Amlodipine Ortodrol 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipine Ortodrol 10 mg tablets EFG
Amlodipine
Read the entire 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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Amlodipine Ortodrol is and what it is used for
- Before you take Amlodipine Ortodrol
- How to take Amlodipine Ortodrol
- Possible side effects
- How to store Amlodipine Ortodrol
- 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 known as angina, including a less common type called Prinzmetal's angina or variant angina.
In patients with high blood pressure, this medicine works by relaxing the blood vessels, allowing blood to flow through them more easily. In patients with angina, Amlodipine Ortodrol 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. Before taking 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 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 heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
- If you suffer from heart failure following 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 Pensa has not been studied in children under 6 years of age. Amlodipine Ortodrol 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.
Use of other medicines
Inform your doctor or pharmacist if you are taking or have recently taken 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 known as protease inhibitors used to treat AIDS)
- rifampicin, erythromycin, clarithromycin (antibiotics)
- Hypericum perforatum (St. John's Wort)
- verapamil, diltiazem (heart medicines)
- dantrolene (by infusion for severe disturbances in body temperature)
- rifampicin, erythromycin, clarithromycin (antibiotics)
If you are already taking other medicines to treat high blood pressure, Amlodipine Ortodrol may lower your blood pressure even further.
Taking Amlodipine Ortodrol with food and drink
People taking Amlodipine Ortodrol 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 lead to 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 must inform your doctor before taking Amlodipine Ortodrol.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start, 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 machinery. 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.
3. How to take Amlodipino Ortodrol
Always take your medicine exactly as your doctor has prescribed. Consult your doctor or pharmacist if you have any doubts.
The usual starting dose is 5 mg of Amlodipino Ortodrol once daily. The dose may be increased to 10 mg of Amlodipino Ortodrol once daily.
You may take your medicine before or after meals. Take it at the same time each day with a glass of water. Do not take Amlodipino Ortodrol with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6–17 years), the recommended starting dose is usually 2.5 mg once daily. The maximum recommended dose is 5 mg daily.
Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be achieved with Amlodipino Ortodrol 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.
It is important not to interrupt treatment. Do not wait until you run out of tablets before seeing your doctor.
If you take more Amlodipino Ortodrol than you should
Taking too many tablets may cause a drop in blood pressure, or even a dangerous decrease. 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, and you could lose consciousness. If you take too many Amlodipino Ortodrol tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take Amlodipino Ortodrol
Do not worry. If you forget to take a dose, do not take that dose. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Amlodipino Ortodrol
Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Amlodipine Ortodrol can cause adverse effects, although not everyone experiences them.
Seek medical attention immediately if you experience any of the following serious adverse effects, which are very rare 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 intense 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, irregular heartbeat
- Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise
The following common adverse effects have been reported. If any of these cause you problems or if they last longer than one week, consult your doctor.
Common: affect between 1 and 10 out of every 100 patients
- Headache, dizziness, drowsiness (especially at the beginning of treatment)
- Palpitations (awareness of heartbeat), flushing
- Abdominal pain, feeling unwell (nausea)
- Swelling of the ankles (edema), fatigue
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 listed in this leaflet, inform your doctor or pharmacist.
Uncommon: affect between 1 and 10 out of every 1,000 patients
- Mood changes, anxiety, depression, insomnia
- Tremor, taste disturbances, fainting, weakness
- Numbness or tingling sensation in the limbs, loss of pain sensation
- Visual disturbances, double vision, ringing in the ears (tinnitus)
- Decreased blood pressure
- Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
- Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea)
- 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
- Weakness, pain, feeling unwell
- Muscle or joint pain, muscle cramps, back pain
- Weight gain or weight loss
Rare: affect between 1 and 10 out of every 10,000 patients
- Confusion
Very rare: affect fewer than 1 in 10,000 patients
- Decreased number of white blood cells, decreased blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
- High blood sugar (hyperglycemia)
- A nerve disorder that may cause weakness, tingling or numbness
- Cough, gum inflammation
- 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 associated with skin rashes
- Light sensitivity
- Disorders combining rigidity, tremor and/or movement disturbances
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.
5. Storage of Amlodipine Ortodrol
Keep out of the reach and sight 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.
Store below 30°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.
6. Additional information
Composition of Amlodipine Ortodrol
The active substance of Amlodipine Ortodrol 10 mg tablets is amlodipine (as besylate).
- The other components are microcrystalline cellulose, dibasic calcium phosphate (dihydrate), sodium carboxymethyl starch from potato, colloidal anhydrous silica and magnesium stearate.
Appearance of Amlodipine Ortodrol and contents of the pack
White or almost white, round tablets, marked on one side with “10” and smooth on the other. Amlodipine Ortodrol 10 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/