Amlodipine Normon 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Amlodipine Normon 10 mg Tablets EFG
amlodipine
Read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Amlodipine Normon is and what it is used for
- What you need to know before taking Amlodipine Normon
- How to take Amlodipine Normon
- Possible side effects
- How to store Amlodipine Normon
- Contents of the pack and other information
1. What Amlodipine Normon is and what it is used for
Amlodipine Normon contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
Amlodipine Normon 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 Normon 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 angina-related chest pain.
2. What you need to know before taking Amlodipine Normon
Do not take Amlodipine Normon
- 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 aortic valve in the heart (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.
Warnings and precautions
Talk to your doctor or pharmacist before you start taking Amlodipine Normon.
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 adjustment
Children and adolescents
Amlodipine Normon has not been studied in children under 6 years of age. Amlodipine Normon 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 Amlodipine Normon with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Amlodipine Normon 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 (administered by infusion for serious body temperature abnormalities)
- tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify immune system function)
- simvastatin (a cholesterol-lowering medicine)
- cyclosporine (an immunosuppressant)
If you are already taking other medicines to treat high blood pressure, Amlodipine Normon may lower your blood pressure even further.
Taking Amlodipine Normon with food and drinks
People taking Amlodipine Normon 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 Normon.
Pregnancy and breast-feeding
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 Normon.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to breastfeed, you should inform your doctor before taking Amlodipine Normon.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Amlodipine Normon may affect your ability to drive or use machines. If the tablets make you feel unwell, dizzy, tired, or cause headache, do not drive or operate machinery and consult your doctor immediately.
Amlodipine Normon contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.
3. How to take Amlodipino Normon
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The usual starting dose is 5 mg of Amlodipino Normon once daily. The dose may be increased to 10 mg of Amlodipino Normon 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 Normon 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 once daily.
Currently, amlodipine 2.5 mg is not available, and the 2.5 mg dose cannot be achieved with Amlodipino Normon 5 mg tablets, as these tablets are not manufactured to be divided into equal parts.
It is important not to interrupt treatment with the tablets. Do not wait until you have run out of tablets before seeing your doctor.
If you take more Amlodipino Normon 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 your skin is cold and clammy and you could lose consciousness. If you have taken too many Amlodipino Normon tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop 24–48 hours after ingestion.
If you forget to take Amlodipino Normon
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 Normon
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 stop.
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 may 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 breathing difficulty
- 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 10 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 flush
- 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 (tinnitus)
- Decrease in blood pressure
- Sneezing/nasal discharge caused by 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 people
- Confusion
Very rare: may affect up to 1 in 10,000 people
- Decrease in white blood cell count, 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
- Gum inflammation, bleeding 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
- Sensitivity to light
- Disorders combining rigidity, tremor and/or movement disorders
Frequency not known: cannot be estimated from the 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 effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Normon
Keep this medicine out of the 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.
Do not store above 25°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Normon
The active substance in Amlodipino Normon 10 mg tablets is amlodipine (as besylate).
The other components are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethyl starch from potato (potato starch), and magnesium stearate.
Appearance of the product and pack contents
White or almost white, round, flat, scored tablets marked with "A10" on one side. The packs contain 30 tablets. The tablet can be divided into equal doses.
Amlodipino Normon 10 mg tablets are available in blister packs containing 30 tablets and in unit-dose blisters containing 500 tablets (hospital pack).
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Date of latest revision of this leaflet: May 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information on this medicine by scanning the QR code included in the package leaflet and carton with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68311/P_68311.html