Amlodipine Cinfa 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
amlodipino cinfa 10 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- 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 only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What amlodipino cinfa is and what it is used for
- What you need to know before taking amlodipino cinfa
- How to take amlodipino cinfa
- Possible side effects
- How to store amlodipino cinfa
- Contents of the pack and other information
1. What amlodipine cinfa is and what it is used for
amlodipine cinfa contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
amlodipine cinfa 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, amlodipine cinfa improves blood flow to the heart muscle, thereby increasing oxygen supply to the heart and preventing chest pain. This medicine does not provide immediate relief of chest pain caused by angina.
2. What you need to know before taking amlodipine cinfa
Do not take amlodipine cinfa
- If you are allergic to amlodipine, or 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 narrowing (aortic stenosis) 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 taking amlodipine cinfa.
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 has not been studied in children under 6 years of age. Amlodipine 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.
Other medicines and amlodipine cinfa
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Amlodipine 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 (administered intravenously for serious body temperature abnormalities)
- tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of the immune system)
- simvastatin (a cholesterol-lowering medicine)
- ciclosporin (an immunosuppressant)
If you are already taking other medicines to treat high blood pressure, amlodipine may lower your blood pressure even further.
Taking amlodipine cinfa with food and drink
People taking amlodipine 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.
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.
Pregnancy
The safety of amlodipine during pregnancy has not been established.
Breastfeeding
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.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Amlodipine may affect your ability to drive or use machinery. If the tablets make you feel unwell, dizzy, or tired, or cause you to have a headache, do not drive or operate machinery and consult your doctor immediately.
amlodipine cinfa contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".
3. How to take amlodipine cinfa
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose is 5 mg of amlodipine once daily. The dose may be increased to 10 mg of amlodipine 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 amlodipine with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6–17 years), the usual recommended starting dose is 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 obtained with amlodipine cinfa 5 mg tablets, as these tablets are not manufactured to be split into equal parts. The tablet score is intended solely for ease of swallowing if you have difficulty swallowing the tablet whole.
It is important not to interrupt treatment with the tablets. Do not wait until you run out of tablets before seeing your doctor.
If you take more amlodipine cinfa 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 when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy and could lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which may develop 24–48 hours after ingestion.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take amlodipine cinfa
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 a missed dose.
If you stop taking amlodipine cinfa
Your doctor will advise you how long to take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately 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 severe 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 10 patients)
- 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 patients)
- 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 patients)
- Mood changes, anxiety, depression, insomnia
- Tremor, taste disturbances, fainting
- Numbness or tingling sensation in the limbs, loss of pain sensation
- Ringing in the ears (tinnitus)
- 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 unwell
- Muscle or joint pain, back pain
- Weight gain or weight loss
Rare (may affect up to 1 in 1,000 patients)
- Confusion
Very rare (may affect up to 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
- 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
Frequency not known (cannot be estimated from available data)
- Tremor, rigid posture, mask-like facial expression, slow movements, and a shuffling, unbalanced gait
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of amlodipine cinfa
Keep this medicine out of sight and reach 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.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of amlodipino cinfa
- The active substance is amlodipine besilate. Each tablet contains amlodipine besilate equivalent to 10 mg of amlodipine.
- The other components are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (type A) (from potato), and magnesium stearate.
Appearance of amlodipino cinfa and contents of the pack
amlodipino cinfa are white, uncoated tablets, scored on one side and engraved with "10" on the other. They are available in PVC/Al blisters in packs containing 30 or 500 tablets (hospital pack).
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer(s)
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
or
Adamed Pharma, S.A.
ul. Marszalka J. Pilsudskiego 5
95-200 Pabianice
Poland
Date of the most recent review of this leaflet: July 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65461/P_65461.html
QR code link: https://cima.aemps.es/cima/dochtml/p/65461/P_65461.html