Amlodipine Alter 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Amlodipino Alter 10 mg tablets EFG
Amlodipine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. 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 give it to other people, 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 adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Amlodipino Alter is and what it is used for
- What you need to know before taking Amlodipino Alter
- How to take Amlodipino Alter
- Possible adverse effects
- How to store Amlodipino Alter
- Contents of the pack and other information
1. What Amlodipino Alter is and what it is used for
Amlodipino Alter contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
Amlodipino Alter 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 flow through them more easily. In patients with angina, Amlodipino Alter improves blood supply to the heart muscle, thereby increasing oxygen delivery 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 Alter
Do not take Amlodipine Alter
- If you are allergic to amlodipine, 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 aortic valve stenosis (narrowing of the aortic valve in the heart) 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 starting to take Amlodipine Alter.
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 may need to be increased.
Children and adolescents
Amlodipine Alter has not been studied in children under 6 years of age. Amlodipine Alter 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 Alter with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Amlodipine Alter 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 serious disturbances in body temperature)
- tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the function of the immune system)
- simvastatin (a cholesterol-lowering medicine)
- cyclosporine (an immunosuppressant).
If you are already taking other medicines to treat high blood pressure, Amlodipine Alter may lower your blood pressure even further.
Taking Amlodipine Alter with food and drink
People taking Amlodipine Alter 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 Alter.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 Alter.
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you should inform your doctor before taking Amlodipine Alter.
Driving and using machines
Amlodipine Alter may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy, tired, or cause headache, do not drive or operate machinery and consult your doctor immediately.
Amlodipine Alter 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 Alter
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The usual starting dose is 5 mg of Amlodipine Alter once daily. The dose may be increased to 10 mg of Amlodipine Alter 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 Amlodipine Alter with grapefruit juice.
Use in children and adolescents
For children and adolescents (between 6–17 years of age), the usual recommended starting dose is normally 2.5 mg 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 Amlodipine Alter 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.
It is important not to interrupt the administration of the tablets. Do not wait until you run out of tablets before seeing your doctor.
If you take more Amlodipine Alter 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 upon standing, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel your skin is cold and clammy and you 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 Alter tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take Amlodipine Alter
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 Alter
Your doctor will advise you how long you should take this medicine. Your condition may recur 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, this medicine can cause adverse effects, although not everyone will experience them.
Seek immediate medical attention 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 intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, 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 marked feeling of malaise.
The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.
Very common: may affect more than 1 in 100 people
- Edema (fluid retention)
The following common adverse effects have been reported. If any of these cause problems or 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
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: 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
- Inflammation of the 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
- Disorders combining rigidity, tremor and/or movement disorders
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificarm.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Amlodipine Alter
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Amlodipine Alter
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The active substance is amlodipine (as besylate). Each tablet contains 10 mg of amlodipine (as besylate).
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The other components are microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium carboxymethyl starch (type A) (from potato), and magnesium stearate.
Appearance of the product and contents of the container
White, biconvex, scored tablets on one side.
The tablet can be divided into equal doses.
Amlodipine Alter 10 mg tablets are available in blister packs containing 28 or 30 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria, 30
28036 Madrid
Spain
Date of the most recent review of this leaflet: June 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/.