Amlodipine TAD 5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Amlodipine TAD 5 mg tablets EFG
Amlodipine TAD 10 mg tablets EFG
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 others, 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 Amlodipine TAD is and what it is used for
- What you need to know before taking Amlodipine TAD
- How to take Amlodipine TAD
- Possible side effects
- How to store Amlodipine TAD
- Contents of the pack and other information
1. What Amlodipine TAD is and what it is used for
Amlodipine contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
Amlodipine is used to treat high blood pressure (hypertension) in adults, adolescents, and children over 6 years of age, or a certain type of chest pain known as angina in adults, 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 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. What you need to know before taking Amlodipine TAD
Do not take Amlodipine TAD 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.
- you have very low blood pressure (severe hypotension).
- you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
- you have heart failure following a heart attack.
Warnings and precautions
Talk to your doctor or pharmacist before starting amlodipine.
You must 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 TAD
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
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 (medicines for the heart)
- dantrolene (by infusion for serious body temperature abnormalities)
- tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of the immune system)
- simvastatin (a medicine that lowers cholesterol)
- ciclosporin (an immunosuppressant)
If you are already taking other medicines to treat high blood pressure, this medicine may further lower your blood pressure.
Taking Amlodipine TAD with food and drink
People taking amlodipine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to increased blood levels of the active ingredient amlodipine, which may 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant or plan to become pregnant, you should inform your doctor before taking this medicine.
Breastfeeding
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 this medicine.
Driving and using machines
This medicine may affect your ability to drive or use machinery. If the tablets make you feel unwell, dizzy, or tired, or cause you to have headaches, do not drive or operate machinery and consult your doctor immediately.
Amlodipine TAD 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 TAD
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, only for the indication of hypertension. The recommended maximum dose is 5 mg once daily. The 5 mg tablet may be divided into equal halves.
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 TAD 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 your skin cold and clammy and you could lose consciousness. Seek immediate medical attention if you have taken too many tablets of this medicine.
Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 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 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Amlodipine TAD
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 forgotten doses.
If you stop taking Amlodipine TAD
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, 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 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 that may cause severe abdominal pain and back pain accompanied by a marked feeling of malaise.
The following adverse effects have also been reported.
The following very common adverse effect has been reported. If this causes problems or if it 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 if they 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, diarrhea, constipation, indigestion
- Fatigue, 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 mentioned 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
- 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 white blood cell count, decrease in blood platelets which may cause easy bleeding or unusual bruising
- High blood sugar (hyperglycemia)
- A nerve disorder that may cause muscle weakness, tingling or numbness (peripheral neuropathy)
- Inflammation of the gums, 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 (hypertonia)
- Inflammation of blood vessels, often with skin rashes (vasculitis)
- Light sensitivity
Frequency not known: cannot be estimated from the available data
- Tremor, rigid posture, mask-like facial expression, slow movements, and shuffling, unbalanced gait
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 TAD
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.
Store in the original packaging to protect from light.
This medicine does not require any special storage temperature.
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 you are unsure, 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 TAD
- The active substance is amlodipine.
Amlodipine TAD 5 mg tablets EFG
Each tablet contains 5 mg of amlodipine (as amlodipine besilate).
Amlodipine TAD 10 mg tablets EFG
Each tablet contains 10 mg of amlodipine (as amlodipine besilate).
- The other components (excipients) are: microcrystalline cellulose (E460), pregelatinized corn starch, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, and magnesium stearate (E470b).
See section 2 “Amlodipine TAD contains sodium”.
Appearance of Amlodipine TAD and contents of the pack
Amlodipine TAD 5 mg tablets EFG:
The tablets are white, round (8 mm in diameter), slightly biconvex with bevelled edges, scored on one side.
The tablet may be divided into equal doses.
Amlodipine TAD 10 mg tablets EFG:
The tablets are white, round (11 mm in diameter), slightly biconvex with bevelled edges.
The tablets are available in cardboard boxes containing:
- Non-perforated blisters of 28, 30 and 90 tablets
- Perforated unit-dose blisters of 28 x 1, 30 x 1 and 90 x 1 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany
Manufacturers
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany
or
KRKA, d. d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:
KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain
This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Member State | Name of the medicinal product |
Slovenia | Amlodipin Krka d.d. 5 mg tablets Amlodipin Krka d.d. 10 mg tablets |
Spain | Amlodipino TAD 5 mg tablets EFG Amlodipino TAD 10 mg tablets EFG |
Malta | Amlodipine TAD 5 mg tablets Amlodipine TAD 10 mg tablets |
Northern Ireland | Amlodipine Krka 5 mg tablets Amlodipine Krka 10 mg tablets |
Date of the most recent review of this leaflet: March 2023
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.