AMLODIPINE ORTODROL 5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amlodipine Ortodrol 5 mg tablets EFG

Amlodipine

Read all of this leaflet carefully before you start taking this medicine.

• 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.

Contents of the pack:

1. What Amlodipine Ortodrol is and what it is used for
2. Before you take Amlodipine Ortodrol
3. How to take Amlodipine Ortodrol
4. Possible side effects
5. Storing Amlodipine Ortodrol
6. Further information

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

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

Amlodipine Ortodrol 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 Ortodrol 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. Before you take Amlodipine Ortodrol

Do not take Amlodipine Ortodrol

• If you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. 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 have heart failure after a heart attack.

Take special care with Amlodipine Ortodrol

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
• You are elderly and your dose needs to be increased

Use in children and adolescents

Amlodipine Ortodrol has not been studied in children under 6 years old. Amlodipine 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.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Amlodipine Ortodrol 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)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature abnormalities)
• rifampicin, erythromycin, clarithromycin (antibiotics)

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

Taking Amlodipine Ortodrol with food and drinks

People taking Amlodipine Ortodrol 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 Ortodrol.

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 should inform your doctor before taking Amlodipine Ortodrol.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, you should inform your doctor before taking Amlodipine Ortodrol.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Ortodrol may affect your ability to drive or use machines. 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.

3. How to take Amlodipine Ortodrol

Always take your medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

The initial normal dose is 5 mg of Amlodipine Ortodrol, once a day. The dose can be increased to 10 mg of Amlodipine, once a day.

You can take your medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Amlodipine Ortodrol with grapefruit juice.

Use in children and adolescents

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

Amlodipine 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained with Amlodipine Ortodrol 5 mg tablets, as these tablets are not designed to be divided into equal parts.

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

If you take more Amlodipine Ortodrol than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from postural dizziness when getting up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness. If you take too many Amlodipine Ortodrol tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine 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 make up for the forgotten dose.

If you stop taking Amlodipine Ortodrol

Your doctor will tell you for how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine Ortodrol can cause side effects, although not everybody gets them.

See your doctor immediatelyif you experience any of the following serious side effects, which are very rare when 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 common side effectshave been reported. If any of these cause problems or last more than a week, consult your doctor.

Common:affects between 1 and 10 in every 100 patients

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, feeling sick (nausea)
• Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are suffering from is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Uncommon:affects between 1 and 10 in every 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Trembling, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or breast enlargement in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

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

• Confusion

Very rare:affects less than 1 in every 10,000 patients

• Decrease in white blood cell count, decrease in blood platelets, which can cause easy bruising or bleeding (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves, which 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, which can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders combining stiffness, trembling, and/or movement disorders

If you think any of the side effects you are suffering from is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storing Amlodipine Ortodrol

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the pack, after EXP. The expiry date is the last day of the month stated.

Store below 30°C.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Further information

Composition of Amlodipine Ortodrol

The active substance of Amlodipine Ortodrol 5 mg tablets is amlodipine (as besylate).

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

Appearance of Amlodipine Ortodrol and pack contents

White or almost white, round, flat tablets.

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

Marketing authorization holder and manufacturer

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

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