Amlodipine Combix 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Amlodipine Combix 10 mg tablets EFG
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, since it may harm them.
- If you think that any of the side effects you experience is severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What Amlodipine Combix is and what it is used for
- Before you take Amlodipine Combix
- How to take Amlodipine Combix
- Possible side effects
- How to store Amlodipine Combix
- Further information
1. What Amlodipino Combix is and what it is used for
Amlodipino Combix contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
Amlodipino Combix 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 Combix 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 Amlodipino Combix
Do not take Amlodipino Combix
- If you are allergic (hypersensitive) to amlodipine, or to any of the other components of the 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 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 Amlodipino Combix
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
Use in children and adolescents
Amlodipino Combix has not been studied in children under 6 years of age. Amlodipino Combix 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 using or have recently used any other medicines, including those obtained without a prescription.
Amlodipino Combix may be affected by, or may affect, 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 (intravenous infusion for severe disturbances in body temperature)
If you are already taking other medicines to treat high blood pressure, Amlodipino Combix may lower your blood pressure even further.
Taking Amlodipino Combix with food and drinks
People taking Amlodipino Combix must 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 Amlodipino Combix.
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 Amlodipino Combix.
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 must inform your doctor before taking Amlodipino Combix.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Amlodipino Combix 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 Combix
Always take this medicine exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.
The usual starting dose is 5 mg of Amlodipino Combix once daily. The dose may be increased to 10 mg of Amlodipino Combix once daily.
You may take this medicine before or after meals. Take it at the same time each day with a glass of water. Do not take Amlodipino Combix with grapefruit juice.
Use in children and adolescents
For children and adolescents (between 6–17 years of age), the recommended starting dose is usually 2.5 mg once daily. The maximum recommended dose is 5 mg once daily.
Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be achieved with Amlodipino Combix 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 Amlodipino Combix than you should
Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.
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 cold and clammy skin and could lose consciousness. If you have taken too many Amlodipino Combix tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take Amlodipino Combix
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 Amlodipino Combix
Your doctor will advise you on 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, Amlodipine Combix may produce adverse effects, although not everyone experiences them.
Go to your doctor immediately if you experience any of the following serious adverse effects, which are very rare after taking this medicine.
- Sudden wheezing (sudden whistling while breathing), chest pain, shortness of breath or difficulty breathing
- Swelling of the eyelids, face or lips
- Swelling of the tongue and throat causing severe difficulty in breathing
- Severe skin reactions including severe rash, hives, redness of the skin all over the body, itching, blistering, peeling and inflammation of the skin, 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 frequent adverse effects have been reported. If any of these cause problems or if they last longer than one week, consult your doctor.
Frequent: affect between 1 and 10 out of every 100 patients
- Headache, dizziness, drowsiness (especially at the beginning of treatment)
- Palpitations (feeling your heartbeat), hot flush
- Abdominal pain, feeling unwell (nausea)
- Swelling of ankles (oedema), 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 mentioned 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
- Decrease in blood pressure
- Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
- Changes in bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (feeling unwell)
- Hair loss, increased sweating, itching of the skin, 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
- Decrease in the number of white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells)
- High blood sugar (hyperglycaemia)
- A nerve disorder which may cause weakness, tingling or numbness
- Cough, swelling 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 stiffness, tremor and/or movement disorders
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Amlodipine Combix
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.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Additional Information
Composition of Amlodipino Combix
The active substance in Amlodipino Combix 10 mg tablets is amlodipine (as besylate).
- The other components are microcrystalline cellulose (E460i), sodium starch glycolate from potato (potato starch), colloidal anhydrous silica (E551), and magnesium stearate (E470b).
Appearance of Amlodipino Combix and contents of the pack
White or almost white, round tablets, marked with "AM10" on one side and smooth on the other.
Amlodipino Combix 10 mg tablets are available in blister packs containing 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Combix, S.L.U.
C/Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain
Manufacturer
Pharmex Advanced Laboratories, S.L.
Ctra. A-431 Km. 19
14720 Almodóvar del Río (Córdoba)
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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/