved in July 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/